Digital apparatus and application for treating myopia

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 to U.S. patent application Ser. No. 16 / 883,369, filed May 26, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates to digital therapeutics (hereinafter, DTx) for the treatment of myopia, including the inhibition of myopia progression. The present disclosure also relates to a system for integrating a digital therapeutic with one or both of a healthcare provider portal and a management portal to treat a patient's myopia. In particular, the present disclosure includes deriving a mechanism of action (hereinafter, MOA) for childhood / adolescent axial myopia through literature survey and expert evaluation of basic science papers and related clinical trial papers that attempt to clarify the mechanism of myopia pathology, and establishing a therapeutic hypothesis and a digital therapeutic hypothesis for the inhibition and treatment of childhood / adolescent axial myopia based on the mechanism of action. The present disclosure also includes the rational design of an application for clinically verifying the digital therapeutic hypothesis for childhood / adolescent axial myopia and realizing it as a digital therapeutic, and the provision of a digital device and application for the inhibition and treatment of childhood / adolescent axial myopia based on the application. [Background technology]

[0003] The prevalence of myopia patients in Korea is very high. An analysis of data from 2008 to 2012 showed that the prevalence of myopia (-0.75 diopters or more) among Korean adolescents aged 12-18 was 80.4%, which is 4.35 times higher than the prevalence of myopia among people in their 60s (18.5%), and the prevalence of severe myopia (-6 diopters or more) was 12%, eight times higher than the prevalence among people in their 60s (1.5%) and nearly three times higher than the prevalence of myopia among adolescents in the US, the UK, and other countries.

[0004] Even more serious, a survey revealed that approximately 70% of adolescent myopia patients in Korea are severe or severe myopia patients. The prevalence of myopia among elementary school students 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 there is still no clear cure for myopia worldwide. With the recent sudden increase in the prevalence of myopia in China, Singapore, and South Korea, it has been emphasized that myopia is an eye disease that can lead to blindness, and it has attracted the attention of academic circles.

[0006] Myopia can be divided into axial myopia, which occurs when the axis of the eyeball becomes longer, and refractive myopia (index myopia), which occurs when the refractive index of the lens or cornea increases. Axial myopia can be further divided into simple myopia, which does not affect the retina or choroid, and degenerative myopia, which causes degeneration of the retina and leads to blindness. With the exception of nuclosclerosis caused by diabetes and keratoconus, most myopia falls into the category of simple axial myopia, which progresses at an accelerated rate from elementary school age onwards.

[0007] A known method to slow or treat myopia is to use a drug (atropine) and special lenses (e.g., Dream Lenses). In such cases, severe glare may occur due to pupil dilation. Also, in the case of the Dream Lens, there is a high risk of corneal damage, so its clinical use is limited compared to vision correction glasses.

[0008] In addition, many myopia treatment devices, eye movement methods, and eye movement applications have been developed and sold, but most of them lack evidence of their clinical effectiveness and are sold without separate approval procedures. As a result, there is no reliable treatment that children and adolescents who have been diagnosed with myopia at a hospital can use to prevent and treat the progression of myopia. Summary of the Invention

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

[0010] In some aspects, the disclosure provides a method for treating myopia in a subject in need of myopia treatment, the method comprising providing to the subject via a digital device a digital application including modules for treating myopia based on a pathogenic mechanism of myopia and a treatment hypothesis regarding myopia, each module including one or more first tasks to be followed by the subject, the digital device including (i) a sensor for sensing the subject's compliance with the one or more first tasks of the modules, (ii) based on the compliance, transmitting compliance information to a server accessible to 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 some aspects, the present disclosure provides a non-transitory computer readable medium having stored thereon software instructions for treating myopia in a subject in need of myopia treatment, the non-transitory computer readable medium, when executed by a processor, causes the processor to display to the subject, via the digital device, modules for treating myopia based on myopia pathogenesis and treatment hypotheses regarding myopia, each module including one or more tasks for the subject to follow, sense the subject's compliance with the tasks of the modules via a sensor in the digital device, transmit, via the digital device, compliance information based on the compliance to a server accessible to a healthcare provider via a healthcare provider portal, and receive, from the server, one or more second tasks from the healthcare provider.

[0012] In some embodiments, the digital application for myopia treatment directs a processor of the digital device to perform operations including generating a digital therapeutic module for treating myopia based on a treatment hypothesis related to myopia and a pathogenic mechanism of myopia. In some embodiments, generating the digital therapeutic module includes generating the digital therapeutic module based on neurohumoral factors related to myopia pathogenesis. In some embodiments, the operations include: compensating for one or more of the light environment and the measurement accuracy of the subject's eye position. In some embodiments, the correction module can be generated prior to generating the digital therapeutic module. In some embodiments, the correction module can be generated prior to 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 can include instructing the subject to position their face as shown on a screen of a digital device, sensing the subject's eyes for a given time, instructing the subject to blink, sensing whether or not they blink, staring at the screen, and detecting whether or not they blink. In some embodiments, the digital device includes one or more of: instructing the subject to perform a specific measurement, instructing the subject to move or rotate the eye in a specified direction, and determining a threshold value for detecting the subject's eye. In some embodiments, the digital device includes one or more sensors for tracking the movement of the subject's eye. In some embodiments, the measurement accuracy of the light environment can be corrected, the light environment correction including one or more of: detecting light in the subject's environment using a light sensor of the digital device, and instructing the subject to turn on one or more lights in his or her environment. In some embodiments, the digital application for myopia treatment instructs the processor of the digital device to perform operations including generating a digital therapeutic agent module for treating myopia based on a treatment hypothesis regarding myopia and a pathogenic mechanism of myopia. In some embodiments, the digital application for myopia treatment instructs the processor of the digital device to perform operations including generating a digital task based on the digital therapeutic agent module. In some embodiments, the digital application for myopia treatment instructs the processor of the digital device to perform operations including providing a digital task to the subject. In some embodiments, the digital application for myopia treatment instructs the processor of the digital device to perform operations including collecting the subject's performance results on the digital task. In some embodiments, generating the digital challenge and collecting the subject's performance on the digital challenge are performed multiple times in multiple feedback loops, and generating the digital challenge includes generating the subject's digital challenge for a current round based on the subject's digital challenge for a previous round and the collected performance data of the subject on the digital challenge provided from the previous round. In some embodiments, collecting the subject's performance on the digital challenge includes determining one or both of an Exercise Intensity (EI) and an 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 the starting eye position measured in a given interval.In some embodiments, the interval is between about 10 milliseconds (ms) and about 500 ms. In some embodiments, EI may be determined by the following formula:

[0013]

number

[0014] In some embodiments, the AEI can be determined as the sum of the dynamic AEI and the static AEI. In some embodiments, generating the digital therapeutic module includes applying virtual parameters for the subject's environment, behavior, emotion, and cognition to the myopia pathogenesis and myopia treatment hypotheses to generate the digital therapeutic module. In some embodiments, the digital application for myopia treatment instructs a processor of the digital device to generate the digital therapeutic module including two or more modules selected from the group consisting of an eye movement module, a relaxation module, and a light therapy module. In some embodiments, the eye movement module includes one or more motor tasks for one or more of an eye movement task, a biofeedback control task, and an eye-related behavior control task. In some embodiments, the relaxation module includes one or more relaxation tasks for one or more of a physical movement task, an ego enhancement task, a feeling of safety task, a feeling of calm task, and a fun task. In some embodiments, the light therapy module includes one or more light therapy tasks to control the subject's light environment. In some embodiments, the one or more relaxation tasks include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises. In some embodiments, the digital therapeutic module further comprises an achievement module including one or more achievement challenges for providing compensation for the subject's compliance with the challenges of the two or more first modules and for completing the tasks. In some embodiments, the digital therapeutic module further comprises a fun module including one or more fun challenges for music, games, or videos. In some embodiments, the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing the prescription for one or more digital therapeutic modules, and communicating with the subject. In some embodiments, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's parental email, the subject's contact phone number, a prescription for the subject, and one or more notes created by the healthcare provider for the subject. In some embodiments, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed to be taken by the subject, and a number of digital therapeutic modules scheduled or prescribed to be taken by the subject per day. In some embodiments, the one or more options include viewing compliance information for the subject, the compliance information for the subject including one or more of a calendar identifying one or more dates when the subject completed, partially completed, or did not complete one or more scheduled or prescribed digital therapeutic modules, and a number of scheduled or prescribed digital therapeutic modules completed by the subject. In some embodiments, the one or more options include viewing subject outcomes, the subject outcomes for the at least partially completed one or more digital therapeutic modules include one or more selected from the group consisting of: a time when the subject started the scheduled or prescribed digital therapeutic module, a time when the subject finished the scheduled or prescribed digital therapeutic module, an indicator for whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and Exercise Intensity (EI).In some embodiments, the one or more options provided to an administrator of the system are selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information of a healthcare provider, viewing or editing de-identified information of a subject, viewing adherence information for a subject, viewing a subject's results for one or more at least partially completed digital therapeutic modules, and communicating with a healthcare provider. In some embodiments, the one or more options include viewing or editing personal information, where the personal information of the healthcare provider includes one or more selected from the group consisting of an identification number for the healthcare provider, a name of the healthcare provider, an email of the healthcare provider, and a contact number for the healthcare provider. In some embodiments, the one or more options include viewing or editing de-identified information of a subject, where the de-identified information of a subject includes one or more selected from the group consisting of an identification number for the subject and a healthcare provider for the subject. In some embodiments, the one or more options include viewing adherence information for a subject, where the adherence information of a subject includes one or more predictions for a given subject. and one or more of a calendar identifying one or more dates for which the scheduled or prescribed digital therapeutic module is completed, partially completed, or not completed, and a number of scheduled or prescribed digital therapeutic modules completed by the subject. In some embodiments, the one or more options include viewing the subject's results, where the subject's results for the at least partially completed one or more digital therapeutic modules include one or more selected from the group consisting of a time the subject started the scheduled or prescribed digital therapeutic module, a time the subject finished the scheduled or prescribed digital therapeutic module, an indicator for whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and Exercise Intensity (EI). In some embodiments, the digital application further includes a push alarm for one or more of reminding the subject to complete the digital therapeutic module and adjusting light settings of the subject's environment. In some embodiments, the push alarm reminds the subject to adjust light settings to expose the subject to sufficiently bright light at least three times per day. In some embodiments, the subject is a child. In some embodiments, the subject is less than about 20 years old, less than about 15 years old, less than about 10 years old, or less than about 5 years old. In some embodiments, the subject is assisted or supervised by an adult. In some embodiments, the digital device includes a digital task generator configured to generate a digital therapeutic module for treating myopia based on a mechanism of action (MOA) of myopia and a treatment hypothesis related to myopia, generate a digital task based on the digital therapeutic module, and provide the digital task to the subject. In some embodiments, the digital device includes a result collector configured to collect a result of the subject's performance of the digital task. In some embodiments, the digital task generator generates the digital therapeutic module based on neurohumoral factors related to myopia pathogenesis. In some embodiments, the neurohumoral factors include insulin-like growth factor (IGF), cortisol, and dopamine. In some embodiments, the digital task generator generates the digital therapeutic module based on input from a healthcare provider. In some embodiments, the digital task generator 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 therapeutic literacy. The digital therapeutic literacy includes the subject's basal factors including activity, heart rate, sleep, and diet (including nutrition and calories), medical information including the subject's EMR (electronic medical record), family history, genetic vulnerability, and genetic susceptibility, and the subject's accessibility and receptive attitude to digital therapeutics and devices. In some embodiments, the digital task generator generates a digital therapeutic module that matches virtual parameters corresponding to the pathogenic mechanism and treatment hypothesis for myopia.In some embodiments, the virtual parameters are derived in relation to the subject's environment, behavior, emotion and cognition. In some embodiments, the digital device collects the performance results of the digital task by having the result collection unit monitor the subject's compliance with the digital task or have the subject directly input the compliance of the subject with the digital task. In some embodiments, the generation of the digital task by the digital task generation unit and the collection of the subject's performance results of the digital task by the result collection unit are performed multiple times in a multiple feedback loop, and the digital task generation unit generates the subject's digital task for the current round based on the subject's digital task for the previous round and the performance result data for the subject's digital task for the previous round collected by the result collection unit. [Brief description of the drawings]

