Ophthalmic lens design having non-inflectional features

Abstract

The present disclosure relates to the use of monofocal ophthalmic lenses for the correction of myopia in a wearer, where the monofocal ophthalmic lens device is configured with a base prescription to correct the individual's myopia and is further intentionally configured with non-refractive features that facilitate increased retinal ganglion cell activity in the wearer, which may act as an optical stop signal to slow, ameliorate, control, inhibit, or reduce the rate of progression of the wearer's myopia.

Description

Technical Field

[0001] Cross-reference This patent application claims priority to Australian Provisional Application Serial No. 2019 / 904536, filed on 1 December 2019, entitled "A multi-zone ophthalmic lens", and another Australian Provisional Application Serial No. 2019 / 904537, filed on 1 December 2019, entitled "An Ophthalmic lens for myopia", both of which are hereby incorporated by reference in their entirety.

[0002] Technical Field The present disclosure relates to ophthalmic lenses, and in particular to contact lenses and spectacle lenses for use in eyes experiencing disorders related to axial length, such as myopia.

Background Art

[0003] The human retina has three main layers: the photoreceptor layer, the outer plexiform layer, and the inner plexiform layer. Cones and rods are photoreceptor cells in the human eye retina that respond to light by converting incident light into electrical signals. The converted electrical signals are transmitted from the photoreceptor cells through bipolar cells and further to retinal ganglion cells and the optic nerve, carrying visual information from the retinal cells to the brain and enabling visual perception of the world. Photoreceptor cells release the neurotransmitter glutamate in proportion to the level of their polarization state in response to a graded membrane potential. For example, in the absence of light stimulation, photoreceptor cells depolarize and release more glutamate compared to their baseline state. When light is present, photoreceptor cells hyperpolarize due to the breakdown of opsin in the photoreceptor cells, causing them to release less glutamate compared to their baseline state. There are two types of bipolar cells in the retina: on-center bipolar cells and off-center bipolar cells, which separately encode positive and negative spatio-temporal contrast from incident light by comparing photoreceptor cell signals with the spatio-temporal average calculated by a layer of horizontally connected horizontal cells.

[0004] Horizontal cells are interconnected by conductive gap junctions and connect to bipolar cells and photoreceptor cells in complex triad synapses. On-center and off-center bipolar cells have different responses to glutamate, and these responses are based on the type and number of glutamate receptors located on each of these bipolar cells.

[0005] Off-center bipolar cells have ion channel receptors that are excitatory to glutamate. These off-center bipolar cells depolarize in response to glutamate and preserve the sign of the photoreceptor cell's signal. When light is present, off-center bipolar cells receive less glutamate from the photoreceptor cells, which causes hyperpolarization and less glutamate is released to the corresponding downstream ganglion cells. When there is no light, off-center bipolar cells receive more glutamate from the photoreceptor cells, which causes depolarization and more glutamate is released to the corresponding downstream ganglion cells.

[0006] On-center bipolar cells have metabotropic receptors that are inhibitory to glutamate. These on-center bipolar cells hyperpolarize in response to glutamate and invert the sign of the photoreceptor cell's signal. When light is present, on-center bipolar cells receive less glutamate from the photoreceptor cells, which causes depolarization and more glutamate is released to the corresponding downstream ganglion cells. When there is no light, on-center bipolar cells receive more glutamate from the photoreceptor cells, which causes hyperpolarization and less glutamate is released to the corresponding downstream ganglion cells. The more glutamate an on-center or off-center bipolar cell releases to the corresponding downstream ganglion cells, the greater the action potential firing of the ganglion cell. The opposite responses of on-center bipolar cells and off-center bipolar cells to light are the key to the response difference to light and dark states. In addition, the depolarization signal activities of on-center bipolar cells and off-center bipolar cells may be amplified or inhibited by horizontal cells that connect to photoreceptor cells in the surround of the corresponding receptive field.

[0007] Horizontal cells receive excitatory input from photoreceptor cells and send inhibitory feedback to neighboring photoreceptor cells to which they are connected. The receptive field is a group of photoreceptor cells that send input to downstream bipolar cells and ganglion cells within the retina.

[0008] The receptive fields of the retina can be described using a concentric zone with a small circular center field and a wider circular field around the center field called the surround field. Receptive fields are classified into two categories: off-center on-surround receptive fields and on-center off-surround receptive fields. Based on differences in bipolar cells, on-center receptive fields and off-center receptive fields respond differently to light.

[0009] At birth, the human eye is farsighted because the length of the eyeball is too short relative to the total refractive power of the eye. As a person ages from childhood to adulthood, the eyeball continues to grow until the refractive state of the eye stabilizes. To maintain constancy by matching the optical system of the eye with the eyeball length, it is understood that the growth of the eyeball is controlled by a feedback mechanism and is mainly regulated by visual experience. This process is called emmetropization. The signal that leads the emmetropization process is initiated by modulation of the light energy received by the retina. The image characteristics of the retina are monitored by a biological process that modulates the signal to start or stop, accelerate or decelerate the growth of the eyeball. By this process, the optical system and the length of the eyeball are adjusted, and emmetropia is achieved or maintained. Deviation from this emmetropization process results in refractive disorders such as myopia. A hypothesis has been proposed that a decrease in retinal activity promotes the growth of the eyeball, and conversely, an increase in retinal activity suppresses the growth of the eyeball.

[0010] The prevalence of myopia is increasing at an alarming rate in many regions of the world, especially in East Asia. In individuals with myopia, the axial length of the eyeball is inconsistent with the overall refractive power of the eye, and distant objects will be focused in front of the retina.

[0011] A simple pair of minus single focus lenses can correct myopia. Such devices can optically correct refractive anomalies related to axial length, but do not address the underlying cause of excessive eye growth in the progression of myopia. Excessive axial length in high myopia is associated with serious vision-threatening conditions such as cataracts, glaucoma, myopic maculopathy, and retinal detachment. Therefore, there is still a need for specific optical devices that not only correct the underlying refractive anomalies for such individuals, but also prevent the eye from becoming overly long or the progression of myopia.

[0012] Definitions As used herein, terms are generally used by those skilled in the art unless otherwise defined below.

[0013] The term "myopic eye" means an eye diagnosed as having a refractive state that is already myopic, in a pre-myopic stage, at risk of becoming myopic, with or without astigmatism, and progressing towards myopia.

[0014] The term "progressive myopic eye" means an eye diagnosed as having established myopia in progression, as measured by either a change in refractive anomaly of at least -0.25 D / year or a change in axial length of at least 0.1 mm / year.

[0015] The term "eye at risk of becoming myopic" means an eye that may be emmetropic or have low hyperopia at that time, but is identified as having an increased risk of becoming myopic based on genetic factors (e.g., both parents are myopic) and / or age (e.g., low hyperopia when young) and / or environmental factors (e.g., time spent outdoors) and / or behavioral factors (e.g., time spent doing near work).

[0016] The term "optical stop signal" or "stop signal" means an optical signal or directional cue that may facilitate deceleration, reversal, arrest, delay, suppression, or control of eye growth and / or the refractive state of the eye.

[0017] The term "spatially and temporally varying optical stop signal" or "spatially and temporally variant optical stop signal" means an optical stop signal provided in the retina that changes over time and varies spatially across the retina of the eye.

