Optical film
By combining a non-refractive, opaque optical film or sheet with a standard single-vision lens, the activity of retinal ganglion cells is increased, solving the problem that existing technologies cannot stop the progression of myopia and achieving the effects of myopia correction and growth inhibition.
Patent Information
- Application Number
- CN202511237594.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2020-03-01
- Filing Date
- 2021-02-22
- Publication Date
- 2025-11-21
AI Technical Summary
In existing technologies, single-vision lenses can only correct myopia but cannot effectively prevent excessive eye growth and the progression of myopia, leading to vision damage caused by high myopia.
It employs an optical film or sheet combined with standard single-vision lenses, configured with non-refractive opacity, to increase retinal ganglion cell activity and provide an optical stopping signal to slow eye growth and myopia progression.
By increasing the activity of retinal ganglion cells, optical films or sheets can correct myopia and inhibit further eye growth, thus slowing down the progression of myopia.
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Figure CN120993630A_ABST
Abstract
Description
This invention is a divisional application of the invention patent application filed on February 22, 2021, with application number 202180018911.5 and invention title "Myopia Management Spectacular Lens that Can Convert Single Vision Spectacular Lens into an Optical Film with Non-Refractive Opaque Features". Cross-references
[0001] This application claims priority to Australian Provisional Application No. 2020 / 900604 entitled “A Single Vision Lens”, filed on 1 March 2020, and Australian Application No. 2020 / 900605 entitled “A Lens for Myopia”, filed on 1 March 2020, both of which are incorporated herein by reference in their entirety. Technical Field
[0002] This disclosure relates to means of treating myopia. This disclosure relates to apparatus and methods for formulating, selecting, supplying, and assembling optical films used in conjunction with standard single-vision spectacle lenses for correcting refractive errors in myopic individuals, wherein the optical film is configured to have non-refractive, opaque features that promote increased activity of retinal ganglion cells and can act as an optical signal to slow down, improve, control, inhibit, or reduce the rate of myopia progression in the wearer. Background Technology
[0003] The human retina has three main layers: the photoreceptor layer, the outer plexiform layer, and the inner plexiform layer. Cone cells and rod cells are photoreceptors that respond to light in the retina by converting incident light into electrical signals. The converted electrical signals travel from the photoreceptors through bipolar cells and are further transmitted to the retinal ganglion cells and optic nerve, transmitting visual information from the retinal cells to the brain, thus enabling visual perception of the world.
[0004] Photoreceptors respond with graded membrane potentials and release the neurotransmitter glutamate in proportion to their polarization state level. For example, in the absence of light stimulation, photoreceptors depolarize and release more glutamate relative to their baseline state.
[0005] In the presence of light, photoreceptors hyperpolarize due to the breakdown of opsins within them, resulting in the release of less glutamate relative to their baseline state. There are two types of bipolar cells in the retina: centrifugal and eccentric bipolar cells. They encode the positive and negative spatiotemporal contrast of incident light, respectively, by comparing the photoreceptor signal with a spatiotemporal average calculated from the lateral connective layer of horizontal cells. Horizontal cells are interconnected via conductive gap junctions and link to bipolar cells and photoreceptors in complex triadic synapses. Centrifugal and eccentric bipolar cells respond differently to glutamate, depending on the type and number of glutamate receptors located on each of these bipolar cells. Eccentric bipolar cells have ionotropic receptors that are excitatory to glutamate. These eccentric bipolar cells depolarize in response to glutamate, retaining the photoreceptor signal. In the presence of light, eccentric bipolar cells receive less glutamate from the photoreceptor, causing hyperpolarization and releasing less glutamate to the corresponding downstream ganglion cells. In the absence of light, eccentric bipolar cells receive more glutamate from their photoreceptors, causing depolarization and releasing more glutamate into their downstream corresponding ganglion cells. Centrifugal bipolar cells possess metabolic receptors that inhibit glutamate. These centrifugal bipolar cells hyperpolarize in response to glutamate and reverse the photoreceptor signal. In the presence of light, centrifugal bipolar cells receive less glutamate from their photoreceptors, causing depolarization and releasing more glutamate into their downstream corresponding ganglion cells. In the absence of light, centrifugal bipolar cells receive more glutamate from their photoreceptors, causing hyperpolarization and releasing less glutamate into their downstream corresponding ganglion cells. The higher the amount of glutamate released into the downstream corresponding ganglion cells by centrifugal or eccentric bipolar cells, the larger the action excitation potential of the ganglion cells. The opposite light responses between centrifugal and eccentric bipolar cells are key to the differential response between bright and dark states. Furthermore, the depolarization signaling activity of central and eccentric bipolar cells can be amplified or inhibited by horizontal cells that connect to the surrounding photoreceptors in the corresponding receptive field. Horizontal cells receive excitatory input from the photoreceptors and send inhibitory feedback back to the photoreceptors connected to the surrounding region.
[0006] The receptive field is a group of photoreceptors that send input signals to bipolar cells and ganglion cells in the downstream retina. The retinal receptive field can be described using concentric circular regions, each with a smaller central circular field and a wider circular field surrounding the central field (called the periphery). Receptive fields are classified into two types: peripherally induced, centrally induced receptive fields and peripherally induced, centrally induced receptive fields. Based on differences in bipolar cells, central and eccentric receptive fields also respond differently to light.
[0007] Humans are born farsighted, with an eye length too short for their total refractive power. As a person ages from childhood to adulthood, the eyeball continues to grow until the eye's refractive state stabilizes. Eye growth is thought to be controlled by feedback mechanisms and primarily regulated by visual experience to match visual acuity to eye length and maintain homeostasis. This process is called emmetropization. The signal that guides the emmetropization process is initiated by the modulation of light energy received by the retina. Retinal imaging features are monitored by biological processes that modulate the signal to initiate or halt, accelerate or slow eye growth. This process coordinates between the optics and eyeball length to achieve or maintain emmetropization. Derailment from this emmetropization process leads to refractive errors such as myopia. It is hypothesized that decreased retinal activity promotes eye growth, while conversely, increased retinal activity inhibits it.
[0008] In many parts of the world, particularly in East Asia, the prevalence of myopia is increasing at an alarming rate. In myopic individuals, the axial length of the eye is mismatched with the overall strength of the eye, causing distant objects to focus in front of the retina. A simple negative single-vision lens can correct myopia. While such devices can optically correct refractive errors related to eye length, they do not address the underlying cause of excessive eye elongation in the development of myopia. Overly elongated eyes in high myopia are associated with serious vision-threatening conditions such as cataracts, glaucoma, myopic macular degeneration, and retinal detachment. Therefore, there is a need for specialized optical devices for individuals that not only correct underlying refractive errors but also prevent excessive eye elongation or the development of myopia. definition
[0009] Unless otherwise defined below, the terms used herein are generally as used by those skilled in the art: the term “myopia” means an eye that has experienced myopia, is in the pre-myopia stage; or is at risk of developing myopia; or is diagnosed with a refractive condition that is progressing toward myopia, with or without astigmatism.
[0010] The term "progressive myopia" refers to a diagnosed, developing myopia, measured by a change in refractive error of at least -0.25 D / year or a change in axial length of at least 0.1 mm / year. The terms "premyopic" or "eye at risk of myopia" refer to an eye that was previously emmetropic or had low distance vision, but was identified as having an increased risk of developing myopia based on genetic factors (e.g., both parents are myopic) and / or age (e.g., being hyperopic at a young age) and / or environmental factors (e.g., time spent outdoors) and / or behavioral factors (e.g., time spent performing near tasks).
[0011] The term "optical stop signal" or "stop signal" refers to an optical signal or directional cue that can help slow down, reverse, brake, delay, inhibit, or control the growth of the eye and / or the refractive condition of the eye.
[0012] The term "spectacles lens" can refer to blank lenses, whether finished or semi-finished. The terms "standard single vision lens," "commercially available single vision glasses," "standard glasses," or "traditional single vision" refer to eyeglasses used to correct intrinsic refractive errors in the eye. These refractive errors may include myopia, with or without astigmatism.
[0013] The term "myopia management glasses" or "myopia control glasses" refers to glasses that are used not only to correct basic refractive errors of the eyes but also to manage refractive errors; these refractive errors may be myopia, with or without astigmatism.
[0014] The term "optical region" or "optical area" refers to the area on the front of an eyeglass lens that has a defined optical effect. The term "optical center" refers to the geometric center of the optical region of an eyeglass lens.
[0015] The term "optical axis" refers to a line that passes through the optical center and is substantially perpendicular to the plane containing the edge of the spectacle lens.
[0016] The terms or phrases “single-beam optical region,” “basic single-beam optics,” “basic single-beam characteristics,” or “spherical optical region” refer to an optical region that has a uniform luminous intensity distribution without significant principal spherical aberration. Single-beam optical regions can be further classified to include those with astigmatism, used to correct distance-related refractive errors. The term “model eye” can refer to a schematic diagram, ray-traced, or physical model eye.
[0017] As used herein, the term "diopter," "photometer," or "D" is a unit of measurement for diopter, defined as the reciprocal of the focal length of a lens or optical system along the optical axis, in meters. The term "D" indicates spherical refractive power, and the term "DC" indicates cylindrical refractive power.
[0018] The term "basic prescription for the correction of refractive errors" refers to the standard prescription of glasses required to correct an individual's potential myopia, with or without astigmatism.
[0019] The term "subfoveal region" refers to the area immediately adjacent to the fovea of the retina, with a diameter of approximately 0.5 mm. The term "foveal region" refers to the area surrounding the fovea pit with a diameter of approximately 1.5 mm. The term "parafoveal region" refers to the area adjacent to the foveal region, approximately 1.5 mm outside the fovea and within 3 mm in diameter. The term "periamacula" refers to the area immediately adjacent to the foveal region, approximately 1.5 mm outside the fovea pit and within 3 mm in diameter. Summary of the Invention
[0020] This disclosure provides a detailed discussion of the prior art and topics of general interest, illustrating the context of the disclosed embodiments, and further distinguishing the intended progress of the invention from the disclosure of prior art. Nothing presented herein should be construed as an prior disclosure, knowledge, or admission of material as part of common sense based on the various embodiments and / or the priority of the claims set forth in this disclosure.
[0021] In short, all prior art optical designs for controlling myopic refractive errors with refractive or phase-changing features involve significant visual effects, primarily due to the use of similar multifocal design features frequently considered in the art. Examples are described in U.S. Patents 6,045,578, 7,025,460, 7,509,863, 7,401,922, 7,803,153, 8,690,319, 8,931,897, 8,950,860, and 8,998,408.
[0022] A catalog of solutions with amplitude-changing features has been proposed in the field of optics to improve the depth of focus in conventional imaging systems. Examples are described in the paper "OTF for Improving Defocus Optics by Using Obscuring Apertures" by Mino and Okano, "Applied Optics 1971". Castaneda et al., in "Arbitrary High Depth of Focus with Quasi-True and Positive Transmittance Apodizers" in "Applied Optics 1989"; Castaneda and Berriel-Valdos, in "Area Plates for Arbitrary High Depth of Focus" in "Applied Optics 1990"; and U.S. Patents 5,965,330A, 8,570,655B2, and 8,192,022. Disadvantages of amplitude-changing solutions include reduced energy transfer at critical frequencies, poorer resolution compared to similar products with phase-changing features, and low luminous flux. In contrast, as described herein, the present invention relates to the use of standard single-vision spectacle lenses intentionally configured with non-refractive opacities designed to provide increased retinal ganglion cell activity and overcome one or more disadvantages of the prior art.
[0023] Some disclosed embodiments relate to devices, supplies, and configurations for use with optical films or sheets in conjunction with standard single-vision lenses, and methods for using optical films or sheets in conjunction with standard single-vision lenses to correct and manage myopia. Some disclosed embodiments aim to both correct myopic refractive errors and simultaneously provide an increase in retinal ganglion cell activity, which acts as an optical stopping signal to reduce the progression of eye growth in the wearer. Some disclosed embodiments include spectacle lenses for altering the characteristics of incident light entering the human eye. Some disclosed embodiments relate to the construction of spectacle lenses for correcting, managing, and treating refractive errors such as myopia. Some embodiments are designed to correct myopic refractive errors and simultaneously provide an optical stopping signal to prevent further eye growth or myopia progression.
[0024] Certain other disclosed embodiments address the ongoing need for evolving eyewear designs that can inhibit the progression of myopia while providing reasonable and appropriate visual performance for a range of daily activities. Various aspects of the embodiments disclosed in this invention address this need of the wearer.
[0025] Some disclosed embodiments include optical films or sheets for use with standard single-vision spectacle lenses, wherein the optical films or sheets are intentionally configured to have non-refractive opacity, and wherein the configured optical films or sheets are used in combination with standard single-vision spectacle lenses to at least partially result in foveal correction of myopia and at least partially result in increased retinal ganglion cell activity in the myopic eye, thereby inhibiting further eye growth or the development of myopia in the wearer. This disclosure relates to eyeglasses for managing eye conditions such as myopia. The proposed methods include correcting myopic refractive errors and controlling, inhibiting, or reducing the rate of myopia progression. This disclosure relates to optical intervention methods that utilize the effect of increasing retinal ganglion cell activity to reduce myopia progression. In some embodiments, the application to one or more regions of the retina that increase retinal activity may be in the fovea, perifoveal region, macula, and / or perimacular region of the retina. In some embodiments, the application to one or more regions of the retina that increase retinal activity may be in the temporal, nasal, inferior, and / or superior regions of the retina.
[0026] Some embodiments of this disclosure relate to a method comprising a procedure for prescribing, selecting, assembling, and supplying an optical film or sheet configured for use with a standard single-vision spectacle lens, for increasing retinal ganglion activity, such as cellular activity, i.e., a stop signal, which can slow the rate of myopia progression. Some embodiments of this disclosure relate to an apparatus and method comprising an optical film that can convert a standard single-vision spectacle lens for myopia correction into a myopia management spectacle lens for myopia correction and for delaying, slowing, and / or reducing the rate of myopia progression; wherein the optical film can be configured on a standard single-vision spectacle lens using desired non-refractive opacity features throughout the optical film.
