SYSTEMS AND METHODS FOR DETERMINING MYOPIA CONTROL SOLUTIONS - Patent application
The system objectively determines myopia suppression solutions by analyzing personal and environmental factors, addressing the lack of uniformity in existing methods and improving myopia control efficacy.
Patent Information
- Application Number
- JP2024529822
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-12-10
- Filing Date
- 2022-12-08
- Publication Date
- 2024-12-26
AI Technical Summary
Existing myopia control solutions lack objectivity and uniformity in their application, as they are often determined by the experience and knowledge of eye care professionals, leading to varying effectiveness among subjects.
A system and method for objectively determining myopia suppression solutions based on personal and environmental factors, using a scoring system to identify the root cause of myopia progression and recommend appropriate solutions, including adjustments to existing treatments.
Enables personalized and effective myopia control by objectively assessing individual factors, ensuring that the most suitable solution is provided, thereby enhancing the efficacy of myopia management.
Smart Images

Figure 2024546594000001_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates to systems and methods for determining myopia control solutions for use by myopic subjects. [Background technology]
[0002] A number of publications describe devices and methods for inhibiting the progression of myopia in a subject, particularly in children.
[0003] Myopia occurs when the eyeball is too long compared to the focusing capabilities of the eye's cornea and lens, causing light rays to focus at a point in front of the retina rather than directly on its surface.
[0004] As a result, distant objects appear blurry to myopic subjects.
[0005] Various types of devices and products are known for slowing the progression of myopia, such as ophthalmic lenses, contact lenses, or medications.
[0006] Additionally, various uses of these devices and products for slowing myopia progression are known, and thus, a variety of myopia control solutions that associate one or more devices and / or products with their particular applications are known and implemented by eye care professionals who attempt to slow myopia progression in a given subject.
[0007] Each subject may respond differently to different myopia control solutions. Therefore, different known myopia control solutions may have different effectiveness for different subjects. Moreover, the effectiveness of each myopia control solution may change over time and depending on other implementation conditions.
[0008] Therefore, monitoring the effect and / or effectiveness of myopia control solutions administered to subjects is necessary to ensure that an efficient myopia control solution is always suggested to the subject.
[0009] The determination of the myopia control solution to be used by a subject and the modification of this myopia control solution are usually determined by an eyecare professional based on the eyecare professional's experience and knowledge, and therefore the modifications are performed in a non-uniform manner. Summary of the Invention [Problem to be solved by the invention]
[0010] In this regard, one object of the present invention is to provide an objective system for determining a myopia control solution to be used by a subject, the system being designed to help eye care professionals make decisions about selecting a myopia control solution to be used by a subject or modifying a myopia control solution already in use by the subject. [Means for solving the problem]
[0011] This is achieved according to the present disclosure by providing a system as claimed in claim 1 for determining a myopia control solution to be used by a subject.
[0012] In the following description and claims, a "myopia prevention solution" refers to - to slow or stop the progression of myopia in myopic subjects, to prevent emmetropic or slightly hyperopic subjects from becoming myopic, or in other words to keep the subjects in an emmetropic or slightly hyperopic state, - To delay the onset of myopia in premyopic subjects The apparatus and methods used are shown.
[0013] Subjects with pre-myopia are defined in the following paper, “IMI-Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiological Studies, Feb 2019.”
[0014] Thus, the devices and methods according to the present disclosure can be used with subjects who are either emmetropic, hyperopic, premyopic, or myopic.
[0015] In the following description, the expression "determining a myopia control solution" includes determining a first myopia control solution if the subject is not currently using a myopia control solution, or determining a modification of a first myopia control solution already being used by the subject.
[0016] In general, the system according to the present disclosure allows for determining a myopia control solution in an objective manner depending on the subject, taking into account the particular cause of myopia in the subject.
[0017] In the following, the determination of the myopia control solution is - changing from a non-myopia-control solution to a myopia-control solution, i.e. determining the first myopia-control solution; - adjusting the myopia control solution currently used by the subject, for example by modifying the implementation parameters of this myopia control solution, such as the addition value, e.g. the sphere value of the lens, the dose of the drug, the duration of wearing the device, etc. - A change in myopia control solution, where the myopia control solution used by the subject is replaced with a different myopia control solution. Thus, when the term "modification" is used, it means that the myopia control solution originally used by the subject is either retained with modified implementation parameters or replaced with another myopia control solution.
[0018] Many different basic myopia control solutions are known and are described in the following description. The myopia control solutions considered below may comprise one basic myopia control solution or several basic myopia control solutions combined, i.e. implemented simultaneously.
[0019] When the first myopia control solution is merely adjusted, the myopia control solution remains the same type. The myopia control solution can be the same single basic myopia control solution or the same combination of two or more basic myopia control solutions, as described below. At least one implementation parameter of one of the basic myopia control solutions of the first myopia control solution is adjusted. For example, the concentration or dosage of atropine is modified, and / or the defocus that is brought about is adjusted.
[0020] Generally, the implementation parameters of the myopia control solutions described herein are: - Drug concentration, dosage, and frequency of administration; values of the optical characteristics of the ophthalmic lens, such as sphere, addition, cut-off level of the wavelength filters, power distribution in the periphery, position, density, size, geometry and / or power of the microlenses, size, density and / or strength of the scattering components, duration of wearing the ophthalmic lens, - Curvature profile, fitting, duration of lens wear for corneal reshaping, etc. may include.
[0021] When the myopia control solution is changed, the type of myopia control solution used is also changed. The change may include replacing at least one of the basic myopia control solutions implemented in said first myopia control solution with at least one other basic myopia control solution. The change may include adding one or more basic myopia control solutions to the first myopia control solution already used or removing one or more basic myopia control solutions from the first myopia control solution already used to obtain a different myopia control solution.
[0022] Other advantageous and non-limiting features of the system according to the present disclosure are recited in claims 2-14.
[0023] The present disclosure also relates to a method according to claim 15 for determining a myopia control solution to be used by a subject.
[0024] The following description, which refers to the accompanying drawings, will make clear what constitutes the present disclosure and how it can be achieved. The present disclosure is not limited to the embodiments shown in the drawings.
[0025] Thus, when features recited in a claim are followed by reference signs, it should be understood that such signs are included solely for the purpose of enhancing the comprehension of the claim and do not limit the scope of the claim. [Brief description of the drawings]
[0026] [Figure 1] FIG. 1 is a schematic diagram of a system. [Diagram 2] 2 is a schematic diagram of various steps of a method performed by the system of FIG. 1; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] FIG. 1 shows a schematic diagram of a system 60 .
[0028] As described below, the system 60 includes one or more memories 10 and one or more processors 20, the one or more memories 10 being - values of personal characteristics of said subjects; - values of environmental parameters relating to the conditions of use of the myopia prevention solution by said subject; in memory, The one or more processors 20 include: i) determining an individual score for the subject depending on the values of the personal characteristics of the subject, the individual score being associated with a role of the personal characteristics in causing myopia in the subject; ii) determining an environmental score for the condition of use of the myopia prevention solution by the subject as a function of the value of the environmental parameter, the environmental score being associated with a role of the environmental parameter in causing myopia in the subject; iii) determining the myopia control solution for the subject based on the individual and environmental scores; and The device is programmed to:
[0029] The present disclosure also relates to a method for determining a myopia control solution to be used by a subject, the method comprising the steps of: - providing values of personal characteristics of said subject and values of environmental parameters related to the conditions of use of said myopia prevention solution by said subject; - determining an individual score for the subject depending on the values of the personal characteristics of the subject, the individual score being associated with a role of the personal characteristics in causing myopia in the subject; - determining an environmental score for the condition of use of the myopia prevention solution by the subject as a function of the value of the environmental parameter, the environmental score being associated with a role of the environmental parameter in causing myopia in the subject; - determining the myopia prevention solution for the subject based on the individual score and the environmental score; The present invention relates to related methods, including
[0030] Indeed, determining a myopia control solution may comprise determining a first myopia control solution or determining a modification of a myopia control solution currently used by the subject.
