Digital devices and applications for myopia treatment

Abstract

To provide systems and methods for treating myopia.SOLUTION: In a digital apparatus, a digital application for treating myopia causes the digital apparatus to steps including: generating a digital therapeutics module for treating myopia based on a mechanism of action in and a therapeutic hypothesis for myopia; generating specified digital instructions based on the digital therapeutics module; providing the digital instruction to a first user; and collecting results of execution of the digital instructions by the first user. A system comprises a healthcare provider portal for a healthcare provider to manage patients and / or an administrative portal.SELECTED DRAWING: Figure 8

Description

Technical Field

[0001] This application claims the benefit of priority based on U.S. Patent Application No. 16 / 883,369, filed on May 26, 2020, and all the contents disclosed in the said document are incorporated herein by reference.

[0002] This disclosure relates to digital therapeutics (hereinafter referred to as DTx) for the purpose of myopia treatment including the suppression of myopia progression. This disclosure also relates to a system that integrates a digital therapeutic with one or both of a healthcare provider portal and a management portal to treat a patient's myopia. In particular, through the literature survey and expert evaluation of basic science papers and related clinical trial papers aiming to clarify the pathogenesis of myopia, the mechanism of action (hereinafter referred to as MOA) for axial myopia in childhood / adolescence is derived, and based on this, a therapeutic hypothesis and a digital therapeutic hypothesis for the suppression of progression and treatment of axial myopia in childhood / adolescence are established. Further, this disclosure clinically verifies the digital therapeutic hypothesis for axial myopia in childhood / adolescence and includes the rational design of an application for realizing it as a digital therapeutic, and the provision of a digital device and an application for the purpose of suppressing the progression and treating axial myopia in childhood / adolescence.

Background Art

[0003] The prevalence rate of myopia patients in Korea is very high. As a result of analyzing the data from 2008 to 2012, the prevalence rate of myopia (-0.75 diopters or more) among adolescents aged 12 to 18 in Korea was 80.4%, and demographically, it was 4.35 times that of the prevalence rate of myopia among the elderly in their 60s (18.5%). The prevalence rate of high myopia (-6 diopters or more) was 12%, which was shown to be 8 times higher than that of those in their 60s (1.5%), and was nearly 3 times higher than the prevalence rate of myopia among adolescents in the United States, the United Kingdom, etc.

[0004] Even more concerning is the finding that approximately 70% of adolescents with myopia in South Korea have severe or high myopia. The prevalence of myopia among elementary school children has also continued to increase, from around 23% in 1980 to 38% in the 1990s and 46.2% in the 2000s.

[0005] The World Health Organization (WHO) recognizes myopia as a disease, but globally, there is still no definitive treatment for it. Recently, with a sharp increase in the prevalence of myopia in countries such as China, Singapore, and South Korea, the fact that myopia is an ophthalmic disease that can lead to blindness has been emphasized and is attracting attention from the academic community.

[0006] Myopia can be divided into two types: axial myopia, which occurs when the axis of the eyeball lengthens, and refractive myopia (index myopia), which occurs when the refractive index of the lens and cornea increases. Axial myopia can be further divided into simple myopia, which does not affect the retina or choroid, and degenerative myopia, which causes retinal degeneration and can lead to blindness. Excluding nucleus sclerosis due to diabetes and keratoconus, most cases of myopia fall under simple axial myopia, which progresses rapidly from elementary school age.

[0007] One known method to slow the progression of myopia or treat it is to use medication (atropine) and special lenses (e.g., Dream Lenses). However, in the case of atropine... In some cases, severe glare can occur due to pupil dilation. Furthermore, with Dream Lenses, the risk of corneal damage is greater, limiting their clinical application compared to corrective eyeglasses.

[0008] Separately, many devices for treating myopia, eye movement methods, and eye movement applications have been developed and are being sold, but most lack sufficient evidence of their clinical effectiveness and are being sold without proper approval procedures. As a result, there are no reliable treatment options available for children and adolescents diagnosed with myopia at a hospital to slow the progression of their condition or treat it. [Overview of the Initiative]

[0009] In certain aspects, the Disclosure provides a system for treating myopia, the system including a digital device configured to run a digital application for treating a subject's myopia; a healthcare provider portal configured to provide a healthcare provider with one or more options to perform one or more tasks for prescribing treatment for a subject's myopia based on information received from the digital application; and an administration portal configured to provide a system administrator with one or more options to perform one or more tasks for managing healthcare providers' access to the system.

[0010] In certain aspects, the Disclosure provides a method for treating myopia in a subject requiring myopia treatment, the method providing the subject by a digital device with a digital application including modules for treating myopia based on the pathogenesis of myopia and a treatment hypothesis for myopia—each module including one or more first tasks to be followed by the subject, the digital device including (i) sensors that sense the subject's compliance with one or more first tasks of the modules, (ii) transferring compliance information based on the compliance to a server that can be accessed by a healthcare provider via a healthcare provider portal, and (iii) receiving one or more second tasks from the healthcare provider based on the compliance information.

[0011] In certain aspects, the Disclosure provides a non-temporary computer-readable medium on which software instructions for treating myopia in a subject requiring myopia treatment are stored. When executed by a processor, the non-temporary computer-readable medium displays modules for treating myopia to the subject via a digital device, based on the pathogenesis of myopia and treatment hypotheses for myopia—each module containing one or more tasks that the subject must follow—the digital device's sensors sense the subject's compliance with the tasks in the modules, the digital device transmits compliance information based on the compliance to a server accessible to the healthcare provider via a healthcare provider portal, and the server receives one or more second tasks from the healthcare provider.

[0012] In some embodiments, a digital application for myopia treatment instructs the processor of a digital device to perform an operation that includes generating a digital therapeutic module for treating myopia based on a therapeutic hypothesis and the pathogenesis of myopia. In some embodiments, generating a digital therapeutic module includes generating a digital therapeutic module based on neurohumoral factors related to the pathogenesis of myopia. In some embodiments, the operation compensates for one or more of the measurement accuracy of the light environment and the position of the subject's eyes. This further includes generating a correction module to correct the error. In some embodiments, the correction module can be generated before generating the digital therapeutic module. In some embodiments, the accuracy of the subject's eye position measurement can be corrected, and correcting the accuracy of the subject's eye position measurement involves instructing the subject to position their face as shown on the screen of the digital device, sensing the subject's eyes for a given amount of time, instructing the subject to blink, sensing whether or not they blink, and staring at the screen. This includes instructing the subject to move or rotate their eyes in a specified direction, and determining a critical value for sensing the subject's eyes. In some embodiments, the digital device includes one or more sensors for tracking the subject's eye movements. In some embodiments, the accuracy of the light environment measurement can be corrected, and the light environment correction includes one or more of using the digital device's light sensors to sense light in the subject's environment and instructing the subject to turn on one or more lights in their environment. In some embodiments, the digital application for myopia treatment instructs the digital device's processor to perform an operation that includes generating a digital therapeutic module for treating myopia based on a therapeutic hypothesis regarding myopia and the pathogenesis of myopia. In some embodiments, the digital application for myopia treatment instructs the digital device's processor to perform an operation that includes generating a digital task based on the digital therapeutic module. In some embodiments, the digital application for myopia treatment instructs the digital device's processor to perform an operation that includes providing the subject with a digital task. In some embodiments, the digital application for myopia treatment instructs the digital device's processor to perform an operation that includes collecting the subject's performance results on the digital task. In some embodiments, generating a digital task and collecting the subject's performance results on the digital task are performed multiple times in a multi-layered feedback loop, and generating a digital task includes generating the subject's digital task for the current session based on the subject's digital task for the previous session and the collected performance data of the subject for the digital task provided from the previous session. In some embodiments, collecting the subject's performance results on the digital task includes determining one or both of the exercise intensity (EI) and average exercise intensity (AEI). In some embodiments, the AEI can be determined as the average sum of the differences between the subject's final eye position and initial eye position measured over a given interval.In some embodiments, the interval is between approximately 10 milliseconds (ms) and approximately 500 ms. In some embodiments, EI can be determined by the following formula.

[0013]