[0015] The above and other objects, features and advantages of the present disclosure will become more apparent to those skilled in the art from the detailed description of illustrative embodiments thereof, taken in conjunction with the accompanying drawings.

[0016] [Figure 1a] FIG. 1 shows the pathogenesis of childhood / adolescent axial myopia proposed in the present disclosure. [Figure 1b] FIG. 1 illustrates the treatment hypothesis for axial myopia proposed in the present disclosure. [Figure 1c] FIG. 1 illustrates the digital treatment hypothesis for axial myopia proposed in the present disclosure. [Diagram 2] FIG. 1 is a block diagram showing the configuration of a digital device for treating myopia according to one embodiment of the present disclosure. [Diagram 3] FIG. 1 illustrates an input and output loop of a digital application for myopia treatment according to one embodiment of the present disclosure. [Figure 4] FIG. 1 illustrates a feedback loop with a digital device and application for myopia treatment according to an embodiment of the present disclosure. [Figure 5a] FIG. 1 illustrates a modular design for implementing digital therapy in a digital myopia device and application for myopia treatment according to an embodiment of the present disclosure. [Figure 5b] FIG. 1 illustrates background factors supporting a digital device and application for myopia treatment according to an embodiment of the present disclosure. [Figure 6] FIG. 1 illustrates a method for specifying a patient-tailored digital prescription using a digital device and application for myopia treatment according to an embodiment of the present disclosure. [Figure 7a] FIG. 2 illustrates a performance environment configuration according to one embodiment of the present disclosure. [Figure 7b] FIG. 13 is a diagram showing an example of specific tasks for each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7c] FIG. 13 is a diagram showing an example of specific tasks for each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7d] FIG. 13 is a diagram showing an example of specific tasks for each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7e] FIG. 13 is a diagram showing an example of specific tasks for each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7f] FIG. 13 is a diagram showing an example of specific tasks for each module and an output data collection method according to an embodiment of the present disclosure. [Figure 7g] FIG. 13 is a diagram showing an example of specific tasks for each module and an output data collection method according to an embodiment of the present disclosure. [Figure 8] 1 is a flowchart illustrating the operation of a digital application for myopia treatment according to one embodiment of the present disclosure. [Figure 9] 1 is a flowchart illustrating a method for generating a digital challenge in a digital application for myopia treatment according to an embodiment of the present disclosure. [Figure 10] 1 is a flow chart illustrating repeated operations in response to feedback control in a digital application for myopia treatment according to an embodiment of the present disclosure. [Figure 11] FIG. 2 is a diagram illustrating a hardware configuration of a digital device for treating myopia according to an embodiment of the present disclosure. [Figure 12] 1 is a flowchart illustrating a system for myopia treatment, the system including an administrative portal (e.g., Admin 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 myopia treatment of a subject. [Figure 13] 1 is a flowchart illustrating the flow of execution of a digital application of the present disclosure. [Figure 14] 1 is a flow chart illustrating the flow of execution of a splash process upon initiation of a digital application of the present disclosure. [Figure 15] 1 is a flow chart illustrating the execution flow for login verification during the splash process at the start of a digital application of the present disclosure. [Figure 16] 13 is a flow chart illustrating the execution flow for prescription verification during the splash process at the start of a digital application of the present disclosure. [Figure 17] 13 is a flow chart illustrating the execution flow for home entry upon prescription verification in the digital application of the present disclosure. [Figure 18] 1 is a flowchart illustrating an execution flow for a session in a digital application of the present disclosure. [Figure 19] 13 is a flow chart illustrating the execution flow for a calibration module in a digital application of the present disclosure. [Figure 20] 1 is a flowchart illustrating the execution flow for a session in a digital application of the present disclosure, the session including two or more digital therapeutic modules. [Figure 21] 1 illustrates a splash screen for a digital application of the present disclosure, the splash screen including a company logo, a loading icon, and / or information regarding the version of the digital application. [Figure 22] 1 illustrates a TrueDepth camera notification screen of a digital application of the present disclosure. [Figure 23] 1 illustrates a home screen of the digital application of the present disclosure, the home screen indicating the availability of sessions for subjects to complete. [Figure 24] 1 illustrates a bright environment request notification screen of the light therapy module of the digital application of the present disclosure, the bright environment request notification screen showing the amount of light sensed by the digital device. [Diagram 25] 1 illustrates a calibration notification screen of a digital application of the present disclosure, the calibration notification screen indicating whether the subject's eyes and / or eye movements are detectable by the camera. [Figure 26a] 1 illustrates a screenshot of the eye movement digital therapeutic module of the present disclosure. [Figure 26b] 13 illustrates a flowchart showing the execution flow for the eye movement digital therapeutic module. [Figure 27a] 1 illustrates a screenshot of the Relaxation Break Digital Therapeutics module of the present disclosure. [Figure 27b] 13 illustrates a flowchart showing the execution flow for the Rest Digital Therapeutic Agent module. [Figure 28a] 1 illustrates a screenshot of the eye movement digital therapeutic module of the present disclosure. [Figure 28b] 13 illustrates a flowchart showing the execution flow for the eye movement digital therapeutic module. [Figure 29a] 13 illustrates a screenshot of a relaxation break using the sound digital therapeutic module of the present disclosure. [Figure 29b] 1 illustrates a flow chart showing the steps for implementing a relaxation break using the sound digital therapeutics module. [Figure 30a] 1 illustrates a screenshot of the eye movement digital therapeutic module of the present disclosure. [Figure 30b] 13 illustrates a flowchart showing the execution flow for the eye movement digital therapeutic module. [Figure 31a]1 illustrates a screenshot of the deep breath digital therapeutic module of the present disclosure. [Figure 31b] 1 illustrates a flowchart showing the execution flow for the deep breath digital therapeutic module. [Figure 32a] 1 illustrates a screenshot of the eye movement digital therapeutic module of the present disclosure. [Figure 32b] 13 illustrates a flowchart showing the execution flow for the eye movement digital therapeutic module. [Figure 33a] 1 is a screenshot of the deep breath digital therapeutic module of the present disclosure. [Figure 33b] 13 is a screenshot of the deep breathing digital therapeutic module as it instructs the subject to inhale (left side) and exhale (right side). [Figure 33c] 13 is a flow chart illustrating the execution flow for the deep breath digital therapeutic module. [Figure 34a] 13 is a screenshot of an eye movement digital therapeutic module of the present disclosure. [Figure 34b] 13 illustrates a flowchart showing the execution flow for the eye movement digital therapeutic module. [Figure 35a] 1 is a screenshot of the break digital therapeutics module of the present disclosure. [Figure 35b] 1 illustrates a flowchart showing the execution flow for the rest digital therapy module. [Diagram 36] 13 illustrates screenshots that are displayed upon completion of a single session, upon completion of all sessions for a day, and upon stop / start verification in the digital application of the present disclosure. [Figure 37a] 1 is a screenshot of a room decoration board in the Achievements module of the digital application of the present disclosure. [Figure 37b] Illustrates a timeline showing the dates by which subjects can acquire a given room decoration item. [Figure 38]1 illustrates a screenshot of the parent section in a digital application of the present disclosure. [Figure 39] 1 illustrates a screenshot of a change password section in a digital application of the present disclosure. [Diagram 40] 1 is a table showing the results of push messages, the time a given push message was forwarded to a subject, and when a given push message was opened. [Diagram 41] 1 illustrates a layout for an example provider portal and / or administrative portal of the present disclosure. A full screen may be used for login screens, etc., where there may be no header or sidebar menu. A basic screen may be used for almost all screens after login, such as dashboard, patient list, etc. A modal pop-up may be used in situations that require a user click, such as confirming before deleting a patient from a patient list. A toast pop-up may be used to provide appropriate notifications to the user, and may use different colors for each situation, such as success or failure, to make it easier for the user to see. [Diagram 42] 1 illustrates a layout for a provider portal and / or administrative portal of the present disclosure. [Diagram 43] 1 illustrates a layout for a provider portal and / or administrative portal of the present disclosure. [Diagram 44] 13 is a flowchart illustrating the execution flow for a provider portal in the system of the present disclosure. [Figure 45a] Illustrates the provider portal dashboard. [Figure 45b] 1 illustrates the patient tab of the provider portal, the patient tab displaying a list of patients. [Figure 45c] 1 illustrates a patient tab on the provider portal, the patient tab displaying detailed information about a given patient. [Fig. 45d]1 illustrates the patient tab of the provider portal for adding a new patient. [Figure 45e] 1 illustrates the patient tab of the provider portal for editing existing patient information. [Fig.45f] 1 illustrates the patient tab of the provider portal displaying detailed prescription information for a given patient. [Figure 45g] 1 illustrates the patient tab of the provider portal for editing prescription information for a given patient. [Fig. 45h] 1 illustrates the patient tab of the provider portal for editing prescription information for a given patient. [Figure 45i] 1 illustrates the patient tab of the provider portal to view details (e.g., date, status, duration, outcome) of a given session for a given patient. [Figure 46] 13 is a flowchart illustrating the execution flow for an administration portal in the system of the present disclosure. [Figure 47a] Illustrates the administration portal dashboard. [Figure 47b] 1 illustrates the Physicians tab of the Administration Portal, showing the Physicians tab displaying a list of physicians. [Figure 47c] 1 illustrates the Physician tab of the Administration Portal, displaying a list of patients the physician is treating, with patient identifying information removed(*). [Fig. 47d] 1 illustrates the Physicians tab of the Administration Portal for adding a new physician. [Figure 47e] 1 illustrates the Physicians tab of the Administration Portal for editing an existing physician's information. [Fig.47f] 1 illustrates the Patients tab of the Administration Portal displaying information about one or more patients with sensitive information removed. [Figure 47g] 1 illustrates the Patients tab of the Admin Portal displaying detailed patient or prescription information for a given patient. [Fig. 47h] 1 illustrates the Patients tab of the Admin Portal displaying detailed prescription information for a given patient. [Figure 47i]1 illustrates the Patients tab of the Administration Portal to view details (e.g., date, status, duration, outcome) of a given session for a given patient. [Figure 48] 1 is a table showing permissions for physicians using the provider portal and administrators using the administrative portal.

