Digital system for treating myopia, method of operating the digital system and computer readable medium

Abstract

To provide a digital device for a myopia treatment.SOLUTION: A digital device for a myopia treatment according to an embodiment of the present invention may include: a digital task generation unit for generating a digital therapeutic agent module for the myopia treatment on the basis of the pathogenetic mechanism and the treatment assumption for myopia, generating an embodied digital task on the basis of the digital therapeutic agent module, and providing the digital task to a first user; and a result collecting unit for collecting the result of execution of the digital task by the first user.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] The present invention relates to digital therapeutics (DTx) aimed at treating myopia, including inhibiting the progression of myopia. In particular, the present invention involves deriving the mechanism of action (MOA) for childhood / adolescent axial myopia through literature research and expert review of basic science papers and related clinical trial papers to identify the pathogenic mechanism of myopia, and establishing a therapeutic hypothesis and digital therapeutic hypothesis for inhibiting and treating the progression of childhood / adolescent axial myopia based on the MOA.

[0002] The present invention also provides a rational design of an application to clinically verify the hypothesis of digital treatment for childhood / adolescent axial myopia and to embody it as a digital therapeutic agent, as well as a digital device and application based thereon for the purpose of inhibiting and treating the progression of childhood / adolescent axial myopia. [Background technology]

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

[0004] More seriously, a survey found that approximately 70% of adolescent myopia patients in Korea are severe or high myopia patients. The prevalence of myopia among elementary school students has also steadily increased from around 23% in 1980 to 38% in the 1990s and 46.2% in the 2000s.

[0005] Although the World Health Organization (WHO) recognizes myopia as a disease, there is still no clear cure for it worldwide. In recent years, the prevalence of myopia has increased sharply in China, Singapore, South Korea, and other countries, and myopia has emerged as an eye disease that can lead to blindness in the future, once again attracting the attention of the academic community.

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

[0007] Known methods for slowing or treating myopia include using medication (atropine) and special lenses (e.g., Dream Lenses). However, atropine can cause severe glare due to pupil dilation. Furthermore, Dream Lenses have a high risk of corneal damage, limiting their clinical use compared to corrective glasses.

[0008] In addition, various myopia treatment mechanisms, eye movement methods, and eye movement applications have been developed and marketed, but most of them lack evidence of their clinical effectiveness and are sold without separate licensing procedures.As a result, there is currently no reliable treatment for childhood / adolescent patients who have been diagnosed with myopia at a hospital to prevent and treat the progression of myopia. Summary of the Invention [Problem to be solved by the invention]

[0009] The present invention first derives the pathogenesis, treatment hypothesis, and digital treatment hypothesis for myopia, taking into consideration the stages of ocular development during childhood and adolescence and the neuro-humoral factors of myopia progression.Based on the myopia digital treatment hypothesis, the present invention aims to provide a digital device and application for myopia treatment that can suppress the progression of myopia and ensure the reliability of providing therapeutic effects by having patients repeatedly perform digital tasks in a light stimulation environment. [Means for solving the problem]

[0010] A digital device for treating myopia according to one embodiment of the present invention may include a digital therapeutics module for treating myopia based on a pathogenic mechanism and a treatment hypothesis for myopia, a digital task generation unit for generating a specific digital task based on the digital therapeutics module, and providing the digital task to a first user, and a result collection unit for collecting execution results of the digital task by the first user.

[0011] A digital application for treating axial myopia according to one embodiment of the present invention may be configured to perform operations including generating a digital therapeutic module for treating myopia based on the pathogenic mechanism and treatment hypothesis of myopia, generating a specific digital task based on the digital therapeutic module, providing the digital task to a first user, and collecting the first user's execution results for the digital task, using a computing device. [Effects of the Invention]

[0012] According to the digital device and application for treating axial myopia of the present invention, by taking into account the neurohumoral factors that contribute to the progression of axial myopia, the pathogenic mechanism of myopia, a treatment hypothesis, and a digital treatment hypothesis are derived, and based on this, digital tasks are presented to the patient in an appropriate light stimulation environment, and the results of these tasks are collected and analyzed, thereby providing a reliable digital device and application that can suppress the progression of myopia and provide treatment. [Brief explanation of the drawings]