[0027] In some embodiments, the non-refractive opacity of the optical film can be different in different regions of the optical film, such that when the optical film is configured on or adhered to a single-vision lens, it provides increased retinal ganglion cell activity in at least one specific region of the wearer's retina, potentially slowing the progression of myopia. The desired non-refractive opacity in the optical film can be formed by the optical film itself. In some examples, the optical film is configured such that the non-refractive opacity is centered relative to the optical center of a standard single-vision lens. In this case, if the shape of the optical film matches the eyeglass frame, it is also centered relative to the geometric center of the optical film.
[0028] In some examples, one or more specific areas of the retina used to introduce increased retinal ganglion cell activity blurring may be on the nasal, temporal, superior, and / or inferior side of the retina. In some other examples, other retinal locations may be identified. In some other embodiments, one or more specific areas of the wearer's retina used to introduce increased retinal cell activity blurring may be on the foveal margin, fovea, perifoveal region, macula, and / or perimacular region of the retina.
[0029] In some other embodiments, one or more specific regions of the wearer's retina used to introduce increased retinal ganglion cell activity may be within at least 2.5, 5, 10, 15, 20, or 25 degrees of visual field. The specific regions or regions of the retina may differ between the wearer's left and right eyes. In some examples, these differences may be configured as differences in the size, orientation, and / or location of optical stimuli. In other examples, the differences may be selected such that at least one eye maintains sufficient visual performance comparable to a standard single-vision lens at any given angle.
[0030] In some embodiments, the intended optical film or sheet may cover the entire standard single-vision spectacle lens; while in other embodiments, the optical film embodiment may be configured only in a specific area of the spectacle lens. Some examples may include an optical film or sheet configured to provide the wearer with a desired increase in retinal ganglion cell activity, the optical film or sheet being configured in an elliptical, circular, or irregular shape.
[0031] In some embodiments of this disclosure, the optical film or sheet to be used in conjunction with a standard single-vision lens having the desired non-refractive opacity can be glued to the standard single-vision lens, or it can be adhered to the standard single-vision lens by finger pressure, or it can be used as a sticker on one surface of the standard single-vision lens, or it can be used as a peelable adhesive to adhere to one surface of the standard single-vision lens, or a combination thereof. In some other examples, the prescribed method of providing the manner of use may include identifying certain specific locations on the base lens and marking these locations within the matrix of the standard single-vision lens with minute embossing or micro-gradations.
[0032] In some embodiments of this disclosure, optical films or sheets having desired non-refractive opacity can be configured using transparent, flexible, thin, conformal materials and can be implemented as labels on standard single-vision lenses. This is intended to correct refractive errors, such as myopia with or without astigmatism.
[0033] In some embodiments of this disclosure, an optical film or sheet with non-refractive opaque features is configured as one or more films on a standard single-vision spectacle lens intended to correct myopia, and may cover a regional portion of the lens. In some examples, the regional portion of the spectacle lens covered by the film may have a surface area of at least 3 square millimeters, at least 4 square millimeters, at least 5 square millimeters, at least 6 square millimeters, at least 7 square millimeters, at least 8 square millimeters, or at least 10 square millimeters.
[0034] Some embodiments relate to an apparatus, device, and / or method capable of altering incident light through an optical film or sheet used in conjunction with a standard single-vision spectacle to provide an active increase in retinal ganglion cell activity to slow the growth rate of an individual eye. This can be achieved through the configuration of certain non-refractive opaque features within the optical film or sheet, a structure designed to introduce spatiotemporal signals applied to a central artificial rim pattern or artificial luminous contrast profile and / or the surrounding retina, with the increased activity of the retinal coding presumably intended to halt further eye growth.
[0035] Artificial edge patterns or artificial luminescent contrast profiles applied to the retina provide spatial contrast profiles across the central and off-center retinal fields throughout the retina. The artificially induced edges increase retinal spur activity or ganglion cell activation activity, which are surrogate measures of overall retinal activity. This disclosure presupposes that the increased retinal ganglion cell activity can provide an optical stopping signal for progressive myopia. In some other embodiments of this disclosure, an optical film or sheet having non-refractive opacity is configured such that the artificial edge patterns or artificial spatial luminescent contrast profiles applied to the retina are further configured to provide temporal variation in overall retinal ganglion cell activity.
[0036] As disclosed herein, certain embodiments of this disclosure relate to one or more variations of the structural features of a non-refractive opaque feature disposed within an optical film or sheet, for use in conjunction with a single-vision spectacle lens. For example, the structural features of the non-refractive opaque feature include one or more of the following: its opacity, its size, width, and shape, its application method, its application location, its distribution, its arrangement, and the area spanned within the optical film or sheet. As disclosed herein, the anticipated variations of the numerous structural features of the non-refractive opaque feature provide the desired visual performance of the eye function while maintaining the ability of spectacle lens embodiments to slow the progression of myopia.
[0037] Certain embodiments of this disclosure relate to the optimization of non-refractive opaque features, including but not limited to features such as opacity, size, shape, variety, pattern, location, and application method, to provide a desired increase in retinal ganglion cell activity and / or a desired level of temporal variation without impairing the eye's resolving power. For example, in some embodiments of this disclosure, one or more features of a non-refractive opaque feature within an optical film or sheet are used in conjunction with a standard single-vision spectacle lens having a basic prescription to correct refractive errors in the eye. When tested on a model eye, the spectacle lens of one of the embodiments presents many common visual scenarios, which may include typical environments and / or scenarios of behavior considered relevant to myopia development and / or progression, thereby increasing retinal ganglion cell activity by at least about 1.25 times, at least 1.5 times, at least 1.75 times, at least 2 times, at least 2.5 times, or at least 3 times that of a standard single-vision spectacle lens without a non-refractive opaque feature; wherein the retinal ganglion cell activity may include activating cells, deactivating cells, or both activating and deactivating cells within the receptive field. In some examples… The activity of retinal ganglion cells can occur in a local area, multiple local areas, or evenly distributed throughout the desired retinal visual field.
[0038] In some other embodiments, when tested on a model eye, spectacle lenses with optical films or sheets are configured with non-refractive opacities, further providing temporal variations in retinal ganglion cell activity. In some examples, retinal ganglion cell activity can be assessed by retinal peak sequence analysis, while in other examples, retinal ganglion cell activity can be measured by the change in average retinal peak rate over time. In some other embodiments of this disclosure, when tested on a model eye, spectacle lenses with optical films or sheets configured with non-refractive opacities provide increased temporal variations, fluctuations, or oscillations in retinal ganglion cell activity. These temporal variations in retinal ganglion cell activity can be represented as one or more of the following: non-monotonic variations, quasi-sinusoidal variations, sinusoidal variations, periodic variations, non-periodic variations, non-periodic quasi-rectangular variations, rectangular variations, square wave variations, or random variations in retinal ganglion cell activity.
[0039] In some examples, specific types of visual stimuli can be used to elicit retinal ganglion cell activity, such as white noise electrical stimulation, sinusoidal variations of visual stimuli, checkerboard patterns, full-field flash stimulation, half-field flash stimulation, full-field Gaussian noise, half-field Gaussian noise, regional flash stimulation, regional Gaussian noise, etc. In other examples, a more refined characterization of the neural response to the stimulus may be required. The stimuli used in this disclosure are considered merely representative means of demonstrating the work of this disclosure, and the selection of stimuli for this invention should not be construed as limiting the scope of this disclosure and / or the claims.
[0040] In some embodiments of this disclosure, the opacity of a non-refractive opaque feature disposed on or within an optical film or sheet can be configured such that the feature absorbs at least 80%, at least 85%, at least 90%, at least 95%, at least 98%, at least 99%, or all 100% of the light incident on the non-refractive opaque feature. In some other embodiments of this disclosure, the opacity of a non-refractive opaque feature disposed on or within an optical film or sheet can be configured such that the feature absorbs between 80% and 90%, or between 80% and 95%, or between 80% and 99% of the light incident on the non-refractive opaque feature.
[0041] In some examples, specialized instruments can be used to capture the amplitude and intensity of light entering and exiting one or more optical film embodiments of this disclosure. The absorption level of the non-refractive opaque feature configured within embodiments of this disclosure, or the magnitude of the amount of incident light absorbed, can be determined by calculating the differences between the light incident on the spectacle lens. In some embodiments of this disclosure, the width of any one or more of the non-refractive opaque features can be configured such that the feature is at least 3 times, at least 4 times, at least 5 times, at least 6 times, at least 7 times, at least 8 times, at least 9 times, or at least 10 times the average wavelength of light in the visible spectrum (i.e., 555 nm).
[0042] In some other embodiments of this disclosure, the width of the non-refractive opaque feature may be configured such that the feature is between 3 and 5 times, or 4 and 7 times, or 5 and 9 times, or 3 and 10 times the average wavelength of light in the visible spectrum (i.e., 555 nm). The lower limit of the width of the non-refractive opaque feature is chosen to be substantially greater than the average wavelength of light in the visible spectrum to avoid unwanted diffraction effects around the edges of the non-refractive opaque feature disclosed herein. In some embodiments, the width of any one or more non-refractive opaque features on the spectacle lens may be configured such that the feature is no greater than 50 μm, or no greater than 75 μm, or no greater than 100 μm, or no greater than 150 μm, or no greater than 200 μm, or no greater than 250 μm, or no greater than 300 μm. The upper limit of the width / size selection of the non-refractive opaque feature is supported by the ideal result of maintaining a sufficient amount of light entering the eye, allowing for minimal energy loss, thereby substantially ensuring that the resolving power of the eye wearing the intended embodiments disclosed herein remains unchanged.
[0043] In some other embodiments of this disclosure, the non-refractive opaque features can be tailored based on the degree and rate of myopia progression, such that the ability to reduce the rate of progression can be balanced with the wearer's desired level of visual compromise. In some embodiments of this disclosure, the shape of any one or more of the non-refractive opaque features that can be configured on or within an optical film or sheet can be configured such that the features are circular, hexagonal, octagonal, regular polygonal, irregular polygonal, straight line, triangle, dotted, arc-shaped, or any other random shape disclosed herein.
[0044] In some other embodiments, the intended design features of the non-refractive opaque features can form apertures of different shapes. In some other embodiments, the plurality of apertures may be referred to as a plurality of regions or portions. The plurality of apertures, regions, or portions may be configured as circular, non-circular, semi-circular, annular, elliptical, rectangular, octagonal, hexagonal, or square. In some embodiments of this disclosure, the arrangement of non-refractive opaque features on or within an optical film used with a standard single-vision spectacle lens can be configured such that the region spanned by all non-refractive opaque features is within 20 mm, or within 25 mm, or within 30 mm, or within 35 mm, or within 40 mm, or within 45 mm, or within 50 mm, or within 60 mm of the center diameter of the single-vision spectacle lens's optical zone.
[0045] In some other examples of this disclosure, the non-refractive opacity features within the optical film or lens used with a standard single-vision spectacle lens can be achieved within 30%, 35%, 40%, 45%, 50%, 55%, or 60% of the central area of the optical region of the single-vision spectacle lens. In some other examples of this disclosure, the non-refractive opacity features on the optical film or lens used in conjunction with a standard single-vision spectacle lens can be achieved within 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the peripheral area of the optical region of the single-vision spectacle lens. Here, the central or peripheral portion of a single-vision spectacle lens refers to the portion located at the optical center of the spectacle lens.
[0046] In some other examples of this disclosure, non-refractive opacity features can be achieved at one or more of the following locations on the matrix of the optical film or sheet: the front surface, the rear surface, and / or the interior of the optical film. In some embodiments, the method of achieving non-refractive opacity features on the optical film can be implemented by pad printing or laser printing methods used in the conventional development of cosmetic lenses. In some other examples of this disclosure, the optical film or sheet can be achieved at one or more of the following locations: the front surface and / or the rear surface of a standard single-vision lens. In some embodiments of this disclosure, the achieved non-refractive opacity features can be arranged in the form of multiple holes, multiple regions, and multiple portions, which can promote increased retinal ganglion cell activity, as disclosed herein, acting as a means to suppress, reduce, or control refractive errors in progressive myopia. In other embodiments, non-refractive opacity features can be achieved by a homogeneous or heterogeneous medium disposed in the matrix of the optical film. In some other embodiments, this implementation may include photoetching or other photoluminescence processes on the surface or within the matrix of the medium. This disclosure relates to an optical film configured with non-refractive opaque features that alter the transmission characteristics of incident light, thereby producing a different luminous contrast distribution (i.e., artificial edges) on the wearer's retina. This alteration of the eye's transmission characteristics is achieved by employing multiple relatively low transmission lines or stripes, or by employing multiple apertures, regions, areas, or other patterns of non-refractive opaque features arranged as envisioned herein. The low transmission lines, stripes, or features can be configured at one or more locations on the optical film: the front surface of the optical film, the rear surface of the optical film, or can be embedded within the matrix of the optical film. The low transmission lines, stripes, or features can be configured to be opaque, translucent, reflective, or absorptive. The dimensional specifications of the low transmission features, such as the width and length of the non-refractive opaque features, can be adjusted as needed in the optical film design to increase the amount of light entering the eye, minimize visual artifacts, and, when properly configured, can be used in conjunction with standard single-vision lenses to achieve the wearer's desired refractive correction and maintain or provide sufficient stopping signals to the wearer's eye.
[0047] This disclosure proposes the use of non-refractive opacities to delay the development of myopia. The use of non-refractive opacities facilitates embodiments of methods that alter the phase without using any positive defocus, positive spherical aberration, or any other variants (e.g., bifocal, multifocal, or depth-of-focus optical features). The current disclosure proposes a method that introduces artificial rim or luminous contrast features into a captured retinal image through an optical film or sheet used in conjunction with a standard single-vision lens, increasing the activity of retinal ganglion cells, which may inhibit further eye growth.
