Systems and methods for determining an appropriate timing for modifying or changing an initial myopia control regimen

Abstract

This invention relates to a system for determining the appropriate timing for modifying or changing an initial myopia control program used by a myopic subject at an initial time. The system includes one or more memories and one or more processors; - the one or more memories include a database of available myopia control programs and data regarding the evolution of the effectiveness of each myopia control program with respect to at least one indicator; - the one or more processors are programmed to: determine a value of the indicator at a later time; determine the effectiveness of the initial myopia control program at that later time and the effectiveness of other myopia control programs in the database based on that value of the indicator at the later time; compare the effectiveness of the initial myopia control program determined for the later time with the effectiveness of the other myopia control programs in the database; and, when the effectiveness of the initial myopia control program at the later time is lower than the effectiveness of at least one of the other myopia control programs, determine the appropriate timing for modifying or changing the initial myopia control program based on the later time.

Description

Technical Field

[0001] This invention relates to a system and method for determining the appropriate timing for modifying or changing the initial myopia control program used by a myopic subject. Background Technology

[0002] Many documents describe devices and methods for controlling myopia development in subjects, especially children.

[0003] The myopia control program specifies the devices or products used to slow the progression of myopia in subjects, as well as the associated methods.

[0004] Myopia occurs when the eyeball is too long relative to the focusing ability of the cornea and lens. This causes light to focus at a point in front of the retina, rather than directly on its surface.

[0005] As a result, distant objects appeared blurry to nearsighted subjects.

[0006] Different types of devices and products are known to be used to slow the progression of myopia, such as ophthalmic lenses, contact lenses, or medications.

[0007] Furthermore, the various uses of these devices and products are known to be able to slow the progression of myopia. Different myopia control programs associated with one or more devices and / or products and their specific uses are therefore known to eye health professionals and implemented in an attempt to limit the progression of myopia in a given subject.

[0008] Each subject may respond differently to different myopia control programs. Therefore, different known myopia control programs may have different efficacies for different subjects. Furthermore, the efficacy of each myopia control program may vary over time and under other implementation conditions.

[0009] Therefore, it is necessary to monitor the effectiveness of the myopia control program implemented for the subjects to ensure that an effective myopia control program is always provided to the subjects. Summary of the Invention

[0010] In this context, one object of the present invention is to provide a system for determining the appropriate timing for modifying or changing the initial myopia control program used by a myopic subject.

[0011] According to the invention, this is achieved by providing a system for determining the appropriate timing for modifying or changing the initial myopia control scheme used by a myopic subject at an initial moment, the system comprising one or more memories and one or more processors.

[0012] - The one or more memories include a database of available myopia control programs and data on the evolution of the effectiveness of each myopia control program with respect to at least one metric.

[0013] -The one or more processors are programmed to:

[0014] Determine the value of the indicator at a later time.

[0015] The effectiveness of the initial myopia control program at that later time point, as well as the effectiveness of other myopia control programs in the database, are determined based on the value of the aforementioned indicator at that later time point.

[0016] The effectiveness of the initial myopia control program determined for the later time point is compared with the effectiveness of other myopia control programs in the database, and...

[0017] When the effectiveness of the initial myopia control program is lower than that of at least one of the other myopia control programs at the later time, the appropriate timing for modifying or changing the initial myopia control program is determined based on the later time.

[0018] Generally speaking, the system according to the invention can improve the overall strategy for limiting the development of myopia in subjects by modifying the initial myopia control scheme at an appropriate time without changing it to a different scheme, or by changing the initial myopia control scheme to a different myopia control scheme at an appropriate time and thus implementing two different myopia control schemes in sequence.

[0019] The initial myopia control program administered to the subjects is predetermined, and the system determines the appropriate time to modify or change the initial myopia control program to ensure that the subjects are always given the most effective myopia control program.

[0020] In the following text, the phrase "modify the initial myopia control program" will be used when the initial myopia control program is modified, such as by changing its implementation parameters, like the spherical power of the lenses, the medication dosage, or the duration of device wear. The phrase "change the initial myopia control program" will be used when the initial myopia control program is replaced with a different one. Therefore, when the phrase "modify or change the initial program" is used, it refers to the myopia control program implemented after a determined appropriate time, which could be either the initial myopia control program with modified implementation parameters or a different myopia control program.

[0021] Many different basic myopia control schemes are known and will be described below. The myopia control schemes considered below may include a single basic myopia control scheme or a combination of multiple basic myopia control schemes, i.e., implemented simultaneously. This is described in more detail below.

[0022] When the initial myopia control plan is modified, the myopia control plan before and after the appropriate time remains of the same type. That is, it can be the same single basic myopia control plan, as described below, or the same combination of two or more basic myopia control plans. For example, the use of drugs such as atropine is a basic myopia control plan, which can be combined with other basic myopia control plans (such as correcting accommodative lag, providing retinal stimulation, peripheral hyperopic astigmatism, or providing myopic astigmatism or corneal reshaping), i.e., used simultaneously.

[0023] When modifying the initial myopia control program, at least one implementation parameter of one of the basic myopia control programs of the initial myopia control program is modified. For example, the concentration or dosage of atropine is modified and / or the provided defocus is modified.

[0024] Generally, the implementation parameters of the myopia control program described here may include:

[0025] - The concentration, dosage, and frequency of intraocular drug instillation.

[0026] - Values ​​of the optical characteristics of ophthalmic lenses, such as spherical power, added power, cutoff level of wavelength filters, power distribution in the periphery, position and / or power of microlenses, size of scattering components, and duration of lens wear.

[0027] - Curvature distribution, duration of wear of lenses used for corneal reshaping.

[0028] When the initial myopia control program is changed, the type of myopia control program after that appropriate time differs from the type of the initial myopia control program. The change may include adding one or more basic myopia control programs to the existing initial myopia control program, or removing one or more basic myopia control programs from the existing initial myopia control program, resulting in a different myopia control program. The change may also include replacing at least one of the basic myopia control programs implemented in the initial myopia control program with at least one other basic myopia control program. Recent research has indeed shown that while many different initial myopia control programs are effective in reducing myopia progression in subjects, their effectiveness tends to decrease over time, or may produce a "rebound" effect after the initial reduction in myopia progression. During this "rebound" effect, myopia progression is accelerated compared to the progression without a myopia control program. Modifying or changing the implemented initial myopia control program is one way to ensure that subjects are always provided with a myopia control program that has satisfactory effectiveness.