[0017] The above-identified drawings set forth the presently disclosed embodiments, however, as noted, other embodiments are contemplated. This disclosure presents exemplary embodiments by way of representation, not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art within the scope and spirit of the principles of the presently disclosed embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Hereinafter, preferred embodiments of the present disclosure will be described in detail. However, the present disclosure is not limited to the embodiments disclosed below, and may be realized in various forms. The following embodiments are provided for the purpose of enabling a person having ordinary skill in the art to which the present disclosure pertains to realize and implement the embodiments of the present 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 only to distinguish one component from another. For example, a first component may be referred to as a second component, and similarly, a second component may be referred to as a first component, without departing from the scope of the exemplary embodiments. The term "and / or" includes all combinations of one or more of the associated listed items.

[0020] The terms used in this document are merely used to describe certain embodiments and are not intended to limit the scope of other embodiments. A singular expression is intended to include a plural expression unless the context clearly indicates otherwise. All terms used herein, including technical or scientific terms, may have the same meaning as commonly understood by a person of ordinary skill in the art of the present disclosure. The terms "comprise", "comprises", and / or "comprises" may be understood to specify the presence of features, integers, steps, operations, elements, components, and / or groups mentioned when used herein. However, they do not exclude the presence or addition of one or more different features, integers, steps, operations, elements, components, and / or groups thereof.

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

[0022] Hereinafter, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In this document, the same reference numerals are used to refer to the same components on the drawings, Duplicate explanations will be omitted.

[0023] Conventional new drug development begins with identifying medical needs in the field, proposing a mechanism of disease onset using expert evaluation and meta-analysis of the disease, and deriving a treatment hypothesis based on this. After preparing a library of drugs that are expected to have a therapeutic effect based on the treatment hypothesis, candidate substances are found through screening, and the candidate substances are optimized and subjected to preclinical testing to confirm efficacy and safety from the preclinical stage to determine the final candidate drug. After establishing CMC (chemistry, manufacturing, and controls) for mass production of the candidate drug, clinical trials of the candidate drug are conducted to verify the mechanism of disease onset and the treatment hypothesis, and the clinical efficacy and safety of the candidate drug are confirmed.

[0024] From a patent perspective, drug targets and signaling, which are upstream of new drug development, have many uncertainties. In many cases, the novelty of an invention is difficult to recognize because the methodology is to synthesize and interpret previously reported results. In contrast, the invention of a drug that can treat a disease by regulating drug targets and signaling requires the highest level of ingenuity, except in the field of some antibodies and nucleic acid (DNA, RNA) therapeutic agents, despite the development of many research methodologies for new drug research and development. As a result, the molecular structure of a drug is the most crucial element that constitutes the most powerful substance patent in the new drug field.

[0025] Unlike drugs, which are protected by such substance patents, digital therapeutics are essentially realized by software. Considering the attributes of digital therapeutics and the clinical validation and approval process as therapeutics, the rational design of a digital therapeutic for a given disease and the software realization based on it can be said to be a highly creative inventive process that should be protected by patents.

[0026] In other words, the core of the digital therapeutic agent as disclosed herein is the rational design of a digital therapeutic agent suitable for treating the disease and the development of specific software that can be clinically verified based on the design. The digital device and application for myopia treatment as disclosed herein, which have been realized from this perspective, will be described in detail below.

[0027] In one aspect, the present disclosure provides a system for myopia treatment. In some embodiments, the system includes a digital device configured to execute a digital application for myopia treatment of the subject. In some embodiments, the system includes a healthcare provider portal configured to provide one or more options to a healthcare provider to perform one or more tasks to prescribe a treatment for myopia of the subject based on information received from the digital application. In some embodiments, the system includes an administration portal configured to provide one or more options to an administrator of the system to perform one or more tasks to manage access to the system by healthcare providers. FIG. 12 illustrates a flow chart illustrating a system for myopia treatment, the system includes an administration portal (e.g., admin web), a healthcare provider portal (e.g., physician web), and a digital device configured to execute a digital application (e.g., application or "app") for myopia treatment of the subject. Although, via the administrator portal, the administrator can issue physician accounts, review physician information, and review de-identified patient information. Although, via the healthcare provider portal, the healthcare provider (e.g., physician) can issue patient accounts and review patient information (e.g., age, prescription information, and status of completing one or more digital therapeutic modules or sessions). However, through the digital application, a patient may complete one or more digital therapeutic modules or sessions. FIG. 13 illustrates a flow chart illustrating an example execution flow for the digital application. Start Digital Application A splash screen is then displayed, which then leads to a login information request and prescription information verification for the subject. FIG. 14 illustrates a flow chart illustrating an execution flow for a splash process upon initiation of a digital application. The splash process may include detecting whether the digital device includes a TrueDepth camera, detecting whether the digital application can access the camera, detecting whether the digital application is connected to a network, detecting whether the digital application has been updated to a latest version, login verification, and prescription verification. FIG. 15 illustrates a flow chart illustrating an execution flow for login verification during a splash process upon initiation of a digital application. Similarly, FIG. 16 illustrates a flow chart illustrating an execution flow for prescription verification during a splash process upon initiation of a digital application. The prescription verification process may include, for example, determining whether a treatment period has expired, determining whether the subject has been recently exposed to bright light (e.g., within the last hour), and determining whether the subject's session for that date based on the prescription has been completed (e.g., the subject is compliant with the prescription). In such cases, the digital device may inform the subject that no session is available for completion and / or expose the subject to the light therapy module before starting the digital therapeutic module. FIG. 21 illustrates a splash screen of a digital application of the present 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 app crash, network error, etc., the data is checked and transferred during splash entry. During the splash entry process, if the process takes too long, a loading icon is displayed. In certain embodiments, appropriate pop-ups are displayed for different situations of the application execution flow.The splash entry process may also include camera sensing. FIG. 22 illustrates a TrueDepth Camera notification screen of a digital application of the present disclosure. In devices that do not support TrueDepth Camera, no further application execution is indicated on the screen since eye movements cannot be performed. The camera (also referred to as a sensor, depth sensor or range sensor) may generate depth data indicating distance to surrounding points. In some embodiments, the digital device includes (i) a camera facing the user (e.g., to obtain facial data about the user's face, such as eye position, hand data about the user's hands, or other data about other parts of the user's body) and / or (i) a camera facing the user's environment (e.g., to obtain position data about the user's physical environment, such as light position). In certain embodiments, the camera is a camera such as a TrueDepth® camera system manufactured by Apple, Inc., Cupertino, Calif (USA). The camera includes a three-dimensional camera system. In another embodiment, 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 eye). In yet another embodiment, the camera includes a structured light 3D scanner (e.g., an infrared emitter and an infrared camera) to implement a structured light technique that projects a well-known pattern (e.g., structured light) onto a surface and captures an image. One of ordinary skill in the art will appreciate that the camera can implement other techniques such as optical triangulation, stereo triangulation, interferometry, etc. As a non-limiting example, the camera may include a ReTouch 3D scanner from Intel®. alSense(R) camera, Microsoft(R) Hololens(R), Apple(R) TrueDepth(R) camera, Google(R) Tango(R) system, Mic In some embodiments, the camera may be configured to capture an image. In some embodiments, the camera may be configured to generate depth data, such as a range image, a depth map, etc. The depth data may include one or more points (e.g., distance traveled by an eye during a given time interval) each represented in the depth data. In some examples, the depth data can be used to identify distances to points in the environment, identify objects or surfaces in the environment, determine distances traveled by objects in a given span, and position and / or maintain representations of other content or users associated with objects or surfaces as the digital device moves within the environment (e.g., in an AR or VR implementation).

[0028] A Mailto link (Label 1) can be included to help the subject forward the email to the support team. Camera access can be allowed / disallowed (e.g. on / off) whenever the user wishes. The camera access status is checked every time the app is run, and if access is not allowed (off), a screen is displayed indicating that camera access is denied and the application is prevented from further execution. A button (Label 2) can also be displayed to help the subject jump to the settings panel of the digital device to adjust the settings (e.g. camera access permission).

[0029] As mentioned above, the availability of a session can be determined during the prescription verification process. FIG. 23 illustrates a home screen of the digital application of the present disclosure, which indicates the availability of sessions for the subject to complete. As shown in FIG. 23, (1) patient name: no need to tap, (2) guardian mode entry button, (3) room decorated as treatment progresses (decorations are automatically added or upgraded as sessions are completed, and decorations can display simple movements), (4) character that appears in the middle of the room does not change during treatment and jumps when tapped, (5) play button, (6) notification that a given day's sessions have been completed, and (7) treatment program end notification can be shown.