[0018] The term "contact lens" means a finished contact lens suitable for fitting to the wearer's cornea to affect the optical performance of the eye.

[0019] The term "eyeglass lens" may mean a finished or semi-finished blank lens. The term "standard single-focus eyeglass lens" or "commercially available single-focus eyeglasses" or "standard eyeglasses" means an eyeglass lens having a basic prescription used to correct a fundamental refractive anomaly of the eye, which may be myopia with or without astigmatism.

[0020] The term "optical zone" or "optic zone" means the region of an ophthalmic lens (e.g., a contact lens or an eyeglass lens) having a predetermined optical effect. The optical zone includes one or both of the anterior optical zone and the posterior optical zone. The anterior optical zone and the posterior optical zone mean the anterior and posterior surface areas of the contact lens that contribute to a predetermined optical effect, respectively.

[0021] The term "optical centre" or "optic centre" means the geometric centre of the optical zone of the eye. The terms "geometrical" and "geometric" are essentially the same.

[0022] The term "optical axis" means a line that passes through the optical centre and is substantially perpendicular to a plane that includes the edge of the ophthalmic lens.

[0023] The term or phrase "single - focus optical zone" or "substantially single - focus optical system" or "substantially single - focus profile" or "spherical optical zone" means that the optical zone has a uniform refractive - power distribution with substantially no significant amount of primary spherical aberration. The single - focus optical zone may further be classified to include an astigmatism component for correcting refractive distance anomalies.

[0024] The term "model eye" may mean a schematic, ray - tracing, or physical model eye.

[0025] The term "Diopter", "Dioptre", or "D" as used herein is a unit measure of refractive power defined as the reciprocal of the focal length in meters along the optical axis of a lens or optical system.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0026] A detailed discussion of the prior art and generally relevant topics of interest is provided as background to the present disclosure to explain the context of the disclosed embodiments and to further distinguish the progress expected by the present disclosure over the prior art. No admission is to be construed from any of the material presented herein as to the priority of any of the various embodiments and / or claims shown in the present disclosure, whether the material is previously disclosed, known, or part of common general knowledge.

[0027] Briefly summarized, all prior - art optical designs having refractive or phase - changing features used to manage myopic refractive anomalies are associated with significant visual compromises, mainly caused by the use of multifocal - like design features often considered in the art. Examples thereof are described in U.S. Pat. Nos. 6045578, 7025460, 7506983, 7401922, 7803153, 8690319, 8931897, 8950860, 8998408.

[0028] A catalog of solutions in the field of optics has been proposed that has features that vary the amplitude to improve the depth of focus for a general imaging system. Examples thereof are the paper entitled "Improvement in the OTF of a defocused optical system through the use of shaded apertures" in Applied Optics 1971 written by Mino and Okano; the paper entitled "Arbitrary high focal depth with a quasi-optimum real and positive transmittance apodizer" in Applied Optics 1989 by Castaneda et al.; the paper entitled "Zone plate for arbitrary high focal depth" published in Applied Optics 1990 by Castaneda and Berriel-Valdos; and those described in U.S. Patent Nos. 5,965,330(A), 8,570,655(B2), and 8,192,022.

[0029] Disadvantages of solutions that vary the amplitude include a reduction in energy transfer at the critical frequency, lower resolution compared to phase conversion solutions, and low light throughput.

[0030] In contrast, the present disclosure is directed to the use of a single-focus ophthalmic lens design intentionally configured by a plurality of non-refractive features, which, as described herein, are intended to provide an increase in retinal ganglion cell activity and to overcome one or more disadvantages of the prior art.

[0031] Certain disclosed embodiments are directed to modifying light incident through a contact lens or spectacle lens that uses a stop signal to slow the progression of myopia. More specifically, the present disclosure relates to the use of single-focus contact lenses and spectacle lenses for the correction of myopia in a wearer, the single-focus ophthalmic lens device being configured with a basic prescription for correcting an individual's myopia and further configured with intentionally non-refractive features that facilitate an increase in retinal ganglion cell activity in the wearer, which may act as an optical stop signal for suppressing, reducing, or controlling the progression rate of the wearer's myopia. In some embodiments, the optical stop signal may be configured to have spatio-temporal variations.

[0032] Certain disclosed embodiments include contact lenses and / or spectacle lenses for altering the characteristics of incident light entering the human eye. Certain disclosed embodiments are directed to the configuration of contact lenses and / or spectacle lenses for correcting, managing, and treating refractive anomalies such as, for example, myopia. Some embodiments are directed to both correcting myopic refractive anomalies and simultaneously providing an optical stop signal that prevents further eye growth or the progression of myopia.

[0033] Certain embodiments relate to an apparatus, device, and / or method that can modify incident light through an ophthalmic lens to provide an active increase in retinal ganglion cell activity in order to slow the growth of an individual's eye. This may be achieved by a configuration of certain non-refractive features used with a single-focus ophthalmic lens aimed at introducing an artificial edge pattern or an artificial light contrast profile imposed on the central and / or peripheral retina. The artificial edge pattern or artificial light contrast profile imposed on the retina provides a spatial contrast profile across on-center and off-center retinal fields across the retina. The artificially induced edges provide an increase in spike activity of the retina or firing activity of ganglion cells, which is an alternative measure of overall retinal activity. The present disclosure hypothesizes that an optical stop signal may be provided to a progressing myopic eye by an increase in retinal ganglion cell activity.

[0034] In some other embodiments of the present disclosure, the non-refractive features of the contact lens are configured such that the artificial edge pattern or artificial spatial light contrast profile imposed on the retina further provides a temporal variation in overall retinal ganglion cell activity.

[0035] Certain embodiments of the present disclosure, as disclosed herein, include one or more variations of the structural characteristics of non-refractive features used with single-focus ophthalmic lenses for both contact lenses and spectacle lenses. For example, the structural characteristics of the non-refractive features include one or more of the following. The opacity of the non-refractive features on the ophthalmic lens, their size, width, and shape, their method of application, their application location, their distribution, their arrangement pattern, and the extent of their spread.

[0036] The intended variations in the numerous structural properties of the non-refractive features, as disclosed herein, provide the desired on-eye functional visual performance while maintaining the effectiveness of the embodiments of the ophthalmic lens for slowing the progression of myopia. Certain embodiments of the present disclosure include the optimization of non-refractive features, including but not limited to the following features, namely opacity, size, shape, multiplicity, pattern, location, and method of application, to provide a desired level of increase and / or a desired level of temporal dispersion in retinal ganglion cell activity without impairing the resolution ability of the eye. For example, in some embodiments of the present disclosure, one or more properties of the non-refractive features are configured on a single-focus ophthalmic lens having a basic prescription for correcting refractive abnormalities of the eye, and when the ophthalmic lens of this embodiment is tested in a model eye presenting several general visual scenes that may include typical scenes of environments and / or behaviors thought to be associated with the development and / or progression of myopia, it provides an increase in retinal ganglion cell activity of at least about 1.25 times, at least 1.5 times, at least 1.75 times, at least 2 times, at least 2.5 times, or at least 3 times that of a single-focus ophthalmic lens without non-refractive features, where 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 some examples, the retinal ganglion cell activity may be within a local region, in multiple local regions, or averaged over a desired retinal field. In some other embodiments, the ophthalmic lens tested in the model further provides temporal variations in retinal ganglion cell activity. In some examples, the retinal ganglion cell activity may be measured by retinal spike train analysis, while in some other examples, it may be measured by the average retinal spike rate as a function of time. In certain other embodiments of the present disclosure, the ophthalmic lens of the embodiment provides increased temporal variations, or jitter or vibration, in retinal ganglion cell activity when tested in a model eye, where the temporal variations in retinal ganglion cell activity may be represented as one or more of the following.Non-monotonic fluctuations, quasi-sinusoidal fluctuations, sinusoidal fluctuations, periodic fluctuations, aperiodic fluctuations, aperiodic quasi-rectangular fluctuations, rectangular fluctuations, square-wave fluctuations, or random fluctuations in retinal ganglion cell activity.

