Digital device and application for treating myopia

Abstract

Systems and methods for treating myopia are provided. The system can include a digital device that can include a digital instruction generation unit configured to generate a digital treatment module for treating myopia based on a mechanism of action (MOA) of myopia and a treatment hypothesis, generate a specified digital instruction based on the digital treatment module and provide the digital instruction to a first user, and a result collection unit configured to collect an execution result of the digital instruction of the first user. The system can also include a healthcare provider portal and / or a management portal for a healthcare provider to manage their patients.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Patent Application No. 16 / 883,369, filed May 26, 2020, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to a digital therapy (hereinafter referred to as DTx) intended for the treatment of myopia, which includes inhibiting the progression of myopia. This disclosure also relates to a system for integrating the digital therapy with one or both of a healthcare provider portal and an administrative portal to treat myopia in patients. In particular, embodiments of this disclosure may include inferring the mechanism of action of childhood / adolescent axial myopia (hereinafter referred to as MOA) through literature searches and expert reviews of basic scientific articles and relevant clinical trial articles to identify the mechanism of action of myopia, and establishing treatment hypotheses and digital therapy hypotheses for inhibiting the progression of childhood / adolescent axial myopia and treating axial myopia based on these findings. This disclosure also relates to a rationally designed application for clinically validating and implementing the digital therapy hypothesis for childhood / adolescent axial myopia, and provides a digital device and application based on this rationally designed digital therapy for inhibiting the progression of childhood / adolescent axial myopia and treating axial myopia. Background Technology

[0004] In South Korea, the incidence of myopia is extremely high. Data analysis from 2008 to 2012 showed that the prevalence of myopia (-0.75 diopters or higher) among South Korean teenagers aged 12 to 18 was 80.4%, which is 4.35 times the prevalence of myopia among the elderly aged 60 (18.5%). Furthermore, the prevalence of high myopia (-6 diopters or higher) was 12%, which is 8 times the prevalence of high myopia among the elderly aged 60 (1.5%), and more than three times the prevalence of myopia among teenagers in countries such as the United States and the United Kingdom.

[0005] More seriously, in South Korea, approximately 70% of teenagers with myopia were found to have moderate to high myopia. Furthermore, the prevalence of myopia among elementary school students was approximately 23% in 1980, but steadily increased from 38% in 1990 to 46.2% in 2000.

[0006] The World Health Organization (WHO) has recognized myopia as a disease, but currently there is no effective treatment for it globally. In recent years, with the rapid increase in the incidence of myopia in countries such as China, Singapore, and South Korea, myopia has once again begun to receive academic attention. Furthermore, myopia has become an eye disease and may lead to vision loss in the future.

[0007] Myopia is classified into two types: axial myopia, caused by elongation of the eyeball axis, and refractive myopia (i.e., index myopia), caused by increased refractive index of the lens or cornea. Axial myopia is further divided into simple myopia, which does not affect the retina or choroid, and degenerative myopia, which causes retinal deformation and induces vision loss. Except for keratoconus and sclerosis caused by diabetes, most myopia corresponds to simple axial myopia, and its progression accelerates from elementary school age.

[0008] As a method for slowing the progression of myopia or treating myopia, one well-known approach involves using medication (atropine) and special lenses (e.g., Dream Lenses). However, atropine causes severe glare accompanied by mydriasis. Furthermore, due to the high risk of corneal damage, Dream Lenses have limited clinical application compared to vision-corroding glasses.

[0009] Furthermore, although various devices, eye exercises, and eye training apps for treating myopia have been developed and sold on the market, most of them lack clinical efficacy evidence and are sold without any additional permission. However, for children / adolescents diagnosed with myopia in a hospital, there is currently no highly reliable treatment method to inhibit the progression of myopia or treat it.

[0010] Invention disclosure

[0011] Problem Solution

[0012] In some aspects, this disclosure provides a system for treating myopia, including a digital device configured to execute a digital application for treating a subject's myopia; a healthcare provider portal configured to provide a healthcare provider with one or more options to perform one or more tasks based on information received from the digital application to prescribe treatment for the subject's myopia; and an administration portal configured to provide a system administrator with one or more options to perform one or more tasks to manage a healthcare provider's access to the system.

[0013] In some aspects, this disclosure provides a method for treating myopia in a subject in need, the method comprising: providing the subject with a digital application via a digital device, the digital application including modules for treating myopia based on mechanisms of action and treatment hypotheses of myopia, each module including one or more first instructions for the subject to follow, wherein the digital device (i) includes sensors for sensing the subject's compliance with one or more of the first instructions of the modules, (ii) sending compliance information based on compliance to a server accessible through a healthcare provider's portal, and (iii) receiving one or more second instructions from the healthcare provider based on the compliance information.

[0014] In some aspects, this disclosure provides a non-transitory computer-readable medium having stored software instructions for treating myopia in a subject in need, which, when executed by a processor, cause the processor to: display modules to the subject via a digital device for treating myopia based on mechanisms of action and treatment hypotheses, each module including one or more instructions for the subject to follow; sense the subject's compliance with the instructions of the modules via sensors in the digital device; transmit compliance information via the digital device to a server accessible through a healthcare provider's portal; and receive one or more second instructions from the healthcare provider from the server.

[0015] In some embodiments, a digital application for treating myopia instructs a processor of a digital device to perform operations including: generating a digital treatment module for treating myopia based on the mechanisms of action and treatment hypotheses of myopia. In some embodiments, generating the digital treatment module includes generating the digital treatment module based on neurohumoral factors associated with the onset of myopia. In some embodiments, the operation further includes generating a calibration module for calibrating one or more of the measurement accuracy of the subject's eye position and the measurement accuracy of the light environment. In some embodiments, the calibration module is generated prior to generating the digital treatment module. In some embodiments, the measurement accuracy of the subject's eye position is calibrated, and... The measurement accuracy of calibrating the subject's eye position includes one or more of the following: instructing the subject to position their face to appear on the screen of the digital device, detecting the subject's eyes within a given time period, instructing the subject to blink, detecting whether the subject blinks, instructing the subject to gaze at the screen, instructing the subject to turn or rotate their eyes in a given direction, and determining a threshold for detecting the subject's eyes. In some embodiments, the digital device includes one or more sensors for tracking the movement of the subject's eyeballs. In some embodiments, the measurement accuracy of the light environment is calibrated, and the calibration of the light environment includes one or more of the following: detecting light in the subject's environment using the light sensor of the digital device, and instructing the subject to turn on one or more lights in the subject's environment. In some embodiments, the digital application for treating myopia instructs the processor of the digital device to perform operations including: generating a digital treatment module for treating myopia based on the mechanism of action and treatment hypothesis of myopia. In some embodiments, the digital application for treating myopia instructs the processor of the digital device to perform operations including: generating digital instructions based on the digital treatment module. In some embodiments, the digital application for treating myopia instructs the processor of the digital device to perform operations including: providing digital instructions to the subject. In some embodiments, a digital application for treating myopia instructs a processor of a digital device to perform operations including: collecting the results of a subject's execution of digital instructions. In some embodiments, generating digital instructions and collecting the results of a subject's execution of digital instructions are repeated multiple times via multiple feedback loops, and generating digital instructions includes generating digital instructions for the current period based on the subject's digital instructions in a previous period and collected execution result data regarding the digital instructions provided by the subject in the previous period. In some embodiments, collecting the results of a subject's execution of digital instructions includes: determining one or both of exercise intensity (EI) and average exercise intensity (AEI). In some embodiments, AEI is determined as the average sum of the differences between the final position and the initial position of the subject's eyeball measured at a given interval. In some embodiments, the interval is between approximately 10 milliseconds (ms) and approximately 500 ms. In some embodiments, EI is determined according to the following formula:

[0016] In some embodiments, AEI is defined as the sum of static AEI and dynamic AEI. In some embodiments, generating a digital therapy module includes applying fictitious parameters about the subject's environment, behavior, emotions, and cognition to the mechanisms of action and treatment hypotheses of myopia. In some embodiments, a digital application for treating myopia instructs the processor of a digital device to generate a digital therapy module, including two or more modules selected from: an eye exercise module, a relaxation module, and a phototherapy module. In some embodiments, the eye exercise module includes one or more of the following exercise instructions: eye exercise instructions, biofeedback control instructions, and eye-related behavior control instructions. In some embodiments, the relaxation module includes one or more of the following relaxation instructions: physical exercise instructions, self-improvement instructions, safety instructions, comfort instructions, and enjoyment instructions. In some embodiments, the phototherapy module includes one or more phototherapy instructions for controlling the subject's light environment. In some embodiments, one or more relaxation instructions include one or more of the following: playing sounds or songs, inducing blinking, and instructing the subject to perform gymnastics. In some embodiments, the digital therapy module further includes a completion module comprising one or more completion instructions for completing a task and compensating the subject for compliance with instructions in two or more first modules. In some embodiments, the digital therapy module further includes a fun module comprising one or more fun instructions related to music, games, or videos. In some embodiments, one or more options provided to the healthcare provider are selected from: adding or removing subjects, viewing or editing subject personal information, viewing subject compliance information, viewing the results of the subject's completion of one or more digital therapy modules at least partially, prescribing one or more digital therapy modules to the subject, changing the prescription for one or more digital therapy modules, and communicating with the subject. In some embodiments, one or more options include: viewing or editing subject personal information, and the personal information includes one or more of the following: the subject's identification number, the subject's name, the subject's date of birth, the subject's email address, the subject's guardian's email address, the subject's contact phone number, the subject's prescriptions, and one or more notes made by the healthcare provider to the subject. In some implementations, personal information includes the subject's prescriptions, and the subject's prescriptions include one or more of the following: prescription identification number, prescription type, start date, duration, completion date, multiple scheduled or prescription digital treatment modules to be performed by the subject, and multiple scheduled or prescription digital treatment modules to be performed by the subject each day.In some implementations, one or more options include: viewing adherence information, and the subject's adherence information includes one or more of the following: multiple pre-booked or prescribed digital therapy modules completed by the subject, and a calendar of one or more days identifying one or more pre-booked or prescribed digital therapy modules completed, partially completed, or not completed by the subject. In some implementations, one or more options include: viewing the subject's results, and the subject's results for one or more at least partially completed digital therapy modules include one or more of the following: the time the subject started the pre-booked or prescribed digital therapy module, the time the subject ended the pre-booked or prescribed digital therapy module, an identifier indicating whether the pre-booked or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI). In some implementations, one or more options provided to the system administrator are selected from: adding or removing healthcare providers, viewing or editing healthcare provider personal information, viewing or editing subject de-identification information, viewing subject adherence information, viewing subject results for one or more at least partially completed digital therapy modules, and communicating with healthcare providers. In some implementations, one or more options include: viewing or editing personal information, and the healthcare provider's personal information includes one or more of the following: the healthcare provider's identification number, the healthcare provider's name, the healthcare provider's email address, and the healthcare provider's contact phone number. In some implementations, one or more options include: viewing or editing the subject's de-identification information, and the subject's de-identification information includes one or more of the following: the subject's identification number, and the subject's healthcare provider. In some implementations, one or more options include: viewing the subject's adherence information, and the subject's adherence information includes one or more of the following: multiple scheduled or prescribed digital therapy modules completed by the subject, and a calendar of one or more days identifying one or more scheduled or prescribed digital therapy modules completed, partially completed, or not completed by the subject. In some implementations, one or more options include: viewing the subject's results, and the subject's results for one or more at least partially completed digital therapy modules include one or more of the following: the time the subject started the scheduled or prescribed digital therapy module, the time the subject ended the scheduled or prescribed digital therapy module, an identifier indicating whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI). In some implementations, the digital application also includes push alerts for reminding the subject to complete digital therapy modules and adjust one or more of the subject's environmental lighting settings. In some implementations, push alerts are activated to remind the subject to adjust lighting settings so that the subject is exposed to sufficiently bright light at least three times a day. In some implementations, 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 instruction generation unit configured to generate a digital treatment module for treating myopia based on the mechanism of action (MOA) and treatment hypothesis of myopia, generate digital instructions based on the digital treatment module, and provide the digital instructions to the subject. In some embodiments, the digital device includes: an outcome collection unit configured to collect the subject's execution results of the digital instructions. In some embodiments, the digital instruction generation unit generates the digital treatment module based on neurohumoral factors associated with the onset of myopia. In some embodiments, neurohumoral factors include insulin-like growth factor (IGF), cortisol, and dopamine. In some embodiments, the digital instruction generation unit generates the digital treatment module based on input from a healthcare provider. In some embodiments, the digital instruction generation unit generates the digital treatment module based on information received from the subject. In some implementations, the information received from the subject includes at least one of the following: the subject's baseline factors, the subject's medical information, and the subject's digital therapy literacy. Baseline factors include the subject's activity, heart rate, sleep, and diet (including nutrition and calories). Medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility. Digital therapy literacy includes the subject's accessibility and technological adoption of digital therapies and devices. In some implementations, a digital instruction generation unit generates digital treatment modules matched with fictitious parameters corresponding to the mechanisms of action and treatment hypotheses of myopia. In some implementations, the fictitious parameters are inferred from the subject's environment, behavior, emotions, and cognition. In some implementations, an outcome collection unit collects the execution results of digital instructions by monitoring the subject's compliance with the digital instructions or by having the subject directly input their compliance with the digital instructions. In some implementations, the generation of digital instructions in the digital instruction generation unit and the collection of the subject's execution results of the digital instructions in the result collection unit are repeatedly performed through multiple feedback loops. The digital instruction generation unit generates the subject's digital instructions for the current period based on the subject's digital instructions in the previous period collected by the result collection unit and the data on the subject's execution results of the digital instructions in the previous period. Attached Figure Description

[0017] The above and other objects, features, and advantages of this disclosure will become more apparent to those skilled in the art from the detailed description of exemplary embodiments thereof with reference to the accompanying drawings, in which: Figure 1A is a diagram showing the mechanism of action of axial myopia in childhood / adolescence proposed in this disclosure, Figure 1B is a diagram showing the treatment hypothesis of axial myopia proposed in this disclosure, and Figure 1C is a diagram showing the digital treatment hypothesis of axial myopia proposed in this disclosure. Figure 2 A block diagram illustrating the configuration of a digital device for treating myopia according to one embodiment of the present disclosure; Figure 3 A diagram illustrating the input and output loop of a digital application for treating myopia according to one embodiment of this disclosure; Figure 4 A diagram illustrating the feedback loop of a digital device and application for treating myopia according to one embodiment of the present disclosure; Figure 5A is a diagram showing a module design for implementing digital treatment in a digital device and application for treating myopia according to an embodiment of the present disclosure, and Figure 5B is a diagram showing background factors supporting a digital device and application for treating myopia according to an embodiment of the present disclosure. Figure 6 The figure illustrates a method for assigning a patient-customized digital prescription using a digital device and application for treating myopia, according to one embodiment of the present disclosure; Figure 7A shows the execution environment setup according to one embodiment of the present disclosure, and Figures 7B to 7G show examples of specific instructions for each module according to one embodiment of the present disclosure, as well as a method for collecting output data; Figure 8 A flowchart illustrating operation in a digital application for treating myopia according to one embodiment of the present disclosure is provided. Figure 9 A flowchart illustrating a method for generating digital instructions in a digital application for treating myopia according to one embodiment of the present disclosure is provided. Figure 10 A flowchart illustrating a method for repeatedly performing an operation under feedback control in a digital application for treating myopia, according to an embodiment of this disclosure; and Figure 11 A diagram illustrating the hardware configuration of a digital device for treating myopia according to one embodiment of the present disclosure.

[0018] Figure 12 A flowchart is provided to illustrate a system for treating myopia, which includes an administration portal (e.g., a network of administrators), a healthcare provider portal (e.g., a network of doctors), and a digital device configured to perform a digital application (e.g., an app) for treating myopia in a subject.

[0019] Figure 13 A flowchart illustrating the execution flow of the digital application of this disclosure is provided.

[0020] Figure 14 A flowchart illustrating the execution flow of the splash process when launching a digital application, as disclosed in this disclosure, is provided.

[0021] Figure 15 This is a flowchart illustrating the execution flow of login authentication during the splash process when launching a digital application, as disclosed in this disclosure.

[0022] Figure 16 This is a flowchart illustrating the execution flow of prescription verification during the splash process when a digital application is launched, as disclosed in this disclosure.

[0023] Figure 17 This is a flowchart illustrating the execution flow of the homepage entry during prescription verification in a digital application, as disclosed in this disclosure.

[0024] Figure 18 A flowchart illustrating the execution flow of a treatment in a digital application according to this disclosure is provided.

[0025] Figure 19 A flowchart illustrating the execution flow of the calibration module in a digital application according to this disclosure.

[0026] Figure 20 A flowchart illustrating the execution flow of a treatment in a digital application according to this disclosure is provided, wherein the treatment includes two or more digital treatment modules.

[0027] Figure 21 A splash screen of the digital application disclosed herein is depicted, wherein the splash screen includes a company logo, a loading icon, and / or information about the version of the digital application.

[0028] Figure 22 The TrueDepth camera notification screen of the digital application disclosed herein is depicted.

[0029] Figure 23 The home screen of the digital application disclosed herein is depicted, wherein the home screen indicates the availability of treatments completed by the subject.

[0030] Figure 24 The bright environment notification screen of the phototherapy module of the digital application of this disclosure is described, wherein the bright environment notification screen indicates the amount of light detected by the digital device.

[0031] Figure 25A calibration notification screen for the digital application of this disclosure is depicted, wherein the calibration notification screen indicates whether the subject's eye and / or eye movements can be detected by the camera.

[0032] Figures 26A and 26B depict (A) a screenshot of the digital eye exercise therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the digital eye exercise therapy module.

[0033] Figures 27A and 27B depict (A) a screenshot of the rest and relaxation digital therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the rest and relaxation digital therapy module.

[0034] Figures 28A and 28B depict (A) a screenshot of the digital eye exercise therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the digital eye exercise therapy module.

[0035] Figures 29A and 29B depict (A) a screenshot of the sound relaxation digital therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the sound relaxation digital therapy module.

[0036] Figures 30A and 30B depict (A) a screenshot of the digital eye exercise therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the digital eye exercise therapy module.

[0037] Figures 31A and 31B depict (A) a screenshot of the deep breathing digital therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the deep breathing digital therapy module.

[0038] Figures 32A and 32B depict (A) a screenshot of the digital eye exercise therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the digital eye exercise therapy module.

[0039] Figures 33A and 33B depict (A) a screenshot of the deep breathing digital therapy module of this disclosure, (B) a screenshot of the deep breathing digital therapy module when instructing the subject to inhale (left) and exhale (right), and (C) a flowchart showing the execution flow of the deep breathing digital therapy module.

[0040] Figures 34A and 34B depict (A) a screenshot of the digital eye exercise therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the digital eye exercise therapy module.

[0041] Figures 35A and 35B depict (A) a screenshot of the rest and relaxation digital therapy module of this disclosure, and (B) a flowchart illustrating the execution flow of the rest and relaxation digital therapy module.

[0042] Figure 36 Screenshots depicting the contents of this disclosure are shown in the digital application when a single treatment session is completed, when all daily treatment sessions are completed, and when stopping / starting verification.

[0043] Figures 37A and 37B depict (A) a screenshot of a room decor panel in the achievement module of a digital application according to the present disclosure, and (B) a timeline showing the dates on which a subject can obtain a given room decor item.

[0044] Figure 38 A screenshot depicting the parent portion of the digital application disclosed herein is shown.

[0045] Figure 39 A screenshot depicting the password change section of the digital application disclosed herein is shown.

[0046] Figure 40 This is a table that displays push notifications, the time a given push notification is sent to a subject, and the results when a given push notification is turned on.

[0047] Figure 41 The layout of an exemplary healthcare provider portal and / or administration portal disclosed herein is depicted. Full-screen displays may be used for login screens, etc., and may lack a title bar or sidebar menu. After login, almost all screens can use default screens, such as control panels, patient lists, etc. Modal pop-ups may be used in situations requiring user clicks, such as for checking before deleting a patient from the patient list. Toast pop-ups may be used to provide appropriate notifications to the user and may use different colors for each condition (such as success or failure) for easy user review.

[0048] Figure 42 The layout of the healthcare provider portal and / or management portal disclosed herein is depicted.

[0049] Figure 43 The layout of the healthcare provider portal and / or management portal disclosed herein is depicted.

[0050] Figure 44 A flowchart illustrating the execution flow of the healthcare provider portal in the system disclosed herein.

[0051] Figures 45A to 45I depict (A) a control panel of the healthcare provider portal, (B) a patient tab in the healthcare provider portal that displays a list of patients, (C) a patient tab in the healthcare provider portal that displays detailed information about a given patient, (D) a patient tab in the healthcare provider portal for adding new patients, (E) a patient tab in the healthcare provider portal for editing information about existing patients, (F) a patient tab in the healthcare provider portal that displays detailed prescription information for a given patient, (G to H) patient tabs in the healthcare provider portal for editing prescription information for a given patient, and (I) a patient tab in the healthcare provider portal for viewing detailed information (e.g., date, status, duration, outcome) for a given course of treatment for a given patient.