[0030] 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 when a subject can obtain a given room decoration item. As shown, (1) a character, (2) a room decoration board with numbers displayed like a calendar and a decoration board map that maps the numbers or room decoration items by date; the user cannot obtain the item on days with only numbers (3-2), can obtain the item on days with decoration items (3-1), and (4) the item in 3-1 (received room decoration item) is shown nearby (e.g., a close-up of the obtained room decoration item).

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

[0032] In some embodiments, the operations further include generating a correction module to correct one or more of the measurement accuracy of the subject's eye position and the lighting 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 performed and the correction settings of the previous session are used. The correction can be performed at any time before, during or after a session that includes two or more digital therapeutic modules. For example, the correction can be performed prior to the session. In another example, if the results of the digital therapeutic module show high variability, the digital application can stop the session and initiate a correction to ensure that the results of the digital therapeutic module are factual and not the result of an erroneous correction. FIG. 19 illustrates a flow chart illustrating the execution flow for the correction module in the digital application. For the accuracy of the visual acuity measurement, daily A correction can be performed at the beginning of a session. The correction can take 35 to 60 seconds, depending on the resulting execution. As illustrated in FIG. 19, the correction module can include a series of tasks for the subject from the digital application, such as turning the subject's face in a certain direction (e.g., to better detect the subject's eyes) or blinking the subject. FIG. 25 illustrates a correction notification screen of the digital application, which indicates whether the subject's eyes and / or eye movements can be detected by the camera. As illustrated in FIG. 25, (1) a ready button, (2) displaying the front camera view on the screen, (3) a character that is displayed only when the digital application recognizes the pupils (the character can be a 2D character with large eyes that mimic the user's eye movements and can be shown semi-transparently so that the user's face can be seen), and (4) a notification that provides an action guide for the user's guardian can be displayed.

[0033] A session can include any number of digital therapeutic agent modules. In some embodiments, a session can include two or more digital therapeutic agent modules. In some embodiments, a session can include 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 agent modules. A session can include any number of digital therapeutic agent modules, where the digital therapeutic agent modules can be independently selected from an eye movement module, a relaxation module, a deep breathing module, and a light therapy module. FIG. 20 illustrates a flow chart illustrating the flow of execution for a session of a digital application, where the session includes ten digital therapeutic agent modules. In some embodiments, a session can be made up of ten digital therapeutic agent modules, where the digital therapeutic agent modules include five eye movement modules, three relaxation modules, and two deep breathing modules. A person of ordinary skill in the art will appreciate that there is a vast number of combinations for the number and type of digital therapeutic agent modules that can go into a particular session. 26a-35b illustrate various types of digital therapeutic modules (e.g., eye movement, relaxation, and deep breathing).

[0034] In some embodiments, the accuracy of the subject's eye position measurement can be corrected, the correction including determining a threshold value for detecting the subject's eye. In further embodiments, correcting the accuracy of the subject's eye position measurement includes one or more of instructing the subject to position his / her face as shown on the screen of the digital device, detecting the subject's eye for a given time, instructing the subject to blink, detecting whether or not to blink, instructing the subject to stare at the screen, instructing the subject to move the eye in a specified direction or rotate the eye, and determining a threshold value for detecting the subject's eye. In some embodiments, the digital device includes one or more sensors for tracking the subject's eye movement. The threshold value for detecting the subject's eye can be determined in various ways. For example, eye movement from left to right can be scaled to 100 with a maximum horizontal look. Eye movement from top to bottom can also be scaled to 100 with a maximum vertical look. The average human eye movement is about 70 on a scale of 100. For children and myopic patients, the eye movement is less than 70. In one example, the critical value can be 70% of 70 (e.g., about 49). In other examples, the critical value can be 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99% of a predetermined value based on a scale of 100. The predetermined value can be 70. In other embodiments, the critical value can be about 40, about 45, about 50, about 55, about 60, about 65, about 70, about 75, about 80, about 85, or about 90. In other embodiments, the critical value is On a scale of 100 it 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 embodiment, the digital therapeutic module is generated based on the threshold value. For example, the eye movement module is generated based on the threshold value. The eye movement can include moving an object within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's threshold value boundary on a scale of 100 to increase the subject's threshold value. The eye movement can include moving an object within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's threshold value boundary after the sensor detects an eye gaze within 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 of the subject's threshold value boundary.

[0036] In some embodiments, the measurement accuracy of the light environment can be corrected, the light environment correction including one or more of: sensing light in the subject's environment using a light sensor of the digital device, and instructing the subject to turn on one or more lights in his / her environment. FIG. 24 illustrates a bright environment request notification screen of the light therapy module of the digital application of the present disclosure, the bright environment request notification screen displays the amount of light sensed by the digital device. It is important to expose to bright light when performing eye movements. The room starts out very dirty and becomes clean as the digital device senses the light. The digital application exposes the patient to bright light at least three times a day. When the app is run, the camera sensor senses bright light and turns on the lights that are off. As illustrated in FIG. 24, (1) the light bulb prompts the user to expose to bright light three times a day. When the digital application is run for the first time, all lights are turned off (1-1), and when enough light is detected, light bulbs start to turn on (1-2), (2) guidance elements guide the user to expose to bright light (e.g., dark background, spiders, cobwebs, dust, etc.), (3) a jump to the bottom of the home element (e.g., play button and completion notification are excluded from this page) can be displayed.

[0037] In some embodiments, the digital application for myopia treatment directs the processor of the digital device to perform operations. In some embodiments, the performed operations include generating a digital therapeutic module for myopia treatment based on a pathogenic mechanism for myopia and a treatment hypothesis for myopia. In some embodiments, the performed operations include generating a digital task based on the digital therapeutic module. In some embodiments, the performed operations include providing a digital task to a subject. In some embodiments, the performed operations include collecting subject performance results of the digital task. In some embodiments, generating the digital task and collecting subject performance results of the digital task are performed multiple times in multiple feedback loops. In some embodiments, generating the digital task includes generating a subject's digital task for a current round based on a previous subject's digital task and collected performance result data for the subject's digital task provided from the previous round.

[0038] In some embodiments, the given interval over which the eye position is measured is about 10 ms (milliseconds), 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 ​​therebetween. In some embodiments, the given interval over which the eye position is measured is about 10 ms to about 500 ms. ms, about 50 ms to about 250 ms, about 75 ms to about 150 ms, or about 90 ms to about 110 ms.

[0039] In some embodiments, generating the digital therapeutic agent module includes applying virtual parameters of the subject's environment, behavior, emotion, and cognition to the myopia pathogenesis and treatment hypotheses for myopia to generate the digital therapeutic agent module. In some embodiments, the digital application for myopia treatment directs a processor of the digital device to generate a digital therapeutic agent module including two or more modules selected from the group consisting of an eye movement module, a relaxation module, and a light therapy module.

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

[0041] In some embodiments, the relaxation module includes one or more relaxation tasks for one or more of a physical movement task, a self-enhancement task, a feeling of safety task, a feeling of calm task, and a fun task. In some embodiments, the light therapy module includes one or more light therapy tasks for controlling the subject's light environment. In some embodiments, the one or more relaxation tasks include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

[0042] In some embodiments, the digital therapeutic module further comprises an achievement module including one or more achievement challenges for providing compensation for the subject's adherence to the two or more first module challenges and for task completion, hi some embodiments, the digital therapeutic module further comprises a fun module including one or more fun challenges for music, games, or videos.

[0043] In some embodiments, the healthcare provider portal provides one or more options to the healthcare provider, the one or more options provided to the healthcare provider selected from the group consisting of adding or removing a subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's outcomes for one or more at least partially completed digital therapeutic modules, prescribing one or more digital therapeutic modules to the subject, changing the prescription for one or more digital therapeutic modules, and communicating with the subject. In some embodiments, the one or more options include viewing or editing personal information about the subject, the personal information including one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's guardian email, the subject's contact phone number, a prescription for the subject, and one or more notes created by the healthcare provider for the subject. In some embodiments, the personal information includes a prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed to be taken by the subject, and a number of digital therapeutic modules scheduled or prescribed to be taken by the subject per day. In some embodiments, the one or more options include viewing compliance information, where the subject's compliance information includes one or more of a number of digital therapeutic modules scheduled or prescribed to be completed by the subject, and a calendar identifying one or more dates on which the subject completed, partially completed, or did not complete the one or more scheduled or prescribed digital therapeutic modules. In some embodiments, the one or more options include viewing subject's outcomes, where the subject's outcomes for one or more at least partially completed digital therapeutic modules are displayed in a timeline that indicates whether the subject completed the scheduled or prescribed digital therapeutic modules. The time the module was started, the time the subject completed 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).

[0044] FIG. 45a illustrates a dashboard of the healthcare provider portal. (1) The number of all patients currently associated with the physician's account, a graph can be used to display the number of patients who have started a digital application for the patient in a single day for the last 90 days. The number of patients in progress can also be displayed. A graph can be used to display the number of patients who have completed a single day session for the last 90 days. FIG. 45b illustrates a Patients tab of the healthcare provider portal, which displays a list of patients. As shown, (1) Patient ID (a unique identification number temporarily assigned when adding a patient to the list), (2) Patient name, (3) a search box that can search by ID, name, email, notes, etc., and (4) an Add New Patient button for adding a new patient can be displayed. FIG. 45c illustrates a Patients tab of the healthcare provider portal, which displays detailed information about the patient. As shown, (1) Patient details, (2) Edit Patient Information button, (3) Prescription information, (4) Add New Prescription button, (5) Progress display for each prescription, and (6) a button or link to forward the email to the patient can be displayed. FIG. 45d illustrates the Patients tab of the Provider Portal for adding a new patient. As shown, (1) shows a button to add a new patient and (3) shows an error message that is displayed when the required patient information is not provided. FIG. 45e illustrates the Patients tab of the Provider Portal for editing an existing patient's information. As shown, (1) is a button or link to reset password, (2) is a button to delete the patient, and (3) is a button to save changes. FIG. 45f illustrates the Patients tab of the Provider Portal displaying detailed prescription information for a patient. As shown, (1) is a button to edit prescription information, (2) shows the duration of sessions the patient or subject participated in, and (3) shows an overview of treatment progress. The 7 days are represented by a line or row of 7 squares. Of the 12 weeks, each 6 weeks can be presented separately.Various colors can be used to identify session status (e.g., gray if session not started, red for unattended session, yellow for partially attended session, green for fully attended session). Figures 45g-45h illustrate the Patient tab of the provider portal for editing prescription information for a patient. Figure 45i illustrates the Patient tab of the provider portal for viewing session details for a patient (e.g., date, status, duration, results such as EI or AEI). As shown, (1) is eye movement intensity, and (2) is a movement intensity graph. Other colors can be used to distinguish up / down or right / left eye movements in the graph. The higher the amplitude in the graph, the more the eye has moved.