number

[0014] In some embodiments, AEI can be determined as the sum of dynamic AEI and static AEI. In some embodiments, generating a digital therapeutic module involves generating a digital therapeutic module by applying virtual mediating variables to the subject's environment, behavior, emotions, and cognition to the pathogenesis of myopia and therapeutic hypotheses regarding myopia. In some embodiments, a digital application for myopia treatment instructs a processor of a digital device to generate a digital therapeutic module that includes two or more modules selected from a group consisting of eye movement modules, relaxation modules, and phototherapy modules. In some embodiments, the eye movement module includes one or more movement tasks for one or more of the following: eye movement tasks, biofeedback control tasks, and eye-related behavior control tasks. In some embodiments, the relaxation module includes one or more relaxation tasks for one or more of the following: bodily movement tasks, ego reinforcement tasks, safety tasks, calmness tasks, and enjoyment tasks. In some embodiments, the phototherapy module includes one or more phototherapy tasks for controlling the subject's light environment. In some embodiments, one or more relaxation tasks include one or more of the following: playing a sound or song, inducing blinking, and instructing the subject to perform exercises. In some embodiments, the digital therapeutic module further includes an achievement module that provides compensation for subject compliance with tasks of two or more first modules and includes one or more achievement tasks for task completion. In some embodiments, the digital therapeutic module includes an enjoyment module that includes one or more enjoyment tasks related to music, games, or videos. The following are further included. In some embodiments, one or more options provided to the healthcare provider are selected from a group consisting of adding or removing subjects, viewing or editing personal information about subjects, viewing compliance information about subjects, viewing the subject's results for one or more digital therapeutic modules that have been at least partially completed, prescribing one or more digital therapeutic modules to a subject, changing prescriptions for one or more digital therapeutic modules, and communicating with subjects. In some embodiments, one or more options include viewing or editing personal information about subjects, and the personal information includes one or more selected from a group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email address, the subject's guardian's email address, the subject's contact telephone number, a prescription for the subject, and one or more notes made by the healthcare provider to the subject. In some embodiments, the personal information includes a prescription for a subject, and the prescription for a subject includes one or more selected from a group consisting of a prescription identification number, prescription type, start date, duration, completion date, the number of digital therapeutic modules that are scheduled to be performed or prescribed by the subject, and the number of digital therapeutic modules that are scheduled to be performed or prescribed by the subject per day. In some embodiments, one or more options include viewing compliance information, which includes one or more dates on which the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapy modules, and the number of scheduled or prescribed digital therapy modules completed by the subject. In some embodiments, one or more options include viewing subject results, which include one or more selected groups 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 completed or partially completed, and exercise intensity (EI).In some embodiments, one or more options provided to the system administrator are selected from a group consisting of adding or removing healthcare providers, viewing or editing healthcare provider personal information, viewing or editing unidentified subject information, viewing compliance information about subjects, viewing subject results for at least one or more partially completed digital therapeutic module, and communicating with healthcare providers. In some embodiments, one or more options include viewing or editing personal information, where healthcare provider personal information includes one or more selected from a group consisting of healthcare provider identification number, healthcare provider name, healthcare provider email address, and healthcare provider contact telephone number. In some embodiments, one or more options include viewing or editing unidentified subject information, where unidentified subject information includes one or more selected from a group consisting of subject identification number and healthcare provider to subject. In some embodiments, one or more options include viewing subject compliance information, where subject compliance information includes one or more subjects. The digital application includes a calendar that identifies one or more dates on which scheduled or prescribed digital therapy modules are completed, partially completed, or not completed, and one or more of the number of scheduled or prescribed digital therapy modules completed by the subject. In some embodiments, one or more options include viewing the subject's results, and the subject's results for at least one or more partially completed digital therapy modules include one or more selected from a 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). In some embodiments, the digital application further includes push alarms to remind the subject to complete the digital therapy modules and to adjust the light settings of the subject's environment. In some embodiments, the push alarms remind the subject to adjust the light settings so that the subject is exposed to sufficiently bright light at least three times a day. To be activated. In some embodiments, the subjects are children. In some embodiments, the subjects are under approximately 20 years of age, under approximately 15 years of age, under approximately 10 years of age, or under approximately 5 years of age. In some embodiments, the subjects are assisted or supervised by an adult. In some embodiments, the digital device includes a digital task generator configured to generate digital therapeutic modules for treating myopia based on the pathogenesis (MOA) of myopia and therapeutic hypotheses regarding myopia, generate digital tasks based on the digital therapeutic modules, and provide the digital tasks to the subjects. In some embodiments, the digital device includes a results collection unit configured to collect the results of the subjects' performance of the digital tasks. In some embodiments, the digital task generator generates digital therapeutic modules based on neurohumoral factors related to myopia development. In some embodiments, neurohumoral factors include IGF (insulin-like growth factor), cortisol, and dopamine. In some embodiments, the digital task generator generates digital therapeutic modules based on input from a healthcare provider. In some embodiments, the digital task generation unit generates a digital therapeutic module based on information received from the subject. In some embodiments, the information received from the subject includes the subject's basal factors, medical information, and digital therapeutics literacy. This includes basal factors such as the subject's activity level, heart rate, sleep, and diet (including nutrition and calories), medical information such as the subject's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility, and digital therapeutics literacy, including the subject's accessibility to and acceptance of digital therapeutics and devices. In some embodiments, the digital task generation unit generates a digital therapeutic module that matches virtual mediating variables corresponding to the pathogenesis and treatment hypotheses for myopia.In some embodiments, virtual mediating variables are derived in relation to the subject's environment, behavior, emotions, and cognition. In some embodiments, the digital device collects the results of performing a digital task, either by having the results collection unit monitor the subject's compliance with the digital task or by having the subject directly input their compliance with the digital task. In some embodiments, the generation of the digital task in the digital task generation unit and the collection of the subject's performance results for the digital task in the results collection unit are performed multiple times in a multi-layered feedback loop, and the digital task generation unit generates the subject's digital task for the current session based on the subject's digital task from the previous session and the performance result data for the subject's digital task from the previous session collected by the results collection unit. [Brief explanation of the drawing]

[0015] The above and other purposes, features and advantages of this disclosure will become more apparent to those skilled in the art by describing in detail the exemplary embodiments thereof with reference to the accompanying drawings.

[0016] [Figure 1a] This figure shows the proposed pathogenesis of axial myopia in childhood / adolescence. [Figure 1b] This figure shows the proposed treatment hypothesis for axial myopia. [Figure 1c] This figure shows the digital treatment hypothesis for axial myopia proposed in this disclosure. [Figure 2] This is a block diagram showing the configuration of a digital device for treating myopia according to one embodiment of the present disclosure. [Figure 3] This figure shows the input and output loops of a digital application for myopia treatment according to one embodiment of the present disclosure. [Figure 4] This figure shows a feedback loop using a digital device and application for myopia treatment according to one embodiment of the present disclosure. [Figure 5a] This figure shows a module design for realizing digital treatment in a digital myopia device and application for myopia treatment according to one embodiment of the present disclosure. [Figure 5b] A diagram showing background factors supporting a digital device and an application for myopia treatment according to an embodiment of the present disclosure. [Figure 6] A diagram showing a method of specifying a digital prescription tailored to a patient using a digital device and an application for myopia treatment according to an embodiment of the present disclosure. [Figure 7a] A diagram showing an execution environment setting according to an embodiment of the present disclosure. [Figure 7b] A diagram showing an illustration of specific problems of each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7c] A diagram showing an illustration of specific problems of each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7d] A diagram showing an illustration of specific problems of each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7e] A diagram showing an illustration of specific problems of each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7f] A diagram showing an illustration of specific problems of each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7g] A diagram showing an illustration of specific problems of each module and an output data collection method according to an embodiment of the present disclosure. [Figure 8] A flowchart showing the operation of a digital application for myopia treatment according to an embodiment of the present disclosure. [Figure 9] A flowchart showing a method of generating digital problems in a digital application for myopia treatment according to an embodiment of the present disclosure. [Figure 10] A flowchart showing repeatedly performing operations according to feedback control in a digital application for myopia treatment according to an embodiment of the present disclosure. [Figure 11] A diagram showing the hardware configuration of a digital device for myopia treatment according to an embodiment of the present disclosure. [Figure 12] This is a flowchart illustrating a system for myopia treatment, which includes a management 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 the treatment of a subject's myopia. [Figure 13] This flowchart shows the execution flow of the digital application disclosed herein. [Figure 14] This flowchart illustrates the execution flow of the splash process at the start of the digital application described in this disclosure. [Figure 15] This flowchart illustrates the execution flow for login verification during the splash process at the start of the digital application described in this disclosure. [Figure 16] This flowchart illustrates the execution flow for prescription verification during the splash process at the start of the digital application of this disclosure. [Figure 17] This flowchart illustrates the execution flow for home entry during prescription verification in the digital application disclosed herein. [Figure 18] This flowchart shows the execution flow for a session in the digital application disclosed herein. [Figure 19] This flowchart shows the execution flow for the calibration module in the digital application of this disclosure. [Figure 20] This is a flowchart illustrating the execution flow for a session in the digital application of this disclosure, where a session includes two or more digital therapeutic modules. [Figure 21] The splash screen of the digital application of this disclosure is illustrated, and the splash screen includes the company logo, a loading icon, and / or information about the version of the digital application. [Figure 22] The TrueDepth camera notification screen of the digital application of this disclosure is illustrated. [Figure 23] The home screen of the digital application of this disclosure is illustrated, and the home screen shows the availability of a session for a subject to complete. [Figure 24] The present disclosure illustrates a bright environment requirement notification screen for a phototherapy module in a digital application, which shows the amount of light detected by the digital device. [Figure 25] The diagram illustrates the calibration notification screen of the digital application of this disclosure, which indicates whether or not the subject's eyes and / or eye movements can be detected by the camera. [Figure 26a] A screenshot of the eye movement digital therapy module of this disclosure is shown. [Figure 26b] A flowchart illustrating the execution flow for the eye movement digital therapy module is provided. [Figure 27a] A screenshot of the relaxation / restoration digital therapeutic module of this disclosure is shown. [Figure 27b] A flowchart illustrating the execution flow for the rest digital therapeutic module is provided. [Figure 28a] A screenshot of the eye movement digital therapy module of this disclosure is shown. [Figure 28b] A flowchart illustrating the execution flow for the eye movement digital therapy module is provided. [Figure 29a] A screenshot of relaxation and rest using the sound digital therapeutic module of this disclosure is shown. [Figure 29b] A flowchart illustrating the process of performing relaxation and rest using a sound digital therapy module is provided. [Figure 30a] A screenshot of the eye movement digital therapy module of this disclosure is shown. [Figure 30b] A flowchart illustrating the execution flow for the eye movement digital therapy module is provided. [Figure 31a]A screenshot of the Deep Breathing Digital Therapy Module of this disclosure is shown. [Figure 31b] A flowchart illustrating the execution flow for the Deep Breathing Digital Therapy Module is provided. [Figure 32a] A screenshot of the eye movement digital therapy module of this disclosure is shown. [Figure 32b] A flowchart illustrating the execution flow for the eye movement digital therapy module is provided. [Figure 33a] This is a screenshot of the Deep Breathing Digital Therapy Module of this disclosure. [Figure 33b] This is a screenshot of the deep breathing digital therapy module when instructing the subject to inhale (left side) and exhale (right side). [Figure 33c] This is a flowchart illustrating the execution flow for the Deep Breathing Digital Therapy Module. [Figure 34a] This is a screenshot of the eye movement digital therapy module of this disclosure. [Figure 34b] A flowchart illustrating the execution flow for the eye movement digital therapy module is provided. [Figure 35a] This is a screenshot of the rest digital therapeutic module of this disclosure. [Figure 35b] A flowchart illustrating the execution flow for the rest digital treatment module is provided. [Figure 36] This disclosure illustrates screenshots of the digital application displayed upon completion of a single session, upon completion of all sessions throughout the day, and during cancellation / start verification. [Figure 37a] This is a screenshot of the room decoration board located in the achievement module of the digital application of this disclosure. [Figure 37b] A timeline is illustrated showing the dates on which subjects can acquire the assigned room decoration items. [Figure 38]A screenshot of the parent section is shown in the digital application of this disclosure. [Figure 39] A screenshot of the password change section in the digital application of this disclosure is shown. [Figure 40] This table shows the push message, the time the given push message was forwarded to the subject, and the result when the given push message was opened. [Figure 41] The following diagram illustrates the layouts for exemplary healthcare provider portals and / or administrative portals in this disclosure. The overall screen can be used for login screens, etc., and may lack a header or sidebar menu. The basic screen can be used for almost all post-login screens, such as dashboards and patient lists. Modal pop-ups can be used in situations requiring a user click, such as confirming before removing a patient from a patient list. Toast pop-ups can be used to provide appropriate notifications to users and may use different colors depending on the situation, such as success or failure, to make them easily noticeable to the user. [Figure 42] The layout of the healthcare provider portal and / or administration portal of this disclosure is illustrated. [Figure 43] The layout of the healthcare provider portal and / or administration portal of this disclosure is illustrated. [Figure 44] This flowchart shows the execution flow for the healthcare provider portal in the system disclosed. [Figure 45a] The dashboard of the healthcare provider portal is illustrated. [Figure 45b] The patient tab in the healthcare provider portal, which displays the patient list, is illustrated. [Figure 45c] The image illustrates the patient tab in the healthcare provider portal, which displays detailed information about a given patient. [Figure 45d]The patient tab in the healthcare provider portal for adding new patients is illustrated. [Figure 45e] The patient tab in the healthcare provider portal for editing existing patient information is illustrated. [Figure 45f] The patient tab of the healthcare provider portal, which displays detailed prescription information for a given patient, is illustrated. [Figure 45g] The patient tab in the healthcare provider portal for editing prescription information for a given patient is illustrated. [Figure 45h] The patient tab in the healthcare provider portal for editing prescription information for a given patient is illustrated. [Figure 45i] The patient tab in the healthcare provider portal is illustrated to show details of a given session for a given patient (e.g., date, status, duration, outcome). [Figure 46] This flowchart shows the execution flow for the management portal in the system disclosed. [Figure 47a] The dashboard of the management portal is illustrated. [Figure 47b] The diagram illustrates the Doctors tab in the management portal and the Doctors tab that displays the list of doctors. [Figure 47c] The image shows the Doctor tab in the management portal, displaying a list of patients currently being treated by the doctor, and illustrating the Doctor tab after the patient identification information has been deleted (*). [Figure 47d] This diagram illustrates the Doctors tab in the administration portal for adding new doctors. [Figure 47e] This diagram illustrates the physician tab in the management portal for editing information on existing physicians. [Figure 47f] The diagram illustrates the patient tab in the administration portal, which displays information about one or more patients from whom sensitive information has been removed. [Figure 47g] The image illustrates the patient tab in the administration portal, which displays detailed patient or prescription information for a given patient. [Figure 47h] The patient tab of the management portal, which displays detailed prescription information for a given patient, is illustrated. [Figure 47i]The diagram illustrates the patient tab in the administration portal, which allows you to view details of a given session for a given patient (e.g., date, status, duration, results). [Figure 48] This table shows the permissions for physicians using the healthcare provider portal and administrators using the management portal.

