Digital apparatus and application for improving eyesight

Abstract

To provide systems and methods for improving the eyesight of a subject.SOLUTION: Systems and methods for improving the eyesight of a subject are provided. The system may include a digital apparatus. The digital apparatus may include: a digital instruction generation unit configured to generate a digital treatment module for improving the eyesight on the basis of a treatment hypothesis and a mechanism of action (MOA) for improving the eyesight, generate specified digital instructions on the basis of the digital treatment module, and provide the digital instructions to a first user; and an outcome collection unit configured to collect the first user's execution outcomes of the digital instructions. The system may also include a healthcare provider portal for a healthcare provider to manage their patients and / or a management portal.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] The present disclosure relates to digital therapeutics (hereinafter referred to as DTx) intended for vision treatment, including myopia treatment, to improve vision, including slowing myopia progression. The present disclosure also relates to a system that integrates digital therapeutics with one or both of a healthcare provider portal and an administrative portal to provide vision treatment and treat a patient's myopia. In particular, embodiments of the present disclosure may include establishing a treatment hypothesis and a digital treatment hypothesis for improving vision and slowing the progression of axial myopia in childhood / adolescence, and providing vision treatment to treat axial myopia based on these findings. The present disclosure also relates to clinically validating digital treatment hypotheses for vision treatment and axial myopia in childhood / adolescence, rationally designing an application for realizing the digital treatment hypothesis for the digital treatment, and providing a digital device and application for improving vision and slowing the progression of axial myopia in childhood / adolescence based on this rational design. [Background technology]

[0002] Axial length (AL) is a combination of anterior chamber depth, lens thickness, and vitreous chamber depth, and is the most important contributor to refractive error. Myopia can occur when AL increases beyond the normal rate expected for age. In children, where myopia progresses rapidly, AL increases more rapidly than the normal rate. Myopic patients have a very high prevalence in Korea. According to the results of an analysis of data from 2008 to 2012, the prevalence of myopia (-0.75 diopters or more) among Korean adolescents aged 12 to 18 was 80.4%, which is 4.35 times higher than the prevalence of myopia among 60-year-olds (18.5%) in terms of demographics. The prevalence of high myopia (-6 diopters or more) was 12%, which is eight times higher than the prevalence of myopia among people in their 60s (1.5%), and was also three times higher than the prevalence of myopia among adolescents in the United States and the United Kingdom.

[0003] Even more serious is the fact that a survey has shown that approximately 70% of adolescent myopia patients in Korea are severely or severely myopic. Furthermore, the prevalence of myopia among elementary school students has been increasing, from approximately 23% in 1980 to 38% in 1990 and 46.2% in 2000.

[0004] Although the World Health Organization (WHO) recognizes myopia as a disease, there is no effective treatment for it worldwide. Recently, myopia has begun to receive more academic attention due to a sudden increase in the prevalence of myopia in China, Singapore, South Korea, and other countries. Myopia has also emerged as an eye disease that can cause future vision loss.

[0005] Myopia is divided into two types: axial myopia, which occurs due to the elongation of the eyeball axis, and refractive myopia (i.e., refractive myopia), which occurs due to an increase in the refractive index of the eye's lens or cornea. Axial myopia is further divided into simple myopia, which does not affect the retina or choroid, and degenerative myopia, which causes deformation of the retina and leads to vision loss. With the exception of diabetes-induced nuclear sclerosis and keratoconus, most myopia is simple axial myopia, the progression of which accelerates from elementary school age.

[0006] Known methods for slowing or treating myopia include the use of drugs (atropine) and special lenses (e.g., Dream Lenses). However, atropine induces severe glare along with pupil dilation. Furthermore, Dream Lenses have a high risk of corneal damage, limiting their clinical application compared to corrective glasses.

[0007] Apart from this, various myopia treatment devices, eye movement methods, and eye movement applications have been developed and sold on the market, but most of these lack evidence of clinical efficacy and are sold without additional authorization.However, there is no highly reliable treatment method that can be used to prevent and treat the progression of myopia in children and adolescents diagnosed with myopia at hospitals. Summary of the Invention [Means for solving the problem]

[0008] In some aspects, the present disclosure provides a method for improving a subject's vision, the method comprising providing a digital application to the subject via a digital device, the digital application including one or more digital therapeutic modules for improving vision, each module including one or more first instructions to be followed by the subject, the first instructions including a first eye movement instruction for the subject to vertically move at least one eye. The digital therapeutic modules for improving vision can be generated based on a mechanism of action and a treatment hypothesis. In some embodiments, the digital therapeutic modules for improving vision can be generated based on neurohormonal factors. Each digital therapeutic module is a basic design unit of a digital therapeutic that can be implemented as a digital application or device. Each digital therapeutic module can include one or more instructions provided to the subject to be followed by the subject.

[0009] In some aspects, the present disclosure provides a method for treating myopia in a subject in need thereof, the method comprising providing, by a digital device, to the subject a digital application including modules for treating myopia, each module including one or more first instructions to be followed by the subject, the first instructions including a first eye movement instruction causing the subject to vertically move at least one eye. In some aspects, the disclosure provides a non-transitory computer-readable medium having stored thereon software instructions for improving the subject's vision, the software instructions, when executed by a processor, causing the processor to display, by the digital device, the modules for improving vision to the subject, each module including one or more instructions to be followed by the subject, the first instructions including a first eye movement instruction causing the subject to vertically move at least one eye, and sensing, by a sensor on the digital device, the subject's compliance with the instructions of the modules.

[0010] In some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 50 of the subject's maximum vertical view 100. In some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 70 of the subject's maximum vertical view 100. In some embodiments, the digital application includes more instructions for vertical eye movement compared to instructions for horizontal eye movement. In some embodiments, the first eye movement instruction is to move the at least one eye upward. In some embodiments, the first eye movement instruction includes more instructions to move the at least one eye upward compared to instructions to move the at least one eye downward. In some embodiments, the first instruction excludes instructions to move the at least one eye horizontally. In some embodiments, the method improves the growth rate of axial length (AL) of the at least one eye of the subject. In some embodiments, the method reduces the growth rate of axial length (AL) of the at least one eye of the subject. The method further includes measuring the subject's maximum vertical view. In some embodiments, the measurement is performed by a sensor of the digital device. In some embodiments, the subject is 10 years of age or older. In some embodiments, the module is selected based on a mechanism of action and a treatment hypothesis, and the digital device (i) includes a sensor that senses the subject's compliance with one or more first instructions of the module, (ii) transmits compliance information based on the compliance to a server accessible to a healthcare provider through a healthcare provider portal, and (iii) receives one or more second instructions from the healthcare provider based on the compliance information. In some embodiments, the one or more second instructions include second eye movement instructions for adjusting the rate of eye movement based on the compliance information. In some embodiments, the digital application directs a processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the treatment hypothesis. In some embodiments, generating the digital therapeutic module includes generating a digital therapeutic module based on neurohormonal factors.In some embodiments, the operations further include generating a calibration module for calibrating one or more of the subject's eye position measurement accuracy and the lighting environment. In some embodiments, the calibration module is generated before generating the digital therapeutic module. In some embodiments, the subject's eye position measurement accuracy is calibrated, and the calibration for the subject's eye position measurement accuracy includes one or more of instructing the subject to position their face so that it appears on the screen of the digital device, detecting the subject's eyes for a given period of time, instructing the subject to blink their eyes, detecting whether the subject blinks their eyes, instructing the subject to gaze at the screen, instructing the subject to move their eyes in a given direction or rotate their eyes, and determining a threshold value for detecting the subject's eyes. In some embodiments, the measurement accuracy of the lighting environment is calibrated, and the calibration for the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment. In some embodiments, the digital device includes one or more sensors for tracking the subject's eye movements. In some embodiments, the digital application directs the processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis; generating digital instructions based on the digital therapeutic module; providing the digital instructions to the subject; and collecting the subject's performance results on the digital instructions. In some embodiments, the generation of the digital instructions and the collection of the subject's performance results on the digital instructions are performed multiple times in multiple feedback loops, and the generation of the digital instructions includes generating the subject's digital instructions for the current visit based on the subject's digital instructions from previous visits and collected performance results data on the subject's digital instructions provided from the previous visits.In some embodiments, collecting the subject's performance on the digital instructions includes determining one or both of exertion intensity (EI) and average exertion intensity (AEI). In some embodiments, AEI is determined as the average sum of the differences between the final and starting positions of the subject's eyes measured over a predetermined interval. In some embodiments, the interval is between about 10 ms and about 500 ms. In some embodiments, EI is determined by the following formula:

[0011]

number

[0012] In some embodiments, the virtual parameters are inferred relative to the subject's environment, behavior, emotions, and cognition. In some embodiments, the result collection unit collects results of the execution of the digital instructions by monitoring the subject's compliance with the digital instructions or by allowing the subject to directly input their compliance with the digital instructions. In some embodiments, the generation of digital instructions in the digital instruction generation unit and the collection of results of the subject's execution of the digital instructions in the result collection unit are performed multiple times in multiple feedback loops, and the digital instruction generation unit generates the subject's digital instructions for the current round based on the subject's digital instructions from previous rounds and the execution result data for the subject's digital instructions from the previous rounds collected by the result collection unit.

[0013] In some aspects, the present disclosure provides a system for improving a subject's vision, the system including: a digital device configured to execute a digital application for improving the subject's vision according to the aforementioned method; a healthcare provider portal configured to provide one or more options to a healthcare provider for performing one or more tasks to prescribe a treatment for improving the subject's vision based on information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system for performing one or more tasks to manage healthcare provider access to the system.

[0014] In some aspects, the present disclosure provides a system for treating myopia in a subject in need of myopia treatment, the system including: a digital device configured to execute a digital application for treating myopia in the subject according to the aforementioned method; a healthcare provider portal configured to provide one or more options to a healthcare provider for performing one or more tasks to prescribe a therapy for treating myopia in the subject based on information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system for performing one or more tasks to manage healthcare provider access to the system.

[0015] In some aspects, the present disclosure provides a non-transitory computer-readable medium having stored thereon software instructions for treating myopia in a subject in need of myopia treatment, the software instructions, when executed by a processor, causing the processor to display, via a digital device, modules for treating myopia to the subject, each module including one or more instructions to be followed by the subject, a first instruction including an eye movement instruction for the subject to vertically move at least one eye, and to sense, via a sensor on the digital device, the subject's compliance with the module's instructions.

[0016] In some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 50 of the subject's maximum vertical view 100. In some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 70 of the subject's maximum vertical view 100. In some embodiments, the digital application includes more instructions for vertical eye movement compared to instructions for horizontal eye movement. In some embodiments, the first eye movement instruction is to move the at least one eye upward. In some embodiments, the first eye movement instruction includes more instructions to move the at least one eye upward compared to instructions to move the at least one eye downward. In some embodiments, the first instruction excludes instructions to move the at least one eye horizontally. In some embodiments, the method improves the growth rate of axial length (AL) of the at least one eye of the subject. In some embodiments, the method reduces the growth rate of axial length (AL) of the at least one eye of the subject. The method further includes measuring the subject's maximum vertical view. In some embodiments, the measurement is performed by a sensor of the digital device. In some embodiments, the subject is 10 years of age or older. In some embodiments, the module is selected based on a mechanism of action and a treatment hypothesis, and the digital device (i) includes a sensor that senses the subject's compliance with one or more first instructions of the module, (ii) transmits compliance information based on the compliance to a server accessible to a healthcare provider through a healthcare provider portal, and (iii) receives one or more second instructions from the healthcare provider based on the compliance information. In some embodiments, the one or more second instructions include second eye movement instructions for adjusting the rate of eye movement based on the compliance information. In some embodiments, the digital application directs a processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the treatment hypothesis. In some embodiments, generating the digital therapeutic module includes generating a digital therapeutic module based on neurohormonal factors.In some embodiments, the operations further include generating a calibration module for calibrating one or more of the subject's eye position measurement accuracy and the lighting environment. In some embodiments, the calibration module is generated before generating the digital therapeutic module. In some embodiments, the subject's eye position measurement accuracy is calibrated, and the calibration for the subject's eye position measurement accuracy includes one or more of instructing the subject to position their face so that it appears on the screen of the digital device, detecting the subject's eyes for a given period of time, instructing the subject to blink their eyes, detecting whether the subject blinks their eyes, instructing the subject to gaze at the screen, instructing the subject to move their eyes in a given direction or rotate their eyes, and determining a threshold value for detecting the subject's eyes. In some embodiments, the measurement accuracy of the lighting environment is calibrated, and the calibration for the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment. In some embodiments, the digital device includes one or more sensors for tracking the subject's eye movements. In some embodiments, the digital application directs the processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis; generating digital instructions based on the digital therapeutic module; providing the digital instructions to the subject; and collecting the subject's performance results on the digital instructions. In some embodiments, the generation of the digital instructions and the collection of the subject's performance results on the digital instructions are performed multiple times in multiple feedback loops, and the generation of the digital instructions includes generating the subject's digital instructions for the current visit based on the subject's digital instructions from previous visits and collected performance results data on the subject's digital instructions provided from the previous visits.In some embodiments, collecting the subject's performance on the digital instructions includes determining one or both of exertion intensity (EI) and average exertion intensity (AEI). In some embodiments, AEI is determined as the average sum of the differences between the final and starting positions of the subject's eyes measured over a predetermined interval. In some embodiments, the interval is between about 10 ms and about 500 ms. In some embodiments, EI is determined by the following formula:

number

[0017] The foregoing and other objects, features and advantages of the present disclosure will become more apparent to those of ordinary skill in the art through the detailed description of illustrative embodiments thereof, taken in conjunction with the accompanying drawings. [Figure 1a] FIG. 1 illustrates the mechanism of action of childhood / adolescent axial myopia proposed in the present disclosure. [Figure 1b] FIG. 1 illustrates the treatment hypothesis for axial myopia proposed in this disclosure. [Figure 1c] FIG. 1 illustrates the digital treatment hypothesis for axial myopia proposed in this disclosure. [Figure 2] FIG. 1 is a block diagram illustrating the configuration of a digital device for treating myopia according to one embodiment of the present disclosure. [Figure 3] FIG. 1 illustrates the input and output loops of a digital application for treating myopia according to one embodiment of the present disclosure. [Figure 4] FIG. 1 illustrates a feedback loop for a digital device and application for treating myopia according to one embodiment of the present disclosure. [Figure 5a] FIG. 1 illustrates a modular design for implementing digital therapeutics in a digital device and application for treating myopia according to one embodiment of the present disclosure. [Figure 5b] FIG. 1 illustrates background factors supporting a digital device and application for treating myopia according to an embodiment of the present disclosure. [Figure 6] FIG. 1 illustrates a method for assigning a patient-tailored digital prescription utilizing a digital device and application for treating myopia according to one embodiment of the present disclosure. [Figure 7a] FIG. 1 illustrates an execution environment configuration according to one embodiment of the present disclosure. [Figures 7b-7g] FIG. 10 illustrates an example of a method for collecting specific instructions and output data for each module according to one embodiment of the present disclosure. [Figure 8] 1 is a flowchart illustrating operations in a digital application for treating myopia according to one embodiment of the present disclosure. [Figure 9] 1 is a flowchart illustrating a method for generating digital instructions in a digital application for treating myopia according to one embodiment of the present disclosure. [Figure 10]1 is a flowchart illustrating a method for repeatedly performing operations responsive to feedback control in a digital application for treating myopia according to one embodiment of the present disclosure. [Figure 11] FIG. 1 illustrates a hardware configuration of a digital device for treating myopia according to one embodiment of the present disclosure. [Figure 12] 1 is a flowchart illustrating a system for treating myopia, the system including an administrative portal (e.g., administrator web), a healthcare provider portal (e.g., physician web), and a digital device configured to run a digital application (e.g., application or "app") for treating myopia in a subject. [Figure 13] 1 is a flowchart illustrating an example execution flow for a digital application of the present disclosure. [Figure 14] 1 is a flowchart illustrating the execution flow for a splash process at the start of a digital application of the present disclosure. [Figure 15] 10 is a flowchart illustrating an execution flow for login verification during a splash process at the start of a digital application of the present disclosure. [Figure 16] 10 is a flowchart illustrating the execution flow for prescription verification during the splash process at the start of a digital application of the present disclosure. [Figure 17] 10 is a flowchart illustrating the flow of execution for home entry during prescription verification in the digital application of the present disclosure. [Figure 18] 1 is a flowchart illustrating an example execution flow for a session in a digital application of the present disclosure. [Figure 19] 10 is a flowchart illustrating an example execution flow for a calibration module in a digital application of the present disclosure. [Figure 20]1 is a flowchart illustrating the flow of execution for a session in a digital application of the present disclosure, the session including two or more digital therapeutic modules. [Figure 21] 1 illustrates a splash screen for a digital application of the present disclosure, the splash screen including a company logo, a loading icon, and / or information about the version of the digital application. [Figure 22] 1 illustrates a TrueDepth camera notification screen of the digital application of the present disclosure. [Figure 23] 1 illustrates a home screen of the digital application of the present disclosure, the home screen displaying the availability of sessions for a subject to complete. [Figure 24] 1 illustrates a bright environment notification screen of the light therapy module of the digital application of the present disclosure, which indicates the amount of light detected by the digital device. [Figure 25] 1 illustrates a calibration notification screen of the digital application of the present disclosure, which indicates whether the subject's eyes and / or eye movements are detectable by the camera. [Figure 26a] 1 illustrates a screenshot of the eye movement digital therapy module of the present disclosure. [Figure 26b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 27a] 1 illustrates a screenshot of a rest period with a relaxation digital therapy module of the present disclosure. [Figure 27b] 10 illustrates a flowchart illustrating the execution flow for a rest period with a relaxation digital therapy module. [Figure 28a] 1 illustrates a screenshot of the eye movement digital therapy module of the present disclosure. [Figure 28b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 29a]10 illustrates a screenshot of a rest period with relaxation using the sound digital therapy module of the present disclosure. [Figure 29b] 10 illustrates a flow chart illustrating an implementation flow for a rest period with relaxation using a sound digital therapy module. [Figure 30a] 1 illustrates a screenshot of the eye movement digital therapy module of the present disclosure. [Figure 30b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 31a] 1 illustrates a screenshot of the deep breathing digital therapy module of the present disclosure. [Figure 31b] 1 illustrates a flowchart illustrating the execution flow for a deep breathing digital therapy module. [Figure 32a] 1 illustrates a screenshot of the eye movement digital therapy module of the present disclosure. [Figure 32b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 33a] 1 illustrates a screenshot of the deep breathing digital therapy module of the present disclosure. [Figure 33b] 1 illustrates screenshots of the deep breathing digital therapy module when instructing the subject to inhale (left side) and exhale (right side). [Figure 33c] 1 illustrates a flowchart illustrating the execution flow for a deep breathing digital therapy module. [Figure 34a] 1 illustrates a screenshot of the eye movement digital therapy module of the present disclosure. [Figure 34b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 35a] 1 illustrates a screenshot of a rest period with a relaxation digital therapy module of the present disclosure. [Figure 35b] 10 illustrates a flowchart illustrating the execution flow for a rest period with a relaxation digital therapy module. [Figure 36] 10 illustrates screenshots of the digital application of the present disclosure upon completion of a single session, upon completion of all sessions for a day, and upon pause / start verification. [Figure 37a] 1 illustrates a screenshot of a room decoration board in the achievement module of the digital application of the present disclosure. [Figure 37b] A timeline showing the dates by which subjects can acquire a given room decoration item is illustrated. [Figure 38] 1 illustrates a screenshot of the parent section of the digital application of the present disclosure. [Figure 39] 10 illustrates a screenshot of the change password section in the digital application of the present disclosure. [Figure 40] 1 is a table showing push messages, the time a given push message is forwarded to a subject, and the results when a given push message is opened. [Figure 41] 1 illustrates layouts for an example healthcare provider portal and / or administrative portal of the present disclosure. A full screen may be used, such as a login screen, and may not have a header or sidebar menu. A basic screen may be used for almost all screens after login, such as the dashboard, patient list, etc. A modal popup may be used in situations where a user click is required to check before deleting a patient from the patient list. A toast popup may be used to provide appropriate notifications to the user and may use different colors for each status, such as success or failure, for the user to easily check. [Figure 42] 1 illustrates a layout for a healthcare provider portal and / or administrative portal of the present disclosure. [Figure 43] 1 illustrates a layout for a healthcare provider portal and / or administrative portal of the present disclosure. [Figure 44]10 is a flowchart illustrating an example execution flow for a healthcare provider portal in the system of the present disclosure. [Figure 45a] Illustrates the provider portal dashboard. [Figure 45b] 1 illustrates a Patients tab within a healthcare provider portal, which displays a list of patients. [Figure 45c] 1 illustrates a patient tab within a provider portal, which displays detailed information about a given patient. [Figure 45d] 1 illustrates the patient tab in the provider portal for adding a new patient. [Figure 45e] 1 illustrates the patient tab in the provider portal for editing information for an existing patient. [Figure 45f] 1 illustrates a patient tab within a healthcare provider portal that displays detailed prescription information for a given patient. [Figure 45g-45h] 1 illustrates a patient tab within a provider portal for editing prescription information for a given patient. [Figure 45i] 1 illustrates a patient tab in a provider portal for viewing details (e.g., date, condition, duration, outcome) of a given session for a given patient. [Figure 46] 10 is a flowchart illustrating an example execution flow for an administration portal in the system of the present disclosure. [Figure 47a] Illustrates the admin portal dashboard. [Figure 47b] 1 illustrates the Physicians tab in the Administration Portal, which displays a list of physicians. [Figure 47c] Physicians Tab in the Administration Portal - The Physicians tab displays a list of patients managed by a given physician and illustrates patients - whose identifying information may be modified (*). [Figure 47d] 1 illustrates the physician tab in the administration portal for adding a new physician. [Figure 47e] 1 illustrates the physician tab in the administration portal for editing information for an existing physician. [Figure 47f] 1 illustrates a patient tab in the administration portal that displays information for one or more patients, where sensitive information may be modified. [Figure 47g] 1 illustrates a patient tab within the administration portal that displays detailed patient or prescription information for a given patient. [Figure 47h] 1 illustrates a patient tab within the administration portal that displays detailed prescription information for a given patient. [Figure 47i] 1 illustrates the Patients tab in the Administration Portal for viewing details (e.g., date, condition, duration, outcome) of a given session for a given patient. [Figure 48] 1 is a table illustrating privileges for physicians using the provider portal and administrators using the administrative portal. [Figure 49] 1 illustrates a graph showing the AL (axial length) change for a group of subjects, including experimental and control groups, between visits (V1, V4, and V5) and its correlation with age. [Figure 50] Graphs showing the AL (axial length) change rate and correlation values ​​of the experimental groups between V1 and V5 with age are shown. [Figure 51] The AL (axial length) growth rate (mm / year) for the ALOS (Oculus Sinister, left eye) of the subject group is shown. [Figure 52] Graph showing AL (axial length) growth rate (mm / year) relative to ALOD (Oculus Dexter, right eye) for the subject group. [Figure 53] Normalized AL (axial length) growth rate relative to ALOS for the subject group is shown. [Figure 54] Normalized AL (axial length) growth rate versus ALOD for the subject group is shown. [Figure 55] 1 illustrates the effect of age on AL (axial length) growth rate of OS and OD in the experimental groups. [Figure 56]Graphs show the correlation between AL (axial length) of the first prescription (e.g., V4-V1) and AL (axial length) of the second prescription (e.g., V5-V4) in the control and experimental groups, respectively. [Figure 57] 1 illustrates the correlation between subjects' compliance with eye movement instructions and the rate of growth in the cycloplegic refraction test (CR). [Figure 58] This figure illustrates the correlation between the velocity of the subject's left eye movement in response to eye movement instructions and the growth rate of AL (axial length). [Figure 59] This figure illustrates the correlation between the velocity of the subject's right eye movement in response to eye movement instructions and the growth rate of AL (axial length). [Figure 60] The correlation between the growth rate of AL and the average distance of eye movements performed by subjects in each game is shown. [Figure 61] The correlation between the growth rate of AL and the average maximum distance of eye movements performed by subjects in each game is shown. [Figure 62] The correlation between the growth rate of CR and the average maximum distance of eye movements performed by subjects in each game is shown. [Figure 63] Illustrates the correlation between CR growth rate and normalized game counts, which illustrate the number of moves per game or participation day to play the corresponding game. [Figure 64] Illustrates the correlation between AL growth rate and eye movement velocity. [Figure 65] 10 illustrates a graph showing the correlation between the average or maximum distance of eye movements that a subject performs a first eye movement instruction and growth rate. [Figure 66] Graphs are shown illustrating total counts, average distance, average distance and maximum distance for up / down motion, up / down motion and down / up motion respectively. [Figure 67] The correlation between CROD growth rate and mean distance, mean distance and maximum distance for upward and downward movements, respectively, is plotted. [Figure 68-71] The correlation between AL (axial length) growth rate and mean and maximum distances for superior and inferior movements, respectively, is shown. [Figure 72a] 1 illustrates an example of a session offered in a digital application of the present disclosure. [Figure 72b] Illustrates one or more digital therapeutic modules within a session. [Figure 73] 1 shows a flowchart illustrating an execution flow for a session of a digital application of the present disclosure. [Figure 74] 1 shows a flowchart illustrating an execution flow for a session of a digital application of the present disclosure. [Figure 75-76] 1 illustrates an example of a user interface provided by a digital application of the present disclosure. [Figure 77-78] 1 illustrates an example of a user interface for eye movement instructions displayed on a digital device. [Figure 79] 79 is a flowchart illustrating an example of the flow of execution in response to the eye movement instructions of FIGS. 77 and 78. [Figure 80] 1 illustrates an example of a user interface for eye movement instructions displayed on a digital device. [Figure 81] 81 is a flowchart illustrating an example of the flow of execution in response to the eye movement instruction of FIG. 80. [Figure 82] 1 illustrates an example of a user interface for eye movement instructions displayed on a digital device. [Figure 83] 83 is a flowchart illustrating an example of the flow of execution in response to the eye movement instruction of FIG. 82. [Fig. 84-85] 1 illustrates an example of a user interface for eye movement instructions displayed on a digital device. [Figure 86] 86 is a flowchart illustrating the flow of execution in response to the eye movement instructions of FIGS. 84 and 85. [Figure 87]1 illustrates an example of a user interface for eye movement instructions displayed on a digital device. [Figure 88] 88 is a flowchart illustrating an example of the flow of execution in response to the eye movement instruction of FIG. 87. [Figure 89a] 77 and 78 illustrate screenshots of the eye movement digital therapy module of the present disclosure. [Figure 89b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 90a] 77 and 78 illustrate screenshots of the eye movement digital therapy module of the present disclosure. [Figure 90b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 91a] 77 and 78 illustrate screenshots of the eye movement digital therapy module of the present disclosure. [Figure 91b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 92a] 77 and 78 illustrate screenshots of the eye movement digital therapy module of the present disclosure. [Figure 92b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 93a] 84 and 85 of the present disclosure. [Figure 93b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 94a] 84 and 85 of the present disclosure. [Figure 94b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 95a]84 and 85 of the present disclosure. [Figure 95b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 96a] 84 and 85 of the present disclosure. [Figure 96b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 97a] 83 illustrates a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure. [Figure 97b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 98a] 83 illustrates a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure. [Figure 98b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 99a] 83 illustrates a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure. [Figure 99b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 100a] 83 illustrates a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure. [Figure 100b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 101a] 88 illustrates a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure. [Figure 101b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 102a] 88 illustrates a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure. [Figure 102b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 103a] 88 illustrates a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure. [Figure 103b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 104a] 88 illustrates a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure. [Figure 104b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 105a] 81 illustrates a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure. [Figure 105b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 106a] 81 illustrates a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure. [Figure 106b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 107a] 81 illustrates a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure. [Figure 107b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figure 108a] 81 illustrates a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure. [Figure 108b] 10 illustrates a flowchart illustrating the execution flow for the eye movement digital therapy module. [Figures 109-112] 10 is a flowchart illustrating the execution flow for the relaxation module. [Figure 113] 10 is a flow chart illustrating the flow of execution for a deep breathing module. [Figures 114a-114c]10 illustrates screenshots of a series of behavioral instructions for the relaxation module. [Figure 115a-115b] 10 illustrates screenshots of a series of instruction actions for the deep breathing module. [Figure 116a] 1 illustrates a flowchart showing the execution flow for the eye movement customization process. [Figure 116b] 1 illustrates a flowchart showing six execution steps of the eye movement customization process. [Figure 116c] 1 illustrates a flowchart showing the execution flow for each execution step of the eye movement customization process. [Figure 117a-117b] 1 illustrates an example of a user interface for the eye movement customization process provided by the digital application of the present disclosure. [Figure 118] 10 is a flowchart illustrating an example execution flow for the eye movement customization process when at least one eye movement is not recognized. [Figure 119a-119b] 1 illustrates an example of a user interface for the eye movement customization process provided by the digital application of the present disclosure. [Figures 120a-120e] These are screen images for various types of games that instruct subjects to perform different eye movements. [Figure 121a] 10 is a photograph showing an example of the eye movement state of a subject playing a game that induces vertical or horizontal eye movement. [Figure 121b-121c] This is a graph measuring the average and maximum distance of effective eye movements of subjects guided by the game illustrated in Figure 120. [Figures 122-125]Graphs showing the results of a clinical trial to confirm the association between motor performance patterns and myopia progression in a subject or group of subjects treated with a digital therapeutic in accordance with the present disclosure. While the foregoing figures present presently disclosed embodiments, as already mentioned, other embodiments are also contemplated. The present disclosure presents exemplary embodiments by way of representation, not limitation. Numerous other modifications and embodiments that fall within the scope and spirit of the principles of the presently disclosed embodiments may be devised by those of ordinary skill in the art. DETAILED DESCRIPTION OF THE INVENTION

[0018]

[0033] Exemplary embodiments of the present disclosure will be described in detail below. However, the present disclosure is not limited to the embodiments disclosed below and can be embodied in various forms. The following embodiments are described to enable those skilled in the art to realize and implement the embodiments of the present disclosure.

[0019] definition Although terms such as first, second, etc. may be used to describe various elements, these elements are not limited by such terms. Such terms are used merely to distinguish one element from another. For example, a first element could be termed a second element, and similarly, a second element could be termed the first element, without departing from the scope of example embodiments. The term "and / or" includes any and all combinations of one or more of the associated listed items.

[0020] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit example embodiments. The singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. It can be further understood that the terms "comprises," "comprising," "includes," and / or "including," when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or groups thereof, but do not exclude the presence or addition of one or more different features, integers, steps, operations, elements, components, and / or groups thereof.

[0021] As used herein, the term "about" generally refers to a particular numerical value within an acceptable error range as determined by one of ordinary skill in the art, which will depend in part on the manner in which the numerical value is measured or determined, i.e., the limitations of the measurement system. For example, "about" can mean a range of ±20%, ±10%, or ±5% of the given numerical value.

[0022] overview Exemplary embodiments of the present disclosure are described in detail below with reference to the accompanying drawings. To facilitate understanding of the present disclosure, like numbers refer to like elements throughout the description of the drawings and descriptions of the same elements will not be repeated.

[0023] In the prior art, new drug development begins with identifying a medical need, proposing a mechanism of action based on expert review and meta-analysis of the corresponding disease, and inferring a therapeutic hypothesis. Based on the therapeutic hypothesis, a library of drugs with predicted therapeutic effects is prepared. Then, candidate substances are identified through screening. These candidate substances are then optimized and subjected to preclinical testing to confirm their efficacy and safety from the preclinical stage. A CMC (chemistry, manufacturing, and control) process is established to mass-produce the candidate drugs. Clinical trials are then conducted to verify the candidate drug's mechanism of action and therapeutic hypothesis, ensuring its clinical efficacy and safety.

[0024] From the perspective of this patent, drug targeting and signaling, which are upstream in new drug development, are subject to various uncertainties. In many cases, drug targeting and signaling require synthesis of results reported in related technical fields and methodologies for interpreting the results, making it difficult to guarantee the novelty of the disclosure. Conversely, the disclosure of a drug that can modulate drug targeting and signaling to treat a disease requires the highest level of ingenuity, with the exception of some antibody or nucleic acid (DNA, RNA) therapeutic fields, despite the development of numerous research methodologies for new drug research and development. As a result, the molecular structure of the drug is the most important factor in constituting the strongest substance patent in the new drug field.

[0025] Unlike drugs, whose rights are strongly protected by substance patents, digital therapeutics are essentially realized using software. Due to the characteristics of digital therapeutics, the rational design of digital therapeutics for corresponding diseases and the software realization of digital therapeutics based on that rational design can be considered a highly original disclosure process that is protected by patents, taking into account the clinical validation and approval process as a treatment.

[0026] That is, the core of the digital therapy as disclosed herein is the rational design of a digital therapy suitable for treating the corresponding disease and the development of specific software that can clinically verify the digital therapy based on the rational design. Below, a digital device and application for treating myopia according to the present disclosure, which are realized in this manner, will be described in detail.

[0027] In certain aspects, the present disclosure provides a system for treating myopia. In some embodiments, the system includes a digital device configured to execute a digital application for treating myopia in a subject. In some embodiments, the system includes a healthcare provider portal configured to provide one or more options to a healthcare provider for performing one or more tasks to prescribe a treatment for myopia in the subject based on information received from the digital application. In some embodiments, the system includes an administration portal configured to provide one or more options to an administrator of the system for performing one or more tasks for managing healthcare provider access to the system. FIG. 12 illustrates a flowchart illustrating a system for treating myopia, the system including an administration portal (e.g., an administrator web), a healthcare provider portal (e.g., a physician web), and a digital device configured to execute a digital application (e.g., an application or "app") for treating myopia in a subject. However, the administrator portal allows the administrator to issue physician accounts, review physician information, and review de-identified patient information. The healthcare provider portal may allow a healthcare provider (e.g., a physician) to issue a patient account and review patient information (e.g., age, prescription information, and status of completing one or more digital therapeutic modules or sessions), although the digital application may allow specifically authorized access to complete one or more digital therapeutic modules or sessions.

[0028] The provider portal can be accessed through a client device (e.g., a personal device) such as a laptop, smartphone, tablet, or other computing device. The administrator's portal can be configured to provide services (e.g., front-end and / or back-end services) related to the digital applications and the provider portal and can communicate with one or more databases for storing information related to the digital applications and the provider portal, such as patient profile information and / or patient behavior information obtained through one or more sensors of the digital device.

[0029] In some implementations, the system for treating myopia is implemented by a network that transmits encrypted information to digital application terminals, a healthcare provider portal, and an administrator portal.

[0030] The software configuration of the myopia treatment system according to some implementations of the present invention can be realized as an integrated application that connects digital applications, a healthcare provider portal, and an administrative portal via a network. This integrated application provides compatibility for input / output with various external sensors from a system perspective, the required environment for operation of various computer or mobile interfaces for patients and physicians, and a security solution for legal management of related information.

[0031] FIG. 13 illustrates a flowchart illustrating the execution flow for a digital application. Upon launching a digital application, a splash screen is displayed, followed by a request for login information as well as verification of prescription information for the subject. FIG. 14 illustrates a flowchart illustrating the execution flow for a splash process at the start of a digital application. The splash process may include detecting whether the digital device includes a TrueDepth camera, detecting whether the digital application has access to a camera, detecting whether the digital application has network connectivity, detecting whether the digital application has been updated to the latest version, login verification, and prescription verification. FIG. 15 illustrates a flowchart illustrating the execution flow for login verification during the splash process at the start of a digital application. Similarly, FIG. 16 illustrates a flowchart illustrating the execution flow for prescription verification during the splash process at the start of a digital application. The prescription verification process may include, for example, determining whether a treatment period has expired, determining whether the subject has recently been exposed to bright light (e.g., within the last hour), and determining whether the subject's sessions for the day based on the prescription have been completed (e.g., the subject is compliant with the prescription). In such cases, the digital device may notify the subject that there are no available sessions to complete or may expose the subject to a light therapy module before starting any digital therapy modules. FIG. 21 illustrates a splash screen for a digital application of the present disclosure, which may include a logo (denoted by 1), a loading icon (denoted by 2), and / or information about the digital application version (denoted by 3). The splash entry process may check for network, version, login verification, etc. based on the execution flow. If there is data that has not been transferred due to an app crash, network error, etc., the data is verified and transferred during splash entry.During the splash entry process, if the process takes too long, a loading icon is presented. In certain embodiments, appropriate pop-ups are presented for different situations in the application execution flow. The splash entry process can also include camera detection. FIG. 22 illustrates a TrueDepth camera notification screen for a digital application of the present disclosure. On devices that do not support a TrueDepth camera, eye movements cannot be performed, thus preventing additional application execution from being displayed on the screen. The camera (also referred to as a sensor, depth sensor, or range sensor) can generate depth data indicating distance to surrounding points. In some embodiments, the digital device includes (i) a camera facing the user (e.g., to acquire facial data about the user's face, such as eye position, hand data about the user's hands, or other data about other parts of the user's body) and / or (ii) a camera facing the user's environment (e.g., to acquire positional data about the user's physical environment, such as the position of lights). In certain embodiments, the camera includes a three-dimensional camera system, such as the TrueDepth® camera system manufactured by Apple, Inc., of Cupertino, California, USA. In other embodiments, the camera includes a time-of-flight (ToF) camera that measures the time of flight of a light signal between the ToF camera and a target in the environment (e.g., a subject's eye). In yet other embodiments, the camera includes a structured light 3D scanner (e.g., an infrared emitter and an infrared camera) to implement structured light techniques that project a known pattern (e.g., structured light) onto a surface and capture an image. Those of ordinary skill in the art will appreciate that the camera can implement other techniques, such as sheet optical triangulation, stereo triangulation, interferometry, etc.As non-limiting examples, the camera may implement technology and / or components used by Intel® RealSense® camera, Microsoft® Hololens®, Apple® TrueDepth® camera, Google® Tango® system, Microsoft® Kinect® system, etc. In some embodiments, the camera is configured to capture images. In some embodiments, the camera is configured to generate depth data such as range images, depth maps, etc. The depth data may indicate one or more distances (e.g., the distance the eye moves over a given time interval) to one or more points respectively represented in the depth data. In some examples, the depth data may be used to identify distances to points in an environment, identify objects or surfaces in the environment, determine the distance an object moves over a given interval, and / or position or maintain a representation of a user or other content relative to an object or surface as the digital device moves within the environment (e.g., in an AR or VR implementation).

[0032] A Mailto link (denoted by 1) can be included to help the subject forward the email to the support team. Camera access can be allowed / disallowed (e.g., turned on / off) by the user whenever the user wishes. The camera access status is checked each time the app is run, and if access is not allowed (off), a screen indicating camera access is denied is displayed, preventing further runs of the application. A button (denoted by 2) can also be displayed to assist the subject when jumping to the settings panel of the digital device to adjust settings (e.g., to allow camera access).

[0033] As previously mentioned, session availability can be determined during the prescription verification process. FIG. 23 illustrates the home screen of the digital application of the present disclosure. The home screen displays the availability of sessions for the subject to complete. As illustrated in FIG. 23, (1) is the patient name—no tapping required; (2) is the parental mode entry button; (3) is the room that is decorated as the treatment progresses (decorations are automatically added or upgraded as sessions are completed, and the decorations can display simple movements); (4) is a character that appears in the middle of the room, does not change between treatments, and jumps when tapped; (5) is the play button; (6) is a notification that a given day's sessions have been completed; and (7) is a notification of the end of the treatment program.

[0034] 37a and 37b illustrate (a) a screenshot of a room decoration board in the achievement module of the digital application of the present disclosure, and (b) a timeline showing the dates on which a subject can acquire a given room decoration item. As shown, (1) is a character, (2) is the room decoration board—numbers are presented like a calendar, and the board maps numbers or room decoration items to each date—the user cannot acquire an item on a certain day (3-2) with only numbers, and vice versa on a day with a decoration item (3-1), and (4) shows a close-up of item 3-1 (the received room decoration item) (e.g., a close-up of the acquired room decoration item).