[0045] In some embodiments, collecting the subject's performance on the digital task includes determining one or both of Exercise Intensity (EI) and Average Exercise Intensity (AEI). In some embodiments, AEI can be determined as the average sum of the differences between the subject's final eye position and the starting eye position measured in 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 eye movement over a given time period. A static AEI can be determined based on maintaining an elongated eye position for a given time period. For example, a dynamic AEI can be determined as the average sum of the difference between the final position of the subject's eyes measured during a given interval and the starting position of the eyes (e.g., a measure of how much the eyes are moving), whereas a static AEI can be determined as the average sum of the eye distances measured from a resting position (e.g., looking straight ahead) over a given interval when the eyes are fixed in an initial position (e.g., not moving). Related to the dynamic AEI, when eye tracking starts from the resting position of the eyes (time=0), the AEI is calculated by measuring the change in the distance the eyes (d) have traveled during a given interval (e.g., 10-500 msec). That is, a larger d results in a higher AEI because more eye movement is measured. A smaller change in d (e.g., less or no eye movement) results in a lower AEI. However, the dynamic AEI does not take into account the movement of the eye muscles when the eyes are fixed in a non-resting position. That is, during a given interval, the subject's eyes can be maintained in a position that is not in a resting state (e.g., d=0), but the eye muscles are still exercising to maintain the eyes in that position.Static AEI considers eye movements that are not related to eye movements.

[0048] In some embodiments, the administration portal provides one or more options to an administrator, the one or more options provided to an administrator of the system selected from the group consisting of adding or removing a healthcare provider, viewing or editing personal information of a healthcare provider, viewing or editing de-identified information of a subject, viewing adherence information for a subject, viewing subject results for one or more at least partially completed digital therapeutic modules, and communicating with a healthcare provider. In some embodiments, the one or more options include viewing or editing personal information, the personal information of a healthcare provider including one or more selected from the group consisting of an identification number for the healthcare provider, a name of the healthcare provider, an email of the healthcare provider, and a contact number for the healthcare provider. In some embodiments, the one or more options include viewing or editing de-identified information of a subject, the de-identified information of a subject including one or more selected from the group consisting of an identification number for the subject and a healthcare provider for the subject. In some embodiments, the one or more options include viewing adherence information for a subject, the subject adherence information including one or more of a number of digital therapeutic modules scheduled or prescribed to be completed 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, the one or more options include viewing the subject's results for one or more at least partially completed digital therapeutic modules, including one or more selected from the group consisting of: the time the subject started the scheduled or prescribed digital therapeutic module, the time the subject finished the scheduled or prescribed digital therapeutic module, an indicator of whether the scheduled or prescribed digital therapeutic module was fully or partially completed, and Exercise Intensity (EI).

[0049] FIG. 47a illustrates (a) the dashboard of the administration portal. As shown, (1) shows the number of physicians. A graph can be used to display the number of physicians who visited the digital application in a single day for the last 90 days, (2) the number of all patients associated with the physician's account. A graph can be used to display the number of patients who started the digital application for the patient in a single day for the last 90 days. The number of ongoing patients can also be displayed. A graph can be used to display the number of patients who completed a single day session in a single day for the last 90 days. FIG. 47b illustrates the Doctors tab of the administration portal, which displays a list of physicians. As shown, (1) shows a search box to search for various physicians by name, email, etc., (2) shows a button to add a new physician, (3) shows a physician ID, (4) shows a button to view detailed physician information, and (5) shows deactivated physician accounts. FIG. 47c illustrates the Doctors tab of the administration portal. FIG. 47 illustrates a Doctors tab displaying a list of patients treated by a given doctor with patient identifying information (*) removed. As shown, (1) Doctor Account Information, (2) Edit Physician Account Information button, (3) List of patients being treated by the doctor, (4) List of patient ID numbers, (5) Link or button to forward registration email to doctor, (6) Notification that the doctor's account has been deactivated which is only displayed for deactivated accounts, (7, 8) Patient information that has been removed or de-identified. FIG. 47d illustrates the Doctors tab of the administration portal for adding a new doctor. FIG. 47e illustrates the Doctors tab of the administration portal for editing an existing doctor's information as well as activating or deactivating a doctor's account. FIG. 47f illustrates the Patients tab of the administration portal displaying information for one or more patients with sensitive information removed. FIG. 47g illustrates the Patients tab of the administration portal displaying detailed patient or prescription information for a given patient. Figure 47h illustrates the Patients tab of the Admin Portal displaying detailed prescription information for a given patient. Figure 47i illustrates the Patients tab of the Admin Portal to view details (e.g., dates, status, duration, results) of a given session for a given patient. Figure 48 is a table showing permissions for physicians using the Provider Portal and administrators using the Admin Portal.

[0050] In some embodiments, the digital application further includes a push alarm and / or push notification to remind the subject to complete the digital therapeutic module and / or to adjust light settings of the subject's environment. In some embodiments, the push alarm and / or push notification is activated to remind the subject to adjust light settings so that the subject is exposed to sufficiently bright light at least three times per day. A patient or subject treated by any of the methods, systems or digital applications described herein can be of any age and can be an adult, an infant or a child, although the methods and systems of the present disclosure are particularly suited to children. In some cases, the patient or subject may have 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 or 99 years old or within a range thereof (e.g., between 2 and 20 years old, between 20 and 40 years old, or between 40 and 90 years old). In some embodiments, the patient or subject is a child. In some embodiments, the patient or subject is a child and is supervised by an adult when using the method, system, or digital application of the present disclosure. In some embodiments, the patient or subject is less than about 20 years old, less than about 15 years old, less than about 10 years old, or less than about 5 years old.

[0051] In some embodiments, the digital device includes a digital task generator configured to generate a digital therapeutic module for treating myopia based on a myopia pathogenesis (MOA) and a treatment hypothesis for myopia, generate a digital task based on the digital therapeutic module, and provide the digital task to the subject. In some embodiments, the digital device includes a result collector configured to collect results of the subject's performance of the digital task. In some embodiments, the digital task generator generates the digital therapeutic module based on neurohumoral factors related to myopia pathogenesis. In some embodiments, the neurohumoral factors include insulin-like growth factor (IGF), cortisol, and dopamine.

[0052] In some embodiments, the digital task generator generates the digital therapeutic agent module based on input from a healthcare provider. In some embodiments, the digital task generator generates the digital therapeutic agent module based on information received from the 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, the basal factors include the subject's activity, heart rate, sleep, diet (including nutrition and calories), and the like. In some embodiments, the medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility. In some embodiments, the digital therapeutics literacy includes the subject's accessibility and receptiveness to digital therapeutics and devices.

[0054] In some embodiments, the digital challenge generator generates a digital therapeutic module that matches virtual parameters corresponding to pathogenetic and treatment hypotheses for myopia. In some embodiments, the virtual parameters are derived in relation to the subject's environment, behavior, emotions, and cognition.

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

[0056] FIG. 36 illustrates screenshots that may be viewed upon single session completion in the digital application of the present disclosure, upon all day session completion and upon stop / start verification. As shown, (1) a button to continue with the next session, (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 FIG. 23 for an example). Pressing the home button in the top left corner while a session is running will show a session stop verification pop-up.

[0057] FIG. 1a illustrates the pathogenetic mechanism of childhood / adolescent axial myopia proposed in the present disclosure, FIG. 1b illustrates the treatment hypothesis for axial myopia proposed in the present disclosure, and FIG. 1c illustrates the digital treatment hypothesis for axial myopia proposed in the present disclosure.

[0058] The digital device and application for inhibiting and treating myopia progression disclosed herein, described below, have been realized based on the pathogenetic mechanism and treatment hypothesis derived through literature research and expert evaluation of clinical trial papers on childhood / adolescent axial myopia.

[0059] Generally speaking, disease treatment involves analyzing a particular disease from the perspective of pathophysiological function and temperament to determine the onset, progression and end point of the disease, defining the indication of the disease through demographic characteristics and disease statistical analysis of the disease, and analyzing the physiology of the patient corresponding to the identified symptoms, particularly the neurohumoral factors, to narrow the scope of the patient's neurohumoral factors to those related to the disease and deriving the mechanism of onset.

[0060] Next, we derive a treatment hypothesis that treats the disease by controlling behavior and environment that are directly related to the regulation of the neurohumoral factors associated with the disease. To realize this treatment hypothesis with a digital therapeutic agent, we propose a digital treatment hypothesis that the therapeutic effect is achieved by repeating digital tasks and their execution, which leads to the patient's "behavior / environment control → neurohumoral factor regulation." The digital treatment hypothesis disclosed here is realized with a digital device and application that presents the patient's behavior (including behavior, emotion, and cognitive domains) changes, environmental improvement, and patient participation in the form of specific tasks (instructions), and collects and analyzes their execution.

[0061] The literature survey on the clinical trials described above can be conducted through meta-analysis and data mining, and feedback and in-depth evaluation from clinical experts can be applied at each analysis step. Essentially, the present disclosure includes that the pathogenesis mechanism and treatment hypothesis of axial myopia can be extracted through the process described above, and based on this, a digital device and application are provided as a digital therapeutic agent for inhibiting and treating the progression of axial myopia by regulating neurohumoral factors.

[0062] However, the method of extracting the pathogenic mechanism and treatment hypothesis of axial myopia according to the present disclosure is not limited to the method described above, and various other methods can be used to extract the pathogenic mechanism and treatment hypothesis of the disease.

[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 an imbalance of neurohumoral factors in childhood / adolescence, which leads to abnormalities in IGF, cortisol, and dopamine, leading to abnormal production of proteoglycan from the sclera around the eyeball, resulting in abnormal growth of the eye axis and the development of axial myopia.