[0031] If the subject does not initially use any device or method as a myopia control solution, a first myopia control solution is determined in step iii), if the subject initially uses a myopia control solution, the modification includes determining an adjusted or modified myopia control solution for the subject.
[0032] The systems and methods of the present disclosure allow for identifying the root cause of myopia progression for a given subject through relevant measurements and data collection, and then allowing for a first myopia control solution to be recommended for the subject based on the root cause.
[0033] The systems and methods of the present disclosure also allow for determining and taking into account a threshold of myopia progression within a given period during which the first myopia control solution is implemented.
[0034] Subjects are re-examined after a given period of time and the underlying cause of myopia progression is again identified through relevant measurements and data collection.
[0035] If a subject's myopia progression is faster than expected, the systems and methods disclosed herein enable identifying why a first myopia control solution did not work and recommend modifications to the first myopia control solution accordingly.
[0036] The system and method allow for determining a myopia control solution, which is recommended to an eye care professional. During the determination of the solution, the system and method may also sort a set of available myopia control solutions stored in the one or more memories. An ordered list of available solutions may be created by sorting from most recommended to least recommended.
[0037] Any known available myopia prevention solution may be considered in a system according to the present disclosure.
[0038] To date, many different myopia control solutions have been described, tested, and are currently in use to reduce myopia progression in subjects.
[0039] Therefore, the following list is provided by way of example and is not intended to be exhaustive or limiting.
[0040] In the following, the myopia control solution includes one or more devices for performing one of the following operations or several of the following operations simultaneously:
[0041] Each of the following operations: - correcting or reducing accommodation delays during near vision activities; - correcting peripheral hyperopic defocus or providing myopic defocus; - providing retinal stimulation; - providing different contrasts to the subject's peripheral vision; - ocular chromatic aberration, limiting the amount of light having a particular wavelength entering a subject's eye in order to reduce exposure of the retina to the particular wavelength; - providing light having a specific wavelength to the eye to inhibit eye elongation; - providing dynamically changing light stimuli; - Providing an agent for modulating retinal and scleral muscarinic receptors; - reshaping the cornea of the eye to reduce refractive error; - reshaping the cornea of the eye to induce an extended depth of focus; - flattening the shape of the cornea to produce myopic defocus and / or optical aberrations in the retinal periphery; - reinforcing or strengthening the sclera of the eye and / or the cornea of the eye and / or the choroid of the eye; represents a basic myopia control solution.
[0042] The ocular accommodative lag is defined as the difference between accommodative demand and accommodative response, resulting in residual refractive error.
[0043] In fact, these actions are the basis for five types of devices for controlling myopia, namely: - ophthalmic lenses integrated into spectacles, - a contact lens placed directly on the subject's eye; - a light source, for example to reproduce normal light indoors or to avoid the emission of wavelengths involved in eye elongation, - a device for correcting the amount of some of the colors entering the eye, which are involved in eye elongation; - Pharmaceuticals This is performed using
[0044] Each device for controlling myopia may perform one or more of the actions listed above. Each myopia control solution may use one or more devices for controlling myopia.
[0045] The device may include, inter alia, a medicinal eye drop delivery device, a multifocal eyeglass lens, a microstructured eyeglass lens, a corneal correction lens or a multifocal soft contact lens, and / or a device for providing at least one retinal stimulus using a light stimulus positioned in front of the retina of the subject's eye.
[0046] For example, correction or reduction of accommodative lag during near vision activities is accomplished using a lens with a positive spherical power in the region of the lens used for near vision tasks, which may be a bifocal lens including a zone with a positive sphere located in the near vision region of the lens or a progressive lens with an add power in the near vision region.
[0047] An example of a multifocal lens used to control myopia can be a prismatic bifocal lens or progressive addition lens (PAL) with two optical zones: the zone located in the distance vision region (top of the lens) compensates for the myopic refractive error of the eye, while the zone located in the near vision region (bottom of the lens) reduces the accommodative demand for near vision and therefore the accommodative lag.
[0048] Correcting peripheral hyperopic defocus or providing myopic defocus can be accomplished by using a lens with positive spherical power at the periphery of the lens.
[0049] A customized lens using a plurality of light stimuli positioned in front of the retina of a subject's eye, comprising: - a refractive zone having a first refractive power according to a prescription for correcting anomalous refraction of the eye; a plurality of at least three optical elements, at least one optical element having an optical function that does not focus an image on a retina of the eye to slow the progression of anomalous refraction of the eye; Lenses may be used, including
[0050] Providing different contrast in peripheral vision can be achieved by inserting scattering elements in the periphery of the lens.
[0051] Modifying the amount of some colors, for example red light, that enters the eye can be achieved using specific filters, for example integrated into the lens or digital screen filters.
[0052] Providing light having specific wavelengths to the eye to inhibit eye elongation can be accomplished by phototherapy, which involves exposing the eye to light having wavelengths that trigger dopamine receptors that regulate eye elongation.
[0053] The presentation of dynamically varying light stimuli can be achieved by exposing the eye to white light that is sinusoidally modulated according to a temporal frequency.
[0054] Providing an agent to modulate retinal and scleral muscarinic receptors can be accomplished, for example, by providing topical atropine delivered directly to the subject's eye using eye drops. Other pharmacological approaches that have been attempted to control myopia include topical timolol, a nonselective beta-adrenergic antagonist, and oral 7-methylxanthine (7-MX), an adenosine antagonist, eye drops containing copper, a cofactor for lysyl oxidase activity.
[0055] The effect of the drug that may be administered to the eye typically lasts for at least several hours, which is why the use of the drug is considered concurrent when administered in conjunction with one or more other underlying myopia control solutions.
[0056] Corneal reshaping, also known as orthokeratology, is performed by fitting a specially designed gas-permeable contact lens to a subject's eye. The contact lens is typically flattened to reshape the cornea of the eye to reduce myopic refractive error. The contact lens is typically worn overnight so that when the contact lens is removed in the morning, the cornea has been reshaped or corrected.
[0057] Reducing myopic defocus and / or optical aberrations in the retinal periphery by flattening the shape of the cornea can be achieved, for example, by using orthokeratology.
[0058] Homatropine eye drops can be used to reinforce or strengthen the sclera of the eye and / or the choroid of the eye as described in “The effect of adrenergic and cholinergic agents on anterior scleral thickness and Schlemm's canal in young healthy adults”, Sander et al. published in Investigative Ophthalmology & Visual Science (IOVS) April 2014,Vol.55,558 (https: / / iovs.arvojournals.org / article.aspx?articleid=2271190&resultClick=1). Cross-linking of corneal collagen by activating riboflavin with UV-A light has been used clinically to increase corneal stiffness as described in “Differential Regional Stiffening of Sclera by Collagen Cross-linking“ by Gawargious and al.in Investigative Ophthalmology & Visual Science July 2019,Vol.60,4359.(https: / / iovs.arvojournals.org / article.aspx?articleid=2746058&resultClick=1).