[0048] In some embodiments of this disclosure, non-refractive opaque features on or within an optical film used in conjunction with a standard single-vision lens may result in an undesirable appearance of the lens. This is undesirable for the wearer. Some embodiments of this disclosure provide spatiotemporal variations in the stopping signal facilitated by eye movement when the intended optical film or lens is worn in conjunction with the standard single-vision lens disclosed herein. The spatiotemporal variations in the presentation of the artificial edge contour or luminous contrast contour minimize the saturation of the effect on myopia progression rate over time. The embodiments presented in this disclosure address the ongoing need for modified spectral lenses that provide the therapeutic benefit of inhibiting or reducing the rate of myopia progression while providing the wearer with single-vision equivalent or sufficient visual performance, distance, and angle of view throughout the range. According to some embodiments, when used in conjunction with a standard single-vision lens, the optical film or lens is configured to have multiple non-refractive design features, such as multiple lines or stripes, or holes or patterns. When the intended optical film or lens is worn in conjunction with the standard single-vision lens disclosed herein, increased activity of the retinal encoding of the spatiotemporal signal is facilitated by eye movement. The embodiments presented in this disclosure address the ongoing need for enhanced optical designs for ophthalmic lenses that can suppress the progression of myopia while providing wearers with reasonable and appropriate visual performance, enabling them to perform a range of daily activities.
[0049] Various aspects of the embodiments of this disclosure address this need of the wearer. Exemplary methods of this disclosure include selecting the size, pattern, and arrangement of desired non-refractive opaque features on or within an optical film or sheet for use in conjunction with standard single-vision spectacle lenses of this disclosure, such that an ideal increase in ganglion cell activity on an individual's retina is balanced against edge perception of any visual disturbances the individual may experience. In one or more embodiments of this disclosure, the non-refractive opaque feature within the optical film or sheet is configured to be substantially opaque and positioned within a designated area of the standard single-vision spectacle lens; that is, the non-refractive opaque feature is configured to be opaque. Such a non-refractive opaque feature increases retinal ganglion cell activity in the central and off-center retinal pathways disclosed herein.
[0050] In some methods of this disclosure, the choice of the type of non-refractive opacity feature and its application location may depend on the activities the wearer may be engaged in while wearing the ophthalmic device, such as reading and wearing glasses. Activities performed at a computer, desk, or telephone may prescribe a specific approach or location on the lens that differs from the approach taken by wearers performing distance visual tasks, thus striking a balance between therapeutic efficacy and the ability to maintain optimal visual performance. In some other methods, the choice of non-refractive opacity feature may depend on myopia progression or potential risk factors for myopia.
[0051] Several other embodiments, including those discussed in the summary, are set forth in the description, drawings, and claims of this disclosure. It is to be understood that it is practically impossible to include every single combination, any combination, or any variation of the embodiments contemplated by this disclosure, which at least in part consider the fundamental concept of increasing retinal ganglion cell activity through the use of non-ganglionic substances. Optical films or on-sheet or internal refractive opacities used with standard single-vision spectacle lenses are considered to be within the scope of this invention. This summary portion of this disclosure is not intended to limit it to the embodiments disclosed herein. Furthermore, any limitation of one embodiment may be combined with any other limitation of any other embodiment to constitute other embodiments of this disclosure. Attached Figure Description
[0052] Figure 1 The operation of the retinal receptive field of the center-activated / peripheral-activated type and the center-activated / peripheral-activated type according to certain embodiments is demonstrated.
[0053] Figure 2 The operation of a center-activated / peripherally closed retinal receptive field according to certain embodiments is demonstrated under different stimuli or peripheral contour conditions.
[0054] Figure 3 A flowchart outlining a virtual retinal platform used to describe the work of some embodiments of this disclosure is shown. The virtual retinal platform relies on the three-layered structure of the retina: the outer plexus layer, the contrast gain control layer, and the ganglion cell layer. As described herein, these retinal-related tools facilitate the encoding of visual scenes into a series of action potentials.
[0055] Figure 4 These are basic samples of retinal input images on retinal receptors, which are assembled to demonstrate the functionality of a virtual retinal platform used to describe some embodiments of this disclosure.
[0056] Figure 5 The spike sequence (i.e., raster map) and mean retinal spike rate of a sample with one of the basic retinal configurations disclosed herein are shown at the neuronal locations on the retinal receptor plane. Retinal ganglion cells exhibit a spatially uniform scintillation response to black dots on a white background and white dots on a black background.
[0057] Figure 6 This paper presents a sample neuron with a different retinal configuration as disclosed herein, showing the spike sequence (i.e., raster map) and average retinal spike rate at the retinal receptor plane. Retinal ganglion cells exhibit a spatially uniform scintillation response to black dots on a white background and white dots on a black background.
[0058] Figure 7A pair of standard single-vision spectacle lenses for myopia correction is shown, as disclosed herein, wherein an optical film or coating is applied to substantially the entire surface area of the left spectacle lens, converting the left lens of the standard single-vision spectacle into a myopia management spectacle lens.
[0059] Figure 8 A front view of an exemplary optical sheet or film embodiment is shown, wherein, as disclosed herein, non-refractive opaque features are arranged as a plurality of circular holes, not drawn to scale.
[0060] Figure 9 A front view of another exemplary embodiment of an optical sheet or film is shown, wherein non-refractive opaque features are arranged as a plurality of hexagonal apertures as disclosed herein, not drawn to scale.
[0061] Figure 10 A front view of another exemplary optical sheet or film embodiment is shown, which has stripes as a non-refractive opaque feature as disclosed herein, and is not drawn to scale.
[0062] Figure 11 A front view of another exemplary optical sheet or film embodiment is shown, which has grid lines as a non-refractive opacity feature as disclosed herein, and is not drawn to scale.
[0063] Figure 12 The illustration shows a front view of three other exemplary optical sheet or film embodiments (i.e., moiré patterns, curve patterns, and Memphis patterns) disclosed herein, not drawn to scale.
[0064] Figure 13 A front view of an exemplary optical sheet or film embodiment with a non-refractive opaque feature, which is a plurality of circular connecting holes arranged in a hexagonal pattern as disclosed herein, is shown, not drawn to scale.
[0065] Figure 14 A front view of an exemplary optical sheet or film embodiment is shown, which has dotted non-refractive opaque features in a hexagonal arrangement pattern as disclosed herein, and is not drawn to scale.
[0066] Figure 15 A front view of an exemplary optical sheet or film embodiment is shown, which has non-refractive opaque features arranged in a random pattern as disclosed herein, and is not drawn to scale.
[0067] Figure 16 A front view of an exemplary optical sheet or film embodiment is shown, which has dotted non-refractive opaque features arranged in a spiral as disclosed herein, and is not drawn to scale.
[0068] Figure 17A front view of an exemplary optical sheet or film embodiment is shown, wherein the stripes are displayed as non-refractive opaque features in a random arrangement (not to scale), as disclosed herein. Figure 18 A front view of an exemplary optical sheet or film embodiment, as disclosed herein, is shown, having lines as non-refractive opaque features in a square grid pattern arrangement, and is not drawn to scale.
[0069] Figure 19 This demonstrates arrays of multiple subsets contained in a kit or assembly, as disclosed herein, suitable for use in... Figure 7 The standard pair of single-vision glasses described herein are used on the surface of the area.
[0070] Figure 20 This paper presents a theoretical schematic diagram of the retinal ganglion cell activity recorded by centrally activated / peripherally closed and centrally closed / peripherally activated retinal circuits when a -1D myopic model eye is corrected with a conventional single-vision spectacle lens and incident light of visible wavelength (e.g., 555 nm) and 0D plano light is incident on the -1D myopic model eye.
[0071] Figure 21 Demonstrates the use of, for example Figure 18 The illustration shows a theoretical schematic diagram of the activity of retinal ganglion cells recorded by centrally activated / peripherally closed and centrally closed / peripherally activated retinal circuits when incident light of a visible wavelength (e.g., 555 nm) and 0D plano is incident on the -1D myopia model eye using a single-vision spectacle lens.
[0072] Figure 22 The source image file (an image of a mobile phone held at a near viewing distance) represents a wide-field visual scene projected onto the retina of a wide-angle schematic eye using a nonlinear projection routine; where the virtual retina is modeled using bundles of neurons arranged in a circular pattern.
[0073] Figure 23 This represents a source image file (an image of a mobile phone at a mid-range distance) of a wide-field visual scene projected onto the retina of a wide-angle schematic eye using a non-linear projection routine; where the virtual retina is modeled using bundles of neurons arranged in a circular pattern.
[0074] Figure 24 The source image file represents a wide-field visual scene (Lenna standard image) projected onto the retina of a wide-angle schematic eye using a nonlinear projection routine; where the virtual retina is modeled using bundles of neurons arranged in a circular pattern.
[0075] Figure 25This diagram illustrates the output spike sequences obtained from intracellular and extracellular pathways of a virtual retina model used to control eyeglass lenses. Spike sequences obtained from activating and deactivating cells are represented as top and bottom subplots. The Y-axis of the diagram represents discrete neuronal bundles, and the X-axis represents time (in milliseconds). Darker sections of the curves represent spikes, while white sections represent the absence of spikes.
[0076] Figure 26 The average peak rate over time is shown from the intracellular (top) and extracellular (bottom) pathways of a virtual retina model obtained from a control spectacle lens.
[0077] Figure 27 This demonstrates how it works when used in conjunction with standard single-vision lenses, such as Figure 18 As shown, the output spike sequences obtained from the intracellular and extracellular pathways of a virtual retina model using an embodiment with optical sheets or membranes are as disclosed herein. The spike sequences obtained from the intracellular and extracellular pathways are represented as top and bottom subplots. The Y-axis of the plot represents discrete neuronal bundles, and the X-axis represents time (in milliseconds). Dark portions of the curves represent spikes, while white portions represent the absence of spikes.
[0078] Figure 28 The average peak rate over time, obtained from the intracellular (top) and extracellular (bottom) pathways of a virtual retina model, is shown. This was obtained when the optical film or sheet embodiment was used in conjunction with a standard single-vision spectacle lens. Figure 18 and 21 As shown.
[0079] Figure 29 This demonstrates how it works when used in conjunction with standard single-vision lenses, such as Figure 18 and 21 The on-axis modulation transfer function of the control group spectacle lenses and optical films or sheets was evaluated at a pupil diameter of 6 mm.
[0080] Figure 30 This demonstrates the effect when used in conjunction with standard single-vision lenses, such as in... Figure 18 and Figure 21 The off-axis modulation transfer function of the control group spectacle lens and optical film or sheet examples was evaluated at a field of view of 10 degrees and a pupil diameter of 6 mm. Detailed Implementation
[0081] Optical solutions that can be used to slow the progression of myopia include optical manipulation of retinal image features, such as using lenses with simultaneous defocus, positive spherical aberration, or positive power in the center and / or periphery of the optical region. One drawback of this design is that it impairs visual quality. Considering the impact of lens fitting compliance on efficacy, a significant reduction in visual performance can lead to even worse compliance, thus reducing efficacy. Therefore, there is a need for designs to correct myopia and slow its progression that do not cause visual impairment associated with manipulation of refractive power. The current disclosure proposes an alternative non-refractive method to delay myopia progression without utilizing optical defocus as a stopping signal. Embodiments of this disclosure propose an alternative method that slows myopia progression by artificially introducing edge or emission contrast distribution into the retinal image. The cost burden is heavy for prospective eyeglass wearers seeking myopia treatment because the standard of care for myopia treatment using existing solutions is very expensive. This disclosure addresses the cost burden problem by considering one or more embodiments involving the practicality of non-permanent, inexpensive optical films used with conventional eyeglass lenses.
[0082] In some embodiments, spatiotemporal variations in the emission contrast profile are also incorporated into the image projected onto the retina, obtained by using an optical film or sheet in conjunction with a standard single-vision spectacle lens disclosed herein, thereby increasing the activity of the entire retina, which in turn inhibits further eye growth. One or more embodiments of this disclosure rely on the central-peripheral structures of retinal ganglion cells, which preferentially respond to spatial and / or temporal variations in the emission morphology incident on the retina.
[0083] In this section, the present disclosure is described in detail with reference to one or more optical film embodiments that will be used with standard single-vision spectacle lenses, and some contemplated embodiments are illustrated and supported in the accompanying drawings. Some optical film embodiments for use with standard single-vision spectacle lenses are provided by way of explanation and should not be construed as limiting the scope of the present disclosure.
[0084] The following description provides several optical film embodiments that may share common features and characteristics of this disclosure. It should be understood that one or more features of one embodiment may be combined with one or more features of any other embodiment that may constitute an additional embodiment. The functional and structural information disclosed herein should not be construed as limiting in any way, but should only be interpreted as a representative basis for teaching those skilled in the art to employ the disclosed embodiments and variations thereof in various ways.
[0085] The subheadings and related subject headings used in the detailed description section are provided solely for the reader's convenience and should never be used to limit the subject matter described throughout this disclosure or the claims. Subheadings and related subject headings should not be used in interpreting the claims or their scope.
[0086] Several techniques have been reported that can be used to identify individuals at risk of developing or progressing myopia, including by asking about one or more of the following factors: genetics, race, lifestyle, environment, excessive close work, etc.
[0087] Certain embodiments of this disclosure are intended for individuals identified as being at risk of developing or progressing myopia. To date, numerous optical designs have been proposed to control the rate of eye growth or slow the progression of myopia. Some of these designs feature the use of a certain degree of relative orthophoto power associated with the basic prescription. Designs based on this optical principle can significantly impair visual quality. Considering the impact of lens wear compliance on efficacy, a significant reduction in visual performance may contribute to poor compliance, thereby leading to reduced efficacy.
[0088] Embodiments of this disclosure relate to optical designs that utilize the effect of purposefully configured optical films or on-sheet or internal non-refractive opaque features for use with standard single-vision lenses to increase the activity of retinal ganglion cells, thereby helping to inhibit or slow the progression of myopia. This disclosure presupposes that an active increase in the retinal encoding of spatiotemporal signals has a protective effect against progressive myopia.
[0089] The human visual system is composed of channels or pathways on and outside the retina. Retinal ganglion cells have circular receptive fields, composed of centrally activated / peripherally closed bipolar cells, and vice versa. Figure 1 and Figure 2 The working principle of a center-activated / surround-activated retinal circuit is briefly described.
[0090] Complex retinal ganglion cell circuits help to convert spatiotemporal information within incident light containing visual input scenes into spike sequences and activity patterns transmitted to the visual cortex via optic nerve fibers formed by retinal ganglion cell axons.
[0091] Two groups of retinal ganglion cells, giant cells and small cells, help to respond differently to incident light signals captured on the retina. The information carried by giant cells and small cells is parallel and independent of each other. Giant cells, or the transient pathway, capture the temporal features of the input light signal, such as motion, change, and initiation within the input scene. Small cells, or the continuous pathway, capture the spatial features of the incident light signal, such as patterns and shapes within the input scene.