[0013] [Figure 1a] FIG. 1 is a diagram showing the pathogenesis of childhood / adolescent axial myopia proposed in the present invention. [Figure 1b] FIG. 1 is a diagram showing a treatment hypothesis for axial myopia proposed in the present invention. [Figure 1c] FIG. 1 is a diagram showing the digital treatment hypothesis for axial myopia proposed in the present invention. [Figure 2] 1 is a block diagram showing the configuration of a digital device for treating myopia according to one embodiment of the present invention. [Figure 3] FIG. 1 illustrates the input and output loops of a digital application for myopia treatment according to an embodiment of the present invention. [Figure 4] FIG. 1 illustrates a feedback loop with a digital device and application for myopia treatment according to an embodiment of the present invention. [Figure 5a] 1 is a diagram illustrating a modular design for implementing digital treatment in a digital myopia treatment device and application according to an embodiment of the present invention. [Figure 5b] FIG. 1 illustrates the background factors behind a digital device and application for myopia treatment according to an embodiment of the present invention. [Figure 6] FIG. 1 illustrates a method for specifying a patient-customized digital prescription using a digital device and application for myopia treatment according to an embodiment of the present invention. [Figure 7a] FIG. 2 illustrates an execution environment configuration according to one embodiment of the present invention. [Figure 7b]10 is a diagram illustrating specific task examples and output data collection methods for each module according to an embodiment of the present invention. FIG. [Figure 7c] 10 is a diagram illustrating specific task examples and output data collection methods for each module according to an embodiment of the present invention. FIG. [Figure 7d] 10 is a diagram illustrating specific task examples and output data collection methods for each module according to an embodiment of the present invention. FIG. [Figure 7e] 10 is a diagram illustrating specific task examples and output data collection methods for each module according to an embodiment of the present invention. FIG. [Figure 7f] 10 is a diagram illustrating specific task examples and output data collection methods for each module according to an embodiment of the present invention. FIG. [Figure 7g] 10 is a diagram illustrating specific task examples and output data collection methods for each module according to an embodiment of the present invention. FIG. [Figure 8] 1 is a flowchart illustrating the operation of a digital application for treating myopia according to an embodiment of the present invention. [Figure 9] 1 is a flowchart illustrating a method for generating a digital challenge in a digital application for myopia treatment according to an embodiment of the present invention. [Figure 10] 1 is a flowchart illustrating the repeated execution of operations with feedback control in a digital application for myopia treatment according to an embodiment of the present invention. [Figure 11] FIG. 1 is a diagram showing the hardware configuration of a digital device for treating myopia according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, various embodiments of the present invention will be described in detail with reference to the drawings. In this document, the same reference numerals are used to refer to the same components in the drawings, and duplicate descriptions of the same components will be omitted.

[0015] Specific structural or functional descriptions of the various embodiments of the present invention disclosed in this document are merely exemplary for purposes of describing the embodiments of the present invention, and the various embodiments of the present invention may be embodied in various forms and should not be construed as being limited to the embodiments described herein.

[0016] The terms "first," "second," "primary," or "second" used in various embodiments may modify various components regardless of order and / or importance, and do not limit the components. For example, a first component may be named a second component, and similarly, a second component may be named instead of a first component, without departing from the scope of the present invention.

[0017] The terms used in this document are merely used to describe particular embodiments and are not intended to limit the scope of other embodiments. The singular expression may include the plural expression unless the context clearly indicates otherwise.

[0018] All terms used herein, including technical and scientific terms, may have the same meaning as commonly understood by a person of ordinary skill in the art of the present invention. Terms defined in commonly used dictionaries may be interpreted as having the same or similar meaning as the meaning they have in the context of the relevant art, and unless explicitly defined in this document, they should not be interpreted in an ideal or overly formal sense. In some cases, even terms defined in this document should not be interpreted to exclude embodiments of the present invention.

[0019] Traditional new drug development begins with identifying a medical need, proposing a pathogenic mechanism for the disease through expert review and meta-analysis, and deriving a treatment hypothesis based on this. Based on the therapeutic hypothesis, a library of drugs with promising therapeutic effects is prepared, and candidate substances are identified through screening. These candidate substances undergo optimization and preclinical testing, and efficacy and safety are confirmed in the preclinical stage to determine the final candidate drug. After establishing chemistry, manufacturing, and controls (CMC) for mass production of the candidate drug, clinical trials are conducted to verify the pathogenic mechanism and therapeutic hypothesis and confirm the candidate drug's clinical efficacy and safety.

[0020] From a patent perspective, drug targets and signaling, which are upstream in new drug development, are fraught with uncertainty. Furthermore, in many cases, the novelty of an invention is often difficult to recognize because it relies on a methodology that synthesizes and interprets previously reported results. In contrast, despite the development of numerous new drug research methodologies, the invention of a drug that can treat disease by regulating drug targets and signaling requires the highest level of inventiveness, with the exception of some antibody and nucleic acid (DNA, RNA) therapeutics. As a result, the molecular structure of a drug is the most crucial element that constitutes the most powerful substance patent in the new drug field.

[0021] Unlike drugs, which are strongly protected by substance patents, digital therapeutics are essentially implemented as software. Considering the attributes of digital therapeutics and the clinical validation and approval process as therapeutics, the rational design of a digital therapeutic for a given disease and the software implementation based on it can be said to be a highly creative inventive process that should be protected by patent protection.

[0022] In other words, the core of the digital therapeutic agent of the present invention is the rational design of a digital therapeutic agent suitable for treating the disease and the development of specific software that can be clinically verified based on the design. The digital device and application for treating myopia of the present invention, which are realized from this perspective, will be described in detail below.

[0023] Figure 1a shows the pathogenesis of childhood / adolescent axial myopia proposed in this invention, Figure 1b shows the treatment hypothesis for axial myopia proposed in this invention, and Figure 1c shows the digital treatment hypothesis for axial myopia proposed in this invention.

[0024] The digital device and application for inhibiting and treating myopia progression of the present invention described below have been embodied based on the pathogenic mechanism and treatment hypothesis derived through literature research and expert review of clinical trial papers on childhood / adolescent axial myopia.

[0025] Generally speaking, disease treatment involves analyzing a specific disease from its pathophysiological and organic aspects to determine its onset, progression, and end point. Then, through a demographic and disease statistical analysis, the disease's symptoms are defined. Furthermore, the patient's physiology, particularly the neurohumoral factors, corresponding to the identified symptoms are analyzed, and the neurohumoral factors of the patient are narrowed down to those related to the disease to derive the pathogenic mechanism.