[0037] In some examples, a specific type of visual stimulus may be used to elicit retinal ganglion cell activity, and the visual stimulus may be, for example, white noise electrical stimulation, sinusoidal fluctuations in visual stimulation, checkerboard patterns, full-field flash stimuli, semi-field flash stimuli, full-field Gaussian noise, semi-field Gaussian noise, local flash stimuli, local Gaussian noise, and the like. In some examples, only a rough characterization of the neural response to the stimulus may be desired. On the other hand, in other examples, a more detailed characterization of the neural response to the stimulus may be desired. The stimuli used in this disclosure are considered to be merely representative means for demonstrating the actions of this disclosure, and the selection thereof should not be construed as limiting the scope of this disclosure and / or the claims.

[0038] In some embodiments of the present disclosure, the opacity of the non-refractive feature in the ocular lens may be configured to 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 feature. In some other embodiments of the present disclosure, the opacity of the non-refractive feature in the ocular lens may be configured to absorb 80% - 90%, or 80% - 95%, or 80% - 99% of the light incident on the non-refractive feature.

[0039] In some embodiments of the present disclosure, the width of any one or more of the individual elements of any non-refractive feature may be configured to be 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).

[0040] In some other embodiments of the present disclosure, the width of any individual element of any non-refractive feature may be configured such that the feature is 3 to 5 times, or 4 to 7 times, or 5 to 9 times, or 3 to 10 times the average wavelength of light in the visible spectrum (i.e., 555 nm). The lower limit in the choice to make the width of any individual element of the non-refractive feature substantially larger than the average wavelength of light in the visible spectrum is supported by the desirable result of avoiding undue diffraction effects related to the edges of the non-refractive features disclosed herein.

[0041] In some embodiments, the width of any one or more individual elements of the non-refractive feature in the ophthalmic lens may be configured such that the feature is 50 μm or less, or 75 μm or less, or 100 μm or less, or 150 μm or less, or 200 μm or less, or 250 μm or less, or 300 μm or less. The upper limit in the choice of the width / size of any individual element of the non-refractive feature is supported by the desirable result of maintaining an appropriate amount of light entering the eye that allows for minimal energy loss and does not substantially change the resolution ability of the eye wearing the contemplated embodiments disclosed herein. In some embodiments, the upper limit of the choice of the width / size of any individual element of the non-refractive feature may vary between contact lens and spectacle lens embodiments, taking into account the vertex distance in the latter.

[0042] In some other embodiments of the present disclosure, the non-refractive feature may be customized based on the degree and progression rate of myopia such that the effectiveness of the reduction in progression rate can be balanced with the desired degree of compromise in visual performance acceptable to the wearer.

[0043] In certain embodiments of the present disclosure, the shape of any one or more individual elements of the non-refractive feature that may be configured on the ophthalmic lens may be such that the feature is circular, hexagonal, octagonal, regular polygon, irregular polygon, line, triangle, dot, arc, or any other random shape disclosed herein.

[0044] In some other embodiments, the contemplated design features of the plurality of apertures, segments, regions, or zones may be circular, non-circular, semi-circular, annular, elliptical, rectangular, octagonal, hexagonal, or square in shape.

[0045] In certain embodiments of the present disclosure, the arrangement of the individual elements of the non-refractive features in a single-focus contact lens is such that the extent of all the non-refractive features is within a 2 mm central diameter, or within a 2.5 mm central diameter, or within a 3 mm central diameter, or within a 3.5 mm central diameter, or within a 4 mm central diameter, or within a 4.5 mm central diameter, or within a 5 mm central diameter, or within a 6 mm central diameter of the optical zone of the single-focus contact lens.

[0046] In certain embodiments of the present disclosure, the arrangement of the individual elements of the non-refractive features in a single-focus spectacle lens is such that the extent of all the non-refractive features is within a 20 mm central diameter, or within a 25 mm central diameter, or within a 30 mm central diameter, or within a 35 mm central diameter, or within a 40 mm central diameter, or within a 45 mm central diameter, or within a 50 mm central diameter, or within a 60 mm central diameter of the optical zone of the single-focus spectacle lens.

[0047] In some other examples of the present disclosure, the non-refractive features may be realized within a range of 30%, 35%, 40%, 45%, 50%, 55%, or 60% of the center of the optical zone of the single-focus ophthalmic lens.

[0048] In some other examples of the present disclosure, the non-refractive features may be realized within a range of 10%, 15%, 20%, 25%, 30%, 35%, or 40% of the periphery of the optical zone of the single-focus ophthalmic lens. The reference to the center or the peripheral portion of the single-focus ophthalmic lens is made with respect to the optical center of the ophthalmic lens.

[0049] In some other examples of the present disclosure, the non-refractive feature may be realized at one or more of the following locations: on the front surface of the ophthalmic lens, on the back surface of the ophthalmic lens, within the base material of the material of the ophthalmic lens. In some embodiments, the method of realizing the non-refractive feature may be achieved by an approach of pad printing or laser printing used in the normal development of cosmetic lenses.

[0050] In some embodiments of the present disclosure, the realized non-refractive feature may be arranged in the form of a plurality of apertures, a plurality of zones, a plurality of regions, a plurality of segments that are essentially above the essentially single-focus ophthalmic lens in other parts, and as disclosed herein, the non-refractive feature may act as an optical stop signal to promote an increase in retinal ganglion cell activity to suppress, reduce, or control progressive myopic refractive anomalies.

[0051] In other embodiments, the non-refractive feature may be realized by a homogeneous medium or a heterogeneous medium configured in the base material of the ophthalmic lens. In some other embodiments, the realization may include photolithography or other photogravure processes of the medium on or in the surface of the base material.

[0052] The present disclosure relates to an ophthalmic lens that changes the transmission characteristics of incident light to create a distinct light contrast profile (i.e., an artificial edge) on the retina of a wearer. The change in the transmission characteristics of the eye can be achieved by using a plurality of relatively lower transmission rate lines or streaks, or alternatively, by using non-refractive features arranged as a plurality of apertures, zones, segments, regions, or other patterns contemplated herein. The low transmission rate lines or streaks or features may be configured at one or more locations of the ophthalmic lens, i.e., on the front surface of the lens or on the back surface of the lens, or may be embedded in the matrix material of the ophthalmic lens. The low transmission rate lines, streaks, or features may be configured to be opaque, translucent, reflective, spectro-sensitive, polarization-sensitive, or absorptive. To achieve polarization-sensitive materials, various combinations of linear polarizing filters with or without a quarter-wave retarder may be considered. In some other embodiments, the desired polarization-sensitive characteristics may be configured using specific lens materials such as, for example, birefringent materials, coatings, or combinations thereof.

