Single vision spectacle lenses can be converted into myopia management spectacle lenses with non-refractive opaque characteristic optical films
By combining a non-refractive opaque optical film or sheet on a standard single-vision lens, the activity of retinal ganglion cells is increased, solving the problem that existing technologies cannot prevent myopia progression, and achieving the dual effects of myopia correction and growth inhibition.
Patent Information
- Application Number
- CN202180018911.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-03-01
- Filing Date
- 2021-02-22
- Publication Date
- 2025-09-19
- Estimated Expiration
- 2041-02-22
AI Technical Summary
Although existing technologies can correct refractive errors when correcting myopia, they cannot prevent excessive eye growth from worsening myopia.
By combining an optical film or sheet with non-refractive opaque features on a standard single vision lens, the activity of retinal ganglion cells is increased, thereby providing an optical stop signal to inhibit eye growth and myopia progression.
While effectively correcting myopic refractive errors, it slows down or inhibits the growth rate of the eyes and reduces the rate of progression of myopia.
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Figure CN115244452B_ABST
Abstract
Description
[0001] Cross-references
[0002] This application claims priority to Australian provisional application number 2020 / 900604 filed on 1 March 2020, entitled “A single vision lens”, and application number 2020 / 900605 filed on 1 March 2020, entitled “A lens for nearsightedness”; both of which are incorporated herein by reference in their entirety. Technical Field
[0003] The present disclosure relates to means for treating myopia. The present disclosure relates to apparatus and methods for prescribing, selecting, supplying, and fitting optical films for use in conjunction with standard single-vision eyeglass lenses for correcting refractive error in myopic individuals, wherein the optical films are configured to have non-refractive, opaque features that promote increased retinal ganglion cell activity, which can serve as optical signals to slow, improve, control, inhibit, or reduce the rate of myopia progression in the wearer. Background Art
[0004] The human retina consists of three main layers: the photoreceptor layer, the outer plexiform layer, and the inner plexiform layer. Cones and rods are photoreceptors that respond to light in the human retina by converting incoming light into electrical signals. These converted electrical signals travel from the photoreceptors, through bipolar cells, and further to the retinal ganglion cells and optic nerve, which transmit visual information from the retinal cells to the brain, resulting in visual perception of the world.
[0005] Photoreceptors respond with graded membrane potentials and release the neurotransmitter glutamate in proportion to the level of their polarization state. For example, in the absence of light stimulation, photoreceptors depolarize and release more glutamate relative to their baseline state.
[0006] In the presence of light, photoreceptors hyperpolarize due to the breakdown of opsins in the photoreceptors, causing them to release less glutamate relative to their baseline state. There are two types of bipolar cells in the retina: central and eccentric bipolar cells. These cells encode the spatiotemporal contrast of positive and negative incident light, respectively, by comparing the photoreceptor signal with the spatiotemporal average calculated by a lateral connection layer of horizontal cells. Horizontal cells are connected to each other and to bipolar cells and photoreceptors in complex tripartite synapses via conductive gap junctions. Central 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 and retain the signal from the light. In the presence of light, eccentric bipolar cells receive less glutamate from photoreceptors, causing hyperpolarization and the release of less glutamate to the corresponding ganglion cells downstream. In the absence of light, eccentric bipolar cells receive more glutamate from photoreceptors, causing depolarization and releasing more glutamate to their downstream ganglion cells. Central bipolar cells have metabotropic receptors that are inhibitory to glutamate. These central bipolar cells hyperpolarize in response to glutamate and reverse the signal from the photoreceptors. In the presence of light, central bipolar cells receive less glutamate from photoreceptors, causing depolarization and releasing more glutamate to their downstream ganglion cells. In the absence of light, central bipolar cells receive more glutamate from photoreceptors, causing hyperpolarization and releasing less glutamate to their downstream ganglion cells. The higher the amount of glutamate released by central or eccentric bipolar cells to their downstream ganglion cells, the larger the action potential of the ganglion cells. The opposite responses to light between central and eccentric bipolar cells are key to the differential responses between light and dark states. In addition, the depolarizing signaling activity of central and eccentric bipolar cells can be amplified or inhibited by horizontal cells that connect to surrounding photoreceptors in the corresponding receptive fields. Horizontal cells receive excitatory input from photoreceptors and send inhibitory feedback back to photoreceptors connected to surrounding areas.
[0007] A receptive field is a group of photoreceptors that sends input signals to downstream bipolar and ganglion cells in the retina. Retinal receptive fields can be described using concentric circles, with a smaller circular central field surrounded by a wider circular field (called the surround field). Receptive fields are divided into two types: surround-on, center-off, and surround-off, center-on. Based on differences in bipolar cell type, central and eccentric receptive fields respond differently to light.
[0008] The human eye is hyperopic at birth, with the eye length being too short for its total refractive power. As people age from childhood to adulthood, the eyeball continues to grow until the refractive state of the eye stabilizes. Eye growth is thought to be controlled by a feedback mechanism, regulated primarily by visual experience, to align visual acuity with eye length and maintain homeostasis. This process is called emmetropization. The signal guiding the emmetropization process is initiated by modulation of light energy received by the retina. Retinal image characteristics are monitored by a biological process that modulates the signal to start or stop, accelerate, or slow eye growth. This process coordinates the optics and eye length to achieve or maintain emmetropia. Derailment of this emmetropization process can lead to refractive errors, such as myopia. It is hypothesized that decreased retinal activity promotes eye growth, while conversely, increased retinal activity inhibits eye growth.
[0009] The prevalence of myopia is increasing at an alarming rate in many parts of the world, particularly in East Asia. In myopic individuals, the axial length of the eye is mismatched with the overall power of the eye, resulting in distant objects focusing in front of the retina. Myopia can be corrected with a simple pair of negative single-vision eyeglass lenses. While such devices can optically correct the refractive error associated with eye length, they do not address the underlying cause of excessive eye lengthening in the development of myopia. Excessive eye lengthening in highly myopic individuals is associated with serious vision-threatening conditions such as cataracts, glaucoma, myopic maculopathy, and retinal detachment. Therefore, there is a need for specialized optical devices for individuals that not only correct the underlying refractive error but also prevent excessive eye lengthening or myopia progression.
[0010] definition
[0011] Unless otherwise defined below, the terms used herein are generally used by those skilled in the art: The term "myopic eye" refers to an eye that has experienced myopia, is in the pre-myopic stage; or is at risk of myopia; or has been diagnosed with a refractive condition that is progressing towards myopia with or without astigmatism.
[0012] The term "progressive myopia" refers to an eye that has been diagnosed as developing myopia, as 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 term "pre-myopia" or "eye at risk for myopia" refers to an eye that may have been emmetropic or had low distance vision at the time, but has been identified as being at increased risk of becoming myopic based on genetic factors (e.g., both parents are myopic) and / or age (e.g., hyperopia as a young child) and / or environmental factors (e.g., time spent outdoors) and / or behavioral factors (e.g., time spent completing near tasks).
[0013] The term "optical stop signal" or "stop signal" refers to an optical signal or directional cue that can help slow, reverse, brake, delay, inhibit, or control the growth of the eye and / or the refractive condition of the eye.
[0014] The term "spectacle lens" can refer to a finished or semi-finished blank lens. The terms "standard single-vision spectacle lens," "commercially available single-vision spectacle lenses," "standard spectacles," or "traditional single-vision" refer to spectacles designed to correct the eye's inherent refractive error. This refractive error can be myopia, with or without astigmatism.
[0015] The term "myopia management glasses" or "myopia prevention glasses" refers to glasses that are used not only to correct the eye's underlying refractive error but also to manage the refractive error; where the refractive error may be myopia, with or without astigmatism.
[0016] The term "optical zone" or "optical zone" refers to the area on a spectacle lens or the front of a spectacle lens having a defined optical effect. The term "optical center" refers to the geometric center of the optical zone of a spectacle lens.
[0017] The term "optical axis" refers to a line passing through the optical center and substantially perpendicular to a plane containing the edge of a spectacle lens.
[0018] The term or phrase "monovision optical zone" or "basic monovision optics" or "basic monovision characteristics" or "spherical optical zone" means an optical zone having a uniform power distribution without significant primary spherical aberration. Monovision optical zones may be further categorized to include astigmatism to correct for distance refractive errors. The term "model eye" may refer to a schematic, ray traced, or physically model eye.
[0019] As used herein, the terms "diopter," "power," or "D" are unit measurements of diopters, which are defined as the reciprocal of the focal length of a lens or optical system along the optical axis, measured in meters. The term "D" refers to spherical power and the term "DC" refers to cylindrical power.
[0020] The term "base prescription for correcting refractive error" refers to the standard eyeglass prescription required to correct an individual's underlying myopia with or without astigmatism.
[0021] The term "subfoveal area" refers to the area immediately adjacent to the fovea of the retina, approximately 0.5 mm in diameter. The term "foveal area" refers to the area approximately 1.5 mm in diameter surrounding the central pit. The term "parafoveal area" refers to the area adjacent to the foveal area, approximately 1.5 mm outside the fovea and within a diameter of 3 mm. The term "parafoveal area" refers to the area immediately adjacent to the foveal area, approximately 1.5 mm outside the central pit and within a diameter of 3 mm. Summary of the Invention
[0022] The background to the present disclosure provides a detailed discussion of the prior art and generally interesting subject matter, presents the context for the disclosed embodiments, and further distinguishes the contemplated advancement of the present invention by disclosure of the prior art. Nothing herein should be taken as an admission that the material antedates the prior art, is known to the public, or is part of the general knowledge based on the priority given to the various embodiments and / or claims set forth in the present disclosure.
[0023] In short, all prior art optical designs with refractive or phase-changing features for controlling myopic refractive error involve significant visual impacts, primarily due to the use of multifocal-like design features commonly 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.
[0024] A catalog of solutions featuring amplitude-modifying features have been proposed in the field of optics to improve the depth of focus of common imaging systems. Examples are described in a paper by Mino and Okano, "Improvement of the OTF of Through-Focus Optical Systems by Using Occluded Apertures," Applied Optics, 1971; Castaneda et al., "Arbitrarily High Depth of Focus with Quasi-True and Positive Transmittance Apodizers," Applied Optics, 1989; Castaneda and Berriel-Valdos, "Zone Plates for Arbitrarily High Depth of Focus," Applied Optics, 1990; and U.S. Patents 5,965,330A, 8,570,655B2, and 8,192,022. Disadvantages of amplitude-modifying solutions include reduced energy transfer at critical frequencies, inferior resolution relative to their phase-modifying counterparts, and low light throughput. In contrast, as described herein, the present invention involves the use of standard single-vision eyeglass lenses purposefully configured with non-refractive opaque features designed to provide an increase in retinal ganglion cell activity and overcome one or more of the shortcomings of the prior art.
[0025] Certain disclosed embodiments are directed to apparatus, supplies, and configurations of optical films or sheets for use in conjunction with standard single vision lenses, and methods of using optical films or sheets for use in conjunction with standard single vision lenses to correct and manage myopia. The purpose of certain disclosed embodiments is twofold, namely to correct myopic refractive error and simultaneously provide an increase in retinal ganglion cell activity that acts as an optical stop signal to reduce the progression of eye growth in the wearer. Certain disclosed embodiments include eyeglass lenses for altering the characteristics of incident light entering a human eye. Certain disclosed embodiments are directed to the construction of eyeglass lenses for correcting, managing, and treating refractive errors such as myopia. Some embodiments are intended to correct myopic refractive error and simultaneously provide an optical stop signal that prevents further eye growth or myopia progression.
[0026] 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 performed by the wearer. Various aspects of the disclosed embodiments address this need of wearers.