[0026] Next, we derive a treatment hypothesis for treating the disease by controlling the behavior and environment that are directly related to the regulation of the neurohumoral factors associated with the disease. To embody this treatment hypothesis as a digital therapeutic agent, we propose a digital treatment hypothesis that achieves therapeutic effects through repeated digital tasks and their execution, linked to the patient's "control of behavior / environment → regulation of neurohumoral factors." The digital treatment hypothesis of the present invention is embodied as a digital device and application that presents specific instructions for changing the patient's behavior (including behavior, emotion, and cognition), improving the environment, and encouraging patient participation, and collects and analyzes their execution.

[0027] The literature search for the clinical trials described above may be performed by meta-analysis and data mining, and feedback and in-depth review from clinical experts may be applied at each analysis stage. Essentially, the present invention provides a digital device and application as a digital therapeutic agent for inhibiting and treating the progression of axial myopia by regulating neurohumoral factors based on the extracted mechanism of pathogenesis and treatment hypotheses of axial myopia through the process described above.

[0028] However, the method for extracting the pathogenesis and treatment hypotheses of axial myopia according to the present invention is not limited to the above-described method, and various other methods can be used to extract the pathogenesis and treatment hypotheses of the disease.

[0029] As shown in Figure 1a, various risk factors in childhood and adolescence, such as close work, education, race, genetics, and other factors (premature birth, diet, light exposure, birth season, high intraocular pressure, etc.), can lead to an imbalance of neurohumoral factors in childhood and adolescence. As a result, abnormalities in IGF, cortisol, and dopamine cause abnormalities in the production of proteoglycans in the sclera around the eyeball, resulting in abnormal growth of the eye axis and the development of axial myopia.

[0030] Referring to Figure 1b, the treatment hypothesis for axial myopia according to the present invention is to inhibit and treat the progression of axial myopia by restoring the balance of neurohumoral factors through the patient's actions (including behavioral, emotional, and cognitive domains) and environment, as well as patient participation.

[0031] Referring to Figure 1c, the digital treatment hypothesis for axial myopia is embodied as a digital device and application that presents patients with specific tasks for behavioral change, environmental improvement, and participation, and collects and analyzes their implementation. Using the digital therapeutic agent of the present invention, it is possible to correct imbalances in neurohumoral factors in childhood / adolescent axial myopia patients through the digital input (tasks) and output (implementation), thereby inhibiting and treating the progression of axial myopia.

[0032] While Figures 1a and 1b illustrate the pathogenic mechanism and treatment hypothesis of axial myopia, the present invention is not limited thereto, and the methodology of the present invention may be applied to all types of myopia and other diseases.

[0033] In addition, although the neurohumoral factors are described as insulin-like growth factor (IGF), cortisol, and dopamine in Figures 1a and 1b, these are merely examples, and the neurohumoral factors in the myopia pathogenesis and treatment hypothesis according to the present invention are not limited to these, and all neurohumoral factors that affect myopia may be considered.

[0034] FIG. 2 is a block diagram showing the configuration of a digital device for treating myopia according to one embodiment of the present invention.

[0035] Referring to FIG. 2, a digital system 000 for myopia treatment according to one embodiment of the present invention may include a digital problem 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.

[0036] Based on the pathogenesis, treatment hypothesis, and digital treatment hypothesis for childhood / adolescent axial myopia, the doctor (second user) can prescribe a digital therapeutic agent embodied as a digital device and application for treating myopia for the patient. In this case, the digital task generator 010 is a device that provides the patient with a prescription for the digital therapeutic agent as a specific behavioral task that the patient can perform based on the interaction between neurohumoral factors related to myopia and behavior / environment. For example, neurohumoral factors may include IGF, cortisol, and dopamine. However, the present invention is not limited thereto, and all neurohumoral factors that may cause myopia may be considered.

[0037] The digital task generator 010 may generate a digital task based on input from a doctor. In this case, the digital task generator 010 may generate a digital task based on information collected by a doctor when diagnosing a patient (first user). The digital task generator 010 may also generate a digital task based on information received from a patient. For example, the information received from a patient may include the patient's basal factors, medical information, and digital therapeutics literacy. In this case, the basal factors may include the patient's activity, heart rate, sleep, diet (nutrition and calories), etc. The medical information may include the patient's electronic medical record (EMR), family history, genetic vulnerability, genetic susceptibility, etc. The digital therapeutics literacy may include the patient's accessibility and posture to the digital therapeutic task and device.

[0038] The digital task generator 010 can generate a digital module by utilizing virtual parameters that reflect the pathogenesis and treatment hypotheses of myopia. In this case, the virtual parameters can be derived from the patient's environment, behavior, emotions, and cognition. This will be described in detail later with reference to FIG. 5.

[0039] The digital task generator 010 generates digital tasks specifically designed to help the patient achieve a therapeutic effect and provides the tasks to the patient. For example, the digital task generator 010 can generate specific digital tasks for each digital therapeutic module while providing light stimuli in a bright light environment.

[0040] The sensing data collection unit 020 and the execution input unit 030 can collect the patient's execution results for the digital tasks provided by the digital task generation unit 010. Specifically, the unit is composed of the sensing data collection unit 020 that senses the patient's adherence to the digital tasks, and the execution input unit 030 that allows the patient to directly input the execution results for the digital tasks, and outputs the patient's execution results for the digital tasks.

[0041] The result analysis unit 040 can collect and report the patient's behavioral compliance and participation at a preset interval, so that doctors can continuously monitor the progress of the digital tasks through the application without the patient needing to visit the clinic in person.