[0035] In some embodiments, the digital application for treating myopia directs a processor of the digital device to perform operations including generating a digital therapeutic module for treating myopia based on a mechanism of action and a treatment hypothesis for myopia, hi some embodiments, the digital therapeutic module includes generating the digital therapeutic module based on neurohormonal factors associated with myopia onset.

[0036] In some embodiments, the operations further include generating a calibration module to calibrate one or more of the subject's eye position measurement accuracy and the lighting environment. In some embodiments, the calibration module can be generated before generating the digital therapeutic module. In some embodiments, the calibration module may not be performed, and calibration settings from a previous session are used. Calibration can be performed any time before, during, or after a session including two or more digital therapeutic modules. For example, calibration can precede the session. In another example, if results from the digital therapeutic module show high variability, the digital application can interrupt the session and initiate calibration to verify that the digital therapeutic module results are factual and not the result of poor calibration. FIG. 19 illustrates a flowchart illustrating the execution flow for a calibration module in the digital application. Calibration can be performed at the beginning of a daily session for eye measurement accuracy. Calibration can take 35 to 60 seconds, depending on the execution result. As illustrated in FIG. 19, the calibration module can include a series of instructions for the subject from the digital application, such as orienting the subject's face in a particular direction or blinking the subject's eyes (e.g., for better detection of the subject's eyes). FIG. 25 illustrates a calibration notification screen of the digital application, which indicates whether the subject's eyes and / or eye movements can be detected by the camera.As shown in FIG. 25, (1) is a Ready button, (2) is a display of the front camera view on the screen, (3) is a character that is displayed only when the digital application recognizes the user's eyes (the character can be a 2D character with large eyes that mimic the movement of the user's eyeballs and can be shown in a semi-transparent manner so that the user's face is visible), and (4) is a notification that provides guidelines for the user's parents.

[0037] A session can include any number of digital therapy modules. In some embodiments, a session can include two or more digital therapy modules. In some embodiments, a session can include three or more, four or more, six or more, seven or more, eight or more, nine or more, ten or more, eleven or more, twelve or more, thirteen or more, fourteen or more, fifteen or more, twenty or more, or twenty-five or more digital therapy modules. A session can include any number of digital therapy modules, where the digital therapy modules can be independently selected from an eye movement module, a relaxation module, a deep breathing module, and a light therapy module. FIG. 20 illustrates a flowchart illustrating the execution flow for a session of a digital application, where the session includes ten digital therapy modules. In some embodiments, a session can be comprised of ten digital therapy modules, where the digital therapy modules include an eye movement module, three relaxation modules, and two deep breathing modules. One of ordinary skill in the art will appreciate that there are numerous combinations for the number and type of digital therapy modules that can be included in a particular session. 26a-35b illustrate various types of digital therapy modules (eg, eye movement, relaxation, and deep breathing).

[0038] In some embodiments, the measurement accuracy of the subject's eye position can be calibrated, and the calibration includes determining a threshold value for detecting the subject's eyes. In further embodiments, the calibration for the measurement accuracy of the subject's eye position includes one or more of instructing the subject to position their face as shown on the screen of the digital device, detecting the subject's eyes for a given period of time, instructing the subject to blink their eyes, detecting whether the subject blinks their eyes, instructing the subject to gaze at the screen, instructing the subject to move their eyes in a given direction or rotate their eyes, and determining a threshold value for detecting the subject's eyes. In some embodiments, the digital device includes one or more sensors for tracking the subject's eye movement. The threshold value for detecting the subject's eyes can be determined in various ways. For example, eye movement from left to right can be scaled to 100 for a maximum horizontal view. Eye movement from top to bottom can also be scaled to 100 for a maximum vertical view. The eye movement for an average person is approximately 70 on a scale of 100. For children and patients with myopia, the eye movement is less than 70. In one example, the critical value can be 70% of 70 (e.g., about 49). In other examples, the critical value can be 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99% of a predetermined value based on a scale of 100. The predetermined value can be 70. In other embodiments, the critical value can be about 40, about 45, about 50, about 55, about 60, about 65, about 70, about 75, about 80, about 85, or about 90.In other embodiments, the critical value can be 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99 based on a scale of 100.

[0039] In one embodiment, a digital therapeutic module is generated based on the threshold. For example, an eye movement module is generated based on the threshold. The eye movement can include moving an object within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's threshold boundary on a scale of 100 to increase the subject's threshold. The eye movement can include moving an object within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's threshold boundary after a sensor detects an eye gaze within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the threshold boundary.

[0040] In some embodiments, the measurement accuracy of the lighting environment can be calibrated, where the calibration for the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and prompting the subject to turn on one or more lights in their environment. FIG. 24 illustrates a bright environment request notification screen of the light therapy module of the digital application of the present disclosure, showing the amount of light detected by the digital device. Bright light exposure is important while performing eye movements. The room starts out very dirty and becomes cleaner as the digital device recognizes the light. The digital application exposes the patient to bright light at least three times a day. After running the app, the camera sensor recognizes bright light and turns on any lights that are off. As shown in FIG. 24, (1) a light bulb helps guide the user to expose themselves to bright light three times a day. All lights are turned off when the digital application is first run (1-1), and light bulbs are turned on after sufficient light is perceived (1-2), (2) guidance elements help guide the user to expose to bright light (e.g., dark background, spiders, spider webs, dust, etc.), and (3) skips the bottom of the home element (e.g., the play button and completion notification are omitted from this page).

[0041] In some embodiments, the digital application for treating myopia instructs a processor of the digital device to perform operations. In some embodiments, the performed operations include generating a digital therapeutic module for treating myopia based on a mechanism of action and a treatment hypothesis for myopia. In some embodiments, the performed operations include generating digital instructions based on the digital therapeutic module. In some embodiments, the performed operations include providing the digital instructions to the subject. In some embodiments, the performed operations include collecting results of the subject's implementation of the digital instructions. In some embodiments, the generation of the digital instructions and the collection of results of the subject's implementation of the digital instructions are performed multiple times with multiple feedback loops. In some embodiments, generating digital instructions includes generating digital instructions for the subject for a current visit based on the subject's digital instructions from a previous visit and collected implementation results data for the subject's digital instructions provided from the previous visit.

[0042] In some embodiments, the interval at which eye position is measured is about 10 ms, 25 ms, 50 ms, 60 ms, 70 ms, 80 ms, 90 ms, 100 ms, 110 ms, 120 ms, 130 ms, 140 ms, 150 ms, 175 ms, 200 ms, 250 ms, 300 ms, 350 ms, 400 ms, or a range between any two of these values. In some embodiments, the interval at which eye position is measured is about 10 ms to about 500 ms, about 50 ms to about 250 ms, about 75 ms to about 150 ms, or about 90 ms to about 110 ms.

[0043] In some embodiments, generating a digital therapeutic module includes applying hypothetical parameters for the subject's environment, behavior, emotions, and cognition to mechanisms of action and treatment hypotheses for myopia to generate the digital therapeutic module.

[0044] In some embodiments, the digital application for treating myopia directs a processor of the digital device to generate a digital treatment module including two or more modules selected from the group consisting of an eye movement module, a relaxation module, and a phototherapy module.

[0045] In some embodiments, the eye movement module includes one or more movement instructions for one or more of eye movement instructions, bio-feedback control instructions, and eye-related behavior control instructions.

[0046] In some embodiments, the relaxation module includes one or more relaxation instructions for one or more of physical exercise instructions, self-enhancement instructions, feeling of safety instructions, feeling of calm instructions, and enjoyment instructions. In some embodiments, the light therapy module includes one or more light therapy instructions for controlling the subject's lighting environment. In some embodiments, the one or more relaxation instructions include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

[0047] In some embodiments, the digital therapeutic module further includes an achievement module that includes one or more achievement instructions for task achievement and for providing compensation for the subject's compliance with the instructions of the two or more first modules. In some embodiments, the digital therapeutic module further includes a fun module that includes one or more fun instructions for music, games, or videos.

[0048] In some embodiments, the healthcare provider portal provides one or more options to the healthcare provider, the one or more options provided to the healthcare provider selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing a subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing a prescription for one or more digital therapeutic modules, and communicating with the subject. In some embodiments, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, a prescription for the subject, and one or more notes created by the healthcare provider for the subject. In some embodiments, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, the number of digital therapeutic modules scheduled or prescribed to be performed by the subject, and the number of digital therapeutic modules scheduled or prescribed to be performed by the subject per day. In some embodiments, the one or more options include viewing compliance information, where the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.In some embodiments, the one or more options include viewing the subject's results, wherein the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of: the time the subject started the scheduled or prescribed digital therapy module; the time the subject finished the scheduled or prescribed digital therapy module; an indication of whether the scheduled or prescribed digital therapy module was fully or partially completed; and exercise intensity (EI).

[0049] Figure 45a illustrates the dashboard of the healthcare provider portal. (1) The number of all patients currently associated with the physician's account. A graph can be used to display the number of patients who have initiated a digital application for the patient per day for the most recent 90 days. The number of ongoing patients can also be displayed. A graph can be used to display the number of patients who have completed a daily session per day within the most recent 90 days. Figure 45b illustrates the Patients tab in the healthcare provider portal, which displays a list of patients. As shown, (1) is the patient ID (a unique identification number temporarily assigned to each patient when adding them to the list), (2) is the patient's name, (3) is a search bar for searching by ID, name, email, notes, etc., and (4) is an Add New Patient button for adding a new patient. Figure 45c illustrates the Patients tab in the healthcare provider portal, which displays detailed information about a given patient. As shown, (1) is detailed patient information, (2) is a button to edit patient information, (3) is prescription information, (4) is a button to add a new prescription, (5) displays the progress for each different prescription, and (6) is a button or link to forward an email to the patient. Figure 45d illustrates the Patients tab in the provider portal for adding a new patient. As shown, (1) indicates the button to add a new patient, and (3) indicates the error message that is displayed when the required patient information is not provided. Figure 45e illustrates the Patients tab in the provider portal for editing an existing patient's information. As shown, (1) is a button or link to reset the password, (2) is a button to delete the given patient, and (3) is a button to save changes. Figure 45f illustrates the Patients tab in the provider portal displaying detailed prescription information for a given patient. As shown, (1) is a button for editing prescription information, (2) displays the duration of sessions the patient or subject has participated in, and (3) provides a graphical summary of treatment progress.Seven days are represented by lines or rows of seven squares. For a 12-week period, each 6 weeks can be presented separately. Different colors can be used to distinguish session status (e.g., gray for sessions not started, red for sessions not attended, yellow for sessions partially attended, and green for sessions fully attended). Figures 45g-45h illustrate the patient tab in the provider portal for editing prescription information for a given patient. Figure 45i illustrates the patient tab in the provider portal for viewing details of a given session for a given patient (e.g., date, status, duration, results such as EI or AEI). As shown, (1) is eye movement intensity, and (2) is a graph of the movement intensity. Different colors can be used in the graph to distinguish up / down or left / right eye movements. In the graph, the higher the amplitude, the more the eyes moved.

[0050] In some embodiments, collecting the subject's performance results in response to the digital instructions includes determining one or both of Exercise Intensity (EI) and Average Exercise Intensity (AEI). In some embodiments, AEI can be determined as the average sum of the differences between the final and starting positions of the subject's eyes measured at a predetermined interval. EI can be determined by the following formula:

number

[0051] In some embodiments, the administrative portal provides one or more options to an administrator, the one or more options provided to the system administrator selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information about the healthcare provider, viewing or editing de-identified information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, and communicating with the healthcare provider. In some embodiments, the one or more options include viewing or editing personal information, the personal information about the healthcare provider including one or more selected from the group consisting of an identification number for the healthcare provider, the healthcare provider's name, the healthcare provider's email, and a contact phone number for the healthcare provider. In some embodiments, the one or more options include viewing or editing de-identified information about the subject, the de-identified information about the subject including one or more selected from the group consisting of an identification number for the subject and a healthcare provider for the subject. In some embodiments, the one or more options include viewing adherence information for the subject, the subject's adherence information including one or more of the following: a number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules. In some embodiments, the one or more options include viewing the subject's results, the subject's results for one or more at least partially completed digital therapeutic modules including one or more selected from the group consisting of: the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indication of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0052] FIG. 47a illustrates (a) the dashboard of the administration portal. As shown, (1) indicates the number of physicians. A graph can be used to display the number of physicians who visited the digital application per day for the most recent 90 days. A graph can be used to display the number of patients who started the digital application for a patient per day for the most recent 90 days. The number of ongoing patients can also be displayed. A graph can be used to display the number of patients who completed a daily session per day within the most recent 90 days. FIG. 47b illustrates the Doctors tab in the administration portal, which displays a list of physicians. As shown, (1) is a search bar for searching various physicians by name, email, etc., (2) indicates a button for adding a new physician, (3) is the physician's ID, (4) is a button for viewing detailed physician information, and (5) indicates inactive physician accounts. FIG. 47c illustrates the Doctors tab in the administration portal, which displays a list of patients managed by a given physician, with patient-identifying information corrected (*). As shown, (1) is the physician's account information, (2) is a button to edit the physician's account information, (3) is a list of patients managed by the physician, (4) is a list of patient ID numbers, (5) is a link or button to forward the registration email to the physician, (6) is a notification that the physician's account has been deactivated—this is only displayed for deactivated accounts—and (7 and 8) are patient information to be modified or de-identified. Figure 47d illustrates the Doctors tab in the administration portal for adding a new physician. Figure 47e illustrates the Doctors tab in the administration portal for editing an existing physician's information, including activating or deactivating a physician's account. Figure 47f illustrates the Patients tab in the administration portal, which displays information about one or more patients, where sensitive information may be modified. Figure 47g illustrates the Patients tab in the administration portal, which displays detailed patient or prescription information for a given patient.Figure 47h illustrates a patient tab in the administration portal that displays detailed prescription information for a given patient. Figure 47i illustrates a patient tab in the administration portal for viewing details (e.g., date, condition, duration, outcome) of a given session for a given patient. Figure 48 provides a table showing privileges for physicians using the provider portal and administrators using the administration portal.

[0053] In some embodiments, the digital application further includes push alarms and / or push notifications for one or more of reminding the subject to complete the digital treatment module and adjusting lighting settings in the subject's environment, hi some embodiments, the push alarms and / or push notifications are activated to remind the subject to adjust lighting settings to ensure the subject is exposed to sufficiently bright light at least three times per day.

[0054] A patient or subject treated by any of the methods, systems, or digital applications described herein can be of any age and can be an adult, infant, or child, although the methods and systems of the present disclosure are particularly suited to children. In some cases, the patient or subject may be 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 1 The patient or subject may be 7, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99 years old, or a range therein (e.g., 2 to 20 years old, 20 to 40 years old, or 40 to 90 years old). In some embodiments, the patient or subject is a child. In some embodiments, the patient or subject is a child and is supervised by an adult when using the methods, systems, or digital applications of the present disclosure. In some embodiments, the patient or subject is under about 20 years old, under about 15 years old, under about 10 years old, or under about 5 years old.

[0055] In some embodiments, the digital device includes a digital instruction generation unit configured to generate a digital therapeutic module for treating myopia based on a mechanism of action (MOA) and a treatment hypothesis for myopia, generate digital instructions based on the digital therapeutic module, and provide the digital instructions to the subject. In some embodiments, the digital device includes a result collection unit configured to collect results of the subject's implementation of the digital instructions. In some embodiments, the digital instruction generation unit generates the digital therapeutic module based on neurohormonal factors associated with myopia onset. In some embodiments, the neurohormonal factors include insulin-like growth factor (IGF), cortisol, and dopamine.

[0056] In some embodiments, the digital instruction generation unit generates the digital therapeutic module based on input from a healthcare provider. In some embodiments, the digital instruction generation unit generates the digital therapeutic module based on information received from the subject.

[0057] In some embodiments, the information received from the subject includes at least one of the subject's baseline factors, medical information, and digital therapeutics utilization capability. In some embodiments, the baseline factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories). In some embodiments, the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities, and genetic susceptibility. In some embodiments, the digital therapeutics utilization capability includes the subject's accessibility and technology receptivity to digital therapeutics and devices.

[0058] In some embodiments, the digital instruction generation unit generates a digital therapeutic module that matches hypothetical parameters corresponding to mechanisms of action and treatment hypotheses for myopia, in some embodiments, the hypothetical parameters are inferred relative to the subject's environment, behavior, emotions, and cognition.

[0059] In some embodiments, the digital device includes a result collection unit configured to collect results of the subject's execution of the digital instructions, and the result collection unit collects results of the execution of the digital instructions by monitoring the subject's compliance with the digital instructions or by allowing the subject to directly input the subject's compliance with the digital instructions. In some embodiments, the generation of digital instructions in the digital instruction generation unit and the collection of results of the subject's execution of the digital instructions in the result collection unit are performed multiple times with multiple feedback loops. In some embodiments, the digital instruction generation unit generates the subject's digital instructions for the current round based on the subject's digital instructions from previous rounds and execution result data for the subject's digital instructions from previous rounds collected by the result collection unit.

[0060] Figure 36 illustrates screenshots shown in the digital application of the present disclosure upon completion of a single session, upon completion of all day sessions, and upon pause / start verification. As shown, (1) is a button to continue with the next session, and (2) is a button to go to the home screen. If it is the last day of the prescribed duration, go to screen 3.1.3; otherwise, go to 3.1.2 (see, e.g., Figure 23). A session pause verification pop-up is shown by tapping the home button on the top left while a session is running.

[0061] FIG. 1a is a diagram showing the mechanism of action of childhood / adolescent axial myopia proposed in the present disclosure, FIG. 1b is a diagram showing the treatment hypothesis for axial myopia proposed in the present disclosure, and FIG. 1c is a diagram illustrating the digital treatment hypothesis for axial myopia proposed in the present disclosure.

[0062] The digital devices and applications for slowing and treating myopia progression according to the present disclosure, as described below, are based on mechanisms of action and treatment hypotheses inferred through literature searches and expert review of clinical trial papers on axial myopia in childhood / adolescents.

[0063] Generally speaking, disease treatment is carried out by analyzing the pathophysiological functions and tendencies of a specific disease to determine the onset, progression, and endpoint of the disease. Furthermore, the symptoms of the disease are defined by characterizing the corresponding disease and statistically analyzing the disease. Furthermore, physiological factors, particularly neurohormonal factors, corresponding to the verified symptoms are analyzed, and the mechanism of action is inferred by narrowly limiting the patient's neurohormonal factors to those related to the disease.

[0064] Next, a therapeutic hypothesis is inferred that controlling behavior and environment directly related to the regulation of corresponding neurohormonal factors associated with the disease will treat the corresponding disease. To realize this therapeutic hypothesis with a digital therapeutic, a digital therapeutic hypothesis is proposed to achieve a therapeutic effect through repeated digital instructions and execution related to "control of patient behavior / environment → regulation of neurohormonal factors." The digital therapeutic hypothesis of the present disclosure is realized as a digital device and an application configured to present patient behavior (including behavioral, emotional, and cognitive domains), improvement of the patient's environment, and changes in patient participation in the form of specific instructions, and to collect and analyze the execution of the specific instructions.

[0065] Literature searches for clinical trials such as those described above can be performed through meta-analysis and data mining, and clinical expert feedback and in-depth review can be applied at each analysis step. Essentially, the present disclosure involves using the procedures described above to extract mechanisms of action and treatment hypotheses for axial myopia, and based on these results, providing applications in digital devices and digital therapy pathways for regulating neurohormonal factors to inhibit and treat the progression of axial myopia.

[0066] However, the method for extracting the mechanism of action and treatment hypotheses for axial myopia according to the present disclosure is not limited to the above-described method, and the mechanism of action and treatment hypotheses for the disease can be extracted using various methods.