[0052] Figure 46 A flowchart illustrating the execution flow of the management portal in the system according to this disclosure is provided.

[0053] Figures 47A to 47I depict (A) the control panel of the management portal, (B) the doctor tab in the management portal displaying a list of doctors, and (C) the doctor tab in the management portal displaying a list of patients cared for by a given doctor, with patient identification information already edited. (A) is the Doctor tab in the management portal for adding new doctors; (B) is the Doctor tab in the management portal for editing information of existing doctors; (C) is the Patient tab in the management portal for displaying information of one or more patients, where sensitive information has been edited; (D) is the Patient tab in the management portal for displaying detailed patient information or prescription information for a given patient; (H) is the Patient tab in the management portal for displaying detailed prescription information for a given patient; and (I) is the Patient tab in the management portal for viewing detailed information (e.g., date, status, duration, outcome) for a given course of treatment for a given patient.

[0054] Figure 48 This displays a permission table for doctors using the healthcare provider portal and administrators using the management portal.

[0055] While the accompanying drawings illustrate the embodiments currently disclosed, other embodiments are contemplated as indicated in the discussion. This disclosure presents illustrative embodiments by way of representation, not limitation. Many other modifications and embodiments can be devised by those skilled in the art, within the scope and spirit of the principles of the embodiments currently disclosed.

[0056] Preferred Implementation

[0057] Exemplary embodiments of this disclosure will be described in detail below. However, this disclosure is not limited to the embodiments disclosed below, but can be implemented in various forms. The following embodiments are described to enable those skilled in the art to embody and practice the embodiments of this disclosure.

[0058] definition

[0059] Although the terms first, second, etc., may be used to describe various elements, these elements are not limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of the exemplary embodiments, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element. The term "and / or" includes any and all combinations of one or more of the associated listed items.

[0060] The terminology used herein is for the purpose of describing particular implementations only and is not intended to limit the exemplary implementations. The singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and / or “including,” when used herein, specify the presence of the stated feature, integer, step, operation, element, component, and / or group thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0061] As used herein, the term “about” generally refers to a specific value within an acceptable range of error as determined by one of ordinary skill in the art, depending in part on how the value was measured or determined, i.e., the limitations of the measurement system. For example, “about” can refer to a range of ±20%, ±10%, or ±5% of a given value.

[0062] Overview

[0063] Exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. To aid in understanding the present disclosure, similar numerals refer to similar elements throughout the description of the drawings, and descriptions of the same elements will not be repeated.

[0064] In existing technologies, new drug development begins with in-situ identification of medical needs, followed by the formulation of mechanisms of action based on expert review and meta-analysis of the corresponding diseases, and the deduction of therapeutic hypotheses based on expert review and meta-analysis. Furthermore, after preparing a drug library with expected therapeutic effects based on the therapeutic hypotheses, candidate materials are identified through screening, and these materials are optimized and subjected to preclinical trials. Their efficacy and safety are examined in the preclinical stage, thus determining which candidate material is the final drug candidate. To facilitate the mass production of the corresponding drug candidates, a CMC (Chemistry, Manufacturing, and Controls) process is established, and clinical trials are conducted to verify the mechanisms of action and therapeutic hypotheses, thereby ensuring the clinical efficacy and safety of the drug candidates.

[0065] This patent reveals that drug targeting and signal transduction, which are upstream in new drug development, are inherently uncertain. In many cases, because drug targeting and signal transduction employ methods that summarize and interpret results already reported in the field, novelty of the disclosed information may be difficult to guarantee. Conversely, while research methods used to study and develop many new drugs have evolved, the disclosure of drugs capable of modulating drug targeting and signal transduction to treat diseases, except in certain antibody or nucleic acid (DNA, RNA) therapy fields, requires the highest level of inventiveness. Therefore, the molecular structure of a drug is the most critical factor constituting the most compelling material patent in the field of new drugs.

[0066] Unlike pharmaceuticals, whose rights are heavily protected through material patents, digital therapies are essentially implemented using software. Due to the nature of digital therapies, the rational design of a digital therapy for a given disease, and the software implementation of that rational design, can be considered a highly inventive public process that, when taken into account as a clinically validated and approved therapy, would be protected as a patent.

[0067] In other words, the core of this digital therapy lies in the rational design of the digital therapy to treat the corresponding disease, and the development of specific software based on the rational design to clinically validate the digital therapy. The digital device and application for treating myopia according to this disclosure, implemented in this respect, will be described in detail below.

[0068] In some aspects, this disclosure provides a system for treating myopia. In some embodiments, the system includes a digital device configured to execute a digital application for treating a subject's myopia. In some embodiments, the system includes a healthcare provider portal configured to provide a healthcare provider with one or more options to perform one or more tasks based on information received from the digital application to prescribe treatment for the subject's myopia. In some embodiments, the system includes an administration portal configured to provide a system administrator with one or more options to perform one or more tasks to manage a healthcare provider's access to the system. Figure 12 A flowchart illustrating a system for treating myopia is depicted, comprising an administrative portal (e.g., a network of administrators), a healthcare provider portal (e.g., a network of doctors), and a digital device configured to perform a digital application (e.g., an app) for treating a subject's myopia. Among other things, the administrator's portal allows administrators to publish doctor accounts, review doctor information, and review de-identified patient information. Among other things, the healthcare provider's portal allows healthcare providers (e.g., doctors) to publish patient accounts and review patient information (e.g., age, prescription information, and status of completion of one or more digital treatment modules or procedures). Among other things, the digital application allows access to complete one or more digital treatment modules or procedures. Figure 13 A flowchart illustrating the execution flow of the digital application is provided. Upon opening the digital application, a splash screen is displayed, followed by a login information request and verification of the subject's prescription information. Figure 14 A flowchart illustrating the execution flow of the splash process when a digital application is launched is depicted. 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 has a network connection, detecting whether the digital application is updated to the latest version, login verification, and prescription verification. Figure 15 A flowchart illustrating the execution flow of login authentication during the splash process when a digital application is launched is depicted. Similarly, Figure 16 A flowchart illustrating the execution flow of prescription verification during the splash process when a digital application is launched is depicted. The prescription verification process may include, for example, determining whether a treatment period has expired, determining whether the subject has recently (e.g., within the last hour) been exposed to bright light, and determining, based on the prescription, whether the subject has completed their treatment for the day (e.g., the subject has complied with the prescription). In this case, the digital device may notify the subject that there is no treatment available to complete, and / or expose the subject to the phototherapy module before starting any digital treatment module. Figure 21A splash screen for the digital application of this disclosure is depicted, wherein the splash screen includes a flag (labeled 1), a loading icon (labeled 2), and / or information about the version of the digital application (labeled 3). The splash entry process checks network, version, login verification, etc., according to the execution flow. If data is not sent due to app forced termination, network errors, etc., the data is checked and sent during the splash entry. During the splash entry process, a loading icon is displayed if the process takes too long. In some embodiments, appropriate pop-ups are displayed depending on the different situations in the application execution flow. The splash entry process may also include camera detection. Figure 22A TrueDepth camera notification screen is depicted for a digital application of this disclosure. In devices that do not support a TrueDepth camera, eye exercises are not possible, thus preventing further application execution from appearing on the screen. The camera (also referred to as a sensor, depth sensor, or distance sensor) can generate depth data indicating distance to surrounding points. In some embodiments, the digital device includes (i) a user-facing camera (e.g., to acquire facial data about the user's face, such as the position of the eyeballs, hand data about the user's hands, or other data about other parts of the user's body) and / or (i) a camera-facing camera to the user's environment (e.g., to acquire location data about the user's physical environment, such as the position of lights). In some embodiments, the camera includes a three-dimensional camera system, such as the TrueDepth® camera system manufactured by Apple, Inc., Cupertino, Calif. (USA). In another embodiment, the camera includes a time-of-flight (ToF) camera that measures the time of flight of light signals between the ToF camera and a target in the environment (e.g., the subject's eyeballs). In yet another embodiment, the camera includes a structured light 3D scanner (e.g., an infrared emitter and an infrared camera) to implement structured light technology that projects a known pattern (e.g., structured light) onto a surface and captures an image. Those skilled in the art will understand that the camera can implement other techniques, such as light sheet triangulation, solid triangulation, interferometry, etc. As a non-limiting example, the camera can implement technologies and / or components used by Intel® RealSense® cameras, Microsoft® HoloLens®, Apple® TrueDepth® cameras, Google® Tango® systems, Microsoft® Kinect® systems, etc. In some embodiments, the camera is configured to capture images. In some embodiments, the camera is configured to generate depth data, such as range images, depth maps, etc. The depth data may indicate one or more distances to one or more points (e.g., the distance the eyeball moves over a given time interval), respectively represented in the depth data. In some examples, depth data can be used to identify distances to points in an environment, identify objects or surfaces in an environment, determine the distance an object travels within a given interval, and / or locate and / or maintain a representation of the user or other content associated with an object or surface as the digital device moves through the environment (e.g., in an AR or VR implementation).

[0069] This could include a Mailto link (labeled 1) to help participants send emails to the support team. Users can allow / disallow (e.g., turn camera access on / off) at any time. The camera access status is checked each time the app is launched; if access is not allowed (off), a screen indicating that camera access has been denied is displayed, and the application is blocked from further execution. A button (labeled 2) could also be displayed to assist participants in navigating to their digital device's settings panel to adjust settings (e.g., allow camera access).

[0070] As mentioned above, the availability of treatment can be determined during the prescription validation process. Figure 23 The home screen of the digital application disclosed herein is depicted, where the home screen indicates the availability of treatment sessions completed by the subject. (As shown in...) Figure 23 As shown, (1) Patient's name: no need to click, (2) Guardian mode entry button, (3) Room, which is decorated as treatment progresses (decorations are automatically added or upgraded as the treatment is completed, and decorations can display simple movements), (4) Character, which appears in the middle of the room and does not change during treatment, and jumps when clicked, (5) Play button, (6) Notification that a given daily treatment has been completed, and (7) Notification that the treatment program has ended.

[0071] Figures 37A and 37B depict (A) a screenshot of a room decor panel in the achievement module of a digital application according to the present disclosure, and (B) a timeline showing the dates on which a subject can obtain a given room decor item. As shown, (1) a role, (2) a room decor panel where numbers are presented like a calendar, and the panel maps a number or room decor item to each date; the user cannot obtain an item on a date with only the number (3-2.), but only on a date with a decor item (3-1.), and (4) a close-up (e.g., a magnified view of the obtained room decor item) of the item 3-1 (the received room decor item).

[0072] In some embodiments, a digital application for treating myopia instructs a processor of a digital device to perform operations including: generating a digital treatment module for treating myopia based on the mechanisms of action and treatment hypotheses of myopia. In some embodiments, the digital treatment module includes generating a digital treatment module based on neurohumoral factors associated with the onset of myopia.