[0059] Pharmacological treatments, such as IVMED-85® (copper-based) from iVeena Delivery Systems, Inc., can be used to flatten the cornea and reinforce the sclera, for example, as mentioned on the Review of Myopia Management website (https: / / reviewofmm.com / advancing-myopia-therapy-with-ivmed-85).
[0060] In effect, the one or more memories 10 contain a database of available myopia control solutions.
[0061] All possible combinations of basic myopia control solutions may be taken into account and therefore included in the database in the memory 10 .
[0062] Usually, combinations of the two basic myopia control solutions are considered, such as the use of a drug such as atropine in combination with any other myopia control solution. Lens combinations that provide retinal stimulation with a positive spherical zone in the near vision region can also be considered.
[0063] In the system of the present disclosure, the one or more memories 10 have in memory one or more values of personal characteristics of the subject.
[0064] The values of the personal characteristics of the subject stored in the one or more memories may, for example, be the following personal characteristics: - personal, family or historical characteristics of the subject, such as, but not limited to, the number of myopic parents and myopic siblings, if any, and / or the level of myopia of the subject's parents, the number of alleles in the subject's genotype that indicate risk of myopia, the subject's sex, the subject's age, IQ, and / or the subject's general academic performance, the subject's season and / or date of birth, the subject's ethnicity and / or geographic origin, - ocular biometry parameters of at least one eye of the subject, such as, but not limited to, eye shape, axial length, anterior chamber depth, choroidal thickness, lens thickness, corneal shape or thickness, subject size, interpupillary distance; - ocular biomechanical parameters of at least one eye of the subject, such as, but not limited to, corneal stiffness, scleral stiffness, - ophthalmoscopic characteristics of the subject, such as, but not limited to, central refraction, peripheral refraction, heterophoria, contrast sensitivity, color sensitivity, spherical or cylindrical refraction of the eye, prism, amplitude of accommodation, near point of convergence, dominant eye, peripheral refraction; - The subject's medical history, including but not limited to age at onset of myopia, previous vision correction devices used, medical conditions, changes in the rate of myopia progression, changes in the eye's biological patterns, changes in on / off receptive fields on the retina, and dry eyes. Contains one or more values from.
[0065] The values of one or more personal characteristics stored in the system may be normalized values. An example of a set of possible values of personal characteristics and corresponding normalized values is shown in Table 1 below.
[0066] [Table 1]
[0067] The one or more memories 10 also have in memory one or more values of environmental parameters related to the conditions of use of the myopia prevention solution by the subject.
[0068] Said values of the environmental parameters are the following environmental parameters of the subject: - characteristics relating to the visual behaviour of the subject, such as the time spent to achieve a near task, e.g. expressed in hours, and / or the working distance for a near task, e.g. expressed in diopters, - time spent outdoors and / or indoors, - type of environment, such as, but not limited to, rural or urban environment; - Country and / or city of residence and / or type of residence, such as, but not limited to, private home, apartment, etc. - activities and / or lifestyle habits, - the type of lighting used while performing near vision tasks, such as, but not limited to, bright or dim light, the usual time of day when using the optical device, and the lighting environment; - the time spent using the myopia control solution, hereinafter also referred to as usage time, - reading posture including viewing distance, the reading distance between the eyes and the smartphone, book or notebook, head or eye tilt when performing some specific tasks such as reading, watching television, working on a laptop, head tilt, document tilt, relative position of the document to the head, etc. - the level of undercorrection of said myopia, - accommodation parameters, such as, but not limited to, level of accommodative delay, amplitude of accommodation, and accommodative function; - Binocular vision parameters, such as, but not limited to, near vision heterophoria, fusion width, stereopsis, Lens use parameters, such as, but not limited to, the distance or near vision zone of a progressive or bifocal lens used for near vision tasks; Contains one or more values from.
[0069] The values of one or more environmental parameters stored in the system may be normalized values. An example of a set of possible values of environmental parameters and corresponding normalized values is shown in Table 2 below.
[0070] [Table 2]
[0071] The system 60 according to the present disclosure includes any necessary device for obtaining the values of the personal characteristics and environmental parameters. In particular, the system 60 may include any measuring device adapted to measure one or more values of the personal characteristics, such as ocular biometric parameters of at least one eye of the subject, ocular biomechanical parameters, and / or optometric characteristics of the subject.
[0072] Objective or subjective evaluation criteria may be considered, for example, to measure ocular shape, axial length, anterior chamber depth, choroidal thickness, lens thickness, corneal shape, corneal stiffness, and scleral stiffness of at least one eye of the subject.
[0073] A system 60 according to the present disclosure may also include an input device 40 for manually inputting data into the one or more memories, or a communication device for retrieving data from a remote location.
[0074] Some of the values may be obtained by having the subject complete a questionnaire and manually entering values into the one or more memories.
[0075] The subject's personal characteristics and environmental parameters taken into account in the system are selected for reasons that may play a role in causing myopia and / or affect the effectiveness of currently used myopia prevention solutions in the subject's eyes.
[0076] The personal characteristics listed above can be considered as the intrinsic causes of myopia, whereas the environmental parameters define the extrinsic causes of myopia.
[0077] According to the present disclosure, the one or more processors 20 of the system 60 are programmed to perform steps i), ii), and iii) described above.
[0078] Steps i) and ii) In step i), the one or more processors are programmed to determine an individual score for the subject depending on the values of the personal characteristics of the subject, the individual score being associated with a role of the personal characteristics in causing myopia in the subject.
[0079] In particular, the values of the subject's personal characteristics are incorporated into said personal score, such that said personal score represents the overall weight of the internal causes causing myopia in the subject's eye, said personal score corresponding to the subject's internal root cause index.
[0080] In step ii), the one or more processors are programmed to determine an environmental score for the conditions of use of the myopia prevention solution by the subject depending on the value of the environmental parameter, the environmental score being associated with a role of the environmental parameter in causing myopia in the subject.
[0081] In particular, the values of the environmental parameters are incorporated into an environmental score such that said environmental score represents the overall weight of the external causes causing myopia in the subject's eye, said environmental score corresponding to the subject's external root cause index.
[0082] The individual score represents the role of said personal characteristics in causing myopia and / or in influencing the effectiveness of the subject's currently used myopia prevention solution. An increasing individual score indicates an increasing role of personal characteristics in causing the subject's myopia. An increasing individual score indicates an increasing role played by internal causes.
[0083] The environmental score represents the role of said environmental parameters in causing myopia and / or in influencing the effectiveness of the subject's currently used myopia prevention solution. An increase in the environmental score indicates an increasing role of the environmental parameters in causing myopia in the subject. An increase in the environmental score indicates an increasing role played by external causes.
[0084] In practice, the one or more processors 20 are programmed to calculate the personal score and the environmental score as an average or weighted average of the values of the personal characteristics or the values of the environmental parameters, respectively.
[0085] If the personal and environmental scores are determined as weighted average values of the values of the personal characteristics or the environmental parameters, respectively, the weights taken into account can be determined in various ways, such as by machine learning techniques or classical epidemiological statistical methods.
[0086] The weights of all personal features and all environmental parameters may be set to 1, for example.
[0087] The personal and environmental scores are determined as the average values of said personal characteristics and environmental parameters, respectively, e.g. as the sum of the normalized values of the personal characteristics or environmental parameters divided by the number of values taken into account.
[0088] The weights can be predetermined and fixed, or can be updated for each new calculation for the same subject by using machine learning techniques and including all of the subject's past data.
[0089] The weights may be updated based on machine learning techniques performed on a database containing data collected from all subjects or from a predefined population of subjects.