[0067] Referring to Figure 1a, various risk factors during childhood / adolescence, such as near work, education, race, genetics, and other factors (e.g., premature birth, diet, light exposure, birth season, increased intraocular pressure, etc.), can cause an imbalance in neurohormonal factors (related to the onset of myopia) during childhood / adolescence. As a result, IGF, cortisol, and dopamine dysregulation leads to abnormal production of proteoglycans from the sclera around the eyeball, which causes abnormal growth of the optical axis, resulting in axial myopia.

[0068] Referring to FIG. 1b, the treatment hypothesis for axial myopia according to the present disclosure involves slowing the progression and treating axial myopia by restoring the balance of neurohormonal factors through patient behavior (including behavioral, emotional, and cognitive domains), the environment, and patient participation.

[0069] 1c, the digital treatment hypothesis for axial myopia is realized by a digital device and application configured to present specific instructions for patient behavioral changes, environmental improvements, and patient participation, and to collect and analyze the execution of the specific instructions. When the digital treatment method of the present disclosure is used, neurohormonal factor imbalances for axial myopic patients in childhood / adolescence can be calibrated through digital input (instructions) and output (execution) to achieve suppression of axial myopia progression and treatment.

[0070] While the mechanism of action in axial myopia and the treatment hypothesis for axial myopia are described with reference to Figures 1a and 1b, the present disclosure is not limited thereto. For example, the methodology of the present disclosure can be applied to all types of myopia and any other diseases.

[0071] Additionally, although insulin-like growth factor (IGF), cortisol, and dopamine are described as neurohormonal factors as illustrated in Figures 1a and 1b, it should be understood that the description of neurohormonal factors is provided merely as an example and is not intended to limit all aspects of the mechanism of action and therapeutic hypotheses for myopia according to the present disclosure. Thus, all neurohormonal factors that affect myopia may be considered.

[0072] FIG. 2 is a block diagram illustrating the configuration of a digital device for treating myopia according to one embodiment of the present disclosure.

[0073] Referring to FIG. 2 , a digital system 000 for treating myopia according to one embodiment of the present disclosure may include a digital instruction generation unit 010, a sensory data collection unit 020, an execution input unit 030, a result analysis unit 040, a database 050 and a security unit 060.

[0074] Based on the mechanism of action and treatment hypothesis for childhood / adolescent axial myopia and the digital treatment hypothesis, the doctor (second user) can prescribe a digital treatment for the corresponding patient, implemented with a digital device and application for treating myopia. In this case, the digital instruction generation unit 010 is a device configured to provide the patient with a prescription for the digital treatment as specific behavioral instructions that the patient can execute based on the interaction between neurohormonal factors for myopia and the patient's behavior / environment. For example, the neurohormonal factors may include IGF, cortisol, dopamine, etc., but the present disclosure is not limited thereto. For example, all types of neurohormonal factors that can induce myopia may be considered.

[0075] The digital instruction generation unit 010 can generate digital instructions based on input from a physician. In this case, the digital instruction generation unit 010 can generate digital instructions based on information collected by a physician when diagnosing a patient. The digital instruction generation unit 010 can also generate digital instructions based on information received from a patient. For example, the information received from a patient can include the patient's baseline factors, medical information, and digital therapeutics utilization capabilities. In this case, the baseline factors can include the patient's amount of activity, heart rate, sleep, diet (nutrition and calories), etc. The medical information can include the patient's electronic medical record (EMR), family history, genetic vulnerability, genetic susceptibility, etc. The digital therapeutics utilization capabilities can include the patient's accessibility and posture to the digital therapeutics instructions and device, etc.

[0076] The digital instruction generation unit 010 can reflect the mechanism of action and treatment hypotheses for myopia to generate a digital module using virtual parameters. In this case, the virtual parameters can be inferred in terms of the patient's environment, behavior, emotions, and cognition. In this regard, the virtual parameters are described in detail as shown in FIG. 5.

[0077] The digital instruction generation unit 010 generates digital instructions specifically designed to enable the patient to achieve a therapeutic effect and provides the instructions to the patient. For example, the digital instruction generation unit 010 can provide light stimulation in a brightly lit environment and simultaneously generate specific digital instructions for each of the digital therapy modules.

[0078] The sensory data collection unit 020 and the execution input unit 030 can collect the patient's execution results for the digital instructions provided by the digital instruction generation unit 010. In some implementations, the sensory data collection unit 020 is an output unit of various sensor devices. Specifically, the sensory data collection unit 020 is configured to sense the patient's compliance with the digital instructions and the execution input unit 030 is configured to allow the patient to directly input the execution results for the digital instructions, and thus serves to output the patient's execution results for the digital instructions. The execution input unit 030 can receive input regarding the results of performing the digital behavior.

[0079] The result analysis unit 040 can collect the patient's behavioral compliance or participation at predetermined intervals and report the patient's behavioral compliance or participation to an external system. Therefore, the doctor can continue to monitor the execution process of the digital instructions through the application even when the patient does not visit the hospital in person.

[0080] The database 050 can store the mechanism of action for myopia, the treatment hypothesis for myopia, the digital instructions provided to the user, and the user's performance result data. Figure 2 illustrates that the database 050 is included in the digital device for treating myopia 000. However, the database 050 can be provided on an external server.

[0081] Meanwhile, a series of loops including inputting digital instructions in the digital instruction generating unit 010, outputting the patient's execution results for the digital instructions in the sensory data collecting unit 020 / execution input unit 030, and evaluating the execution results in the result analyzing unit 040 can be executed multiple times. In this case, the digital instruction generating unit 010 can generate digital instructions tailored to the patient for the current visit by reflecting the patient's digital instructions, output values, and evaluations provided from the previous visit.

[0082] As described above, according to the digital therapeutic device for treating and inhibiting the progression of axial myopia disclosed herein, the neurohormonal factors for axial myopia are taken into consideration to infer the mechanism of action for axial myopia, a treatment hypothesis for axial myopia, and a digital treatment hypothesis. Based on the mechanism of action and the treatment hypothesis, digital instructions for setting an appropriate light stimulation environment and treating axial myopia are presented to the patient, and the execution of the specific instructions is collected and analyzed, thereby enabling a myopia treatment method that can be guaranteed to be reliable.

[0083] FIG. 3 is a diagram illustrating the input and output loop of a digital application for treating myopia according to one embodiment of the present disclosure.

[0084] Referring to FIG. 3, a digital application for treating myopia according to one embodiment of the present disclosure can input a corresponding digital prescription for a patient in the form of instructions and can output the results of executing the corresponding digital instructions.

[0085] The digital instructions provided to the patient may include specific action instructions for behavior, emotion, cognition, etc., as well as control of the patient's lighting environment. As illustrated in Figure 3, the digital instructions may include eye movement, reduced stress, a sense of accomplishment, light stimulation, etc. However, the digital instructions are provided merely by way of example and are not intended to be limiting of the digital instructions according to the present disclosure.

[0086] The patient's execution results for digital instructions consist of 1) login / logout information for instructions and execution, 2) compliance information sensed as manual data such as eye movements, heart rate related to stress, changes in oxygen saturation, etc., and 3) direct input information for the patient's execution results.

[0087] FIG. 4 is a diagram illustrating a feedback loop for a digital device and application for treating myopia according to one embodiment of the present disclosure.

[0088] Referring to FIG. 4, it is illustrated that the inhibition of progression and treatment of axial myopia is achieved by multiple iterations of the single feedback loop described above in FIG. 3 to regulate neurohormonal factors.

[0089] In the case of axial myopia, digital therapy and observation may require a short period of 10 weeks to the entire childhood / adolescence period to treat axial myopia due to its pathological characteristics. Due to these characteristics, the inhibitory and therapeutic effects on the progression of axial myopia can be achieved more effectively through gradual improvement of instruction-action sessions in a feedback loop than through simple repeated instruction-action sessions during the course of the corresponding therapy.

[0090] For example, the digital instructions and execution results for a first iteration are provided as input and output values ​​in a single loop, but when the feedback loop is executed N times, new digital instructions can be generated by using the loop's feedback process to reflect the input and output values ​​generated in this loop to adjust the input for the next loop. This feedback loop can be repeated to infer digital instructions tailored to the patient and maximize the therapeutic effect.

[0091] In this way, in the digital device and application for treating myopia according to one embodiment of the present disclosure, the patient's digital instructions provided in a previous session (e.g., the N-1th session) and data on the execution results of the instructions can be used to calculate the patient's digital instructions and execution results in the current session (e.g., the Nth session). That is, the digital instructions in the next loop can be generated based on the patient's digital instructions and execution results calculated in the previous loop. In this case, various algorithms and statistical models can be used for the feedback process when necessary.

[0092] As previously mentioned, a digital device and application for treating myopia according to one embodiment of the present disclosure allows for optimization of patient-specific digital instructions via a rapid feedback loop.

[0093] FIG. 5a is a diagram showing a modular design for implementing a digital therapy in a digital device and application for treating myopia according to one embodiment of the present disclosure, and FIG. 5b is a diagram illustrating background factors supporting a digital device and application for treating myopia according to one embodiment of the present disclosure.

[0094] As shown in FIG. 5a, when a mechanism-based treatment hypothesis for myopia is generated, target neurohormonal factors (e.g., IGF, cortisol, dopamine, etc.) can be inferred. Virtual parameters can be utilized to ensure that specific instructions correspond to the modulation of such neurohormonal factors. The modules necessary to treat myopia are inferred using the "neurohormonal factor-virtual parameter module" interrelationship. Each module is described in more detail in the form of modular instructions with reference to FIG. 7, as described below. In this case, each module is a basic design unit and a set of specific instructions for a digital therapeutic that is actually implemented in a digital device or application.

[0095] Specifically, referring to Figure 5a, the neurohormonal factors inferred based on the mechanism of action and treatment hypothesis for axial myopia can be IGF, cortisol (or TGF-beta, which is influenced by cortisol), and dopamine (or GABA agonist / antagonist, glucagon). To treat myopia, neurohormonal factors must be adjusted at the appropriate age group to promote the secretion of IGF and dopamine, which affect ocular development, and suppress the secretion of cortisol.

[0096] The control of each neurohormonal factor corresponds to a digital therapeutic module that uses environmental (light), behavioral (exercise), emotional (reduced stress), and cognitive (sense of accomplishment) parameters. Specific digital instructions for each module are generated based on the transformed module. In this case, the digital instructions can include execution environment settings and modules (e.g., eye movement, exercise, ego, safety / calmness, enjoyment, and accomplishment modules), which can be output by monitoring. However, the modules are provided merely as examples and are not intended to be limiting to the modules according to the present disclosure.

[0097] Meanwhile, referring to FIG. 5b, in designing the digital device and application module for treating myopia according to one embodiment of the present disclosure, background factors can both be taken into consideration.

[0098] In this case, the background factors are elements necessary for correcting clinical trial results during verification of the clinical effectiveness of the digital myopia treatment method according to the present disclosure. Specifically, in the background factors illustrated in FIG. 5b, the basic factors may include activity, heart rate, sleep, diet (nutrition and calories), etc., medical information may include EMR recorded when the patient visits the hospital, family history, genetic vulnerability and susceptibility, etc., and digital treatment utilization ability may include the patient's accessibility to and posture regarding digital treatment instructions and devices.

[0099] FIG. 6 is a diagram illustrating a method for assigning a patient-tailored digital prescription using a digital device and application for treating myopia according to one embodiment of the present disclosure.

[0100] FIG. 6A illustrates a prescription procedure for a physician to examine a patient's routine medical condition, and FIG. 6B illustrates a method for enabling a physician to assign a personalized digital prescription to a patient based on the analysis of multiple digital instructions and the results of executing the digital instructions.

[0101] In this manner, when the digital device and application for treating myopia according to one embodiment of the present disclosure is used, the doctor can check the patient's instructions and execution results during a given period and adjust the type of modules for treating myopia and the instructions for each module in a patient-specific manner, as illustrated in FIG. 6(B).

[0102] FIG. 7a illustrates an execution environment configuration according to one embodiment of the present disclosure, and FIGS. 7b-7g illustrate an example of how to collect specific instructions and output data for each module according to one embodiment of the present disclosure.

[0103] In the case of digital therapy for axial myopia, patient participation is generally required for 10 weeks or more, so it is most important that adolescents find the digital therapy enjoyable and voluntarily participate in it. In this context, modules can be configured by adding game elements to each module. In digital devices and applications for treating myopia that are realized to alleviate and treat axial myopia, as described below, each module is a basic design unit and a set of specific instructions.

[0104] 7a, a specific example of instructions for setting up an execution environment and a method for collecting output data is shown, where the execution environment setting can be included as part of the configuration of the digital instruction generation unit 010 shown in FIG.

[0105] Specifically, the execution environment setting includes setting the brightness of the execution environment using an illuminance sensor, and other modules are executed under the set lighting environment.

[0106] In general, sunlight is closely related to ocular health. Strong light stimuli, the same as exposure to direct sunlight, act on retinal nerve cells to promote the secretion of dopamine, which induces the synthesis of proteoglycans, an essential factor for the normal adjustment of axial length of the eye.

[0107] As mentioned above, to provide light stimulation to the patient, the illuminance in the current environment can be measured using an illuminance sensor, and an alarm of the current lighting environment can be provided to control the brightness of the environment in which the patient participates in digital therapy.

[0108] Referring to Figure 7b, a specific example of a method for collecting instructions and output data for an eye movement module is shown, where the application can be included as part of the digital instruction generation unit 010 configuration shown in Figure 2.

[0109] The digital instructions for eye movement include controlling the patient's eye movement, biofeedback, eye-related behavior, etc., and promoting IGF secretion in the eye movement muscles. Specifically, the behavioral instructions for the eye movement module can be monitored for patient compliance using eye tracking technology, such as eye movement, blinking, distance gaze, eye closing, etc. However, the collection of execution results for the eye movement module is not limited to eye tracking technology and can include direct input of the execution results of instructions by the patient.

[0110] 7c, a specific example of instructions for the physical exercise module and a method for collecting output data is illustrated. In this case, the physical exercise module may be included as part of the configuration of the digital instruction generation unit 010 illustrated in FIG. 2. The physical exercise module may be configured with a series of behavioral instructions including slow, gentle physical exercise and abdominal exercises, and configured to reduce stress through rest, relaxation, deep breathing, etc. to suppress cortisol secretion.

[0111] Specifically, the behavioral instructions for the physical movement module include behavioral instructions such as relaxation exercise, deep breathing, meditation, eye massage, etc. The behavioral instructions also include a method of collecting the execution results of the behavioral instructions in the sensory data collection unit 020 using a bio-feedback device (for measuring EEG, ECG, EMG, EDG, etc.) or a general-purpose sensor (for measuring activity, HR, etc.), or a method of allowing the patient to directly input the execution results using the execution input unit 030. The behavioral instructions of the present disclosure are configured based on a behavioral therapy method widely used in pediatric psychiatry to relieve stress in children.

[0112] Generally, the progression of myopia is closely related to the course of adolescence. In particular, there can be significant differences among adolescents during this period, depending on their age, gender, personality, and preferences. To address these differences, digital instructions for each module are preferably presented in a format tailored to each patient's individual characteristics. In particular, instructions requiring interactive communication (e.g., conversation) with the application can be developed in combination with big data analysis and artificial intelligence analysis.

[0113] Referring to Figure 7d, a specific example of a method for collecting instructions and output data for an ego module is shown, where the ego module can be included as part of the digital instruction generation unit 010 configuration shown in Figure 2.

[0114] Specifically, the ego module instructions are intended to increase the adolescent's self-esteem and relieve stress. To this end, the ego module instructions may include, for example, instructions for talking, drawing, meditating, writing in a diary, creating one's own safe space (safe place instructions), one's favorite things (places, times, seasons, colors, foods, people, etc.), one's own bucket list, choosing a place to travel and planning a trip. Such instructions are based on psychotherapy methods widely used in child psychiatry to increase the self-esteem and relieve stress in children or adolescents.

[0115] 7e, a specific example of instructions for the safe / calm module and a method for collecting output data is shown, where the safe / calm module may be included as part of the digital instruction generation unit 010 configuration shown in FIG.

[0116] Specifically, the instructions for the safety / calmness module are aimed at serving as a means of ventilation to reduce stress in adolescents. To this end, the instructions for the safety / calmness module may include, for example, instructions such as talking, expression (writing, singing, drawing), and letting unpleasant feelings out in animated situations (such as "trash"). These instructions are based on psychotherapy techniques that have been widely used in pediatric psychiatry to increase the self-esteem and relieve stress in children or adolescents.

[0117] Referring to Figure 7f, a specific example of instructions for a fun module and a method for collecting output data is shown, where the fun module may be included as part of the configuration of the digital instruction generation unit 010 shown in Figure 2.

[0118] Specifically, the instructions for the fun module are instructions that allow the patient to enjoy using the application and may consist of various content such as music, games, or videos tailored to the characteristics of young people. The fun instructions in the fun module also aim to improve the patient's continued participation in the digital therapy.

[0119] Referring to Figure 7g, a specific example of a method for collecting instructions and output data for an achievement module is shown, where the achievement module may be included as part of the digital instruction generation unit 010 configuration shown in Figure 2.

[0120] Specifically, the instructions for the achievement module may include instructions that promote dopamine secretion through a sense of accomplishment, such as when the patient performs and completes a task. Here, the task achievement instructions are instructions that allow the patient to feel a sense of accomplishment when a given task is accomplished, and thus may include a game in which the task can be updated over the patient's participation duration and can induce the patient's voluntary participation. For example, the specific format of the game may be configured for various durations, such as learning, finding hidden or different pictures, quizzes, etc.

[0121] In particular, some of the instructions provided in the form of quizzes in the achievement module can be expected to have the additional effect of improving a patient's ability to utilize health information and digital therapeutics, which are essential elements for a patient's continued participation and implementation in a therapy.

[0122] As mentioned above, the digital therapeutics of the present disclosure require the patient's participation for 10 weeks or more. During this period, faithfully completing the instructions for the aforementioned modules allows the achievement module to form a praise instruction so that the patient feels a sense of accomplishment. The praise instruction can be based on the dependency and compensation between the patient and guardian and between the patient and doctor, and can provide feedback on the patient's active participation in the therapy as a sense of accomplishment.

[0123] 7b-7g, the digital instructions illustrated above are provided merely as examples and are not intended to limit the present disclosure. For example, the digital instructions provided to the patient can be configured in various ways when needed.

[0124] FIG. 8 is a flowchart illustrating operations in a digital application for treating myopia according to one embodiment of the present disclosure.

[0125] 8, a digital application for treating myopia according to an embodiment of the present disclosure may first generate a digital therapeutic module for treating myopia based on the mechanism of action and treatment hypothesis for myopia (S810). In this case, in S810, the digital therapeutic module may be generated based on neurohormonal factors for myopia (e.g., IGF, cortisol, dopamine, etc.).

[0126] Alternatively, in S810, the digital therapeutic module may be generated based on input from a physician. In this case, the digital therapeutic module may be generated based on information collected by the physician when diagnosing the patient and prescription results recorded based on this information. Also, in S810, the digital therapeutic module may be generated based on information received from the patient (e.g., underlying factors, medical information, digital therapeutic utilization capabilities, etc.).

[0127] Next, in S820, a specified digital instruction can be generated based on the digital therapeutic module. S820 can generate the digital therapeutic module by applying hypothetical parameters related to the patient's environment, behavior, emotions, and cognition to the mechanism of action and treatment hypotheses for myopia. This digital therapeutic module has been described with reference to FIG. 5, and therefore, its description will be omitted.

[0128] In this case, digital instructions can be generated for at least one of the lighting environment settings, eye movement, body movement, self, safety / calmness, enjoyment, and achievement modules. The description of the execution environment settings and specific digital instructions for each module is as described in Figures 7a-7g.

[0129] Next, digital instructions can be provided to the patient (S830). In this case, the digital instructions can be provided in the form of digital instructions related to behavior, emotion, cognition, and the patient's compliance with instructions such as eye movement / body movement can be monitored using sensors, or the digital instructions can be provided in the form of digital instructions that allow the patient to directly input the results of their implementation.

[0130] After the patient implements the provided digital instructions, the patient's implementation results for the digital instructions can be collected (S840). In S840, the implementation results for the digital instructions can be collected by monitoring the patient's compliance with the digital instructions as described above, or by having the patient input the implementation results for the digital instructions.