[0017] The drawings identified above illustrate the currently disclosed embodiments, but other embodiments are also considered, as mentioned. This disclosure presents exemplary embodiments in a manner of expression, not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art within the scope and idea of ​​the principles of the currently disclosed embodiments. [Modes for carrying out the invention]

[0018] Preferred embodiments of the Disclosure are described in detail below. However, the Disclosure is not limited to the embodiments disclosed below and can be implemented in various forms. The following embodiments are intended to enable a person ordinary skill in the art to implement and practice the embodiments of the Disclosure.

[0019] Terms such as "first," "second," etc., may be used to describe various components, but these components are not limited by such terms. Such terms are used solely to distinguish one component from another. For example, without departing from the scope of the exemplary embodiments, the first component may be referred to as the second component, and similarly, the second component may be referred to as the first component. The term "and / or" includes all combinations of one or more of the related listed items.

[0020] The terms used herein are used solely to describe specific embodiments and are not intended to limit the scope of other embodiments. Singular expressions are intended to include plural expressions unless the context clearly indicates otherwise. All terms used herein, including technical or scientific terms, may have the same meaning as those commonly understood by a person of ordinary skill in the art of this disclosure. The terms “include,” “contain,” and / or “include” can be understood to indicate the presence of features, integers, steps, actions, elements, components, and / or groups as used herein. However, they do not preclude the presence or addition of one or more different features, integers, steps, actions, elements, components, and / or groups thereof.

[0021] As used herein, the term “approximately” generally refers to a particular number whose value is within an acceptable margin of error determined by a normal technician, which in part depends on how the number’s value is measured or determined, i.e., the limits of the measuring system. For example, “approximately” could mean a range of ±20%, ±10%, or ±5% of the value of a given number.

[0022] Hereinafter, exemplary embodiments of the present disclosure will be described in detail with reference to the attached drawings. In this document, the same reference numerals will be used for the same components in the drawings, and the same components will be referred to as Conversely, redundant explanations will be omitted.

[0023] Traditional drug development begins by confirming the medical need in the field, proposing a disease pathogenesis based on expert evaluations and meta-analyses of the disease in question, and deriving a treatment hypothesis based on this. After preparing a library of drugs expected to have therapeutic effects based on the treatment hypothesis, candidate substances are identified through screening, and these candidate substances are optimized and preclinical trials are conducted to confirm efficacy and safety from the preclinical stage and determine the final candidate drug. Then, after establishing CMC (chemistry, manufacturing, and controls) for the mass production of the candidate drug, clinical trials are conducted to verify the disease pathogenesis and treatment hypothesis, and to confirm the clinical efficacy and safety of the candidate drug.

[0024] From a patent perspective, drug targets and signaling, which constitute the upstream of new drug development, are subject to many uncertainties. Furthermore, because methodologies often rely on synthesizing and interpreting previously reported results, it is often difficult to recognize the novelty of the invention. In contrast, the invention of drugs that can treat diseases by modulating drug targets and signaling requires the highest level of ingenuity, despite the development of numerous research methodologies for new drug research and development, with the exception of some antibody and nucleic acid (DNA, RNA) therapeutic areas. Consequently, the molecular structure of a drug is the most core element constituting the strongest substance patent in the field of new drugs.

[0025] Unlike drugs, which receive strong protection from such substance patents, digital therapeutics are, in principle, implemented as software. Given the nature of digital therapeutics, and considering the clinical validation and approval processes for them, the rational design of a digital therapeutic for a given disease and its subsequent software implementation constitute a highly innovative invention that deserves patent protection.

[0026] In other words, the core of digital therapeutic agents like those disclosed lies in the rational design of digital therapeutic agents suitable for treating the disease in question, and the development of specific software that enables clinical validation based on these designs. The digital devices and applications for myopia treatment described in this disclosure, realized from this perspective, are described in detail below.

[0027] In one embodiment, this disclosure provides a system for myopia treatment. In some embodiments, the system includes a digital device configured to run a digital application for the treatment of a subject's myopia. In some embodiments, the system includes a healthcare provider portal configured to provide a healthcare provider with one or more options to perform one or more tasks for prescribing treatment for a subject's myopia based on information received from the digital application. In some embodiments, the system includes an administration portal configured to provide a system administrator with one or more options to perform one or more tasks for managing healthcare provider access to the system. Figure 12 illustrates a flowchart illustrating a system for myopia treatment, 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 run a digital application for the treatment of a subject's myopia (e.g., an application or “app”). However, via the administrator portal, the administrator can issue physician accounts, review physician information, and review unidentified patient information. However, via the healthcare provider portal, a healthcare provider (e.g., a physician) can issue patient accounts and review patient information (e.g., age, prescription information, and status of completion of one or more digital therapeutic modules or sessions). However, through the digital application, patients can complete one or more digital therapy modules or sessions. Figure 13 illustrates a flowchart illustrating the execution flow for the digital application. Start the digital application. A splash screen is then displayed, followed by a request for login information and verification of prescription information regarding the subject. Figure 14 illustrates a flowchart illustrating the execution flow for the splash process at the start of a digital application. The splash process may include detecting whether the digital device includes a TrueDepth camera, whether the digital application can access the camera, whether the digital application is connected to a network, whether the digital application is updated to the latest version, login verification, and prescription verification. Figure 15 illustrates a flowchart illustrating the execution flow for login verification during the splash process at the start of a digital application. Similarly, Figure 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 the treatment period has expired, determining whether the subject has been exposed to bright light recently (e.g., within the last hour), and determining, based on the prescription, whether the subject's session for that date has been completed (e.g., the subject is complying with the prescription). In such cases, the digital device may notify the subject that there are no sessions available to complete, or expose the subject to the phototherapy module before starting the digital therapeutic module. Figure 21 illustrates the splash screen of the digital application of this disclosure, which includes a logo (label 1), a loading icon (label 2), and / or information about the version of the digital application (label 3). The splash entry process checks the network, version, login verification, etc., based on the execution flow. If there is data that has not been transferred due to application termination, network errors, etc., the data is checked and transferred during the splash entry. If the process takes too long during the splash entry process, a loading icon is displayed. In certain embodiments, appropriate pop-ups are displayed for different situations in the application execution flow.The splash entry process may also include camera sensing. Figure 22 illustrates the TrueDepth camera notification screen of the digital application of this disclosure. Devices that do not support TrueDepth Camera cannot perform eye movements, and therefore no further application execution is shown on the screen. A camera (also called a sensor, depth sensor, or range sensor) can generate depth data indicating the distance to surrounding points. In some embodiments, the digital device includes (i) a camera facing the user (to obtain face data about the user's face, such as the position of the eyeballs, hand data about the user's hands, or other data about other parts of the user's body) and / or (i) a camera facing the user's environment (to obtain position data about the user's physical environment, such as the position of light). In certain embodiments, the camera is such as the TrueDepth(R) camera system manufactured by Apple, Inc., Cupertino, Calif (USA). This includes a three-dimensional camera system. 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., the subject's eyeball). In yet another embodiment, 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 well-known pattern (e.g., structured light) onto a surface and capture an image. A typical technician would understand that the camera can implement other techniques such as optical triangulation, stereo triangulation, and interferometry. As a non-limiting example, the camera may be Intel(R) Re alSense(R) camera, Microsoft(R) Hololens(R), Apple(R) TrueDepth(R) camera, Google(R) Tango(R) system, Mic This enables the implementation of technologies and / or components used in systems such as Microsoft's Kinect(R). In some embodiments, the camera is configured to capture an image. In some embodiments, the camera is configured to generate depth data, such as a range image or depth map. The depth data represents one or more points (e.g., the distance traveled by the eyeball during a given time interval) each represented in the depth data. Depth data can indicate one or more distances to a point (or object). In some examples, depth data can be used to identify the distance to a point in the environment, identify an object or surface in the environment, determine the distance an object has traveled within a given interval, and position and / or maintain other content or user representations related to the object or surface as a digital device moves within the environment (e.g., in an AR or VR implementation).