[0090] Step iii) In step iii), the one or more processors 20 are programmed to determine the myopia control solution for the subject based on the individual and environmental scores.
[0091] This is accomplished, for example, by using a predetermined and fixed relationship that associates myopia control solutions with the individual and environmental scores.
[0092] The determined myopia control solution is displayed, for example, on the screen 50 of the system 60 (FIG. 1).
[0093] Generally, system 60 includes a device for emitting a signal indicating to an eye care professional the determined myopia control solution.
[0094] In an embodiment, the one or more processors 20 are programmed to determine a final score based on the personal score and the environmental score, and to determine the modification of the myopia control solution taking the final score into account.
[0095] For example, the one or more processors may be programmed to calculate the final score as a ratio of the individual score to a sum of the individual score and the environmental score.
[0096] The final score indicates whether the personal characteristics and environmental parameters play a major role in causing myopia and / or influencing the effectiveness of the myopia control solution currently used by the subject. In other words, the final score indicates whether the root cause of the subject's myopia is mainly internal or mainly external. The final score corresponds to the root cause index.
[0097] The one or more memories 10 of the system 60 may, for example, include a database that associates each possible value of the final score with a myopia control solution.
[0098] This database provides the relationship between the modification of the myopia control solution and the individual and environmental scores.
[0099] An example of such a database is shown in Table 3.
[0100] [Table 3]
[0101] In embodiments, the final scores in Table 3 may be modified depending on the dose used. For example, for atropine, the final score may be 1 if a high dose is used and 0.7 if a low dose is used.
[0102] The one or more processors 20 of the system 60 are then programmed to determine a myopia control solution by determining which myopia control solution is associated with the value of the final score calculated in the database.
[0103] In step iii), the one or more processors 20 return the myopia control solution recommendation to the eye care professional, which is displayed, for example, on the screen 50.
[0104] This myopia control solution takes into account the underlying cause of myopia which is reflected in the final score.
[0105] The one or more processors are programmed to establish the relationship between the modification of the myopia control solution and the final score using a machine learning algorithm, for example a Bayesian model.
[0106] For example, with a database containing N entries, each entry containing values of an individual score and an environmental score and the solution used, a machine learning algorithm can be trained to provide a solution by establishing a function that links the individual score and the environmental score with the myopia control solution used, i.e., f(individual score, environmental score) = final score (myopic control solution).
[0107] In another embodiment, the one or more processors are programmed to update the relationship between the myopia control solutions and the final score using a machine learning algorithm.
[0108] An initial relationship may be established initially based on scientific theory and clinical results, but as more and more cases are recorded in the system, the myopia control solutions determined and used are recorded, and the subsequent results are recorded, weighted and entered into the calculation. Over time, a database is obtained that can be used to train machine learning algorithms. This database allows the improvement of the range of final scores associated with each myopia control solution, and allows its gradual evolution according to the population's lifestyle and / or based on geographic location. It also allows the system to be updated when new generations of myopia control solutions are introduced, which may be more efficient than previous generations.
[0109] The first values of the personal characteristics and environmental parameters may be determined during a first visit to an eye care professional, and a first value of the final score is determined and taken into account by the system for determining a first myopia control solution to be used by the subject.
[0110] Future values of the personal characteristics and environmental parameters may then be determined during future visits to an eye care professional. As the subject's personal characteristics and environmental parameters may change over time, a future value of the final score is determined. The first myopia solution used by the subject may then be modified taking into account this future value of the final score. The system then determines such modifications. The update of the final score and subsequent modifications of the myopia control solution currently used by the subject may be performed at certain time intervals.
[0111] In particular, if the myopia correction currently being used by the subject does not have the predicted efficiency, determining the individual and environmental scores as well as the final score allows for a determination of whether the underlying cause of this lack of efficiency is attributable to internal or external causes.
[0112] More precisely, by determining a subject's future personal and environmental scores and comparing these scores with the subject's previous personal and environmental scores, it is possible to determine which scores have changed primarily and, therefore, whether the underlying cause of the inefficiency of the myopia control solution is primarily internal or external.
[0113] In summary, if the inefficiency of the myopia control solution is mainly due to internal causes, it indicates that the currently used myopia control solution is not suitable for the subject and should be changed to another different myopia control solution. If the insufficiency of the myopia control solution is mainly due to external causes, it indicates that the lack of efficiency can be linked to the subject's lack of compliance with the use of the myopia control solution or with the implementation parameters of the myopia control solution that are not suitable. The implementation parameters of the currently used myopia control solution should be modified to increase compliance and / or effectiveness.
[0114] In another embodiment, the one or more processors 20 are programmed to use a decision tree to determine which is the underlying cause of the subject's myopia and to determine a first myopia control solution or a modification of a currently used myopia control solution.
[0115] In another embodiment, the processor or processors 20 are programmed to use a Bayesian model or other machine learning algorithm to determine which underlying cause is most likely and to determine the myopia prevention solution with the best expected effectiveness.
[0116] In a first example of the disclosed method, the following data is collected for a first subject during a first visit to an eye care professional: the spherical equivalent of the right eye is −2.50D and the spherical equivalent of the left eye is −2.25D.
[0117] The values of the personal characteristics stored in the one or more memories of the system according to the present disclosure during this first visit are summarized in the second column of Table 4.
[0118] [Table 4]
[0119] All weights for calculating the weighted average are set to 1.
[0120] The individual score calculated by the one or more processors at this first visit is equal to 2 / 3=0.66.
[0121] The values of the environmental parameters stored in the one or more memories of a system according to the present disclosure during this first visit are summarized in the second column of Table 5.
[0122] [Table 5]
[0123] The child plays soccer a lot and does not study much. The environmental parameters indicate that there are no factors that increase the risk of myopia or cause myopia. The weights for calculating the weighted average are all set to 1.
[0124] The environmental score calculated by the one or more processors is equal to 0 at the first visit.
[0125] The final score for the first subject is calculated as the ratio 0.66 / (0.66+0)=1. A final score of 1 is associated with a recommendation of high dose atropine by Table 3 stored in the system 60. Therefore, the system 60 determines in step iii) that the myopia control solution is high dose atropine.
[0126] The first subject returns one year later. At this second visit, the spherical equivalent in the right eye is -3.50D and the spherical equivalent in the left eye is -3D.
[0127] The values of the personal characteristics stored in the one or more memories 10 of the system 60 according to the present disclosure during this second visit are summarized in the third column of Table 4.
[0128] All weights for calculating the weighted average are set to 1.
[0129] The individual score calculated by the one or more processors 20 at this second visit is equal to 2 / 3=0.66.
[0130] The values of the environmental parameters stored in the one or more memories 10 of the system 60 according to the present disclosure during this second visit are summarized in the third column of Table 5.
[0131] The environmental parameters indicate the absence of factors that increase the risk of or cause myopia. The weights for calculating the weighted average are all set to 1.
[0132] The environmental score calculated by the one or more processors at the second visit is equal to 0.
[0133] The final score for the first subject at the second visit is calculated as the ratio 0.66 / (0.66+0)=1. A final score of 1 is associated by the system with a recommendation of a high dose of atropine. The system determines this to be the same myopia control solution without modification.
[0134] However, if the one or more processors determine that the currently used atropine eye drops are less effective than expected as myopia progresses, e.g., if the absolute increase in the refractive power of the eye within one year exceeds a predetermined threshold, the system may recommend modifying the implementation of the current myopia control solution, e.g., by increasing the dosage of atropine eye drops to increase efficiency. This variation is described below.