[0042] The database 050 can store data related to the pathogenic mechanism of myopia, treatment hypotheses, digital tasks provided to the user, and the results of the user's execution. Although the database 050 is shown in FIG. 2 as being included in the digital system for treating myopia 000, the database 050 may be provided on an external server.

[0043] Meanwhile, a series of loops including input of a digital task by the digital task generation unit 010, output of the patient's digital task execution results by the sensing data collection unit 020 / execution input unit 030, and evaluation by the result analysis unit 040 may be repeated multiple times. In this case, the digital task generation unit 010 can generate a patient-customized digital task for the current session by reflecting the patient's digital task provided in the previous session, its output value, and evaluation.

[0044] In this way, the digital treatment device for inhibiting and treating the progression of axial myopia of the present invention takes into account the neurohumoral factors of axial myopia, derives the pathogenesis of axial myopia, a treatment hypothesis, and a digital treatment hypothesis, and based on this, presents the patient with an appropriate light stimulation environment and digital tasks for treating axial myopia, and collects and analyzes the execution of these tasks, thereby enabling reliable myopia treatment.

[0045] FIG. 3 is a diagram illustrating the input and output loop of a digital application for myopia treatment according to one embodiment of the present invention.

[0046] Referring to FIG. 3, a digital application for myopia treatment according to an embodiment of the present invention can input the digital prescription to a patient in the form of a task and output the execution result for the digital task.

[0047] The digital tasks provided to the patient may include specific behavioral, emotional, and cognitive tasks, as well as controlling the patient's lighting environment. As shown in FIG. 3, the digital tasks may include eye movement, stress reduction, a sense of accomplishment, and light stimulation. However, these are merely examples, and the digital tasks of the present invention are not limited thereto.

[0048] The patient's performance results for the digital tasks consist of 1) task-performance login / logout information, 2) compliance information sensed in the form of passive data such as eye movement, stress-related heart rate, and changes in oxygen saturation, and 3) directly input information on the patient's performance results.

[0049] FIG. 4 is a diagram illustrating a feedback loop of a digital device and application for the treatment of axial myopia according to one embodiment of the present invention.

[0050] Referring to Figure 4, it is shown that the single feedback loop shown in Figure 3 is repeated multiple times to regulate neurohumoral factors, thereby achieving the inhibition and treatment of axial myopia progression.

[0051] Due to the characteristics of axial myopia, its treatment requires long-term digital treatment and observation, from as little as 10 weeks to as long as the entire childhood / adolescence period. Due to these characteristics, the prevention of axial myopia progression and treatment effects can be achieved more effectively through gradual improvement of task-performance through a feedback loop than through simple repetition of task-performance during the treatment process.

[0052] For example, the initial digital task and execution results are given as input and output values ​​in a single loop, but after N executions, a loop feedback process is used to adjust the input for the next loop based on the input and output values ​​generated in the current loop, generating a new digital task. By repeating this feedback loop, patient-customized digital tasks can be derived, while simultaneously maximizing the therapeutic effect.

[0053] As described above, the digital device and application for myopia treatment according to an embodiment of the present invention can calculate the patient's digital task and execution results for the current session (e.g., Nth session) using data on the patient's digital task and task execution results provided in the previous session (e.g., N-1th session). That is, the digital task for the next session can be generated based on the patient's digital task and task execution results calculated in the previous session. In this case, the feedback process can use various algorithms and statistical models as needed.

[0054] Thus, a digital device and application for myopia treatment according to an embodiment of the present invention allows for a rapid feedback loop to optimize a patient-customized digital challenge that is suitable for the patient.

[0055] FIG. 5a is a diagram showing a modular design for implementing digital treatment in a digital myopia treatment device and application according to one embodiment of the present invention, and FIG. 5b is a diagram showing background factors supporting the digital myopia treatment device and application according to one embodiment of the present invention.

[0056] As shown in Figure 5a, once a treatment hypothesis based on the pathogenic mechanism of myopia is established, target neurohumoral factors (e.g., IGF, cortisol, dopamine, etc.) can be derived. Virtual parameters were used to match specific tasks to the regulation of these neurohumoral factors. Modules necessary for myopia treatment were derived using the correlation between "neurohumoral factors - virtual parameters - modules." Each module will be explained in more detail in the form of module-specific tasks in Figure 7, which will be described later. Each module is a basic design unit of a digital therapeutic agent that is embodied as an actual digital device or application, and is a collection of specific tasks.

[0057] Specifically, referring to Figure 5a, the neurohumoral factors derived from the pathogenic mechanism and treatment hypothesis for axial myopia may be IGF, cortisol (or TGF-beta, which is influenced by cortisol), and dopamine (or GABA agonist / antagonist, glucagon). To treat myopia, the secretion of IGF and dopamine, which affect eye development at that age, must be promoted, and the secretion of cortisol must be suppressed.

[0058] The control of each neurohumoral factor was associated with a digital therapeutic module by using the environment (light), behavior (exercise), emotion (stress reduction), and cognition (sense of accomplishment) as virtual parameters. Specific digital tasks were then generated for each module based on the converted modules. In this case, the digital tasks may include execution environment settings and modules (eye movement, exercise, self-awareness, safety and peace, enjoyment, and accomplishment modules) that can be output through monitoring. However, these are merely examples, and the modules according to the present invention are not limited thereto.