[0028] A Mailto link (label 1) may be included to help subjects forward emails to the support team. Camera access can be allowed / denied (e.g., on / off) 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 that camera access is denied will be displayed, and the application will not run further. A button (label 2) may also be displayed to help subjects jump to the digital device's settings panel to adjust settings (e.g., grant camera permission).

[0029] As described above, session availability can be determined during the prescription verification process. Figure 23 illustrates the home screen of the digital application of this disclosure, which shows the availability of sessions for which the subject will complete. As shown in Figure 23, (1) patient name: no tap required, (2) Guardian Mode entry button, (3) room decorated as treatment progresses (decorations are automatically added or upgraded as sessions are completed, and the decorations can display simple movements), (4) character that appears in the middle of the room, which does not change during treatment and jumps when tapped, (5) play button, (6) notification that a given day session has been completed, and (7) treatment program completion notification.

[0030] Figures 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 illustrated, the room decoration board has (1) characters, (2) numbers displayed like a calendar, and a decoration board map mapping the numbers or room decoration items by date; the user cannot acquire an item on days with only numbers (3-2), can acquire an item on days with decoration items (3-1), and (4) a close-up of the item on 3-1 (room decoration item received) (e.g., a close-up of the acquired room decoration item).

[0031] In some embodiments, a digital application for myopia treatment instructs a processor in a digital device to perform operations including generating a digital therapeutic module for treating myopia based on a therapeutic hypothesis and the pathogenesis of myopia. In some embodiments, the digital therapeutic module includes generating a digital therapeutic module based on neurohumoral factors related to the development of myopia.

[0032] In some embodiments, the operation further includes generating a correction module to correct one or more of the following: the accuracy of the measurement of the subject's eye position and the light environment. In some embodiments, the correction module can be generated before generating the digital therapeutic module. In some embodiments, the correction module may not be generated, and the correction settings from the previous session are used. Correction can be performed at any time before, during, or after a session containing two or more digital therapeutic modules. For example, correction can be performed before the session. In other examples, if the results of the digital therapeutic module show high variability, the digital application may terminate the session and initiate correction to verify that the results of the digital therapeutic module are factual and not the result of incorrect correction. Figure 19 illustrates a flowchart illustrating the execution flow for the correction module in the digital application. For accuracy in visual acuity measurement, daily Correction can be performed at the start of a session. Correction can take 35 to 60 seconds, depending on the results. As illustrated in Figure 19, the correction module may include a series of tasks related to the subject from a digital application, such as orienting the subject's face in a specific direction (for example, to better sense the subject's eyes) or the subject blinking. Figure 25 illustrates a correction notification screen for a digital application, which indicates whether the subject's eyes and / or eye movements can be sensed by the camera. As illustrated in Figure 25, (1) a ready button, (2) a front camera view displayed on the screen, (3) a character that appears only when the digital application recognizes the pupils (the character may be a 2D character with large eyes that mimic the user's eye movements and may be shown semi-transparently so that the user's face is visible), and (4) a notification providing behavioral guidance for the user's guardian.

[0033] A session can contain any number of digital therapeutic modules. In some embodiments, a session can contain two or more digital therapeutic modules. In some embodiments, a session can contain three or more, four or more, five 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 therapeutic modules. A session can contain any number of digital therapeutic modules, and the digital therapeutic modules can be independently selected from eye movement modules, relaxation modules, deep breathing modules, and phototherapy modules. Figure 20 illustrates a flowchart illustrating the execution flow for a session of a digital application in which the session contains ten digital therapeutic modules. In some embodiments, the session can consist of ten digital therapeutic modules, which include five eye movement modules, three relaxation modules, and two deep breathing modules. A typical technician will understand that there are a vast number of combinations for the number and type of digital therapeutic modules that can be included in a given session. Figures 26a to 35b illustrate various types of digital therapeutic modules (e.g., eye movement, relaxation, and deep breathing).

[0034] In some embodiments, the accuracy of measuring the position of the subject's eyes can be corrected, and the correction includes determining a critical value for sensing the subject's eyes. In further embodiments, correcting the accuracy of measuring the position of the subject's eyes includes instructing the subject to position their face as shown on the screen of the digital device, sensing the subject's eyes during a given time, instructing the subject to blink, sensing whether or not they blink, instructing them to stare at the screen, instructing them to move or rotate their eyes in a specified direction, and determining a critical value for sensing the subject's eyes. In some embodiments, the digital device includes one or more sensors for tracking the movement of the subject's eyeballs. The critical value for sensing the subject's eyes can be determined in various ways. For example, eye movement from left to right can be scaled to 100 at maximum horizontal view. Eye movement from top to bottom can also be scaled to 100 at maximum vertical view. The average person's eye movement is about 70 on a scale of 100. In children and myopic patients, eye movement is less than 70. In one example, the critical value can be 70% of 70 (e.g., approximately 49). In another example, 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 is Based on a scale of 100, the values ​​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.

[0035] In one mode, a digital therapeutic module is generated based on a critical value. For example, an eye movement module is generated based on a critical value. The eye movement may involve moving an object within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's critical value boundary, on a scale of 100, in order to increase the subject's critical value. The eye movement may involve moving an object within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's critical value boundary after the sensor has detected a line of sight within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's critical value boundary.

[0036] In some embodiments, the accuracy of the measurement of the light environment can be corrected, and the light environment correction includes one or more of the following: using the light sensor of the digital device to sense light in the subject's environment, and instructing the subject to turn on one or more lights in their environment. Figure 24 illustrates the bright environment request notification screen of the phototherapy module of the digital application of the present disclosure, which displays the amount of light sensed by the digital device. Exposure to bright light is important when performing eye movements. The room starts in a very dirty state and becomes cleaner as the digital device senses light. The digital application exposes the patient to bright light three or more times a day. When the app is run, the camera sensor senses bright light and turns on lights that are off. As illustrated in Figure 24, (1) a light bulb guides the user to expose to bright light three times a day. (1) When a digital application is run for the first time, all lights are turned off (1-1), and when sufficient light is detected, the lights begin to turn on (1-2). (2) Guidance elements guide the user to expose them to bright light (e.g., dark background, spider, spiderweb, dust, etc.). (3) A jump to the bottom of the home element may be displayed (e.g., the play button and completion notification are excluded from this page).

[0037] In some embodiments, a digital application for myopia treatment instructs a processor in a digital device to perform an action. In some embodiments, the performed action includes generating a digital therapeutic module for myopia treatment based on the pathogenesis of myopia and therapeutic hypotheses regarding myopia. In some embodiments, the performed action includes generating a digital task based on the digital therapeutic module. In some embodiments, the performed action includes providing the digital task to a subject. In some embodiments, the performed action includes collecting the subject's performance results on the digital task. In some embodiments, generating the digital task and collecting the subject's performance results on the digital task are performed multiple times in a multi-layered feedback loop. In some embodiments, generating the digital task includes generating the subject's digital task for the current session based on the subject's digital task from the previous session and the collected performance result data for the subject's digital task provided from the previous session.

[0038] In some embodiments, the given interval in which the position of the eyeball is measured is approximately 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, 400 ms, or a range of two values ​​in between. In some embodiments, the given interval in which the position of the eyeball is measured is approximately 10 ms to approximately 500 ms. These ranges from ms, approximately 50ms to 250ms, approximately 75ms to 150ms, or approximately 90ms to 110ms.

[0039] In some embodiments, generating a digital therapeutic module involves generating the module by applying virtual mediating variables to the subject's environment, behavior, emotions, and cognition to the pathogenesis of myopia and therapeutic hypotheses regarding myopia. In some embodiments, a digital application for myopia treatment instructs a processor in a digital device to generate a digital therapeutic module that includes two or more modules selected from a group consisting of eye movement modules, relaxation modules, and phototherapy modules.

[0040] In some embodiments, the eye movement module includes one or more motor tasks for one or more of the following: eye movement tasks, biofeedback control tasks, and eye-related behavior control tasks.

[0041] In some embodiments, the relaxation module includes one or more relaxation tasks in relation to one or more of the following: physical movement tasks, ego reinforcement tasks, safety tasks, calmness tasks, and enjoyment tasks. In some embodiments, the phototherapy module includes one or more phototherapy tasks for controlling the subject's light environment. In some embodiments, one or more relaxation tasks include one or more of the following: playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

[0042] In some embodiments, the digital therapeutic module further includes an achievement module that provides compensation for subject adherence to tasks in two or more first modules and includes one or more achievement tasks for task completion. In some embodiments, the digital therapeutic module further includes an entertainment module that includes one or more entertainment tasks related to music, games, or videos.

[0043] In some embodiments, the healthcare provider portal provides the healthcare provider with one or more options, which are selected from a group consisting of adding or removing subjects, viewing or editing personal information about subjects, viewing compliance information about subjects, viewing the subject's results for one or more digital therapeutic modules that have been at least partially completed, prescribing one or more digital therapeutic modules to a subject, modifying prescriptions for one or more digital therapeutic modules, and communicating with subjects. In some embodiments, one or more options include viewing or editing personal information about a subject, which includes one or more selected from a group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email address, the subject's guardian's email address, the subject's contact telephone number, a prescription for the subject, and one or more notes made by the healthcare provider to the subject. In some embodiments, personal information includes a prescription for a subject, which includes one or more selected from a group consisting of a prescription identification number, prescription type, start date, duration, completion date, the number of digital therapeutic modules scheduled or prescribed by the subject, and the number of digital therapeutic modules scheduled or prescribed by the subject per day. In some embodiments, one or more options include viewing compliance information, which includes one or more of the number of digital therapeutic modules scheduled or prescribed for completion by the subject, and a calendar identifying one or more dates on which the subject has completed, partially completed, or not completed one or more scheduled or prescribed digital therapeutic modules. In some embodiments, one or more options include viewing the subject's results, which include the subject's results for at least one or more digital therapeutic modules that have been partially completed, which include the number of digital therapeutic modules scheduled or prescribed for completion by the subject. This includes one or more groups selected from those comprising the time the module was started, the time the subject completed the scheduled or prescribed digital therapy module, an indicator of whether the scheduled or prescribed digital therapy module was completed completely or partially, and exercise intensity (EI).