[0073] In some implementations, the operation further includes generating a calibration module for calibrating one or more of the measurement accuracy of the subject's eye position and the measurement accuracy of the light environment. In some implementations, the calibration module may be generated before the digital treatment module is generated. In some implementations, the calibration module may not be performed, and calibration settings from the previous treatment session may be used. Calibration can be performed at any time before, during, or after a treatment session that includes two or more digital treatment modules. For example, calibration can be performed before the treatment session. In another example, if the results from the digital treatment modules exhibit significant variability, the digital application can stop the treatment session and initiate calibration to confirm that the results from the digital treatment modules are genuine and not poorly calibrated. Figure 19 A flowchart illustrating the execution flow of the calibration module within a digital application is provided. Calibration can be performed at the start of each daily treatment session to ensure the accuracy of eye measurements. Calibration may take 35 to 60 seconds, depending on the results being performed. (As in...) Figure 19 As shown, the calibration module may include a series of instructions from the digital application to the subject, such as orienting the subject toward a specific direction (e.g., to better detect the subject's eyes) or causing the subject's eyes to blink. Figure 25 A calibration notification screen for a digital application is depicted, indicating whether the subject's eye and / or eye movements are detectable by the camera. (As shown in...) Figure 25 As shown, (1) a ready button, (2) a display of the front camera view on the screen, (3) a character that is only displayed when the digital application senses the pupil (the character can be a 2D character with large eyes that replicates the user's eye movements and can appear in a semi-transparent manner so that the user's face can be seen), and (4) a notification that provides action guidelines to the user's guardian.

[0074] A treatment session may include any number of digital therapy modules. In some embodiments, a treatment session may include two or more digital therapy modules. In some embodiments, a treatment session may 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 therapy modules. A treatment session may include any number of digital therapy modules, and these digital therapy modules may be independently selected from eye exercise modules, relaxation modules, deep breathing modules, and light therapy modules. Figure 20A flowchart illustrating the execution flow of a therapy session within a digital application is depicted, where the session comprises 10 digital therapy modules. In some embodiments, a session may consist of 10 digital therapy modules, including 5 eye exercise modules, 3 relaxation modules, and 2 deep breathing modules. Those skilled in the art will understand that there are numerous combinations of the number and type of digital therapy modules that can be incorporated into a particular session. Figures 26A through 35B depict various types of digital therapy modules (e.g., eye exercises, relaxation, and deep breathing).

[0075] In some implementations, the measurement accuracy of a subject's eye position can be calibrated, and the calibration includes determining a threshold for detecting the subject's eyes. In other implementations, calibrating the measurement accuracy of a subject's eye position includes one or more of the following: instructing the subject to position their face to appear on the screen of a digital device, detecting the subject's eyes over a given time period, instructing the subject to blink, detecting whether the subject blinks, instructing the subject to gaze at the screen, instructing the subject to turn or rotate their eyes in a given direction, and determining a threshold for detecting the subject's eyes. In some implementations, the digital device includes one or more sensors for tracking the movement of the subject's eyeballs. The threshold for detecting the subject's eyes can be determined in various ways. For example, eye movement from left to right can be scaled to 100% of the maximum horizontal view. Eye movement from top to bottom can also be scaled to 100% of the maximum vertical view. Based on a scaling of 100%, the average person's eye movement is approximately 70%. For children and myopic individuals, eye movement is less than 70%. In one example, the threshold could be 70% of 70 (e.g., approximately 49%). In another example, the threshold 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 percent of a predetermined value, scaled by 100. The predetermined value can be 70. In other implementations, the threshold can be approximately 40, approximately 45, approximately 50, approximately 55, approximately 60, approximately 65, approximately 70, approximately 75, approximately 80, approximately 85, or approximately 90 percent. In other implementations, the threshold can be 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99, based on a scaling of 100.

[0076] On one hand, digital therapy modules are generated based on thresholds. For example, a threshold-based eye training module. Eye training could include moving an object within a range of 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 from the subject's threshold boundary, based on a scaling factor of 100, to increase the subject's threshold. Eye training could also include moving an object within a range of 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 from the subject's threshold boundary after a sensor detects eye fixation within that range.

[0077] In some implementations, the measurement accuracy of the light environment can be calibrated, and the calibration of the light environment includes one or more of the following: using a light sensor of a digital device to detect light in the subject's environment, and instructing the subject to turn on one or more lights in the subject's environment. Figure 24 The bright environment notification screen of the phototherapy module in the digital application of this disclosure is described, indicating the amount of light detected by the digital device. Exposure to bright light is important during eye exercises. The room starts out very cluttered 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. Upon app launch, the camera sensor detects bright light and off lights turn on. (As shown in...) Figure 24 As shown, (1) light bulbs help induce users to be exposed to bright light 3 times a day. All lights are off when the digital application is launched for the first time (1-1), and the light bulbs start to turn on after sensing enough light (1-2), (2) inducing elements help induce users to be exposed to bright light (e.g., dark background, spider, cobweb, dust, etc.), (3) skipping the bottom of home page elements (e.g., play button, completion notification omitted on the page).

[0078] In some embodiments, a digital application for treating myopia instructs the processor of a digital device to perform operations. In some embodiments, the operations performed include generating a digital treatment module for treating myopia based on the mechanisms of action and treatment hypotheses of myopia. In some embodiments, the operations performed include generating digital instructions based on the digital treatment module. In some embodiments, the operations performed include providing digital instructions to a subject. In some embodiments, the operations performed include collecting the subject's execution results of the digital instructions. In some embodiments, generating digital instructions and collecting the subject's execution results of the digital instructions are repeatedly performed through multiple feedback loops. In some embodiments, generating digital instructions includes generating the subject's digital instructions for the current cycle based on the subject's digital instructions in the previous cycle and collected execution result data regarding the digital instructions provided by the subject in the previous cycle.

[0079] In some implementations, the given interval for measuring eye position is approximately 10 milliseconds (ms), 25 ms, 50 ms, 60 ms, 70 ms, 80 ms, 90 ms, 100 ms, 110 ms, 120 ms, 130 ms, 140 ms, 150 ms, 175 ms, 200 ms, 250 ms, 300 ms, 350 ms, 400 ms, or a range of two values ​​in between. In some implementations, the given interval for measuring eye position is approximately 10 ms to approximately 500 ms, approximately 50 ms to approximately 250 ms, approximately 75 ms to approximately 150 ms, or approximately 90 ms to approximately 110 ms.

[0080] In some embodiments, generating a digital therapy module involves applying fictitious parameters about the subject's environment, behavior, emotions, and cognition to a hypothesis regarding the mechanism of action and treatment of myopia. In some embodiments, a digital application for treating myopia instructs a processor of a digital device to generate a digital therapy module, including two or more modules selected from: an eye exercise module, a relaxation module, and a phototherapy module.

[0081] In some implementations, the eye training module includes one or more of the following training instructions: eye exercise instructions, biofeedback control instructions, and eye-related behavior control instructions.

[0082] In some embodiments, the relaxation module includes one or more of the following relaxation instructions: physical exercise instructions, self-improvement instructions, safety instructions, comfort instructions, and enjoyment instructions. In some embodiments, the light therapy module includes one or more light therapy instructions for controlling the subject's light environment. In some embodiments, one or more relaxation instructions include one or more of the following: playing sounds or songs, inducing blinking, and instructing the subject to perform gymnastics.

[0083] In some embodiments, the digital therapy module further includes a completion module that includes one or more completion instructions for completing a task and for compensating the subject for compliance with instructions from two or more first modules. In some embodiments, the digital therapy module also includes a fun module that includes one or more fun instructions related to music, games, or videos.

[0084] In some implementations, the healthcare provider portal provides the healthcare provider with one or more options, which include: adding or removing subjects, viewing or editing subjects' personal information, viewing subjects' compliance information, viewing the results of subjects on one or more digital therapy modules that have been at least partially completed, prescribing one or more digital therapy modules to subjects, changing prescriptions for one or more digital therapy modules, and communicating with subjects. In some implementations, one or more options include: viewing or editing subjects' personal information, which includes one or more of the following: the subject's identification number, the subject's name, the subject's date of birth, the subject's email address, the subject's guardian's email address, the subject's contact phone number, the subject's prescriptions, and one or more notes made by the healthcare provider to the subject. In some implementations, the personal information includes the subject's prescriptions, which include one or more of the following: prescription identification number, prescription type, start date, duration, completion date, multiple scheduled or prescribed digital therapy modules to be performed by the subject, and multiple scheduled or prescribed digital therapy modules to be performed by the subject daily. In some implementations, one or more options include: viewing adherence information, and the subject's adherence information includes one or more of the following: multiple scheduled or prescribed digital therapy modules completed by the subject, and a calendar of one or more days identifying one or more scheduled or prescribed digital therapy modules completed, partially completed, or not completed by the subject. In some implementations, one or more options include: viewing the subject's results, and the subject's results for one or more at least partially completed digital therapy modules include one or more of the following: the time the subject started the scheduled or prescribed digital therapy module, the time the subject ended the scheduled or prescribed digital therapy module, an identifier indicating whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI).

[0085] Figure 45A depicts the control panel of the healthcare provider portal. (1) The number of all patients associated with the current physician account. A chart can be used to display the number of patients who opened the Patient Digital Application each day in the last 90 days. The number of patients in progress can also be viewed. A chart can be used to display the number of patients who completed their daily treatment each day in the last 90 days. Figure 45B depicts the Patients tab in the healthcare provider portal, which displays a list of patients. As shown, (1) Patient ID (a unique identifier temporarily given to each patient when they are added to the list), (2) Patient Name, (3) Search bar for searching by ID, name, email, memo, etc., and (4) Add New Patient button for adding new patients. Figure 45C depicts the Patients tab in the healthcare provider portal, which displays detailed information about a given patient. As shown, (1) Detailed patient information, (2) Button for editing patient information, (3) Prescription information, (4) Button for adding new prescriptions, (5) Displaying the progress status of each different prescription, and (6) Button or link for sending emails to patients. Figure 45D depicts the Patients tab in the healthcare provider portal for adding new patients. As shown, (1) shows the button for adding a new patient, and (3) shows the error message displayed when the required patient information is not provided. Figure 45E depicts the Patients tab in the healthcare provider portal for editing existing patient information. As shown, (1) is a button or link for resetting the password, (2) is a button for deleting a given patient, and (3) is a button for saving changes. Figure 45F depicts the Patients tab in the healthcare provider portal for displaying detailed prescription information for a given patient. As shown, (1) is a button for editing prescription information, (2) shows the duration of the treatment course the patient or subject is participating in, and (3) shows an overview of the treatment progress. 7 days are represented as 7 squares in a row or column. For 12 weeks, each 6 weeks can be presented separately. Different colors can be used to distinguish the treatment status (e.g., gray for a treatment course not started, red for a treatment course not attended, yellow for a treatment course partially attended, and green for a treatment course fully attended). Figures 45G to 45H depict the Patient tabs in the healthcare provider portal used to edit prescription information for a given patient. Figure 45I depicts the Patient tabs in the healthcare provider portal used to view details of a given course of treatment for a given patient (e.g., date, status, duration, results such as EI or AEI). As shown, (1) is an eye exercise intensity chart, and (2) is a chart of exercise intensity. Different colors can be used in the chart to distinguish up / down or right / left eye movements. In the chart, the larger the amplitude, the more eye exercise.