[0059] Meanwhile, referring to FIG. 5b, in modular design of a digital device and application for myopia treatment according to an embodiment of the present invention, background factors may be taken into consideration.

[0060] Here, the background factors are elements necessary for correcting clinical test results in the process of verifying the clinical effectiveness of the digital myopia treatment according to the present invention. Specifically, the basal factors among the background factors shown in Figure 5b may include activity, heart rate, sleep, diet (nutrition and calories), etc., the medical information may include EMR created when the patient visited the hospital, family history, genetic vulnerability and susceptibility, etc., and the digital therapeutic agent comprehension ability may include the patient's accessibility and attitude to the digital therapeutic task and device.

[0061] FIG. 6 is a diagram illustrating a method for specifying a patient-customized digital prescription using a digital device and application for treating myopia according to an embodiment of the present invention.

[0062] Figure 6 (A) shows the prescription process based on a routine patient-doctor consultation, and Figure 6 (B) shows a method in which a doctor specifies a patient-customized digital prescription through an analysis of multiple digital tasks and their execution results.

[0063] In this way, when using the digital device and application for myopia treatment according to one embodiment of the present invention, as shown in (B) of Figure 6, the doctor can review the patient's tasks and performance results over a certain period of time and adjust the types of modules for myopia treatment and the tasks for each module in a patient-customized manner.

[0064] FIG. 7a shows the execution environment setting according to one embodiment of the present invention, and FIGS. 7b to 7g show specific task examples and output data collection methods for each module according to one embodiment of the present invention.

[0065] In the case of digital treatment for axial myopia, continuous patient participation for at least 10 weeks is usually required, so it is most important that adolescents find digital treatment enjoyable and participate voluntarily. In this context, each module can be configured with game-like elements. As described below, each module is a basic design unit and a collection of specific tasks in the digital device and application for myopia treatment implemented to improve and treat axial myopia.

[0066] 7A shows a specific example of a task and a method of collecting output data for the execution environment setting. In this case, the execution environment setting may be included in the configuration of the digital task generation unit 010 of FIG.

[0067] Specifically, the execution environment setting includes setting the brightness of the execution environment using an illuminance sensor, and other modules are executed under the set lighting environment.

[0068] In general, sunlight has a close relationship with ocular health. Intense light stimulation, similar to exposure to direct sunlight, acts on retinal nerve cells to promote the secretion of dopamine, which induces the synthesis of protein polysaccharides that support the sclera. This is an essential factor in regulating normal axial length.

[0069] In this way, in order to provide light stimulation to the patient, an illuminance sensor can be used to measure the illuminance of the current environment, or a notification of the current light environment can be provided, thereby controlling the brightness of the environment in which the patient participates in digital therapy.

[0070] 7b shows a specific task example and output data collection method of the eye movement module, in which the eye movement module may be included in the configuration of the digital task generator 010 of FIG.

[0071] The digital eye movement tasks involve controlling the patient's eye movements, biofeedback, and eye-related behaviors to stimulate IGF secretion in the oculomotor muscles. Specifically, the eye movement module's behavioral tasks, such as eye movements, blinking, distance gaze, and eye closure, can be monitored for patient compliance using eye tracking technology. However, the collection of performance results from the eye movement module is not limited to eye tracking technology and can include direct patient input of performance results for the tasks.

[0072] 7c shows a specific example of a task and an output data collection method for the physical exercise module. In this case, the physical exercise module may be included in the configuration of the digital task generator 010 of FIG. 2. The physical exercise module may be configured with a series of behavioral instructions, including slow, easy physical exercise and abdominal exercise, and rest, relaxation, deep breathing, etc., to reduce stress and suppress cortisol secretion.

[0073] Specifically, the behavioral tasks of the physical movement module include relaxation exercises, deep breathing, meditation, eye massage, etc. The execution results are collected by the sensing data collection unit 020 using a biofeedback device (measuring EEG, ECG, EMG, EDG, etc.) or a general-purpose sensor (measuring activity, HR, etc.), or the patient directly inputs the results using the execution input unit 030. The behavioral tasks of the present invention are configured by applying behavioral therapy methods widely used in pediatric psychiatry to relieve stress in children.

[0074] Generally, the progression of myopia is closely related to the progression of adolescence. In particular, during this period, there is bound to be a great deal of diversity in self, safety and peace (ventilation), enjoyment, and achievement depending on age, gender, personality, and preferences. To address these variations, it is desirable to provide customized digital tasks for each module according to the individual characteristics of each patient. In particular, tasks that require interactive communication with applications, such as conversation, can be developed in combination with big data analysis and artificial intelligence analysis.

[0075] 7d shows a specific task example and output data collection method of the ego module, in which the ego module may be included in the configuration of the digital task generator 010 of FIG.

[0076] Specifically, the ego module tasks are intended to enhance adolescents' self-esteem and reduce stress. To this end, tasks may include conversation, drawing, meditation, journaling, creating a safe space, identifying favorite things (places, times, seasons, colors, foods, people, etc.), making a bucket list, and planning a trip. These tasks were adapted from psychotherapy methods widely used in pediatric psychiatry to enhance self-esteem and relieve stress in children and adolescents.

[0077] 7e shows a specific task example and output data collection method of the safety and security module. In this case, the safety and security module may be included in the configuration of the digital task generator 010 of FIG.

[0078] Specifically, the tasks in the Safety and Peace module aim to play a role in reducing stress in adolescents through ventilation. For this purpose, tasks such as chatting, expressing oneself (writing, singing, drawing), and animating to throw away unpleasant feelings (trash can task) may be configured. These tasks are based on psychological treatments widely used in child psychiatry to relieve stress in children and adolescents.