[0131] Meanwhile, a digital application for treating myopia according to an embodiment of the present disclosure may perform operations repeatedly, including generating digital instructions and collecting patient implementation results of the digital instructions, where generating digital instructions may include generating digital instructions for the patient for a current visit based on the patient's digital instructions provided from a previous visit and the patient's implementation result data for the collected digital instructions provided from the previous visit.

[0132] As described above, according to the digital application for treating myopia according to one embodiment of the present disclosure, the neurohormonal factors for myopia are taken into consideration to infer the mechanism of action of myopia and a hypothesis for treating myopia, digital instructions are presented to the patient based on the mechanism of action of myopia and a hypothesis for treating myopia, the digital instructions are given under an appropriate light stimulation environment, and the results of the digital instructions are collected and analyzed, thereby ensuring the inhibition of myopia progression and the reliability of the treatment.

[0133] Although the digital device and application for treating myopia according to one embodiment of the present disclosure have been described in terms of myopia therapy, the present disclosure is not limited thereto. For diseases other than myopia, the digital therapy can be performed in substantially the same manner as described above.

[0134] FIG. 9 is a flowchart illustrating a method for generating digital instructions in a digital application for treating myopia according to one embodiment of the present disclosure.

[0135] Referring to Figure 9, the operation of the method for generating digital instructions is the same as that described in the process of generating a module for treating myopia and specific digital instructions based on the mechanism of action of myopia and treatment hypothesis (S810 and S820 shown in Figure 8) and the process shown in Figure 5.

[0136] In S910, first, the mechanism of action and treatment hypothesis for myopia can be input. In this case, the mechanism of action and treatment hypothesis for myopia can be preliminarily inferred through literature search and expert review of systematic related clinical trials for myopia, as described above.

[0137] Next, neurohormonal factors for myopia can be predicted from the input mechanism of action and treatment hypothesis (S920). In this case, the neurohormonal factors for myopia predicted in S920 can be inferred in the form of IGF, cortisol, dopamine, etc. These neurohormonal factors have been described in detail with reference to FIG. 5, so further description thereof will be omitted.

[0138] In S930, a digital therapeutic module can be generated so that virtual parameters correspond to the predicted neurohormonal factors, where the virtual parameters can act as a converter to convert the neurohormonal factors for myopia into the digital therapeutic module, and this procedure is to establish physiological correlations between the neurohormonal factors and environmental, behavioral, emotional, and cognitive factors, as illustrated in FIG.

[0139] Thereafter, specified digital instructions can be generated based on the generated digital treatment modules (S940). In this case, specific digital instructions can be generated for the lighting environment setting, eye movement, body movement, self, safety / calmness, enjoyment, and achievement modules described above with reference to Figures 7a to 7g.

[0140] FIG. 10 is a flow chart illustrating a method for repeatedly performing operations responsive to feedback control in a digital application for treating myopia according to one embodiment of the present disclosure.

[0141] 10 illustrates that the generation of digital instructions and the collection of execution results of a digital application for treating myopia are executed N times. In this case, the mechanism of action and treatment hypothesis for myopia may be first input (S1010). Also, the digital instructions and execution result data provided from the previous execution may be received (S1020). When the first execution execution is first in progress, S1020 may be omitted because there is no previous data.

[0142] Next, digital instructions for the current session can be generated based on the input mechanism of action and treatment hypothesis, the provided digital instructions from the previous session, and the execution result data (S1030). Then, the user's execution results of the generated digital instructions can be collected (S1040).

[0143] In S1050, it is determined whether the current number is greater than the Nth number. If the current number is less than the Nth number (No), it can return to S1020, and thus S1020 to S1040 are repeated. On the other hand, if the current number is greater than the Nth number (for example), that is, if the generation of digital instructions and the collection of execution results are executed N times, the feedback operation can be terminated.

[0144] 11 is a diagram illustrating a hardware configuration of a digital device for treating myopia according to one embodiment of the present disclosure. Various examples of digital devices include desktop computers, laptops, tablet computers, server computers, server systems, wearable devices such as smart watches, and other computing devices. A digital device can be a data server that can host one or more databases (e.g., image or video databases), models, or modules, or provide various executable applications or modules.

[0145] Referring to FIG. 11, hardware 600 of a digital device for treating myopia according to one embodiment of the present disclosure may include a CPU 610, a memory 620, an input / output I / F 630 and a communication I / F 640.

[0146] The CPU 610 may include a processor configured to execute a digital program for treating myopia stored in the memory 620, process various data for treating digital myopia, and perform functions related to a digital myopia treatment method. That is, the CPU 610 can act to perform functions for each component illustrated in FIG. 2 by executing a digital program for treating myopia stored in the memory 620.

[0147] The memory 620 may have stored therein a digital program for treating myopia, and may also include data used for the digital myopia treatment contained in the aforementioned database 050, such as the patient's digital instructions and instruction execution results, the patient's medical information, etc.

[0148] A plurality of such memories 620 may be provided as needed. The memories 620 may be volatile or nonvolatile. If the memory 620 is a volatile memory, RAM, DRAM, SRAM, etc. may be used as the memory 620. If the memory 620 is a nonvolatile memory, ROM, PROM, EAROM, EPROM, EEPROM, flash memory, etc. may be used as the memory 620. The examples of the memory 620 listed above are provided for illustrative purposes only and are not intended to limit the present disclosure.

[0149] In some implementations, memory 620 or the computer-readable storage medium of memory 620 stores the following programs, modules, and data structures, or a subset or extended set thereof:

[0150] An operating structure that includes procedures for handling various basic system services and performing hardware-dependent tasks;

[0151] a communications module used to couple computing device 200 to other computers and devices via one or more communications network interfaces 204 (wired or wireless), such as the Internet, other wide area networks, local area networks, metropolitan area networks, etc.;

[0152] a web browser (or other application capable of displaying web pages) that allows a user to communicate with a remote computer or device over a network;

[0153] an audio input module (e.g., a microphone module) for processing audio captured by an audio input device, which can be transferred to a remote server or processed by an application running on the digital device;

[0154] A healthcare application including a graphical user interface that allows a user to explore the healthcare application, such as accessing patient program files, viewing patient information for the patient program files, and selecting digital therapeutic modules. In some implementations, the healthcare application can utilize a healthcare provider communication module to transmit patient information, such as adherence information or sensor information, to a healthcare provider. The healthcare application can also utilize the healthcare provider communication module to receive instructions from a healthcare provider to update or modify one or more computer programs (or one or more digital therapeutic modules). In some implementations, the healthcare application can include a sensor module that stores information regarding sensor configurations for tracking user activity or user adherence to the computer programs (digital therapeutic modules);

[0155] a digital therapeutic module configured to generate and / or modify instructions for the subject to follow to generate a customized digital therapeutic module tailored to the particular patient based on the patient's patient profile; and

[0156] It can include a database that stores information such as patient program files, healthcare provider data, and digital therapeutic modules. The patient profile can include sensor information such as user adherence information and / or usage progress information, and patient information such as age, gender, weight height, diagnosis, and healthcare provider.

[0157] The input / output I / F 630 can provide an interface through which input devices (not shown) such as a display device (e.g., a screen or monitor), a keyboard, a mouse, a touch panel, etc., and output devices such as a display (not shown) can transfer and receive data to the CPU 610 (e.g., wirelessly or via a wired connection). The display device includes a touch-sensitive surface, in which case the display device is a touch-sensitive display. In some implementations, the touch-sensitive surface is configured to detect various swipe gestures (e.g., successive gestures in vertical and / or horizontal directions) and / or other gestures (e.g., single / double tabs). The input / output I / F 630 also includes an audio output connection or an audio output device such as a speaker coupled to a speaker, earphones, or headphones. Some digital devices 600 can also use a microphone and audio recognition software to supplement or replace a keyboard. The audio input device (e.g., a microphone) captures audio (e.g., speech from a user).

[0158] The communication I / F 640 is configured to transfer and receive various types of data to and from a server and can be one of various types of devices that can support wired or wireless communication. For example, the data type for the digital behavior-based therapy described above can be received from a separately available external server through the communication I / F 640.

[0159] Each of the above-identified executable modules, applications, or sets of procedures can be stored in one or more of the previously mentioned memories 620 and correspond to sets of instructions for performing the functions described above. The above-identified modules or programs (i.e., sets of instructions) need not be implemented as separate software programs, procedures, or modules; thus, various subsets of such modules can be combined or otherwise rearranged in various implementations. In some implementations, memory 620 stores a subset of the above-identified modules and data structures. Memory 620 can also store additional modules or data structures not described above.

[0160] As described above, a computer program according to an embodiment of the present disclosure can be, for example, recorded in memory 620 and processed by CPU 610, and the computer program can be realized as modules configured to perform each of the functional blocks illustrated in FIG. 2.

[0161] A processor according to exemplary embodiments of the present disclosure may be a hardware device implemented by various electronic circuits (e.g., a computer, a microprocessor, a CPU, an ASIC, a circuit, a logic circuit, etc.). The processor may be implemented by a non-transitory memory that stores, for example, a program, software instructions that implement an algorithm, etc., and a processor configured to execute the program, software instructions that implement an algorithm, etc., which perform various functions described below when executed. Here, the memory and the processor may be implemented as separate semiconductor circuits. Alternatively, the memory and the processor may be implemented as a single integrated semiconductor circuit. The processor may be implemented as one or more processors.

[0162] According to the digital device and application for treating axial myopia disclosed herein, by taking into account neurohormonal factors affecting the progression of axial myopia, the mechanism of action of myopia and a treatment hypothesis and digital treatment hypothesis for myopia can be inferred, and based on the mechanism of action, treatment hypothesis and digital treatment hypothesis, digital instructions can be presented to the patient under appropriate light stimulation environment settings, and the results of executing the digital instructions can be collected and analyzed, thereby providing a reliable digital device and application that can inhibit and treat the progression of myopia.

[0163] Although the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, those of ordinary skill in the art will recognize that various changes in form and details can be made therein without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0164] Axial length (AL) is a combination of anterior chamber depth, lens thickness, and vitreous chamber depth, and is the most important contributor to refractive error. Myopia occurs when AL increases outside the normal rate expected for age. In children with rapidly progressing myopia, AL increases more rapidly than normal.

[0165] Thus, a method for improving the visual acuity of a subject is provided in the present disclosure. The method for improving the visual acuity of a subject according to the present disclosure includes providing, via a digital device, a digital application to the subject, the digital application including one or more digital therapeutic modules for improving visual acuity. The method according to the present disclosure can improve the growth rate of axial length (AL) of the at least one eye of the subject. The method according to the present disclosure can decrease the growth rate of axial length (AL) of the at least one eye of the subject.

[0166] In some embodiments, a method for treating myopia in a subject in need of myopia treatment includes providing the subject with a digital application including one or more digital treatment modules for treating myopia via a digital device, each module including one or more first instructions to be followed by the subject, the first instructions including first eye movement instructions causing the subject to vertically move at least one eye.

[0167] In some embodiments, in a system for improving a subject's vision, the system includes a digital device configured to execute a digital application for improving the subject's vision according to the methods described above and below; a healthcare provider portal configured to provide a healthcare provider with one or more options for performing one or more tasks to prescribe a treatment for improving the subject's vision based on information received from the digital application; and an administration portal configured to provide an administrator of the system with one or more options for performing one or more tasks to manage healthcare provider access to the system.

[0168] In some embodiments, a system for treating myopia in a subject in need of myopia treatment includes a digital device configured to execute a digital application for treating myopia in the subject according to the methods described above and below; a healthcare provider portal configured to provide one or more options to a healthcare provider for performing one or more tasks to prescribe a therapy for treating myopia in the subject based on information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system for performing one or more tasks to manage access to the system by healthcare providers.

[0169] In some embodiments, the non-transitory computer-readable medium has stored thereon software instructions for improving the subject's vision, which, when executed by the processor, cause the processor to cause the digital device to display to the subject modules for improving vision, each module including one or more instructions to be followed by the subject, a first instruction including an eye movement instruction causing the subject to move at least one eye vertically; and cause a sensor within the digital device to sense the subject's compliance with the module's instructions.

[0170] In some embodiments, a non-transitory computer-readable medium having stored thereon software instructions for treating myopia in a subject in need thereof, the instructions, when executed by a processor, cause the processor to: display, via a digital device, modules for treating myopia to the subject, each module including one or more instructions to be followed by the subject, a first instruction including an eye movement instruction causing the subject to move at least one eye vertically; and sense, via a sensor within the digital device, the subject's compliance with the module's instructions.

[0171] The method of improving the visual acuity of a subject according to the present disclosure can be applied to subjects in a developmental state between 5 and 12 years of age, and preferably the subject is 10 years of age or older.

[0172] In some embodiments, the modules are selected based on a mechanism of action and a treatment hypothesis, and the digital device (i) includes a sensor that senses a subject's compliance with one or more first instructions of the modules, (ii) based on the compliance, transmits the compliance information to a server accessible to a healthcare provider through a healthcare provider portal, and (iii) receives one or more second instructions from the healthcare provider based on the compliance information.

[0173] In some embodiments, the one or more second instructions include a second eye movement instruction for an adjusted rate of eye movement based on the adherence information.

[0174] In some embodiments, the digital application directs a processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and treatment hypothesis.

[0175] In some embodiments, generating a digital therapeutic module includes generating a digital therapeutic module based on neurohormonal factors.

[0176] In some embodiments, the operations further include generating a calibration module to calibrate one or more of the measurement accuracy of the subject's eye position and the lighting environment.

[0177] In some embodiments, the calibration module is generated prior to generating the digital therapy module.

[0178] In some embodiments, the accuracy of measuring the position of the subject's eyes is calibrated, and said calibration of the accuracy of measuring the position of the subject's eyes includes one or more of instructing the subject to position their face so that it appears on the screen of the digital device, detecting the subject's eyes for a given period of time, instructing the subject to blink their eyes, detecting whether the subject blinks their eyes, instructing the subject to stare at the screen, instructing the subject to move their eyes in a given direction or rotate their eyes, and determining a threshold value for detecting the subject's eyes.

[0179] In some embodiments, the measurement accuracy of the lighting environment is calibrated, and said calibration to the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment.

[0180] In some embodiments, the digital device includes one or more sensors for tracking the subject's eye movements.

[0181] In some embodiments, the digital application instructs a processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis; generating digital instructions based on the digital therapeutic module; providing the digital instructions to the subject; and collecting results of the subject's implementation of the digital instructions.

[0182] In some embodiments, generating the digital instructions and collecting the subject's performance results on the digital instructions are performed multiple times in multiple feedback loops, and generating the digital instructions includes generating the subject's digital instructions for the current round based on the subject's digital instructions from previous rounds and collected performance result data on the subject's digital instructions provided from the previous rounds.

[0183] In some embodiments, collecting the subject's performance results in relation to the digital instructions includes determining one or both of Exertion Intensity (EI) and Average Exertion Intensity (AEI).

[0184] In some embodiments, the AEI is determined as the average sum of the differences between the final and starting positions of the subject's eye measured at predetermined intervals.

[0185] In some embodiments, the interval is between about 10 ms and about 500 ms.

[0186] In some embodiments, the EI is determined by the following formula:

number

[0187] In some embodiments, generating the digital therapeutic module includes applying hypothetical parameters for the subject's environment, behavior, emotions, and cognition to the treatment hypothesis and mechanism of action to generate the digital therapeutic module.

[0188] In some embodiments, the digital application directs a processor of the digital device to generate (i) an eye movement module including eye movement instructions, and (ii) a digital therapy module including at least one of a relaxation module and a light therapy module.

[0189] In some embodiments, the eye movement module further includes one or more of bio-feedback control instructions and eye-related behavior control instructions; the relaxation module includes one or more relaxation instructions for one or more of body movement instructions, self-enhancement instructions, feeling of safety instructions, feeling of calm instructions, and enjoyment instructions; and the light therapy module includes one or more light therapy instructions for controlling the subject's lighting environment.

[0190] In some embodiments, the one or more relaxation instructions include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

[0191] In some embodiments, the digital therapeutic module further includes an achievement module that includes one or more achievement instructions for task achievement and for providing compensation for the subject's compliance with the instructions of the two or more first modules.

[0192] In some embodiments, the digital therapeutic module further includes a fun module that includes one or more fun instructions for music, games, or videos.

[0193] In some embodiments, the healthcare provider portal is configured to provide the healthcare provider with one or more options to perform one or more tasks to prescribe a treatment to the subject based on the adherence information, wherein the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing the subject, viewing or editing personal information about the subject, viewing adherence information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing the prescription for one or more digital therapeutic modules, and communicating with the subject.

[0194] In some embodiments, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, prescriptions for the subject, and one or more notes created by a healthcare provider for the subject.

[0195] In some embodiments, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed to be performed by the subject, and a number of digital therapeutic modules scheduled or prescribed to be performed by the subject per day.

[0196] In some embodiments, the one or more options include viewing compliance information, where the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0197] In some embodiments, the one or more options include viewing the subject's results, wherein the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of: the time the subject started the scheduled or prescribed digital therapy module; the time the subject finished the scheduled or prescribed digital therapy module; an indication of whether the scheduled or prescribed digital therapy module was fully or partially completed; and exercise intensity (EI).

[0198] In some embodiments, the server is accessible by an administrator through an administrative portal configured to provide one or more options to an administrator of the system to perform one or more tasks for managing healthcare provider access to the system, wherein the one or more options provided to the administrator of the method are selected from the group consisting of adding or removing healthcare providers, viewing or editing personal information about healthcare providers, viewing or editing de-identified information about subjects, viewing compliance information about subjects, viewing subject outcomes for one or more at least partially completed digital treatment modules, and communicating with healthcare providers.

[0199] In some embodiments, the one or more options include viewing or editing personal information, wherein the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, a name of the healthcare provider, an email address for the healthcare provider, and a contact phone number for the healthcare provider.

[0200] In some embodiments, the one or more options include viewing or editing the subject's de-identified information, where the subject's de-identified information includes one or more selected from the group consisting of an identification number for the subject, and a healthcare provider for the subject.

[0201] In some embodiments, the one or more options include viewing compliance information for the subject, where the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0202] In some embodiments, the one or more options include viewing the subject's results, wherein the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of: the time the subject started the scheduled or prescribed digital therapy module; the time the subject finished the scheduled or prescribed digital therapy module; an indication of whether the scheduled or prescribed digital therapy module was fully or partially completed; and exercise intensity (EI).

[0203] In some embodiments, the digital application further includes a push alarm for one or more of reminding the subject to complete a digital treatment module and adjusting lighting settings in the subject's environment.

[0204] In some embodiments, a push alarm is activated to remind the subject to adjust lighting settings to ensure the subject is exposed to sufficiently bright light at least three times per day.

[0205] In some embodiments, the digital device includes a digital instruction generation unit configured to generate a digital treatment module based on a mechanism of action (MOA) and a treatment hypothesis, generate digital instructions based on the digital treatment module, and provide the digital instructions to the subject; and a result collection unit configured to collect results of the subject's implementation of the digital instructions.

[0206] In some embodiments, the digital instruction generation unit generates a digital therapeutic module based on the neurohormonal factors.

[0207] In some embodiments, the neurohormonal factors include insulin-like growth factors (IGFs), cortisol, and dopamine.

[0208] In some embodiments, the digital instruction generation unit generates the digital treatment module based on input from a healthcare provider.

[0209] In some embodiments, the digital instruction generation unit generates a digital therapy module based on information received from the subject.

[0210] In some embodiments, the information received from the subject includes at least one of the subject's baseline factors, medical information, and digital therapeutics utilization capability, where the baseline factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories); the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities, and genetic susceptibility; and the digital therapeutics utilization capability includes the subject's accessibility and technology receptivity to digital therapeutics and devices.

[0211] In some embodiments, the digital instruction generation unit generates a digital therapeutic module that matches the hypothesized parameters corresponding to the therapeutic hypothesis and mechanism of action.

[0212] In some embodiments, the virtual parameters are inferred relative to the subject's environment, behavior, emotions, and cognition.