[0092] The giant cell pathway has a large receptive field, a short latency, and responds in a transient manner using rapidly conducting axons. On the other hand, the small cell pathway has a smaller receptive field, a longer latency, and responds in a sustained manner using slowly conducting axons. Relative change events captured by the small cell pathway and sustained grayscale image frames captured by the small cell pathway are two highly orthogonal representations of a visual scene.
[0093] Given that the regulation of eye growth is local rather than ocular, giant cell pathways in at least some individuals may be involved in the regulation or homeostasis of eye growth. In other words, giant retinal ganglion cells containing information on local relative changes provide the ability to encode dynamic or temporal contrast in a visual scene, which can be transcribed into on or off signals.
[0094] Increased spatiotemporal contrast in a visual scene has the potential to introduce spikes or short-term increases in retinal ganglion cell activity; higher retinal ganglion cell activity corresponds to a stronger growth-inhibiting signal in the eye. Due to the structure of the retinal receptive field circuitry, the following two conditions cannot excite retinal ganglion cells: (a) a uniformly illuminated retinal scene without distinct edges (i.e., no spatial contrast in the visual scene); and (b) a scene lacking change over a long period (i.e., no temporal contrast).
[0095] Less stimulation of retinal ganglion cells results in lower firing activity, which in turn implies lower overall retinal activity; greater retinal inactivity leads to lower growth-inhibiting signals, resulting in further eye growth. The relative difference in the temporal integration of activating and deactivating receptive field activity determines further eye growth. This disclosure assumes that an inactive retina triggers eye growth, while an active retina inhibits growth or triggers a stop signal. This disclosure further considers that standard single-vision spectacle lenses and / or spatially uniform visual images in the prior art contribute to the formation of uniform and substantially borderless visual images, keeping the retina in a baseline state (i.e., baseline or constant retinal ganglion firing pattern), thereby promoting further eye growth and leading to more myopia.
[0096] Figure 1 The working principle of peripherally central and peripherally eccentric retinal receptive fields used to describe one or more embodiments of the present disclosure is illustrated.
[0097] Figure 1The first and third columns highlight four instances of the theoretical stimulus representation: (a) the entire retinal receptive field is dark (101 and 111); (b) in well-lit surroundings, there is no light in the central region of the retinal receptive field (102 and 112); (c) the peripheral region of the retinal receptive field is dark, while the central region is fully illuminated (103 and 113); and (d) both the central and peripheral regions of the retinal receptive field are fully illuminated (104 and 114). The second and fourth columns show… Figure 1 The various corresponding stimulus conditions disclosed in the paper trigger action potentials over time (e.g., the four examples (a) to (d) above).
[0098] For example, when considering a retinal receptive field with a central initiation and a peripherally closed type (i.e. Figure 1 In the absence of light stimulation (101), retinal ganglion cells fire at the baseline rate (106). When light falls only on the peripheral region (102) and not on the central region, baseline firing is suppressed during the firing cycle (107).
[0099] When the light beam coincides with the central region (103), the emissivity of the retinal ganglion cells is at its maximum (108). As the aperture expands to cover both the central and peripheral fields (104), the firing mode decreases from its maximum and becomes closer to the basic firing rate (109). This is when the central closure of the peripheral initiation receptive field (i.e., Figure 1 In the last two columns), without light stimulation (111), retinal ganglion cells are fired at the baseline rate (116). The emission rate of retinal ganglion cells reaches its maximum when light falls only on the peripheral area (112) and not on the eccentric area (117). When the light coincides with the central area (113), baseline emission is suppressed during the firing cycle (118).
[0100] As the light range expands to cover both the eccentric and surrounding fields (114), the firing mode decreases from its maximum value and becomes closer to the baseline firing rate (119). Those skilled in the art will understand that... Figure 1 The diagram represents the theoretical best-case scenario, which may be difficult to replicate in real life, except for benchtop laboratory experiments.
[0101] Figure 2 This is another graphical illustration of the emission pattern of the retinal receptive field, which has a central initiation and peripheral closure, when subjected to different stimuli. Figure 2The upper part shows five different light stimulation conditions, which describe certain edge (206) detection scenarios that the receptive field may encounter: (i) when the entire receptive field is in the dark part of the edge (201); (ii) when a part of the periphery is on the bright side of the edge, while the center and the rest of the peripheral region are still in the dark part of the edge (202); (iii) when a part of the peripheral and central regions are on the bright side of the edge, while most of the central and peripheral regions are in the dark spot of the edge (203); (iv) when all the central regions are on the bright side of the edge, while some of the peripheral regions are on the dark side of the edge (204); and finally (v) when the entire receptive field is on the bright side of the edge (205).
[0102] Figure 2 The lower half of the diagram illustrates the ganglion-activated action potentials that the receptive field may encounter over time in five different edge detection scenarios (201-205). For example, when the entire receptive field is located in the dark part of the edge (201), the ganglion firing rate is at the base rate, as shown in the diagram. Figure 2 The double black solid lines indicate that when a portion of the peripheral region is on the bright side of the edge, while the center remains on the dark side of the edge (202), the firing rate of ganglion cells is suppressed below the basic rate. When a portion of the peripheral and central regions moves toward the bright side of the edge (203), the firing rate recovers to the basic rate. When the entire central region is on the bright side of the edge, while some parts of the periphery are on the dark side (204), the firing rate reaches its peak. Finally, when the entire receptive field is on the bright side of the edge (205), the firing rate decreases toward the basic rate, but decreases over a higher range. The periphery of the receptive field also affects the amount of glutamate released by the photoreceptor. If the surrounding field is dark, the photoreceptors in that region will depolarize, thus releasing more glutamate. When light falls on the central region, at least a portion of the non-peripheral environment experiences relative darkness, and the horizontal cells connected to the photoreceptors in the surrounding environment will depolarize in response to glutamate and release their own inhibitory neurotransmitters, which will further inhibit the central photoreceptors, causing them to release less glutamate. This situation will produce the highest response in the firing action potential of retinal ganglion cells.
[0103] The opposite occurs when ambient light is present. Photoreceptors hyperpolarize in the surrounding light, releasing less glutamate. Horizontal cells connected to photoreceptors in the ambient field hyperpolarize in response and release less inhibitory neurotransmitters, resulting in a less inhibitory response that leaves the central photoreceptor uninhibited, or even releases more glutamate. This condition produces the highest response in the central closed ganglion receptor region. Virtual retina model
[0104] Figure 2A theoretical working model of the intra- and extra-channel retinal fields in the human eye is presented. To demonstrate relevance to various real-world test cases, a virtual retinal simulation platform is used to demonstrate the work of various embodiments. The operating principles and technical framework of the virtual retinal platform used are described herein. The virtual retinal platform is configured to take a set of retinal images, including time series, as input and convert them into a set of peak sequences or action potentials as output, representing the overall activity of the retina. Essentially, this paper utilizes the edge detection capabilities of the central pericentric structures of ganglion cells, which provide preferential responses to spatial and / or temporal changes in the incoming visual scene. Several variables within the framework of the virtual retinal platform can be adjusted to fine-tune the simulation of wide-field-of-view retinal images to simulate real-world scenarios. Some information regarding retinal circuitry and neurophysiology, as described in the following scientific articles, is required to perform the inventions disclosed herein. This article cites in full the scientific journal article "Exploring the Potential of Artificial Dynamic On / Off Stimuli to Inhibit Myopia Development" by Wang, Aleman, and Schaeffer, published in the June 2019 issue of *Investigative Ophthalmology and Vision Science*. It also cites in full another article by Wohrer and Kornprobst, published in the *Journal of Computational Neuroscience* in 2009, entitled "Virtual Retina: A Biological Retina Model and Simulator with Contrast Gain Control." Furthermore, this article cites in full a scientific article entitled "A New Platform for Retinal Analysis and Simulation" by Cessac, Kornprobst, Kraria, Nasser, Pamplona, Portelli, and Viéville, published in the 2017 issue of *Frontiers in Neuroinformatics*.
[0105] Ideally, the input retinal source image for the virtual retinal platform should be an approximate representation of the image formed on the human retina when an individual wears one of the intended embodiments disclosed herein. Since an actual retinal image is unavailable, the intended image can be simulated using a schematic model eye equipped with the disclosed embodiments, or an image can be obtained using a physical model eye equipped with the embodiments disclosed herein. This disclosure extensively utilizes advanced ray tracing and schematic modeling to obtain virtual retinal images of various objects when coupled with a range of refractive schematic model eyes within the scope of embodiments disclosed herein. For other embodiments, alternative methods may be considered that involve the practicality of physical or desktop model eyes to demonstrate the operation of the disclosed embodiments. The established virtual retinal processing model is used to describe the operation of various ophthalmic lens embodiments of this disclosure.
[0106] Figure 3 A flowchart illustrating the global structure of the virtual retina model, which serves as the platform for describing the internal workings of the various embodiments disclosed herein. This model is adapted from the work of Wohrer and Kornprobst, published as a peer-reviewed paper entitled "Virtual Retina: A Biological Retina Model and Simulator with Contrast Gain Control." The virtual retina model employs a simulated three-layer architecture (…). Figure 3 This facilitates the creation of continuous spatiotemporal maps that continuously transmit and transform input signals appearing in a visual scene. The brightness curve of the incoming retinal signal is L(x, y, t); where brightness is defined at time point (t) for each spatially separated point or pixel (x, y) of the retina.
[0107] For all simulations used to describe embodiments of this disclosure, the input visual scene is digitized to have an intensity between 0 and 255 representing 8-bit gray levels. However, input image distributions with intensities between 0 and 1023, or 0 and 4095, or 0 and 65535 can also be used to represent 10-bit, 12-bit, or 16-bit gray levels. Examples of other embodiments of this disclosure are provided. Subsequent layers of virtual retinal cells are modeled as a spatial continuum driven by a set of mathematical equations described herein.
[0108] As from Figure 3 As indicated by the diagram, the first stage of the virtual retina model involves processing the input signal in an outer plexiform layer, which relates to the photoreceptors and horizontal cells. In this first stage, based on the teachings of Wohrer and Kornprobst (referenced herein), a simple spatiotemporal linear filter is used to decompose the input sequence L(x, y, t) into the photoreceptor central response C(x, y, t) and the response S(x, y, t) of the horizontal surrounding cells. Furthermore, a bandpass excitation current IOPL(x, y, t) is defined in the outer plexiform layer filter using the responses C(x, y, t) and S(x, y, t), and then fed to the bipolar cells in the second stage of the model. Instantaneous nonlinear contrast gain control is applied to the bipolar layer V using a variable feedback gate parallel conductance gA(x, y, t). BP (x, y, t), thereby generating an excitation current I. GANG (x, y, t).
[0109] In the third stage, the integrated control of noise and the discrete equations of the emission cell model help to integrate I GANG(x, y, t) is converted into a spike sequence for evaluating retinal ganglion cell activity. The spikes can be modeled using one-to-one connections or synaptic cisterns using received excitatory currents. Multiple linear filters are used at different stages of the model to approximate the signal transformations occurring in the various layers of the retina. To simplify computational complexity and minimize large computational inefficiencies while maintaining relevance to the real world, several assumptions are made in the model to describe the work of embodiments of this disclosure. This disclosure is not limited to the virtual retinal model describing the work of the embodiments, and modifications to the disclosed model and the use of alternative models for design or validation are considered to be within the scope of this invention. In the first stage of the virtual retinal model appearing in the outer plexiform layer, the bipolar cells receive currents I from photoreceptor cells C(x, y, t) and horizontal cells S(x, x, y). OPL (x, y, t) is obtained as: Equation 1: I OPL (x,y,t)=λ OPL (C(x,y,t)-w OPL S(x,y,t)) Equation 2: Equation 3:
[0110] In Equation 1, C(x, y, t) represents the center signal associated with the photoreceptor; S(x, y, t) represents the surrounding signal associated with the horizontal pixel. The photoconductive process is modeled as a partially transient linear kernel cascade, which has a transient filter T ωU,τU Modulated exponential time low-pass kernel E τS And gamma exponential cascade E ηC,τC In Equation 2, the symbol C represents the kernel operation on the center signal, and U represents the undershoot. In Equation 3, S represents the kernel operation on the surround signal. The function G in Equation 2... σC This encompasses the spatial blurring of the gaps between photoreceptors. The function G in Equation 3... σS This encompasses the spatial fuzziness of the coupling gap connections between horizontal units. The symbol (t*) in Equations 2 and 3 denotes temporal convolution. The symbol ((x, y)|*) denotes spatial convolution. From this disclosure onward, the symbols used to denote temporal and spatial convolutions are... The constant λ... OPL It is the total gain of the center surround filter; while w OPL The relative weights of the center and surrounding signals are used. The contrast gain control operation in the second stage of the virtual retina model describes the influence of the local contrast of the visual input scene on the electrical signal transmission properties of the retina, which are inherently nonlinear and dynamic. Contrast gain control based on a bipolar unit-level nonlinear feedback loop can be described as: Equation 4: Equation 5: Equation 6:
[0111] In equations 4, 5, and 6, g A The variable leakage in a bipolar cell membrane can be represented using the static function QV. BP Activate it. Leakage determines the gain of the current integral at this level, where g A For V BP The evolution of g involves splitting. In these models, g A The dynamics depend on the values considered for a bipolar cell with a time scale of τA and a spatial range of σA.
[0112] The third stage of the virtual retina model involves generating spike sequences of retinal ganglion cells from the activity of bipolar cells. This is related to the bipolar signal V. BP Rectification is performed and other spatiotemporal shaping is received to achieve the desired effect in ganglion cells I. GANG An excitation current is generated on (x, y, t), as described in Equations 7 and 8. Equation 7: Equation 8:
[0113] The models proposed by Wohrer and Kornprobst use empirical formulas to simulate signal shaping from the transition of currents from bipolar cells to periganglionic ganglion cells. These models are suitable for demonstrating the work of one or more embodiments disclosed herein. The model proposes the use of multiple variables to functionally reproduce the expected response obtained from another biologically feasible model, as described in Equations 7 and 8. The parameter ε takes two input values, -1 and +1, where a negative value represents extraganglionic cell activity and a positive value represents intraganglionic cell activity. The bipolar layer signal is rectified using a static nonlinear function N(V); where the parameter λ... G and It has a reduced current magnitude. It is the linear threshold of ganglion cells. Masmoudi, Antonini, and Kornprobst proposed some other models in their paper entitled “Transmitting images through the eye: the retina as a scalable image encoder for jitter”: Image Processing, Vol. 28, 2013, the entire contents of which are incorporated herein by reference.