[0079] 7f shows a specific example of a task and a method of collecting output data for the fun module. In this case, the fun module may be included in the configuration of the digital task generator 010 of FIG.

[0080] Specifically, the fun module is a task that allows the patient to feel fun using the application, and may be configured using various content such as music, games, or videos depending on the characteristics of adolescents. Another purpose of the fun task in the fun module is to improve the continuity of the patient's participation in digital therapy.

[0081] 7g shows a specific task example and output data collection method of the achievement module. In this case, the achievement module may be included in the configuration of the digital task generation unit 010 of FIG.

[0082] Specifically, the achievement module may include a task that promotes the release of dopamine through the patient's task execution and the sense of accomplishment of completing the task. Here, the task achievement task is a task that gives the patient a sense of accomplishment by completing the task, and may include a game that can update the task over the patient's participation period and induce voluntary participation. For example, the specific format of the game may be various, such as learning, finding hidden pictures or different pictures, quizzes, etc.

[0083] In particular, the quiz-style portion of the achievement module is expected to have the added effect of enhancing patients' ability to understand health information and digital therapeutics. Such improved ability to understand health information and digital therapeutics is essential for patients' continued participation in treatment and improved performance.

[0084] As mentioned above, the digital treatment of the present invention requires patient participation for 10 weeks or more, and during this period, the patient's sincere execution of the tasks in the above modules can create a sense of accomplishment in the patient. A praise (reward) task can be created in the accomplishment module so that the patient's active participation in treatment through the praise task can be fed back as a sense of accomplishment through trust and reward between the patient and guardian and between the patient and doctor.

[0085] The digital tasks shown in Figures 7b to 7g above are merely exemplary and the present invention is not limited thereto, and the digital tasks provided to the patient may be set in various ways depending on the case.

[0086] FIG. 8 is a flowchart illustrating the operation of a digital application for treating myopia according to one embodiment of the present invention.

[0087] 8, a digital application for myopia treatment according to an embodiment of the present invention may first generate a digital therapeutic agent module for myopia treatment based on the pathogenesis mechanism and treatment hypothesis of myopia (S810). In this case, in step S810, the digital therapeutic agent module may be generated based on neurohumoral factors for myopia (e.g., IGF, cortisol, dopamine, etc.).

[0088] Meanwhile, in step S810, a digital therapeutic agent module can be generated based on input from a doctor. In this case, the digital therapeutic agent module can be generated based on information collected by the doctor when diagnosing the patient and prescription results prepared based on the information. In addition, in step S810, the digital therapeutic agent module can be generated based on information received from the patient (e.g., underlying factors, medical information, digital therapeutic agent comprehension ability, etc.).

[0089] Then, in step S820, a specific digital task can be generated based on the digital therapeutic module. In step S820, the digital therapeutic module can be generated by applying virtual parameters related to the patient's environment, behavior, emotions, and cognition to the pathogenesis mechanism and treatment hypothesis for myopia. This has been described in FIG. 5, so a detailed description will be omitted.

[0090] In this case, the digital task may be generated for at least one of the light environment setting, eye movement, body movement, self, safety and peace, enjoyment, and achievement modules. The explanation of the execution environment setting and the specific digital task for each module is the same as that described with reference to FIGS. 7a to 7g.

[0091] Next, a digital task can be provided to the patient (S830). In this case, the digital task may be provided in the form of a digital task related to behavior, emotion, or cognition, and in which the patient's compliance with the task, such as eye movement / body movement, can be monitored using a sensor, or in which the patient directly inputs the results of the execution.

[0092] Once the patient has completed the presented digital tasks, the patient's performance results for the digital tasks can be collected (S840). In step S840, the performance results for the digital tasks can be collected by monitoring the patient's compliance with the digital tasks or by the patient inputting the performance results for the digital tasks, as described above.

[0093] Meanwhile, in the digital application for myopia treatment according to an embodiment of the present invention, the step of generating a digital assignment and the step of collecting the patient's execution results for the digital assignment may be repeated multiple times using a feedback loop. In this case, the step of generating a digital assignment may generate a digital assignment for the patient for a current session based on the patient's digital assignment provided in a previous session and the collected execution result data for the patient's digital assignment.

[0094] As described above, according to the digital application for myopia treatment according to one embodiment of the present invention, the pathogenic mechanism of myopia and a treatment hypothesis are derived taking into account the neurohumoral factors of myopia, and based on this, digital tasks are presented to patients, who are then asked to perform the tasks under an appropriate light stimulation environment. The results are then collected and analyzed, thereby suppressing the progression of myopia and ensuring the reliability of treatment.

[0095] The above describes a digital device and application for myopia treatment according to one embodiment of the present invention only from the perspective of myopia treatment, but the present invention is not limited thereto, and digital treatment may be performed for diseases other than myopia in a manner substantially similar to that described above.

[0096] FIG. 9 is a flow chart illustrating a method for generating a digital challenge in a digital application for myopia treatment according to one embodiment of the present invention.

[0097] Referring to Figure 9, this is a detailed description of the process of generating a module and a specific digital task for treating myopia based on the pathogenic mechanism and treatment hypothesis for myopia (steps S810 and S820 of Figure 8) and the process of Figure 5.