[0213] In some embodiments, the results collection unit collects results of the execution of the digital instructions by monitoring the subject's compliance with the digital instructions or by allowing the subject to directly input the subject's compliance with the digital instructions.

[0214] In some embodiments, the generation of digital instructions in the digital instruction generation unit and the collection of subject's execution results for the digital instructions in the result collection unit are performed multiple times in multiple feedback loops, and the digital instruction generation unit generates the subject's digital instructions for the current round based on the subject's digital instructions from previous rounds and execution result data for the subject's digital instructions from previous rounds collected by the result collection unit.

[0215] 49 to 71 show data results obtained by analyzing data from the eye movements of a subject or group of subjects in real time.

[0216] Figures 49 and 50 show the correlation between ALOD or ALOS and subject age in the subject group.

[0217] FIG. 49 illustrates a graph showing the ALOD and ALOS difference and the correlation between ALOD and ALOS, where the subject's age during Visits V1, V4, and V5 is verified using a p-value. In some embodiments, the subject is between 5 and 12 years old. In some embodiments, the subject is a child. In some embodiments, the subject is under about 15 years old. In some embodiments, the subject is assisted or supervised by an adult.

[0218] ALOD indicates the axial length of the right eye (right eye) and is measured from the right eye of each subject. ALOS indicates the axial length of the left eye (left eye) and is measured from the left eye of each subject. Axial length indicates the normalized axial length.

[0219] The subject group can include an experimental group to which the method according to the present disclosure is applied and a control group to which the corresponding experimental group is compared.

[0220] Each graph in Figure 49 shows a p-value for the total subject group, a p-value for the experimental group, and a p-value for the control group based on measurements of the axial length of the right or left eye of subjects in the subject group. In the graphs, the x-axis shows the age of the subjects in the subject group, and the y-axis shows the difference in measured axial length of the right or left eye of subjects in the subject group.

[0221] In the graph, the letter V indicates a subject group's visit to the physician, and the number placed after the letter V indicates a time offset from the first visit to identify the particular visit for the subject group. For example, V1 can indicate the subject group's first visit, V3 can indicate the subject group's visit 3 weeks after the first visit, V4 can indicate the subject group's visit 12 weeks after the first visit, and V5 can indicate the subject group's visit 24 weeks after the first visit.

[0222] In some embodiments, a prescription can be provided to a subject group at each visit or at a particular visit. For example, a prescription can be provided to an experimental group at a first visit corresponding to V1, and a prescription can be provided at a visit corresponding to V4. In some embodiments, the prescription provided at the first visit can be referred to as a first prescription, and the prescription provided at a visit corresponding to V4 can be referred to as a second prescription.

[0223] In some embodiments, ALOD V4-V1 can indicate that a first prescription was provided to a group of subjects at an initial visit and the difference in axial length measurements of one or more subjects' right eyes between the initial visit and the visit 12 weeks after the initial visit. ALOD V5-V4 can indicate that a second prescription was provided to a group of subjects at a visit 12 weeks after the initial visit and the difference in axial length measurements of one or more subjects' right eyes between the 12-week visit and the 24-week visit. ALOD V5-V1 can indicate that a first prescription was provided to a group of subjects at an initial visit and the difference in axial length measurements of one or more subjects' right eyes between the initial visit and the visit 24 weeks after the initial visit.

[0224] In some embodiments, ALOS V4-V1 can indicate that a first prescription was provided to a subject group at an initial visit and the difference in axial length measurements of the left eye of one or more subjects in the subject group between the initial visit and the visit 12 weeks after the initial visit. ALOS V5-V4 can indicate that a second prescription was provided to a subject group at a visit 12 weeks after the initial visit and the difference in axial length measurements of the left eye of one or more subjects in the subject group between the 12-week visit and the 24-week visit. ALOS V5-V1 can indicate that a first prescription was provided to a subject group at an initial visit and the difference in axial length measurements of the left eye of one or more subjects in the subject group between the initial visit and the visit 24 weeks after the initial visit. The disclosed method of improving vision significantly reduces AL growth rate, particularly in subjects aged 10 years or older.

[0225] Figure 50 illustrates the ALOS and ALOD change ratios of experimental groups (e.g., ALOD V5 / V1 and ALOS V5 / V1). The correlation between ALOS and ALOD change ratios and the age factor (age-subgroup) is verified with p-values. The age-subgroups are categorized by predetermined ages, including age 1 and age 2. Age 1 is 9 years or younger, and age 2 is older than 9 years.

[0226] The method of improving the visual acuity of a subject according to the present disclosure can reduce the growth rate of the subject's AL (axial length). Figures 51-54 show the slowing of the growth rate of AL (axial length) due to the method of improving visual acuity of the present disclosure.

[0227] Figure 51 illustrates the ALOS growth rate (mm / year) for the experimental and control groups, respectively, for the periods V1 to V4 (V1-V4) and V4 to V5 (V4-V5). As illustrated in the right graph, the change (and / or rate of change) in ALOS growth rate for the experimental group between V1-V4 and V4-V5 is less than the change (and / or rate of change) in ALOS growth rate for the control group.

[0228] Figure 52 illustrates the ALOD growth rate (mm / year) for the experimental and control groups during the periods V1 to V4 (V1-V4) and V4 to V5 (V4-V5). As shown in the graphs on the right, the change (and / or rate of change) in ALOD growth rate for the experimental group between V1-V4 and V4-V5 was less than the change (and / or rate of change) in ALOD growth rate for the control group.

[0229] Figure 53 illustrates the normalized ALOS for the experimental group (red) and the control group (blue) during the V1-V4 period (V4-V1) and the V4-V5 period (V5-V4), respectively. As shown in the graph, the rate of change (or change) in normalized AL for the experimental group was smaller than that for the control group.

[0230] Figure 54 illustrates the normalized ALOD for the experimental group (red) and the control group (blue) during the V1-V4 period (V4-V1) and the V4-V5 period (V5-V4), respectively. As shown in the graph, the rate of change in normalized AL for the experimental group was smaller than that for the control group.

[0231] The method of improving the visual acuity of a subject according to the present disclosure can control the growth rate of the subject's axial length (AL). Figures 55-57 show the growth rate of the AL regulated by the method of improving visual acuity of the present disclosure.

[0232] Figure 55 illustrates the effect of age on ALOS and ALOD growth rates in experimental groups (e.g., ALOS V5 / V4 and ALOD V5 / V4). Age-subgroups are categorized by predetermined ages, including age 1 and age 2. Age 1 is 9 years or younger, and age 2 is older than 9 years. The method of improving vision of the present disclosure significantly reduces AL growth rates, particularly in subjects aged 10 years or older on their second prescription (see Figure 49). Here, time may not affect AL growth rates at V1-V4 among age-subgroups.

[0233] Figure 56 illustrates the correlation between the AL (axial length) growth rate according to a first prescription (e.g., V4-V1) and the AL (axial length) growth rate according to a second prescription (e.g., V5-V4) in the control group and the experimental group, respectively. The graph on the left side of Figure 56 shows the correlation between the AL of the first prescription (e.g., V4-V1) and the AL of the second prescription (e.g., V5-V4). The method of improving vision of the present disclosure can adjust the AL based on the correlation illustrated in Figure 57.

[0234] 57-64 show correlations between the growth rate of AL (axial length) and several factors in a subject's performance of eye movement instructions provided by a method for improving a subject's vision according to the present disclosure.

[0235] In some embodiments, a method according to the present disclosure can provide a digital application including one or more digital therapeutic modules for improving vision, each module including one or more first instructions including a first eye movement instruction to be followed by a subject. In some embodiments, the first instructions include a first eye movement instruction for the subject to move at least one eye vertically. In some embodiments, the first eye movement instruction is for the subject to move at least one eye by at least 50 of the subject's maximum vertical view of 100. In some embodiments, the first eye movement instruction is for the subject to move at least one eye by at least 70 of the subject's maximum vertical view of 100. In some embodiments, a method according to the present disclosure can measure the maximum vertical view using a sensor in the digital device.

[0236] In some embodiments, the digital application includes more instructions for vertical eye movement than instructions for horizontal eye movement. In some embodiments, the first eye movement instruction is to move at least one eye upward. The first instructions exclude instructions to move the at least one eye horizontally.

[0237] Figure 57 illustrates the correlation between a subject's adherence to eye movement instructions and CR (cycloplegic refraction) growth rate. As shown in Figure 57, subjects with high adherence have significantly lower growth rates than subjects with lower adherence. High adherence can be greater than 70%, and low adherence can be less than 70%.

[0238] Figure 58 illustrates the correlation between the eye movement velocity and the growth rate of AL (axial length) for subjects in the ALOS group following eye movement instructions, and Figure 59 illustrates the correlation between the eye movement velocity and the growth rate of AL for subjects in the ALOD group following eye movement instructions. Velocity can be expressed as total counts / total number of minutes or movements / minute. As shown in Figures 58-59, subjects with high velocity had significantly lower growth rates than subjects with low velocity.

[0239] According to the present disclosure, the first eye movement module may be implemented as a game, and the subject may enjoy playing the game in accordance with the first eye movement instructions provided by the game. In some embodiments, the game may provide various eye movement instructions for vertical eye movements, horizontal eye movements, or a combination thereof.

[0240] In the first eye movement instruction, which required subjects to move at least one eye vertically, the growth rate of AL (eye axial length) was significantly correlated with the average distance of eye movement. Figure 60 illustrates the correlation between the growth rate of AL and the average distance of eye movement performed by subjects in each game.

[0241] In the first eye movement instruction, which required subjects to move at least one eye vertically, the growth rate of AL (eye axial length) was significantly related to the maximum distance of eye movement. Figure 61 illustrates the correlation between the growth rate of AL and the maximum distance of eye movement performed by subjects in each game.

[0242] In the first eye movement instruction, which requires the subject to move at least one eye vertically, the growth rate of CR (cycloplegic refraction) is significantly related to the maximum distance of eye movement. Figure 62 illustrates the correlation between the growth rate of CR and the maximum distance of eye movement performed by the subject in each game.

[0243] In the first eye movement instruction, which requires the subject to move at least one eye vertically, the growth rate of CR (cycloplegic refraction) is significantly related to the game count the subject performs in each game. Figure 63 illustrates the correlation between the growth rate of CR and the normalized game count. The normalized game count illustrates the number of movements per game or per participation day for playing the corresponding game.

[0244] In the first eye movement instruction, which instructs the subject to move at least one eye vertically, the growth rate of AL (axial length) is related to the velocity of eye movement. Figure 64 illustrates the correlation between the growth rate of AL and the velocity of eye movement. As shown in Figure 64, subjects with higher velocity have lower growth rates than subjects with lower velocity.

[0245] Vertical eye movements according to the present disclosure can include up-down movements, upward movements, and downward movements.

[0246] FIG. 65 illustrates a graph showing the correlation between the growth rate and the average distance or maximum distance of eye movement when a subject performs a first eye movement instruction. The first eye movement instruction instructs the subject to move at least one eye vertically and can be implemented as a game. The game implementing the first eye movement can be the third game described in FIGS. 60 to 63. As shown in FIG. 65, there is a significant correlation between the growth rate and the average distance or maximum distance.

[0247] Figure 66 illustrates graphs depicting total counts, average distance, average maximum distance, and maximum distance for up / down, up / down, and down movements, respectively. Figure 66 illustrates five groups, each containing four graphs depicting total counts, average distance, average maximum distance, and maximum distance for up / down, up / down, and down movements, respectively. Each group represents the performance of each patient as they perform the first eye movement (or Game 3).

[0248] Figure 67 illustrates the correlation between CROD growth rate and mean distance, mean distance and maximum distance for upward and downward movements, respectively. Figure 67 discloses a graph showing the correlation when the patient performs the first eye movement.

[0249] Figures 68-71 illustrate the correlation between the growth rate of AL (axial length) and the mean and maximum distances for superior and inferior movements, respectively. Figures 68-71 disclose graphs showing the correlation when the patient performs the first eye movement.

[0250] 72a illustrates an example of a session provided by a digital application of the present disclosure. In some embodiments, the session includes one or more digital therapy modules. The one or more digital therapy modules can include an eye movement digital therapy module, a relaxation digital therapy module, and a deep breathing module.

[0251] FIG. 72b illustrates one or more digital therapy modules within a session. The one or more digital therapy modules may include an eye movement digital therapy module for improving vision, a relaxation digital therapy module, and a deep breathing module. The eye movement digital therapy module includes one or more eye movement instructions for the subject to follow. The one or more eye movement instructions may include an eye movement instruction for the subject to move at least one eye horizontally (or left and / or right), an eye movement instruction for the subject to rotate at least one eye, an eye movement instruction for the subject to move at least one eye vertically, an eye movement instruction for the subject to move at least one eye vertically and horizontally, and an eye movement instruction for the subject to move at least one eye repeatedly left and right.

[0252] FIG. 73 illustrates a flowchart illustrating the execution flow for a session of the digital application of the present disclosure. A session can be provided to a user (or patient) to follow a sequence of instructions within a predetermined time duration (e.g., 5 minutes). Thus, a session includes one or more digital therapeutic modules to provide the user with instructions to follow in a predetermined order. In some embodiments, the predetermined order can be changed. A session can include at least five periods. At least one eye movement module and one of a relaxation module and a deep breathing module can be provided in each period, but is not limited to this.

[0253] FIG. 74 illustrates a flowchart illustrating an execution flow for a session of a digital application of the present disclosure. The execution flow includes a first flow for executing the session based on user interaction and a second flow for determining whether to pause the session based on detection of at least one user eye state. In response to detection of a user input signal, the digital application can execute, suspend, or continue the session. In some embodiments, the digital application can detect or acquire at least one user state while the user follows one or more instructions provided during the session (Q1) and can pause the session based on the user state. For example, the user state can include i) no movement of at least one user eye for a predetermined period of time, ii) failure to detect two user eyes, iii) detection of a user gaze that does not correspond to a forward direction, and iv) failure to detect a user face within a predetermined distance. If any one of the user states is no longer detected, the digital application can continue the session (Q2).

[0254] 75 and 76 illustrate examples of user interfaces provided by the digital application of the present disclosure. The user interface can include visual images such as icons, images, characters, and / or information indicating one or more eye movements. The user interface can receive user input for selecting at least one eye movement. The user input causes the digital application of the present disclosure to instruct the processor of the digital device to perform operations. The performed operations include a digital therapy module for improving vision.

[0255] 77 and 78 illustrate examples of a user interface for eye movement instructions displayed on a digital device. The user interface can include visual images such as icons, images, characters, and / or information and can be displayed by the digital device. The eye movement digital therapy module includes eye movement instructions that cause the subject to move at least one eye horizontally (or left and / or right) according to an object moving between rails displayed on the user interface. The eye movement is detected by a sensor in the digital device and indicates the subject's compliance with the eye movement instructions of the eye movement digital therapy module.

[0256] Figure 79 is a flow chart illustrating the execution flow for the eye movement instructions of Figures 77 and 78. The boxes illustrated in Figure 79 indicate the execution flow of the user interface for the eye movement instructions displayed by the digital device.

[0257] FIG. 80 illustrates an example of a user interface for eye movement instructions displayed on a digital device. The user interface can include visual images such as icons, images, characters, and / or information and can be displayed by the digital device. The eye movement digital therapy module includes eye movement instructions that cause the subject to repeatedly move at least one eye to the left and right. The eye movement is sensed by a sensor in the digital device and indicates the subject's compliance with the eye movement instructions of the eye movement digital therapy module.

[0258] FIG. 81 is a flowchart illustrating the flow of execution in response to the eye movement instruction of FIG.

[0259] FIG. 82 illustrates an example of a user interface for eye movement instructions displayed on a digital device. The user interface can include visual images such as icons, images, characters, and / or information and can be displayed by the digital device. The eye movement digital therapy module includes eye movement instructions that cause the subject to vertically move at least one eye. The eye movement is sensed by a sensor in the digital device and indicates the subject's compliance with the eye movement instructions of the eye movement digital therapy module.

[0260] FIG. 83 is a flowchart illustrating the flow of execution in response to the eye movement instruction of FIG.

[0261] 84 and 85 illustrate examples of user interfaces for eye movement instructions displayed on a digital device. The user interface can include visual images such as icons, images, characters, and / or information and can be displayed by the digital device. The eye movement digital therapy module includes eye movement instructions that cause the subject to rotate at least one eye. The eye movement is sensed by a sensor in the digital device and indicates the subject's compliance with the eye movement instructions of the eye movement digital therapy module.

[0262] FIG. 86 is a flowchart illustrating the flow of execution for the eye movement instructions of FIGS. 84 and 85.

[0263] FIG. 87 illustrates an example of a user interface for eye movement instructions displayed on a digital device. The user interface can include visual images such as icons, images, characters, and / or information and can be displayed by the digital device. The eye movement digital therapy module includes eye movement instructions that cause the subject to move at least one eye vertically and horizontally. The eye movement is sensed by a sensor in the digital device and indicates the subject's compliance with the eye movement instructions of the eye movement digital therapy module.

[0264] FIG. 88 is a flowchart illustrating the flow of execution in response to the eye movement instruction of FIG.

[0265] 89a and 89b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 77 and 78 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0266] 90a and 90b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 77 and 78 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0267] 91a and 91b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 77 and 78 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0268] 92a and 92b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 77 and 78 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0269] 93a and 93b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 84 and 85 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0270] 94a and 94b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 84 and 85 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0271] 95a and 95b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 84 and 85 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0272] 96a and 96b illustrate (a) screenshots of the eye movement digital therapy module of FIGS. 84 and 85 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0273] 97a and 97b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0274] 98a and 98b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure, and (b) a flowchart illustrating the flow of execution for the eye movement digital therapy module.

[0275] 99a and 99b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0276] 100a and 100b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 82 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0277] 101a and 101b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0278] 102a and 102b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0279] 103a and 103b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0280] 104a and 104b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 87 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0281] 105a and 105b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0282] 106a and 106b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0283] 107a and 107b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0284] 108a and 108b illustrate (a) a screenshot of the eye movement digital therapy module of FIG. 80 of the present disclosure, and (b) a flowchart illustrating the execution flow for the eye movement digital therapy module.

[0285] Figures 109-112 are flow charts showing the execution flow for the relaxation module, and Figure 113 is a flow chart showing the execution flow for the deep breathing module. The relaxation module can consist of a series of behavioral instructions for the subject to follow to rest through blinking, stretching arms to the sides, listening to music, etc. The deep breathing module can consist of a series of behavioral instructions for the subject to follow to take deep breaths.

[0286] 114a-114c illustrate screenshots of a series of behavioral instructions for the Relaxation Module.

[0287] 115a and 115b illustrate screenshots of a series of action instructions for the deep breathing module.

[0288] 116a-116c illustrate (a) a flowchart showing the execution flow for an eye movement customization process, (b) a flowchart showing six execution steps of the eye movement customization process, and (c) a flowchart showing the execution flow for each execution step of the eye movement customization process. The customization process can recognize at least one eye of a subject or at least one eye movement of the subject, and provide a series of eye movement instructions for the subject based on the recognized eye movement.

[0289] 117a and 117b illustrate examples of user interfaces for the eye movement customization process provided by the digital application of the present disclosure. The user interface may include visual images such as icons, images, characters, and / or information that prompt the subject to move at least one eye. A sensor in the digital device may detect at least one eye of the subject or the movement of at least one eye of the subject. Depending on the detected results, the digital application of the present disclosure may instruct the processor of the digital device to perform operations for the customization process.

[0290] FIG. 118 is a flow chart illustrating the execution flow for the eye movement customization process when at least one eye movement is not recognized.

[0291] 119a and 119b illustrate examples of user interfaces for the eye movement customization process provided by the digital application of the present disclosure. The user interface can include visual images such as icons, images, text, and / or information indicating a failure to detect at least one eye of the subject; a movement of at least one eye of the subject; or pausing, resetting, and / or continuing the session.

[0292] 120 to 125 are diagrams for explaining the method and results of a clinical trial to confirm the association between the motor performance pattern of a subject or group of subjects receiving a digital therapy according to the present disclosure and the progression of myopia.