[0029] The appropriate timing determined by the system according to the invention can be specifically the later moment itself or the timing determined based on the later moment under consideration.

[0030] In the embodiments described below, the effectiveness of the initial myopia control scheme determined for the later time point is compared with the effectiveness of other myopia control schemes in the database by comparing a graphical representation of the effectiveness of each considered myopia control scheme over time. In this case, the appropriate timing can be determined based on the moment when the graphical representations intersect.

[0031] In another embodiment, comparing the effectiveness of the initial myopia control scheme determined for the later time point with the effectiveness of other myopia control schemes in the database includes comparing these effectivenesses at multiple later time points and determining the appropriate time to modify or change the initial myopia control scheme when the effectiveness of the initial myopia control scheme becomes equal to the effectiveness of another myopia control scheme.

[0032] Other advantageous and non-limiting features of the system according to the invention may be as follows:

[0033] - The indicators include at least one of the following: the duration of use of the initial myopia control program and the subject's activity;

[0034] - The efficacy is estimated based on a predetermined relationship between efficacy and the indicator;

[0035] - The myopia control scheme includes one or more means for performing one or more of the following actions simultaneously:

[0036] - Correcting accommodative lag during near vision activities, for example by using lenses with positive spherical power or providing myopic defocus.

[0037] - Reduce regulatory lag

[0038] - Correcting peripheral hyperopic astigmatism, for example by using lenses with positive spherical power in the area corresponding to peripheral vision.

[0039] - Provide retinal stimulation, for example by using various light stimuli located in front of the subject's retina.

[0040] - Provide different contrasts in the subject's peripheral vision, for example, by using lenses with lower transmittance in the region corresponding to peripheral vision.

[0041] - Limiting the amount of red light entering the eye to reduce chromatic aberration, for example, by using specific filters.

[0042] - Provide the eyes with light of a specific wavelength to inhibit eye elongation.

[0043] - Provide dynamically changing light stimuli, such as flashing.

[0044] -Provide drugs to modulate muscarinic receptors in the retina and sclera.

[0045] - To reshape the cornea of ​​the eye to reduce refractive errors.

[0046] - By flattening the shape of the cornea, myopic defocus and / or optical aberrations in the peripheral retina are provided;

[0047] - The system includes one or more devices for monitoring subjects and / or the subjects' environment and / or the subjects' activities and / or one or more input devices for inputting data related to the subjects and / or their environment and / or their activities;

[0048] - The indicators include at least the activities of the subjects, and the system includes one or more devices for monitoring the activities of the subjects, such as: a clock, a timer, a viewing distance sensor, a lighting condition sensor, a motion sensor, a digital plan of the subjects' activities, and a questionnaire completed by the subjects;

[0049] - The one or more memories include a database in which at least one individual characteristic of the subject is recorded, and wherein the data on the effectiveness of each myopia control program with respect to the evolution of at least one indicator is determined taking into account the individual characteristics of the subject;

[0050] - The subject's individual characteristics are updated at a predetermined time, the data on the effectiveness of each myopia control program with respect to the evolution of at least one indicator are updated in consideration of the subject's updated individual characteristics, and the appropriate time to modify or change the initial myopia control program is determined based on the updated data;

[0051] - The one or more memories include a database in which at least one individual characteristic of the subject is recorded, and the one or more processors are programmed to preselect a set of myopia control programs in the database of available myopia control programs that are suitable for the subject based on the individual characteristics, determine their effectiveness, and compare them with the effectiveness of an initial myopia control program.

[0052] - The one or more memories include a database in which at least one individual characteristic of the subject is recorded, and the one or more processors are programmed to determine the initial myopia control scheme, the determination including:

[0053] - To determine the effectiveness of the myopia control program for each of a set of myopia control programs recorded in one or more memories, based on the individual characteristics of the subject.

[0054] - A predetermined relationship model is used, which is configured to provide the efficacy of the myopia control program in controlling the myopia of the subjects, taking into account the individual characteristics of the subjects;

[0055] - The one or more memories include a database in which at least one individual characteristic of the subject is recorded, and the one or more processors are programmed to determine the initial myopia control scheme, the determination including:

[0056] - A predetermined relational model is used, which is configured to consider the individual characteristics of the subjects to provide the efficacy of each myopia control program.

[0057] - Compare the determined efficacy, and

[0058] - The initial myopia control scheme is determined based on this comparison;

[0059] - The subject's individual characteristics include one or more of the following:

[0060] -The subject's personal history or physical characteristics

[0061] -Refraction characteristics of the subject

[0062] -The subject's biological characteristics,

[0063] -General health characteristics of the subjects,

[0064] -Characteristics related to the visual behavior of the subjects,

[0065] - The subject's postural characteristics;

[0066] - The indicators include at least the subject's activities, and the one or more processors are programmed to determine whether to modify the current myopia control scheme or change to another myopia control scheme, taking into account the subject's activities with respect to the visual task, the environment, and the characteristics of the subject's eye safety and protection.

[0067] -The one or more processors are further programmed to determine a modified initial myopia control scheme or an altered myopia control scheme for the subject;

[0068] - The system includes a device for transmitting a signal that indicates to the subject the appropriate time to modify or change the initial myopia control program.

[0069] Generally, the system according to the invention is programmed to implement the method according to the invention for determining the appropriate timing for modifying or changing the initial myopia control scheme used by a myopic subject at an initial time, the method comprising the following steps:

[0070] - Provides a database of available myopia control programs and data on the evolution of the effectiveness of each program with respect to at least one indicator.

[0071] - Determine the value of the indicator at a later time.

[0072] -The effectiveness of the initial myopia control program and the effectiveness of other myopia control programs in the database at that later time are determined based on the value of the aforementioned indicator at that later time.

[0073] - Compare the effectiveness of the initial myopia control program determined for the later time point with the effectiveness of other myopia control programs in the database, and

[0074] When the effectiveness of the initial myopia control program is lower than that of the alternative program at the later time, the appropriate time to modify or change the initial myopia control program is determined based on the later time. Attached Figure Description

[0075] The following description, given with reference to the accompanying drawings, will make the scope of the invention and the manner in which it is implemented clear. The invention is not limited to the embodiments shown in the drawings. Accordingly, it should be understood that where features mentioned in the claims are followed by reference numerals, such reference numerals are included only for the purpose of enhancing the comprehensibility of the claims and are in no way intended to limit the scope of the claims.