[0135] The first subject returns one year later (two years after the first visit). At this third visit, the spherical equivalent in the right eye is -4.00D and the spherical equivalent in the left eye is -3.75D.
[0136] Here the child studies a lot and has near esotropia.
[0137] The values of the personal characteristics stored in the one or more memories 10 of the system according to the present disclosure during this third visit are summarized in the fourth column of Table 4.
[0138] All weights for calculating the weighted average are set to 1.
[0139] The individual score calculated by the one or more processors at this second visit is equal to 2 / 3=0.66.
[0140] The values of the environmental parameters stored in the one or more memories 10 of the system according to the present disclosure during this third visit are summarized in the fourth column of Table 5.
[0141] The environmental parameters of the first subject have changed due to changes in his / her lifestyle. All weights for calculating the weighted average are set to 1.
[0142] The environmental score calculated by the one or more processors 20 at the third visit is equal to 0.5.
[0143] The final score for the first subject at the third visit is calculated as the ratio 0.66 / (0.66+0.5)=0.56. The final score of 0.56 is associated by the system with a recommendation for orthodontic treatment. The system 60 determines a change in myopia control solution from atropine eye drops to orthodontic treatment.
[0144] In a second example of the disclosed method, the following data is collected for a second subject during a first visit to an eye care professional: the spherical equivalent of the right eye is −4.50D and the spherical equivalent of the left eye is −4.00D.
[0145] The values of the personal characteristics stored in the one or more memories 10 of the system 60 during this first visit are summarized in the second column of Table 6.
[0146] [Table 6]
[0147] All weights for calculating the weighted average are set to 1.
[0148] The individual score calculated by the one or more processors at this first visit is equal to 1.33 / 3=0.44.
[0149] The values of the environmental parameters stored in the one or more memories 10 of the system 60 according to the present disclosure during this first visit are summarized in the second column of Table 7.
[0150] [Table 7]
[0151] The child is academically intensive and lives in an apartment in a big city, conditions that increase the risk of myopia. She has near esotropia, an undercorrection of 0.75D, an accommodative lag of 1.5D, and uses her current myopia control solution for only 5 hours per day. Hence, the environmental parameters promote myopia. The weights for calculating the weighted average are all set to 1.
[0152] The environmental score calculated by the one or more processors at visit 1 is equal to 4.8 / 5=0.96.
[0153] The final score for the first subject is calculated as the ratio 0.44 / (0.44+0.96)=0.31. The final score of 0.31 is associated with a recommendation of a prism bifocal lens according to Table 3. Therefore, the system is programmed to determine a prism bifocal lens.
[0154] The second subject returns six months later. At this second visit, the refraction is not determined because it is too close to the first visit. However, the second subject's axial length increases by 0.22 millimeters. This increase indicates progression of myopia as described below.
[0155] The values of the personal characteristics stored in the one or more memories 10 of the system 60 according to the present disclosure during this second visit are summarized in the third column of Table 6.
[0156] All weights for calculating the weighted average are set to 1.
[0157] The individual score calculated by the one or more processors 20 at this second visit is equal to 1.33 / 3=0.44.
[0158] The values of the environmental parameters stored in the one or more memories 10 of the system 60 during this second visit are summarized in the third column of Table 7.
[0159] The values of the environmental parameters remain the same. A new parameter is available that is related to the hours of daily use of the myopia prevention solution. The weights for calculating the weighted average are all set to 1.
[0160] The environmental score calculated by the one or more processors 20 at the second visit is equal to 4.8 / 5=0.96.
[0161] The final score for the first subject is calculated as the ratio 0.44 / (0.44+0.96)=0.31. The final score of 0.31 is associated with a prism bifocal decision. Therefore, the system 60 is programmed to recommend a prism bifocal.
[0162] And no changes in myopia control solutions are recommended by the system.
[0163] However, if the axial length is increasing, the system may recommend adjusting the implementation of the current myopia control solution, for example, by increasing the number of hours of use per day to increase its efficiency, a variation that is described in more detail below.
[0164] In an embodiment of system 60, if the subject is already using a myopia control solution, the system is programmed to take into account the lack of efficiency of the currently used myopia control solution when determining a modification of the myopia control solution.
[0165] The system 60 then comprises an acquisition device 30 for acquiring actual values of one or more eye state parameters upon validation, and the method implemented comprises a step 100 of acquiring said actual values of one or more eye state parameters upon validation (Figure 2).
[0166] The verification time may be, for example, the time of a future visit to an eye care professional.
[0167] Each ocular condition parameter represents the myopia of the subject in the sense that the ocular condition parameter is linked to and varies with the myopia of the subject, and the value of the ocular condition parameter may increase or decrease, respectively, with increasing myopia, and decrease or increase, respectively, with decreasing myopia.
[0168] Myopia power may be quantified, for example, by the absolute value of the refractive power of the eye or lens required to correct the myopia of the eye. Myopia power may be described in terms of the power of ideal diopter correction required by the eye, measured, for example, in diopters.
[0169] Indeed, each ocular condition parameter representative of myopia power may include optical and / or physical characteristics of the eye, and may be based on, inter alia, the axial length of the eye, the spherical equivalent of the subject's eye, the choroidal thickness of the eye, or a combination thereof, or the rate of decrease in axial elongation of these or of the cumulative axial elongation.
[0170] The axial length increases with increasing myopia and decreases with decreasing myopia, while the spherical equivalent decreases with increasing myopia and increases with decreasing myopia, since the myopic spherical power has a negative value. In the following, only the absolute value of the spherical equivalent is considered.
[0171] Cumulative axial elongation absolute reduction (CARE) is the cumulative treatment effect across treatments.
[0172] For example, if axial elongation is 0.35 mm at 1 year, 0.29 mm at 2 years, and 0.25 mm at 3 years, then the CARE at 1 year is 0.35 mm, the CARE at 2 years is 0.64 mm, and the CARE at 3 years is 0.89 mm.
[0173] Axial length (AL) is the distance between the anterior surface of the cornea and the retinal pigment epithelium measured at the level of the fovea. Axial length is usually measured by A-scan ultrasonography or optical coherence biometry.
[0174] The spherical equivalent power is calculated by adding the sum of the spherical power and half the cylindrical power. For example, for a spectacle correction of -3.00-1.00x180, the spherical equivalent power is -3.00D+1 / 2(-1.00D)=-3.00D-0.50D=-3.50D.
[0175] The device 30 for determining the actual value of the one or more ocular state parameters preferably comprises a device for measuring the actual value for the subject. In a variant, the device 30 may comprise a device programmed to retrieve this actual value or to estimate it from measurements performed by another device, possibly at another location.
[0176] The device 30 may include any device suitable for determining these values, such as, for example, a phoropter and / or a biometric device, or a device for A-scan ultrasound or optical coherence biometry or cycloplegic autorefraction.
[0177] These devices and methods for determining the spherical equivalent power and / or axial length of an eye are well known in the state of the art and are not the object of this disclosure, therefore, these devices and methods will not be described in detail here.
[0178] The one or more memories 10 have statistical data stored therein regarding the statistical progression of the one or more ocular condition parameters over time while the myopia control solution is being implemented.
[0179] The statistical data regarding the statistical progression of the eye condition parameter over time while the initial myopia control solution is being implemented may, for example, comprise an average progression of the eye condition parameter over time while the initial myopia control solution is being implemented. The statistical data may also comprise data regarding the variance of eye condition parameter values, such as the progression of a standard deviation of the eye condition parameter over time while the initial myopia control solution is being implemented.