[0293] 120a to 120e are execution screens for different types of games that instruct the test subject to perform different eye movements.

[0294] Figure 120a is an execution screen of a game (game 1) for inducing horizontal (side-to-side) movement of the eyeball, Figure 120b is an execution screen of a game (game 2) for inducing rotational movement of the eyeball, Figure 120c is an execution screen of a game (game 3) for inducing vertical (up-down) movement of the eyeball, Figure 120d is an execution screen of a game (game 4) for inducing up-down, left-to-right movement of the eyeball, and Figure 120e is an execution screen of a game (game 5) for inducing horizontal (side-to-side) movement of the eyeball.

[0295] FIG. 121a is a photograph illustrating the eye movement of a subject playing a game that induces vertical or horizontal eye movement.

[0296] This is a photographic example of the eye positions when a subject moves their eyes up, down, left and right in response to the guidance of the game illustrated in Figure 120. The subject's eye positions can be detected by sensors in the digital device.

[0297] 121b and 121c are graphs measuring the average and maximum distance of the subjects' effective eye movements guided by the game illustrated in FIG.

[0298] Figure 121b is a graph showing the average distance measured in the subjects' effective eye movements for Games 1 and 5, which are games for inducing horizontal (side-to-side) eye movements, and Game 3, which is a game for inducing vertical (up-down) eye movements. Referring to Figure 121b, the average distance of horizontal eye movements for the games for inducing horizontal (side-to-side) eye movements (Games 1 and 5) is longer than the average distance of vertical eye movements for the game for inducing vertical (up-down) eye movements (Game 3).

[0299] Figure 121c is a graph showing the maximum distance measured in the subjects' effective eye movements when playing Games 1 and 5, which are games for inducing horizontal (side-to-side) eye movements, and Game 3, which is a game for inducing vertical (up-down) eye movements. Referring to Figure 121c, the maximum distance of horizontal eye movements when playing Games 1 and 5, which are games for inducing horizontal (side-to-side) eye movements, is longer than the maximum distance of vertical eye movements when playing Game 3, which is a game for inducing vertical (up-down) eye movements.

[0300] 122-125 are graphs showing the results of a clinical trial to ascertain the association between motor performance patterns and myopia progression in a subject or group of subjects in a digital therapeutic regimen according to the present disclosure.

[0301] This clinical trial had an exploratory purpose to evaluate the safety and effectiveness of a digital therapy for improving vision, and the experimental group consisted of pediatric myopic patients aged 5 to 13 years. The pediatric myopic patients in the experimental group used the digital therapy for 30 minutes per day, five times a week, for 48 weeks (approximately one year) in addition to their usual myopia treatment (wearing glasses). The clinical trial also aimed to examine the relationship between motor performance patterns over a specified period (one year) and myopia progression, and only included subjects who completed the entire one-year treatment, including four prescriptions, and collected all efficacy evaluation variables.

[0302] This clinical trial was designed to test the hypothesis that the subjects' performance in horizontal versus vertical exercises is associated with myopia progression.To this end, the efficacy variables used in this clinical trial to indicate myopia progression were i) the change in axial length (AL) from baseline to 48 weeks [AL at 48 weeks - AL at baseline] and ii) the change in cycloplegic refraction (CR) from baseline to 48 weeks [CR at 48 weeks - CR at baseline]. In addition, in this clinical trial, the percentage of subjects performing vertical movements relative to horizontal movements was calculated as follows: i) the annual average of the maximum daily distance measured by the subjects' eye movements using Game 3 (for vertical movements) divided by the annual average of the maximum daily distance measured by the subjects' eye movements using Game 1 (for horizontal movements); or ii) the annual average of the maximum daily distance measured by the subjects' eye movements using Game 3 (for vertical movements) divided by the annual average of the maximum daily distance measured by the subjects' eye movements using Game 5 (for horizontal movements). [Table 1] In this clinical trial, correlation analysis was used to statistically confirm the relationship between the efficacy evaluation variables and the performance rate of vertical movement versus horizontal movement. Two-sample t-test, a parameter-based test method, and Mann-Whitney test, a non-parameter-based test method, were both used.

[0303] Figure 122 is a graph summarizing the results when the subject's percentage of horizontal versus vertical movement performance was measured as [1-year average of maximum daily distance measured by the subject's eye movement in Game 3 / 1-year average of maximum daily distance measured by the subject's eye movement in Game 1], and the efficacy evaluation variable was measured as the change in axial length (AL) from baseline to 48 weeks [AL at 48 weeks - AL at baseline]. Referring to Figure 122, it was confirmed that the higher the subject's percentage of horizontal versus vertical movement performance (i.e., the more horizontal and vertical movements possible), the lower the degree of myopia progression (smaller change in axial length over one year). However, the left eye (Figure 122a) showed a statistically significant correlation, while the right eye (Figure 122b) showed a similar trend, though not statistically significant.

[0304] Figure 123 is a graph summarizing the results when the subjects' percentage of vertical movement compared to horizontal movement was measured as [1-year average of maximum daily distance measured by the subjects' eye movements using Game 3 / 1-year average of maximum daily distance measured by the subjects' eye movements using Game 5], and the efficacy evaluation variable was measured as the change in axial length (AL) from baseline to 48 weeks [AL at 48 weeks - AL at baseline]. Referring to Figure 123, it was confirmed that the higher the subjects' percentage of vertical movement compared to horizontal movement (i.e., the more horizontal movement they were able to perform, the lower the progression of myopia (smaller change in axial length over one year), and this showed a statistically significant correlation (p<0.05) for both the left eye (Figure 123a) and the right eye (Figure 123b).

[0305] Figure 124 is a graph summarizing the results when the subject's percentage of vertical movement compared to horizontal movement was measured as [1-year average of maximum daily distance measured by the subject's eye movement in Game 3 / 1-year average of maximum daily distance measured by the subject's eye movement in Game 1], and the efficacy evaluation variable was measured as the change in refractive power (CR) from baseline to 48 weeks [CR at 48 weeks - CR at baseline]. Referring to Figure 124, it was confirmed that the higher the subject's percentage of vertical movement compared to horizontal movement (i.e., the more horizontal movement they were able to perform, the lower the progression of myopia (smaller change in refractive power over one year), and both eyes (Figures 124a and 124b) showed similar trends, although not significant.

[0306] Figure 125 is a graph summarizing the results when the subject's percentage of vertical movement compared to horizontal movement was measured as [1-year average maximum daily distance measured by the subject's eye movement in Game 3 / 1-year average maximum daily distance measured by the subject's eye movement in Game 5], and the efficacy evaluation variable was measured as the change in refractive power (CR) from baseline to 48 weeks [CR at 48 weeks - CR at baseline]. Referring to Figure 125, it was confirmed that the higher the subject's percentage of vertical movement compared to horizontal movement (i.e., the more horizontal movement they were able to perform, the lower the progression of myopia (smaller change in refractive power over one year), and this showed a statistically significant correlation (p<0.05) for both the left eye (Figure 125a) and the right eye (Figure 125b).

[0307] In one aspect, the present disclosure relates to the following embodiments:

[0308] Embodiment 1. A method for improving a subject's vision, the method comprising providing to the subject by a digital device a digital application including one or more digital therapeutic modules for improving vision, each module including one or more first instructions to be followed by the subject, the first instructions including a first eye movement instruction causing the subject to vertically move at least one eye.

[0309] Embodiment 2. A method of treating myopia in a subject in need of myopia treatment, the method comprising providing, by a digital device, to the subject a digital application including one or more digital treatment modules for treating myopia, each module including one or more first instructions to be followed by the subject, the first instructions including first eye movement instructions causing the subject to vertically move at least one eye.

[0310] Embodiment 3. In a method of any one of the preceding embodiments, in some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 50 of the subject's maximum vertical view 100.

[0311] Embodiment 4. In a method of any one of the preceding embodiments, in some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 70 of the subject's maximum vertical view 100.

[0312] Embodiment 5. A method of any one of the preceding embodiments, wherein the digital application includes more instructions for vertical eye movement than instructions for horizontal eye movement.

[0313] Embodiment 6. The method of any one of the preceding embodiments, wherein the first eye movement instruction is to move the at least one eye upward.

[0314] Embodiment 7. In the method of any one of embodiments 1 to 5, the first eye movement instructions include more instructions to move the at least one eye upward than instructions to move the at least one eye downward.

[0315] Embodiment 8. The method of any one of the preceding embodiments, wherein the first instruction excludes an instruction to move the at least one eye horizontally.

[0316] Embodiment 9. The method of any one of the preceding embodiments, wherein the method improves the growth rate of AL (axial length) of said at least one eye of the subject.

[0317] Embodiment 10. The method of any one of the preceding embodiments, wherein the method reduces the growth rate of AL (axial length) of said at least one eye of the subject.

[0318] Embodiment 11 The method of any one of the preceding embodiments, further comprising measuring the maximum vertical view of the subject.

[0319] Embodiment 12. In the method of embodiment 10, the measurement is performed by a sensor of the digital device.

[0320] Embodiment 13 In the method of any one of the preceding embodiments, the subject is 10 years of age or older.

[0321] Embodiment 14. In the method of any one of the preceding embodiments, the modules are selected based on a mechanism of action and a treatment hypothesis, and the digital device (i) includes a sensor that senses the subject's compliance with one or more first instructions of the modules, (ii) based on the compliance, transmits the compliance information to a server accessible to the healthcare provider through a healthcare provider portal, and (iii) receives one or more second instructions from the healthcare provider based on the compliance information.

[0322] Embodiment 15. The method of embodiment 14, wherein the one or more second instructions include a second eye movement instruction for adjusting the rate of eye movement based on compliance information.

[0323] Embodiment 16. In the method of any one of the preceding embodiments, the digital application directs a processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis.

[0324] Embodiment 17. In the method of embodiment 14, generating the digital therapeutic module includes generating the digital therapeutic module based on neurohormonal factors.

[0325] Embodiment 18. In the method of embodiment 14 or 15, the operations further include generating a calibration module for calibrating one or more of the measurement accuracy of the subject's eye position and the lighting environment.

[0326] Embodiment 19. In the method of embodiment 18, the calibration module is generated before generating the digital therapy module.

[0327] Embodiment 20. In the method of embodiment 18 or 19, the measurement accuracy of the subject's eye position is calibrated, and said calibration of the measurement accuracy of the subject's eye position includes one or more of instructing the subject to position their face so that it appears on the screen of the digital device, detecting the subject's eyes for a given period of time, instructing the subject to blink their eyes, detecting whether the subject blinks their eyes, instructing the subject to stare at the screen, instructing the subject to move their eyes in a given direction or rotate their eyes, and determining a threshold value for detecting the subject's eyes.

[0328] Embodiment 21. In any one of the methods of embodiments 18 to 20, the measurement accuracy of the lighting environment is calibrated, and said calibration to the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment.

[0329] Embodiment 22. In the method of any one of the preceding embodiments, the digital device includes one or more sensors for tracking eye movements of the subject.

[0330] Embodiment 23. In the method of any one of the preceding embodiments, the digital application instructs the processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis; generating digital instructions based on the digital therapeutic module; providing the digital instructions to the subject; and collecting results of the subject's implementation of the digital instructions.

[0331] Embodiment 24. In the method of embodiment 23, generating digital instructions and collecting subject performance results on the digital instructions are performed multiple times in multiple feedback loops, and generating digital instructions includes generating subject digital instructions for a current round based on the subject's digital instructions from previous rounds and collected performance result data on the subject's digital instructions provided from the previous rounds.

[0332] Embodiment 25 In the method of embodiment 23 or 24, collecting results of the subject's performance of the digital instructions includes determining one or both of Exertion Intensity (EI) and Average Exertion Intensity (AEI).

[0333] Embodiment 26. The method of embodiment 25, wherein the AEI is determined as the average sum of the differences between the final position of the subject's eye and the starting position of the eye measured at a given interval.

[0334] Embodiment 27. The method of embodiment 26, wherein the interval is between about 10 milliseconds (ms) and about 500 ms.

[0335] Embodiment 28. In the method of any one of Embodiments 25-27, EI is determined by the following formula:

number

[0336] Embodiment 30. In any one of the methods of embodiments 16 to 29, the step of generating a digital therapeutic module includes a step of generating a digital therapeutic module by applying virtual parameters for the subject's environment, behavior, emotions, and cognition to the treatment hypothesis and mechanism of action.

[0337] Embodiment 31. In the method of any one of the preceding embodiments, the digital application instructs the processor of the digital device to generate (i) an eye movement module including eye movement instructions, and (ii) a digital therapy module including at least one of a relaxation module and a light therapy module.

[0338] Embodiment 32. In the method of embodiment 31, the eye movement module further includes one or more of bio-feedback control instructions and eye-related behavior control instructions; the relaxation module includes one or more relaxation instructions for one or more of physical movement instructions, ego-enhancement instructions, feeling of safety instructions, feeling of calmness instructions, and enjoyment instructions; and the light therapy module includes one or more light therapy instructions for controlling the subject's lighting environment.

[0339] Embodiment 33. In the method of embodiment 32, the one or more relaxation instructions include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

[0340] Embodiment 34. In any one of the methods of embodiments 31 to 33, the digital therapeutic module further includes an achievement module including one or more achievement instructions for task achievement and for providing compensation for the subject's compliance with the instructions of the two or more first modules.

[0341] Embodiment 35. In any one of the methods of embodiments 31-34, the digital therapeutic module further includes a fun module including one or more fun instructions for music, games, or videos.

[0342] Embodiment 36. In any one of the methods of embodiments 14 to 35, the healthcare provider portal is configured to provide the healthcare provider with one or more options to perform one or more tasks to prescribe a treatment to the subject based on the adherence information, and the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing the subject, viewing or editing personal information about the subject, viewing adherence information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing the prescription for one or more digital therapeutic modules, and communicating with the subject.

[0343] Embodiment 37. In the method of embodiment 36, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, prescriptions for the subject, and one or more notes created by a healthcare provider for the subject.

[0344] Embodiment 38. In the method of embodiment 37, the personal information includes a prescription for the subject, and the prescription for the subject includes one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, the number of digital therapeutic modules scheduled or prescribed to be performed by the subject, and the number of digital therapeutic modules scheduled or prescribed to be performed by the subject per day.

[0345] Embodiment 39. In the method of embodiment 36 or 37, one or more options include viewing compliance information, wherein the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0346] Embodiment 40. In any one of the methods of embodiments 36-39, one or more options include viewing the subject's results, wherein the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapy module, the time the subject finished the scheduled or prescribed digital therapy module, an indication of whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI).

[0347] Embodiment 41. In the method of any one of embodiments 14 to 40, the server is accessible by an administrator through an administrative portal configured to provide one or more options to the administrator of the system to perform one or more tasks for managing healthcare provider access to the system, wherein the one or more options provided to the administrator of the method are selected from the group consisting of adding or removing healthcare providers, viewing or editing personal information about healthcare providers, viewing or editing de-identified information about subjects, viewing compliance information about subjects, viewing subject outcomes for one or more at least partially completed digital treatment modules, and communicating with healthcare providers.

[0348] Embodiment 42. In the method of embodiment 41, the one or more options include viewing or editing personal information, and the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, a name of the healthcare provider, an email address of the healthcare provider, and a contact phone number for the healthcare provider.

[0349] Embodiment 43. In the method of embodiment 41 or 42, one or more options include viewing or editing the subject's de-identified information, the subject's de-identified information including one or more selected from the group consisting of an identification number for the subject and a health care provider for the subject.

[0350] Embodiment 44. In any one of the methods of embodiments 41-43, one or more options include viewing compliance information regarding the subject, wherein the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0351] Embodiment 45. In any one of the methods of embodiments 41-44, one or more options include viewing the subject's results, and the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapy module, the time the subject finished the scheduled or prescribed digital therapy module, an indication of whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI).

[0352] Embodiment 46. In the method of any one of the preceding embodiments, the digital application further includes a push alarm for one or more of reminding the subject to complete a digital treatment module and adjusting lighting settings in the subject's environment.

[0353] Embodiment 47. In the method of embodiment 45, the push alarm is activated to remind the subject to adjust lighting settings so that the subject is exposed to sufficiently bright light at least three times per day.

[0354] Embodiment 48 In the method of any one of the preceding embodiments, the subject is a child.

[0355] Embodiment 49 In the method of embodiment 48, the subject is under about 15 years of age.

[0356] Embodiment 50 In the method of any one of the preceding embodiments, the subject is assisted or supervised by an adult.

[0357] Embodiment 51. In the method of any one of the preceding embodiments, the digital device includes a digital instruction generation unit configured to generate a digital treatment module based on a mechanism of action (MOA) and a treatment hypothesis, generate digital instructions based on the digital treatment module, and provide the digital instructions to the subject; and a result collection unit configured to collect the subject's execution results regarding the digital instructions.

[0358] Embodiment 52 In the method of embodiment 51, the digital instruction generation unit generates a digital therapeutic module based on neurohormonal factors.

[0359] Embodiment 53 In the method of embodiment 52, the neurohormonal factors include insulin-like growth factor (IGF), cortisol, and dopamine.

[0360] Embodiment 54. In the method of any one of embodiments 51 to 53, the digital instruction generation unit generates a digital treatment module based on input from a healthcare provider.

[0361] Embodiment 55. In the method of any one of embodiments 51 to 54, the digital instruction generation unit generates a digital therapeutic module based on information received from the subject.

[0362] Embodiment 56. In the method of embodiment 55, the information received from the subject includes at least one of the subject's basic factors, medical information, and digital therapeutics utilization capability, where the basic factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories), the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities, and genetic susceptibility, and the digital therapeutics utilization capability includes the subject's accessibility and technology receptivity to digital therapeutics and devices.

[0363] Embodiment 57. In the method of any one of embodiments 51 to 56, the digital instruction generation unit generates a digital therapeutic module that matches the hypothetical parameters corresponding to the therapeutic hypothesis and mechanism of action.

[0364] Embodiment 58 In the method of embodiment 57, the virtual parameters are inferred relative to the subject's environment, behavior, emotions, and cognition.

[0365] Embodiment 59. In any one of the methods of embodiments 51 to 58, the result collection unit collects the results of the execution of the digital instructions by monitoring the subject's compliance with the digital instructions or by allowing the subject to directly input the subject's compliance with the digital instructions.

[0366] Embodiment 60. In any one of the methods of embodiments 51 to 59, the generation of digital instructions in the digital instruction generation unit and the collection of the subject's execution results regarding the digital instructions in the result collection unit are performed multiple times in multiple feedback loops, and the digital instruction generation unit generates the subject's digital instructions for the current round based on the subject's digital instructions from the previous round and the execution result data regarding the subject's digital instructions from the previous round collected by the result collection unit.

[0367] Embodiment 61. A system for improving a subject's vision, the system including: a digital device configured to execute a digital application for improving the subject's vision [by the methods of embodiments 1 to 59]; a healthcare provider portal configured to provide a healthcare provider with one or more options for performing one or more tasks to prescribe a treatment for improving the subject's vision based on information received from the digital application; and an administration portal configured to provide an administrator of the system with one or more options for performing one or more tasks to manage healthcare provider access to the system.

[0368] Embodiment 62. A system for treating myopia in a subject in need of myopia treatment, the system including: a digital device configured to execute a digital application for treating myopia in the subject [by the methods of embodiments 1-59]; a healthcare provider portal configured to provide a healthcare provider with one or more options for performing one or more tasks to prescribe a therapy for treating the subject's myopia based on information received from the digital application; and an administration portal configured to provide an administrator of the system with one or more options for performing one or more tasks to manage healthcare provider access to the system.

[0369] Embodiment 63. A non-transitory computer-readable medium having stored thereon software instructions for improving a subject's vision, the software instructions, when executed by a processor, cause the processor to display, via a digital device, modules for improving vision to the subject - each module including one or more instructions to be followed by the subject, a first instruction including an eye movement instruction causing the subject to move at least one eye vertically - and to sense, via a sensor within the digital device, the subject's compliance with the module's instructions.