[0076] In the attached diagram:

[0077] - Figure 1 This is a schematic diagram of the system according to the present invention.

[0078] - Figure 2 This is a schematic diagram illustrating different steps of the method implemented by the system according to the present invention.

[0079] - Figure 3 This is a diagram comparing the effectiveness of two different myopia control programs over time. Detailed Implementation

[0080] Figure 1 The diagram shown is a schematic representation of a system according to the present invention. This system for determining the appropriate timing for modifying or changing the initial myopia control protocol used by a myopic subject at an initial moment includes one or more memories 100 and one or more processors 200.

[0081] As described below, the system according to the invention allows for the implementation of a method according to the invention for determining the appropriate timing for modifying or changing the initial myopia control scheme used by a myopic subject at an initial time, the method comprising the following steps:

[0082] - Provides a database of available myopia control programs and data on the evolution of the effectiveness of each program with respect to at least one indicator.

[0083] - Determine the value of the indicator at a later time.

[0084] -The effectiveness of the initial myopia control program and the effectiveness of other myopia control programs in the database at that later time are determined based on the value of the aforementioned indicator at that later time.

[0085] - Compare the effectiveness of the initial myopia control program determined for the later time point with the effectiveness of other myopia control programs in the database, and

[0086] When the effectiveness of the initial myopia control program is lower than that of the alternative program at the later time, the appropriate time to modify or change the initial myopia control program is determined based on the later time.

[0087] Therefore, the system and method according to the invention relate to determining the appropriate timing for modifying the initial myopia control program. This initial myopia control program is predetermined using any means or methods known to those skilled in the art. Such means / methods for determining the initial myopia control program are described, for example, in document WO2020 / 120595.

[0088] The one or more memories 100 include a database 101 of available myopia control programs and data 102 on the evolution of the effectiveness of each myopia control program with respect to at least one metric.

[0089] The data 102 regarding the evolution of the effectiveness of each myopia control program with respect to at least one indicator may be included in the same database 101 as the database containing available myopia control programs or in a different database.

[0090] Any known and available myopia control scheme can be considered in the system according to the invention.

[0091] To date, many different myopia control programs have been described and tested, and are currently being used to limit the progression of myopia in subjects.

[0092] Therefore, the following list is provided as an example only and is not exhaustive or restrictive.

[0093] The myopia control scheme may include a device for simultaneously performing one or more of the following actions. Each of the following actions and the device or product for performing it corresponds to a basic myopia control scheme:

[0094] a) Correct or reduce accommodative lag during near vision activities;

[0095] b) Correct peripheral hyperopic astigmatism or provide myopic astigmatism;

[0096] c) Provide retinal light stimulation by using multiple light stimuli located in front of the subject's retina;

[0097] d) By using lenses with lower transmittance in the region corresponding to peripheral vision, different contrasts in the subject's peripheral vision are provided;

[0098] e) Limit the amount of red light entering the eyes to reduce color difference in the eyes;

[0099] f) Provide the eyes with light of a specific wavelength to inhibit eye elongation;

[0100] g) Provide dynamically changing light stimuli, such as flickering, to reduce peripheral contrast on the retina by enabling / disabling diffuse elements according to the flickering frequency;

[0101] h) Provide drugs to modulate muscarinic receptors in the retina and sclera of the eye;

[0102] j) Corneal reshaping to reduce refractive errors;

[0103] k) Provides myopic defocus and / or optical aberrations in the peripheral retina by flattening the shape of the cornea.

[0104] Accommodative lag in the eye is defined as the difference between accommodative demand and accommodative response, which leads to residual refractive error.

[0105] Each myopia control program may include one or more basic myopia control programs as described above. In practice, these actions are performed using five myopia control devices:

[0106] - Ophthalmic lenses integrated into glasses

[0107] -Contact lenses worn directly on the subject's eyes

[0108] - Light sources, such as those used to reproduce everyday light indoors or to avoid emitting wavelengths that cause eye strain.

[0109] - Filters that cut off wavelengths that cause eye strain, such as blue light cutoff filters, may be integrated into lenses or included in digital screen filters.

[0110] -drug.

[0111] Each myopia control device can perform one or more of the actions listed above. Each myopia control program can use one or more myopia control devices.

[0112] For example, correcting or reducing accommodative lag in near vision is accomplished using a lens with a positive spherical power in the lens region used in near tasks. This can be a bifocal lens that includes a zone with positive spherical power in the near vision region of the lens, or a progressive lens with added power in the near vision region. An example of a bifocal lens used to control myopia could be a prism bifocal lens with two optical zones: a zone in the distance vision region (upper part of the lens) compensates for the eye's myopic refractive error, while a zone in the near vision region (lower part of the lens) reduces the accommodative demand for near vision and thus reduces accommodative lag.

[0113] Correcting peripheral hyperopic astigmatism or providing myopic astigmatism can be achieved by using lenses with positive spherical power in the periphery of the lens.

[0114] Custom-made lenses that provide retinal stimulation by using various light stimuli located in front of the subject's retina can be used. These custom-made lenses include:

[0115] - A refractive region having a first refractive power based on a prescription for correcting the refractive error of the eye; and

[0116] - Multiple, at least three optical elements, at least one of which has the optical function of not focusing the image onto the retina of the eye, thereby slowing the development of abnormal refractive errors in the eye;

[0117] Such lenses are described, for example, in document WO 2019166654.

[0118] Different contrasts in peripheral vision can be achieved by inserting scattering elements around the periphery of the lens.

[0119] Limiting the amount of red light entering the eye can be achieved using specific filters, such as filters integrated into the lens.

[0120] Limiting the amount of red light entering the eye can be achieved using specific filters, such as filters integrated into the lens.

[0121] Providing the eye with light of a specific wavelength to inhibit eye elongation can be achieved through luminescent therapy that involves exposing the eye to wavelengths that trigger dopamine receptors that regulate eye elongation.

[0122] Providing dynamically changing light stimuli can be achieved by exposing the eye to sinusoidal modulations of white light (targeting blue or yellow) according to time frequency.