[0053] The dimensional specifications of the low transmission rate features, such as the width of the non-refractive features, etc., can be adjusted as desired in the lens design to increase the amount of light entering the eye and minimize visual artifacts, while properly configuring the ophthalmic lens for the desired refractive correction of the wearer's eye and maintaining or providing an appropriate stop signal to the wearer's eye.

[0054] The present disclosure proposes the use of non-refractive features to slow the progression of myopia. The use of non-refractive features facilitates embodiments that do not use any phase change approach such as positive defocus, positive spherical aberration, or any other deformation, such as optical features of bifocal, multifocal, or extended depth of focus.

[0055] The present disclosure proposes a method of slowing the progression of myopia by introducing an artificial edge or light contrast profile into an image of the retina captured while looking through an ophthalmic lens, providing an increase in retinal ganglion cell activity that can suppress further eye growth.

[0056] In some embodiments, the ophthalmic lens may mean a contact lens, but in other embodiments, the ophthalmic lens may mean an eyeglass lens. In some embodiments of the present disclosure contemplating eyeglass lenses, incorporating non-refractive features may degrade the cosmetic appearance of the eyeglass lens, which may be undesirable to the wearer. Additional material properties of the lens may be contemplated to mitigate the inferior cosmetic issues. For example, in some embodiments, the non-refractive features realized may be configured to have one or more of the following additional material properties, namely, complete non-sensitivity, partial sensitivity, or sufficient sensitivity to the polarization state of incident light. In some other embodiments of the eyeglass lenses of the present disclosure, the non-refractive features realized may be configured to be electrically adjustable. In some embodiments, a combination of pairs of polarized contact lenses and pairs of polarized eyeglass lenses may be contemplated to provide additional temporal variations in retinal ganglion cell activity without requiring excessive movement of the contact lens over the eye.

[0057] Certain embodiments of the present disclosure include contact lenses intentionally designed with non-refractive features arranged in, for example, moiré patterns, curved patterns, Memphis patterns, rectangular grid patterns, hexagonal patterns, helical patterns, spiral patterns, radial patterns, arrays of lines, zigzag or random patterns, where the non-refractive features are configured within the optical zone to introduce an optical contrast profile, i.e., an artificial edge, into the image on the retina. In one embodiment of the present disclosure, the intended moiré pattern or moiré fringes may be achieved by generating a large-scale interference pattern when an opaque regular pattern with transparent gaps is overlaid on another similar pattern separated laterally. In another embodiment, the moiré pattern may be achieved by printing regular patterns on both sides of the contact lens with a predetermined offset and orientation. Alternatively, in other embodiments, the resulting moiré pattern may be printed or configured on one surface of the contact lens.

[0058] Certain embodiments of the present disclosure are directed to a combined single-focus contact lens design made of a hydrogel material or a silicone hydrogel material that incorporates non-refractive features within the optical zone of a single-focus contact lens for the purpose of suppressing, preventing, and / or controlling the progression of myopia.

[0059] Some embodiments of the ophthalmic lenses of the present disclosure provide a spatio-temporal variation of a stop signal that is facilitated by, for example, the movement of an ophthalmic lens, such as a contact lens, on the eye, the natural blinking motion of the eyelid during wearing of the contact lens of the present disclosure, or any of the eye movements during wearing of the contemplated spectacle lens embodiments disclosed herein. The spatio-temporal variation of the presentation of an artificial edge profile or a light contrast profile makes it possible to minimize the saturation of the efficacy over time at the progression rate of myopia. The embodiments presented in the present disclosure are directed to the continuing need for improved ophthalmic lenses that provide a therapeutic benefit of suppressing or reducing the progression rate of myopia while providing the wearer with a single focus of equivalent or appropriate visual performance over a range of distances and viewing angles.

[0060] Certain other embodiments of the present disclosure are directed to maintaining the effectiveness of the therapeutic benefit over time. Various aspects of the embodiments of the present disclosure address such requirements of the wearer. The embodiments of the present disclosure are directed to contact lenses for at least one of slowing, decelerating, or preventing the progression of myopia. The contact lens includes a front surface, a back surface, an optical zone, and an optical center, and the optical zone around the optical center is configured with a plurality of fine lines, or a plurality of striations, or a plurality of streaks, and the other portions are configured with a single focus prescription for providing appropriate foveal vision correction at least substantially in part, and a further contemplated design feature is configured to provide a stop signal for reducing the progression rate of myopia by providing an increase in retinal ganglion cell activity at least in part.

[0061] According to some embodiments, the contact lens is configured with a plurality of non-refractive design features, such as for example a plurality of lines, or streaks, or apertures, or patterns, within a substantially single focal optical zone, the non-refractive design features providing an active enhancement of the spatio-temporal signal retinal encoding facilitated by any of the on-eye movement of the contact lens, the natural blinking motion of the eyelid, or the eye movement during wear of the contact lens as disclosed herein. Thus, saturation of the efficacy over time against the progression rate of myopia can be minimized.

[0062] According to some embodiments, an ophthalmic lens is configured with a plurality of non-refractive design features, such as for example a plurality of lines, or streaks, or apertures, or patterns, within a substantially single focal optical zone, the non-refractive design features providing an active enhancement of the spatio-temporal signal retinal encoding facilitated by eye movements during wearing of the contemplated ophthalmic lens disclosed herein. The embodiments presented in this disclosure are directed to the continuing need for improved optical designs of ophthalmic lenses that can suppress the progression of myopia while providing wearers with reasonable and appropriate visual performance for the range of activities that a wearer may perform as part of their daily life. Various aspects of the embodiments of this disclosure address such needs of the wearer. Exemplary methods of this disclosure include measuring the refractive state of an individual's eye based on standard refractometry techniques, identifying a basic prescription of the eye based at least in part on the refractive measurement of the eye, selecting the refractive power of the single focal lens of this disclosure to substantially match the basic prescription required to correct the underlying refractive anomaly, and further selecting the size, pattern, and placement of the non-refractive features contemplated in this disclosure to balance the desired increase in ganglion cell activity in the individual's retina with any threshold perception of visual impairment that may be experienced by the individual. In one or more embodiments of this disclosure, the non-refractive features are substantially opaque and are arranged within a designated region of the single focal ophthalmic lens such that these non-refractive features provide an increase in retinal ganglion cell activity in the on-center and off-center retinal pathways disclosed herein. In some methods of this disclosure, the selection of the non-refractive features may depend on the activities that a wearer may perform while wearing the ophthalmic device, for example, a different pattern may be prescribed for a wearer engaged in distance vision tasks than for a wearer who reads and acts on a computer or table or phone such that a balance between the effectiveness of the therapeutic benefit and visual performance is maintained at a desirable level. In some other methods, the selection of the non-refractive features may depend on the underlying risk factors for the development or experience of progressive myopia.