[0027] Certain disclosed embodiments include an optical film or sheet for use with a standard single vision eyeglass lens, wherein the optical film or sheet is purposefully constructed to have non-refractive opaque characteristics, and wherein the constructed optical film or sheet is used in conjunction with a standard single vision eyeglass lens to at least partially result in foveal correction of a myopic eye and at least partially result in increased retinal ganglion cell activity in a myopic eye, thereby inhibiting further eye growth or progression of myopia in the wearer. The present disclosure relates to eyeglasses for managing eye conditions such as myopia. The proposed methods include correcting myopic refractive error and controlling, inhibiting or reducing the rate of progression of myopia. The present disclosure relates to optical intervention methods that utilize the effect of increasing retinal ganglion cell activity to reduce the progression of myopia. In some embodiments, the one or more regions of the retina applied to increase retinal activity can be in the fovea, perifoveal, macula and / or perimacular regions of the retina. In some embodiments, the one or more regions of the retina applied to increase retinal activity can be in the temporal, nasal, inferior and / or superior portions of the retina.
[0028] Certain embodiments of the present disclosure are directed to methods comprising procedures for prescribing, selecting, fitting, and supplying an optical film or sheet configured for use with a standard single vision spectacle lens for increasing retinal ganglion activity, such as cell activity, i.e., stop signals, which can slow the rate of myopia progression. Certain embodiments of the present disclosure are directed to an apparatus and method comprising an optical film that can convert a standard single vision spectacle lens for correcting myopia into a myopia management spectacle lens for correcting myopia as well as 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 opaque features throughout the optical film.
[0029] In some embodiments, the non-refractive opaque characteristics of the optical film can be different in different areas of the optical film, so that when the optical film is configured on or adhered to a single-vision eyeglass lens, it provides an effect of increasing retinal ganglion cell activity in at least one specific area of the wearer's retina, thereby reducing the rate of myopia progression. The desired non-refractive opaque characteristics in the optical film can be formed by the optical film. In some examples, the optical film is configured so that the non-refractive opaque characteristics are centered relative to the optical center of a standard single-vision eyeglass. 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.
[0030] In some examples, the one or more specific regions of the retina for introducing increased retinal ganglion cell activity blur can be located in the nasal, temporal, superior, and / or inferior regions of the retina. In some other examples, other retinal locations can be identified. In some other embodiments, the one or more specific regions of the wearer's retina for introducing increased retinal ganglion cell activity blur can be located in the foveal perifoveal, foveal, perifoveal, macula, and / or perimacular regions of the retina.
[0031] In some other embodiments, the specific area or areas of the wearer's retina targeted for increased retinal ganglion cell activity may be within at least 2.5 degrees, 5 degrees, 10 degrees, 15 degrees, 20 degrees, or 25 degrees of the visual field. The specific area or areas 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 position of the optical stimulus. In other examples, the differences may be selected so that at least one eye maintains adequate visual performance comparable to standard single-vision lenses at any given angle.
[0032] In some embodiments, the contemplated optical film or sheet may cover the entirety of a standard single vision eyeglass lens; while in other embodiments, the optical film embodiments may be configured only in specific areas of the eyeglass lens. Certain examples may include an optical film or sheet configured to provide a desired increase in retinal ganglion cell activity to a wearer, the optical film or sheet configured in an oval, circular, or irregular shape.
[0033] In some embodiments of the present disclosure, an optical film or sheet to be used in conjunction with a standard single-vision eyeglass lens having desired non-refractive opaque characteristics can be glued to the standard single-vision eyeglass lens, can be adhered to the standard single-vision eyeglass lens using finger pressure, can be applied as a sticker to one surface of the standard single-vision eyeglass lens, can be applied as a removable adhesive to one surface of the standard single-vision eyeglass lens, or a combination thereof. In some other examples, the prescribed method for providing the manner of use can include identifying certain specific locations on the base eyeglass lens and marking these locations with tiny embossing or micro-gradients within the matrix of the standard single-vision eyeglass lens.
[0034] In some embodiments of the present disclosure, an optical film or sheet having the desired non-refractive opaque characteristics can be configured using a transparent, flexible, thin, conformable material and implemented as a tab on a standard single-vision eyeglass lens intended to correct refractive errors, such as myopia with or without astigmatism.
[0035] In some embodiments of the present disclosure, an optical film or sheet configured with non-refractive opaque features is configured as one or more coatings on a standard single-vision spectacle lens intended to correct myopia, and can cover a portion of the spectacle lens. In some examples, the portion of the spectacle lens covered by the coating can 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.
[0036] Certain embodiments relate to an apparatus, device, and / or method capable of modifying incident light via an optical film or sheet used in conjunction with a standard single vision lens to provide an active increase in retinal ganglion cell activity to slow the growth of an individual's eye. This can be achieved by configuring certain non-refractive opaque features within the optical film or sheet, which, when used in conjunction with the single vision lens, is designed to introduce a spatiotemporal signal applied to the central artificial edge pattern or artificial luminous contrast profile and / or the peripheral retina, whereby the increased activity encoded by the retina is hypothesized to arrest further eye growth.
[0037] An artificial edge pattern or artificial luminous contrast profile applied to the retina provides a spatial contrast profile across central and eccentric retinal fields across the entire retina. The artificially induced edge increases retinal spiking activity or ganglion cell firing activity, which is a surrogate measure of overall retinal activity. The present disclosure hypothesizes that increased retinal ganglion cell activity can provide an optical stop signal to progressive myopia. In some other embodiments of the present disclosure, an optical film or sheet having non-refractive opaque features is configured such that the artificial edge pattern or artificial spatial luminous contrast profile applied to the retina is further configured to provide temporal variation in overall retinal ganglion cell activity.
[0038] As disclosed herein, certain embodiments of the present disclosure relate to one or more variations of the structural characteristics of non-refractive opaque features configured within an optical film or sheet for use in conjunction with a single-vision ophthalmic lens. For example, the structural characteristics of the non-refractive opaque features include one or more of: their opacity; their size, width, and shape; their method of application; their location of application; their distribution; their arrangement; and the area they span within the optical film or sheet. As disclosed herein, the contemplated variations of the numerous structural characteristics of the non-refractive opaque features provide the desired ophthalmic functional visual performance while maintaining the ability of the ophthalmic lens embodiments to slow the progression of myopia.
[0039] Certain embodiments of the present disclosure relate to the optimization of non-refractive opaque features, including but not limited to the following: opacity, size, shape, variety, pattern, location, and method of application, to provide a desired increase in retinal ganglion cell activity and / or a desired temporal variation in activity without compromising the eye's resolution. For example, in some embodiments of the present disclosure, one or more of the non-refractive opaque features within an optical film or sheet are used in conjunction with a standard single-vision ophthalmic lens having a base prescription to correct the eye's refractive error. The ophthalmic lenses of these embodiments, when tested on model eyes and presented with a number of common visual scenes, which may include scenes representative of environments and / or behaviors believed to be associated with the development and / or progression of myopia, increase retinal ganglion cell activity by at least approximately 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, compared to retinal ganglion cell activity produced by a standard single-vision ophthalmic lens without the non-refractive opaque features. The retinal ganglion cell activity may include on-type cells, off-type cells, or both on-type and off-type cells within the receptive field. In certain examples, the ophthalmic lenses of these embodiments, when tested on model eyes and presented with a number of common visual scenes, which may include scenes representative of environments and / or behaviors believed to be associated with the development and / or progression of myopia, increase retinal ganglion cell activity by at least approximately 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, compared to retinal ganglion cell activity produced by a standard single-vision ophthalmic lens without the non-refractive opaque features. The activity of retinal ganglion cells can be localized in one local region, in multiple local regions, or evenly distributed across the entire desired retinal field of view.
[0040] In some other embodiments, an eyeglass lens having an optical film or sheet configured with non-refractive opaque features, when tested on a model eye, additionally provides temporal variation in retinal ganglion cell activity. In some examples, retinal ganglion cell activity can be assessed by retinal spike train analysis, while in other examples, retinal ganglion cell activity can be measured by changes in average retinal spike rate over time. In certain other embodiments of the present disclosure, an eyeglass lens having an optical film or sheet configured with non-refractive opaque features, when tested on a model eye, provides increased temporal variation, fluctuation, or oscillation in retinal ganglion cell activity. The temporal variation in retinal ganglion cell activity can be represented by one or more of the following: non-monotonic variation, quasi-sinusoidal variation, sinusoidal variation, periodic variation, non-periodic variation, non-periodic quasi-rectangular variation, rectangular variation, square wave variation, or random variation in retinal ganglion cell activity.
[0041] In some examples, specific types of visual stimulation can be used to elicit retinal ganglion cell activity, such as white noise electrical stimulation, sinusoidal variations of visual stimulation, 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 stimulation may be required. The stimuli used in this disclosure are considered only as representative means of demonstrating the workings of the disclosure, and the selection of the present invention should not be interpreted as limiting the scope of the disclosure and / or claims.
[0042] In some embodiments of the present disclosure, the opacity of the non-refractive opaque features configured on or within an optical film or sheet can be configured such that the features absorb 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 features. In some other embodiments of the present disclosure, the opacity of the non-refractive opaque features on or within an optical film or sheet can be configured such that the features absorb between 80% and 90%, or between 80% and 95%, or between 80% and 99% of the light incident on the non-refractive opaque features.
[0043] In some examples, specialized instrumentation can be used to capture the amplitude and intensity of light entering and exiting one or more optical film embodiments of the present disclosure. The level of absorption of the non-refractive opaque features configured within the disclosed embodiments, or the amount of absorption of incident light, can be determined by calculating the difference between the light incident on the eyeglass lens. In some embodiments of the present 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).
[0044] In some other embodiments of the present disclosure, the width of the non-refractive opaque feature can be configured such that the feature is between 3 and 5 times, or between 4 and 7 times, or between 5 and 9 times, or between 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 selected to be substantially larger than the average wavelength of light in the visible spectrum to avoid unwanted diffraction effects around the edges of the non-refractive opaque features disclosed herein. In some embodiments, the width of any one or more non-refractive opaque features on an ophthalmic lens can be configured such that the feature is no larger than 50 μm, or no larger than 75 μm, or no larger than 100 μm, or no larger than 150 μm, or no larger than 200 μm, or no larger than 250 μm, or no larger than 300 μm. The upper limit of the width / size of the non-refractive opaque feature is selected based on the ideal result of maintaining a sufficient amount of light entering the eye with minimal energy loss, thereby substantially leaving the resolving power of an eye wearing the contemplated embodiments disclosed herein unchanged.
[0045] In some other embodiments of the present disclosure, the non-refractive opaque features can be customized based on the degree and rate of progression of myopia, so that the ability to reduce the rate of progression can be balanced with the desired degree of visual compromise that the wearer can accept. In certain embodiments of the present 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 so that the feature is a circle, hexagon, octagon, regular polygon, irregular polygon, line, triangle, point, arc, or any other random shape disclosed herein.
[0046] In some other embodiments, the intended design features of the non-refractive opaque features can form holes of different shapes. In some other embodiments, the multiple holes can be referred to as multiple areas or portions. The multiple holes, areas or portions can be configured as circular, non-circular, semi-circular, annular, elliptical, rectangular, octagonal, hexagonal or square. In certain embodiments of the present disclosure, the arrangement of the non-refractive opaque features on or within an optical film or sheet used with a standard single-vision eyeglass lens can be configured so that the area spanned by all the 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 optical zone of the single-vision eyeglass lens.
[0047] In some other examples of the present disclosure, the non-refractive opaque features within an optical film or sheet used with a standard single-vision spectacle lens can be implemented within the central 30%, 35%, 40%, 45%, 50%, 55%, or 60% of the optical zone area of the single-vision spectacle lens. In some other examples of the present disclosure, the non-refractive opaque features on an optical film or sheet used in conjunction with a standard single-vision spectacle lens can be implemented within the peripheral 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the optical zone area of the single-vision spectacle lens. References to the central or peripheral portion of a single-vision spectacle lens herein refer to the portion located at the optical center of the spectacle lens.