[0123] Medications that modulate retinal and scleral muscarinic receptors can be delivered, for example, by topical atropine delivered directly to the subject's eye via eye drops. Other pharmacological approaches being tested for myopia control include topical timolol (a non-selective β-adrenergic antagonist) and oral 7-methylxanthine (7-MX) (an adenosine antagonist). The efficacy of atropine in myopia control has been demonstrated in several studies, such as Wu, P.-C., Chuang, M.-N., Choi, J., Chen, H., Wu, G., Ohno-Matsui, K., Jonas, JB, Cheung, CMG, 2019, Update in myopia and treatment strategy of atropine use in myopia control, Eye, 33, 3–13.

[0124] The effects of medications delivered to the eyes typically last for at least several hours. This is why medication use is considered simultaneous when implemented in conjunction with another myopia control program.

[0125] Corneal reshaping (also known as corneal orthokeratology) is performed by placing specially designed gas-permeable contact lenses into the subject's eyes. These contact lenses are typically flat and reshape the cornea to reduce refractive errors associated with nearsightedness.

[0126] Providing myopic defocus and / or optical aberrations in the periphery of the retina by flattening the shape of the cornea can be achieved, for example, by using the ortho-K scheme.

[0127] Any other myopia control schemes known to those skilled in the art can be considered and therefore included in the database 101 in the memory 100. All possible combinations of basic myopia control schemes can be considered and therefore included in the database 101 in the memory 100. Combinations of two basic myopia control schemes are typically considered, such as the use of a drug like atropine with any other myopia control scheme. Combination lenses that provide retinal stimulation by using positive spherical power zones in the near vision region can also be considered.

[0128] The one or more memories 100 of the system according to the invention also include data 102 regarding the evolution of the effectiveness of each myopia control scheme with respect to at least one indicator.

[0129] The effectiveness of the myopia control program is defined as the magnitude of its ability to produce the desired or anticipated results in controlling the wearer's myopia. Effectiveness can be quantified, for example, as a percentage value, with 100% representing the highest effectiveness and 0% representing the lowest effectiveness.

[0130] Typically, the efficacy of a myopia control program can be determined during clinical trials involving both control and test groups of subjects.

[0131] Subjects in the control group were given standard myopia correction methods, while subjects in the test group were given a myopia control program with undetermined efficacy.

[0132] For example, the control group consisted of children wearing classic ophthalmic single-vision lenses, while the test group was given a myopia control program, such as lenses that provide retinal stimulation through various light stimuli located in front of the subject's retina.

[0133] The evolution of myopia in each subject in both the control and test groups was tracked by determining the magnitude of myopia in their eyes at different points during the clinical trial. Axial length, or axial elongation (the difference between the current value and a reference value of the axial length), is an example of this magnitude representing the degree of myopia. The equivalent spherical power of the eye, or the absolute value of the equivalent spherical power, is another example. This magnitude representing the degree of myopia can also be determined, for example, based on the ideal refractive power correction required by the eye, measured in diopters.

[0134] Axial length (AL) is the distance between the anterior surface of the cornea and the fovea. It is typically measured using A-mode ultrasound or optical coherence biometry.

[0135] The equivalent spherical power is calculated by adding the spherical power to half the cylindrical power. For example, for eyeglasses with a power of -3.00 to -1.00 x 180, the equivalent spherical power is -3.00D + 1 / 2(-1.00D) = -3.00D - 0.50D = -3.50D equivalent spherical power.

[0136] Then, at each time t, the current average value representing the magnitude of the subject's myopia can be determined for each group.

[0137] The efficacy of the myopia control program obtained at time t can then be determined based on the difference between the current average of the magnitudes of myopia in the control and test groups at time t. The efficacy can be equal to the absolute value of this difference or equal to the ratio between this difference and the current average of the magnitudes of myopia in the control group subjects.

[0138] According to the present invention, the indicators include at least one of the following: the time spent using the initial myopia control program and the subject's activities.

[0139] The effectiveness of each myopia control scheme for a given value of the indicator can be estimated, for example, based on a predetermined relationship between the effectiveness and the indicator.

[0140] This relationship may be theoretical, empirical, or measured, and is based on previous clinical trial results. The relationship then provides the efficacy of each myopia control program as a function of at least one of the indicators. Such a relationship is described, for example, in the document WO 2020 / 120595.

[0141] Generally, the relationship can be based on the correlation between the indicator and the efficacy. This can be obtained through statistical processing of data including the determined efficacy and the corresponding value of the indicator. In particular, the relationship includes a mathematical function that links the indicator and the efficacy. Thus, instead of actually determining the actual values ​​of the eye state parameters used to determine the efficacy of the myopia control program, determining the value of the indicator is sufficient to determine the efficacy of the myopia control program.

[0142] In the first embodiment of the invention, described in more detail below, the indicator is the time the subject uses the initial myopia control program. In this case, the efficacy evolution with the indicator corresponds to the evolution of efficacy over time, which is recorded in the memory 100.

[0143] As mentioned earlier, this evolution can be achieved through a predetermined relationship linking the effectiveness of each myopia control program to the duration of its use, or by allowing measurements to determine the effectiveness after using the myopia control program for different durations.

[0144] In a second embodiment of the invention, described in more detail below, the indicators include the activities of the subjects. In this case, the memory 100 includes a table having values ​​for the effectiveness of each myopia control scheme for each activity in the list of possible activities. These values ​​are preferably predetermined by statistical methods. For example, it is an average of the effectiveness determined by measurements on different subjects.

[0145] In addition to the previously described databases 101 and 102, the one or more storage devices may include a database 103 in which at least one individual characteristic of the subject is recorded. This database may also include data related to the subject's environment.

[0146] In fact, according to the present invention, the system includes one or more devices 400 for monitoring subjects and / or the subjects' environment and / or the subjects' activities, and / or one or more input devices 500 for inputting data relating to the subjects and / or their environment and / or their activities.

[0147] Therefore, the system may include sensors for monitoring the subject's environment / activity, such as the time of day or night, the intensity / spectrum of ambient light, near or far vision tasks, etc. It may also include input devices for allowing the subject to input information about themselves and / or their environment and / or activities, such as through questionnaires. Figure 1 This is implemented, for example, in applications running on smartphones.

[0148] Data collected by monitoring device 400 or input device 500 is recorded in one or more memories 100 and provided to one or more processors 200.