[0063] Several other embodiments, including the embodiments discussed in the summary, are shown in the description, drawings, and claims of this disclosure. As can be understood, it is practically impossible to include all single combinations of the contemplated embodiments of this disclosure, and any combination or any variation that at least partially contemplates the basic concept of increasing retinal ganglion cell activity through the use of non-refractive features together with an ophthalmic lens is considered to be within the scope of the invention. This summary portion of this disclosure is not intended to be limited to the embodiments disclosed herein. Further, any limitation of one embodiment may be combined with any other limitation of any other embodiment to form additional embodiments of this disclosure.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0065] Optical solutions that can be used to slow the progression of myopia include some form of optical manipulation of retinal image characteristics, such as simultaneous defocus, positive spherical aberration, positive refractive power at the center and / or periphery of the optical zone, or lenses that utilize higher-order aberrations to extend the depth of focus.

[0066] One weakness of these optical designs is that they compromise visual quality. Considering the impact of lens wear compatibility on the effectiveness of such lenses, a significant reduction in visual performance may encourage low compatibility and thus result in lower effectiveness.

[0067] Therefore, what is needed is a design for the correction of myopia and the delay of its progression that does not cause visual impairment associated with the manipulation of refractive power within the ophthalmic lens. The present disclosure proposes an alternative non-refractive method for delaying the progression of myopia that does not use optical defocus as a stop signal. Embodiments of the present disclosure propose an alternative method for delaying the progression of myopia by artificially introducing an edge or light contrast profile into the retinal image. Some embodiments further introduce spatio-temporal variations in the light contrast profile into the image projected onto the retina through the lenses of the present disclosure, thereby enhancing the overall retinal activity, and as a result, further eye growth can be suppressed. One or more embodiments of the present disclosure rely on the center-surround architecture of retinal ganglion cells that generate a preferential response to spatial and / or temporal changes in the light profile incident on the retina.

[0068] In this section, the present disclosure is described in detail with reference to embodiments of one or more contact lenses or one or more eyeglasses, and some of the expected embodiments are illustrated and supported by the accompanying drawings. Some embodiments of contact lenses and eyeglass lenses are provided for illustrative purposes and should not be construed as limiting the scope of the present disclosure.

[0069] The following description is provided in relation to several contact lens and spectacle lens embodiments that may share common characteristics and features 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 that may constitute additional embodiments. The functional and structural information disclosed herein should not be construed in any limiting sense, but rather should be interpreted merely as a representative basis for teaching those skilled in the art to use the disclosed embodiments and variations of those embodiments in various ways. The subheadings and related topic headings used in the detailed description section are included only to facilitate the reader's reference and should in no way be used to limit the subject matter described throughout the present disclosure or the claims of the present disclosure. Subheadings and related topic headings should not be used when interpreting the scope of the claims or limitations of the claims.

[0070] Several techniques have been reported to be usable for identifying individuals having a risk of developing myopia or progressive myopia and include inquiries regarding one or more of the following factors: namely, genetics, ethnicity, lifestyle, environment, excessive near work, etc. Certain embodiments of the present disclosure are directed to persons identified as having a risk of developing myopia or progressive myopia. To date, numerous optical designs have been proposed for controlling the growth rate of the eye or slowing the progression of myopia. Some of these designs feature the use of a certain degree of relative positive refractive power related to the basic prescription. Designs based on such optical principles result in a significant reduction in visual quality. Considering the impact of lens fit on efficacy, a significant reduction in visual performance may promote a reduction in fit, which may in turn result in less adequate efficacy.

[0071] Embodiments of the present disclosure relate to an optical design that utilizes the effect of non-refractive features intentionally configured within the optical zone of a single-focus ophthalmic lens, designed to help suppress or slow the progression rate of myopia by increasing retinal ganglion cell activity.

[0072] The human visual system is organized into on and off retinal channels or pathways. Retinal ganglion cells have circular receptive fields that are organized into on-center / off-surround bipolar cells or vice versa, and their operation is briefly explained in FIGS. 1 and 2.

[0073] Complex retinal ganglion cell circuits help convert the spatio-temporal information contained in the incident light of a visual input scene into spike trains and activity patterns that are transmitted to the visual field by the axons of retinal ganglion cells that form the optic nerve fibers.

[0074] Two groups of retinal ganglion cells, the magnocellular and parvocellular cells, help with different types of responses to the incident light signals captured in the retina. The information transmitted by the magnocellular and parvocellular cells is parallel and independent of each other.

[0075] The magnocellular pathway or transient pathway captures the temporal features of the incident light signal, such as motion, change, and onset within the input scene, while the parvocellular pathway or sustained pathway captures the spatial features of the incident light signal, such as patterns and shapes within the input scene.

[0076] The magnocellular pathway has large receptive fields, short delays, and uses fast-conducting axons to respond in a transient manner. On the other hand, the parvocellular pathway has smaller receptive fields, long delays, and uses slow-conducting axons to respond in a sustained manner. The relative change events captured by the magnocellular pathway and the sustained image frames of gray levels captured by the parvocellular pathway are two highly orthogonal representations of the visual scene.

[0077] If the regulation of eye growth is adjusted locally rather than globally, the magnocellular pathway may be involved in the regulation of eye growth or the regulation of eye growth homeostasis for at least some individuals. In other words, magnocellular retinal ganglion cells that contain information about local relative changes provide the ability to encode dynamic or temporal contrast within a transcribable visual scene into growth-on or growth-off signals.

[0078] An increase in the spatio-temporal contrast of the visual scene may introduce spikes or short-term increases in retinal ganglion cell activity, and the greater the retinal ganglion cell activity, the higher the growth inhibitory signal to the eye. Due to the structure of the retinal receptive field circuit, the following two conditions do not excite retinal ganglion cells: (a) a uniformly illuminated retinal scene without distinct edges (i.e., no spatial contrast in the visual scene), or (b) too little change in the scene over too long a time (i.e., no temporal contrast). The lower the excitation of retinal ganglion cells, the lower the firing activity, which indicates an overall decrease in retinal activity. The greater the retinal inactivity, the lower the growth inhibitory signal, resulting in further eye growth. The relative difference in the temporal integration of on receptive field activity and off receptive field activity determines further eye growth.

[0079] This disclosure is premised on the idea that an inactive retina causes eye growth, while an active retina inhibits growth or causes a stop signal. This disclosure further anticipates that prior art standard single focus contact lenses or eyeglass lenses, and / or spatially uniform visual images, contribute to a homogeneous and substantially edge-free visual image that promotes further eye growth leading to myopia by keeping the retina in a baseline state (i.e., the baseline or steady firing pattern of retinal ganglion cells).

[0080] Figure 1 shows the operation of on-center off-surround and off-center on-surround retinal receptive fields used to illustrate one or more embodiments of this disclosure.

[0081] The first and third columns of FIG. 1 highlight the following four cases of theoretical stimulus presentation. (a) No light in the entire retinal receptive field (101 and 111); (b) No light in the central region of the retinal receptive field, but the periphery is fully lit (102 and 112); (c) No light in the peripheral region of the retinal receptive field, but the central region is fully lit (103 and 113); and (d) Both the central and peripheral regions of the retinal receptive field are fully lit (104 and 114). The second and fourth columns show the firing activity potentials over time for the various corresponding stimulus conditions disclosed in FIGS. 1(a) - 1(d).