[0114] From I GANG(x, y, t), a series of noise leakage integrals and firing neurons (nLIF) produce a set of output spikes. In the real retina, other complex conversions of electrical signals are facilitated by the synaptic structures of the inner plexiform layer, which is the site of synaptic interactions between bipolar cells, amacrine cells, and ganglion cells. For modeling purposes to demonstrate the effectiveness of embodiments of this disclosure, in some examples, the complex synaptic relationships between amacrine cells and bipolar cells are neglected in lieu of computational efficiency.
[0115] In some other examples, as disclosed herein, the complexity of one or more of the interactions between horizontal cells and bipolar cells, amacrine cells, and bipolar cells is considered. Further extensions of the model to include various other plausible combinations of interactions between external and internal plexiform layers are considered to describe the function of the intended ophthalmic lens embodiments of this disclosure, which are believed to be within the scope of the invention.
[0116] The continuous signal I is obtained from the unit output using the standard nLIF model. GANG The method for converting (x, y, t) into a discrete set of spike sequences, described in the standard nLIF model, is as follows: Equation 9:
[0117] When the threshold (V) is reached n (t) = 1 and during the refractory period (V) n When (t) = 0, the standard nLIF model exhibits a spike. Where (η) υ (t) is a noise source that can be added to the spike generation process to reproduce the variability of real ganglion cells.
[0118] To simulate the spikes of the retinal ganglion cell layer, a virtual retina was defined in the model using the following parameters, which provide a relative level of biological plausibility and adaptive complexity. Figure 4 The following examples demonstrate the effectiveness of the virtual retina model configured with certain specific retinal parameters described herein, as described in paragraphs
[00103] through
[00117] of this disclosure.
[0119] In this example, a series of 50 image frames (each 512×512 pixels) are configured as an image montage to serve as the input source for a virtual retinal model. Odd-numbered frames of the video input stream consist of a central circular dark area on a dark background (401), while even-numbered frames consist of a central circular dark area on a white background (402). In this example, each frame is configured to be displayed for 50 milliseconds, illustrating a 2.5-second real-time stimulus display for the virtual retinal model. For both odd and even frames of the video input stream, the diameter of the central circular area is configured to be approximately 50 pixels, corresponding to a 0.5° angle diagonal to the fovea. The bit depth of each pixel in the input stream is digitized, ranging from 0 to 255 (i.e., 8 bits). The angular orientation of the video input stream is configured so that each frame is oriented approximately 5°×5° in the foveal region of the model retina. When the input image stream is presented on the virtual retina, two simulated test conditions are used to calculate the activity of retinal ganglion cells. The simulation is performed under two different cell polarities: on and off modes. Retinal activity was measured by spike activity emanating from the ganglion cell layer of the virtual retina model. Peak activity for each test condition was represented as the average neuronal peak sequence for each bundle and expressed as a histogram of the surrounding stimulation, showing the change in average peak rate over time. The first test condition included a neuronal bundle (403) positioned such that the center of the video input stream coincided with the center of the circular neuronal bundle. The second test condition included seven circular neuronal bundles (404) arranged in a hexagonal pattern, with one bundle located at the center of the video input stream and the remaining six bundles arranged circumferentially such that the circumferential diameter was approximately 2.5° × 2.5° over the foveal region of the model retina. Additionally, to demonstrate the operation of the virtual retina platform, in this example, the outer plexiform layer was configured with a central region oriented at approximately 1.5° (i.e., σC in Equation 2) and a surrounding region oriented at approximately 4.75° (i.e., σS in Equation 3). The time scale for the center and surrounding regions of the outer plexiform layer was set to approximately 1 millisecond, representing the variables τC and τS in Equations 2 and 3, respectively. As described in Equation 1 of this paper, the variable controlling the signal surrounding the integration center is chosen as w. OPL =1 and λ OPL =10.
[0120] Given in Figure 4 The example considers the simplicity of the input image stimulus characteristics, muting the options for contrast gain control and lateral connectivity without long-necked cells when computing spike sequences and spike rate analyses. Static nonlinear coefficients for bipolar and ganglion cell synapses were adapted from Wohrer and Kornprobst, where the bipolar linear threshold was set to 0, the linear threshold remained constant at 80, and the bipolar amplification value remained at 100. The neuron model was also adapted from Wohrer and Kornprobst, where for… Figure 4 , 5 The example described in section 6 considers a leakage of 0.75, neuronal noise of 20, membrane capacitance of 150, and a firing threshold of 2.4. The postsynaptic merging Sigma variable is ignored.
[0121] To demonstrate the work of one or more embodiments of this disclosure, the static nonlinear coefficients of bipolar and ganglion synapses can be compared with those used for Figure 4 The static nonlinear coefficients of the examples differ. For example, in some embodiments, the bipolar linear threshold can be at least 2, at least 5, at least 10, or at least 15. To illustrate the operation of one or more embodiments of this disclosure, the linear threshold can be at least 30, at least 60, at least 90, or at least 120. To demonstrate the operation of one or more lens embodiments of this disclosure, the bipolar magnification value can be at least 50, at least 75, at least 125, or at least 150.
[0122] To demonstrate the work of one or more embodiments of this disclosure, the leakage of the neuron model can be set to a value of at least 0.25, at least 0.5, at least 1, or at least 1.25. To demonstrate the work of one or more spectacle lens embodiments of this disclosure, the neuron noise can be set to at least 10, at least 25, or at least 50. To demonstrate the work of one or more embodiments of this disclosure, the activation threshold of the neuron can be set to at least 1.2, at least 2.4, or at least 3.6. In various other exemplary embodiments used to describe the work of optical films or sheets to be used in conjunction with standard single-vision spectacle lenses of this disclosure, various configurations with different complexities are conceivable, as described in Equations 1 to 9 herein. Non-refractive opacity features of the disclosed embodiments
[0123] Due to the arrangement of retinal pathways within and outside the channels in the temporal domain, retinal neurons primarily respond to rapidly increasing brightness (open cells) or decreasing brightness (closed cells) within the visual scene. In the spatial domain, the retinal receptive fields are arranged in a circular pattern in the central and peripheral regions, and vice versa. This arrangement of retinal cells allows for optimized utilization of retinal circuitry to achieve desired visual processing while maintaining sufficient spatial and / or temporal resolution. A clear lack of spatial and / or temporal variation in the visual scene captured at the retinal plane would result in poor excitability of retinal ganglion cells and poor retinal activity, or presumably, retinal inactivity or insufficient retinal activity would trigger eye growth. Certain embodiments of this disclosure are intended for individuals at risk of developing or progressing myopia.
[0124] One or more embodiments of this disclosure rely on the assumption that a distinct lack of distinct edges across the entire retina, different edge or spatial emission contrast distributions over time, or spatial emission contrast distributions over time, may result in retinal ganglion cell activity tending to resemble its baseline state; in other words, a substantially inactive retina.
[0125] The outputs of all receptive fields are integrable, reflecting the relative intensity of input and disconnection from the visual environment. It is assumed that the relative temporal difference in the activity of on and off receptive fields determines further eye growth. This disclosure assumes that an inactive retina triggers eye growth, while an active retina inhibits growth or triggers a stop signal.
[0126] This disclosure further envisions that standard single-vision lenses and / or spatially homogeneous visual images in the prior art contribute to the formation of homogeneous visual images with substantially no spatial margins, keeping the retina in a baseline state (i.e., the baseline or the baseline of the continuous emission pattern of retinal ganglion cells), thereby promoting further eye growth and leading to more myopia. One or more of the following advantages are found in one or more of the disclosed embodiments.
[0127] An optical film or sheet used with a standard single-vision spectacle lens provides a stopping signal to delay or halt the growth rate of the wearer's eye or the increase in refractive error. The eye is formed based on the enhancement of retinal activity by artificially introducing marginal or enhanced luminous spatial contrast profiles or enhanced temporal contrast profiles into the retinal image generated by a predetermined design feature configuration of the optical film or sheet using multiple non-refractive features. In some examples, the optical film can be permanently attached to a standard single-vision spectacle lens, while in other examples, the optical film can be non-permanently configured to obtain additional advantages, as disclosed herein.
[0128] A key difference in this disclosure is the utility of devices or methods based on optical films or sheets, which are not solely based on optical manipulation of defocus, astigmatism, or positive spherical aberration—all of which are prior art and, if compromised, could lead to a decline in the wearer's visual performance. The following exemplary embodiments relate to a method of modifying incident light via optical films or sheets for use in conjunction with standard single-vision spectacle lenses that can utilize selective effects on eye growth and myopia progression both within and outside the visual pathway, thereby converting a standard single-vision spectacle lens into a single-vision myopia management spectacle lens.
[0129] Another significant advantage of this invention is that it provides an assistive system, method, and apparatus that can be conveniently used with multiple pairs of spectacle lenses that a wearer may have. Another separate advantage of this disclosure is that it provides an economically advantageous option for myopia management for spectacle wearers. The following exemplary embodiments pertain to a method of modifying incident light by using an optical film or sheet in conjunction with standard single-vision spectacle, which provides increased retinal ganglion activity by artificially introducing inhomogeneities into the retina, thereby stimulating pathways on the retina, resulting in a visual image, and by creating or increasing the luminous contrast profile (i.e., artificial edge) on the retinal plane of the corrected eye. This can be achieved by using a fundamentally non-refractive opaque feature forming multiple holes, regions, or boundaries of regions within the optical film or sheet.
[0130] In short, the use of multiple apertures, non-refractive areas, or non-refractive zones within an optical film or lens used with standard single-vision spectacle lenses provides increased activity. When light passes through the optical film or lens used in conjunction with a standard single-vision spectacle lens, it stimulates retinal ganglion cells by stimulating open and / or closed pathways triggered by artificially introduced spatial edge contours. This increased activity of the retinal encoding of spatiotemporal signals is presumed to slow the progression of myopia. Furthermore, this use of excitatory areas, non-refractive areas, or multiple apertures within the optical film or lens used with standard single-vision spectacle lenses can provide variations in temporal contrast, complemented by the eye movements disclosed herein. Implementation methods of optical films
[0131] Since the formed image cannot be captured on a real retina, various alternative methods can be used to measure retinal activity. One or more of the disclosed embodiments can be characterized structurally and / or functionally. Structural characterization is performed by examining non-refractive opaque features configured within the optical film or sheet; the functional properties of the optical film combined with a single-vision spectacle lens can be achieved using a model eye. Various embodiments of optical films or sheets are shown and modeled to demonstrate that non-refractive opaque features used in conjunction with single-vision optical morphologies provide an increase in retinal ganglion cell activity, which is measured by alternative methods. The average retinal ganglion cell proliferation rate of the virtual retina platform simulates the performance of the wearer's eye. Figure 7 A standard pair of glasses for correcting myopia is shown, with an optical film or coating applied to substantially the entire surface area of the left lens to convert or transform the standard single-vision glasses into myopia management glasses, wherein a method for distributing the optical film or coating is described herein. Figure 7 The left side shows a pair of standard single-vision spectacle lenses 700, which have a right lens (701) and a left lens (702) and can be used to correct myopic refractive errors with or without astigmatism.
[0132] Figure 7 The right side of the image shows an exemplary embodiment including an optical film or sheet designed to substantially cover the left lens 702, shown by the dashed line; wherein the optical film or sheet 703 is configured to have a basic plano power 705 spanning the optical film or sheet, and wherein non-refractive opacities 706 are configured such that they fall in the central region of the left lens of the spectacle. In this example, when used in conjunction with standard single-vision glasses, the region 705 of the optical film does not impart any additional power or affect the refractive power.
[0133] The optical film or sheet can be peeled off using portion 704 of the film to place it onto a spectacle lens. In this example, the optical film embodiment (703) configured with the non-refractive opacity feature (706) includes a grid pattern comprising four horizontal lines and four vertical lines. The grid pattern, located at the center of the spectacle lens embodiment, spans approximately 25 mm in height and width. In some examples, the optical film or sheet configured with the non-refractive opacity feature of the present invention includes an adhesive backing to bond the optical sheet or film to a standard single-vision spectacle lens. The adhesive backing can be peelable, self-adhesive, or any other suitable adhesive means to bond the optical film or sheet to a standard single-vision spectacle lens.
[0134] This document describes exemplary methods of using the disclosed optical film or sheet with the wearer's own eyeglass lenses. For example, the shape of the wearer's own eyeglass lenses and / or frames can be followed by an optometrist or optician or any other trained professional to determine the shape and size of the optical film or sheet, requiring adherence to the care protocols disclosed herein. For example, according to the present disclosure, the optical film or sheet can then be cut or punched to substantially match the trace shape of its eyeglass frame or lens. It can then be distributed in the form of individually customized films or sheets in kits or sets of tools, which include various arrangements and combinations of the shape, design, and placement of one or more non-refractive opaque features configured within the optical film or sheet, such as... Figure 7 As shown.
[0135] An exemplary method of using an eyewear device kit with an optical film and / or sheet includes the following steps: (i) measuring the shape and size of the wearer's own eyeglasses and / or frames to determine the shape and size of the optical film; (ii) cutting or punching a non-permanent optical film to substantially match the shape of the eyeglass lenses or frames; (iii) distributing the film in the form of a set or kit comprising multiple pairs of individually customized cut or punched optical film pairs, each pair including various arrangements and combinations of the desired non-refractive opacity features in size, shape, design, and position within the optical film or sheet; and (iv) providing a set of instructions to conform to a specific care regimen. In some other examples, the optical film or sheet may be configured to have at least two or three different non-refractive opacity features.
[0136] Figure 8 A non-scale front view of an exemplary optical film or sheet embodiment is shown, having an optical film diameter (802) and a plurality of non-refractive opaque features (803) as intended. The optical film can be peeled off using section 801, thereby placing it on a single-vision lens. In this exemplary example, the optical film diameter is approximately 25 mm, and the non-refractive opaque features are arranged in the form of the boundaries of a plurality of circular holes within the optical region, each with a diameter of approximately 1 mm.