[0149] In the case of the second embodiment described above, the system according to the present invention may specifically include one or more of the following devices for monitoring the activities of a subject: a clock, a viewing distance sensor, a lighting condition sensor, a motion sensor, a digital plan of the subject's activities, and a questionnaire completed by the subject.

[0150] In this case, the individual characteristics of the subjects can be taken into account to determine the data 102 regarding the evolution of the effectiveness of each myopia control program with respect to at least one indicator.

[0151] Furthermore, when determining the data 102 regarding the evolution of the effectiveness of each myopia control program with respect to at least one indicator, taking into account the individual characteristics of the subject, the individual characteristics of the subject can be updated at a predetermined time. Then, the data regarding the evolution of the effectiveness of each myopia control program with respect to at least one indicator is updated in consideration of the updated individual characteristics of the subject, and the appropriate time to modify or change the initial myopia control program is determined based on the updated data.

[0152] The individual characteristics of the subject may include one or more of the following:

[0153] - Personal history or physical characteristics of the subject, such as the number of myopic parents, age, sex, race, past or present optical equipment, pathology, changes in the rate of myopia progression, changes in the eye's biological pattern, and changes in the on / off sensory field of the retina (the subject's refraction characteristics, such as spherical or cylindrical refractive error, prism, strabismus, accommodative amplitude, near convergence point, dominant eye, and peripheral refractive error).

[0154] - The subject's biological characteristics, such as axial length, body shape, interpupillary distance, and corneal thickness;

[0155] - General health characteristics of the subjects, especially eye health characteristics, such as dry eyes;

[0156] - Characteristics related to the visual behavior of the subjects, such as the time spent completing near or far visual tasks, the activities performed, the daily time spent using optical equipment, the lighting environment, and the sleep time.

[0157] - The subject's postural characteristics, such as viewing distance, head or eye angle when performing certain tasks (e.g., reading, watching TV, working on a laptop).

[0158] These individual characteristics of the subject may also be taken into account in other steps of the method according to the invention described below.

[0159] The one or more processors 200 of the system according to the present invention are programmed to:

[0160] -i) determines the value of the indicator at a later time. Figure 2 (frame 10)

[0161] -ii) Determine the effectiveness of the initial myopia control program and the effectiveness of other myopia control programs in the database at that later time point based on the value of the aforementioned indicator. Figure 2 (frame 30)

[0162] -iii) Compare the effectiveness of the initial myopia control scheme determined for the later time point with the effectiveness of other myopia control schemes in the database. Figure 2 (frame 40), and

[0163] -iv) When the effectiveness of the initial myopia control scheme at the later time is less than the effectiveness of at least one of the other myopia control schemes ( Figure 2 Arrow A), determining the appropriate timing for modifying or changing the initial myopia control scheme based on the subsequent time ( Figure 2 (frame 50).

[0164] When the effectiveness of the initial myopia control program is higher than that of all other myopia control programs at the later time ( Figure 2 Arrow B), repeat steps i) to iii).

[0165] The one or more processors may also be programmed to determine an initial myopia control scheme before performing steps i) to iv) above. This determination or selection of the initial myopia control scheme can be achieved by any method known to those skilled in the art, and will not be described in detail below.

[0166] Typically, the one or more processors 200 are programmed to determine the efficacy of each available myopia control scheme, compare them, and select the scheme with the highest efficacy as the initial myopia control scheme for the subject. Preferably, when the one or more memories 100 include a database in which at least one individual characteristic of the subject is recorded, the one or more processors 200 are programmed to determine the initial myopia control scheme by: using a predetermined relational model configured to provide the efficacy of each myopia control scheme taking into account the individual characteristics of the subject, comparing the determined efficiencies, and determining the initial myopia control scheme as the one with the highest determined efficacy.

[0167] Furthermore, the one or more processors 200 can be programmed to:

[0168] -Determine a set of myopia control programs suitable for the subject, taking into account the subject's individual characteristics.

[0169] - A predetermined relational model is used, configured to provide the efficacy of each myopia control scheme in the set of myopia control schemes, taking into account the individual characteristics of the subjects.

[0170] - Compare the effectiveness of each myopia control scheme in the aforementioned set of myopia control schemes, and

[0171] - The initial myopia control scheme is determined based on this comparison.

[0172] Such a pre-defined relationship model is described, for example, in WO 2020 / 120595.

[0173] Generally, this pre-defined relationship model can be updated regularly based on real-time / periodic updates of new clinical trials and subject test results, so as to dynamically adjust the expected efficacy of each myopia control program based on this data.

[0174] The initial myopia control program was then determined to be the most effective myopia control program among all myopia control programs in the set of myopia control programs for the subject.

[0175] Furthermore, when the one or more memories include the database 103 in which at least one individual characteristic of the subject is recorded, the one or more processors may be additionally programmed to: preselect from the database 101 of available myopia control schemes ( Figure 2 (Box 20) A set of myopia control programs based on the individual characteristics are suitable for the subject, their effectiveness is determined, and compared with the effectiveness of the initial myopia control program.

[0176] The pre-selection step is performed before step ii), thereby determining the effectiveness or quantity of myopia control schemes in step ii). Therefore, the processor can execute step ii) more quickly. The processor 200 can, for example, be programmed to compare the individual characteristics with thresholds for those characteristics and select a pre-selected myopia control scheme based on that comparison.

[0177] For example, a child's individual characteristics might indicate that their cornea is particularly thin, meaning the child's corneal thickness is below a predetermined thickness threshold. The one or more processors are then programmed to remove a myopia control scheme using soft contact lenses from the list of available myopia control schemes for that child. All other myopia control schemes are pre-selected.

[0178] As another example, for a child with severe exotropia at near distances—that is, exotropia exceeding a predetermined exotropia threshold—the one or more processors are programmed to remove bifocal lenses and progressive multifocal lenses from the list of available myopia control options for this child. All other myopia control options are pre-selected.

[0179] The system according to the invention may further include means 300 for transmitting a signal that indicates to the subject the appropriate time to modify or change the initial myopia control program. This signal can be of any type: sonar signal, visual signal, tactile signal, notification on a parent's mobile phone. The signal may also indicate how to modify or change the initial myopia control program. In this case, the corresponding method according to the invention includes the step of transmitting a signal that indicates to the subject the appropriate time to modify or change the initial myopia control program. Figure 2 (60)

[0180] The system according to the invention can actually determine how to modify or change the initial myopia control scheme, that is, how to modify the implementation parameters of the initial myopia control scheme to adjust its effect on the subject, or change the initial myopia control scheme to another different myopia control scheme.