[0082] For example, when considering an on - center off - surround retinal receptive field (i.e., the first two columns of FIG. 1), in the absence of a light stimulus (101), the retinal ganglion cells fire at a baseline rate (106). When light impinges only on the off - surround region (102) and not on the on - center region, the baseline firing is suppressed during the stimulus period (107).

[0083] When the light spot coincides with the on - center zone (103), the firing rate of the retinal ganglion cells is maximal (108). As the circle of light expands to cover both the on - center field and the off - surround field (104), the firing pattern decreases from its maximum and approaches the basal firing rate (109).

[0084] When considering an off - center on - surround receptive field (i.e., the last two columns of FIG. 1), in the absence of a light stimulus (111), the retinal ganglion cells fire at a baseline rate (116).

[0085] When light impinges only on the on-surround region (112) and not on the off-center region, the firing rate of retinal ganglion cells is maximum (117). When the light spot coincides with the off-center zone (113), the baseline firing is suppressed during the stimulation period (118). As the circle of light expands to cover both the off-center field and the on-surround field (114), the firing pattern decreases from its maximum and approaches the baseline firing rate (119). As would be recognized by those skilled in the art, the illustration in FIG. 1 is a theoretical best-case scenario and may be difficult to reproduce in real-life scenarios other than experiments in a bench-top laboratory.

[0086] FIG. 2 is another graph of the firing patterns of an on-center off-surround retinal receptive field when subjected to different stimulus conditions. The upper half of FIG. 2 shows the following five different light stimulus conditions that illustrate some of the edge (206) detection scenarios that the receptive field may encounter. (i) When the entire receptive field is in the dark part of the edge (201); (ii) When a part of the surround is on the bright side of the edge and the center and the remaining part of the off-surround zone are still in the dark part of the edge (202); (iii) When a part of the off-surround region and the on-center region are on the bright side of the edge and most of the on-center region and the off-surround region are in the dark patch of the edge (203); (iv) When all of the on-center region is on the bright side of the edge and some of the off-surround region is on the dark side of the edge (204); and finally (v) When the entire receptive field is on the bright side of the edge (205).

[0087] The lower half of FIG. 2 shows the action potentials of the firing activities of ganglion cells for five different edge detection scenarios (201-205) that the receptive field may encounter over time. For example, when the entire receptive field is in the dark part of the edge (201), the firing rate of the ganglion cells is the baseline rate indicated by the double black solid line in FIG. 2. When a part of the off-surround region is on the bright side of the edge and the on-center is still on the dark side of the edge (202), the firing rate of the ganglion cells is suppressed lower than the baseline rate. When a part of the off-surround region and the on-center region move towards the bright side of the edge (203), the firing rate returns to the baseline rate. When the entire center region is on the bright side of the edge and some of the surround is on the dark side (204), the firing rate reaches a peak.

[0088] Finally, when the entire receptive field is on the bright side of the edge (205), the firing rate decreases to approach the baseline rate, but remains in a range slightly higher than the baseline rate. The surround of the receptive field also affects the amount of glutamate released by the photoreceptor cells. When the surround field is dark, the photoreceptor cells in this area will depolarize and release more glutamate.

[0089] When light shines on the on-center region while at least a portion of the off-surround experiences relative darkness, the horizontal cells connected to the photoreceptor cells in the surround field depolarize in response to glutamate and release their inhibitory neurotransmitters, further suppressing the center photoreceptor cells so that they release less glutamate. This situation results in the highest response of the retinal ganglion cell's firing action potential. The exact opposite occurs when there is light in the surround. Since the photoreceptor cells hyperpolarize in the surround, they release less glutamate.

[0090] The horizontal cells connected to the photoreceptor cells in the surround field hyperpolarize in response and release less of their inhibitory neurotransmitters, resulting in less inhibitory response, so that the center photoreceptor cells can be released from inhibition and release more glutamate. This is the situation that results in the highest response in an off-center ganglion receptive field.

[0091] Virtual Retina Model As would be recognized by those skilled in the art, the illustration in Figure 2 is a theoretical scenario of the operating models of various on-channel and off-channel retinal fields, and they may not reflect the typical real-life scenarios experienced by individual eyes. To demonstrate the suitability for various real-life test cases, a virtual retina simulation platform is used to show the operation of various embodiments. The operating principle and technical framework of the virtual retina platform used are described herein.

[0092] The virtual retina platform is configured to use a set of retinal images that include a temporal sequence as input and convert them into an output of a set of spike trains or action potentials that represent the overall activity of the retina. Essentially, the edge detection ability of the center-surround architecture of ganglion cells, which provides a preferential response to spatial and / or temporal changes in the incoming visual scene, was used herein. To fine-tune the emulation of wide-field retinal images to mimic real-life scenarios, several variables within the framework of the virtual retina platform can be adjusted.

[0093] Some information regarding retinal circuits and neurophysiology described in the following scientific papers is necessary to practice the invention disclosed herein. Here, the scientific journal paper titled "Probing the potency of Artificial Dynamic On- or Off- stimuli to inhibit myopia development," written by Wang, Aleman, and Schaeffel and published in the Investigative Ophthalmology and Vision Science journal in June 2019, is hereby incorporated by reference in its entirety. Another paper titled "Virtual Retina: A biological retina model and simulator, with contrast gain control," written by Wohrer and Kornprobst and published in the Journal of Computational Neuroscience in 2009, is hereby incorporated by reference in its entirety. Additionally, another scientific paper titled "A New Platform for Retinal Analysis and Simulation," written by the authors Cessac, Kornprobst, Kraria, Nasser, Pamplona, Portelli, and Vieville and published in the Frontiers of Neuroinformatics journal in 2017, is hereby incorporated by reference in its entirety.

[0094] Ideally, the source input retinal image for a virtual retinal platform should be a representation that closely resembles the image formed on an individual human retina when the individual wears one of the contemplated embodiments disclosed herein. Since access to actual retinal images is not possible, the expected image effects can be emulated using a schematic model eye that conforms to the disclosed embodiments, or alternatively, an image can be obtained using a physical model eye that conforms to the embodiments disclosed herein.

[0095] The present disclosure makes extensive use of high - degree ray tracing and schematic modeling to obtain virtual retinal images of various subjects when the range of schematic model eyes for refractive anomalies is adapted to the scope of the embodiments disclosed herein. For other embodiments, alternative approaches including the use of physical or bench - top model eyes may be considered to demonstrate the effects of the disclosed embodiments. Established models of virtual retinal processing have been used to explain the effects of various ophthalmic lens embodiments of the present disclosure. Figure 3 represents a flow diagram of the overall structure of a virtual retinal model used as a platform for explaining the internal workings of the various embodiments disclosed herein. This model is an adaptation of the research of Waller and Corn Probst, published as a peer - reviewed paper titled "Virtual Retina: A biological retina model and simulator, with contrast gain control".

[0096] The three - layer architecture of the proposed virtual retina model (Figure 3) facilitates a sequential and continuous spatio - temporal map that progressively transmits and converts incoming signals present in the visual scene. The incoming retinal signal has a luminance profile of L(x,y,t), where luminance is defined for each spatially separated point or pixel (x,y) on the retina at a given time (t). For all simulations used to illustrate embodiments of the present disclosure, the input visual scene was digitized and had intensities between 0 and 255 representing 8 - bit gray levels. However, the use of input images having intensities between 0 and 1023, or 0 and 4095, or 0 and 65535 representing 10 - bit, or 12 - bit, or 16 - bit gray levels may also be used to demonstrate the usefulness 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 formulas described herein.