[0180] These statistics may include thresholds for myopia progression within a given time period while implementing each available myopia control solution. These thresholds may be determined in several ways, namely: - deviation from the empirically defined mean efficacy or percentage of the mean efficacy, - Based on a prediction model of myopia progression, - Based on expert experience It can be defined.
[0181] Such a threshold may be expressed, for example, as a predicted value of a magnitude representative of myopia progression (such as axial length or spherical equivalent).
[0182] Thus, the one or more processors - determining a predicted value of a magnitude associated with each ocular condition parameter at the time of validation based on the statistical data regarding the statistical progression of the ocular condition parameters over time while the myopia reduction solution is in use (block 150 of FIG. 2 ) and an actual value of the magnitude based on the actual values of the ocular condition parameters (block 100 of FIG. 2 ), - comparing the actual value of the magnitude for each ocular condition parameter with the predicted value of the magnitude (block 200 of FIG. 2); It is programmed as follows.
[0183] The magnitude may be the ocular condition parameter itself, the magnitude may comprise an effective progression parameter of the ocular condition parameter or a magnitude quantifying the effectiveness of a myopia control solution.
[0184] The effectiveness of the myopia control solution is defined as a measure that represents the ability of the myopia control solution to produce the desired or intended result in controlling the myopia of the wearer. Effectiveness can be quantified, for example, as a percentage value, with 100% being maximum effectiveness and 0% being minimum effectiveness.
[0185] Typically, the effectiveness of a myopia control solution may be determined during a clinical trial that includes a control group of subjects and a test group of subjects.
[0186] In the example described herein, the size is: - axial length or spherical equivalent or choroidal thickness of the eye, a valid progression parameter, for example an absolute valid progression parameter or a percentage of a valid progression parameter as defined above, which represents the progression of the myopia of the eye over time, determined on the basis of the axial length or the spherical equivalent or the choroidal thickness, - parameters linked to the effectiveness of the myopia control solution; - Blur index that can also be used to monitor myopia progression PCT application WO2020120595 describes a method to determine what should be the progression for a given child with a given lens. The size used can depend on the time since the last visit.
[0187] The duration can be a few days, a few months, a semester, or a year.
[0188] The magnitude and measurement for each period is specific to the duration: - Choroidal thickness is used over a period of several days; - Axial length and / or choroidal thickness are measured when the time has elapsed is between 1 and 6 months, - Refraction and / or axial length are measured if the time elapsed is 1 year or more.
[0189] Refraction is measured, for example, by cycloplegic autorefraction.
[0190] If this comparison indicates that the subject's myopia is statistically progressing more slowly or as predicted by the myopia control solution, the one or more processors 20 are programmed to determine that the myopia control solution should be maintained, i.e., not to modify the current myopia control solution (path 202 and block 300 of FIG. 2).
[0191] If the comparison indicates that the myopia power of the subject's eye at the time of verification is higher than the predicted myopia power, the one or more processors 20 are programmed to perform steps i) to iii) (path 201 of Figure 2).
[0192] These steps allow the system to take into account the underlying causes of faster myopia progression than a subject would expect.
[0193] In one example of such an embodiment, for example, two different eye condition parameters are taken into account: the spherical equivalent (SER) and the axial length (AL) of the eye. Other eye condition parameters may also be taken into account.
[0194] During a subject's visit to an eye care professional, the devices of system 60 are used to measure the spherical equivalent and axial length values of the subject's eye.
[0195] The one or more processors 20 of the system 60 use the statistical data in the one or more memories 10 to determine predicted values of the spherical equivalent and axial length, optionally taking into account the subject's personal characteristics and values of environmental parameters.
[0196] In particular, the predetermined actual values of the spherical equivalent and axial length and the time elapsed since using the current myopia control solution are preferably taken into account.
[0197] The actual value of each ocular state parameter is compared to the corresponding predicted value of that ocular state parameter (block 200 of FIG. 2).
[0198] If this comparison indicates that the subject's myopia is progressing faster than statistically predicted by the myopia control solution, the one or more processors 20 are programmed to perform additional steps to determine a modification to the current myopia control solution (path 201).
[0199] In a specific implementation of this embodiment, a figure of merit of the myopia control solution may be specified for or estimated from the actual value of the magnitude. The figure of merit may be, for example, equal to the spherical equivalent of the eye, the axial length, or the axial length elongation or increase.
[0200] A suppression target may be specified for or estimated from the predicted value of magnitude. The suppression target may be stored in the one or more memories. Alternatively, the suppression target may have a predetermined fixed value.
[0201] In this case, the one or more processors are then programmed to determine the control performance index of the myopia control solution and compare the control performance index to the control target.
[0202] If the suppression performance index falls short of the suppression target, one or more processors are programmed to identify a root cause of the suppression performance index falling short of the suppression target and determine the modification of the myopia suppression solution for the subject based also on the root cause, for example by calculating the final score.
[0203] In an advantageous embodiment of system 60, the values of the environmental parameters stored in the one or more memories 10 include values of parameters relating to the time or frequency of use of the myopia prevention solution or to the subject's compliance level with the conditions for use of the myopia prevention solution.
[0204] The duration of use may include wear time when contact lenses or ophthalmic lenses are used as eyewear in the myopia prevention solution.
[0205] If the comparison indicates that the myopic power of the subject's eye at the validation time is higher than the predicted myopic power or that the figure of merit is below the suppression target, the one or more processors 20: - in a preliminary step 400, before carrying out steps i) to iii), comparing said values of said parameters related to the duration or frequency of use of said myopia prevention solution or related to the subject's compliance level with the conditions for use of said myopia prevention solution with corresponding threshold values, - Execute steps i)-iii) only if the comparison indicates that the duration, frequency or compliance of use is above the threshold (path 401 in FIG. 2) It is programmed as follows.
[0206] If the comparison indicates that the time of use, frequency of use, or compliance level is below the threshold (path 402 of FIG. 2), the one or more processors 20 may select the modification of the myopia control solution as follows: - adjusting 600 the myopia control solution to increase the duration or frequency of use of said myopia control solution or the compliance level of the subject; or - changing said myopia prevention solution to another myopia prevention solution 700 The device is programmed to determine whether the
[0207] More precisely, the one or more processors 20 are programmed to compare the usage time, frequency of use, or compliance level with a maximum usage time, frequency of use, or compliance level (block 500 of FIG. 2), and if the current usage time, frequency of use, or compliance level is below this maximum, an adjustment of the myopia prevention solution to increase the usage time or frequency of use or compliance level is recommended by the system (block 600 of FIG. 2).
[0208] Otherwise, if the duration, frequency, or compliance level is already at a maximum or cannot be increased, the system 60 is programmed to determine a new, different myopia control solution having the next best predicted effectiveness (block 700 of FIG. 2), e.g., based on statistical data in memory.
[0209] The suboptimal myopia solution may be the myopia solution associated with the range of final scores that is closest to the actual calculated final score for the subject.
[0210] If the comparison indicates that the time of use, frequency of use, and / or compliance level is above the threshold (path 401), the one or more processors are programmed to perform steps i) and ii), thereby re-evaluating the underlying cause of the subject's myopia.
[0211] The one or more processors 20 are then programmed to perform step i) (block 800 of FIG. 2) and step ii) (block 900 of FIG. 2) to determine the personal score and the environmental score.
[0212] One or more processors 20 are programmed to determine the final score based on the personal scores and the environmental scores (block 1100 of FIG. 2).