[0181] The system according to the invention is then further programmed to determine a modified or altered myopia control scheme.

[0182] Basically, since the effectiveness of the initial myopia control program and the effectiveness of other myopia control programs in the database have been determined for the later time point, the system can be programmed to determine the modified myopia control program as the one with the highest effectiveness at the later time point.

[0183] The aforementioned modification to the initial myopia control program means not changing the nature of the already implemented myopia control program, but rather modifying the implementation parameters of the initial myopia control program. This modification aims to increase the effectiveness or efficacy of the initial myopia control program. It may also aim to improve subject compliance with the myopia control program.

[0184] For example, the expected values ​​for eye condition parameters may not be achieved because the initial myopia control program provided by the practitioner or solution manufacturer is not being followed. In the case of eyeglass lenses, this could be due to insufficient daytime wear or not wearing them daily. One parameter that needs modification is the frame, to achieve a more stable or comfortable fit.

[0185] Depending on the modified myopia control plan, other possible modifications may include:

[0186] - For treatments related to correcting or reducing accommodative lag during near vision, increase the power or make the spherical power more corrective;

[0187] - For solutions that correct peripheral hyperopic astigmatism in the area corresponding to peripheral vision, increase the positive spherical power;

[0188] - For protocols that provide retinal stimulation by using multiple light stimuli located in front of the subject's retina, increase the number of microlenses and / or the range of positive focal length of the microlenses;

[0189] - For schemes that provide different and lower contrast in the peripheral vision of the subject, reduce the transmittance in the peripheral of the lens to increase contrast;

[0190] - For solutions that use specific filters to limit the amount of red light entering the eye in order to reduce chromatic aberration, reduce the amount of red light;

[0191] -For solutions that provide light with a specific wavelength to the eye to suppress eye elongation, increase wavelength transmission;

[0192] - For schemes that provide dynamically changing light stimuli (e.g., flashing), increase the frequency;

[0193] - For regimens that provide drugs to modulate muscarinic receptors in the retina and sclera, increase the dosage;

[0194] - Modify the shape of the lens used in the corneal orthokeratology procedure to provide a flatter base curve or at least a flatter central area.

[0195] The method according to the invention then includes determining a modified or altered myopia control scheme. Finally, the method may include the final step of implementing the modified or altered myopia control scheme. Figure 2 (frame 70).

[0196] In the first embodiment, the metric is the time the subject uses the initial myopia control program.

[0197] The data 102 regarding the evolution of the effectiveness of each myopia control program in database 101 includes, for example, a table or graphical representation of the evolution of the effectiveness of each available myopia control program over time.

[0198] Figure 3 The image shows an example of this evolution over time for two different myopia control schemes. Curve MC n This corresponds to the change in the effectiveness of the initial myopia control program over time. Curve MC n+1 The effectiveness of another myopia control program varies with the duration of use.

[0199] In this example of the first embodiment, the system includes an input device, such as a smartphone application, which is used in the first step to input at least one individual characteristic of the subject, as described above.

[0200] The one or more processors are programmed to preselect a set of myopia control schemes from the available myopia control schemes listed in database 101, the set being suitable for the subject based on the individual characteristics.

[0201] As already described, in an optional preparatory step, the one or more processors may be programmed to determine an initial myopia control scheme to be proposed to the subject.

[0202] Then, the system according to the invention can determine the value of the usage time at a later time, and based on the value of the usage time at the later time, determine the effectiveness of the initial myopia control scheme and the effectiveness of other myopia control schemes in the database at that later time.

[0203] These two steps, i) and ii), are achieved simultaneously here by determining the evolution of the effectiveness of the initial myopia control program over time and by determining the initial effectiveness of each other myopia control program when the time of use is zero. The effectiveness of all other myopia control programs is, in fact, equal to the effectiveness at any later time when the time of use is zero, because they have not yet been implemented.

[0204] Step iii) Comparing the effectiveness of the initial myopia control program determined for the later time point with the effectiveness of other myopia control programs in the database can be done for any later time point by comparing the evolution of the effectiveness of the initial myopia control program over time with the initial effectiveness of each other myopia control program. This can be advantageously achieved by comparing the initial myopia control program MC n Its efficacy compared to other myopia control programs MC n+1 MC n+2 MCn+3 MC n+4 The initial efficacy value is represented graphically to complete ( Figure 3 The appropriate time to modify or change the initial myopia control plan (T) 切换1 The value is determined when the effectiveness of the initial myopia control program reaches the value of the initial effectiveness of the other myopia control programs with the highest initial effectiveness among the available myopia control programs.

[0205] At the determined appropriate time T 切换1 The subsequent myopia control program can be identified as the second most effective myopia control program, MC. n+1 Alternatively, it can be determined by another method or apparatus, as described below.

[0206] In a simplified embodiment, the effectiveness of all available myopia control programs is calculated only once, and the appropriate timing for modifying or altering the current myopia control program can be determined from the outset as corresponding to each usage time of each successive program when the effectiveness of the current myopia control program decreases below the maximum effectiveness of another myopia control program. In this case, the at least one individual characteristic of the subject initially input is used to determine the appropriate timing for each successive program.

[0207] In different embodiments, the subject's individual characteristics are updated before determining the appropriate time to modify or change the current myopia control program. The updated individual characteristics are taken into account to determine the effectiveness of the available myopia control program. In a second embodiment, the indicators include at least the subject's activity.

[0208] The data 102 regarding the evolution of the effectiveness of each myopia control scheme in database 101 includes, for example, a table giving values ​​for the effectiveness of each myopia control scheme available for each activity in the activity list recorded in the system.

[0209] For example, for near-vision activities such as reading, the system's memory includes data indicating that the effectiveness of the first basic myopia control scheme is 45%. A second myopia control scheme, combining the first basic scheme with a second basic myopia control scheme, has an effectiveness of 36%, and a third myopia control scheme, combining the second basic myopia control scheme with a third basic myopia control scheme, has an effectiveness of 68%.

[0210] Conversely, for subjects engaging in activities involving movement, such as commuting, the second myopia control program showed a 22% efficacy rate, while the fourth basic myopia control program showed a 75% efficacy rate.