[0097] As shown in the chart of Figure 3, the first stage of the virtual retina model involves the processing of the input signal in the outer plexiform layer, which includes photoreceptor and horizontal cells. In the first stage, the input sequence L(x,y,t) is decomposed into the photoreceptor center response C(x,y,t) and the horizontal surround cell response S(x,y,t) using a simple spatio - temporal linear filter based on the teachings of Waller and Cornprobeust referenced herein. Further, the responses C(x,y,t) and S(x,y,t) are used in the outer plexiform layer filter to define the band - pass excitatory current I OPL (x,y,t), which is then applied to the bipolar cells in the second stage of the model. Instantaneous non - linear contrast gain control is applied to the bipolar layer V A (x,y,t) using a variable feedback - gated shunt conductance g BP (x,y,t) to yield the excitatory current I GANG (x,y,t). In the third stage, a discrete set of equations governing noise integration and spiking cell models act on I GANGHelps convert (x, y, t) into a spike train used to measure retinal ganglion cell activity. Spikes can be modeled using a one-to-one connection or, alternatively, synaptic pooling of the received excitatory current.

[0098] To approximate the signal conversion occurring in the retinal layers, multiple linear filters are used at different stages of the model. To simplify the computational complexity and minimize large computational inefficiencies while maintaining real-world compatibility, several assumptions are made in the model for explaining the operation of the embodiments of the present disclosure.

[0099] The present disclosure is not limited to the virtual retinal model for explaining the operation of the embodiments, and the use of modified forms for the disclosed models and alternative models for design or verification is considered to be within the scope of the present invention. In the first stage of the virtual retinal model occurring in the outer plexiform layer, the resulting current I received by bipolar cells from photoreceptor cells C(x, y, t) and horizontal cells S(x, y, t) OPL (x, y, t) is obtained as follows.

[0100]

Equation

[0101] In Equation 1, C(x, y, t) represents the central signal related to photoreceptor cells, and S(x, y, t) represents the surround signal related to horizontal cells. The light transmission process is a partial transient linear kernel cascade having an exponential temporal low-pass kernel E τS and a gamma exponential function cascade E ωU,τU modulated by a partial transient filter T ηC,τC and is modeled as.

[0102] The symbol C in Equation 2 represents the kernel operation on the central signal, U represents the undershoot, and S in Equation 3 represents the kernel operation on the surround signal. The function G in Equation 2 σCincludes the spatial blurring of gap junctions between photoreceptor cells.

[0103] Function G in Equation 3 σC includes the spatial blurring of coupled gap junctions between horizontal cells. The symbols in Equations 2 and 3

[0104]

Number

[0105] indicates temporal convolution, while the symbol

[0106]

Number

[0107] indicates spatial convolution. The symbols will be used hereinafter in this disclosure to indicate temporal and spatial convolutions. The constant λ OPL is the overall gain of the center-surround filter, while w OPL is the relative weight of the center signal and the surround signal.

[0108] The contrast gain control operation in the second stage of the virtual retina model describes the influence of the local contrast of the visual input scene on the electrical signal transmission characteristics of the retina, which is essentially non-linear and dynamic. The contrast gain control based on the non-linear feedback loop at the bipolar cell level can be described as follows.

[0109]

Number

[0110] In Equations 4, 5, and 6, g A represents the variable leak in the membrane of bipolar cells that can be activated using the static function QV BP . The leak is related to the evolution of V BP with respect to g AThe divisive effect determines the gain of current integration at this level. In this model, g A is dynamically dependent on the values considered by bipolar cells together with the time scale τ A and the spatial spread σ A .

[0111] The third stage of the virtual retina model involves generating spike trains of retinal ganglion cells from the activity of bipolar cells. The bipolar signal V BP is rectified and undergoes additional spatio-temporal shaping to generate the excitatory current I GANG (x,y,t) for ganglion cells described by Equations 7 and 8.

[0112]

Equation

[0113] The models proposed by Waller and Cornelious used empirical formulas to model signal shaping in the transition from bipolar cells to center-surround ganglion cell currents. These models were adapted to demonstrate the operation of one or more embodiments disclosed herein.

[0114] The model proposes the use of several variables that allow for a diversity in the functional reproduction of the responses expected from alternative biologically plausible models described by Equations 7 and 8. The parameter ε takes two input values, -1 and +1, where the negative value represents off-ganglion cell activity and the positive value allows for the representation of on-ganglion cell activity.

[0115] The bipolar layer signal is rectified using the static non-linear function N(V), where the parameter λ G and

[0116]

Equation

[0117] has the dimension of reduced current, while

[0118]

Number

[0119] is the linear threshold of ganglion cells. Several additional models were proposed by Masmoudi, Antonini, and Kornprobst in the paper "Streaming an image through the eye: the retina seen as a dithered scalable image coder" published in Volume 28 (2013) of the journal Signal Processing: Image Communication, which is hereby incorporated by reference in its entirety. I GANG An array of noisy leaky-integrate-and-fire neurons (nLIF) generates a set of output spikes from (x, y, t). In the actual retina, additional complex conversions of electrical signals occur, which are facilitated by the synaptic structure of the inner plexiform layer, which is the site of synaptic interaction between bipolar cells, amacrine cells, and ganglion cells.

[0120] For the purpose of modeling to demonstrate the effects of embodiments of the present disclosure, in some examples, the complex synaptic relationships between amacrine cells and bipolar cells are ignored in favor of computational efficiency.

[0121] In some other examples, as disclosed herein, one or more of the complexities of the interactions between horizontal cells and bipolar cells and between amacrine cells and bipolar cells are considered. To describe the operation of the contemplated embodiments of the ophthalmic lens of the present disclosure, further expanding the model to include various other appropriate combinations of interactions of the outer plexiform layer and the inner plexiform layer is considered to be within the scope of the present invention.

[0122] Continuous signal I GANG (x, y, t) is converted into a discrete set of spike trains, obtained from the output of the cell using a standard nLIF model as described below.

[0123] [Number]

[0124] The standard nLIF model spikes when the threshold is reached, i.e., (V n )(t) = 1, and (V n )(t) = 0 during the refractory period. Here, (η υ )(t) is a noise source that can be added to the spiking process to reproduce the variability in actual ganglion cells.

[0125] To mimic the spikes of the retinal ganglion cell layer, the virtual retina is defined in a model that uses the following parameters to provide relative biological plausibility and an acceptable level of complexity. The following example in Figure 4 establishes the effectiveness of the virtual retina model described in paragraphs

[0091] to

[0124] of the present disclosure, which is composed of specific retinal parameters described herein.

[0126] In this example, a series of 50 image frames, each having dimensions of 512 × 512 pixels, are configured as an image montage to serve as an input source for the virtual retina model. The odd frames of the video input stream consist of a central circular bright region (401) on a dark background, while the even frames are composed of a central circular dark region (402) on a white background.