[0098] In step S910, a pathogenic mechanism and a treatment hypothesis for myopia may be input. In this case, the pathogenic mechanism and the treatment hypothesis for myopia may be pre-derived through a literature search and expert review of systematic related clinical trials for myopia, as described above.

[0099] Then, neurohumoral factors of myopia can be predicted from the input pathogenic mechanism and treatment hypothesis (S920). In this case, the neurohumoral factors of myopia predicted through step S920 may be derived from IGF, cortisol, dopamine, etc. These neurohumoral factors have been specifically described in FIG. 5, so detailed description thereof will be omitted.

[0100] In step S930, a digital therapeutic module can be generated by associating virtual parameters with the predicted neurohumoral factors. Here, the virtual parameters act as a converter that converts the neurohumoral factors of myopia into a digital therapeutic module, and this is a process of establishing physiological relationships between the neurohumoral factors and environmental, behavioral, emotional, and cognitive factors, as shown in FIG. 5.

[0101] Next, a specific digital task can be generated based on the generated digital therapeutic module (S940). In this case, the specific digital task may be generated based on the light environment setting, eye movement, body movement, self, safety and peace, enjoyment, and achievement modules described in Figures 7a to 7g.

[0102] FIG. 10 is a flow chart illustrating the repeated execution of operations with feedback control in a digital application for myopia treatment according to one embodiment of the present invention.

[0103] 10, it is assumed that the generation of digital tasks and collection of execution results by a digital application for myopia treatment are executed N times. In this case, the myopia pathogenesis mechanism and treatment hypothesis can be input (S1010). Also, the digital tasks and execution result data provided in the previous execution can be received (S1020). If the currently executed execution is the first time, there is no previous data, so step S1020 can be omitted.

[0104] Next, a digital task for the current session can be generated based on the input disease mechanism and treatment hypothesis, the digital task provided in the previous session, and the execution result data (S1030), and the execution results of the user for the generated digital task can be collected (S1040).

[0105] In step S1050, it is determined whether the current number of times is equal to or greater than N. If the current number of times is less than N (NO), the process may return to step S1020 and repeat steps S1020 to S1040. On the other hand, if the current number of times is equal to or greater than N (YES), that is, if the process of generating digital tasks and collecting execution results has been performed N times, the feedback operation may be terminated.

[0106] FIG. 11 is a diagram showing the hardware configuration of a digital device for treating myopia according to one embodiment of the present invention.

[0107] Referring to FIG. 11, hardware 600 of a digital device for treating myopia according to an embodiment of the present invention may include a CPU 610, a memory 620, an input / output I / F 630, and a communication I / F 640.

[0108] The CPU 610 may be a processor that executes a digital program for myopia treatment stored in the memory 620, processes various data for digital myopia treatment, and performs functions related to the digital myopia treatment. That is, the CPU 610 can perform the functions of each component shown in FIG. 2 by executing a digital program for myopia treatment stored in the memory 620.

[0109] The memory 620 may store a digital program for myopia treatment. The memory 620 may also include data used for the digital myopia treatment, such as the patient's digital assignments, assignment execution results, and patient medical information, which are included in the database 050 described above.

[0110] A plurality of such memories 620 may be provided as necessary. The memories 620 may be volatile memories or non-volatile memories. As the volatile memories 620, RAM, DRAM, SRAM, etc. may be used. As the non-volatile memories 620, ROM, PROM, EAROM, EPROM, EEPROM, flash memory, etc. may be used. The examples of the memories 620 listed above are merely illustrative and are not limiting.

[0111] The input / output I / F 630 can provide an interface that connects input devices (not shown) such as a keyboard, mouse, or touch panel and output devices such as a display (not shown) to the CPU 610, enabling data to be sent and received.

[0112] The communication I / F 640 is configured to transmit and receive various data to and from a server and may be any device capable of supporting wired or wireless communication. For example, various data related to the digital behavior-based treatment described above may be received from a separately provided external server through the communication I / F 640.

[0113] In this way, a computer program according to an embodiment of the present invention may be embodied as a module that is recorded in the memory 620 and is processed by the CPU 610 to execute, for example, each functional block shown in FIG.

[0114] Although it has been described above that all components constituting the embodiments of the present invention are combined or operate in combination, the present invention is not necessarily limited to such an embodiment, and all components may be selectively combined and operate in one or more combinations within the scope of the present invention.

[0115] Furthermore, unless otherwise specified, the terms "comprise," "constitute," "have," and the like used above mean that the relevant element may be present, and should be interpreted as meaning that other elements may be included, rather than excluding other elements. All terms, including technical and scientific terms, unless otherwise defined, should be interpreted as having the same meaning as commonly understood by a person of ordinary skill in the art to which the present invention pertains. Commonly used terms, such as dictionary-defined terms, should be interpreted to be consistent with the contextual meaning of the relevant art, and should not be interpreted as having an ideal or overly formal meaning unless expressly defined in the present invention.