[0048] In some other examples of the present disclosure, non-refractive opaque features can be implemented on one or more of the following locations within the substrate of an optical film or sheet: the front surface of the optical film, the back surface of the optical film, and / or within the interior. In some embodiments, the method for implementing the non-refractive opaque features on the optical film can be implemented using pad printing or laser printing methods commonly used in the development of cosmetic lenses. In some other examples of the present disclosure, the optical film or sheet can be implemented on one or more of the following locations: the front surface of a standard single-vision lens and / or the back surface of a standard single-vision lens. In some embodiments of the present disclosure, the implemented non-refractive opaque features can be arranged in the form of multiple holes, multiple areas, or multiple sections, which can promote increased retinal ganglion cell activity, as disclosed herein, acting as optical stop signals for inhibiting, reducing retinal myopia, or controlling refractive error in progressive myopia. In other embodiments, the non-refractive opaque features can be implemented via a homogeneous or heterogeneous medium configured into the substrate of the optical film. In some other embodiments, this implementation can include photolithography of the medium on the surface or within the substrate, or other photolithography processes. The present 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., an artificial edge) on the wearer's retina. The alteration of the transmission characteristics to the eye is achieved by employing a plurality of relatively low transmission lines or stripes, or by employing non-refractive opaque features arranged as a plurality of holes, areas, regions, or other patterns as contemplated herein. The low transmission lines, stripes, or features can be configured at one or more locations on the optical film: on the front surface of the optical film, on the back surface of the optical film, or embedded within the substrate 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 and minimize visual artifacts. The appropriately configured optical film can be used in conjunction with a standard single-vision lens to achieve the desired refractive correction for the wearer's eye and maintain or provide an adequate stop signal to the wearer's eye.
[0049] The present disclosure proposes the use of non-refractive opaque features to delay the progression of myopia. The use of non-refractive opaque features facilitates embodiments of phase-modifying methods that do not utilize any positive defocus, positive spherical aberration, or any other variants (e.g., bifocal, multifocal, or extended depth of focus optical features). The current disclosure proposes a method for introducing artificial edge or luminous contrast features into a captured retinal image via an optical film or sheet used in conjunction with a standard single-vision lens, thereby increasing the activity of retinal ganglion cells, which may inhibit further growth of the eye.
[0050] In some embodiments of the present disclosure, non-refractive opaque features on or within an optical film or sheet used in conjunction with a standard single-vision spectacle lens may result in an undesirable appearance of the spectacle lens. This is undesirable for the wearer. Some embodiments of the present disclosure provide for spatiotemporal variations in stop signals facilitated by eye movement when the intended optical film or sheet is worn in conjunction with a standard single-vision spectacle lens disclosed herein. The spatiotemporal variations in the presentation of an artificial edge profile or luminous contrast profile minimize the saturation of the effect of myopia progression rate over time. The embodiments presented in the present disclosure address the ongoing need for improved frame lenses that provide the benefits of treatment that inhibits or reduces the rate of myopia progression while providing the wearer with single-vision equivalent or adequate visual performance across the entire range, distance, and viewing angles. According to some embodiments, when used in conjunction with a standard single-vision spectacle lens, the optical film or sheet is configured with multiple non-refractive design features, such as multiple lines or stripes, or holes or patterns. When the intended optical film or sheet is worn in conjunction with a standard single-vision spectacle lens disclosed herein, increased activity in the retinal encoding of the spatiotemporal signal is facilitated by eye movement. The embodiments presented in this disclosure address the continuing need for enhanced optical designs for ophthalmic lenses that can inhibit the progression of myopia while providing the wearer with reasonable and adequate visual performance to enable the wearer to perform a range of activities as part of their daily routine.
[0051] Various aspects of embodiments of the present disclosure address this need of wearers. Exemplary methods of the present disclosure include selecting the size, pattern, and arrangement of contemplated non-refractive opaque features on or within an optical film or piece for use in conjunction with a standard single-vision spectacle lens of the present disclosure to provide a desired increase in ganglion cell activity on the retina of an individual, balanced against the peripheral perception of any visual disturbances that the individual may experience. In one or more embodiments of the present disclosure, the non-refractive opaque features within the optical film or piece are configured to be substantially opaque and are positioned within a designated area of the standard single-vision spectacle lens; that is, the non-refractive opaque features are configured to be opaque. Such non-refractive opaque features increase retinal ganglion cell activity in the central and eccentric retinal pathways disclosed herein.
[0052] In some methods of the present disclosure, the type of non-refractive opaque feature and its location of application may be determined by the activities a wearer may perform while wearing the ophthalmic device, for example, a wearer who reads and wears glasses. A wearer performing activities at a computer, desk, or phone may be prescribed in a specific manner or location on the eyeglass lens, which may differ from a wearer engaging in distance vision tasks, thereby striking a balance between therapeutic efficacy and therapeutic effectiveness to maintain optimal visual performance. In certain other methods, the selection of non-refractive opaque features may be determined by potential risk factors for myopia progression or myopia.
[0053] Several other embodiments, including those discussed in the Summary, are set forth in the description, drawings, and claims of the present disclosure. It is understood that it is not practically possible to include every single combination, any combination, or any variation of the embodiments contemplated by the present disclosure that takes into account, at least in part, the basic concept of increasing retinal ganglion cell activity through the use of non-ganglionic devices. Refractive opaque features on or within optical films or sheets for use with standard single vision eyeglass lenses are considered to be within the scope of the present invention. This Overview section of the present disclosure is not intended to be limited to the embodiments disclosed herein. Furthermore, any limitation of one embodiment may be combined with any other limitation of any other embodiment to constitute additional embodiments of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS
[0054] Figure 1 The operation of retinal receptive fields of center-on / surround-off and center-off / surround-on types according to certain embodiments is demonstrated.
[0055] Figure 2 The operation of a center-on / periphery-off retinal receptive field under different stimulus or edge contour conditions according to certain embodiments is demonstrated.
[0056] Figure 3 A flowchart outlining a virtual retina platform used to describe the operation of some embodiments of the present disclosure is shown. The virtual retina platform relies on the three layers of the retina: the outer plexiform layer, the contrast-gain control layer, and the ganglion cell layer. As described herein, these retina-related tools help encode visual scenes as a series of action potentials.
[0057] Figure 4 is a basic sample of retinal input images on retinal receptors, assembled to demonstrate the functionality of the virtual retina platform used to describe the workings of some embodiments of the present disclosure.
[0058] Figure 5 Spike trains (i.e., raster plots) and mean retinal spike rates for neuronal locations in the retinal receptor plane are shown for a sample of one of the basic retinal configurations disclosed herein. Retinal ganglion cells responded to uniform flashes of space between a black dot on a white background and a white dot on a black background.
[0059] Figure 6 The spike trains (ie, raster plots) and average retinal spike rates of a sample neuron at the retinal receptor plane of another retinal configuration disclosed herein are shown. Retinal ganglion cells responded to spatially uniform flashes between a black dot on a white background and a white dot on a black background.
[0060] Figure 7A pair of standard single-vision eyeglass lenses for correcting myopia is shown with an optical sheet or film applied to substantially the entire surface area of the left eyeglass lens, as disclosed herein, converting the left lens of the standard single-vision eyeglasses into a myopia management eyeglass lens.
[0061] Figure 8 Shown is a front view of an exemplary optical sheet or film embodiment in which non-refractive opaque features are arranged as a plurality of circular apertures as disclosed herein, not drawn to scale.
[0062] Figure 9 An elevational view of another exemplary optical sheet or film embodiment is shown in which the non-refractive opaque features are arranged as a plurality of hexagonal holes as disclosed herein, not drawn to scale.
[0063] Figure 10 A front view of another exemplary optical sheet or film embodiment having stripes as non-refractive opaque features as disclosed herein is shown, not to scale.
[0064] Figure 11 Shown is a front view of another exemplary optical sheet or film embodiment having grid lines as non-refractive opaque features as disclosed herein, not drawn to scale.
[0065] Figure 12 Illustrated are elevation views, not drawn to scale, of three other exemplary optical sheet or film embodiments (ie, Moire pattern, Curvilinear pattern, Memphis pattern) as disclosed herein.
[0066] Figure 13 An elevational view of an exemplary optical sheet or film embodiment having non-refractive opaque features, which are a plurality of circular connected apertures in a hexagonal arrangement as disclosed herein, is shown, not to scale.
[0067] Figure 14 Shown is a front view of an exemplary optical sheet or film embodiment having dot-shaped non-refractive opaque features in a hexagonally arranged pattern as disclosed herein, not drawn to scale.
[0068] Figure 15 Shown is a front view of an exemplary optical sheet or film embodiment having non-refractive opaque features in a random arrangement as disclosed herein, not drawn to scale.
[0069] Figure 16 An elevation view of an exemplary optical sheet or film embodiment having dot-shaped non-refractive opaque features arranged in a spiral as disclosed herein is shown, not to scale.
[0070] Figure 17Shown are front views of exemplary optical sheet or film embodiments with stripes shown as non-refractive opaque features in a random arrangement (not to scale), as disclosed herein. Figure 18 Shown is a front view of an exemplary optical sheet or film embodiment, as disclosed herein, having lines as non-refractive opaque features arranged in a square grid pattern, not drawn to scale.
[0071] Figure 19 Presented are arrays of ready-made optical sheets or films, as disclosed herein, in a plurality of subsets packaged in a kit or set suitable for use in Figure 7 The standard pair of single vision glasses described in this article is used on the regional surface.
[0072] Figure 20 A theoretical schematic diagram of retinal ganglion cell activity recorded by center-on / peripheral-off type and center-off / peripheral-on type retinal circuits when a -1D myopic model eye is corrected with a prior art single-vision spectacle lens and incident light of a visible wavelength (e.g., 555 nm) and 0D plano is incident on the -1D myopic model eye.
[0073] Figure 21 Demonstrated the use of Figure 18 The shown embodiment of an optical sheet or film with non-refractive opaque features is a theoretical schematic diagram of retinal ganglion cell activity recorded from center-on / peripheral-off and center-off / peripheral-on retinal circuits when incident light of a visible wavelength (e.g., 555 nm) and 0D plano is incident on a -1D myopic model eye using a single-vision eyeglass lens correcting a -1D myopic model eye.
[0074] Figure 22 Source image file representing a wide-area visual scene (image of a mobile phone held at a close viewing distance) projected onto the retina of a wide-angle schematic eye using a nonlinear projection routine; where the virtual retina is modeled with bundles of neurons arranged in a circular pattern.
[0075] Figure 23 Source image file representing a wide-area visual scene (image of a mobile phone at an intermediate distance) projected onto the retina of a wide-angle schematic eye using a nonlinear projection routine; where the virtual retina is modeled with bundles of neurons arranged in a circular pattern.
[0076] Figure 24 Source image file representing a wide-area 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 with bundles of neurons arranged in a circular pattern.
[0077] Figure 25Figure 2 shows the output spike trains obtained from the intracellular and extracellular pathways of a virtual retinal model used to control eyeglass lenses. Spike trains obtained from on- and off-cells are shown in the top and bottom panels. The Y-axis represents discrete neuronal bundles, and the X-axis represents time in milliseconds. Dark areas of the graph represent spikes, while white areas represent the absence of spikes.
[0078] Figure 26 Shown are the time-varying mean spike rates obtained from the intracellular (top) and extracellular (bottom) pathways of a virtual retinal model obtained from a control ophthalmic lens.
[0079] Figure 27 shows that when used in conjunction with standard single vision eyeglass lenses, e.g. Figure 18 1 and 2. Output spike trains obtained from intracellular and extracellular pathways of a virtual retinal model using an embodiment of an optical sheet or membrane, as disclosed herein, are shown. Spike trains obtained from intracellular and extracellular pathways are shown as the top and bottom subplots. The Y-axis of the graph represents discrete neuronal bundles and the X-axis represents time in milliseconds. Dark portions of the graph represent spikes, while white portions represent the absence of spikes.
[0080] Figure 28 Shown are the time-varying average spike rates obtained from the intracellular (top) and extracellular (bottom) pathways of a virtual retinal model, obtained when an optical film or sheet embodiment is used in conjunction with a standard single vision spectacle lens, e.g. Figure 18 and 21 shown.