[0086] In some implementations, collecting the results of a subject's execution of digital instructions includes determining one or both of exercise intensity (EI) and average exercise intensity (AEI). In some implementations, AEI may be determined as the average sum of the differences between the final position and the initial position of the subject's eyeballs measured at a given interval. In some implementations, the interval is between approximately 10 milliseconds (ms) and approximately 500 ms. EI can be determined according to the following formula:

[0087] In some implementations, the total AEI can be determined as the sum of the static AEI and the dynamic AEI. The dynamic AEI can be determined based on eye movements over a given time period, while the static AEI can be determined based on the eye maintaining an extended position over a given time period. For example, while the dynamic AEI can be determined as the average sum of the differences between the final and initial positions of a subject's eye measured at a given interval (e.g., a measure of how much eye movement), the static AEI can be determined as the average sum of the distances from the eye to a stationary position (e.g., looking straight ahead) measured over a given interval where the eye is fixed in a position (e.g., without movement). For the dynamic AEI, when eye tracking begins at a stationary position (time = 0), the AEI is calculated by measuring the change in the distance (d) traveled by the eye over a given time interval (e.g., 10 milliseconds to 500 milliseconds). That is, if d is large, a large amount of eye movement is measured, resulting in a high AEI. Small changes in d (e.g., when there is little or no eye movement) result in a low AEI. However, dynamic AEI does not consider eye muscle training when the eyes are fixed in a non-static position. In other words, within a given interval, the subject's eyes may remain in a non-static position (e.g., d=0), yet the eye muscles are still being trained to hold the eyes in that position. Static AEI considers eye training independent of eye movement.

[0088] In some implementations, the management portal provides an administrator with one or more options, and these options are selected from: adding or removing healthcare providers, viewing or editing healthcare provider information, viewing or editing subject de-identification information, viewing subject compliance information, viewing the results of a subject's completion of one or more at least partially completed digital treatment modules, and communicating with healthcare providers. In some implementations, one or more options include: viewing or editing personal information, where the healthcare provider's personal information includes one or more of the following: the healthcare provider's identification number, the healthcare provider's name, the healthcare provider's email address, and the healthcare provider's contact number. In some implementations, one or more options include: viewing or editing subject de-identification information, where the subject's de-identification information includes one or more of the following: the subject's identification number, and the subject's healthcare provider. In some implementations, one or more options include: viewing subject compliance information, where the subject's compliance information includes one or more of the following: multiple pre-booked or prescribed digital treatment modules completed by the subject, and a calendar of one or more days identifying the subject's completed, partially completed, or incomplete pre-booked or prescribed digital treatment modules. In some implementations, one or more options include: viewing the subject's results, and the subject's results for one or more at least partially completed digital therapy modules include one or more of the following: the time when the subject started the scheduled or prescribed digital therapy module, the time when the subject ended the scheduled or prescribed digital therapy module, an identifier of whether the scheduled or prescribed digital therapy module was fully or partially completed, and exercise intensity (EI).

[0089] Figure 47A depicts (A) the control panel for the management portal. As shown, (1) the number of doctors is displayed. A chart can be used to display the number of doctors who accessed the digital application each day in the last 90 days, and (2) the number of all patients associated with any doctor account. A chart can be used to display the number of patients who opened the patient digital application each day in the last 90 days. The number of patients in progress can also be viewed. A chart can be used to display the number of patients who completed daily treatments each day in the last 90 days. Figure 47B depicts the Doctors tab in the management portal, which displays a list of doctors. As shown, (1) a search bar for searching doctors by name, email, etc., (2) a button for adding a new doctor, (3) the doctor's ID, (4) a button for viewing detailed doctor information, and (5) a list of deactivated doctor accounts. Figure 47C depicts the Doctors tab in the management portal, which displays a list of patients cared for by a given doctor, with patient identification information edited. As shown in the figures, (1) is the doctor's account information, (2) is the button for editing the doctor's account information, (3) is the list of patients cared for by the doctor, (4) is the list of patient ID numbers, (5) is the link or button for sending a registration email to the doctor, (6) is the notification that the doctor's account has been deactivated, which only appears for deactivated accounts, and (7 and 8) is the edited or de-identified patient information. Figure 47D depicts the doctor tab in the management portal for adding a new doctor. Figure 47E depicts the doctor tab in the management portal for editing the information of an existing doctor, including starting or deactivating a doctor's account. Figure 47F depicts the patient tab in the management portal for displaying information of one or more patients, where sensitive information has been edited. Figure 47G depicts the patient tab in the management portal for displaying detailed patient information or prescription information for a given patient. Figure 47H depicts the patient tab in the management portal for displaying detailed prescription information for a given patient. Figure 47I depicts the patient tab in the management portal for viewing detailed information (e.g., date, status, duration, outcome) for a given course of treatment for a given patient. Figure 48 A permission table is provided that displays the permissions of doctors using the healthcare provider portal and administrators using the management portal.

[0090] In some embodiments, the digital application also includes push alerts and / or push notifications to remind the subject to complete one or more of the digital therapy modules and adjust the subject's environmental lighting settings. In some embodiments, push alerts and / or push notifications are activated to remind the subject to adjust the lighting settings so that the subject is exposed to sufficiently bright light at least three times a day. Patients or subjects treated by any of the methods, systems, or digital applications described herein can be of any age and can be adults, infants, or children, but the methods and systems of this disclosure are particularly suitable for children. In some cases, the patient or subject is 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55 The age range is 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 one of these ranges (e.g., 2 to 20 years old, 20 to 40 years old, or 40 to 90 years old). In some embodiments, the patient or subject is a child. In some embodiments, the patient or subject is a child and is supervised by an adult when using the methods, systems, or digital applications of this 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.

[0091] In some embodiments, the digital device includes: a digital instruction generation unit configured to generate a digital treatment module for treating myopia based on the mechanism of action (MOA) and treatment hypothesis of myopia, generate digital instructions based on the digital treatment module, and provide the digital instructions to a subject. In some embodiments, the digital device includes: a result collection unit configured to collect the subject's execution results of the digital instructions. In some embodiments, the digital instruction generation unit generates the digital treatment module based on neurohumoral factors associated with the onset of myopia. In some embodiments, neurohumoral factors include insulin-like growth factor (IGF), cortisol, and dopamine.

[0092] In some implementations, the digital instruction generation unit generates the digital treatment module based on input from a healthcare provider. In other implementations, the digital instruction generation unit generates the digital treatment module based on information received from the subject.

[0093] In some implementations, the information received from the subject includes at least one of the following: the subject's baseline factors, the subject's medical information, and the subject's digital therapy literacy. In some implementations, baseline factors include the subject's activity level, heart rate, sleep, and diet (including nutrition and calories). In some implementations, medical information includes the subject's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility. In some implementations, digital therapy literacy includes the subject's accessibility and technological adoption of digital therapies and devices.

[0094] In some implementations, the digital instruction generation unit generates digital treatment modules that match fictitious parameters corresponding to the mechanisms of action and treatment hypotheses of myopia. In some implementations, the fictitious parameters are inferred from the subject's environment, behavior, emotions, and cognition.

[0095] In some embodiments, the digital device includes: a result collection unit configured to collect the execution results of a subject's digital instructions, wherein the result collection unit collects the execution results of the digital instructions by monitoring the subject's compliance with the digital instructions or by having the subject directly input the subject's compliance with the digital instructions. In some embodiments, the generation of digital instructions in the digital instruction generation unit and the collection of the subject's execution results of the digital instructions in the result collection unit are repeated several times through multiple feedback loops. In some embodiments, the digital instruction generation unit generates the subject's digital instructions for the current period based on the subject's digital instructions collected by the result collection unit in the previous period and data regarding the subject's execution results of the digital instructions in the previous period.

[0096] Figure 36 Screenshots of the present disclosure displayed in the digital application upon completion of a single treatment session, upon completion of all daily treatment sessions, and upon stopping / starting verification are shown. As shown, (1) a button to continue to the next treatment session, and (2) a button to navigate to the home screen. If it is the last day of the prescription duration, the user proceeds to screen 3.1.3; otherwise, they proceed to 3.1.2 (see, for example, [link to relevant documentation]). Figure 23 During the treatment, when the homepage button in the upper left corner is clicked, a pop-up window appears to verify that the treatment has stopped.

[0097] Figure 1A is a diagram showing the mechanism of action of axial myopia in childhood / adolescence proposed in this disclosure, Figure 1B is a diagram showing the treatment hypothesis of axial myopia proposed in this disclosure, and Figure 1C is a diagram showing the digital treatment hypothesis of axial myopia proposed in this disclosure.

[0098] The digital device and application for inhibiting the progression of myopia and treating myopia, as described below according to this disclosure, are based on mechanisms of action and treatment hypotheses inferred through literature search and expert review of clinical trial articles on axial myopia in children / adolescents.

[0099] Generally, disease treatment involves analyzing the pathophysiological functions and characteristics of a disease to determine its starting point, progression point, and endpoint. Furthermore, disease indications are defined through the corresponding disease characteristics and statistical analysis. Simultaneously, analyzing the patient's physiological factors, especially neurohumoral factors, corresponding to validated indications, and limiting the patient's neurohumoral factors to a narrow range associated with the disease, allows for the inference of the mechanism of action.

[0100] Next, a treatment hypothesis is deduced, in which the corresponding disease is treated by controlling behaviors and environments directly related to the regulation of corresponding neurohumoral factors associated with the disease. To realize this treatment hypothesis as a digital therapy, a digital therapy hypothesis is proposed, namely, achieving therapeutic effects through repetitive digital instructions and execution, which is associated with "controlling the patient's behavior / environment → regulating neurohumoral factors". The digital therapy hypothesis disclosed herein is implemented as a digital device and application configured to present changes in the patient's behavior (including behavioral, emotional, and cognitive areas), improvements in the patient's environment and patient engagement in the form of specific instructions, and to collect and analyze the execution of these specific instructions.