[0044] Figure 45a illustrates the healthcare provider portal dashboard. (1) The total number of patients currently associated with the physician's account can be displayed, and a graph can show the number of patients who have initiated a digital application for themselves in a day over the past 90 days. The number of patients in progress can also be displayed. A graph can show the number of patients who have completed a daily session over the past 90 days. Figure 45b illustrates the patient tab of the healthcare provider portal, which displays the patient list. As shown, (1) the patient ID (a unique identification number temporarily assigned when adding a patient to the list), (2) the patient's name, (3) a search box that can be used to search by ID, name, email, notes, etc., and (4) an "Add New Patient" button for adding a new patient can be displayed. Figure 45c illustrates the patient tab of the healthcare provider portal, which displays detailed information about the patient. As shown, (1) patient details, (2) an edit patient information button, (3) prescription information, (4) an "Add New Prescription" button, (5) a progress display for each prescription, and (6) a button or link to forward an email to the patient can be displayed. Figure 45d illustrates the patient tab of the healthcare provider portal for adding new patients. As shown, (1) is the button for adding a new patient, and (3) is the error message displayed when the required patient information is not provided. Figure 45e illustrates the patient tab of the healthcare provider portal for editing information of existing patients. As shown, (1) is the button or link for resetting the password, (2) is the button for deleting the patient, and (3) is the button for saving the changes. Figure 45f illustrates the patient tab of the healthcare provider portal for displaying detailed prescription information about a patient. As shown, (1) is the button for editing the prescription information, (2) displays the duration of the sessions in which the patient or subject participated, and (3) displays an overview of the treatment progress. Seven days are represented by a line or row consisting of seven squares. Twelve weeks, each of six weeks, can be presented separately.Various colors can be used to identify session status (e.g., gray if the session has not started, red for a session not attended, yellow for a partially attended session, and green for a fully attended session). Figures 45g-45h illustrate the patient tab in the healthcare provider portal for editing prescription information about a patient. Figure 45i illustrates the patient tab in the healthcare provider portal for viewing session details for a patient (e.g., date, status, duration, and results such as EI or AEI). As illustrated, (1) is eye movement intensity, and (2) is the movement intensity graph. In the graph, other colors can be used to distinguish up / down or right / left eye movements. In the graph, a larger amplitude indicates more eye movement.

[0045] In some embodiments, collecting the subject's performance on a digital task involves determining one or both of the following: exercise intensity (EI) and average exercise intensity (AEI). In some embodiments, AEI can be determined as the average sum of the differences between the subject's final and initial eye positions measured over a given interval. EI can be determined by the following formula:

[0046]

number

[0047] In certain embodiments, the overall AEI can be determined as the sum of the dynamic AEI and the static AEI. The dynamic AEI can be determined based on the movement of the eyeballs over a given time. Static AEI can be determined based on maintaining an extended position of the eyeball over a given period of time. For example, dynamic AEI can be determined as the average sum of the differences between the final and initial positions of the subject's eyeball measured over a given interval (e.g., a measure of how much the eyeball moves), while static AEI can be determined as the average sum of the eyeball distances measured over a given interval from a resting position (e.g., forward gaze) when the eyeball is fixed in its initial position (e.g., not moving). In relation to dynamic AEI, when eye tracking starts from the eyeball's resting position (time = 0), AEI is calculated by measuring the change in the distance the eyeball (d) has moved over a given interval (e.g., 10 to 500 msec). That is, a larger d means more eye movement is measured and a higher AEI. A small change in d (e.g., little or no eye movement) will result in a lower AEI. However, dynamic AEI does not take into account the movement of the eye muscles when the eye is fixed in a position other than the resting position. In other words, during a given interval, the subject's eyes can be maintained in a position that is not at rest (e.g., d=0), but the eye muscles are still moving to maintain that position. Static AEI takes into account eye movements that are not related to eyeball movement.

[0048] In some embodiments, the management portal provides the administrator with one or more options, which are selected from a group consisting of adding or removing healthcare providers, viewing or editing healthcare provider personal information, viewing or editing subject unidentified information, viewing subject compliance information, viewing subject results for at least one or more digital therapeutic modules that have been partially completed, and communicating with healthcare providers. In some embodiments, one or more options include viewing or editing personal information, where healthcare provider personal information includes one or more selected from a group consisting of a healthcare provider identification number, healthcare provider name, healthcare provider email address, and healthcare provider contact telephone number. In some embodiments, one or more options include viewing or editing subject unidentified information, where subject unidentified information includes one or more selected from a group consisting of a subject identification number and the healthcare provider for the subject. In some embodiments, one or more options include viewing subject compliance information, where subject compliance information includes one or more of the number of digital therapeutic modules that the subject was scheduled to complete or prescribed, 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, one or more options include viewing subject results, where the subject's results for at least one partially completed digital therapeutic module include one or more selected from groups comprising 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 indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and exercise intensity (EI).

[0049] Figure 47a illustrates (a) the dashboard of the administration portal. As shown, (1) shows the number of doctors. Using graphs, the number of doctors who visited the digital application in a day for the past 90 days, and (2) the total number of patients associated with a doctor's account can be displayed. Using graphs, the number of patients who initiated the digital application for themselves in a day for the past 90 days can be displayed. The number of patients in progress can also be displayed. Using graphs, the number of patients who completed a day session in a day for the past 90 days can be displayed. Figure 47b illustrates the Doctors tab of the administration portal, which displays the list of doctors. As shown, (1) is a search box that allows searching for doctors by name, email, etc., (2) is a button to add a new doctor, (3) is the doctor's ID, (4) is a button to view detailed doctor information, and (5) displays inactive doctor accounts. Figure 47c shows the Doctors tab of the administration portal. Figure 47d illustrates the physician tab of the administration portal for adding a new physician. Figure 47e illustrates the physician tab of the administration portal for editing information of an existing physician, including the ability to activate or deactivate a physician's account. Figure 47f illustrates the patient tab of the administration portal for displaying information about one or more patients from which sensitive information has been removed. Figure 47g illustrates the patient tab of the administration portal for displaying detailed patient or prescription information about a given patient. Figure 47h illustrates the patient tab in the administration portal, which displays detailed prescription information for a given patient. Figure 47i illustrates the patient tab in the administration portal, which allows viewing details of a given session for a given patient (e.g., date, status, duration, outcome). Figure 48 is a table showing permissions for physicians using the healthcare provider portal and administrators using the administration portal.

[0050] In some embodiments, the digital application further includes push alarms and / or push notifications regarding one or more of the following: reminding the subject to complete a digital therapeutic module and adjusting the light settings of the subject's environment. In some embodiments, the push alarms and / or push notifications are activated to remind the subject to adjust the light settings so that the subject is exposed to sufficiently bright light at least three times a day. Patients or subjects treated by any of the methods, systems or digital applications described herein may be of any age and may be adults, infants or children, but the methods and systems of this disclosure are particularly suited to children. In some cases, the patient or subject is 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 years of age or 99 years of age or within that range (for example, between 2 and 20 years of age, between 20 and 40 years of age, or between 40 and 90 years of age). 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 this disclosure. In some embodiments, the patient or subject is about under 20 years of age, about under 15 years of age, about under 10 years of age, or about under 5 years of age.

[0051] In some embodiments, the digital device includes a digital task generation unit configured to generate digital therapeutic modules for treating myopia based on the pathogenesis (MOA) of myopia and therapeutic hypotheses regarding myopia, generate digital tasks based on the digital therapeutic modules, and provide the digital tasks to the subject. In some embodiments, the digital device includes a results collection unit configured to collect the subject's performance on the digital tasks. In some embodiments, the digital task generation unit generates digital therapeutic modules based on neurohumoral factors related to the pathogenesis of myopia. In some embodiments, the neurohumoral factors include IGF (insulin-like growth factor), cortisol, and dopamine.

[0052] In some embodiments, the digital task generation unit generates a digital therapeutic module based on input from a healthcare provider. In some embodiments, the digital task generation unit generates a digital therapeutic module based on information received from a subject.

[0053] In some embodiments, the information received from the subject includes the subject's basal factors, medical information, and digital therapeutics literacy. In some embodiments, basal factors include the subject's activity level, heart rate, sleep, and diet (including nutrition and calories). In some embodiments, medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility. In some embodiments, digital therapeutics literacy includes the subject's accessibility to and acceptance of digital therapeutics and devices.

[0054] In some embodiments, the digital task generation unit generates a digital therapeutic module that matches virtual mediating variables corresponding to the pathogenesis and treatment hypotheses for myopia. In some embodiments, the virtual mediating variables are derived in relation to the subject's environment, behavior, emotions, and cognition.

[0055] In some embodiments, the digital device includes a results collection unit configured to collect the results of a subject's performance on a digital task, which collects the results of the digital task by monitoring the subject's compliance with the digital task or by having the subject directly input their compliance with the digital task. In some embodiments, the generation of the digital task in the digital task generation unit and the collection of the subject's performance results on the digital task in the results collection unit are performed multiple times in a multi-layered feedback loop. In some embodiments, the digital task generation unit generates the subject's digital task for the current session based on the subject's digital task from the previous session and the performance result data for the subject's digital task from the previous session collected by the results collection unit.

[0056] Figure 36 illustrates screenshots of the digital application of this disclosure upon completion of a single session, and at the end of all daily sessions and during cancellation / start verification. As illustrated, (1) a button to continue in the next session and (2) a button to go to the home screen may be displayed. If it is the last day of the prescribed period, it will go to the 3.1.3 screen, otherwise it will go to the 3.1.2 screen (see, for example, Figure 23). Pressing the home button in the upper left corner during session execution will display a session cancellation verification popup.

[0057] Figure 1a shows the pathogenesis of axial myopia in childhood / adolescence as proposed in this disclosure, Figure 1b shows the treatment hypothesis for axial myopia as proposed in this disclosure, and Figure 1c shows the digital treatment hypothesis for axial myopia as proposed in this disclosure.

[0058] The digital devices and applications for myopia progression control and treatment described below in this disclosure are based on pathogenesis and treatment hypotheses derived through a literature review and expert evaluation of clinical trial papers on axial myopia in childhood / adolescence.