[0081] Figure 29 shows that when used in conjunction with standard single vision eyeglass lenses, e.g. Figure 18 and 21 The on-axis modulation transfer functions of the control spectacle lenses and the optical film or sheeting embodiments evaluated at a pupil diameter of 6 mm are shown.
[0082] Figure 30 Demonstrates that when used in conjunction with standard single vision lenses, e.g. Figure 18 and Figure 21 The off-axis modulation transfer functions of the control ophthalmic lenses and the optical film or sheeting embodiments evaluated at a field angle of 10 degrees and a pupil diameter of 6 mm are described. DETAILED DESCRIPTION
[0083] Optical solutions that can be used to slow the rate of myopia progression include optical manipulation of retinal image features, for example, utilizing lenses with simultaneous defocus, positive spherical aberration, or positive power in the center and / or periphery of the optical zone. One disadvantage of such designs is that they compromise the quality of vision. Given the impact of lens compliance on efficacy, a significant reduction in visual performance can lead to poorer compliance and, consequently, poorer efficacy. Therefore, there is a need for designs for correcting myopia and slowing progression that do not cause the visual impairments associated with manipulation of refractive power. The current disclosure proposes an alternative non-refractive approach to delaying myopia progression that does not utilize optical defocus as a stopping signal. Embodiments of the present disclosure propose an alternative approach that slows myopia progression by artificially introducing edge or luminous contrast distributions into the retinal image. The cost burden for prospective eyeglass wearers who wish to obtain myopia treatment is significant because the standard of care for myopia treatment using existing solutions is very expensive. The present disclosure addresses the cost burden issue by considering one or more embodiments that relate to the practicality of non-permanent, inexpensive optical films for use with traditional eyeglass lenses.
[0084] In certain embodiments, spatiotemporal variations in the luminous contrast profile are also introduced into the image projected onto the retina, obtained by the optical film or sheet used in conjunction with the standard single vision lenses disclosed herein, thereby increasing overall retinal activity, which in turn inhibits further eye growth. One or more embodiments of the present disclosure rely on the center-surround structure of retinal ganglion cells, which preferentially respond to spatial and / or temporal variations in the luminous profile incident on the retina.
[0085] In this section, the present disclosure is described in detail with reference to one or more optical film embodiments to be used with standard single vision eyeglass lenses, with some contemplated embodiments shown and supported in the accompanying drawings. Some optical film embodiments for use with standard single vision eyeglass lenses are provided by way of illustration and should not be construed as limiting the scope of the present disclosure.
[0086] The following description is provided with respect to several optical film embodiments that may share common features and characteristics of the present 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 to form additional embodiments. The functional and structural information disclosed herein should not be interpreted as limiting in any way, but rather as a representative basis for teaching those skilled in the art to employ the disclosed embodiments and variations of those embodiments in various ways.
[0087] The subheadings and related subject headings used in the detailed description are merely for the convenience of the reader and should not be used to limit the subject matter described throughout the present disclosure or the claims of the present disclosure. The subheadings and related subject headings should not be used in interpreting the claims or the scope of the claims.
[0088] Several techniques have been reported to identify individuals at risk for developing or progressing myopia, including by questioning one or more of the following factors: genetics, ethnicity, lifestyle, environment, excessive near work, etc.
[0089] Certain embodiments of the present disclosure are directed to individuals identified as being at risk for developing myopia or progressive 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 a degree of relative plus power relative to the base prescription. Designs based on this optical principle can significantly compromise visual quality. Considering the impact of lens wear compliance on efficacy, a significant reduction in visual performance may contribute to poor compliance, leading to reduced efficacy.
[0090] Embodiments of the present disclosure relate to optical designs that utilize the effects of purposefully configured optical films or non-refractive opaque features on or within an ophthalmic lens for use with standard single-vision lenses to increase the activity of retinal ganglion cells, thereby helping to inhibit or slow the rate of myopia progression. The present disclosure hypothesizes that active enhancement of retinal encoding of spatiotemporal signals has a protective effect against progressive myopia.
[0091] The human visual system consists of channels or pathways on and off the retina. Retinal ganglion cells have circular receptive fields and are composed of center-on / surround-off bipolar cells, or vice versa. Figure 1 and Figure 2 The working principle of the center-on / peripheral-off retinal circuit is briefly described.
[0092] The complex retinal ganglion cell circuitry helps convert the spatiotemporal information within the incoming light comprising the visual input scene into spike trains and activity patterns that are transmitted to the visual cortex via optic nerve fibers formed by retinal ganglion cell axons.
[0093] Two groups of retinal ganglion cells, the giant cells and the parvocellular cells, contribute to different types of responses to the incoming light signals captured on the retina. The information carried by the giant cells and the parvocellular cells is parallel and independent of each other. The giant cells, or transient pathway, captures temporal features of the incoming light signals, such as motion, changes, and onsets within the input scene. The parvocellular, or persistent pathway, captures spatial features of the incoming light signals, such as patterns and shapes within the input scene.
[0094] The magnocellular pathway has a large receptive field, short latency, and responds in a transient manner using fast-conducting axons. The parvocellular pathway, on the other hand, has a smaller receptive field, longer latency, and responds in a sustained manner using slow-conducting axons. The relative change events captured by the parvocellular pathway and the grayscale sustained image frames captured by the parvocellular pathway are two highly orthogonal representations of the visual scene.
[0095] Given that eye growth regulation is local rather than global, it is likely that at least some individual magnocellular pathways are involved in the regulation or homeostatic mediation of eye growth. In other words, magnocellular retinal ganglion cells, which contain information about local relative changes, provide the ability to encode dynamic or temporal contrast in the visual scene that can be transcribed as on or off signals.
[0096] Increases in the spatiotemporal contrast of visual scenes have the potential to induce spikes, or short-term increases, in retinal ganglion cell activity; higher retinal ganglion cell activity results in a higher growth-inhibitory signal to the eye. Due to the architecture of the retinal receptive field circuitry, the following two conditions fail to excite retinal ganglion cells: (a) uniformly illuminated retinal scenes without distinct edges (i.e., no spatial contrast in the visual scene); and (b) scenes lacking change over extended periods of time (i.e., no temporal contrast).
[0097] The less stimulation of the retinal ganglion cells, the lower the excitation activity, which in turn means lower retinal activity overall; the greater the inactivity of the retina, the lower the growth inhibition signal, leading to further eye growth. The relative difference in the temporal integration of the on-type and off-type receptive field activity determines the further growth of the eye. The present disclosure assumes that the inactive retina triggers eye growth, while the active retina inhibits growth or triggers a stop signal. The present disclosure further takes into account that standard single vision spectacle lenses and / or spatially uniform visual images of the prior art contribute to the formation of a uniform and essentially edgeless visual image, which puts the retina in a baseline state (i.e., a baseline or constant retinal ganglion cell firing pattern), thereby promoting further growth of the eye, thereby leading to more myopia.
[0098] Figure 1 The working principles of the peripheral-centered and peripheral-eccentric retinal receptive fields used to describe one or more embodiments of the present disclosure are presented.
[0099] Figure 1The first and third columns highlight four examples of theoretical stimulus representations: (a) no light in the entire retinal receptive field (101 and 111); (b) no light in the central region of the retinal receptive field with sufficient ambient light (102 and 112); (c) no light in the peripheral region of the retinal receptive field 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 Action potentials fired over time for various corresponding stimulation conditions disclosed in (a) to 1(d).
[0100] For example, when considering a retinal receptive field with a center-on, periphery-off pattern (i.e. Figure 1 In the first two columns of Figure 1, in the absence of light stimulation (101), retinal ganglion cells fire at a baseline rate (106). When light falls only on the peripheral region (102) and not on the central region, baseline firing is suppressed during the excitation period (107).
[0101] When light is incident on the central region (103), the firing rate of retinal ganglion cells is at its maximum (108). As the aperture is widened to cover both the central and peripheral fields (104), the firing pattern decreases from its maximum and becomes closer to the base firing rate (109). When considering the central closed peripheral activation receptive field (i.e., Figure 1 (The last two columns of the image show that in the absence of light stimulation (111), retinal ganglion cells fire at a baseline rate (116). When light falls only on the peripheral region (112) and not on the eccentric region, the firing rate of the retinal ganglion cells reaches a maximum (117). When light coincides with the central region (113), baseline firing is suppressed during the excitation period (118).
[0102] As the range of light expands to cover the off-center and surrounding fields (114), the click pattern decreases from its maximum value and becomes closer to the baseline firing rate (119). As will be appreciated by those skilled in the art, Figure 1 The diagrams shown are theoretical best-case scenarios that may be difficult to replicate in real life, except in benchtop laboratory experiments.
[0103] Figure 2 is another graphical illustration of the firing pattern of a retinal receptive field with a center-on, surround-off pattern when subjected to different stimulation conditions. Figure 2The top half of the figure shows five different light stimulus conditions that describe some edge (206) detection scenarios that the receptive field may encounter: (i) when the entire receptive field is on the dark part of the edge (201); (ii) when part of the periphery is on the light side of the edge, while the center and the rest of the peripheral area are still in the dark part of the edge (202); (iii) when the peripheral area and part of the central area are on the light side of the edge, while most of the central area and the peripheral area are in the dark patch of the edge (203); (iv) when all of the central area is on the light side of the edge, while some of the peripheral area is on the dark side of the edge (204); and finally (v), when the entire receptive field is on the light side of the edge (205).
[0104] Figure 2 The lower part of the graph shows the action potentials fired by the ganglion cell for five different edge detection scenarios (201-205) that the receptive field may encounter over time. For example, when the entire receptive field is located in the dark part of the edge (201), the firing rate of the ganglion cell is at the base rate, as shown in Figure 2. Figure 2 The double black solid line is shown in Figure 2. When part of the peripheral area is on the light side of the edge, while the center is still on the dark side of the edge (202), the firing rate of the ganglion cells is suppressed below the base rate. When part of the peripheral and central areas move toward the light side of the edge (203), the firing rate will return to the base rate. When the entire central area is on the light side of the edge, and some part of the surrounding is on the dark side (204), the firing rate reaches its peak. Finally, when the entire receptive field is on the light side of the edge (205), the firing rate drops toward the base rate, but at a higher range. The surrounding of the receptive field also affects the amount of glutamate released by the photoreceptors. If the surrounding field is dark, the photoreceptors in this area will depolarize, thereby releasing more glutamate. When light falls on the central area, at least part of the non-surrounding 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 condition will produce the highest response in firing action potentials from retinal ganglion cells.
[0105] When light is present in the periphery, the opposite occurs. Photoreceptors in the periphery hyperpolarize, releasing less glutamate. Horizontal cells connected to photoreceptors in the periphery hyperpolarize in response and release less inhibitory neurotransmitter, resulting in a less inhibitory response, leaving central photoreceptors uninhibited and releasing even more glutamate. This scenario results in the highest response in the center-closed ganglion receptive field.
[0106] Virtual retinal model
[0107] Figure 2A theoretical working model of the intra- and extra-channel retinal fields in the human eye is presented. To show relevance to various real-life test cases, a virtual retinal simulation platform is utilized to demonstrate the working of various embodiments. The operating principles and technical framework of the virtual retina platform used are described herein. The virtual retina platform is configured to utilize as input a set of retinal images comprising a time series and convert them into an output a set of spike trains or action potentials that represent the overall activity of the retina. Essentially, the invention utilizes the edge detection capabilities of the pericentric structures of ganglion cells that provide a preferential response to spatial and / or temporal variations of the incoming visual scene. Several variables within the virtual retina platform framework can be adjusted to fine-tune the simulation of wide-field retinal images to mimic real-life scenarios. Some information on retinal circuitry and neurophysiology described in the following scientific articles is required to perform the invention disclosed herein. This article references in full a scientific journal article titled “Exploring the potential of artificial dynamic on / off stimulation to inhibit myopia progression” by Wang, Aleman, and Schaeffel, published in the journal Investigative Ophthalmology and Vision Science in June 2019. This article references in full another article titled “Virtual retina: a biological retinal model and simulator with contrast gain control” by Wohrer and Kornprobst, published in the Journal of Computational Neuroscience in 2009. Furthermore, this article references in full a scientific article titled “A new platform for retinal analysis and simulation” by Cessac, Kornprobst, Kraria, Nasser, Pamplona, Portelli, and Viéville, published in the journal Frontiers in Neuroinformatics in 2017.