[0137] The non-refractive opaque feature (803) arranged in the form of multiple circular apertures can be configured to be between completely opaque and substantially opaque. For example, the transmissive properties of the non-refractive opaque feature, in this example the boundaries of the multiple circular apertures, can be configured such that >85% of the light incident on the non-refractive opaque feature is absorbed or not transmitted. Figure 8 The width of the boundaries of the multiple circular apertures considered, i.e., the non-refractive opaque features, is approximately 50 μm (804). This is enlarged relative to the size of the optical film described herein to demonstrate and improve the legibility of its features. The remainder of the optical film, lacking the expected non-refractive opaque features, includes transparent areas within the multiple apertures and has plano power. The use of plano power within the main portion of the optical film provides the wearer with visual performance substantially similar to that obtained with single-vision lenses, which is another advantage of this disclosure over the prior art.
[0138] Figure 9 A non-scale front view of another exemplary embodiment of an optical film or sheet is shown, having multiple interconnected hexagonal non-refractive opaque features of an optical film diameter (902) and a desired design (903). The optical film can be peeled off using section 901, thereby placing it on a single-vision lens.
[0139] In this exemplary example, the lens diameter is approximately 25 mm, and the maximum diameter of each of the non-refractive opaque features arranged in the form of the boundaries of a plurality of hexagonal apertures within the optical region is approximately 1 mm. The non-refractive opaque features arranged in the form of a plurality of hexagonal apertures (903) can be configured to be between completely opaque and translucent. For example, the transmission characteristics can be configured such that >90% of the light incident on the non-refractive opaque features is absorbed or not transmitted. Figure 9 The boundary width of the multiple hexagonal apertures envisioned herein, i.e., the non-refractive opaque feature, is approximately 25 μm (904). This is scaled up relative to the dimensions of the optical film or sheet described herein to demonstrate and improve the readability of the feature. The remainder of the optical film with the non-refractive opaque feature, including the transparent regions within the multiple apertures, has a plano power.
[0140] In yet another embodiment of the optical film or sheet, a plurality of non-refractive opaque features may be arranged as boundaries of a plurality of circular, semi-circular, elliptical, hexagonal, or any other polygonal apertures; wherein the plurality includes at least 2, 3, 5, 7, 9, 12, or 15 non-refractive opaque features.
[0141] In some other embodiments of optical films or sheets, the number of non-refractive design features arranged in the form of multiple polygonal aperture boundaries can be between 4 and 7, or between 3 and 9, or between 2 and 12, or between 3 and 15. In some embodiments, the non-refractive design features arranged in the form of multiple aperture boundaries can be separate, while in other embodiments they can be adjacent or combined.
[0142] In some other embodiments, the boundaries of the intended design features within the optical film or sheet may be opaque, and in some other embodiments, the boundaries of the intended design features may be translucent.
[0143] In some embodiments, the width of the boundary or design feature may not be constant across the multiple holes. In one embodiment of this disclosure, the shapes of the multiple holes may also be different.
[0144] Figure 10 A non-scale front view of another exemplary embodiment of an optical film or sheet is shown, having an optical film diameter (1002) as intended and multiple non-refractive opaque features (1003). The optical film can be peeled off using section 1001, thereby placing it on a single-vision lens. In this exemplary example, the optical film diameter is approximately 25 mm, and the length of the non-refractive opaque features constructed as line segments or stripes is approximately 2 mm. These non-refractive opaque features (1003) can be substantially opaque; wherein 95% of the light incident on the non-refractive opaque features is not transmitted or absorbed. Figure 10The width of the non-refractive opaque feature (1004) considered in the figure is approximately between 25 μm and 50 μm, and is only magnified in the figure to show the feature relative to the size of the optical film or sheet described herein. In a preferred embodiment, the maximum width of the non-refractive opaque feature does not exceed 100 μm, 150 μm, or 200 μm to avoid unnecessary consequences on resolution characteristics.
[0145] In this example, the remainder of the optical region of the non-refractive opaque feature (including transparent areas within multiple line segments or stripes) has a plano power. Figure 11 A front view, not drawn to scale, shows an embodiment of another exemplary optical film or sheet having an optical film diameter (1102) and non-refractive opacity (1103). The optical film can be peeled off using section 1101, thereby placing it on a single-vision lens.
[0146] In this example, the optical film has a diameter of approximately 25 mm, and the intended design feature of this embodiment is a grid pattern located at the center of the optical film, with a height and width spanning approximately 10 mm. The boundaries of these grid lines (1103) can be configured to be completely opaque or substantially opaque. Figure 11 The width of the non-refractive opaque feature (1104) considered in the figure is approximately between 50 μm and 100 μm, and is shown only when magnified in the figure to show the feature relative to the size of the optical film or sheet described herein.
[0147] Figure 11 The embodiments can also be configured in other variations, for example, the width of the intended non-refractive design feature in the optical region can be at least 5 μm, 10 μm, 20 μm, 30 μm, 40 μm or 50 μm. Figure 11 The embodiments can also be configured into other variations, for example, the width of the desired non-refractive design feature within the optical film can be between 5 and 15 μm, 15 and 25 μm, or 10 and 50 μm. Figure 11 In a preferred variant of the embodiment, the maximum width of the non-refractive opaque feature, i.e. the width of the lines forming the grid pattern, does not exceed 150 μm, 200 μm, or 250 μm, in order to avoid unnecessary consequences on the eye's resolution characteristics.
[0148] In other embodiments, the desired non-refractive design features can be positioned on the periphery of the optical film. In yet another embodiment of the optical film or sheet, the number of lines or stripes forming the grid pattern can be at least 5, 9, 15, or 25. In some other embodiments of the optical film or sheet, the number of design features forming the grid pattern lines or stripes can be between 5 and 9, or between 9 and 15, or between 9 and 15, or between 5 and 25. Alternatively, the zigzag lines can be designed to extend through the optical film or sheet with a length of at least 3 mm, 6 mm, 9 mm, or 12 mm.
[0149] In another embodiment of the optical film or sheet, one or more stripes may be arranged symmetrically or randomly, and they may be centered or off-center from the geometric center of the optical film or sheet. The stripes may also consist of straight lines or curves, and they may contact or intersect each other, or be placed independently or in combination. The width and length of the stripes may vary. Different patterns may be used for optical films placed on the left and right lenses of a standard single-vision spectacle.
[0150] In yet another embodiment of the optical film or sheet, the intended design features (i.e., multiple stripes or moiré patterns) within the optical film can be arranged separately from each other. In yet another embodiment, the contemplated multiple non-refractive opaque features can be configured to be adjacent to or staggered with each other.
[0151] Figure 12 The front views of three additional exemplary optical film or sheet embodiments with a diameter of 1201 are shown out of scale. These three exemplary optical film or sheet embodiments illustrate three anticipated non-refractive design features (1203a, 1203b, and 1203c). In this example, the non-refractive design feature (1203a) is a representative example of a anticipated moiré pattern configured remote from the geometric center of the optical film or sheet embodiment.
[0152] The non-refractive design feature (1203b) illustrates another representation of the desired curved pattern across the optical film; it is spiral-shaped. The non-refractive design feature (1203c) illustrates a Memphis pattern centered on the geometric center of the optical film or sheet. The width of the design feature ranges from 5 to 150 μm, and the substantially opaque feature is highlighted in the figure to show the feature relative to the size of the optical film or sheet described herein. In yet another embodiment of the optical film or sheet, the design feature (i.e., multiple non-refractive stripes or moiré fringes) may be contained within 1, 5, 10, 15, 20, or 25 mm of the center of the optical film or sheet. In yet another embodiment of the optical film or sheet, the design feature (i.e., multiple non-refractive stripes or moiré fringes) may be contained between 1 mm and 5 mm, between 5 mm and 10 mm, between 1 mm and 15 mm, or between 5 mm and 25 mm of the center of the optical film or sheet. In yet another embodiment of the optical film or sheet, the desired design feature (i.e., multiple stripes or moiré patterns) within the optical film may be separated from each other. In yet another embodiment, the contemplated plurality of non-refractive opaque features can be configured to be adjacent to or staggered with each other. In some embodiments of optical films or sheets, the width of the intended design features (i.e., a plurality of stripes or moiré fringes) within the optical film can be at least 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm. In some embodiments of optical films or sheets, the width of the intended design features within the optical film can be between 5 and 15 μm, 15 and 25 μm, or 10 and 50 μm. In some other embodiments, the boundaries of the intended design features within the optical film can be opaque, but in some other embodiments, the boundaries of the intended design features can be translucent. In some embodiments, the width of the design features may not be constant across the plurality of non-refractive opaque features.
[0153] Figure 13 A non-scale front view of an exemplary optical film or sheet is shown, having an optical film diameter (1302) and multiple non-refractive opaque features (1303), including combined circular non-refractive opaque features. The total number of circular holes is 7. The total diameter of the non-refractive opaque features including the multiple holes is approximately 3.75 mm. The size of each hole is approximately 1.25 mm in diameter. The boundary width of each hole is approximately 100 μm (1304). The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and legibility. The remainder of the portion of the non-refractive opaque features of the optical film, without an exemplary embodiment, is configured to have a plano power. The optical film can be partially peeled off using 1301, thereby placing it on a single-vision lens.
[0154] Figure 14A non-scale front view of an exemplary optical film or sheet showing an optical film diameter (1402) and multiple non-refractive opaque features (1403) including a dot pattern (1403), comprising a plurality of dots arranged in a hexagonal pattern, totaling 7 dots. The overall diameter of each dot pattern is approximately 4 mm. The size of each dot in the dot pattern is approximately 200 μm (1404). The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and legibility. The remainder of the portion of the non-refractive opaque features of the optical film, without an exemplary embodiment, is configured to have a plano power. The optical film can be partially peeled off using 1401, thereby placing it on a single-vision spectacle. Figure 15 A non-scale front view of an exemplary optical film or sheet is shown, having an optical film diameter (1502) and multiple non-refractive opaque features (1503) comprising a random pattern of bars or thick lines (1503), including multiple bars. The total number of bars is 7. The overall size of the random pattern of bars is approximately 4 mm in diameter. The size of each bar in the random bar pattern is approximately between 50 μm x 1.25 mm (1504). The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and legibility. The remainder of the portion of the non-refractive opaque features of the optical film, without an exemplary embodiment, is configured to have a plano power. The optical film can be partially peeled off using 1501, thereby placing it on a single-vision lens.
[0155] Figure 16 A non-scale front view of an exemplary optical film or sheet is shown, having an optical film diameter (1602) and a plurality of dot-like non-refractive opaque features (1603) arranged in a spiral pattern. The total number of spiral arms is 6. The overall size of the spiral pattern is approximately 6 mm in diameter. The size of each dot within the spiral pattern is approximately 50 μm (1604). The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and legibility. The remainder of the portion of the non-refractive opaque features of the optical film, without an exemplary embodiment, is configured to have a plano power. The optical film can be partially peeled off using 1601, thereby placing it on a single-vision lens.
[0156] Figure 17 A non-scale front view of an exemplary optical film or sheet is shown, having an optical film diameter (1702) and multiple stripe-like non-refractive opaque features (1703) arranged in a random pattern. The overall diameter of the pattern is approximately 5 mm. The size of each stripe in the random pattern is approximately 50 μm (1704).
[0157] The non-refractive opaque features are amplified relative to other features of the optical film or sheet for identification and legibility. The remainder of the non-refractive opaque features in the optical film, without an exemplary embodiment, is configured to have a substantially plano power or substantially no power. The optical film can be peeled off using section 1701, thereby placing it on a single-vision lens. Figure 18 A non-scale exemplary optical film or sheet is shown in a front view, having an optical film diameter (1802) and a plurality of square apertures arranged as a non-refractive opaque feature (1803) in a square grid pattern. The total number of apertures designed within the pattern (1803) is approximately 16. The overall size of the pattern is approximately 3 x 3 mm in diameter. The width of the lines or the boundaries of the square apertures are formed at approximately 50 μm (1804). The non-refractive opaque feature is magnified relative to other features of the optical film or sheet for identification and legibility. The remainder of the portion of the non-refractive opaque feature of the optical film, without an exemplary embodiment, is configured to have a plano power. The optical film can be peeled off using portion 1801, thereby placing it on a single-vision lens.
[0158] Figure 19 An array of optical sheets or films with different non-refractive opacities is shown, the optical sheets or films being packaged in multiple subsets within a kit. For example, Figure 19 Group A comprises a plurality of circular optical films, each configured with a Memphis pattern as shown in Figure 1203c. The optical films in groups B, C, and D respectively have... Figure 15 , Figure 18 and Figure 10 The non-refractive opacity is shown. The diameter of the optical film in each group varies between 3 mm and 30 mm. In some examples, the optical film may have a surface area of at least 200 sq mm, 400 sq mm, 800 sq mm, 1200 sq mm, 1600 sq mm, 2400 sq mm, or 2800 sq mm. In some other examples, the optical film may have a surface area of at least 20 sq mm, 50 sq mm, 75 sq mm, 100 sq mm, or 150 sq mm.
[0159] Figure 20A schematic diagram is shown depicting a -3D myopia model eye corrected with a standard single-vision spectacle (1702) of the prior art, with incident light (2000) in visible light (e.g., 555 nm) and plano 0D entering from a wide field of view (2001). When the eye is using the standard single-vision spectacle (2002), retinal ganglion cell activity recorded by a circuit (2003) with central activation and peripheral closure or central closure and peripheral activation shows minimal or minimal retinal activity. The relative difference in the temporal integration of the activity of the open and closed receptive fields determines further eye growth. This disclosure assumes that an inactive retina triggers eye growth, while an active retina reduces growth or triggers a cessation signal. This disclosure further anticipates that a standard single-vision spectacle lens of the prior art and / or a spatially uniform visual image contribute to the formation of a uniform and substantially borderless visual image, thereby keeping the retina in a baseline state (i.e., a baseline or constant emission pattern of retinal ganglion cells), thus promoting further eye growth and resulting in deeper myopia.