[0059] Generally speaking, disease treatment involves analyzing a specific disease from a pathophysiological and temperamental perspective to determine its onset, progression, and endpoint. The disease's indications are then defined through demographic and statistical analysis. Furthermore, the physiology of patients exhibiting these established symptoms, particularly their neurohumoral factors, is analyzed to narrow down the scope of these factors to those relevant to the disease, thereby deriving the pathogenesis.

[0060] Next, we derive a treatment hypothesis that treats the disease through actions and environmental control directly related to the regulation of the neurohumoral factors associated with the disease. To realize such a treatment hypothesis with a digital therapeutic agent, we propose a digital therapeutic hypothesis that involves the patient achieving therapeutic effects through repeated digital tasks and their execution, leading to "action / environmental control → regulation of neurohumoral factors." The digital therapeutic hypothesis disclosed herein is realized by digital devices and applications that present changes in the patient's actions (including behavioral, emotional, and cognitive domains), environmental improvements, and patient participation in the form of specific tasks (instructions), and collect and analyze their execution.

[0061] The literature review of the clinical trials described above can be conducted through meta-analysis and data mining, and feedback and in-depth evaluation from clinical specialists can be applied at each analytical step. Essentially, this disclosure includes extracting the pathogenesis and treatment hypotheses of axial myopia through the process described above, and based on this, providing digital devices and applications as digital therapeutic agents for inhibiting and treating the progression of axial myopia by modulating neurohumoral factors.

[0062] However, the method for extracting the pathogenesis and treatment hypotheses for axial myopia as disclosed herein is not limited to the method described above; the pathogenesis and treatment hypotheses for the disease can also be extracted using various other methods.

[0063] Referring to Figure 1a, various risk factors in childhood / adolescence, such as close-range work, education, race, genetics, and other factors (premature birth, diet, light exposure, season of birth, high intraocular pressure, etc.), can cause neurohumoral imbalances during childhood / adolescence. This leads to abnormalities in IGF, cortisol, and dopamine levels, resulting in abnormal proteoglycan production from the sclera around the eyeball, and consequently, abnormal growth of the eyeball, leading to axial myopia.

[0064] Referring to Figure 1b, the treatment hypothesis for axial myopia presented in this disclosure is the suppression and treatment of axial myopia progression by restoring the balance of neurohumoral factors through the patient's actions (including behavioral, emotional, and cognitive domains), environment, and patient participation.

[0065] Referring to Figure 1c, the digital treatment hypothesis for axial myopia is realized through digital devices and applications that present patient behavioral changes, environmental improvements, and participation in the form of specific tasks, and collect and analyze their performance. Using the digital therapeutic agents of this disclosure, the aforementioned digital inputs (tasks) and outputs (performance) can correct the neurohumoral imbalance in children and adolescents with axial myopia, thereby achieving inhibition of axial myopia progression and treatment.

[0066] On the other hand, while Figures 1a and 1b illustrate the pathogenesis and treatment hypotheses for axial myopia, this disclosure is not limited to this, and the methodology of this disclosure can be applied to all types of myopia and other diseases.

[0067] Furthermore, while Figures 1a and 1b illustrate neurohumoral factors as IGF (insulin-like growth factor), cortisol, and dopamine, these are illustrative examples, and the neurohumoral factors in the pathogenesis and treatment hypotheses of myopia presented here are not limited to these; all neurohumoral factors that influence myopia can be considered.

[0068] Figure 2 is a block diagram showing the configuration of a digital device for myopia treatment according to one embodiment of the present disclosure.

[0069] Referring to Figure 2, a digital system 000 for myopia treatment according to one embodiment of the present disclosure may include a digital task generation unit 010, a sensing data collection unit 020, an execution input unit 030, a result analysis unit 040, a database 050, and a security unit 060.

[0070] Based on the pathogenesis, treatment hypotheses, and digital treatment hypotheses for axial myopia in childhood / adolescence, a physician (second user) can prescribe a digital therapeutic agent implemented with digital devices and applications for the treatment of the patient's myopia. Here, the digital task generation unit 010 is a device that provides the patient with a specific behavioral task that allows the patient to perform the digital therapeutic agent prescription, based on the interaction between neurohumoral factors and behavior / environment regarding myopia. For example, neurohumoral factors may include IGF, cortisol, and dopamine, but are not limited to these; all neurohumoral factors that can cause myopia can be considered.

[0071] The digital task generation unit 010 can generate digital tasks based on input from a physician. In this case, the digital task generation unit 010 can generate digital tasks based on information collected by the physician when diagnosing a patient (first user). The digital task generation unit 010 can also generate digital tasks based on information received from the patient. For example, information received from the patient may include the patient's basal factors, medical information, and digital therapeutics literacy. Here, basal factors may include the patient's activity level, heart rate, sleep, and diet (nutrition and calories). Medical information may include the patient's EMR (electronic medical record), family history, genetic vulnerability, and genetic susceptibility. This may include things like susceptibility. Understanding of digital therapeutics may include patient accessibility and acceptance of digital therapeutic challenges and devices.

[0072] The digital problem generation unit 010 can generate digital modules by utilizing virtual mediating variables, reflecting the pathogenesis and treatment hypotheses for myopia. Here, the virtual mediating variables can be derived from aspects of the patient's environment, behavior, emotions, and cognition. This will be described in detail later in Figure 5.

[0073] The digital task generation unit 010 generates digital tasks specifically designed to help patients achieve therapeutic effects and provides these tasks to the patients. For example, the digital task generation unit 010 can provide light stimulation through a bright light environment and generate specific digital tasks for each digital therapeutic agent module.

[0074] The sensing data collection unit 020 and the execution input unit 030 can collect the patient's performance results for digital tasks provided via the digital task generation unit 010. Specifically, the sensing data collection unit 020 senses the patient's adherence to digital tasks, and the execution input unit 030 allows the patient to directly input their performance results for digital tasks, and outputs the patient's performance results for digital tasks.

[0075] The results analysis unit 040 can collect and report patient compliance and participation data at pre-set intervals. Therefore, physicians can continue to monitor the progress of patients completing digital tasks via the application, even if patients do not come to the hospital in person.

[0076] Database 050 can store data on the pathogenesis of myopia, treatment hypotheses, digital tasks provided to the user, and the user's performance. Figure 2 shows that database 050 is included in the digital device 000 for myopia treatment, but data Tabes 050 may be installed on an external server.

[0077] On the other hand, the series of loops—input of digital tasks by the digital task generation unit 010, output of the patient's digital task execution results by the sensing data collection unit 020 / execution input unit 030, and evaluation by the results analysis unit 040—can be repeated multiple times. Here, the digital task generation unit 010 can generate a digital task tailored to the patient for the current session by reflecting the patient's digital tasks, output values, and evaluations provided from the previous session.

[0078] Thus, according to the digital treatment device for inhibiting and treating axial myopia progression of this disclosure, by considering the neurohumoral factors of axial myopia, it is possible to derive a pathogenesis and treatment hypothesis for axial myopia, as well as a digital treatment hypothesis, and based on this, present the patient with an appropriate light stimulation environment and a digital task for axial myopia treatment, and collect and analyze the results of their performance, thereby enabling reliable myopia treatment.

[0079] Figure 3 shows the input and output loops of a digital application for myopia treatment according to one embodiment of the present disclosure.

[0080] Referring to Figure 3, a digital application for myopia treatment according to one embodiment of the present disclosure can input the digital prescription to the patient in the form of a task and output the results of completing the digital task.

[0081] The digital tasks provided to patients may include specific behavioral tasks related to behavior, emotion, and cognition, as well as controlling the patient's light environment. As shown in Figure 3, digital tasks may include eye movements, stress reduction, achievement, and light stimulation. However, these are illustrative examples, and the digital tasks described herein are not limited to these.

[0082] Patient performance outcomes for digital tasks consist of 1) task-performance login / logout information, 2) compliance information sensed in the form of passive data such as eye movements, stress-related heart rate, and oxygen saturation changes, and 3) direct input information of patient performance outcomes.

[0083] Figure 4 shows a feedback loop for a digital device and application for the treatment of axial myopia according to one embodiment of the present disclosure.

[0084] Referring to Figure 4, it is shown that by repeating the single feedback loop described in Figure 3 multiple times to regulate neurohumoral factors, the progression of axial myopia can be suppressed and treated.

[0085] In the case of axial myopia, due to its disease characteristics, treatment requires long-term digital therapy and observation ranging from as short as 10 weeks to the entire childhood / adolescence period. Because of these characteristics, the suppression of axial myopia progression and the therapeutic effect can be more effectively achieved through gradual improvement of task performance via a feedback loop than through simple task-performance repetition during the treatment process.

[0086] For example, the initial digital task and its results are given as input and output values ​​in a single loop. However, after N executions, the loop's feedback process can be used to adjust the inputs for the next loop, reflecting the input and output values ​​generated in the current loop, thereby generating a new digital task. By repeating this feedback loop, it is possible to derive digital tasks tailored to the patient and maximize the therapeutic effect.

[0087] Thus, in a digital device and application for myopia treatment according to one embodiment of the present disclosure, the patient's digital task and performance results for the current session (e.g., the Nth session) can be calculated using data on the patient's digital task and task performance results provided in the previous session (e.g., the N-1th session). That is, the digital task for the next loop can be generated based on the patient's digital task and task performance results calculated in the previous loop. Here, the feedback process can use various algorithms and statistical models as needed.

[0088] Thus, in one embodiment of the present disclosure, a digital device and application for myopia treatment enables the optimization of patient-specific digital tasks through a rapid feedback loop.

[0089] Figure 5a is a diagram showing a modular design that enables digital treatment with a digital myopia device and application for myopia treatment according to one embodiment of the present disclosure, and Figure 5b is a diagram showing background factors supporting the digital device and application for myopia treatment according to one embodiment of the present disclosure.

[0090] As shown in Figure 5a, once a treatment hypothesis based on the pathogenesis of myopia is formulated, target neurohumoral factors (e.g., IGF, cortisol, dopamine, etc.) can be identified. To address specific challenges in regulating these neurohumoral factors, virtual mediating variables are utilized. Using the correlation between "neurohumeral factors - virtual mediating variables - modules," modules necessary for myopia treatment were derived. Each module will be explained in more detail in Figure 7, which will be described later, in terms of the form of the module-specific challenges. Here, each module is the basic design unit of a digital therapeutic agent that will be realized in an actual digital device or application, and is a collection of specific challenges.