[0108] Ideally, the input retinal source image to the virtual retina platform should be an approximate representation of the image formed on the human retina obtained when an individual wears one of the contemplated embodiments disclosed herein. Since actual retinal images are not available, a schematic model eye equipped with the disclosed embodiments can be used to simulate the operation of the contemplated images, or a physical model eye equipped with the embodiments disclosed herein can be used to obtain the images. The present disclosure makes extensive use of advanced ray tracing and schematic modeling to obtain virtual retinal images of various objects when a range of refractive schematic model eyes are used with the range of embodiments disclosed herein. For other embodiments, alternative approaches may be considered that involve the practicality of physical or benchtop 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 the present disclosure.
[0109] Figure 3 A flowchart representing the global structure of the virtual retina model used as a platform for describing the internal workings of various embodiments disclosed herein. The model was adapted from the work of Wohrer and Kornprobst, which was published as a peer-reviewed paper titled "The Virtual Retina: A Biological Retinal Model and Simulator with Contrast Gain Control." The virtual retina model has a three-layer architecture ( Figure 3 ) helps realize continuous spatiotemporal maps that continuously transmit and transform the input signals present in the visual scene. The brightness curve of the incoming retinal signal is L(x, y, t); where the brightness is defined for each spatially separated point or pixel (x, y) of the retina at a time point (t).
[0110] For all simulations used to describe embodiments of the present disclosure, the input visual scene was digitized to have intensities between 0 and 255 representing 8-bit grayscale. However, input image distributions with intensities between 0 and 1023, or 0 to 4095, or 0 to 65535 representing 10-bit, 12-bit, or 16-bit grayscale can also be used. Examples of other embodiments of the present disclosure. The subsequent layers of virtual retinal cells are modeled as a spatial continuum driven by a set of mathematical equations described herein.
[0111] As from Figure 3 As indicated by the diagram of , the first stage of the virtual retina model involves processing the input signal in the outer plexiform layer, which involves photoreceptors and horizontal cells. In this first stage, based on the teachings of Wohrer and Kornprobst referenced in this paper, a simple spatiotemporal linear filter is used to decompose the input sequence L(x, y, t) into the photoreceptor center response C(x, y, t) and the response of the horizontal surround cells S(x, y, t). In addition, the responses C(x, y, t) and S(x, y, t) are used in the outer plexiform layer filter to define a bandpass excitation current IOPL(x, y, t), which is 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 shunt conductance gA(x, y, t) BP (x, y, t), thus generating the excitation current I GANG (x, y, t).
[0112] In the third stage, the integration of the noise and the discrete equations of the firing cell model help to transform I GANG(x, y, t) is converted into a spike train for evaluating retinal ganglion cell activity. The spikes can be modeled using a one-to-one connection or using a synaptic pool of received excitatory currents. In order to approximate the signal transformations occurring in the layers of the retina, multiple linear filters are used at different stages of the model. In order to simplify the complexity of the calculations and minimize large computational inefficiencies while maintaining relevance to the real world, some assumptions are made in the model to describe the workings of the embodiments of the present disclosure. The present disclosure is not limited to the virtual retinal model that describes the workings of the embodiments, and modifications to the disclosed model and the use of alternative models for design or verification are considered to be within the scope of the present invention. In the first stage of the virtual retinal model that appears in the outer plexiform layer, the current I received by the bipolar cell from the photoreceptor cell C(x, y, t) and the horizontal cell S(x, x, y) OPL (x, y, t) is obtained as:
[0113] Equation 1: I OPL (x, y, t) = λ OPL (C(x,y,t)-w OPL S(x, y, t)
[0114] Equation 2:
[0115] Equation 3:
[0116] In Equation 1, C(x, y, t) represents the central signal associated with the photoreceptor; S(x, y, t) represents the surround signal associated with the horizontal pixel. The photoconductive process is modeled as a cascade of partially transient linear kernels with a temporal transient filter T ωU,τU Modulated exponential time low-pass kernel E τS and gamma exponential cascade E ηC,τC The symbol C in Equation 2 represents the kernel operation on the center signal, U represents the undershoot, and S in Equation 3 represents the kernel operation on the surround signal. The function G in Equation 2 σC The function G in Equation 3 covers the spatial blurring of gap junctions between photoreceptors. σS The spatial blurring of the coupled gap connections between horizontal units is covered. The symbol (t*) in Equations 2 and 3 represents temporal convolution. Denotes spatial convolution. From now on, the notation is used in this disclosure to denote temporal and spatial convolution. The constant λ OPL is the total gain of the center-surround filter; and w OPLis the relative weight of the center and surround signals. The contrast gain control operation in the second stage of the virtual retinal model describes the effect of the local contrast of the visual input scene on the electrical signal transmission properties of the retina, which are inherently nonlinear and dynamic. The contrast gain control based on the nonlinear feedback loop at the bipolar unit level can be described as:
[0117] Equation 4:
[0118] Equation 5:
[0119] Equation 6:
[0120] In equations 4, 5, and 6, g A To represent the variable leakage in the bipolar cell membrane, the static function QV can be used BP Activate it. The leakage determines the gain of the current integral at this level, where g A V BP The evolution of g has a divisive effect. In these models, g A The dynamics depend on the values considered for the bipolar cell with a time scale of τA and a spatial extent of σA.
[0121] The third stage of the virtual retina model involves generating spike trains of retinal ganglion cells from the activity of bipolar cells. BP Performs rectification and receives other spatiotemporal shaping to GANG An excitation current is generated at (x, y, t) as described in Equations 7 and 8.
[0122] Equation 7:
[0123] Equation 8:
[0124] The model proposed by Wohrer and Kornprobst uses empirical formulas to simulate the signal shaping of the transition from bipolar cells to pericentral ganglion cell currents. These models are suitable for demonstrating the operation of one or more embodiments disclosed herein. The model proposes the use of multiple variables in order to functionally reproduce the expected response obtained from another biologically plausible model, as described in Equations 7 and 8. The parameter ε takes two input values -1 and +1, where a negative value indicates extraganglionic cell activity and a positive value indicates supraganglionic cell activity. The bipolar layer signal is rectified using a static nonlinear function N(V); where the parameter λ G and With a reduced current magnitude. is the linear threshold of the ganglion cell. Some other models were proposed by Masmoudi, Antonini, and Kornprobst in their paper entitled “Transmitting images through the eye: The retina as a jittered scalable image encoder”: Image Processing, vol. 28, 2013, which is incorporated herein in its entirety.
[0125] From I GANG (x, y, t), a series of noise leaky integrate and fire neurons (nLIF) produces a set of output spikes. In the real retina, other complex transformations of electrical signals are facilitated by the synaptic structure 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 the embodiments of the present disclosure, in some examples, the complex synaptic relationship between amacrine cells and bipolar cells was ignored for computational efficiency.
[0126] In some other examples, as disclosed herein, one or more of the complexities of interactions between horizontal cells and bipolar cells, amacrine cells, and bipolar cells are considered. Further expansion of the model to include various other reasonable combinations of outer and inner plexiform layer interactions to describe the operation of the contemplated ophthalmic lens embodiments of the present disclosure is considered within the scope of the present invention.
[0127] The standard nLIF model is used to obtain the continuous signal I from the output of the unit. GANG The method of converting (x, y, t) into a discrete set of spike trains is described by the standard nLIF model:
[0128] Equation 9
[0129] When the threshold (V n )(t)=1 and during the refractory period (V n When )(t)=0, the standard nLIF model will have a sharp peak. υ )(t) is a source of noise that can be added to the spike generation process to reproduce the variability of real ganglion cells.
[0130] To simulate spiking in the retinal ganglion cell layer, a virtual retina was defined in the model using the following parameters, which provide relative biological plausibility and an adaptive level of complexity. Figure 4 The following examples establish the validity of the virtual retinal model described in paragraphs
[00103] to
[00117] of this disclosure, configured with certain specific retinal parameters described herein.
[0131] In this example, a series of 50 image frames (each 512 × 512 pixels in size) are configured as an image montage to be used as an input source for a virtual retina model. The odd frames of the video input stream consist of a central circular dark area on a dark background (401), while the even 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, which illustrates a 2.5 second real-time stimulus display of the virtual retina 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, equivalent to 0.5° angular subtended by 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 subtended by the video input stream is configured so that each frame subtends approximately 5° × 5° in the foveal area 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 simulations are 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. The spike activity for each test condition was expressed as the average neuronal spike train for each bundle and as a histogram representation of the surrounding stimulus, showing the variation of the average spike rate over time. The first test condition included one neuronal bundle (403) positioned so 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) placed in a hexagonal pattern, with one bundle located at the center of the video input stream and the remaining six bundles arranged circumferentially so that the circumference had a diameter of approximately 2.5° × 2.5° over the foveal region of the model retina. Additionally, to demonstrate the working principle of the virtual retina platform, in this example, the outer plexiform layer was configured to have a central region that subtended approximately 1.5° (i.e., σC of Equation 2) and a surrounding region that subtended approximately 4.75° (i.e., σS of Equation 3). The central and surrounding time scales of the outer plexiform layer were set to approximately 1 millisecond, representing the variables τC and τS of Equations 2 and 3, respectively. As described in Equation 1 of this paper, the variable controlling the integrated center-surround signal is chosen to be w OPL =1 and λ OPL =10.
[0132] Given that Figure 4 The simplicity of the input image stimulus characteristics considered in the example, with the option to mute the contrast gain control mechanism and the lateral connectivity of amacrine cells when computing spike trains and spike rate analysis. The static nonlinear coefficients of bipolar and ganglion cell synapses were adapted from Wohrer and Kornprobst, where the bipolar linear threshold was set to 0, the linear threshold was kept constant at 80, and the bipolar amplification value was kept constant at 100. The neuronal model was also adapted from Wohrer and Kornprobst, where for Figure 4 、 5 The example described in [6] considers a leakage of 0.75, a neuronal noise of 20, a membrane capacitance of 150, and a firing threshold of 2.4. The postsynaptic pooling sigma variable is ignored.
[0133] To demonstrate the operation of one or more embodiments of the present disclosure, the static nonlinear coefficients of bipolar and ganglion cell synapses can be compared with the Figure 4 For example, in some embodiments, the bipolar linear threshold may be at least 2, at least 5, at least 10, or at least 15. To demonstrate operation of one or more embodiments of the present disclosure, the linear threshold may be at least 30, at least 60, at least 90, or at least 120. To demonstrate operation of one or more ophthalmic lens embodiments of the present disclosure, the bipolar magnification value may be at least 50, at least 75, at least 125, or at least 150.
[0134] To demonstrate operation of one or more embodiments of the present 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 operation of one or more ophthalmic lens embodiments of the present disclosure, the neuron noise can be set to at least 10, at least 25, or at least 50. To demonstrate operation of one or more embodiments of the present disclosure, the firing threshold of the neuron can be set to at least 1.2, at least 2.4, or at least 3.6. In various other example embodiments for describing operation of optical patch or sheeting embodiments to be used in conjunction with standard single vision ophthalmic lenses of the present disclosure, various configurations of varying complexity are contemplated, as described in Equations 1 through 9 herein.
[0135] Non-refractive opaque features of the disclosed embodiments
[0136] Due to the arrangement of retinal pathways into and out of channels in the time domain, retinal neurons respond primarily to rapidly increasing luminance (open cells) or decreasing luminance (closed cells) within the visual scene. Retinal receptive fields are arranged in a circular pattern in the spatial domain with central and peripheral regions and vice versa. This arrangement of retinal cells allows for optimized utilization of retinal circuitry while maintaining sufficient spatial and / or temporal resolution to achieve desired visual processing. The explicit lack of spatial and / or temporal variation in the visual scene captured at the retinal plane results in poor retinal ganglion cell excitability and poor retinal activity, or it is assumed that retinal inactivity or insufficient retinal activity triggers eye growth. Certain embodiments of the present disclosure are directed to persons at risk of developing myopia or progressive myopia.