[0160] Figure 21 A schematic diagram is shown depicting an incident beam of visible light at a visible wavelength, such as 555 nm and flat 0D, entering the eye (2100) of a -3D myopia model from a wide field of view (2101), and being corrected using one of the exemplary optical film or sheet embodiments (1804) used in conjunction with a standard single-vision spectacle lens (2102) disclosed herein.
[0161] The non-refractive opaque features within the optical film are configured as a square grid pattern, such as Figure 18 As shown. When the eye moves behind the exemplary embodiment (2104) located on a standard single-vision lens (2102), the center-activated peripheral-off or center-off peripheral-activated circuitry (2103) demonstrates or displays an increase in activity on the retina compared to the baseline state. To illustrate this, in Figure 20 and 21A simple model eye has been chosen in this embodiment; however, in other embodiments, schematic ray-tracing model eyes such as those of Liou-Brennan, Escudero-Navarro, etc., may be used alternatively. The examples provided herein have used a -1D myopia model eye to disclose the invention, but the same disclosure can be extended to other myopia degrees, i.e., -2D, -3D, -5D, or -6D. Furthermore, it is understood that astigmatism can be incorporated to extend the scope to eyes with different degrees of myopia. In the embodiments, a specific wavelength of 555 nm is referenced; however, it should be understood that the extension can be extended to other visible wavelengths between 420 nm and 760 nm. Modeling of various exemplary optical film or sheet embodiments used in conjunction with standard single-vision spectacle lenses has shown that the considered non-refractive opacity features can increase the activity of retinal ganglion cells, which can be measured by an increase in the average retinal spike rate obtained using the lens. The virtual retina platform disclosed herein. In other embodiments, various other alternative measurements of retinal ganglion cell activity may be considered, such as examining the spike analysis of selected neuronal bundles. Theoretical eye and simulated retinal image
[0162] The advanced schematic model eye can be used to compute wide-area simulated retinal images and wide-area optical performance for one or more exemplary embodiments disclosed herein. Table 1 below provides a general prescription for obtaining retinal images as input to a virtual retinal platform performed by embodiments of this disclosure, to demonstrate the described effects obtained using embodiments of this disclosure. This should be considered one of many methods for obtaining retinal images to facilitate retinal processing simulation performed on the virtual retinal platform described herein.
[0163] The general parameters of the schematic model eye used are based on the prescriptions listed in Table 1. In this example, the general prescription in Table 1 is a schematic model eye of myopia with refractive error and myopia of -1D, without any astigmatism (Rx: -1D), configured to be in a state of accommodation of 1D, wherein the pupil diameter of the model's far-distance prescription eye is defined as 6mm and the dominant wavelength is 589nm. Table 1: Prescriptions for a schematic myopic model eye, with a refractive prescription of -1D and 1D accommodation.
[0164] In the various other exemplary embodiments disclosed herein, various modifications can be considered to evaluate the performance of other optical film or sheet embodiments described herein. Furthermore, various parameters of the illustrative model eye (e.g., anterior corneal, posterior corneal, corneal thickness, anterior lens, posterior lens, lens thickness, refractive index of the ocular media, retinal curvature, or combinations thereof) can be modified to demonstrate the work of this disclosure at various levels of myopia with or without astigmatism, and for modeling various myopic eyes in their relaxed and accommodative states. To obtain a wide-area simulated retinal image using the illustrative model eye when an embodiment of this disclosure is assembled, the source image file is convolved with an array of point spread functions spanning the desired field of view, taking into account the nonlinear projection of the image. As disclosed herein, the visual scene is transformed into a wide-angle illustrative eye. Figure 22 , Figure 23 and Figure 24 The document shows three source image files (2201, 2301, and 2401) of a visual scene used to describe the operation of the embodiments.
[0165] A virtual retina is modeled using bundles of neurons (2202, 2302, and 2402) arranged in a circular pattern. The first image (2201) represents a mobile phone screen display on a white background screen, where the diagonal of the source scene is configured to capture a 15-degree field of view at a viewing distance of 50 cm. The second image (2301) also represents a mobile phone screen display on a white background screen, where the diagonal of the source scene is configured to capture a 15-degree field of view at a viewing distance of 1 meter. The third source image (2401) shows an 8-bit grayscale Lenna image configured to be oriented 5 degrees at a viewing distance of 6 meters. In some other examples, the source image files for the three visual scenes (2201, 2301, and 2401) can be configured to be oriented at 5, 10, 15, or 20 degrees towards the retinal field of view to illustrate the performance of the various embodiments disclosed herein. An array of point spread functions is interpolated for each pixel in the modified image file. At each pixel, the effective point spread function is convolved with the modified source image file. In order to compute the point spread function on the desired field, the Huygens principle has been modified in this disclosure because the modeling effect of relatively small non-refractive opacities may be affected by Fourier estimation, which is usually used to improve computational efficiency.
[0166] The calculation of the point spread function array over the desired field of view includes the effects of diffraction and aberration. A scaled and diffracted simulated retinal image is generated to address the detected degree of distortion. The brightness of the simulated retinal image is determined by normalizing the intermediate output image to have the same peak brightness as the input source image used for the convolution operation disclosed herein.
[0167] In various embodiments of this disclosure, the settings of various parameters required for the simulation of virtual retinal images are varied to capture a variety of realistic situations that an individual might experience. In some embodiments, because the accuracy of the retinal image simulation is limited by the resolution of the input source image, care must be taken to maintain the input image resolution at least 512×512 pixels to avoid significant pixel discretization in the output image as manifested by aliasing effects. Moreover, in any case, necessary oversampling of the input source must be considered to minimize this effect at the cost of relatively long computation time. Design of contrasting single-vision spectacle lenses and exemplary embodiments
[0168] exist Figure 7 The example of the left optical film used in conjunction with a standard single-vision spectacle lens, as shown, was modeled and demonstrated to increase the activity of retinal ganglion cells compared to the right lens without the non-refractive opacity feature of the optical film. Specific non-refractive opacity features within the optical film include, for example... Figure 18 and Figure 21 The checkered pattern described in the text.
[0169] In this example, the schematic model eye in Table 1 is set to focus on an object 1 meter away from the eye. Myopia is progressively corrected in the schematic model eye using a standard single-vision lens and an exemplary optical film implementation scheme used in conjunction with the standard single-vision lens. The standard single-vision lens is modeled using the following parameters: front surface (R = 2000 mm), center thickness (1.5 mm), rear surface (R = 379.1 mm), and refractive index of 1.5, with a lens diameter of 50 mm. This standard single-vision lens does not have any non-refractive opaque features.
[0170] The second lens represents an exemplary embodiment, which is also a single-vision spectacle lens having the same parameters as the previous lens, and is further configured with... Figure 18 The disclosed square grid non-refractive opacity feature. An example of this exemplary embodiment includes a square grid pattern (1803) that further includes a plurality of square apertures positioned around the optical center of the optical film. Figure 18 The total number of holes designed within the pattern (1803) is approximately 16. The total size of the square grid is approximately 3 x 3 mm. The line width or the boundary of the square holes is approximately 50 μm (1804). The remainder of this portion of the exemplary embodiment is configured with a plano power. The non-refractive opaque feature of the exemplary embodiment is configured such that it absorbs at least 85% of the light incident on the non-refractive opaque feature.
[0171] By comparing a standard single-vision lens without non-refractive opaque features with an embodiment, i.e. a standard single-vision lens having an optical film including a non-refractive checkered pattern, simulated retinal images were calculated and analyzed when the opaque features were mounted on the schematic model eye in Table 1 using the steps disclosed in paragraphs
[00163] to
[00165] .
[0172] In this example, other variables of the virtual retina platform are envisioned to have the following settings; for example, the choice of contrast gain control mechanism is described in Equations 1, 5, and 6. The neural bundles are arranged in a circular pattern with a span of 20° x 20° field of view. The sparse lateral connectivity pattern of the virtual retina is used with 10 presynaptic neurons, a positive weight of 10%, and a weight variation of 0.01. The supplementary high-pass filter option for the outer retina layer described in Equations 2 and 3 has been muted. The postsynaptic merging option has also been muted. As described herein, post-processing the computed simulated retinal image of the controlled glasses design using the virtual retina platform results in a peak sequence that varies over time ( Figure 25 Furthermore, the histogram surrounding the stimulus highlights the mean peak frequency as a function of time. For cells with both open and closed polarities, both are functions of time. Figure 26 ). Figure 25 and Figure 26 The top and bottom subplots represent data for open and closed cells, respectively.
[0173] As discussed herein, post-processing of the simulated retinal image calculated using a virtual retina platform on the optical film embodiment results in a sequence of spikes in the time function. Figure 27 ) and the histogram of peripheral stimulation with time functions of open and closed polar cells highlight the average spike sequence ( Figure 28 ). Figure 27 and Figure 28 The top and bottom subplots represent data for open and closed cells, respectively.
[0174] For cells exhibiting two types of polarity, the neuronal activity of the control spectacle lens was characterized as Figure 25 The peak sequence is relatively time-invariant, or exhibits minimal change or fluctuation relative to a function of time. On the other hand, the neuronal activity of the spectacle lenses in the optical film embodiment is described as... Figure 27 The spikes are relative to time and fluctuate periodically as a function of time. In this example, after the initial 50 milliseconds, the neuronal activity of the control lens (e.g., Figure 26The average peak frequency (shown as a function of time) follows a relatively monotonic characteristic, indicating signal stability. The observed pattern is similar for both open and closed cells with polarity types. The response of closed cells does show a change in the average peak rate as a function of time, but the magnitude of the change is small. On the other hand, the neuronal activity of the spectacle lens obtained using the optical film embodiment, to... Figure 28 The average peak rate of the time function described in the figure follows a time-varying pattern for both open and closed types. For both polarities, neuronal activity in the control lens is depicted as follows: Figure 25 The peak sequence is relatively time-invariant. The non-stationary and non-linearity in the peak response obtained with the example lens is attributed to artificial edges or the distribution of emission contrast in the retinal image, or the temporal variation of artificial edges.
[0175] The responses of discrete neuron bundles show that the number of actively closed discrete neuron bundles is 3 to 4 times less than the corresponding number of actively open discrete neuron bundles. On the other hand, the neuronal activity in the optical membrane embodiment, such as... Figure 27 As shown in the spike pattern, the peaks are relative to time for both polarities. Furthermore, the total number of actively closed discrete neuron bundles is equal to the number of actively open discrete neuron bundles.
[0176] In this example, on-axis and off-axis evaluations of optical performance are modeled using a monochromatic light mode (589 nm) and a pupil analysis diameter of 5 mm. (As per this paper...) Figure 29 and Figure 30 The wide-field optical performance, measured as a function of spatial frequency versus modulation transfer function, is virtually indistinguishable between the control and exemplary optical film embodiment spectacle lenses at a pupil diameter of 5 mm. For off-axis performance, in this example, the field of view considered for performance evaluation is 20°, with a distance of ±10° from the center point.
[0177] This article describes another approach to using optical films on a wearer's own spectacle lenses. For example, an eye physician, optician, or any other trained professional can follow up and determine a predetermined set of locations on the wearer's own spectacle lenses to facilitate the wearer changing the position of the optical film according to a care protocol. In some examples, laser engraving in the form of dots, lines, or cross-shaped patterns can be used to define specific or prescribed locations on the spectacle lenses to which the optical film will be adhered. In some examples, the prescription kit or applicator approach involves the wearer pasting or adhering the optical film to a designated area on the spectacle lenses. In some examples, the selection of a predetermined set of locations on the wearer's own spectacle lenses can be determined by considering various patient-related factors, such as the degree of myopia, the onset of myopia, parental myopia, age, sex, and other risks typically associated with the progression of myopia or high myopia.
[0178] For example, according to the present disclosure, an optical film or sheet can be cut or punched to substantially match the trace shape of its eyeglass frame or lens. In other examples, the shape of the optical film may not be determined by the trace shape of the wearer's eyeglass frame or lens. Instead, as disclosed herein, predetermined shapes, such as circles, ovals, or any other regular or irregular shapes, can be used. Individually customized optical films or sheets can be configured in the form of a kit or set of tools, which includes various arrangements and combinations of the shape, design, and position of one or more non-refractive opaque features configured within the optical film or sheet, such as in... Figures 19 to 22 As described in [the text].
[0179] Some methods of this disclosure include care protocols to provide a spatiotemporally varying optical cessation signal; thus, the efficacy in reducing ocular growth progression can remain substantially consistent over time. In some other embodiments, standard single-vision glasses include basic spherical single-vision lenses for correcting myopia without astigmatism, or basic astigmatic / torsional single-vision lenses for correcting myopia with astigmatism.
[0180] As will be understood by those skilled in the art, this invention can be used in conjunction with any device / method that may affect the development of myopia. This may include, but is not limited to, various designs of eyeglass lenses, color filters, drugs, or behavioral modifiers.
Claims
1. An optical film for use in the eyes of a wearer with myopia or pre-myopia, characterized in that, The optical film includes a refractive region having substantially flat light and a non-refractive region containing multiple non-refractive opaque features; Wherein, at least one of the plurality of non-refractive opaque features is configured as: a dot, a straight line, a stripe, an uninterrupted curve, an arc, or a zigzag line; Each of the plurality of said non-refractive opaque features has a width between 25 micrometers and 75 micrometers, such that the non-refractive opaque feature remains substantially non-diffractive; Each of the plurality of said non-refractive opaque features absorbs at least 80% of the incident light; The total number of the non-refractive opaque features is at least 25; The optical film is configured together with a standard single-vision spectacle lens for myopia, the lens including an optical center, a front surface, and a rear surface, forming a basic prescription that provides substantial correction for myopic distance refractive errors; and The optical film, when combined with the standard single-vision spectacle lens and tested on a model eye for at least one pupil diameter and at least one wavelength between 420 nm and 760 nm, is configured to have a distance refractive error matching the basic prescription, and is configured to maintain a modulation transfer function that is substantially equivalent to the modulation transfer function of the standard single-vision spectacle lens without the optical film over a wide field of view.
2. The optical film according to claim 1, wherein, The length of at least a straight line, stripe, uninterrupted curve, or arc is at least 1250 micrometers.
3. The optical film according to claim 1, wherein, The non-refractive opaque features are arranged in a pattern that avoids the central circular area of the single-vision lens, which has a diameter of at least 3 mm.