[0091] Specifically, referring to Figure 5a, the neurohumoral factors derived through the pathogenesis and treatment hypotheses for axial myopia can be IGF, cortisol (or TGF-beta, which is affected by cortisol), and dopamine (or GABA agonist / antagonist, glucagon). For myopia treatment, it is necessary to regulate the secretion of IGF and dopamine, which affect ocular development in the relevant age group, to promote secretion, while suppressing cortisol secretion.

[0092] The control of each neurohumoral factor was mapped to a digital therapeutic module by utilizing environment (light), behavior (movement), emotion (stress reduction), and cognition (sense of accomplishment) as virtual mediating variables. Based on the converted modules, specific digital tasks were generated for each module. Here, the digital tasks may include performance environment settings and modules (eye movement, gymnastics, self-awareness, safety / calmness, enjoyment, and achievement modules) that can be output via monitoring. However, this is illustrative, and the modules described herein are not limited to these.

[0093] On the other hand, referring to Figure 5b, background factors can be taken into consideration in the modular design of a digital device and application for myopia treatment according to one embodiment of the present disclosure.

[0094] Here, background factors are elements necessary for correcting clinical trial results in the process of verifying the clinical effectiveness of digital myopia treatment according to this disclosure. Specifically, among the background factors shown in Figure 5b, basal factors can include activity level, heart rate, sleep, diet (nutrition and calories), and medical information is created when the patient visits the clinic. This may include EMR, family history, genetic vulnerability and susceptibility, and understanding of digital therapeutics may include the patient's accessibility and acceptance of digital therapeutic challenges and devices.

[0095] Figure 6 shows a method for specifying a patient-specific digital prescription using a digital device and application for myopia treatment according to one embodiment of the present disclosure.

[0096] Figure 6(A) shows the prescription process based on routine patient-physician interviews, while Figure 6(B) shows a system in which a physician specifies a digital prescription tailored to the patient by analyzing multiple digital tasks and their results.

[0097] Thus, when using the digital device and application for myopia treatment according to one embodiment of the present disclosure, as shown in Figure 6(B), a physician can review the patient's challenges and results over a predetermined period and adjust the type of myopia treatment module and the challenges for each module to suit the patient.

[0098] Figure 7a shows the execution environment settings according to one embodiment of the present disclosure, and Figures 7b to 7g show examples of specific problems of each module and output data collection methods according to one embodiment of the present disclosure.

[0099] In the case of digital treatment for axial myopia, continuous patient participation for at least 10 weeks is usually required, so it is of paramount importance that adolescent children find digital treatment enjoyable and participate voluntarily. In this context, each module can be designed with game-like elements. As will be discussed later, in digital devices and applications for myopia treatment realized for the improvement and treatment of axial myopia, each module is a basic design unit and a collection of specific challenges.

[0100] Referring to Figure 7a, specific examples of tasks for setting up the execution environment and the method for collecting output data are shown. Here, the execution environment setting can be included as the configuration of the digital task generation unit 010 in Figure 2.

[0101] Specifically, the execution environment settings include setting the brightness of the execution environment using an illuminance sensor, and other modules are performed under the set light environment.

[0102] Generally, sunlight is closely related to eye health. Strong light stimulation, similar to exposure to direct sunlight, acts on retinal nerve cells to stimulate dopamine secretion and induce the synthesis of proteoglycans that support the sclera. This is an essential factor in regulating the normal length of the eyeball.

[0103] In this way, to provide light stimulation to patients, illuminance sensors can be used to measure the illuminance of the current environment or to provide notifications about the current light environment, thereby controlling the brightness of the environment in which patients participate in digital therapy.

[0104] Referring to Figure 7b, a specific example of the eye movement module's tasks and the method for collecting output data are shown. Here, the eye movement module can be included as part of the configuration of the digital task generation unit 010 in Figure 2.

[0105] The digital tasks for eye movement include patient eye movements, biofeedback, and eye-related behavioral control, and stimulate IGF secretion in the extraocular muscles. Specifically, the behavioral tasks of the eye movement module, such as eye movements, blinking, long-distance gaze, and eye closing, are performed using eye tracking technology. Patient compliance can be monitored. However, the collection of performance results for the eye movement module is not limited to eye tracking technology and includes direct patient input of performance results for the task.

[0106] Referring to Figure 7c, a specific example of a physical exercise module and a method for collecting output data are shown. Here, the physical exercise module can be included as part of the configuration of the digital task generation unit 010 in Figure 2. The physical exercise module can consist of a series of behavioral instructions that include slow-speed, calm physical exercises and abdominal exercises, and reduce stress and suppress cortisol secretion through rest, relaxation, deep breathing, etc.

[0107] Specifically, the behavioral tasks of the physical exercise module include behavioral tasks such as relaxation exercises, deep breathing, meditation, and eye massage. The results of these tasks are collected by a sensing data collection unit 020 using biofeedback devices (measuring EEG, ECG, EMG, EDG, etc.) or general-purpose sensors (measuring activity, HR, etc.), or by the patient directly inputting the data using an input unit 030. The behavioral tasks in this disclosure are constructed by applying behavioral therapy methods widely used in child psychiatry to relieve stress in children.

[0108] Generally, there is a close relationship between the progression of myopia and its progression during adolescence. In particular, during this period, there is great diversity in self-identity, safety and peace (ventilation, release of stress), enjoyment, and achievement, depending on age group, gender, personality, and preferences. To address these deviations, it is preferable to present digital tasks for each module in a format tailored to the individual characteristics of each patient. Tasks requiring interactive communication with an app, such as conversations, can be developed in conjunction with big data analysis and artificial intelligence analysis.

[0109] Referring to Figure 7d, a specific example of a task for the ego module and a method for collecting output data are shown. Here, the ego module can be included as part of the configuration of the digital task generation unit 010 in Figure 2.

[0110] Specifically, the tasks in the ego module aim to enhance adolescents' self-esteem and reduce stress. To this end, tasks can be composed of activities such as conversation, drawing, meditation, journaling, creating a safe space (safety place task), identifying favorite things (places, times, seasons, colors, food, people, etc.), creating a personal bucket list, and deciding on and planning travel destinations. These tasks were constructed by applying psychotherapies widely used in child psychiatry to enhance self-esteem and relieve stress in children and adolescents.

[0111] Referring to Figure 7e, specific examples of issues and output data collection methods for the safety and tranquility module are shown. Here, the safety and tranquility module can be included as part of the configuration of the digital issue generation unit 010 in Figure 2.

[0112] Specifically, the tasks in the safety and calmness module aim to provide a form of ventilation to reduce stress in adolescents. For this purpose, tasks such as chatting, self-expression (writing, singing, drawing), and the release of unpleasant emotions through animation (trash can tasks) can be incorporated. These tasks were designed using methods adapted from psychotherapeutic approaches widely used in child psychiatry for stress relief in children and adolescents.

[0113] Referring to Figure 7f, a specific example of a fun module's challenges and an output data collection method are shown. Here, the fun module can be included as part of the configuration of the digital challenge generation unit 010 in Figure 2.

[0114] Specifically, the fun module consists of tasks designed to make patients feel entertained while using the application, and can be structured using various content such as music, games, or videos, tailored to the characteristics of adolescents. Another objective of the fun module is to improve the patient's sustained participation in digital therapy.

[0115] Referring to Figure 7g, specific examples of tasks in the achievement module and the output data collection method are shown. Here, the achievement module can be included as part of the configuration of the digital task generation unit 010 in Figure 2.

[0116] Specifically, the achievement module can include tasks that promote dopamine secretion through the patient's task performance and the sense of accomplishment that comes from completing them. Here, the task achievement task is a task that provides the patient with a task and allows them to feel a sense of accomplishment upon its completion. It can include games that can be updated according to the patient's participation period and that can encourage voluntary participation. For example, the specific form of the game can be diverse, such as learning, hidden picture or different picture search, or quizzes.

[0117] In particular, the quiz-based implementation within the achievement module is expected to have the additional effect of enhancing patients' ability to understand health information and digital therapeutics. Such improvements in understanding health information and digital therapeutics are essential elements for sustained patient participation in and improved treatment performance.

[0118] As described above, the digital therapy described in this disclosure requires patient participation for more than 10 weeks, and during this period, the achievement module can be designed with reward (compensation) tasks so that the patient's honest completion of the tasks in the module itself fosters a sense of accomplishment. In the reward tasks, the patient's active participation in the therapy can be fed back as a sense of accomplishment through trust and compensation between the patient and their guardian, and between the patient and their doctor.

[0119] The digital tasks shown in Figures 7b to 7g are merely illustrative examples, and this disclosure is not limited thereto. The digital tasks provided to patients can be set in a variety of ways depending on the circumstances.

[0120] Figure 8 is a flowchart showing the operation of a digital application for myopia treatment according to one embodiment of the present disclosure.

[0121] Referring to Figure 8, a digital application for myopia treatment according to one embodiment of the present disclosure can first generate a digital therapeutic agent module for the treatment of myopia based on the pathogenesis and treatment hypothesis for myopia (S810). Here, in step S810, the digital therapeutic agent module can be generated based on neurohumoral factors for myopia (e.g., IGF, cortisol, dopamine, etc.).

[0122] On the other hand, in step S810, a digital therapeutic module can be generated based on input from a physician. In this case, a digital therapeutic module can be generated based on information collected by the physician during the diagnosis of the patient and the prescription results created based on this information. Alternatively, in step S810, a digital therapeutic module can be generated based on information received from the patient (e.g., underlying factors, medical information, digital therapeutic understanding ability, etc.).

[0123] Then, in step S820, a digital challenge can be generated based on the digital therapeutic module. Step S820 applies virtual mediating variables related to the patient's environment, behavior, emotions, and cognition to the pathogenesis and treatment hypotheses for myopia and digitally... A therapeutic agent module can be generated. This was explained in Figure 5, so a detailed explanation will be omitted here.

[0124] Here, digital tasks can be generated for at least one of the following modules: lighting environment settings, eye movements, body movements, self-awareness, safety and peace, enjoyment, and achievement. Descriptions of the performance environment settings and specific digital tasks for each module are shown in Figures 7a to 7g.

[0125] Next, digital tasks can be provided to the patient (S830). In this case, the digital tasks can be related to behavior, emotion, and cognition, and can be provided in the form of digital tasks in which the patient's adherence to the task can be monitored using sensors, such as eye movements / body movements, or digital tasks in which the patient directly inputs the results of their performance.