[0137] One or more embodiments of the present disclosure rely on the assumption that a clear lack of distinct edges across the entire retina, time-varying varying edges or spatial luminance contrast profiles, or time-varying spatial luminance contrast profiles may result in retinal ganglion cell activity that tends to resemble its baseline state, in other words, a substantially inactive retina.
[0138] The output of all receptive fields can be integrated to reflect the relative input and off-input strength of the visual environment. It is hypothesized that the relative temporal differences in the activity of on and off receptive fields determine further eye growth. The present disclosure assumes that an inactive retina triggers eye growth, while an active retina inhibits growth or triggers a stop signal.
[0139] The present disclosure further contemplates that prior art standard single vision lenses and / or spatially homogeneous visual images facilitate formation of a homogeneous and substantially spatially edge-free visual image, placing the retina in a baseline state (i.e., baseline or baseline sustained firing pattern of retinal ganglion cells), thereby promoting further eye growth, leading to more myopia. One or more of the following advantages are found in one or more disclosed embodiment designs disclosed herein.
[0140] An optical film or sheet for use with a standard single-vision spectacle lens that provides a stop signal to delay the growth rate of the wearer's eye or to stop the growth rate or increase in the refractive error state of the eye. The film or sheet is configured to shape the eye based on enhanced retinal activity by artificially introducing an edge or enhanced luminous spatial contrast profile or enhanced temporal contrast profile into the retinal image produced by the desired 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 the standard single-vision spectacle lens, while in other examples, the optical film can be configured non-permanently to obtain additional advantages, as disclosed herein.
[0141] A significant difference of the present disclosure is the utility of devices or methods based on optical films or sheets that are not solely based on the optical manipulation of defocus, astigmatism, or positive spherical aberration, all of which are prior art and whose impairment may result in decreased visual performance for the wearer. The following exemplary embodiments relate to methods for modifying incident light through optical films or sheets for use in conjunction with standard single-vision spectacle lenses that can utilize selective effects on and off the visual pathway to control eye growth and myopia progression, thereby converting standard single-vision spectacle lenses into single-vision myopia management spectacle lenses.
[0142] Another distinct advantage of the present invention is the provision of an assistive system, method, and apparatus that can be conveniently used with multiple pairs of eyeglass lenses that a wearer may have. Another separate advantage of the present disclosure is the provision of an economically advantageous myopia management option for eyeglass wearers. The following exemplary embodiments are directed to a method for modifying incident light by an optical film or sheet used in conjunction with standard single-vision eyewear that provides increased retinal ganglion activity by artificially introducing inhomogeneities into the retina, by stimulating pathways on the retina that provide for the visual image, and by creating or increasing a luminous contrast profile (i.e., an artificial edge) on the retinal plane of the corrective eye. This can be accomplished by using substantially non-refractive opaque features that form multiple holes, regions, or boundaries of regions within the optical film or sheet.
[0143] In short, the use of multiple holes, non-refractive zones, or non-refractive areas within an optical film or sheet used with a standard single-vision spectacle lens can provide increased activity. When light passes through the optical film or sheet used in conjunction with a standard single-vision spectacle lens, retinal ganglion cells are stimulated by stimulating on and / or off pathways excited by artificially introduced spatial edge profiles. This increased activity in the retinal encoding of spatiotemporal signals is hypothesized to prevent the slowing of myopia progression. Furthermore, the use of excitable zones, non-refractive areas, or multiple holes within an optical film or sheet used with a standard single-vision spectacle lens can provide temporal contrast variations that are complemented by the eye movements disclosed herein.
[0144] Embodiments of the optical film
[0145] Since the formed image cannot be captured on the actual retina, various surrogate measures may be used to measure retinal activity. One or more of the disclosed embodiments may be characterized structurally and / or functionally. Structural characterization is performed by examining non-refractive opaque features configured within an optical film or sheet; functional properties of the optical film in combination with a single vision spectacle lens may be achieved using a model eye. Various embodiments of optical films or sheets are shown and modeled to demonstrate that the non-refractive opaque features used in conjunction with a single vision optical modality provide an increase in retinal ganglion cell activity as measured by surrogate measures. Average retinal ganglion cell spiking rate of a virtual retina platform that simulates the performance of the wearer's eye. Figure 7 Standard spectacles for correcting myopia are shown with an optical sheet or film applied over substantially the entire surface area of the left eye lens to convert or transform the standard pair of single vision spectacles into myopia management spectacles, wherein a method of dispensing the optical sheet or film is described herein. Figure 7 The left portion of FIG shows a pair of standard single vision eyeglass lenses 700 having a right lens ( 701 ) and a left lens ( 702 ) that can be used to correct myopic refractive errors with or without astigmatism.
[0146] Figure 7 The right side of the diagram illustrates an exemplary embodiment including an optical film or sheet designed to substantially cover a left lens 702, shown as a dotted line; wherein the optical film or sheet 703 is configured to have a substantially plano optical power 705 across the optical film or sheet; and wherein the non-refractive opaque features 706 are configured such that they fall within a central region of the left lens of the ophthalmic lens. In this example, region 705 of the optical film does not impart any additional power or affect refractive power when used in conjunction with a standard single-vision eyeglass.
[0147] The optical film or sheet can be peeled off using the 704 portion of the film to place it on the eyeglass lens. In this example, the optical film embodiment (703) configured with non-refractive opaque features (706) includes a grid pattern comprising 4 horizontal lines and 4 vertical lines. The grid pattern located at the center of the eyeglass lens embodiment spans approximately 25 mm in height and width. In some examples, the optical film or sheet configured with the non-refractive opaque features of the present invention includes an adhesive backing to bond the optical sheet or film to a standard single-vision eyeglass 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 eyeglass lens.
[0148] Described herein are exemplary methods of using the disclosed optical films or sheets for use with a wearer's own eyeglass lenses. For example, the shape of the wearer's own eyeglass lenses and / or frames can be followed up by an optometrist or optician or any other trained professional to determine the shape and size of the optical film or sheet needed to comply with the care regimen disclosed herein. For example, in accordance with the current disclosure, the optical film or sheet can then be cut or die-cut to substantially match the trace shape of their eyeglass frames or lenses. The individually customized films or sheets can then be distributed in a kit or set of kits that include various permutations and combinations of shapes, designs, and locations of one or more non-refractive opaque features configured within the optical film or sheet, such as Figure 7 shown.
[0149] 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 eyewear and / or eyeglass frames to determine the shape and size of the optical film; (ii) cutting or die-cutting the non-permanent optical film to substantially match the shape of the eyeglass lens or frame; (iii) distributing in a kit or set comprising a plurality of individually customized pairs of cut or die-cut optical films, each pair including various arrangements and combinations of the size, shape, design, and location of desired non-refractive opaque features 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 can be configured to have at least two or three different non-refractive opaque features.
[0150] Figure 8 A front view of an exemplary optical film or sheet embodiment, not to scale, is shown, having an optical film diameter (802) and a plurality of non-refractive opaque features (803) of a desired design. The optical film can be peeled off using section 801 for placement 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 a plurality of circular apertures within the optical zone, each having a diameter of approximately 1 mm.
[0151] The non-refractive opaque features (803) arranged in the form of a plurality of circular apertures can be configured to be between completely opaque and substantially opaque. For example, the transmission properties of the non-refractive opaque features, in this example the boundaries of the plurality of circular apertures, can be configured such that >85% of the light incident on the non-refractive opaque features is absorbed or not transmitted. Figure 8 The plurality of circular apertures, i.e., the boundaries of the non-refractive opaque features, are considered to have a width of approximately 50 μm (804). The dimensions relative to the optical films described herein are exaggerated to demonstrate and improve the legibility of the features thereof. The remainder of the optical film, lacking the intended non-refractive opaque features, including the transparent areas within the plurality of apertures, has a plano power. The use of a plano power within the majority of the optical film provides the wearer with visual performance that is substantially similar to that obtained with a single vision spectacle lens, which is another advantage of the present disclosure over the prior art.
[0152] Figure 9 A front view of another exemplary optical film or sheet embodiment, not to scale, is shown having an optical film diameter (902) and a plurality of connected hexagonal non-refractive opaque features of a desired design (903). The optical film can be peeled off using section 901 for placement on single vision lenses.
[0153] In this illustrative example, the lens diameter is approximately 25 mm, and the non-refractive opaque features arranged in the form of a boundary of a plurality of hexagonal holes within the optical zone each have a maximum diameter of approximately 1 mm. The non-refractive opaque features arranged in the form of a plurality of hexagonal holes (903) can be configured to be between completely opaque and semi-transparent. 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 width of the boundary of the plurality of hexagonal holes contemplated in the embodiment, i.e., the non-refractive opaque features, is approximately 25 μm (904). This is exaggerated relative to the dimensions of the optical films or sheets described herein to demonstrate and improve the legibility of the features. The remainder of the optical film, including the transparent areas within the plurality of holes, is of plano optical power.
[0154] 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 or hexagonal or any other polygonal holes; wherein the plurality comprises at least 2, 3, 5, 7, 9, 12 or 15 non-refractive opaque features.
[0155] In some other optical film or sheet embodiments, the number of non-refractive design features arranged in the form of boundaries of the plurality of polygonal apertures may 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 boundaries of the plurality of apertures may be separate, while in other embodiments, they may be abutted or joined.
[0156] 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.
[0157] In some embodiments, the width of the border or design feature may not be constant across the plurality of holes. In one embodiment of the present disclosure, the shapes of the plurality of holes may also be different.
[0158] Figure 10 A front view of another exemplary optical film or sheet embodiment, not to scale, is shown having an optical film diameter (1002) of a desired design and a plurality of non-refractive opaque features (1003). The optical film can be peeled off using section 1001 for placement on single-vision eyeglasses. In this exemplary example, the optical film diameter is approximately 25 mm, and the length of the non-refractive opaque features, which are configured 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 features (1004) contemplated herein is approximately between 25 μm and 50 μm, exaggerated in the figures only to illustrate the features relative to the dimensions of the optical films or sheets described herein. In preferred embodiments, the maximum width of the non-refractive opaque features does not exceed 100 μm, 150 μm, or 200 μm to avoid undesirable consequences for resolution characteristics.
[0159] In this example, the remainder of the optical zone of the non-refractive opaque feature (including the transparent areas within the plurality of segments or stripes) has a plano power. Figure 11 Not drawn to scale, a front view of another exemplary optical film or sheet embodiment is shown having an optical film diameter (1102) and non-refractive opaque features (1103). Portion 1101 can be used to peel the optical film apart for placement on a single vision lens.
[0160] In this example, the optical film diameter is approximately 25 mm in diameter, and the intended design feature of this embodiment is a grid pattern located in 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 features (1104) considered in FIG. 5 is approximately between 50 μm and 100 μm, and is exaggerated in the figures only to illustrate the features relative to the size of the optical films or sheets described herein.
[0161] Figure 11 Embodiments may also be configured with other variations, for example, the width of the intended non-refractive design features within the optical zone may be at least 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm. Figure 11 Embodiments may also be configured with other variations, for example, the width of the intended non-refractive design features within the optical film may 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 features, 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 resolution characteristics of the eye.
[0162] In other embodiments, the intended non-refractive design features can be located within 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 certain other embodiments of the optical film or sheet, the number of design features forming the lines or stripes of the grid pattern can be between 5 and 9, or between 9 and 15, or between 9 and 15, or between 5 and 25. Furthermore, the meander 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.
[0163] In yet another embodiment of the optical film or sheet, one or more stripes can be arranged in a symmetrical or random pattern, centered about or eccentric to the geometric center of the optical film or sheet. The stripes can also be composed of straight or curved lines, touching or intersecting each other, or placed independently or in combination. The width and length of the stripes can vary. Different patterns can be used for optical films placed on the left and right lenses of standard single-vision glasses.