[0101] The literature search for the aforementioned clinical trials can be performed through meta-analysis and data mining, and feedback and in-depth review from clinical experts can be applied to each analytical step. Essentially, this disclosure includes using the aforementioned procedures to extract the mechanisms of action and treatment hypotheses for axial myopia, and based on these results, modulating neurohumoral factors to provide digital devices and applications as digital therapies for inhibiting the progression of axial myopia and treating axial myopia.

[0102] However, the methods for extracting the mechanisms of action and treatment hypotheses for axial myopia according to this disclosure are not limited to the methods described above. Furthermore, various methods can be used to extract the mechanisms of action and treatment hypotheses for the disease.

[0103] Referring to Figure 1A, various risk factors during childhood / adolescence, such as close-range work, education, genetics, and other factors (prematurity, diet, light exposure, birth season, elevated intraocular pressure, etc.), can lead to an imbalance of neurohumoral factors in childhood / adolescence (related to the onset of myopia). Therefore, due to abnormal regulation of IGF, cortisol, and dopamine, proteoglycans are abnormally produced in the sclera around the eye, leading to the development of axial myopia due to abnormal growth of the optical axis.

[0104] Referring to Figure 1B, the axial myopia treatment hypothesis according to this disclosure includes inhibiting the progression of axial myopia and treating axial myopia through patient behavior (including behavioral, emotional, and cognitive areas) and environment, as well as patient participation in restoring the balance of neurohumoral factors.

[0105] Referring to Figure 1C, the digital therapy hypothesis for axial myopia is realized as a digital device and application configured to present changes in patient behavior, improvements in the patient's environment and patient engagement in the form of specific instructions, and to collect and analyze the execution of these specific instructions. When using the digital therapy of this disclosure, the imbalance of neurohumoral factors in children / adolescents with axial myopia can be corrected through digital input (instructions) and output (execution), thereby achieving the goal of inhibiting the progression of axial myopia and treating axial myopia.

[0106] Meanwhile, the mechanisms of action and treatment hypotheses for axial myopia will be described with reference to Figures 1A and 1B, but this disclosure is not limited thereto. For example, the methods of this disclosure can be applied to all types of myopia and any other diseases.

[0107] Furthermore, although insulin-like growth factor (IGF), cortisol, and dopamine are described as neurohumoral factors, as shown in Figures 1A and 1B, it should be understood that the description of neurohumoral factors is given by way of example only and is not intended to limit all aspects of the mechanisms of action and treatment hypotheses of myopia according to this disclosure. Therefore, all neurohumoral factors that may influence myopia can be considered.

[0108] Figure 2 A block diagram illustrating the configuration of a digital device for treating myopia according to one embodiment of the present disclosure.

[0109] refer to Figure 2 According to one embodiment of the present disclosure, a digital system 000 for treating myopia may include a digital instruction generation unit 010, a sensing data collection unit 020, an execution input unit 030, a result analysis unit 040, a database 050, and a security unit 060.

[0110] Based on the mechanisms of action and treatment hypotheses of childhood / adolescent axial myopia and the digital therapy hypothesis, a physician (second user) can prescribe a digital therapy, implemented in a digital device and application for treating myopia, for the corresponding patient. In this case, the digital instruction generation unit 010 is a device configured to provide the patient with a digital therapy prescription based on the interaction between neurohumoral factors of myopia and the patient's behavior / environment, as specific behavioral instructions that the patient can execute. For example, neurohumoral factors may include IGF, cortisol, dopamine, etc., but this disclosure is not limited thereto. For example, all types of neurohumoral factors that may lead to myopia can be considered.

[0111] The digital instruction generation unit 010 can generate digital instructions based on input from the doctor. In this case, the digital instruction generation unit 010 can generate digital instructions based on information collected by the doctor during patient diagnosis. Furthermore, the digital instruction generation unit 010 can generate digital instructions based on information received from the patient. For example, the information received from the patient may include the patient's baseline factors, medical information, and digital therapy literacy. In this case, baseline factors may include the patient's activity level, heart rate, sleep, diet (nutrition and calories), etc. Medical information includes the patient's electronic medical record (EMR), family history, genetic vulnerability, genetic susceptibility, etc. Digital therapy literacy may include patient accessibility and acceptance of digital therapy instructions and devices, etc.

[0112] The digital instruction generation unit 010 can reflect the mechanisms of action and treatment hypotheses of myopia to utilize fictitious parameters and generate digital modules. In this case, fictitious parameters can be inferred based on the patient's environment, behavior, emotions, and cognition. In this regard, the fictitious parameters will be described in detail as shown in Figure 5.

[0113] The digital instruction generation unit 010 generates digital instructions specifically designed to provide therapeutic effects to the patient and provides these instructions to the patient. For example, the digital instruction generation unit 010 can provide light stimulation in a bright lighting environment and simultaneously generate specific digital instructions in each digital therapy module.

[0114] The sensing data collection unit 020 and the execution input unit 030 can collect the execution results of the digital instructions provided by the patient in the digital instruction generation unit 010. Specifically, the sensing data collection unit 020 is configured to sense the patient's compliance with the digital instructions, and the execution input unit 030 is configured to allow the patient to directly input the execution results of the digital instructions, thereby outputting the patient's execution results of the digital instructions.

[0115] The results analysis unit 040 can collect patient behavioral compliance or engagement data within a predetermined time period and report this data to an external system. Therefore, even if a patient does not directly visit the hospital, doctors can continue to monitor the execution of digital instructions through the application.

[0116] Database 050 can store the mechanisms of myopia, hypotheses about myopia treatment, digital instructions provided to users, and the user's execution results data. Figure 2 The database 050 is included in the digital device 000 for treating myopia. However, the database 050 can be provided on an external server.

[0117] Simultaneously, the digital instruction generation unit 010 inputs digital instructions, the sensing data collection unit 020 / execution input unit 030 outputs the patient's execution result of the digital instructions, and the result analysis unit 040 evaluates the execution result. This series of cycles can be repeated several times. In this case, the digital instruction generation unit 010 can generate patient-customized digital instructions for this cycle by reflecting the digital instructions and output values ​​provided by the patient in the previous cycle and evaluating the results.

[0118] As described above, the digital therapy device for inhibiting the progression of axial myopia and treating axial myopia according to this disclosure, taking into account the neurohumoral factors of axial myopia, ensures the reliability of myopia treatment by inferring the mechanism of action of axial myopia and the treatment hypothesis and digital therapy hypothesis of axial myopia. Based on the mechanism of action and the treatment hypothesis, it presents a setting of light stimulation environment suitable for patients and digital instructions for treating axial myopia, and collects and analyzes the execution of specific instructions.

[0119] Figure 3 A diagram illustrating the input and output loops of a digital application for treating myopia according to one embodiment of this disclosure is provided.

[0120] refer to Figure 3 According to one embodiment of the present disclosure, a digital application for treating myopia can input a corresponding digital prescription for the patient in the form of instructions, and can output the execution result of the corresponding digital instructions.

[0121] Digital instructions provided to patients can include specific action commands related to behavior, emotions, and cognition, as well as control over the patient's light environment. For example, in... Figure 3 The numerical instructions shown may include eye exercises, stress reduction, a sense of accomplishment, light stimulation, etc. However, the numerical instructions are given by way of example only and are not intended to limit the numerical instructions according to this disclosure.

[0122] The patient's execution of digital instructions consists of the following: 1) login / logout information of the instruction and execution; 2) compliance information sensed as passive data, such as eye exercises, stress-related changes in heart rate and oxygen saturation; and 3) direct input information about the patient's execution results.

[0123] Figure 4 A diagram illustrating the feedback loop of a digital device and application for treating myopia according to one embodiment of this disclosure.

[0124] refer to Figure 4 Inhibiting the progression of axial myopia and treating axial myopia have been shown to be achieved through repeated administration of [treatment methods]. Figure 3 The aforementioned single feedback loop is used to regulate neurohumoral factors to achieve this.

[0125] For axial myopia, due to its pathological characteristics, digital treatment and observation require a short period of 10 weeks to the entire childhood / adolescent period to treat axial myopia. Because of these characteristics, by progressively improving the command-execution cycle within the feedback loop, the inhibition and treatment of axial myopia progression can be achieved more effectively compared to the simple repetitive command-execution cycle during the corresponding treatment process.

[0126] For example, the numerical instructions and execution results of the first cycle are given as input and output values ​​in a single loop. However, as the feedback loop executes N times, new numerical instructions can be generated by reflecting the input and output values ​​generated in that loop using the feedback process of the loop, thus adjusting the input for the next loop. This feedback loop can be repeated to infer patient-customized numerical instructions while maximizing therapeutic effects.

[0127] In this way, in a digital device and application for treating myopia according to one embodiment of the present disclosure, the digital instructions provided by the patient in the previous cycle (e.g., the N-1th cycle) and the data of the instruction execution results can be used to calculate the patient's digital instructions and execution results in the current cycle (e.g., the Nth cycle). In other words, the digital instructions for the next cycle can be generated from the patient's digital instructions and the execution results of the digital instructions calculated in the previous cycle. In this case, various algorithms and statistical models can be used for the feedback process as needed.

[0128] As described above, in a digital device and application for treating myopia according to one embodiment of the present disclosure, patient-customized digital instructions can be optimized to suit the patient through a rapid feedback loop.

[0129] Figure 5A is a diagram showing the module design for implementing digital treatment in a digital device and application for treating myopia according to one embodiment of the present disclosure, and Figure 5B is a diagram showing the background factors supporting a digital device and application for treating myopia according to one embodiment of the present disclosure.

[0130] As shown in Figure 5A, when creating a treatment hypothesis based on the mechanism of myopia, targeting neurohumoral factors (e.g., IGF, cortisol, dopamine, etc.) can be inferred. Fictitious parameters can be used to correspond specific instructions to the regulation of these neurohumoral factors. The modules required for treating myopia are inferred using the "neurohumoral factor-fictitious parameter module" interrelationship. Each module will be described in more detail below in the form of modular instructions with reference to Figure 7. In this context, each module is actually a basic design unit for implementing digital therapy in a digital device or application and is a set of specific instructions.

[0131] Specifically, referring to Figure 5A, the neurohumoral factors inferred from the mechanism of action and treatment hypothesis of axial myopia can be IGF, cortisol (or TGF-β influenced by cortisol), and dopamine (or GABA agonists / antagonists, glucagon). Treatment of myopia should regulate neurohumoral factors at the appropriate age to promote the secretion of IGF and dopamine, which affect eye development, and inhibit the secretion of cortisol.