[0064] Referring to FIG. 1b, the treatment hypothesis of axial myopia according to the present disclosure is to inhibit the progression and treat axial myopia by restoring the balance of neurohumoral factors through the patient's actions (including behavioral, emotional, and cognitive domains) and environment, and through the patient's participation.

[0065] Referring to Figure 1c, the digital treatment hypothesis for axial myopia is realized by a digital device and application that presents the patient's behavioral changes, environmental improvements, and participation in the form of specific tasks and collects and analyzes their execution. By using the digital therapeutic agent disclosed herein, the imbalance of neurohumoral factors in childhood / adolescent axial myopia patients can be corrected through the digital input (task) and output (execution), thereby inhibiting the progression of axial myopia and achieving treatment.

[0066] While Figures 1a and 1b describe the pathogenesis and treatment hypothesis of axial myopia, the present disclosure is not limited thereto and the methodology of the present disclosure can be applied to all types of myopia as well as other diseases.

[0067] In addition, although the neurohumoral factors are described as insulin-like growth factor (IGF), cortisol, and dopamine in Figures 1a and 1b, these are merely examples, and the neurohumoral factors in the myopia pathogenesis and treatment hypothesis according to the present disclosure are not limited to these, and all neurohumoral factors that affect myopia may be taken into consideration.

[0068] FIG. 2 is a block diagram illustrating the configuration of a digital device for treating myopia according to one embodiment of the present disclosure.

[0069] Referring to FIG. 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, a performance input unit 030, a result analysis unit 040, a database 050 and a security unit 060.

[0070] Based on the pathogenesis mechanism, treatment hypothesis, and digital treatment hypothesis for childhood / adolescent axial myopia, the doctor (second user) can prescribe a digital therapeutic agent realized by a digital device and application for the treatment of myopia of the patient. Here, the digital task generation unit 010 is a device that provides the patient with a digital therapeutic agent prescription as a specific behavioral task that the patient can execute based on the interaction between neurohumoral factors for myopia and behavior / environment. For example, neurohumoral factors may include IGF, cortisol, dopamine, etc. However, the present invention is not limited thereto, and all neurohumoral factors that may cause myopia may be considered.

[0071] The digital task generating unit 010 can generate a digital task based on an input from a doctor. In this case, the digital task generating unit 010 can generate a digital task based on information collected by the doctor diagnosing the patient (first user). The digital task generating unit 010 can also generate a digital task based on information received from the patient. For example, the information received from the patient can include the patient's basal factors, medical information, and digital therapeutics literacy. Here, the basal factors can include the patient's activity, heart rate, sleep, diet (nutrition and calorie), and the like. The medical information can include the patient's EMR (electronic medical record), family history, genetic vulnerability, genetic susceptibility, and the like. Digital therapeutic comprehension may include the patient's accessibility and receptiveness to digital therapeutic tasks and devices.

[0072] The digital task generator 010 can generate a digital module by utilizing virtual parameters reflecting the pathogenesis and treatment hypothesis of myopia. Here, the virtual parameters can be derived from the environmental, behavioral, emotional and cognitive aspects of the patient. This will be described in detail later with reference to FIG. 5.

[0073] The digital task generator 010 generates digital tasks specifically designed to help the patient obtain a therapeutic effect, and provides the tasks to the patient. For example, the digital task generator 010 can provide light stimuli in a bright light environment and generate specific digital tasks for each digital therapeutic module.

[0074] The sensing data collecting unit 020 and the performance input unit 030 can collect the performance results of the patient for the digital task provided through the digital task generating unit 010. Specifically, the system includes the sensing data collecting unit 020 that senses the patient's adherence to the digital task and the performance input unit 030 that allows the patient to directly input the performance results for the digital task, and outputs the performance results of the patient for the digital task.

[0075] The result analysis unit 040 can collect and report the patient's behavioral compliance and participation at a preset interval to an external party. Therefore, a doctor can continue to monitor the progress of the digital task through the application even if the patient does not visit the hospital in person.

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

[0077] Meanwhile, a series of loops including input of a digital task by the digital task generating unit 010, output of the patient's digital task performance results by the sensing data collecting unit 020 / performance input unit 030, and evaluation by the result analyzing unit 040 can be repeated multiple times. Here, the digital task generating unit 010 can generate a digital task tailored to the patient for the current session by reflecting the patient's digital task provided from the previous session, its output value, and evaluation.

[0078] In this way, according to the digital therapeutic device for inhibiting the progression of and treating axial myopia disclosed herein, the pathogenesis, treatment hypothesis, and digital treatment hypothesis for axial myopia are derived by taking into account the neurohumoral factors of axial myopia, and based on this, an appropriate light stimulation environment is set for the patient and digital tasks for treating axial myopia are presented, and the execution of these tasks is collected and analyzed, making it possible to provide reliable myopia treatment.

[0079] FIG. 3 is a diagram illustrating the input and output loop of a digital application for myopia treatment according to one embodiment of the present disclosure.

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

[0081] The digital tasks provided to the patient may include specific behavioral tasks for behavior, emotion, cognition, and controlling the patient's light environment. As shown in Fig. 3, the digital tasks may include eye movement, stress reduction, a sense of accomplishment, light stimulation, etc. However, this is merely an example, and the digital tasks according to the present disclosure are not limited thereto.

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

[0083] FIG. 4 illustrates a feedback loop of a digital device and application for treating axial myopia according to one embodiment of the present disclosure.

[0084] Referring to FIG. 4, it is shown that the single feedback loop of FIG. 3 described above is repeated multiple times to regulate neurohumoral factors, thereby achieving inhibition of progression and treatment of axial myopia.

[0085] In the case of axial myopia, due to the characteristics of the disease, its treatment requires long-term digital treatment and observation, which can last from as little as 10 weeks to as long as the entire childhood / adolescence. Due to these characteristics, the inhibition of progression of axial myopia and the effect of treatment can be achieved more effectively by gradual improvement of task performance through a feedback loop, rather than simple repetition of task performance during the treatment process.

[0086] For example, the first digital task and its execution results are given as input and output values ​​in a single loop, but after N executions, the loop feedback process is used to adjust the input of the next loop by reflecting the input and output values ​​generated in the current loop, and a new digital task is generated. By repeating this feedback loop, it is possible to derive digital tasks tailored to the patient and maximize the therapeutic effect.

[0087] In this way, in the digital device and application for myopia treatment according to an embodiment of the present disclosure, the digital task and performance result of the patient for the current round (e.g., Nth round) can be calculated using data on the patient's digital task and task performance results provided in the previous round (e.g., N-1th round). 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 necessary.

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

[0089] FIG. 5a is a diagram showing a modular design for implementing digital therapy in a digital myopia treatment device and application according to one embodiment of the present disclosure, and FIG. 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 established, the target neurohumoral factors (e.g., IGF, cortisol, dopamine, etc.) can be derived. Virtual parameters are used to match specific tasks to the regulation of such neurohumoral factors. The modules required for myopia treatment were derived using the correlation between "neurohumoral factors - virtual parameters - modules." Each module will be explained in more detail in the form of a task for each module in Figure 7 described later. Here, each module is a basic design unit of a digital therapeutic agent that is realized by an actual digital device or application, and is a collection of specific tasks.

[0091] Specifically, referring to Figure 5a, the neurohumoral factors derived from the pathogenic mechanism and treatment hypothesis for axial myopia can be IGF, cortisol (or TGF-beta influenced by cortisol), and dopamine (or GABA agonist / antagonist, glucagon). For the treatment of myopia, it is necessary to promote the secretion of IGF and dopamine, which affect eye development in the relevant age group, and to suppress the secretion of cortisol.

[0092] The control of each neurohumoral factor was made to correspond to a digital therapeutic module by using the environment (light), behavior (exercise), emotion (stress reduction), and cognition (sense of accomplishment) as virtual parameters. Then, specific digital tasks were generated for each module based on the converted modules. Here, the digital tasks may include performance environment settings and modules (eye movement, exercise, self, safety and calm, fun, and accomplishment modules) that can be output through monitoring. However, this is merely an example, and the modules according to the present disclosure are not limited thereto.

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

[0094] Here, the background factors are elements necessary for correcting the results of clinical experiments in the process of verifying the clinical effectiveness of the digital myopia treatment according to the present disclosure. Specifically, the basal factors among the background factors shown in FIG. 5b may include activity, heart rate, sleep, and diet (nutrition and calorie), and the medical information is the information created when the patient visits the hospital. The digital therapeutics comprehension capabilities may include the patient's accessibility and receptiveness regarding digital therapeutics tasks and devices.

[0095] FIG. 6 illustrates a method for specifying a patient-tailored 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 a routine patient-doctor interview, and Figure 6 (B) shows a method in which a doctor specifies a digital prescription tailored to a patient by analyzing multiple digital tasks and the results of their execution.

[0097] In this manner, when using a digital device and application for myopia treatment according to one embodiment of the present disclosure, as shown in FIG. 6(B), a doctor can review the patient's tasks and performance results over a specified period of time and adjust the types of modules for myopia treatment and the tasks for each module to suit the patient.

[0098] FIG. 7a illustrates an execution environment setting according to an embodiment of the present disclosure, and 7b to 7g illustrate examples of specific tasks of each module and an output data collection method according to an embodiment of the present disclosure.

[0099] In the case of digital treatment for axial myopia, since continuous patient participation for 10 weeks or more is usually required, it is most important that adolescents find digital treatment enjoyable and participate voluntarily. In this context, each module can be configured with game elements. As described below, in the digital device and application for myopia treatment realized to improve and treat axial myopia, each module is a basic design unit and a collection of specific tasks.

[0100] 7a, a specific task example and output data collection method for the performance environment setting is shown, where the performance environment setting can be included as a component of the digital task generator 010 of FIG.

[0101] Specifically, the performance environment setting includes setting the brightness of the performance environment using an illuminance sensor, and other modules are executed under the set light environment.

[0102] In general, sunlight is closely related to the health of the eye. Strong light stimuli, similar to exposure to direct sunlight, act on retinal nerve cells to promote dopamine secretion and induce the synthesis of proteoglycans that support the sclera. This is an essential factor in regulating normal axial length.

[0103] In this way, to provide light stimuli to the patient, a light sensor can be used to measure the light intensity of the current environment or provide notification of the current light environment so as to control the brightness of the environment in which the patient participates in digital therapy.