[0164] In yet another embodiment of an optical film or sheet, the desired design features (i.e., multiple stripes or moiré patterns) within the optical film can be set 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.
[0165] Figure 12 Not drawn to scale, three additional exemplary optical film or sheet embodiments are shown in elevation views having an optical film diameter of 1201. These three exemplary optical film or sheet embodiments are shown in elevation views showing three contemplated non-refractive design features (1203a, 1203b, and 1203c). In this example, the non-refractive design feature (1203a) is a representative example of a contemplated moiré pattern that is configured away from the geometric center of the optical film or sheet embodiment.
[0166] The non-refractive design feature (1203b) shows another representation of the intended curvilinear pattern across the optical film; in the shape of a spiral. The non-refractive design feature (1203c) shows a Memphis pattern centered on the geometric center of the optical film or sheet. The width of the design features ranges from 5 to 150 μm, with the substantially opaque features highlighted in the figure to illustrate the features relative to the dimensions of the optical films or sheets described herein. In yet another embodiment of the optical film or sheet, the designed features (i.e., multiple non-refractive fringes or moiré fringes) can be contained within 1, 5, 10, 15, 20, or 25 mm of the center of the optical film. In yet another embodiment of the optical film or sheet, the design features (i.e., multiple non-refractive fringes or moiré fringes) can 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 intended design features (i.e., multiple fringes or moiré patterns) within the optical film can be separated from each other. In yet another embodiment, the contemplated multiple non-refractive opaque features may be configured to be adjacent to or staggered with one another. In certain embodiments of the optical film or sheet, the width of the intended design features (i.e., multiple stripes or moiré fringes) within the optical film may be at least 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm. In certain embodiments of the optical film or sheet, the width of the intended design features within the optical film may 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 may be opaque, but in some other embodiments, the boundaries of the intended design features may be translucent. In some embodiments, the width of the design features may not be constant across the multiple non-refractive opaque features.
[0167] Figure 13 A front view of an exemplary optical film or sheet is shown, not drawn to scale, having an optical film diameter (1302) and a plurality of non-refractive opaque features (1303), the non-refractive opaque features comprising joined circular non-refractive opaque features. The total number of circular holes is 7. The total size of the non-refractive opaque features including the plurality of holes is approximately 3.75 mm in diameter. The size of each hole is approximately 1.25 mm in diameter. The border 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 readability. The remainder of the portion of the optical film without the non-refractive opaque features of the exemplary embodiment is configured to have a plano power. The optical film can be partially peeled off using 1301 to be placed on a single vision lens.
[0168] Figure 14A front view of an exemplary optical film or sheet having an optical film diameter (1402) and a plurality of non-refractive opaque features (1403) comprising a dot pattern (1403), not drawn to scale, is shown, comprising a plurality of dots arranged in a hexagonal arrangement, the total number of dots being 7. The total size of each dot pattern is approximately 4 mm in diameter. 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 readability. The remainder of the portion of the optical film without the non-refractive opaque features of the exemplary embodiment is configured to have a plano power. The optical film can be partially peeled off using 1401 to be placed on single vision glasses. Figure 15 A front view of an exemplary optical film or sheet is shown, not drawn to scale, having an optical film diameter (1502) and a plurality of non-refractive opaque features (1503), the non-refractive opaque features comprising a random pattern of bars or thick lines (1503), comprising a plurality of bars. The total number of bars is 7. The total 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 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 readability. The remainder of the portion of the optical film without the non-refractive opaque features of the exemplary embodiment is configured to have a plano power. The optical film can be partially peeled off using 1501 to place it on a single vision lens.
[0169] Figure 16 A front view of an exemplary optical film or sheet is shown, not to scale, having an optical film diameter (1602) and a plurality of point-shaped non-refractive opaque features (1603) arranged in a spiral pattern. The total number of spiral arms is 6. The total size of the spiral pattern is approximately 6 mm in diameter. The size of each dot within the spiral pattern is approximately between 50 μm (1604). The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and readability. The remainder of the portion of the optical film that does not have the non-refractive opaque features of the exemplary embodiment is configured to have a plano power. The optical film can be partially peeled off using 1601 to place it on a single vision lens.
[0170] Figure 17 A front view of an exemplary optical film or sheet is shown, not to scale, having an optical film diameter (1702) and a plurality of striped, non-refractive, opaque features (1703) arranged in a random pattern. The overall size of the pattern is approximately 5 mm in diameter. The size of each stripe in the random pattern is approximately 50 μm (1704).
[0171] The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and legibility. The remaining portions of the optical film that are free of the non-refractive opaque features of the exemplary embodiments are configured to have a substantially plano optical power, or substantially no optical power. The optical film can be peeled away using section 1701 for placement on a single vision lens. Figure 18 A front view of an exemplary optical film or sheet, not to scale, is shown having an optical film diameter (1802) and a plurality of square apertures as non-refractive opaque features (1803) arranged 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 3x3 mm in diameter. The width of the line or boundary forming the square apertures is approximately 50 μm (1804). The non-refractive opaque features are magnified relative to other features of the optical film or sheet for identification and readability. The remainder of the portion of the optical film without the non-refractive opaque features of the exemplary embodiment is configured to have a plano power. The optical film can be peeled off using portion 1801 so that it can be placed on a single vision lens.
[0172] Figure 19 An array of optical sheets or films having different non-refractive opaque characteristics is presented, packaged in multiple subsets within a kit. For example, Figure 19 Group A includes a plurality of circular optical films, each of which is configured with a Memphis pattern as described in Figure 1203c. The optical films in Groups B, C, and D respectively have a Memphis pattern as described in Figure 1203c. Figure 15 、 18 and 10. The diameter of the optical films in each set ranges from 3 mm to 30 mm. In some examples, the optical films may have a surface area of at least 200 mm2, 400 mm2, 800 mm2, 1200 mm2, 1600 mm2, 2400 mm2, or 2800 mm2. In some other examples, the optical films may have a surface area of at least 20 mm2, 50 mm2, 75 mm2, 100 mm2, or 150 mm2.
[0173] Figure 20A schematic diagram is shown depicting a 3D myopic model eye corrected with a prior art standard single vision lens (1702) with incident light (2000) of visible light (e.g., 555 nm) and plano 0D from a wide angle field of view (2001). When the eye is using a prior art standard single vision lens (2002), retinal ganglion cell activity recorded by a center-on-peripheral-off or center-off-peripheral-on circuit (2003) shows little retinal activity or basal retinal activity. The relative difference in the temporal integration of the activity of the open and closed receptive fields determines further eye growth. The present disclosure hypothesizes that an inactive retina triggers eye growth, while an active retina reduces growth or triggers a stop signal. The present disclosure further anticipates that a prior art standard single vision lens and / or a spatially uniform visual image facilitates the formation of a uniform and substantially edgeless visual image, thereby placing the retina in a baseline state (i.e., a baseline or constant firing pattern of retinal ganglion cells), thereby promoting further eye growth, thereby leading to deeper myopia.
[0174] Figure 21 A schematic diagram is shown depicting an incident beam of visible light at a visible wavelength, e.g., 555 nm, and plano 0D, entering a 3D myopic model eye (2100) from a wide angle field of view (2101) and corrected with one of the exemplary optical film or sheet embodiments (1804) used in conjunction with a standard single vision lens (2102) disclosed herein.
[0175] The non-refractive opaque features within the optical film are configured as a square grid pattern, e.g. Figure 18 As shown. When the eye moves behind the exemplary embodiment (2104) positioned on a standard single vision spectacle lens (2102), the center-activated peripheral-off or center-off peripheral-activated circuit (2103) demonstrates or displays increased activity on the retina compared to a baseline state. To illustrate this, Figure 20 and 21A simple model eye has been chosen in the examples, however, in other embodiments, a schematic ray tracing model eye such as that of Liou-Brennan, Escudero-Navarro, etc. may be used instead. The examples provided herein have used a -1D myopic model eye to disclose the present invention, but the same disclosure can be extended to other degrees of myopia, i.e., -2D, -3D, -5D, or -6D. Furthermore, it will be appreciated that extension to eyes with varying degrees of myopia can be incorporated with astigmatism. In the examples, reference is made to a specific wavelength of 555 nm, but it will be appreciated that the extension can be extended to other visible wavelengths between 420 nm and 760 nm. Modeling of various exemplary optical film or sheeting embodiments used in conjunction with standard single vision lenses has shown that the contemplated non-refractive opaque features can increase retinal ganglion cell activity, as measured by an increase in the average retinal spike rate obtained using the lenses. Virtual Retina Platform disclosed herein. In other embodiments, various other alternative measurements of retinal ganglion cell activity may be considered, for example, examining spike analysis of selected neuronal bundles.
[0176] Schematic eye and simulated retinal images
[0177] A high-level schematic model eye can be used to calculate 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 a schematic model eye used to obtain retinal images used to simulate the input to the virtual retinal platform implemented by embodiments of the present disclosure. This demonstrates the described effects achieved using embodiments of the present disclosure. This should be considered one of many methods for obtaining retinal images to facilitate retinal processing simulations performed by the virtual retinal platform described herein.
[0178] The generic parameters of the schematic model eye used are based on the prescription listed in Table 1. In this example, the generic prescription of Table 1 is a myopic schematic model eye with a refractive error of -1D and myopia, without any astigmatism (Rx: -1D), configured in a state of accommodation 1D, wherein the pupil diameter of the model's distance prescription eye is defined as 6mm and the dominant wavelength is 589nm.
[0179]
[0180] Table 1: Prescriptions for an illustrative myopic model eye with a diopter prescription of -1D in 1D accommodation.
[0181] In various other example embodiments disclosed herein, various modifications may be considered to evaluate the performance of other optical film or sheet embodiments described herein. In addition, various parameters of the schematic model eye (e.g., anterior cornea, posterior cornea, corneal thickness, anterior lens, posterior lens, lens thickness, refractive index of ocular media, retinal curvature, or a combination thereof) may be changed to demonstrate the working of the present disclosure in various myopia levels with or without astigmatism, and to model various myopic eyes in their relaxed and accommodative states. In order to obtain a wide-area simulated retinal image using the schematic model eye when equipped with an embodiment of the present disclosure, 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. The visual scene is transformed into a wide-angle schematic eye as disclosed herein. In Figure 22 、 23 Three source image files (2201, 2301 and 2401) of a visual scene used to describe the working of the embodiment are shown in FIG.
[0182] A virtual retina is modeled using neuronal bundles (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) 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 subtend 5 degrees at a viewing distance of 6 meters. In some other examples, the source image files of the three visual scenes (2201, 2301, and 2401) can be configured to subtend 5, 10, 15, or 20 degrees of the retinal field of view to describe the performance of various embodiments disclosed herein. The point spread function array will be 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. To compute the point spread function over the desired field, the Huygens principle is modified in this disclosure because the modeling effect of relatively small non-refractive opaque features may be affected by the Fourier estimation commonly used to improve computational efficiency.
[0183] The calculation of the point spread function array over the desired field of view includes the effects of diffraction and aberrations. The resulting simulated retinal image is scaled and derived to account for 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.
[0184] In various embodiments of the present disclosure, the settings of various parameters required for the simulation of virtual retinal images are varied to capture a variety of realistic situations that individuals may experience. In certain 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 at 512×512 pixels to avoid significant pixel discretization in the output image, manifested by aliasing effects. Furthermore, in all cases, necessary supersampling of the input source must be considered to minimize this effect at the expense of relatively long computation time.
[0185] Comparative Single Vision Lenses and Designs of Exemplary Embodiments
[0186] exist Figure 7 The left optical film embodiment shown in FIG was used in conjunction with a standard single vision eyeglass lens and modeling demonstrated that the non-refractive opaque features of the optical film increased retinal ganglion cell activity when compared to a right lens without the non-refractive opaque features of the optical film. Specific non-refractive opaque features within the optical film include, for example, Figure 18 and Figure 21 Checkered pattern as described in.