[0370] Embodiment 64. A non-transitory computer-readable medium having stored thereon software instructions for treating myopia in a subject in need of myopia treatment, wherein the software instructions, when executed by a processor, cause the processor to display, via a digital device, modules for treating myopia to the subject - each module including one or more instructions to be followed by the subject, a first instruction including an eye movement instruction causing the subject to move at least one eye vertically - and to sense, via a sensor within the digital device, the subject's compliance with the module's instructions.

[0371] Embodiment 65. In a non-transitory computer-readable medium of any one of the preceding embodiments, in some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 50 of the subject's maximum vertical view 100.

[0372] Embodiment 66. In a non-transitory computer-readable medium of any one of the preceding embodiments, in some embodiments, the first eye movement instruction is for the subject to move the at least one eye by at least 70 of the subject's maximum vertical view 100.

[0373] Embodiment 67. The non-transitory computer-readable medium of any one of the preceding embodiments, wherein the digital application includes more instructions for vertical eye movements than instructions for horizontal eye movements.

[0374] Embodiment 68. The non-transitory computer-readable medium of any one of the preceding embodiments, wherein the first eye movement instruction is to move the at least one eye upward.

[0375] Embodiment 69. In any one of the non-transitory computer-readable media of embodiments 63 to 68, the first eye movement instructions include more instructions to move the at least one eyeball upward than instructions to move the at least one eyeball downward.

[0376] Embodiment 70. The non-transitory computer-readable medium of any one of the preceding embodiments, wherein the first instructions exclude instructions to move the at least one eyeball horizontally.

[0377] Embodiment 71. In the non-transitory computer-readable medium of any one of the preceding embodiments, the method improves the growth rate of AL (axial length) of the at least one eye of the subject.

[0378] Embodiment 72. In the non-transitory computer-readable medium of any one of the preceding embodiments, the method reduces the growth rate of AL (axial length) of the at least one eye of the subject.

[0379] Embodiment 73. The non-transitory computer-readable medium of any one of the embodiments, further comprising measuring the maximum vertical view of the subject.

[0380] Embodiment 74. In the non-transitory computer-readable medium of embodiment 73, the measurement is performed by a sensor of the digital device.

[0381] Embodiment 75. The non-transitory computer-readable medium of any one of the preceding embodiments, wherein the subject is 10 years of age or older.

[0382] Embodiment 76. In the non-transitory computer-readable medium of embodiment 63 or 64, the modules are selected based on a mechanism of action and a therapeutic hypothesis.

[0383] Embodiment 77. In the non-transitory computer-readable medium of embodiment 63 or 64, the non-transitory computer-readable medium is further configured to, for the processor, transmit, by the digital device, compliance information based on compliance to a server accessible to the healthcare provider through a healthcare provider portal; and receive, from the server, one or more second instructions from the healthcare provider.

[0384] Embodiment 78. In the non-transitory computer-readable medium of embodiment 77, the digital application instructs the processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis.

[0385] Embodiment 79. In the non-transitory computer-readable medium of embodiment 78, generating a digital therapeutic module includes generating a digital therapeutic module based on neurohormonal factors.

[0386] Embodiment 80. In the non-transitory computer-readable medium of embodiment 78 or 79, the operation further includes generating a calibration module for calibrating one or more of the measurement accuracy of the subject's eye position and the lighting environment.

[0387] Embodiment 81. In the non-transitory computer-readable medium of embodiment 80, the calibration module is generated prior to generating the digital therapy module.

[0388] Embodiment 82. In the non-transitory computer-readable medium of embodiment 80 or 81, the accuracy of measuring the position of the subject's eyes is calibrated, and said calibration of the accuracy of measuring the position of the subject's eyes includes one or more of instructing the subject to position their face so that it appears on the screen of the digital device, detecting the subject's eyes for a given period of time, instructing the subject to blink their eyes, detecting whether the subject blinks their eyes, instructing the subject to stare at the screen, instructing the subject to move their eyes in a given direction or rotate their eyes, and determining a threshold value for detecting the subject's eyes.

[0389] Embodiment 83. In the non-transitory computer-readable medium of embodiment 82, the digital device includes one or more sensors for tracking eye movements of the subject.

[0390] Embodiment 84. In the non-transitory computer-readable medium of any one of embodiments 80 to 83, the measurement accuracy of the lighting environment is calibrated, and said calibration for the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment.

[0391] Embodiment 85. In a non-transitory computer-readable medium of any one of embodiments 77 to 84, the digital application instructs a processor of the digital device to perform operations including generating a digital therapeutic module based on the mechanism of action and the therapeutic hypothesis; generating digital instructions based on the digital therapeutic module; providing the digital instructions to a subject; and collecting results of the subject's execution of the digital instructions.

[0392] Embodiment 86. In the non-transitory computer-readable medium of embodiment 85, generating digital instructions and collecting subject performance results on the digital instructions are performed multiple times in multiple feedback loops, and generating digital instructions includes generating subject digital instructions for a current round based on the subject's digital instructions from previous rounds and collected performance result data on the subject's digital instructions provided from the previous rounds.

[0393] Embodiment 87. In the non-transitory computer-readable medium of embodiment 85 or 86, collecting results of the subject's performance of the digital instructions includes determining one or both of exertion intensity (EI) and average exertion intensity (AEI).

[0394] Embodiment 88. The non-transitory computer-readable medium of embodiment 87, wherein the AEI is determined as the average sum of the differences between the final position of the subject's eye and the starting position of the eye measured at a given interval.

[0395] Embodiment 89. In the non-transitory computer-readable medium of embodiment 88, the interval is between about 10 milliseconds (ms) and about 500 ms.

[0396] Embodiment 90. In the non-transitory computer-readable medium of any one of embodiments 87-89, EI is determined by the following formula:

number

[0397] Embodiment 92. In any one of the non-transitory computer-readable media of embodiments 78 to 91, the step of generating a digital therapeutic module includes a step of generating a digital therapeutic module by applying virtual parameters for the subject's environment, behavior, emotions, and cognition to a treatment hypothesis and mechanism of action.

[0398] Embodiment 93. In the non-transitory computer-readable medium of any one of embodiments 78 to 92, the digital application instructs a processor of the digital device to generate a digital therapy module including two or more modules selected from the group consisting of an eye movement module, a relaxation module, and a phototherapy module.

[0399] Embodiment 94. In the non-transitory computer-readable medium of embodiment 93, the eye movement module includes one or more movement instructions for one or more of eye movement instructions, bio-feedback control instructions, and eye-related behavior control instructions; the relaxation module includes one or more relaxation instructions for one or more of physical movement instructions, ego-enhancement instructions, feeling of safety instructions, feeling of calmness instructions, and enjoyment instructions; and the light therapy module includes one or more light therapy instructions for controlling the subject's lighting environment.

[0400] Embodiment 95. In the non-transitory computer-readable medium of embodiment 94, the one or more relaxation instructions include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

[0401] Embodiment 96. In the non-transitory computer-readable medium of any one of embodiments 93 to 95, the digital therapeutic module further includes an achievement module including one or more achievement instructions for task achievement and for providing compensation for the subject's compliance with the instructions of the two or more first modules.

[0402] Embodiment 97. In the non-transitory computer-readable medium of any one of embodiments 93 to 96, the digital therapeutic module further includes a fun module including one or more fun instructions for music, games, or videos.

[0403] Embodiment 98. In the non-transitory computer-readable medium of any one of embodiments 77 to 97, the healthcare provider portal is configured to provide the healthcare provider with one or more options to perform one or more tasks to prescribe a treatment to the subject based on the adherence information, and the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing adherence information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing the prescription for one or more digital therapeutic modules, and communicating with the subject.

[0404] Embodiment 99. In the non-transitory computer-readable medium of embodiment 98, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian's email, a contact phone number for the subject, prescriptions for the subject, and one or more notes created by a healthcare provider for the subject.

[0405] Embodiment 100. In the non-transitory computer-readable medium of embodiment 99, the personal information includes a prescription for the subject, and the prescription for the subject includes one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, the number of digital therapeutic modules scheduled or prescribed to be performed by the subject, and the number of digital therapeutic modules scheduled or prescribed to be performed by the subject per day.

[0406] Embodiment 101. In the non-transitory computer-readable medium of any one of embodiments 98 to 100, one or more options include viewing compliance information, wherein the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0407] Embodiment 102. In the non-transitory computer-readable medium of any one of embodiments 98 to 101, one or more options include viewing the subject's results, wherein the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapy module, the time the subject finished the scheduled or prescribed digital therapy module, an indicator of whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI).

[0408] Embodiment 103. In the non-transitory computer-readable medium of any one of embodiments 77 to 102, the server is accessible by an administrator through an administrative portal configured to provide one or more options to the administrator of the system to perform one or more tasks for managing access to the system by healthcare providers, and the one or more options provided to the administrator of the method are selected from the group consisting of adding or removing healthcare providers, viewing or editing personal information about healthcare providers, viewing or editing de-identified information about subjects, viewing compliance information about subjects, viewing subject results for one or more at least partially completed digital treatment modules, and communicating with healthcare providers.

[0409] Embodiment 104. In the non-transitory computer-readable medium of embodiment 103, the one or more options include viewing or editing personal information, and the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, a name of the healthcare provider, an email address of the healthcare provider, and a contact phone number for the healthcare provider.

[0410] Embodiment 105. In the non-transitory computer-readable medium of embodiment 103 or 104, the one or more options include viewing or editing the subject's de-identified information, the subject's de-identified information including one or more selected from the group consisting of an identification number for the subject and a health care provider for the subject.

[0411] Embodiment 106. In the non-transitory computer-readable medium of any one of embodiments 103 to 105, one or more options include viewing compliance information regarding the subject, wherein the subject's compliance information includes one or more of: the number of digital therapeutic modules completed (scheduled or prescribed) by the subject; and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules.

[0412] Embodiment 107. In the non-transitory computer-readable medium of any one of embodiments 103 to 106, one or more options include viewing the subject's results, wherein the subject's results for one or more at least partially completed digital therapy modules include one or more selected from the group consisting of the time the subject started the scheduled or prescribed digital therapy module, the time the subject finished the scheduled or prescribed digital therapy module, an indicator of whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI).

[0413] Embodiment 108. In the non-transitory computer-readable medium of any one of embodiments 77 to 107, the digital application further includes a push alarm for one or more of reminding the subject to complete a digital treatment module and adjusting lighting settings in the subject's environment.

[0414] Embodiment 109. In the non-transitory computer-readable medium of any one of embodiments 77 to 108, a push alarm is activated to remind the subject to adjust lighting settings so that the subject is exposed to sufficiently bright light at least three times a day.

[0415] Embodiment 110. In the non-transitory computer-readable medium of any one of embodiments 77 to 109, the subject is a child.

[0416] Embodiment 111. In the non-transitory computer-readable medium of embodiment 110, the subject is under about 15 years of age.

[0417] Embodiment 112. In the non-transitory computer-readable medium of any one of embodiments 77 to 111, the subject is assisted or supervised by an adult.

[0418] Embodiment 113. In a non-transitory computer-readable medium of any one of embodiments 77 to 112, the digital device includes a digital instruction generation unit configured to generate a digital treatment module based on a mechanism of action (MOA) and a treatment hypothesis, generate digital instructions based on the digital treatment module, and provide the digital instructions to a subject; and a result collection unit configured to collect the subject's execution results regarding the digital instructions.

[0419] Embodiment 114. In the non-transitory computer-readable medium of embodiment 113, the digital instruction generation unit generates a digital therapeutic module based on neurohormonal factors.

[0420] Embodiment 115. In the non-transitory computer-readable medium of embodiment 114, the neurohormonal factors include insulin-like growth factor (IGF), cortisol, and dopamine.

[0421] Embodiment 116. In the non-transitory computer-readable medium of any one of embodiments 113 to 115, the digital instruction generation unit generates a digital treatment module based on input from a healthcare provider.

[0422] Embodiment 117. In the non-transitory computer-readable medium of any one of embodiments 113 to 116, the digital instruction generation unit generates a digital therapeutic module based on information received from the subject.

[0423] Embodiment 118. In the non-transitory computer-readable medium of embodiment 117, the information received from the subject includes at least one of the subject's basic factors, medical information, and digital therapeutics utilization capability, wherein the basic factors include the subject's activity, heart rate, sleep, and diet (including nutrients and calories), the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerabilities, and genetic susceptibility, and the digital therapeutics utilization capability includes the subject's accessibility and technology receptivity to digital therapeutics and devices.

[0424] Embodiment 119. In the non-transitory computer-readable medium of any one of embodiments 113 to 118, the digital instruction generation unit generates a digital therapeutic module that matches the hypothetical parameters corresponding to the therapeutic hypothesis and mechanism of action.

[0425] Embodiment 120. In the non-transitory computer-readable medium of embodiment 119, the virtual parameters are inferred in relation to the subject's environment, behavior, emotions, and cognition.

[0426] Embodiment 121. In the non-transitory computer-readable medium of any one of embodiments 113 to 120, the result collection unit collects the results of the execution of the digital instructions by monitoring the subject's compliance with the digital instructions or by allowing the subject to directly input the subject's compliance with the digital instructions.

[0427] Embodiment 122. In any one of the non-transitory computer-readable media of embodiments 113 to 121, the generation of digital instructions in the digital instruction generation unit and the collection of the subject's execution results regarding the digital instructions in the result collection unit are performed multiple times in multiple feedback loops, and the digital instruction generation unit generates the subject's digital instructions for the current round based on the subject's digital instructions from the previous round and the execution result data regarding the subject's digital instructions from the previous round collected by the result collection unit.

Claims

1. 1. A method for improving vision in a subject, comprising: providing to the subject by a digital device a digital application including one or more digital therapeutic modules for improving vision; A method for improving a subject's vision, wherein the digital therapeutic module includes one or more first instructions to be followed by the subject, the first instructions including a first eye movement instruction that causes the subject to move at least one eye vertically.

2. 2. The method of claim 1, wherein the first eye movement instruction causes the subject to move the at least one eye at least 50 of the subject's maximum vertical view 100.

3. 2. The method of claim 1, wherein the first eye movement instruction causes the subject to move the at least one eye at least 70 degrees out of the subject's maximum vertical view 100.

4. 10. The method of claim 1, wherein the digital application includes more instructions for vertical eye movements than for horizontal eye movements.

5. The method of claim 1 , wherein the first eye movement instruction is to move the at least one eye upward.

6. 2. The method of claim 1, wherein the first eye movement instructions include more instructions to move the at least one eye upward than instructions to move the at least one eye downward.

7. 10. The method of claim 1, wherein the method reduces the growth rate of axial length (AL) of the at least one eye of the subject.

8. The method of claim 1 , further comprising measuring the subject's maximum vertical view.

9. The method for improving a subject's vision according to claim 1 , further comprising a calibration step for calibrating one or more of a measurement accuracy of the subject's eye position and a lighting environment.

10. 10. The method of claim 9, wherein the lighting environment is calibrated, and the calibration to the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment.

11. 10. The method of claim 1, further comprising the step of generating a digital therapeutic module by applying virtual parameters for the subject's environment, behavior, emotions, and cognition to a therapeutic hypothesis and mechanism of action.

12. 10. The method of claim 1, further comprising the step of sensing the subject's compliance with said first instructions.

13. 13. The method of claim 12, further comprising the steps of: transmitting compliance information to a server based on the subject's compliance; and receiving one or more second instructions from the server.

14. 14. The method of claim 13, wherein the one or more second instructions include a second eye movement instruction for adjusting a rate of eye movement based on compliance information.

15. The digital application causes a processor of the digital device to: Generate digital therapeutic modules based on mechanisms of action and therapeutic hypotheses; generating digital instructions based on the digital treatment module; providing digital instructions to the subject; and 10. The method of claim 1, further comprising: instructing a subject to perform an action comprising: collecting the subject's performance results in relation to the digital instructions.

16. 16. The method of claim 15, wherein generating the digital instructions and collecting the subject's performance results on the digital instructions are performed multiple times in multiple feedback loops, and generating the digital instructions includes generating the subject's digital instructions for a current session based on the subject's digital instructions from a previous session and collected performance result data on the subject's digital instructions provided from the previous session.

17. 16. The method of claim 15, wherein collecting the subject's performance on the digital instructions includes determining one or both of Exertion Intensity (EI) and Average Exertion Intensity (AEI).

18. 20. The method of claim 17, wherein the AEI is determined as the average sum of the differences between the final position of the subject's eye and the starting position of the eye measured at a given interval.

19. 10. The method of claim 1, wherein the digital therapeutic module is generated based on neurohormonal factors.

20. 1. A digital device for improving the visual acuity of a subject, a digital instruction generation unit configured to generate a digital treatment module based on the mechanism of action (MOA) and the treatment hypothesis, generate digital instructions based on the digital treatment module, and provide the digital instructions to the subject; and a result collection unit configured to collect results of the subject's performance on the digital instructions; A digital device for improving a subject's vision, wherein the digital therapeutic module includes one or more first instructions to be followed by the subject, the first instructions including first eye movement instructions that cause the subject to move at least one eye vertically.

21. 21. The digital device for improving a subject's vision of claim 20, wherein the first eye movement instruction causes the subject to move the at least one eye at least 50 of the subject's maximum vertical view 100.

22. 21. The digital device for improving a subject's vision of claim 20, wherein the first eye movement instruction causes the subject to move the at least one eye at least 70 degrees out of the subject's maximum vertical view 100 degrees.

23. 21. The digital device for improving a subject's vision of claim 20, wherein the digital therapeutic module includes more instructions for vertical eye movements than instructions for horizontal eye movements.

24. 21. The digital device for improving a subject's vision of claim 20, wherein the first eye movement instruction is to move the at least one eye upward.

25. 21. The digital device for improving a subject's vision as described in claim 20, wherein the first eye movement instructions include more instructions to move the at least one eye upward than instructions to move the at least one eye downward.

26. 21. The digital device for improving a subject's vision of claim 20, wherein the device provides functionality for calibrating one or more of the measurement accuracy of the subject's eye position and the lighting environment.

27. 27. A digital device for improving a subject's vision as described in claim 26, wherein the lighting environment is calibrated, and the calibration to the lighting environment includes one or more of detecting light in the subject's environment using a light sensor in the digital device and instructing the subject to turn on one or more lights in their environment.

28. 21. The digital device for improving a subject's vision as described in claim 20, wherein the device generates a digital therapeutic module by applying virtual parameters for the subject's environment, behavior, emotions, and cognition to a therapeutic hypothesis and mechanism of action.

29. 21. The digital device for improving a subject's vision of claim 20, comprising a sensor for sensing the subject's compliance with said first instructions.

30. 30. The digital device for improving a subject's vision of claim 29, wherein the digital device transmits compliance information to a server and receives one or more second instructions from the server based on the subject's compliance.

31. 31. The digital device for improving a subject's vision of claim 30, wherein the one or more second instructions include a second eye movement instruction for adjusting a rate of eye movement based on compliance information.

32. The digital application causes a processor of the digital device to: Generate digital therapeutic modules based on mechanisms of action and therapeutic hypotheses; generating digital instructions based on the digital treatment module; providing digital instructions to the subject; and 21. The digital device for improving a subject's vision of claim 20, wherein the digital device instructs the subject to perform an action including: collecting the subject's performance results in relation to the digital instructions.

33. 33. The digital device for improving a subject's vision as described in claim 32, wherein generating the digital instructions and collecting the subject's performance results on the digital instructions are performed multiple times in multiple feedback loops, and generating the digital instructions includes generating the subject's digital instructions for a current session based on the subject's digital instructions from a previous session and collected performance result data on the subject's digital instructions provided from the previous session.

34. 31. The digital device for improving a subject's vision of claim 30, wherein collecting the subject's performance results in relation to the digital instructions includes determining one or both of Exercise Intensity (EI) and Average Exercise Intensity (AEI).

35. 35. The digital device for improving a subject's vision of claim 34, wherein the AEI is determined as the average sum of the differences between the final position of the subject's eye and the starting position of the eye measured at a given interval.

36. 21. The digital device for improving a subject's vision of claim 20, wherein the digital therapeutic module is generated based on neurohormonal factors.

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