[0104] 7b shows a specific task example and output data collection method of the eye movement module, where the eye movement module can be included as a component of the digital task generator 010 of FIG.

[0105] The digital tasks for eye movements include controlling the patient's eye movements, biofeedback, and eye-related behaviors to stimulate IGF secretion in the oculomotor muscles. Specifically, the behavioral tasks for the eye movement module are performed using eye tracking technology, such as eye movements, blinking, far-distance gaze, and eye closure. , patient compliance can be monitored. However, performance collection by the eye movement module is not limited to eye tracking technology, but includes direct patient input of performance on tasks.

[0106] 7c shows a specific task example and an output data collection method of the physical exercise module. Here, the physical exercise module can be included as a component of the digital task generator 010 of FIG. 2. The physical exercise module can be configured with a series of behavioral instructions including slow-speed calm physical exercise and abdominal exercise, rest, relaxation, deep breathing, etc. to reduce stress and suppress the secretion of cortisol.

[0107] Specifically, the behavioral tasks of the physical movement module include relaxation exercises, deep breathing, meditation, eye massage, etc. The performance results are collected by the sensing data collection unit 020 using a biofeedback (EEG, ECG, EMG, EDG, etc.) device or a general-purpose sensor (activity, HR, etc.) or are directly input by the patient using the performance input unit 030. The behavioral tasks of the present disclosure are configured by applying mutatis mutandis a behavioral therapy method that is widely used in pediatric psychiatry to relieve children's stress.

[0108] In general, the progression of myopia is closely related to the progression of adolescence. In particular, during this period, there is a great deal of diversity in self, safety and peace (ventilation), enjoyment, and achievement, depending on age group, gender, personality, and tastes. In order to cover such deviations, it is preferable to present digital tasks for each module in a format that is tailored to the individual characteristics of each patient. In particular, tasks that require interactive communication with an app, such as conversation, can be developed in combination with big data analysis and artificial intelligence analysis.

[0109] 7d shows a specific task instantiation and output data collection scheme of the ego module, where the ego module can be included as part of the digital task generator 010 of FIG.

[0110] Specifically, the tasks of the ego module are intended to increase the self-esteem of adolescents and reduce stress. For this purpose, tasks can be configured such as conversation, drawing, meditation, writing a diary, creating one's own safe space (safety place task), deciding on one's favorite things (places, time, seasons, colors, food, people, etc.), one's own bucket list, deciding on travel destinations one wants to go to, and making plans. These tasks were configured by applying psychotherapy methods widely used in pediatric psychiatry to increase self-esteem and relieve stress in children and adolescents.

[0111] 7e shows a specific task example and output data collection method of the safety and calm module, where the safety and calm module can be included as a component of the digital task generator 010 of FIG.

[0112] Specifically, the tasks in the safety and calm module are intended to play a role in reducing stress in adolescents through ventilation. For this purpose, tasks such as talking, expressing oneself (writing, singing, drawing), and animating to release unpleasant feelings (trash can task) can be configured. These tasks were configured by applying psychotherapy methods widely used in child psychiatry to relieve stress in children and adolescents.

[0113] 7f shows a specific task instantiation and output data collection method of the fun module, where the fun module can be included as a component of the digital task generator 010 of FIG.

[0114] Specifically, the fun module is a task that allows the patient to feel fun using the application, and may be configured using various contents such as music, games, or videos in accordance with the characteristics of adolescents. In addition, the fun task in the fun module has another purpose of improving the continuity of the patient's participation in digital treatment.

[0115] 7g shows a specific task instantiation and output data collection method of the achievement module, where the achievement module can be included as a component of the digital task generator 010 of FIG.

[0116] Specifically, the achievement module may include a task that promotes the secretion of dopamine through the patient's accomplishment of the task and the sense of accomplishment of the completion. Here, the task achievement task is a task that gives the patient a sense of accomplishment by completing the task, and may include a game that can update the task according to the patient's participation period and induce voluntary participation. For example, the specific form of the game may be variously configured such as learning, finding hidden pictures or different pictures, quizzes, etc.

[0117] In particular, the quiz format in the achievement module is expected to have the added effect of enhancing the patient's ability to understand health information and digital therapeutics. Such improvement in the ability to understand health information and digital therapeutics is an essential element for patients to continue participating in treatment and improve their performance.

[0118] As described above, digital therapy according to the present disclosure requires patient participation for 10 weeks or more, and sincerely completing the tasks in the above modules during this period can create a praise (reward) task in the achievement module so that the patient's sense of accomplishment is formed. In the praise task, the patient's active participation in treatment can be fed back as a sense of accomplishment through trust and reward between the patient and guardian and the patient and doctor.

[0119] The digital tasks shown in Figures 7b to 7g above are merely exemplary, and the present disclosure is not limited thereto. The digital tasks provided to the patient may be set in a variety of ways depending on the circumstances.

[0120] FIG. 8 is a flow chart illustrating the operation of a digital application for myopia treatment according to one embodiment of the present disclosure.

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

[0122] Meanwhile, in step S810, the digital therapeutic agent module can be generated based on input from a doctor. In this case, the digital therapeutic agent module can be generated based on information collected by the doctor through diagnosing the patient and prescription results created based on the information. Also, in step S810, the digital therapeutic agent module can be generated based on information received from the patient (e.g., baseline factors, medical information, digital therapeutic agent comprehension ability, etc.).

[0123] In step S820, a specific digital task can be generated based on the digital therapeutic module. Step S820 applies virtual parameters related to the patient's environment, behavior, emotion, and cognition to the pathogenesis mechanism and treatment hypothesis of myopia to generate a digital task. A therapeutic agent module can be generated, which has been described in FIG.

[0124] Here, the digital task may be generated for at least one of the light environment setting, eye movement, body movement, self, safety and calm, fun, and achievement modules. The performance environment setting and the specific digital tasks for each module are as described in Figs. 7a to 7g.

[0125] Next, a digital task can be provided to the patient (S830). In this case, the digital task can be provided in the form of a digital task related to behavior, emotion, or cognition, in which the patient's compliance with the task can be monitored using a sensor such as eye movement / body movement, or in which the patient directly inputs the performance result.

[0126] After the patient performs the presented digital task, the patient's performance results for the digital task can be collected (S840). In step S840, as described above, the performance results for the digital task can be collected by monitoring the patient's compliance with the digital task or by the patient inputting the performance results for the digital task.

[0127] Meanwhile, in the digital application for myopia treatment according to an embodiment of the present disclosure, the step of generating a digital task and the step of collecting a patient's performance results for the digital task may be repeated multiple times by a feedback loop. In this case, the step of generating a digital task may generate a digital task for the patient for a current visit based on the patient's digital task provided from a previous visit and the collected performance result data for the patient's digital task.

[0128] In this way, according to a digital application for myopia treatment according to one embodiment of the present disclosure, the pathogenetic mechanism of myopia and a treatment hypothesis are derived taking into account the neurohumoral factors of myopia, and digital tasks are presented to the patient based on this, and the patient is asked to perform the digital tasks under an appropriate light stimulation environment. The results are collected and analyzed, thereby ensuring the reliability of the treatment for inhibiting and treating the progression of myopia.

[0129] While the above describes a digital device and application for treating myopia according to one embodiment of the present disclosure only from the perspective of treating myopia, the present disclosure is not limited thereto, and digital treatment can be performed for diseases other than myopia in substantially the same manner as described above.

[0130] FIG. 9 is a flow chart illustrating 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 FIG. 9, the process of generating a module and an embodied digital task for treating myopia based on the pathogenic mechanism and treatment hypothesis for myopia (steps S810 and S820 in FIG. 8) and the process in FIG. 5 will be described in detail.

[0132] In step S910, the pathogenic mechanism and treatment hypothesis for myopia may be input. Here, the pathogenic mechanism and treatment hypothesis for myopia may be preliminarily derived through literature research and expert evaluation on systematic related clinical trials for myopia, as described above.

[0133] Then, the neurohumoral factors of myopia can be predicted from the input pathogenesis mechanism and treatment hypothesis (S920). Here, the neurohumoral factors of myopia predicted through step S920 can be derived as IGF, cortisol, dopamine, etc. Since the neurohumoral factors have been specifically explained in FIG. 5, detailed explanation thereof will be omitted.

[0134] In step S930, a digital therapeutic module can be generated corresponding to the predicted neurohumoral factors and virtual parameters, where the virtual parameters act as a converter to convert the myopic neurohumoral factors into a digital therapeutic module, and as shown in FIG. 5, this is a process of setting up physiological relationships between the neurohumoral factors and the environment, behavior, emotion, and cognition factors.

[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, enjoyment, and achievement modules described in Figures 7a to 7g.

[0136] FIG. 10 is a flow chart illustrating repeated operations responsive to feedback control in a digital application for myopia treatment according to one embodiment of the present disclosure.

[0137] In Fig. 10, it is explained that the generation of digital tasks and collection of performance results by a digital application for myopia treatment are performed N times. In this case, first, the onset mechanism of myopia and treatment hypothesis can be input (S1010). Also, the digital task and performance result data provided from the previous round can be received (S1020). If the currently performed round is the first, there is no previous data, so step S1020 can be omitted.

[0138] Next, a digital task for the current round can be generated based on the input pathogenesis mechanism and treatment hypothesis, and the digital task and performance result data provided from the previous round (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 number of times is N or more. If the current number of times is less than N (NO), the process returns to step S1020 and steps S1020 to S1040 can be repeated. On the other hand, if the current number of times is N or more (YES), that is, if the process of generating digital tasks and collecting execution results has been performed N times, the feedback operation can be ended.

[0140] FIG. 11 is a diagram illustrating a hardware configuration of a digital device for treating myopia according to one embodiment of the present disclosure.

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

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

[0143] The memory 620 can store a digital program for myopia treatment. The memory 620 can also store data used for digital myopia treatment included in the database 050 described above, such as digital assignments for patients, assignment results, and medical information for patients. This can be done.

[0144] A plurality of such memories 620 may be provided as necessary. The memories 620 may be volatile memories or nonvolatile memories. The volatile memories 620 may be RAM, DRAM, SRAM, etc. The nonvolatile memories 620 may be ROM, PROM, EAROM, EPROM, EEPROM, flash memory, etc. The above-mentioned examples of the memories 620 are merely illustrative and are not limited to these examples.