[0187] In this example, the schematic model eye of Table 1 was set to focus on an object at a distance of 1 meter from the eye, and the myopia of the schematic model eye was corrected successively using a standard single vision lens and an exemplary optical film embodiment used in combination with the standard single vision lens. The standard single vision lens was modeled using the following parameters: front surface (R = 2000 mm), center thickness (1.5 mm), back surface (R = 379.1 mm) and refractive index of 1.5, with a lens diameter of 50 mm. The standard single vision lens did not have any non-refractive opaque features.
[0188] 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 also configured with Figure 18 The square grid non-refractive opaque features disclosed in the example of the exemplary embodiment include a square grid pattern (1803) that further includes a plurality of square holes ( Figure 18 ). The total number of holes designed within the pattern (1803) is approximately 16. The total size of the square grid is approximately 3x3 mm. The width of the line or the boundary forming the square hole is approximately between 50 μm (1804). The remainder of this portion of the exemplary embodiment is configured with a flat optical power. The non-refractive opaque features of the exemplary embodiment are configured so that they absorb at least 85% of the light incident on the non-refractive opaque features.
[0189] The simulated retinal images were calculated and analyzed 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, when the opaque features were mounted on the schematic model eye of Table 1.
[0190] In this example, the other variables of the virtual retina platform were envisioned to have the following settings; for example, the choice of contrast gain control mechanism is described in Equations 1, 5, and 6. The arrangement of neural bundles was arranged in a circular pattern spanning a 20° x 20° field of view. The sparse lateral connectivity pattern of the virtual retina was used with 10 presynaptic neurons, a forward weight of 10%, and a weight variation of 0.01. The supplementary high-pass filter option for the external plexiform layer described in Equations 2 and 3 was muted. The postsynaptic merging option was also muted. Post-processing of the simulated retinal images calculated to control the eyewear design using the virtual retina platform, as described in this paper, resulted in spike trains that varied over time ( Figure 25 ), and the histogram around the stimulus highlights the mean spike frequency as a function of time. For cells with both open and closed polarity, both are functions of time ( Figure 26 ). Figure 25 and Figure 26 The top and bottom subplots represent the data for on-type cells and off-type cells, respectively.
[0191] As discussed herein, post-processing of the computed simulated retinal images of the optical film embodiments using the virtual retina platform resulted in a spike train as a function of time ( Figure 27 ) and surrounding stimulus histograms as a function of time for cells with open and closed polarity highlight the average spike train ( Figure 28 ). Figure 27 and Figure 28 The top and bottom subplots represent the data for open and closed cells, respectively.
[0192] For cells with both types of polarity, the neuronal activity of the control eyeglass lens is depicted as Figure 25 The spike train is relatively time-invariant or has minimal variation or fluctuation as a function of time. On the other hand, the neuronal activity of the spectacle lens of the optical patch embodiment is depicted as Figure 27 The spike train is time-varying and fluctuates periodically as a function of time. In this example, after the initial 50 milliseconds, the neuronal activity of the control eyeglass lens (e.g. Figure 26The observed patterns were similar for both open and closed cells with polarity types. The responses of closed cells did show variations in the average spike rate as a function of time, but the magnitude of the variations was small. Figure 28 The average spike rate of the temporal function described in follows the temporal variation pattern for both open and closed polarities. For both polarities, the neuronal activity of the control eye lens is depicted as Figure 25 The spike train is relatively time-invariant. The non-stationarity and nonlinearity in the spike response obtained with the embodiment lens are attributed to artificial edges in the retinal image or temporal variations in the luminous contrast distribution or artificial edges.
[0193] From the responses of the discrete neuron bundles, it can be seen that the number of actively closed discrete neuron bundles is 3 to 4 times less than the number of corresponding actively open discrete neuron bundles. On the other hand, the neuron activity of the optical film embodiment, such as Figure 27 As shown in the spike column, the relative time variation is observed for both polarities. In addition, the total number of active closed discrete neuron bundles is equal to the number of active open discrete neuron bundles.
[0194] In this example, on-axis and off-axis evaluation of optical performance is modeled with a monochromatic light pattern (589 nm) and a pupil analysis diameter of 5 mm. Figure 29 and Figure 30 As described above, wide-field optical performance, measured using modulation transfer function as a function of spatial frequency, was virtually indistinguishable between the control and exemplary optical patch embodiment eyeglass lenses at a 5mm pupil diameter. For off-axis performance, in this example, the field of view considered for performance evaluation was 20°, ±10° from the center point.
[0195] Another method for using an optical film in conjunction with a wearer's own spectacle lenses is described herein. For example, a set of predetermined positions on the wearer's own spectacle lenses can be followed up and determined by an eye care practitioner or optician or any other trained professional to facilitate the wearer to change the position of the optical film in accordance with a care regimen. In some examples, laser engraving in the form of dots, lines, or cross-shaped patterns can be used to define specific or prescribed positions of the optical film to be adhered to the spectacle lenses. In some examples, the method of the prescription package or kit includes the wearer affixing or adhering the optical film to a specified area of the spectacle lens. In some examples, the selection of the set of predetermined positions on the wearer's own spectacle lenses can be determined by considering various patient-related factors, for example, the degree of myopia, the onset of myopia, myopia of the parents, age, gender, and other risks generally associated with the progression of myopia or high myopia.
[0196] For example, according to the present disclosure, an optical film or sheet can be cut or die cut 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 eyeglasses. Instead, as disclosed herein, a predetermined shape, such as a circle, an oval, or any other regular or irregular shape can be used. Individually customized optical films or sheets can be formulated in the form of a kit or set of kits that include various arrangements and combinations of shapes, designs, and locations of one or more non-refractive opaque features configured in the optical film or sheet, such as in Figures 19 to 22 As described in.
[0197] Certain methods of the present disclosure include a regimen that provides a temporally and spatially varying optical stop signal; thus, the efficacy of reducing the progression of ocular growth can remain substantially consistent over time. In certain other embodiments, a standard single vision eyeglass comprises a primary spherical single vision eyeglass lens for correcting myopia without astigmatism, or a primary astigmatic / toric single vision eyeglass for correcting myopia with astigmatism.
[0198] As will be appreciated by those skilled in the art, the present invention may be used in conjunction with any device / method that may influence the progression of myopia. This may include, but is not limited to, spectacle lenses of various designs, color filters, medications, or behavioral changes.
Claims
1. An optical film comprising a refractive area having a plano focal power and a non-refractive area, wherein the non-refractive area comprises a plurality of non-refractive opaque features; in, Each of the plurality of non-refractive opaque features is configured in at least a dot shape, a straight line shape, an arc shape, a zigzag line shape, or a stripe shape; wherein each non-refractive opaque feature has a width between 25 microns and 75 microns such that the non-refractive opaque feature remains substantially non-diffractive; wherein the total number of non-refractive opaque features is at least 6; wherein the optical film has a surface area of at least 1200 square millimeters; wherein the plurality of non-refractive opaque features are disposed within a central 60% of the optical film for application to a standard single vision spectacle lens; and wherein the remainder of the optical film is free of the plurality of non-refractive opaque features; The optical film is configured in combination with a standard single-vision spectacle lens for myopia, the spectacle lens comprising an optical center, a front surface, and a back surface, and providing a basic prescription for correction of distance refractive error for myopia; Among them, the non-refractive area can actively increase the overall retinal ganglion cell activity of the myopic eye to provide at least one solution that can slow down, delay or prevent the progression of myopia. wherein the optical film is combined with the standard single vision spectacle lens, when tested on a bench or physical model eye, wherein the retina of the bench or physical model eye includes a camera having a charge coupled device or complementary metal oxide sensor configured to capture an image of a visual scene projected through the model eye corrected with the optical film; wherein the image captured by the retina of the model eye is used as an input stream to a virtual retina simulator, comprising 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 integrate-and-fire cell models that produces spike trains depicting overall retinal ganglion cell activity; wherein the plurality of non-refractive opaque features are configured to provide an active increase in overall retinal ganglion cell activity compared to that obtained using a single-vision eyeglass lens without the optical film; wherein the overall retinal ganglion cell activity, measured as an average retinal spike rate integrated over a certain time frame, is at least 1.25 times the overall retinal ganglion cell activity of the single-vision eyeglass lens without the optical film; wherein the specific time frame over which the average retinal spike rate is integrated is at least 2 seconds.
2. The optical film of claim 1 , wherein the plurality of non-refractive opaque features form one or more non-refractive opaque patterns; The one or more non-refractive opaque patterns include at least a checkered pattern, a spoke wheel pattern, a spiral pattern, a swirl pattern, a Memphis pattern, a dot pattern, a regular pattern, an irregular pattern, a Moire fringe pattern, an interference pattern, or a random pattern.
3. The optical film of claim 1 , wherein the plurality of non-refractive opaque features form a plurality of apertures, wherein each aperture surrounds a substantially transparent region; wherein The shape of at least one of the plurality of holes is circular, symmetrical or asymmetrical oval, triangle, rectangle, square, pentagon, hexagon, octagon, or any other regular polygon, irregular polygon, or arbitrary shape; wherein the plurality of holes are arranged in a circular, hexagonal, radial, spiral, regular, irregular or random arrangement; wherein the total number of holes in the plurality of holes is at least 6; and wherein the surface area of the substantially transparent area enclosed by at least one of the plurality of holes is between 0.25 square millimeters and 7.5 square millimeters.
4. The optical film of any one of claims 1 to 3, wherein each of the non-refractive opaque features is configured such that it absorbs at least 80% of incident light that strikes the opaque feature.
5. The optical film according to any one of claims 1 to 3, wherein the application of the non-refractive opaque features can be implemented by embossing, laser etching, photoetching, coloring or laser printing.
6. The optical film of any one of claims 1 to 3, wherein the optical film can be permanently or non-permanently configured.
7. The optical film according to any one of claims 1 to 3, wherein The optical film, in combination with the standard single vision eyeglass lens, provides on-axis and off-axis wide field modulation transfer functions for at least one pupil diameter and at least one wavelength between 420 nanometers and 760 nanometers when tested on a model eye configured to have a distance refractive error that matches the base prescription; wherein the off-axis wide field of view includes a field of view of at least 5°; wherein the model eye is a schematic, physical, or bench model eye.
8. The optical film of claim 7, wherein the optical film, in combination with the standard single vision spectacle lens, when tested on a model eye configured to have a distance refractive error matching the base prescription, results in spatial and temporal variations in the artificial edge or spatial luminous contrast morphology distributed across an off-axis wide field of view of the model eye; wherein the non-refractive opaque features provide the spatial variations as well as the temporal variations that simulate eye movement.
9. The optical film according to claim 1, wherein the non-stationarity of the overall retinal ganglion cell activity or neural response, measured by the average retinal spike rate, can be observed in a retinal field with center on / peripheral off, or a retinal field with peripheral on / center off, or both; wherein the function describing the non-stationarity of the overall retinal ganglion cell activity or neural response of the model eye is measured by the average retinal spike rate as a function of time, and follows a nonlinear, non-periodic or sinusoidal curve, or a quasi-sinusoidal wave, rectangular wave, quasi-rectangular wave, square wave, quasi-square wave or non-monotonic characteristic, describing the temporal variation of the overall retinal ganglion cell activity.
10. The optical film according to claim 9, wherein The optical film provides, at least in part, a temporally and spatially varying stop signal to reduce the rate of myopia progression.
11. The optical film of claim 2, wherein the one or more non-refractive opaque patterns are configured such that the pattern is offset from a geometric center of the eyeglass lens.
12. The optical film of claim 3, wherein the plurality of holes are configured to be separated, abutted, or combined. 13 . The optical film according to claim 1 , wherein the optical film can be arranged at least on the front surface of the spectacle lens, the back surface of the spectacle lens, or inside the spectacle lens.
14. A method of using the optical film according to any one of claims 1 to 13, wherein a method of applying the optical film comprises at least one of the following options: (i) bonding to the eyeglass lens, (ii) bonding by pressing the eyeglass lens with a finger, (iii) bonding using a sticker on one surface of the eyeglass lens, (iv) using a removable adhesive on one surface of the eyeglass lens, or a combination thereof.
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