[0132] The control of each neurohumoral factor corresponds to a digital therapy module using environment (light), behavior (exercise), emotion (stress reduction), and cognition (sense of accomplishment) as hypothetical parameters. Specific digital instructions for each module are generated based on the transformed modules. In this context, digital instructions may include the execution of environmental settings and modules (e.g., eye exercises, gymnastics, self-care, safety / comfort, fun, and achievement modules), which can be monitored by output monitoring. However, the modules are given by way of illustration only and are not intended to limit the modules according to this disclosure.

[0133] Meanwhile, referring to Figure 5B, background factors can be considered together in the module design of a digital device and application for treating myopia according to one embodiment of the present disclosure.

[0134] In this context, background factors are elements necessary to correct clinical trial results in validating the clinical effectiveness of digital myopia treatment according to this disclosure. Specifically, among the background factors shown in Figure 5B, baseline factors may include activity, heart rate, sleep, diet (nutrition and calories), etc.; medical information may include EMR, family history, genetic susceptibility, predisposition, etc., which are already recorded when the patient visits the hospital; and digital therapy literacy may include the patient's accessibility to and acceptance of digital therapy instructions and devices.

[0135] Figure 6 The figure illustrates a method for assigning a patient-customized digital prescription using a digital device and application for treating myopia, according to one embodiment of the present disclosure.

[0136] Figure 6 (A) Shows the prescribing procedure a doctor uses when performing routine medical examinations on a patient, and Figure 6 (B) Shows a method that allows doctors to assign customized digital prescriptions to patients based on the analysis of multiple digital instructions and the results of their execution.

[0137] Thus, when using the digital device and application for treating myopia according to one embodiment of this disclosure, the doctor can examine the patient's instructions and execution results within a given time period and adjust the type of module for treating myopia, and adjust the instructions of each module in a patient-customized manner, such as in Figure 6 As shown in (B).

[0138] Figure 7A shows the execution environment setup according to one embodiment of the present disclosure, and Figures 7B to 7G show examples of specific instructions for each module according to one embodiment of the present disclosure, as well as a method for collecting output data.

[0139] For digital therapy of axial myopia, since continuous patient involvement for 10 weeks or more is generally required, it is even more important that adolescents find enjoyment in digital therapy and participate voluntarily. In this context, modules can be configured by adding game elements to each module. In the digital devices and applications for myopia treatment that have been implemented to alleviate and treat axial myopia, as described below, each module is a basic design unit and a set of specific instructions.

[0140] Referring to Figure 7A, a specific example of instructions for setting up the execution environment and a method for collecting output data are shown. In this case, setting up the execution environment can be included as... Figure 2 This is part of the configuration of the digital instruction generation unit 010 shown.

[0141] Specifically, the execution environment settings include using an illuminance sensor to set the brightness of the execution environment, and other modules execute under the set lighting conditions.

[0142] Generally speaking, sunlight is closely related to eye health. Bright light, similar to exposure to direct sunlight, stimulates nerve cells in the retina, promoting dopamine secretion, which in turn induces the synthesis of proteoglycans. This is an essential factor for the normal adjustment of axial length.

[0143] As mentioned above, illuminance sensors can be used to measure the illuminance in the current environment to provide light stimulation to patients, and can provide alerts of the current light environment to brightly control the environment in which patients participate in digital therapy.

[0144] Referring to Figure 7B, a specific example of the instructions for the eye training module is shown, along with a method for collecting output data. In this case, the eye training module can be included as... Figure 2 This is part of the configuration of the digital instruction generation unit 010 shown.

[0145] Digital instructions for eye training include controlling patient eye exercises, biofeedback, and eye-related behaviors. Specifically, behavioral instructions in the eye training module can use eye-tracking technologies such as eye exercises, blinking, distant gazing, and eye closing to monitor patient compliance. However, the set of execution results from the eye training module is not limited to eye-tracking technology; it also includes execution results from instructions directly input by the patient.

[0146] Referring to Figure 7C, a specific example of the instructions for the physical exercise module is shown, along with a method for collecting output data. In this case, the physical exercise module can be included as... Figure 2 This is part of the configuration of the digital instruction generation unit 010 shown. The physical exercise module includes slow and comfortable physical exercises and abdominal exercises, which can consist of a series of behavioral instructions configured to reduce stress and suppress cortisol secretion through rest, relaxation, deep breathing, etc.

[0147] Specifically, the behavioral instructions in the physical exercise module include instructions such as relaxation exercises, deep breathing, meditation, and eye massage. Furthermore, the behavioral instructions include methods for collecting the execution results of the behavioral instructions using biofeedback devices (for measuring EEG, ECG, EMG, EDG, etc.) or general sensors (for measuring activity, heart rate, etc.) in the sensor data collection unit 020, or methods for allowing the patient to directly input the execution results using the execution input unit 030. The behavioral instructions disclosed herein are based on behavioral therapy methods widely used to alleviate stress in children in child psychiatry.

[0148] Generally, the progression of myopia is closely related to the process of puberty. In particular, there can be significant differences among adolescents at this stage, depending on the child's age, gender, personality, and preferences. To compensate for these variations, it is best to present the digital instructions for each module in a customized manner based on each patient's individual characteristics. Specifically, instructions that require interaction with the application (e.g., dialogue) can be developed by combining big data analytics and artificial intelligence analysis.

[0149] Referring to Figure 7D, a specific example of the instructions for a self-module is shown, along with a method for collecting output data. In this case, the self-module can be included as... Figure 2 This is part of the configuration of the digital instruction generation unit 010 shown.

[0150] Specifically, the instructions in the self-module are designed to enhance adolescents' self-esteem and relieve stress. For this purpose, the self-module instructions may include, for example, instructions such as talking, drawing, meditating, journaling, creating their own safe space (safe place instructions), their favorite things (places, times, seasons, colors, foods, people, etc.), their own life wish list, choosing travel destinations, and planning trips. These instructions are based on a psychotherapy widely used in child psychiatry to enhance self-esteem and relieve stress in children or adolescents.

[0151] Referring to Figure 7E, a specific example of the instructions for the safety / comfort module is shown, along with a method for collecting output data. In this case, the safety / comfort module can be included as... Figure 2This is part of the configuration of the digital instruction generation unit 010 shown.

[0152] Specifically, the instructions in the Safety / Comfort Module are designed to provide respite and reduce stress in teenagers. For this purpose, the instructions in the Safety / Comfort Module may include, for example, instructions to chat, express oneself (writing, singing, drawing), or leave unpleasant emotions in anime (trash can instructions). These instructions are based on a psychotherapy widely used in child psychiatry to improve the self-esteem of children or adolescents and relieve stress.

[0153] Referring to Figure 7F, a specific example of the instructions for the Fun module is shown, along with a method for collecting output data. In this case, the Fun module can be included as... Figure 2 This is part of the configuration of the digital instruction generation unit 010 shown.

[0154] Specifically, the instructions in the Fun module are designed to allow patients to use the application and have fun, and can consist of various content such as music, games, or videos, tailored to the characteristics of teenagers. Furthermore, the fun instructions in the Fun module also aim to increase patients' continued engagement with digital therapy.

[0155] Referring to Figure 7G, a specific example of the instructions for a completion module is shown, along with a method for collecting output data. In this case, the completion module can be included as... Figure 2 This is part of the configuration of the digital instruction generation unit 010 shown.

[0156] Specifically, the instructions in the achievement module may include instructions that promote dopamine release through a sense of accomplishment, such as the patient's task execution and completion. Here, task completion instructions are those that give the patient a sense of accomplishment when a given task is completed, and therefore may include games whose tasks can be updated during the patient's engagement time and can induce the patient's voluntary participation. For example, specific forms of games may consist of various time periods, such as learning, hidden or difference picture puzzles, quizzes, etc.

[0157] In particular, some instructions implemented in the form of quizzes within the achievement module may be expected to have an additional effect on improving patients' health information literacy and digital therapy literacy. This improvement in health information and digital therapy literacy is an essential element for patients' continued participation in and adherence to treatment.

[0158] As stated above, the digital therapy according to this disclosure requires patient participation for no less than 10 weeks. During this period, sincere execution of the instructions in the aforementioned modules can lead to praise instructions within the completed modules, giving the patient a sense of accomplishment. For praise instructions, based on trust and compensation between the patient and caregiver, and between the patient and physician, the patient's active participation in treatment may be rewarded as a sense of accomplishment.

[0159] The digital instructions shown in Figures 7B to 7G above are given by way of illustration only and are not intended to limit this disclosure. For example, the digital instructions provided to the patient can be set in various ways as necessary.

[0160] Figure 8 A flowchart illustrating the operation of a digital application for treating myopia according to one embodiment of the present disclosure is provided.

[0161] refer to Figure 8 According to one embodiment of this disclosure, a digital application for treating myopia can first generate a digital therapy module for treating myopia based on the mechanism of action and treatment hypothesis of myopia (S810). In this case, in S810, the digital therapy module can be generated based on neurohumoral factors of myopia (e.g., IGF, cortisol, dopamine, etc.).

[0162] Simultaneously, in S810, a digital therapy module can be generated based on input from the doctor. In this case, the digital therapy module can be generated based on information collected by the doctor during patient diagnosis and the prescription results recorded based on that information. Furthermore, in S810, the digital therapy module can be generated based on information received from the patient (e.g., underlying factors, medical information, digital therapy literacy, etc.).

[0163] Next, in S820, specified digital instructions can be generated based on the digital therapy module. S820 generates the digital therapy module by applying fictitious parameters about the patient's environment, behavior, emotions, and cognition to the mechanisms of action and treatment hypotheses of myopia. This digital therapy module is described with reference to Figure 5, therefore its description will be omitted.

[0164] In this configuration, digital instructions can be generated for at least one of the following modules: light environment setting module, eye exercise module, physical exercise module, self module, safety / comfort module, fun module, and achievement module. The execution environment settings and specific digital instructions for each module are described in Figures 7A through 7G.

[0165] Then, digital instructions can be provided to the patient (S830). In this case, digital instructions can be provided in the form of digital instructions associated with behavior, emotion, or cognition, where sensors can be used to monitor the patient's compliance with the instructions, such as eye exercises / physical exercises, or in the form of digital instructions that allow the patient to directly input the execution result.

[0166] After the patient executes the presented digital instructions, the patient's execution result of the digital instructions can be collected (S840). In S840, the execution result of the digital instructions can be collected by monitoring the patient's compliance with the digital instructions as described above, or by having the patient input the execution result of the digital instructions.

[0167] Furthermore, a digital application for treating myopia according to one embodiment of this disclosure can repeatedly perform operations, including generating digital instructions and collecting the patient's execution results of the digital instructions. In this case, generating digital instructions may include generating the patient's digital instructions for the current period based on digital instructions provided by the patient in the previous period and collected execution result data regarding the digital instructions provided by the patient in the previous period.