[0116] The above description is merely illustrative of the technical concept of the present invention, and various modifications and alterations may be made by those skilled in the art without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed herein are for illustrative purposes only, and do not limit the technical concept of the present invention. The scope of the present invention should be interpreted in accordance with the following claims, and all technical concepts within the scope of the claims should be interpreted as being within the scope of the present invention. [Explanation of symbols]

[0117] 000 Digital Myopia Treatment System 010 Digital Task Generation Department 020 Sensing Data Collection Unit 030 Execution Input Section 040 Results Analysis Department 050 Database 060 Security Department 600 Digital Myopia Treatment Device 610 CPU 620 Memory 630 Input / Output Interface 640 Communication I / F

Claims

1. 1. A digital system for treating myopia, comprising: at least one memory for storing a digital program; and at least one processor, wherein the at least one processor executes the digital program to providing, by a digital challenge generator, one or more first digital challenges to a first user who is a target of myopia treatment based at least in part on a plurality of first modules configured to correct an imbalance of a plurality of neuro-humoral factors for treating myopia, each of the first modules including one or more digital challenges to be followed by the first user; and collecting, by a results collection unit, results of the first user's performance of the one or more first digital tasks using a sensor.

2. 2. The digital system according to claim 1, wherein the one or more neurohumoral factors include at least one of an insulin-like growth factor (IGF), cortisol, or dopamine.

3. The digital system of claim 1 , wherein the plurality of first modules include at least one of a light environment setting module, an eye movement module, a body movement module, a fun module, an ego module, a safety and peace module, or an achievement module.

4. the plurality of first modules include the light environment setting module and the eye movement module; the light environment setting module includes one or more light environment setting tasks for promoting IGF secretion; The digital system of claim 3 , wherein the eye movement module includes one or more eye movement tasks for promoting IGF secretion.

5. The digital system of claim 4 , wherein the one or more light environment setting tasks for promoting IGF secretion include one or more digital tasks related to light environment control or light environment notification for the first user.

6. the one or more eye movement tasks for promoting IGF secretion include at least one of digital tasks related to eye movement, blinking, distance gaze, eye closure, or eye-related behavior control for the first user; 5. The digital system of claim 4, wherein the at least one processor is further configured to execute the digital program and collect the first user's performance on the one or more first digital tasks using eye tracking technology.

7. the plurality of first modules includes the body movement module; The digital system according to claim 3 , wherein the physical exercise module includes one or more physical exercise tasks for promoting IGF secretion and suppressing cortisol secretion.

8. 8. The digital system of claim 7, wherein the one or more physical exercise tasks for promoting IGF secretion and suppressing cortisol secretion include at least one of digital tasks for the first user relating to slow, easy physical exercise, abdominal exercises, rest, relaxation, deep breathing, meditation, or eye massage.

9. the plurality of first modules includes a fun module; The digital system of claim 3 , wherein the fun module includes one or more fun tasks for increasing dopamine secretion and suppressing cortisol secretion.

10. the plurality of first modules include at least one of the ego module and the safety and peace module; the ego module includes one or more ego tasks for suppressing cortisol secretion; 4. The digital system of claim 3, wherein the safety and well-being module includes one or more safety and well-being tasks for suppressing cortisol secretion.

11. the plurality of first modules includes the achievement module; The digital system of claim 3 , wherein the achievement module includes one or more achievement tasks for promoting dopamine release.

12. 12. The digital system of claim 11, wherein the one or more achievement tasks for promoting dopamine release include one or more digital tasks related to compensation for performing a digital task.

13. 10. The digital system of claim 1, wherein the at least one processor is further configured to execute the digital program to provide the one or more first digital challenges based on at least one of information received from the first user or input from a second user.

14. 14. The digital system of claim 13, wherein the input from the second user includes an execution result for a prescription by the second user for the first user.

15. The information received from the first user includes at least one of basal factors, medical information, or digital therapeutics literacy of the first user; the basic factors include the first user's activity level, heart rate, sleep, and diet; The medical information includes the first user's electronic medical record (EMR), family history, genetic vulnerability, and genetic susceptibility; 14. The digital system of claim 13, wherein the digital therapeutic comprehension capabilities include the first user's proximity and posture with respect to digital therapeutics and devices.

16. The digital system of claim 1 , wherein the plurality of first modules include one or more digital tasks derived based on physiological correlations between the one or more neurohumoral factors and parameters for treating myopia.

17. the at least one processor is further configured to execute the digital program to provide, by the digital challenge generator, one or more second digital challenges to the first user based at least in part on a plurality of second modules configured to regulate one or more neurohumoral factors to treat myopia based on the first user's performance results of the one or more first digital challenges, each of the second modules including one or more digital challenges to be followed by the first user; The digital system of claim 1 , wherein the one or more second digital challenges are different from the one or more first digital challenges.

18. 18. The digital system of claim 17, wherein the at least one processor is further configured to execute the digital program, transmit the first user's performance results for the one or more first digital tasks to a server, and generate the one or more second digital tasks based on the first user's performance results for the one or more first digital tasks.

19. The digital system of claim 1 , wherein the first plurality of modules includes one or more digital tasks derived in relation to environmental, behavioral, emotional, and cognitive parameters.

20. 1. A method of operating a digital system for treating myopia, comprising at least one memory storing a digital program, at least one processor, and at least one sensor, wherein the digital program is executed by the processor to: generating, by a digital challenge generator, one or more first digital challenges based at least in part on a plurality of first modules configured to correct an imbalance of a plurality of neurohumoral factors for treating myopia, and presenting the generated first digital challenges to a first user who is a target of myopia treatment, wherein each of the first modules includes one or more digital challenges to be followed by the first user; collecting, by a results collection unit, results of the first user's performance of the one or more first digital challenges using a sensor.

21. 21. The method of claim 20, wherein the first plurality of modules comprises one or more digital tasks derived in relation to environmental, behavioral, emotional, and cognitive parameters.

22. A computer-readable medium storing a program for causing a computer to execute the method of claim 20.

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