[0211] Of course, more than two basic myopia control schemes can be considered, and the corresponding tables can be multidimensional.

[0212] In this example of the second embodiment, the system includes an input device, such as a smartphone application, for inputting at least one individual characteristic of the subject in the step, as described above.

[0213] The one or more processors can then be programmed to preselect a set of myopia control schemes from the available myopia control schemes listed in database 101, the set being suitable for the subject based on the individual characteristics.

[0214] In an optional preparatory step, the system according to the invention can be programmed to determine an initial myopia control scheme based on the subject's initial activity, based on his / her most frequent activity, and / or by taking into account the subject's individual characteristics.

[0215] Taking into account the individual characteristics of the subjects, the initial myopia control program should be the one that is most effective for the initial or most frequent activity. Alternatively, it can be determined based on any known method.

[0216] In this example of the first embodiment, the system includes an input device, such as a smartphone application, for inputting at least one individual characteristic of the subject, as previously described.

[0217] The one or more processors are programmed to preselect a set of myopia control schemes from the available myopia control schemes listed in database 101, the set being suitable for the subject based on the individual characteristics.

[0218] In this second embodiment, the system includes means for monitoring the activity of the subject. Each time the system detects a change in activity, the one or more processors are programmed to compare the effectiveness of all available myopia control schemes or a scheme from a pre-selected set of myopia control schemes. If a myopia control scheme different from the initial or current myopia control scheme demonstrates higher effectiveness than the initial or current myopia control scheme, the moment the activity change is detected is determined as the appropriate time to modify or change the initial or current myopia control scheme.

[0219] Specifically, the device for monitoring the subject's activities may include the subject's electronic schedule and an input device for the subject to input their activities. Therefore, the timing of activity changes can be determined directly based on information from the electronic schedule.

[0220] The device for monitoring subject activity may include sensors for motion detection and artificial intelligence algorithms that can identify motion patterns and correlate them with activity.

[0221] In addition, the one or more processors can be programmed to determine the next myopia control scheme to be presented to the subject.

[0222] In the case of the second embodiment, they can be fundamentally programmed to propose myopia control schemes that are optimally effective for the subject's current or planned activities.

[0223] Alternatively, the one or more processors may be programmed to take into account the subject's activities with respect to the visual task, the environment, and characteristics of the subject's eye safety and protection to determine whether to modify the current myopia control scheme or change to another myopia control scheme.

[0224] For example, during near-vision activities, the eye is adjusting and may experience accommodative lag. Therefore, any approach designed to correct or reduce accommodative lag seems more suitable for such near-vision activities.

[0225] Conversely, this multifocal lens scheme is unsuitable for distance vision that does not require accommodation during the process. It is preferable to use multiple light stimuli positioned in front of the subject's retina to provide peripheral hyperopic defocus or retinal stimulation.

[0226] In this variant, the steps of determining the effectiveness of each myopia control program for each activity of the subject and comparing the effectiveness of all available myopia control programs are performed in the preparatory steps, so that the myopia control program with the highest effectiveness is directly associated with each activity. When the system detects a change in activity, it can directly compare the myopia control programs associated with the initial activity and the next activity and check whether the myopia control program needs to be modified or changed.

[0227] As a concrete example, the initial myopia control protocol implemented by the subject could be “adding a myopic defocus signal to a clear image.” This protocol corresponds to action c): providing retinal stimulation by using multiple light stimuli located in front of the subject’s retina, as listed above.

[0228] In this specific example, the initial myopia control program is implemented with a pair of active glasses that the subject wears most of the time. The subject is typically a child.

[0229] The system is integrated into a portable device, such as a smartphone, tablet, or smartwatch that controls active glasses. The system includes at least one device 400 for monitoring the subject, the subject's environment, and the subject's activities, as well as an input device for inputting data related to the subject and / or their environment and / or their activities. The system may include multiple monitoring devices. These may be integrated into the active glasses or the portable device.

[0230] The monitoring device specifically measures the time of day, the subject's movement, light intensity, and viewing distance.

[0231] The system operates continuously every day.

[0232] At the start of each day, the system detects when the subject wakes up. It automatically sends a message instructing the subject to use the initial myopia control plan, i.e., wear their glasses. The system also analyzes the subject's schedule and reminds them not to forget to bring their contact lenses to school, as they are going to play soccer that day. In other words, the system is programmed to determine at later moments whether to modify or change the current myopia control plan, or switch to another plan, taking into account the subject's activities related to visual tasks and their safety characteristics. Under these conditions, contact lenses can also be more effective than glasses.

[0233] While the subject was on their way to school, the smartwatch detected motion and activated the active glasses' option to reduce peripheral astigmatism. This corresponds to the appropriate moment to determine another modification or change to a second myopia control scheme.

[0234] Once inside the school, the system removes the option to reduce peripheral astigmatism from the active glasses. By measuring the viewing distance using sensors included in the active glasses, the system determines whether the current visual task is a near task. When a near task is detected, the system activates the "reduce accommodative hysteresis" option on the lenses of the active glasses, thus modifying the implemented myopia control scheme again.

[0235] When football time arrives, the smartwatch will send a signal to indicate to the subject that it is the appropriate time to temporarily switch the myopia control solution from glasses to contact lenses.

[0236] At the end of football training, the smartwatch will send a signal to indicate to the subject that it is the appropriate time to switch the myopia control scheme from contact lenses back to glasses.

[0237] On the way home after school, the smartwatch detected motion and activated the active glasses' option to reduce peripheral defocus.

[0238] At home, the system removes the option to reduce peripheral astigmatism from the active glasses. By measuring the viewing distance using sensors included in the active glasses, the system determines whether the current visual task is a near task. When a near task is detected, the system activates the "reduce accommodative hysteresis" option on the lenses of the active glasses, thus modifying the implemented myopia control scheme again.

[0239] Before going to sleep, the smartwatch will send a signal to indicate that it is time to change the myopia control plan by removing the glasses and putting atropine drops into the eyes.

[0240] As previously mentioned, in addition to considering the effectiveness of available myopia control programs to determine the appropriate time to modify or change the myopia control program, the system according to the invention can also consider the characteristics of the subject's current or future activities. The system may include a device for measuring ambient light intensity and activating a solar filter when needed, for example, above 1000 lux, or signaling the need for additional illumination, for example, below 10 lux. Upon detecting dynamic activity, the system can determine the need for contact lenses of protective goggles.