[0168] As described above, according to one embodiment of the present disclosure, a digital application for treating myopia, taking into account the neurohumoral factors of myopia, can ensure the reliability of inhibiting the progression of myopia and treating myopia by inferring the mechanism of action and treatment hypothesis of myopia. Based on the mechanism of action and treatment hypothesis of myopia, digital instructions are presented to the patient, executed in a suitable light stimulation environment, and the results of the digital instructions are collected and analyzed.

[0169] Although a digital device and application for treating myopia according to one embodiment of this disclosure has been described from the perspective of myopia treatment, this disclosure is not limited thereto. For other diseases besides myopia, digital treatment can be performed in essentially the same manner as described above.

[0170] Figure 9 A flowchart illustrating a method for generating digital instructions in a digital application for treating myopia according to one embodiment of the present disclosure is provided.

[0171] refer to Figure 9 The method for generating digital instructions operates as described above, in the process of generating modules and specifying digital instructions for treating myopia based on the mechanism of action and treatment hypothesis of myopia (in... Figure 8 (S810 and S820 shown in Figure 5) and the process shown in Figure 5.

[0172] In S910, the mechanism of action and treatment hypothesis of myopia can be input first. In this case, through literature search and expert review of systemic clinical trials related to myopia, the mechanism of action and treatment hypothesis of myopia can be inferred in advance, as described above.

[0173] Next, the neurohumoral factors of myopia can be predicted from the input mechanism and treatment hypothesis (S920). In this case, the neurohumoral factors of myopia predicted in S920 can be inferred to be in the form of IGF, cortisol, dopamine, etc. These neurohumoral factors have been described in detail with reference to Figure 5, so their description will be omitted.

[0174] In S930, a digital therapy module can be generated, allowing fictitious parameters to correspond to predicted neurohumoral factors. Here, the fictitious parameters can be used as a converter to transform the neurohumoral factors of myopia into digital therapy modules. This procedure is designed to establish the physiological interactions between neurohumoral factors and environmental, behavioral, emotional, and cognitive factors, as shown in Figure 5.

[0175] Then, specific digital instructions can be generated based on the generated digital therapy module (S940). In this case, specific digital instructions can be generated in the aforementioned light environment setting module, eye exercise module, physical exercise module, self module, safety / comfort module, fun module, and achievement module, as shown in Figures 7A to 7G.

[0176] Figure 10 A flowchart illustrating a method for repeatedly performing an operation under feedback control in a digital application for treating myopia, according to one embodiment of the present disclosure.

[0177] exist Figure 10 The text explains that the generation of digital instructions and the collection of execution results at a digital application for treating myopia are performed N times. In this case, the mechanism of action of myopia and the treatment hypothesis can be input first (S1010). In addition, digital instructions provided in the previous cycle and execution result data can be received (S1020). When the first execution cycle is in progress, S1020 can be omitted because there is no previous data.

[0178] Next, the digital instructions for this cycle can be generated based on the input mechanism of action and treatment hypothesis, the digital instructions provided in the previous cycle, and the execution result data (S1030). Then, the user's execution results of the generated digital instructions can be collected (S1040).

[0179] In S1050, it is determined whether the current iteration is greater than the Nth iteration. If the current iteration is less than the Nth iteration (No), the process can return to S1020 and repeat S1020 to S1040. On the other hand, if the current iteration is greater than the Nth iteration (Yes), that is, when the generation of numeric instructions and the collection of execution results have been performed N times, the feedback operation can be terminated.

[0180] Figure 11 A diagram illustrating the hardware configuration of a digital device for treating myopia according to one embodiment of the present disclosure.

[0181] refer to Figure 11 According to one embodiment of the present disclosure, the hardware 600 of a digital device for treating myopia may include a CPU 610, a memory 620, an input / output I / F 630, and a communication I / F 640.

[0182] CPU 610 may be a processor configured to execute a digital program for treating myopia stored in memory 620, process various data for treating digital myopia, and perform functions associated with digital myopia treatment. That is, CPU 610 can be used to execute a digital program for treating myopia stored in memory 620, process various data for treating digital myopia, and perform functions associated with digital myopia treatment. Figure 2 The functionality of each configuration shown.

[0183] The memory 620 may contain a digital program for treating myopia stored therein. Furthermore, the memory 620 may include data included in the aforementioned database 050 for digital myopia treatment, such as the patient's digital instructions and the results of instruction execution, the patient's medical information, etc.

[0184] Multiple such memories 620 may be provided if necessary. The memory 620 may be volatile or non-volatile. When the memory 620 is volatile, RAM, DRAM, SRAM, etc., may be used as the memory 620. When the memory 620 is non-volatile, ROM, PROM, EAROM, EPROM, EEPROM, flash memory, etc., may be used as the memory 620. The examples of memories 620 listed above are given by way of illustration only and are not intended to limit this disclosure.

[0185] The input / output I / F 630 can provide interfaces for input devices (not shown) such as a keyboard, mouse, or touch panel and output devices such as a display (not shown), wherein the input devices and output devices can send and receive data to and from the CPU 610 (e.g., wirelessly or via hardwired).

[0186] The Communication I / F 640 is configured to send various types of data to / receive various types of data from the server, and can be one of various devices capable of supporting wired or wireless communication. For example, data types concerning the aforementioned digital behavior-based therapy can be received from a separately available external server via the Communication I / F 640.

[0187] As described above, for example, a computer program according to one embodiment of this disclosure can be recorded in memory 620 and processed at CPU 610, such that the computer program can be implemented as a module configured to execute each functional block, as in Figure 2 As shown in the image.

[0188] According to the digital device and application for treating axial myopia disclosed herein, considering the neurohumoral factors of axial myopia progression, by inferring the mechanism of action and treatment hypothesis of myopia as well as the digital treatment hypothesis of myopia, a reliable digital device and application capable of inhibiting the progression of myopia and treating myopia can be provided. Based on the mechanism of action, treatment hypothesis, and digital treatment hypothesis, digital instructions are presented to the patient under appropriate light stimulation environment settings, and the execution results of the digital instructions are collected and analyzed.

[0189] While this disclosure has been shown and described with reference to certain exemplary embodiments thereof, those skilled in the art will understand that various changes in form and detail may be made therein without departing from the spirit and scope of this disclosure as defined by the appended claims.

Claims

1. A digital system for treating myopia, said digital system comprising: At least one processor; and A memory that stores digital programs for treating myopia; The processor is configured to execute the digital program to: A digital instruction generation unit generates one or more digital instructions based on at least a portion of a plurality of digital treatment modules configured to regulate one or more neurohumoral factors to treat myopia, wherein the plurality of digital treatment modules include an eye exercise module for promoting IGF secretion. The digital instruction generation unit provides one or more digital instructions to the subject; and The results collection unit collects the results of the subjects' execution of one or more digital instructions.

2. The digital system of claim 1, wherein the processor is further configured to perform calibration of the measurement accuracy of the subject's eye position.

3. The digital system of claim 2, wherein the processor is further configured to determine a threshold for detecting the subject's eyes based on a calibration of the accuracy of the measurement of the subject's eye position.

4. The digital system of claim 2, wherein the calibration of the measurement accuracy of the subject's eye position includes one or more of the following: instructing the subject to position their face to appear on the screen of the digital system, detecting the subject's eyes for a given period of time, instructing the subject to blink, detecting whether the subject blinks, or instructing the subject to move or rotate their eyes in a given direction.

5. The digital system of claim 2, wherein the processor is configured to calibrate daily at the start of a treatment session.

6. The digital system of claim 1, wherein the processor is further configured to perform calibration of the measurement accuracy of the light environment, wherein the calibration of the measurement accuracy of the light environment comprises one or more of the following: detecting light in the subject's environment using the light sensor of the digital system, and instructing the subject to turn on one or more lights in their environment.

7. The digital system of claim 1, wherein the processor is further configured to determine at least one of exercise intensity (EI) and average exercise intensity (AEI) based on the subject's execution of the digital instructions.

8. 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 healthcare providers with one or more options to perform one or more tasks, based on information received from the digital application, to prescribe myopia treatment for the subject. as well as The management portal is configured to provide system administrators with one or more options to perform one or more tasks related to managing healthcare providers' access to the system. The digital device is configured to execute the digital application to: One or more digital instructions are generated based on at least a portion of a plurality of digital therapy modules configured to regulate one or more neurohumoral factors to treat myopia. Provide the subject with one or more digital instructions; and Collect the results of subjects' execution of one or more numerical instructions.

9. The system of claim 8, wherein the plurality of digital therapy modules include behavioral instructions regarding the subject's environment, behavior, emotions, and cognitive inferences; The digital device (i) includes a sensor that senses the subject’s compliance with the digital instruction, (ii) sends compliance information to a server based on the compliance, and (iii) receives a second digital instruction from the server based on the compliance information.

10. The system of claim 8, wherein one or more options provided to the healthcare provider include viewing or editing the subject's personal information, and the personal information includes one or more of the following: the subject's identification number, the subject's name, the subject's date of birth, the subject's email address, the subject's guardian's email address, the subject's contact number, the subject's prescriptions, and one or more notes made by the healthcare provider to the subject.

11. The system of claim 8, wherein one or more options provided to the healthcare provider include viewing the subject's compliance information, and the subject's compliance information includes one or more of the following: multiple pre-booked or prescribed digital treatment modules completed by the subject, and a calendar of one or more days identifying one or more pre-booked or prescribed digital treatment modules completed, partially completed, or not completed by the subject.

12. The system of claim 8, wherein one or more options provided to the healthcare provider include viewing the results of the subject on one or more at least partially completed digital treatment modules, and the results of the subject on one or more at least partially completed digital treatment modules include one or more of the following: the time when the subject started the scheduled or prescribed digital treatment module, the time when the subject ended the scheduled or prescribed digital treatment module, an identifier of whether the scheduled or prescribed digital treatment module was fully or partially completed, and exercise intensity (EI).

13. The system of claim 8, wherein one or more options provided to the administrator of the system are selected from: adding or removing the healthcare provider, viewing or editing the personal information of the healthcare provider, viewing or editing the de-identification information of the subject, viewing the compliance information of the subject, viewing the results of the subject on one or more digital treatment modules that are at least partially completed, and communicating with the healthcare provider.

14. A computer-readable recording medium storing a program on a computer for executing a method of operating a digital system for treating myopia, the method comprising: A digital instruction generation unit generates one or more digital instructions based on at least a portion of a plurality of digital treatment modules configured to regulate one or more neurohumoral factors to treat myopia, wherein the plurality of digital treatment modules include an eye exercise module for promoting IGF secretion. The digital instruction generation unit provides one or more digital instructions to the subject. and The results collection unit collects the results of the subjects' execution of one or more digital instructions.

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