4. The optical film according to claim 1, wherein, The non-refractive opaque feature is disposed within the center diameter of the optical zone of the single-vision lens, which is 60 mm.
5. The optical film according to claim 1, wherein, The non-refractive opaque features are arranged in at least one pattern, selected from: spoke wheel pattern, regular pattern, irregular pattern, radial pattern, circular pattern, grid pattern, or random pattern.
6. The optical film according to claim 1, wherein, The non-refractive opaque features are configured such that adjacent features are spaced apart, intersecting, or adjacent, and the spacing (if present) is sufficient to maintain the individual identity of each feature.
7. The optical film according to claim 1, wherein, The modulation transfer function is measured using a model eye selected from schematic model eye, desktop model eye, or physical model eye.
8. The optical film according to claim 1, wherein, The modulation transfer function is substantially equivalent to or almost indistinguishable from the modulation transfer function of a standard single-vision spectacle lens in a field of view of at least 5 degrees.
9. The optical film according to claim 1, wherein, The modulation transfer function is substantially equivalent to or almost indistinguishable from the modulation transfer function of a standard single-vision spectacle lens over a field of view of at least 10 degrees.
10. The optical film according to claim 1, wherein, The modulation transfer function is substantially equivalent to or almost indistinguishable from the modulation transfer function of a standard single-vision spectacle lens over a field of view of at least 15 degrees.
11. The optical film according to claim 1, wherein, The optical film is configured to maintain visual quality for the wearer equivalent to that of a standard single-vision spectacle lens.
12. The optical film according to claim 1, wherein, The retina of the desktop or physical model eye includes a camera, charge-coupled device, or complementary metal-oxide sensor for capturing images of a visual scene projected through the model eye; wherein the images captured by the retina of the model eye are used as an input stream or time series for a virtual retina simulator.
13. The optical film according to claim 12, wherein, The non-refractive opacity feature results in a spatially non-uniform contrast pattern within the input stream or time series of images captured on the retina of the model eye, wherein the spatially non-uniform contrast pattern varies with simulated eye movements of the model eye.
14. The optical film according to claim 12, wherein, The non-refractive opacity features result in artificial edges or spatial and temporal luminous contrast distributions across the wide field of view of the model eye within the input stream or time series of images captured on the retina of the model eye, the variations of which change with simulated eye movements of the model eye.
15. The optical film according to claim 13 or 14, wherein, The input stream or time series of images captured on the retina of the model eye is fed into a virtual retinal model, comprising: (a) at least one spatiotemporal filter configured to extract bandpass current simulating the outer plexus layer function of the retina of the model eye or wearer; (b) an instantaneous nonlinear contrast gain step configured with a variable feedback gate shunt conductance, resulting in an excitatory current output of the retinal ganglion cell layer of the model eye or wearer, simulating the bipolar layer function of the retina of the model eye or wearer; and (c) a set of noise-integrated and emission cell models for converting the excitatory current output of the retinal ganglion cell layer of the model eye or wearer into a spike sequence of activity representing the retinal ganglion cell activity of the retina of the model eye or wearer.
16. The optical film according to claim 1, wherein, The non-refractive opacity feature is configured to induce temporal changes in overall retinal ganglion cell activity, such as the mean retinal peak rate over time.
17. The optical film according to claim 15, wherein, The spike sequence output depicts the time variation or time difference of the average spike rate following a nonlinear, sine wave, quasi-sine wave, rectangular wave, square wave, quasi-square wave, or non-periodic pattern.
18. The optical film according to claims 1 to 17, wherein, The average peak rate of the integral over a duration of at least 2 seconds differs from the average peak rate observed using a standard single-vision spectacle lens without an optical coating in its variation over time.
19. The optical film according to claims 1 to 17, wherein, The average peak rate of the integral over a duration of at least 2 seconds is greater than the peak rate observed using a standard single-vision spectacle lens without an optical coating.
20. The optical film according to claims 1 to 17, wherein, The average peak rate of the integral over a duration of at least 2 seconds is less than the peak rate observed with a standard single-vision lens without an optical coating.
21. The optical film according to claims 17 to 20, wherein, The temporal difference in the average peak rate of the integral over a duration of at least 2 seconds was observed between an optical film with non-refractive characteristics and a spectacle lens without an optical film in the perifoveal, foveal, macula, or perimacular region of the retina of a model eye or wearer.
22. The optical film according to claims 17 to 20, wherein, The temporal variation or temporal difference in the average peak rate of the integral over a duration of at least 2 seconds was observed within a 5-degree wide field of view of the model eye or the wearer's retina, between an optical film with non-refractive characteristics and a spectacle lens without an optical film.
23. The optical film according to claims 17 to 20, wherein, The temporal variation or temporal difference in the average peak rate of the integral over a duration of at least 2 seconds was observed within a 15-degree wide field of view of the model eye or the wearer's retina, between an optical film with non-refractive characteristics and a spectacle lens without an optical film.
24. The optical film according to claims 17 to 20, wherein, The temporal variation or temporal difference in the average peak rate of the integral over a duration of at least 2 seconds is observed between an optical film with non-refractive characteristics and a spectacle lens without an optical film within a 25-degree range of the wide field of view of the model eye or the wearer's retina.
25. The optical film according to claim 1, wherein, The non-refractive opaque feature is manufactured using one or more methods selected from the following options: inkjet printing, laser printing, photolithography, laser etching, coloring, embossing, or engraving.
26. The optical film according to claim 1, wherein, The film is permanently or non-permanently attached to the front, back, or embedded within the lens of the eyeglasses, and its shape matches the curvature or shape of the lens.
27. The optical film according to claim 26, wherein, Application methods include coating, pressing, peelable adhesive, self-adhesive, or combinations thereof.
28. The optical film according to claim 1, wherein, The optical film at least partially provides a spatiotemporal change facilitated by eye movement to slow, reverse, block, delay, inhibit, or control the growth of myopia or pre-myopia in the wearer.
29. The optical film according to claim 1, wherein, The effects of slowing down, reversing, inhibiting, delaying, suppressing, or controlling the growth of myopia or myopic anterior eye in the wearer remain largely consistent over a period of time.
30. A method of using the optical film as described in claim 1, characterized in that, include: (i) Measure the shape and size of the wearer’s lenses and / or frames to determine the shape and size of the optical film; (ii) cut or scribble the optical film to roughly match the shape of the lenses or frames; (iii) package the optical film in a kit containing multiple pairs of custom optical films arranged in various sizes, shapes, designs and non-refractive features; (iv) provide a set of instructions to follow a specific care regimen.
31. An optical film for use by a wearer with myopia, characterized in that, include: A refractive zone with basic flatness and a non-refractive zone containing multiple non-refractive opaque features; Each of the plurality of non-refractive opaque features has a width between 25 micrometers and 75 micrometers, such that the non-refractive opaque feature remains substantially non-diffractive; Each of the multiple non-refractive opaque features absorbs at least 80% of the incident light; Among them, the total number of non-refractive opacity features is at least 25; Among them, at least one of the multiple non-refractive opaque features is configured as: a dot, a straight line, a stripe, an uninterrupted curve, an arc, or a zigzag line; The optical film is configured in combination with a standard myopic single-vision spectacle lens, which includes an optical center, a front surface, and a back surface, to provide a basic prescription for the correction of myopic distance refractive errors. The optical film is combined with a standard single-vision spectacle lens, and when tested on a desktop or physical model eye, the retina of the desktop or physical model eye includes a camera with a charge-coupled device or a complementary metal oxide sensor, the camera being configured to capture an image of the visual scene projected by the model eye corrected with the optical film. The image captured from the retina of the model eye is used as the input stream of the virtual retinal simulator, including at least one of the following three image processing steps: (a) spatiotemporal filtering of the input image stream to generate a bandpass current, (b) instantaneous nonlinear contrast gain control using a variable feedback gate shunt conductance, and (c) a set of discrete noisy integration and emission cell models that generate a spike sequence describing the overall retinal ganglion cell activity. Among them, multiple non-refractive opaque features were configured to induce time-varying changes in overall retinal ganglion cell activity compared to retinal ganglion cell activity obtained using single-vision spectacle lenses without optical films; Among them, overall retinal ganglion cell activity, measured as the average retinal peak rate integrated over a time span of at least 2 seconds, differs from the time variation or time difference of a single-vision spectacle lens without an optical film.
32. The optical film according to claim 31, wherein, The length of the at least one straight line, stripe, uninterrupted curve, or arc is at least 1250 micrometers.
33. The optical film according to claim 31, wherein, The non-refractive opaque features are arranged in a pattern that avoids a central circular area of at least 3 mm in diameter on the single-vision lens.
34. The optical film according to claim 31, wherein, The non-refractive opaque feature is disposed within the center diameter of 60 mm of the optical region of the single-vision lens.
35. The optical film according to claim 31, wherein, The non-refractive opaque features are arranged in at least one pattern, selected as: a regular pattern, an irregular pattern, a radial pattern, a circular pattern, a grid pattern, or a random pattern.
36. The optical film according to claim 31, wherein, The non-refractive opaque features are configured such that adjacent features are spaced apart, intersecting, or adjacent, and the spacing (if present) is sufficient to maintain the individual identity of each feature.
37. The optical film according to claim 31, wherein, The spike sequence depicts the time variation of the average spike rate following a nonlinear, sinusoidal, quasi-sine, rectangular, square, quasi-square, or non-periodic pattern.
38. The optical film according to claim 31, wherein, The average peak rate of the integral over at least 2 seconds is greater than the peak rate observed using a standard single-vision lens without an optical coating.
39. The optical film according to claim 31, wherein, The average peak rate of the integral over at least 2 seconds is less than the peak rate observed with a standard single-vision spectacle lens without an optical coating.
40. The optical film according to claim 31, wherein, The modulation of the peak rate is evident in the central / surround or eccentric / surround receptive field.
41. The optical film according to claim 31, wherein, Modeling variations in retinal ganglion cell spike activity using natural image sequences with different spatial and temporal contents.
42. The optical film according to claim 31, wherein, Modulation of spike activity helps time-varying neural signals to reduce or stop axial elongation or myopia progression.
43. The optical film according to claim 31, wherein, The spike sequence output is time-analyzed to generate one or more features, loop stimulation histograms, raster plots, and average spike rate curves as a function of time for each neuronal bundle selected from the neuronal spike sequence.
44. The optical film according to claim 31, wherein, The optical film is configured to provide visual quality comparable to that of a single-vision spectacle lens without an optical film.
45. The optical film according to claim 31, wherein, The one or more non-refractive opaque patterns are configured to be offset from the geometric center of the single-vision lens.
46. The optical film according to claim 31, wherein, The spike sequence activity is temporally correlated with specific spatial locations within the model eye's visual field to assess local variations in retinal ganglion cell responses.
47. The optical film according to claim 31, wherein, The non-refractive opaque features are arranged in at least one pattern selected from annular patterns, grid patterns, radial patterns, random patterns, regular patterns, irregular patterns, symmetrical patterns, or asymmetrical patterns.
48. The optical film according to claim 31, wherein, The non-refractive opaque features are arranged in at least one pattern defined by the distribution and spacing of the non-refractive opaque features.
49. The optical film according to claim 31, wherein, The arrangement of the non-refractive opaque features on the optical film is asymmetrical.
50. The optical film according to claim 31, wherein, The arrangement of the non-refractive opaque features depends on wearer-specific data.
51. The optical film according to any one of claims 31 to 50, wherein, The optical film, combined with a standard single-vision spectacle lens, is configured to maintain a modulation transfer function in both on-axis and off-axis regions of the field of view for at least one pupil diameter and at least one wavelength between 420 nm and 760 nm, when tested on a model eye configured to match a basic prescription for the spectacle lens; wherein the model eye is selected from schematic model eyes, desktop model eyes, or physical model eyes; wherein the off-axis region includes a field of view of at least 5 degrees.
52. The optical film according to claim 51, wherein, For modulation transfer functions with off-axis angles up to 10 degrees, they are essentially equivalent to single-vision lenses without optical coatings.
53. The optical film according to claim 51, wherein, For modulation transfer functions with off-axis angles up to 15 degrees, they are essentially equivalent to single-vision lenses without optical coatings.
54. The optical film according to claim 51, wherein, For modulation transfer functions with off-axis angles up to 20 degrees, the results are essentially equivalent to a single-vision lens without an optical coating.
55. The optical film according to claim 31, wherein, The non-refractive opaque feature is manufactured using one or more methods selected from inkjet printing, photolithography, laser etching, coloring, photographic processes, embossing, or engraving.
56. The optical film according to claim 31, characterized in that, The optical film is permanently or non-permanently attached to the front or back of the eyeglass lens or embedded within the eyeglass lens, and is applied using a method of bonding, pressing, pasting, peelable adhesive or a combination thereof, and its shape matches the curvature of the lens.
57. The optical film according to any of the preceding claims, wherein, The optical film is configured to induce spatiotemporal changes in retinal input facilitated by natural eye movements, and wherein such changes contribute to the temporal regulation of retinal ganglion cell activity over time, thereby maintaining therapeutic effects that slow, stop, or inhibit the progression of myopia.
58. The optical film according to any of the preceding claims, wherein, The optical film is configured to: (i) induce spatiotemporal variations in retinal input facilitated by natural eye movements; (ii) maintain a consistent therapeutic effect over time in slowing, halting, or inhibiting myopia progression; (iii) be assigned to the wearer as part of a kit containing multiple pairs of custom optical films configured with different sizes, shapes, or non-refractive features; and (iv) include instructions for applying the optical film to a base single-vision lens and a care plan for a wearing schedule.
59. The optical film according to any of the preceding claims, wherein, The refractive zone has a substantially flat power and is also configured to include spherical refractive power, cylindrical refractive power, or spherical aberration.
60. The optical film according to any of the preceding claims, wherein, The optical film is configured for use in the myopic anterior eye, defined as an eye that is emmetropic or hypohyperopic but is identified as having an increased risk of developing myopia based on one or more of the following: genetic predisposition, hypohyperopia in young people, limited time spent outdoors, or prolonged engagement in close-range work activities.
61. The optical film according to any of the preceding claims, for use in conjunction with a drug, behavioral therapy, or other optical device for managing myopia progression, wherein, The combination therapy is configured to provide a synergistic effect in reducing or stopping axial elongation or myopia progression.
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