[0241] Generally speaking:

[0242] - When peripheral vision is needed, such as when moving at speeds exceeding 5 km / h, the "Reduce Peripheral Defocus" option is enabled.

[0243] - When close-range work activities (reading, gaming, smartphones) with a viewing distance of less than 30cm are detected, the "Reduce Accommodation Lag" option is enabled.

[0244] - For safety reasons, it is recommended to apply the contact lens during dynamic activities.

[0245] In a variant, this can be applied to the two embodiments described without using a graphical representation of the relationship between efficacy and indicators, by which the expected efficacy at multiple subsequent moments can be determined, and the appropriate timing for modifying or changing the initial myopia control program is determined when the expected efficacy of the initial myopia control program becomes equal to or less than the expected efficacy of another myopia control program.

Claims

1. A system for determining an appropriate time to modify or change an initial myopia control regimen used by a myopic subject at an initial time, the system comprising one or more memories and one or more processors, - the one or more memories comprising a database of available myopia control regimens and data on evolution of efficacy of each myopia control regimen as a function of at least one indicator, - the one or more processors being programmed to: determine a value of the indicator at a later time, determine, based on the value of the indicator at the later time, an efficacy of the initial myopia control regimen at the later time and an efficacy of other myopia control regimens in the database, compare the efficacy of the initial myopia control regimen determined for the later time with the efficacy of other myopia control regimens in the database, and determine, from the later time, the appropriate time to modify or change the initial myopia control regimen when the efficacy of the initial myopia control regimen at the later time is lower than the efficacy of at least one of the other myopia control regimens.

2. The system of claim 1, wherein, the indicator comprises at least one of: a time of use of the initial myopia control regimen and an activity of the subject.

3. The system of claim 1, wherein, the efficacy is estimated based on a predetermined relationship between the efficacy and the indicator.

4. The system of claim 1, wherein, the myopia control regimen comprises at least means for performing one or several of the following actions: - correcting or reducing accommodation lag during near vision activities; - correcting peripheral hyperopic defocus or providing myopic defocus by: - providing retinal stimulation; - providing different contrast in the periphery of the subject; - limiting the amount of red light entering the eye to reduce ocular chromatic aberration; - providing light with specific wavelengths to the eye to inhibit ocular elongation; - providing dynamic varying light stimuli, such as flickering; - providing drugs to modulate retinal and scleral muscarinic receptors; - reshaping the cornea of the eye to reduce refractive defects; - providing myopic defocus and / or optical aberrations in the periphery of the retina by flattening the shape of the cornea.

5. The system of claim 1, wherein, the system comprises one or more means for monitoring the subject and / or the environment of the subject and / or the activities of the subject and / or one or more input means for inputting data related to the subject and / or his environment and / or his activities.

6. The system of claim 1, wherein, the one or more memories comprise a database in which at least one individual characteristic of the subject is recorded, and wherein the data on evolution of efficacy of each myopia control regimen as a function of at least one indicator are determined taking into account the individual characteristic of the subject.

7. The system of claim 6, wherein, the individual characteristic of the subject is updated at predetermined times, the data on evolution of efficacy of each myopia control regimen as a function of at least one indicator are updated taking into account the updated individual characteristic of the subject, and the appropriate time to modify or change the initial myopia control regimen is determined based on the updated data.

8. The system of claim 1, wherein, The one or more memories comprise a database in which are recorded at least one individual characteristic of the subject, and the one or more processors are programmed to preselect, in the database of available myopia control schemes, a set of myopia control schemes that are adapted to the subject based on the individual characteristic, determine their efficacy, and compare with the efficacy of the initial myopia control scheme.

9. The system of claim 1, wherein, The one or more memories comprise a database in which are recorded at least one individual characteristic of the subject, and the one or more processors are programmed to determine the initial myopia control scheme, the determination comprising: - using a predetermined relationship model configured to provide the efficacy of each myopia control scheme taking into account the individual characteristic of the subject, - comparing the determined efficacies, and - determining the initial myopia control scheme based on the comparison.

10. The system of claim 8, wherein, The individual characteristic of the subject comprises one or more of: - a personal history or physical characteristic of the subject; - a refraction characteristic of the subject; - a biological characteristic of the subject; - a general health characteristic of the subject; - a characteristic related to the visual behavior of the subject; - a posture characteristic of the subject.

11. The system of claim 1, wherein, The indicator comprises at least the activity of the subject, and the one or more processors are programmed to determine to modify the current myopia control scheme or to change to another myopia control scheme taking into account the activity of the subject in relation to a visual task, the environment, the characteristics of the eye safety and protection of the subject.

12. The system of claim 1, wherein, The one or more processors are additionally programmed to determine the modified initial myopia control scheme or the changed myopia control scheme for the subject.

13. The system of claim 1, wherein, The system comprises means for emitting a signal indicating to the subject the determined appropriate moment to modify or change the initial myopia control scheme.

14. A method of determining an appropriate moment to modify or change an initial myopia control scheme used by a myopic subject at an initial time, the method comprising the steps of, - providing a database of available myopia control schemes and data on the evolution of the efficacy of each myopia control scheme as a function of at least one indicator, - determining a value of the indicator at a later time, - determining, based on the value of the indicator at the later time, the efficacy of the initial myopia control scheme and the efficacy of other myopia control schemes in the database at the later time, - comparing the efficacy of the initial myopia control scheme determined for the later time with the efficacy of other myopia control schemes in the database, and determining the appropriate moment to modify or change the initial myopia control scheme as a function of the later time when the efficacy of the initial myopia control scheme at the later time is lower than the efficacy of an alternative scheme.

15. A system for determining an appropriate moment to modify or change an initial myopia control scheme used by a myopic subject at an initial time, the system comprising: - a database of available myopia control schemes and data on the evolution of the efficacy of each myopia control scheme as a function of at least one indicator, - means for determining a value of the indicator at a later time, - means for determining, based on the value of the indicator at the later time, the efficacy of the initial myopia control scheme and the efficacy of other myopia control schemes in the database at the later time, - means for comparing the efficacy of the initial myopia control scheme determined for the later time with the efficacy of other myopia control schemes in the database, and - means for determining the appropriate moment to modify or change the initial myopia control scheme as a function of the later time when the efficacy of the initial myopia control scheme at the later time is lower than the efficacy of an alternative scheme.

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