[0213] In a next step, the one or more processors 20 are programmed to compare the final score determined during the validation with a previous value determined for this score (block 1200).
[0214] If the underlying cause has changed, meaning that the personal or environmental score has changed and the new value of the final score is associated with a myopia control solution different from the myopia control solution already used by the subject, in step iii), the one or more processors 20 are programmed to determine a modification of said myopia control solution (path 1202 and block 1600 of FIG. 2 ). The modification comprises a change of the myopia control solution associated with the new value of the final score according to Table 3.
[0215] If the underlying cause has not changed, meaning that the personal and environmental scores have not changed and / or the final score is associated with the same myopia prevention solution as the myopia prevention solution already used by the subject, in step iii), the one or more processors 20 are programmed to check whether a comparison of each actual value of the magnitude with the corresponding predicted value of the magnitude indicates that the myopia power of the subject's eye at the time of the verification is higher than the predicted myopia power for all of the one or more eye condition parameters, or whether at least one value of the magnitude indicates that the myopia power of the subject's eye at the time of the verification is lower than the predicted myopia power (path 1201 and block 1300 in FIG. 2 ).
[0216] If all of the magnitude values indicate that the myopia power of the subject's eye at the time of verification is higher than the predicted myopia power, the one or more processors 20 are programmed to determine a modification of the myopia control solution (block 1400 of FIG. 2), including adjusting the implementation parameters of the myopia control solution, for example increasing the dose of atropine or increasing the refractive power of the lens, to increase the effectiveness of the myopia control solution.
[0217] If at least one value of the magnitude indicates that the myopia power of the subject's eye at the time of verification is lower than the predicted myopia power, the one or more processors 20 are programmed to determine a modification of the myopia control solution (block 1500 of FIG. 2), including changing the myopia control solution for a different myopia control solution, for example by determining a myopia control solution having a suboptimal effectiveness according to statistical data in the one or more memories, or by determining a different myopia control solution that combines the current myopia control solution with another solution.
[0218] If the myopia control solution currently used by the subject is performing better than expected, three different scenarios, namely: - Adjustment of only the sphere of the corrective lenses used, - Adjustment of other implementation parameters (if any) of said myopia control solution (other than spherical) to make it easier to use, - Switching to an easier to use alternative myopia control solution (if any) There is.
[0219] The present disclosure includes computer-implemented methods and systems used to carry out the methods, which may include smartphones, tablets, and / or appliance interfaces that can be used by eye care professionals for routine control and by patients as part of their home monitoring.
[0220] When used by an eye care professional, the control / data entry time interval is, for example, 6 months to 1 year. The eye care professional uses eye condition parameters such as spherical equivalent, axial length, and choroidal thickness.
[0221] Nevertheless, environmental parameters such as wear time can be monitored directly by the subject on a daily basis, and changes in personal characteristics such as visual acuity can be monitored at intervals of several weeks with complementary tools.
[0222] In other words, the method may be performed using input data collected at different significant time intervals, which are then aggregated.
[0223] Two examples of the above embodiment of the method and system 60 are described below.
[0224] In the first example above, the first subject is a boy age 6. As explained above, the final score calculated for the first subject is 1 at the first visit.
[0225] The myopia control solution associated with this final score is atropine, according to Table 3. System 60 then determines that the myopia control solution is atropine eye drops.
[0226] The one or more memories of the system have in their memory predicted myopia progression thresholds for the first subject using atropine, calculated from existing clinical trials based on age, sex, and other personal characteristics, of up to 0.20 mm of axial elongation, i.e., increase in axial length, after six months, and 0.40 mm of axial elongation and 0.60 D increase in absolute spherical equivalent power after one year.
[0227] At the second visit, the first subject returns one year later. The first subject's spherical equivalent has progressed by 0.75 D and axial length has progressed by 0.44 mm. Both the spherical equivalent and axial length progressions are greater than the predefined thresholds.
[0228] The first subject's compliance with regular instillation of atropine eye drops is satisfactory and the final score, and therefore the underlying cause of myopia, has not changed over the past year. The final score is still equal to 1.
[0229] According to the steps described above, the one or more processors 20 are programmed to determine a modification of the myopia control solution, including adjusting the current myopia control solution to increase the effectiveness of the myopia control solution. The system 60 determines the modification, including increasing the dose of atropine.
[0230] Based on age, sex, and other personal characteristics, the predicted myopia progression threshold for the first subject using low-dose atropine remains at a maximum of 0.20 mm axial elongation after 6 months, and 0.40 mm axial elongation and 0.60 D absolute increase in spherical equivalent after 1 year.
[0231] At the third visit, the first subject's spherical equivalent had progressed by 0.75 D and his axial length had progressed by 0.44 mm, both progressions being greater than the predefined thresholds.
[0232] The final score determined, and therefore the root cause index, is 0.56, due to an increase in near work. As mentioned before, the first subject is switched from atropine to orthodontic treatment. In fact, according to Table 3, the closest myopia control solution is orthodontic treatment.
[0233] In the second example above, the second subject is a 15-year-old girl. The final score determined at the first visit is 0.31. The system determines that the second subject's first myopia control solution should be prism bifocal lenses.
[0234] Based on age, sex, and other personal characteristics, the predicted myopia progression thresholds for the second subject wearing prism bifocal lenses, calculated from existing clinical trials, are a maximum axial elongation of 0.15 mm after six months, and an axial elongation of 0.30 mm and an absolute increase in spherical equivalent of 0.50 D after one year.
[0235] At the second visit, axial elongation measured over the past 6 months was 0.22 mm, i.e., 0.07 mm greater than the predefined threshold.
[0236] The one or more processors are then programmed to compare a time of use of the myopia control solution to a usage time threshold. In this case, the one or more processors determine that the time of use is below the usage time threshold. The second subject does not wear glasses at school.
[0237] The system 60 determines that a myopia control solution modification includes adjusting a current myopia control solution to increase usage time or compliance.
[0238] After investigation by eye care professionals, the reason for the short usage time was that the frames did not fit well and caused pain.
[0239] The frame is re-fitted for comfort and the second subject is encouraged to increase the duration of use.
[0240] Other possible adjustments to the myopia control solution are: - increasing or decreasing the add or more positive sphere power for solutions related to the correction or reduction of accommodative delay during near vision activities; - an increase or decrease in the positive sphere of the solution correcting the peripheral hyperopic defocus in the area corresponding to the peripheral vision, - increasing or decreasing the number of lenslets and / or the power of the positive range of the lenslets for a solution that uses multiple light stimuli to provide retinal stimulation, located in front of the retina of the subject's eye; - A reduction in the transmission in the periphery of the lens to enhance contrast for a solution that provides a different low contrast to the subject's peripheral vision; - Increased transmission in the periphery of the lens to reduce contrast for a solution that provides a different, lower contrast to the subject's peripheral vision; - Increasing or decreasing the amount of red light for solutions that limit the amount of red light entering the eye to reduce ocular chromatic aberration using specific filters; - increasing or decreasing the transmittance of wavelengths for solutions that provide light having specific wavelengths to the eye to prevent eye elongation; - increasing or decreasing the frequency of solutions that provide dynamically changing light stimuli, such as flashing, - increasing or decreasing the dosage of a solution providing a drug for modulating muscarinic receptors in the retina and sclera; - Modifying the shape of the lenses used in orthokeratology solutions to provide a flatter base curve and / or a flatter central zone. may include.