[0126] After the patient completes the presented digital task, the patient's performance on the digital task can be collected (S840). In step S840, as described above, the patient's adherence to the digital task can be monitored, or the patient can input their performance results for the digital task, thereby collecting the results of their performance on the digital task.

[0127] On the other hand, a digital application for myopia treatment according to one embodiment of the present disclosure may involve a feedback loop in which the steps of generating a digital task and collecting the patient's performance results on the digital task are repeated multiple times. In this case, the step of generating a digital task may be configured to generate the patient's digital task for the current session based on the patient's digital tasks provided in previous sessions and the collected data on the patient's performance results on the digital tasks.

[0128] Thus, according to one embodiment of the present disclosure, a digital application for myopia treatment can be used to derive a pathogenesis mechanism and treatment hypothesis for myopia by considering the neurohumoral factors of myopia, present a digital task to the patient based on this, have them perform the digital task in an appropriate light stimulation environment, and collect and analyze the results to ensure the reliability of myopia progression suppression and treatment.

[0129] The above description of a digital device and application for myopia treatment according to one embodiment of the disclosure has been made solely from the perspective of myopia treatment. However, the disclosure is not limited thereto, and digital treatment can be performed for other diseases besides myopia in substantially the same manner as described above.

[0130] Figure 9 is a flowchart showing a method for generating a digital challenge in a digital application for myopia treatment according to one embodiment of the present disclosure.

[0131] Referring to Figure 9, we will detail the process of generating modules and specific digital tasks for myopia treatment based on the pathogenesis and treatment hypotheses for myopia (steps S810 and S820 in Figure 8) and the process shown in Figure 5.

[0132] In step S910, the pathogenesis and treatment hypotheses for myopia are first input. Here, the pathogenesis and treatment hypotheses for myopia can be derived in advance through a literature review and expert evaluation of systematic relevant clinical trials for myopia, as described above.

[0133] Then, the neurohumoral factors of myopia can be predicted from the input disease pathogenesis and treatment hypotheses (S920). Here, the neurohumoral factors of myopia predicted via step S920 can be derived as IGF, cortisol, dopamine, etc. Since neurohumoral factors were explained in detail in Figure 5, a detailed explanation will be omitted here.

[0134] In step S930, a digital therapeutic module can be generated corresponding to the predicted neurohumoral factors and virtual mediating variables. Here, the virtual mediating variables act as a converter, transforming the myopia neurohumoral factors into digital therapeutic modules and establishing physiological relationships between neurohumoral factors and environmental, behavioral, emotional, and cognitive factors, as shown in Figure 5.

[0135] Next, a specific digital task can be generated based on the generated digital therapeutic module (S940). Here, the specific digital task can be generated by the light environment setting, eye movement, body movement, self, safety / calmness, fun, and achievement modules described in Figures 7a to 7g.

[0136] Figure 10 is a flowchart showing how an action is repeated in response to feedback control in a digital application for myopia treatment according to one embodiment of the present disclosure.

[0137] Figure 10 illustrates that the generation of digital tasks and collection of completion results using a digital application for myopia treatment are performed N times. In this case, first, the pathogenesis of myopia and the treatment hypothesis can be input (S1010). Also, the digital tasks and completion result data provided in the previous time can be received (S1020). If the current time is the first, there is no previous data, so step S1020 can be omitted.

[0138] Next, based on the input disease pathogenesis and treatment hypothesis, and the digital tasks and performance result data provided from the previous session, a digital task for the current session can be generated (S1030). Then, the user's performance results for the generated digital task can be collected (S1040).

[0139] In step S1050, it is determined whether the current iteration is N or greater. If the current iteration is less than N (NO), the process returns to step S1020 and steps S1020 to S1040 are repeated. On the other hand, if the current iteration is N or greater (YES), that is, if the process of generating the digital task and collecting the completion results has been performed N times, the feedback operation can be terminated.

[0140] Figure 11 shows the hardware configuration of a digital device for myopia treatment according to one embodiment of the present disclosure.

[0141] Referring to Figure 11, the hardware 600 of a digital device for myopia treatment according to one embodiment of the present disclosure may include a CPU 610, memory 620, input / output I / F 630, and communication I / F 640.

[0142] The CPU 610 can be a processor that executes a digital program for myopia treatment stored in memory 620, processes various data for digital myopia treatment, and performs functions related to digital myopia treatment. In other words, the CPU 610 can perform the functions of each configuration shown in Figure 2 by executing a digital program for myopia treatment stored in memory 620.

[0143] Memory 620 can store digital programs for myopia treatment. Memory 620 also contains data used for digital myopia treatment, such as the patient's digital tasks, task completion results, and the patient's medical information, which are included in the aforementioned database 050. It is possible.

[0144] Multiple such memory 620s may be provided as needed. The memory 620 can be either volatile or non-volatile. For volatile memory, RAM, DRAM, SRAM, etc., can be used. For non-volatile memory, ROM, PROM, EAROM, EPROM, EEPROM, flash memory, etc., can be used. The examples of memory 620 listed above are merely illustrative and not limiting.

[0145] The input / output interface 630 can provide an interface (e.g., wireless or wired) that allows input devices (not shown) such as keyboards, mice, and touch panels, and output devices (not shown) such as displays, to send and receive data to and from the CPU 610.

[0146] The communication interface 640 is configured to send and receive various types of data with the server and can be various devices that support wired or wireless communication. For example, various types of data related to the aforementioned digital behavioral base therapy can be received from an external server separately provided via the communication interface 640.

[0147] Thus, a computer program according to one embodiment of the present disclosure can be stored in memory 620 and processed by CPU 610, and can be realized as a module that performs each of the functional blocks shown in Figure 2, for example.

[0148] While it has been described above that all components constituting the embodiments of the Disclosure either combine into one or operate in combination, the Disclosure is not necessarily limited to such embodiments. That is, within the scope of the purposes of the Disclosure, all components may also selectively combine into one or more units and operate in combination.

[0149] Furthermore, unless otherwise specified, terms such as “includes,” “constitutes,” or “possesses” as used above should be interpreted as meaning that the component in question may be inherent, and that it may include other components rather than excluding them. All terms, including technical and scientific terms, have the same meaning as that generally understood by a person of ordinary skill in the art to which this disclosure belongs, unless otherwise defined. Commonly used terms, such as those defined in dictionaries, should be interpreted to match their meaning in the context of the relevant technology, and should not be interpreted in an ideal or overly formal sense unless explicitly defined in this disclosure.

[0150] The above description is merely illustrative of the technical concept of this disclosure, and any person with ordinary skill in the art to which this disclosure pertains can make various modifications and variations without departing from the essential characteristics of this disclosure. Accordingly, the embodiments disclosed in this disclosure are for illustrative purposes only, not to limit the technical concept of this disclosure, and such embodiments do not limit the scope of the technical concept of this disclosure. The scope of protection of this disclosure should be interpreted in accordance with the claims below, and all technical concepts within an equivalent scope should be construed as being included in the scope of rights of this disclosure.

Claims

1. A digital system for treating myopia, At least one processor, It includes at least one memory for storing a digital program for myopia treatment, The processor executes the digital program, The digital task generation unit generates one or more digital tasks based on at least some of a plurality of digital therapeutic agent modules configured to contribute to myopia treatment by regulating one or more neurohumoral factors. The aforementioned plurality of digital therapeutic modules include an eye movement module for regulating cortisol and / or dopamine, and at least one of a relaxation module and a phototherapy module. The digital task generation unit provides one or more digital tasks to the subject, The results collection unit collects the results of the subjects' performance on one or more of the aforementioned digital tasks. The digital task generation unit generates one or more digital tasks for the next session based on the subject's performance results. A digital system for treating myopia.

2. The digital system for treating myopia according to claim 1, wherein the neurohumoral factor further comprises IGF (insulin-like growth factor).

3. The aforementioned digital problem generation unit, The digital system for treating myopia according to claim 1, wherein generating the digital task generates the digital task for the subject for the current session based on the subject's digital task for the previous session and the collected performance result data of the subject for the digital task provided from the previous session.

4. The aforementioned digital problem generation unit, A digital system for treating myopia according to claim 1, wherein a physician can generate digital tasks based on information collected by diagnosing the subject.

5. The aforementioned results include sensing compliance and input compliance. The aforementioned results collection unit, A sensing data collection unit that continuously monitors the subject's compliance with the aforementioned digital task, The digital system for treating myopia according to claim 1, comprising at least one performance input unit that receives the input compliance level entered by the subject.

6. The aforementioned digital therapeutic module includes an eye movement module. The aforementioned eye movement module is A digital system for treating myopia according to claim 1, comprising at least one of an eye movement task, a biofeedback control task, and an eye-related behavior control task for promoting IGF secretion.

7. The aforementioned digital therapeutic module includes a relaxation module. The relaxation module is, A digital system for treating myopia according to claim 1, comprising at least one of the following: a physical activity task, an ego-enhancing task, a sense of safety task, a sense of calm task, and a fun task.

8. The aforementioned physical exercise task is, A digital system for treating myopia according to claim 7, comprising a series of behavioral instructions for reducing stress and suppressing cortisol secretion, comprising at least one of relaxation exercises, deep breathing, meditation, and eye massage.

9. The aforementioned digital therapeutic module includes a phototherapy module. The aforementioned phototherapy module is A digital system for treating myopia according to claim 1, comprising one or more phototherapy tasks for controlling the light environment of the subject.

10. The aforementioned digital therapeutic module includes an achievement module, The digital system for treating myopia according to claim 1, wherein the achievement module can provide compensation for the subject's adherence to the digital tasks and update the tasks according to the subject's participation period, and provides at least one of game-based achievement tasks.

11. One or more sensors for tracking the eye movements of the subject, It further includes a light sensor for measuring the light environment, The digital system for treating myopia according to claim 1, wherein the processor corrects the accuracy of the measurement of the subject's eye position by the one or more sensors and corrects the accuracy of the measurement of the light environment by the light sensor.

12. The digital system for treating myopia according to claim 11, wherein the correction is performed before generating the digital therapeutic module.

13. The aforementioned results collection unit, A digital system for treating myopia according to claim 1, comprising collecting the compliance or participation of the subject at predetermined intervals.

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