[0145] The input / output I / F 630 can provide an interface (e.g., wireless or wired) through which input devices (not shown) such as a keyboard, mouse, touch panel, etc. and output devices such as a display (not shown) can send and receive data to the CPU 610.

[0146] The communication I / F 640 is configured to be capable of transmitting and receiving various data to and from a server, and may be any device capable of supporting wired or wireless communication. For example, various data related to the digital behavior-based treatment described above may be received from a separately provided external server via the communication I / F 640.

[0147] In this manner, a computer program according to an embodiment of the present disclosure can be realized as a module that performs each of the functional blocks illustrated in FIG. 2, for example, by being recorded in the memory 620 and processed by the CPU 610.

[0148] Although it has been described above that all components constituting the embodiments of the present disclosure are combined or operate in combination, the present disclosure is not necessarily limited to such embodiments, that is, within the scope of the present disclosure, all components may be selectively combined and operate as one or more.

[0149] In addition, the terms "comprise", "constitute" or "have" described above, unless otherwise specified to the contrary, should be interpreted to mean that the relevant element may be present and to further include other elements, not to exclude other elements. All terms, including technical and scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the art to which this disclosure belongs, unless otherwise defined. Commonly used terms, such as terms defined in a dictionary, should be interpreted to be consistent with the contextual meaning of the relevant art, and should not be interpreted in an ideal or overly formal sense unless expressly defined in this disclosure.

[0150] The above description is merely an illustrative description of the technical idea of ​​the present disclosure, and a person having ordinary knowledge in the technical field to which the present disclosure belongs can make various modifications and variations without departing from the essential characteristics of the present disclosure. Therefore, the embodiments disclosed in the present disclosure are not intended to limit the technical idea of ​​the present disclosure, but are intended to explain it, and such embodiments do not limit the scope of the technical idea of ​​the present disclosure. The scope of protection of the present disclosure must be interpreted according to the following claims, and all technical ideas within the equivalent range should be interpreted as being included in the scope of the present disclosure.

Claims

1. 1. A system for treating myopia, comprising: a digital device configured to execute a digital application for treating myopia in a subject; a healthcare provider portal configured to provide one or more options to a healthcare provider to perform one or more tasks of prescribing a treatment for the myopia of the subject based on the information received from the digital application; and an administration portal configured to provide one or more options to an administrator of the system to perform one or more tasks that manage access to the system by the healthcare providers.

2. The digital application for treating myopia includes: The system for treating myopia according to claim 1, further comprising instructions to perform an operation including generating a digital therapeutic agent module for treating myopia based on the mechanism of action (MOA) of myopia and the treatment hypothesis regarding myopia.

3. 3. The system for treating myopia of claim 2, wherein generating the digital therapeutic module comprises generating a digital therapeutic module based on neurohumoral factors related to the onset of myopia.

4. The system for treating myopia according to claim 2 , wherein the operations further comprise generating a correction module for correcting one or more of a light environment and a measurement accuracy of the subject's eye position.

5. The system for treating myopia according to claim 4 , wherein the correction module is generated prior to generating the digital therapeutic agent module.

6. The measurement accuracy of the subject's eye position is corrected; and 4. Correcting the measurement accuracy of the subject's eye position, comprising:

5. The system for treating myopia of claim 4, comprising one or more of instructing the subject to position his or her face as shown on the screen of the digital device, sensing the subject's eyes for a predetermined period of time, instructing the subject to blink, sensing whether the subject has blinked, instructing the subject to stare at the screen, instructing the subject to move or rotate their eyes in a specified direction, and determining a threshold value for sensing the subject's eyes.

7. The system for treating myopia according to claim 6 , wherein the digital device includes one or more sensors for tracking eye movements of the subject.

8. The measurement accuracy of the light environment is corrected; and The correcting of the light environment includes:

5. The system for treating myopia of claim 4, comprising one or more of: sensing light in the subject's environment using a light sensor of the digital device; and instructing the subject to turn on one or more lights in their environment.

9. The digital application for treating myopia includes: generating a digital therapeutic agent module for treating myopia based on the pathogenesis of myopia and the treatment hypothesis for myopia; generating a digital challenge based on the digital therapeutic module; providing the subject with the digital challenge; and collecting the subject's performance results on the digital task.

10. generating the digital task and collecting the subject's performance on the digital task are performed multiple times in multiple feedback loops; and The system for treating myopia as described in claim 9, wherein generating the digital assignment includes generating a digital assignment for the subject for a current session based on the subject's digital assignment for a previous session and collected performance result data of the subject on the digital assignment provided from the previous session.

11. The system for treating myopia as described in claim 2, wherein generating the digital therapeutic agent module includes generating the digital therapeutic agent module by applying virtual parameters for the subject's environment, behavior, emotion and cognition to the pathogenetic mechanism of myopia and treatment hypotheses regarding the myopia.

12. 2. The system for myopia treatment of claim 1, wherein the digital application for myopia treatment instructs a processor of the digital device to generate a digital therapeutic agent module including two or more modules selected from the group consisting of an eye movement module, a relaxation module, and a light therapy module.

13. The eye movement module includes one or more motor tasks for one or more of an eye movement task, a biofeedback control task, and an eye-related behavior control task; the relaxation module includes one or more relaxation tasks for one or more of a physical exercise task, a self-enhancement task, a feeling of safety task, a feeling of calm task, and a fun task; The system for treating myopia according to claim 12 , wherein the light therapy module includes one or more light therapy tasks for controlling the subject's light environment.

14. The system for treating myopia according to claim 13, wherein the one or more relaxation tasks include one or more of playing a sound or song, inducing blinking, and instructing the subject to perform exercises.

15. 13. The system for treating myopia of claim 12, wherein the digital therapeutic module further includes an achievement module including one or more achievement challenges for providing compensation for the subject's adherence to the challenges of the two or more first modules and for task achievement.

16. The system for treating myopia of claim 12, wherein the digital therapeutic module further comprises a fun module including one or more fun challenges for music, games or videos.

17. 2. The system for treating myopia of claim 1, wherein the one or more options provided to the healthcare provider are selected from the group consisting of adding or removing the subject, viewing or editing personal information about the subject, viewing compliance information about the subject, viewing the subject's results for one or more at least partially completed digital therapeutic agent modules, prescribing one or more digital therapeutic agent modules to the subject, changing the prescription for one or more digital therapeutic agent modules, and communicating with the subject.

18. the one or more options include viewing or editing personal information about the subject; 18. The system for treating myopia of claim 17, wherein the personal information includes one or more selected from the group consisting of an identification number for the subject, the subject's name, the subject's date of birth, the subject's email, the subject's parental email, the subject's contact phone number, a prescription for the subject, and one or more notes created by the medical provider for the subject.

19. 20. The system for treating myopia of claim 18, wherein the personal information includes the prescription for the subject, the prescription for the subject including one or more selected from the group consisting of a prescription identification number, a prescription type, a start date, a duration, a completion date, a number of digital therapeutic modules scheduled or prescribed to be taken by the subject, and a number of digital therapeutic modules scheduled or prescribed to be taken by the subject in a day.

20. 20. The system for treating myopia of claim 17, wherein the one or more options include viewing the compliance information, and the compliance information for the subject includes one or more of 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 agent modules, and a number of digital therapeutic agent modules scheduled or prescribed to be completed by the subject.

21. 18. The system for treating myopia as described in claim 17, wherein the one or more options include viewing the results of the subject, and the results of the subject for the at least partially completed one or more digital therapeutic agent modules include one or more selected from the group consisting of a time the subject started a scheduled or prescribed digital therapeutic agent module, a time the subject finished a scheduled or prescribed digital therapeutic agent module, an indication of whether the scheduled or prescribed digital therapeutic agent module was fully or partially completed, and exercise intensity (EI).

22. 2. The system for treating myopia as described in claim 1, wherein the one or more options provided to the administrator of the system are selected from the group consisting of adding or removing the healthcare provider, viewing or editing the healthcare provider's personal information, viewing or editing the subject's de-identified information, viewing compliance information regarding the subject, viewing the subject's results for one or more at least partially completed digital therapeutic agent modules, and communicating with the healthcare provider.

23. The system for treating myopia according to claim 1 , wherein the subject is a child.

24. The system for treating myopia according to claim 1 , wherein the subject is assisted or supervised by an adult.

25. The digital device comprises: A digital task generator configured to generate a digital therapeutic agent module for treating myopia based on the myopia pathogenesis (MOA) and the myopia treatment hypothesis, generate a digital task based on the digital therapeutic agent module, and provide the digital task to the subject; 2. The system for treating myopia according to claim 1, further comprising: a result collection unit configured to collect results of the subject's performance of the digital task.

26. The digital problem generator generates the digital problem based on neurohumoral factors related to the onset of myopia.

26. A system for treating myopia as described in claim 25, further comprising a tal therapeutic agent module.

27. 27. The system for treating myopia according to claim 26, wherein the neurohumoral factors include IGF (insulin-like growth factor), cortisol, and dopamine.

28. 1. A method for treating myopia in a subject in need thereof, comprising: providing, via a digital device, to the subject, a digital application including modules for treating myopia based on the pathogenesis of myopia and a treatment hypothesis regarding myopia, each of the modules including one or more first tasks to be followed by the subject; A method for treating myopia, wherein the digital device (i) includes a sensor for sensing the subject's compliance with the one or more first tasks of the module, (ii) based on the compliance, transmits the compliance information to a server accessible to a healthcare provider via a healthcare provider portal, and (iii) receives one or more second tasks from the healthcare provider based on the compliance information.

29. 1. A non-transitory computer readable medium having stored thereon software instructions for treating myopia in a subject in need thereof, the software instructions, when executed by a processor, causing the processor to: displaying to the subject, by a digital device, modules for treating myopia based on the pathogenic mechanism of myopia and a treatment hypothesis regarding myopia, each of the modules including one or more tasks for the subject to follow; sensing the subject's compliance with the tasks of the module by a sensor of the digital device; transmitting, by the digital device, compliance information based on the compliance to a server accessible to a healthcare provider via a healthcare provider portal; and A non-transitory computer readable medium having stored thereon software instructions for treating myopia, the non-transitory computer readable medium causing the server to receive one or more secondary tasks from the healthcare provider.

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