[0241] The parameters to be taken into account for defining said follow-up schedule may be: - combination of age and myopia level: the younger the age and the higher the myopia level, the shorter the period, for example meaning a period between two follow-up visits equal to 3 months or less; - Myopia progression rate: the higher the risk of rapid progression, the shorter the time between visits, e.g., equal to or less than 3 months; - predicted efficacy of the myopia control solution: the lower the efficacy, the sooner the follow-up visit is determined, for example, equal to 3 months or less; - Regular visits according to a prescribed schedule according to a standard myopia management program or package: depending on the frequency which can be every 3 months, 6 months, or yearly.
Claims
1. 1. A system (60) for determining a myopia control solution for use by a subject, the system comprising one or more memories (10) and one or more processors (20); The one or more memories (10) the values of the subject's personal characteristics; and values of environmental parameters related to conditions of use of the myopia prevention solution by the subject; in memory, The one or more processors (20): i) determining an individual score for the subject depending on the values of the personal characteristics of the subject, the individual score being associated with a role of the personal characteristics in causing myopia in the subject; ii) determining an environmental score for the condition of use of the myopia prevention solution by the subject as a function of the value of the environmental parameter, the environmental score being associated with a role of the environmental parameter in causing myopia in the subject; iii) determining the myopia control solution for the subject based on the individual and environmental scores; and The system (60) is programmed to:
2. The one or more processors (20) are programmed in step iii) to determine a first myopia control solution or a modification of a myopia control solution currently used by the subject, the myopia control solution being adapted to perform the following operations: Correcting or reducing accommodation delay during near viewing activities; Correcting or reducing hyperopic defocus in the periphery or providing myopic defocus; Providing retinal stimulation; providing different contrasts to the subject's peripheral vision; limiting the amount of light having a particular wavelength entering the subject's eye to reduce ocular chromatic aberration or retinal exposure to the particular wavelength; providing light to said eye having a specific wavelength to inhibit eye elongation; Providing a dynamically changing light stimulus; To provide an agent for modulating retinal and scleral muscarinic receptors; reshaping a cornea of the eye to reduce refractive error; reshaping the cornea of the eye to induce an extended depth of focus; flattening the shape of the cornea to cause myopic defocus and / or optical aberrations at the retina periphery; reinforcing or strengthening the sclera of the eye and / or the cornea of the eye and / or the choroid of the eye; 2. The system (60) of claim 1, comprising one or more devices for simultaneously performing one of the operations.
3. 3. The system (60) of claim 2, wherein the device comprises a medicinal eye drop delivery device, a multifocal eyeglass lens, a microstructured eyeglass lens, an orthodontic lens or a multifocal soft contact lens, and / or a device for providing at least one retinal stimulus using a light stimulus positioned in front of the retina of the subject's eye.
4. 2. The system of claim 1, wherein the one or more processors are programmed to determine the myopia control solution using a predetermined and constant relationship relating the myopia control solution to the individual score and the environmental score.
5. 5. The system of claim 4, wherein the one or more processors are programmed to determine a final score based on the individual score and the environmental score, and to determine the myopia control solution taking into account the final score.
6. The system (60) of claim 5, wherein the one or more processors (20) are programmed to calculate the final score as a ratio of the individual score to a sum of the individual score and the environmental score.
7. The system (60) of claim 1, wherein the one or more processors (20) are programmed to establish and / or update a relationship between the myopia control solutions and the final score using a machine learning algorithm.
8. The values of the personal characteristics of the subject stored in the one or more memories (10) are selected from the following personal characteristics: the number of myopic parents and myopic siblings and / or the level of myopia of the subject's parents and / or myopic siblings, the number of alleles of the subject's genotype that is indicative of risk of myopia; ocular biometry parameters of at least one eye of the subject; ocular biomechanical parameters of at least one eye of the subject; optometric characteristics of the subject; the subject's medical history; the sex of the subject; the age of the subject; the subject's intelligence quotient and / or general academic achievement, The subject's season of birth and / or date of birth, the ethnicity and / or geographic origin of the subject; The system (60) of claim 1, comprising one or more values of:
9. The values of the environmental parameters stored in the memory (10) are the following environmental parameters of the subject: time spent accomplishing a near task and / or working distance for a near task; time spent outdoors and / or indoors; Type of environment, Country and / or city of residence and / or type of residence, activities and / or lifestyle habits, The type of lighting used while performing near vision tasks, the time spent using said myopia control solution; Reading posture, the level of undercorrection of said myopia; Accommodation parameters, Binocular vision parameters, Lens usage parameters, The system (60) of claim 1, comprising one or more values of:
10. 2. The system of claim 1, wherein the one or more processors are programmed to calculate each of the personal score and the environmental score as an average or weighted average of the values of the personal characteristics and the environmental parameters, respectively.
11. the system (60) comprising an acquisition device (30) for acquiring actual values of each of one or more ocular state parameters upon validation, the subject is using an initial myopia control solution, and the one or more memories have statistical data stored therein regarding the statistical progression of each ocular condition parameter over time while the initial myopia control solution is being implemented; The one or more processors (20): determining a predicted value of a magnitude associated with each of the one or more ocular state parameters at the time of validation based on the statistical data regarding the statistical progression of each ocular state parameter over time while the first myopia control solution is in use, and an actual value of the magnitude based on the actual value of each ocular state parameter; comparing the actual value of the magnitude for each ocular condition parameter to the predicted value of the magnitude; It is programmed to if the comparison indicates that the myopia power of the subject's eye at the time of validation is higher than a predicted myopia power for at least one of the one or more ocular condition parameters, the one or more processors (20) are programmed to perform steps i) to iii); The system (60) of claim 1.
12. the one or more memories (10) having stored therein a control goal of the first myopia control solution; The one or more processors (20): determining a control performance index for said first myopia control solution; comparing the suppression performance index to the suppression target; If the suppression performance index falls short of the suppression target, identifying a root cause of the suppression performance index falling short of the suppression target; In step iii), determining a modified myopia control solution for the subject taking into account the underlying cause. The system (60) of claim 11, programmed to:
13. the values of the environmental parameters stored in the one or more memories (10) include values of parameters related to a duration or frequency of use of the first myopia control solution or related to a level of compliance of the subject with the conditions of use of the first myopia control solution; If the comparison indicates that the myopia power of the eye of the subject at the time of the validation is higher than a predicted myopia power, the one or more processors (20) comparing the value of the parameter related to the duration or frequency of use of the first myopia control solution or related to the subject's level of compliance with the conditions of use of the first myopia control solution with a corresponding threshold value; performing steps i)-iii) only if the comparison indicates that the time of use, the frequency of use, or the compliance is above the threshold; The system (60) of claim 11, programmed to:
14. If the comparison indicates that the time of use, the frequency of use, or the level of compliance is at or below the threshold, the one or more processors 20: adjusting the initial myopia control solution to increase the duration or frequency of use of the myopia control solution or the level of compliance of the subject; or changing said first myopia control solution to another myopia control solution; 14. The system (60) of claim 13, programmed to determine the revised myopia control solution by:
15. 1. A method for determining a myopia control solution to be used by a subject, comprising: - providing values of personal characteristics of said subject and values of environmental parameters relating to conditions of use of said myopia prevention solution by said subject; determining an individual score for the subject depending on the values of the personal characteristics of the subject, the individual score being associated with a role of the personal characteristics in causing myopia in the subject; determining an environmental score for the condition of use of the myopia prevention solution by the subject as a function of the value of the environmental parameter, the environmental score being associated with a role of the environmental parameter in causing myopia in the subject; determining the myopia prevention solution for the subject based on the individual score and the environmental score; A method comprising:
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