[0127] In this example, each frame was configured to be presented for 50 milliseconds, constituting a 2.5 - second real - time stimulus presentation to the virtual retina model. For both the odd and even frames of the video input stream, the diameter of the central circular region was configured to be approximately 50 pixels, which is equivalent to the visual angle of the 0.5° fovea. The bit - depth of each pixel in the input stream was digitized in the range of 0 - 255 (i.e., 8 bits). The visual angle of the video input stream was configured such that each frame corresponded to approximately 5°×5° on the foveal region of the model retina.

[0128] Using two simulation test conditions, the retinal ganglion cell activity when the input image stream was presented on the virtual retina was calculated. The simulation was performed in two different cell polarities, the on - cell mode and the off - cell mode. The retinal activity was measured by the spike activity arising from the ganglion cell layer of the virtual retina model. The spike activity for each test condition was represented as a pre - and post - stimulus histogram representation that shows the average neuronal spike train for each bundle and the average spike rate as a function of time.

[0129] The first test condition included one neuron bundle (403) positioned such that the center of the video input stream coincided with the center of the circular neuron bundle. The second test condition included seven circular neuron bundles (404), where one bundle was at the center of the video input stream and the remaining six bundles were positioned in a hexagonal pattern on a circumference such that the circumferential diameter corresponded to approximately 2.5°×2.5° on the foveal region of the model retina.

[0130] In addition, to show the effect on the virtual retina platform, in this example, the outer plexiform layer was configured to have a central region corresponding to approximately 1.5° (i.e., σC in Equation 2) and a surrounding region corresponding to approximately 4.75° (i.e., σS in Equation 3). The temporal scales of the center and the surround of the outer plexiform layer were set to approximately 1 millisecond, which represent the variables τC and τS in Equations 2 and 3 respectively. The variables governing the integrated center - surround signal as described in Equation 1 herein are w 0PL = 1 and λ0PL It was selected to be 10.

[0131] Due to the simplicity of the input image stimulus characteristics considered in this example of FIG. 4, when calculating the spike train and spike rate analysis, the options for the contrast gain control mechanism and the lateral connectivity of amacrine cells were eliminated. The static nonlinearity coefficients of bipolar and ganglion cell synapses were fitted from Waller and Corn probe stimuli, where the bipolar linear threshold was set to 0, while the linear threshold was held constant at 80, and the bipolar amplification value was held at 100.

[0132] The values for the neuron model were also fitted from Waller and Corn probe stimuli, where a leak of 0.75, neuron noise of 20, membrane capacitance of 150, and firing threshold of 2.4 were considered for the examples described in FIGS. 4, 5, and 6. The postsynaptic pooling variable sigma was ignored.

[0133] To show the operation of one or more embodiments of the ophthalmic lens of the present disclosure, the static nonlinearity coefficients of bipolar and ganglion cell synapses may be different from those used in the example of FIG. 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.

[0134] To show the operation of one or more embodiments of the ophthalmic lens of the present disclosure, the linear threshold may be a constant value of at least 30, at least 60, at least 90, or at least 120. To show the operation of one or more embodiments of the ophthalmic lens of the present disclosure, the bipolar amplification value may be at least 50, at least 75, at least 125, or at least 150.

[0135] To demonstrate the operation of one or more embodiments of the ophthalmic lenses of the present disclosure, the leak of the neuron model may be set to a value of at least 0.25, at least 0.5, at least 1, or at least 1.25. To demonstrate the operation of one or more embodiments of the ophthalmic lenses of the present disclosure, the neuron noise may be set to at least 10, at least 25, or at least 50.

[0136] To demonstrate the operation of one or more embodiments of the ophthalmic lenses of the present disclosure, the firing threshold of the neuron may be set to at least 1.2, at least 2.4, or at least 3.6.

[0137] In various other example embodiments used to explain the operation of the contact lens and spectacle lens embodiments of the present disclosure, as described herein, as described in Formulas 1 to 9, various configurations may be contemplated with different degrees of complexity. The specific configuration settings used for each simulation of the contact lens embodiments of Examples 1 to 7 are described in the following section.

[0138] Non-refractive features of the disclosed embodiments For the arrangement of the retinal pathways to the on-channel and off-channel, in the time domain, retinal neurons respond mainly to luminance that rapidly increases (on-cells) or decreases (off-cells) within the visual scene. In the spatial domain, the retinal receptive fields are arranged in a circular pattern of center-on and surround-off regions or vice versa. Such an arrangement of retinal cells enables an optimized use of the retinal circuitry to achieve the desired visual processing while maintaining appropriate spatial and / or temporal resolution.

[0139] A critical lack of spatial and / or temporal variation within the visual scene captured on the retinal surface results in insufficient excitation of retinal ganglion cells, and insufficient retinal activity, or an inactive retina, or a retina with insufficient activity is hypothesized to cause eye growth. Certain embodiments of the present disclosure are directed to individuals at risk of developing myopia or progressive myopia. One or more embodiments of the present disclosure rely on the hypothesis that a critical lack of distinct edges across the retina, distinct edges that vary over time, or a spatial light contrast profile, or a spatial light contrast profile that varies over time, contributes to a retinal ganglion cell activity that is close to its baseline state, in other words a substantially inactive retina.

[0140] The outputs of all receptive fields are integrated to reflect the relative on-input intensity and off-input intensity to the visual environment. A relative difference in the temporal integration of on-receptive field and off-receptive field activity is hypothesized to determine further eye growth. The present disclosure hypothesizes that an inactive retina causes eye growth and that an active retina suppresses that growth or causes a stop signal.

[0141] The present disclosure further anticipates that prior art standard single focal ophthalmic lenses and / or spatially homogeneous visual images contribute to a homogeneous and substantially spatially edge-free visual image that keeps the retina in a baseline state (i.e., a baseline or constant firing pattern of retinal ganglion cells), thus promoting further eye growth leading to more advanced myopia.

[0142] One or more of the following advantages are found in one or more of the disclosed optical devices and / or the methods of ophthalmic lens design disclosed herein. The ophthalmic lens or method uses a plurality of non-refractive features to configure the intended design features on the ophthalmic lens, thereby artificially introducing an edge or enhanced optical spatial contrast profile or enhanced temporal contrast profile into the generated retinal image, based on an increase in retinal activity, to slow the growth rate of the eye, or stop the growth rate of the eye, or provide a stop signal to halt an increase in the refractive error condition of the wearer's eye.

[0143] The movement of the contact lens on the eye can further increase the strength of the therapeutic effect by providing spatially and temporally varying stop signals to increase the effectiveness of the management of progressive myopia.

[0144] Certain other embodiments are directed to contact lens devices or methods that are not based solely on the optical manipulation of defocus, astigmatism, or positive spherical aberration, all of which may be subject to potential visual performance degradation for the wearer. The following exemplary embodiments are directed to methods of modifying incident light passing through an ophthalmic lens that can utilize the selective effects of the on and off visual pathways on eye growth and the progression of myopia.

[0145] The following exemplary embodiments are directed to methods of modifying incident light passing through an ophthalmic lens that provide an increase in retinal ganglion activity by stimulating the on pathway on the retina by artificially introducing inhomogeneity into the visual image and creating or increasing the optical contrast profile (i.e., artificial edge) at the retinal surface of the corrected eye. This may be achieved by using substantially opaque boundaries of a plurality of apertures, zones, segments, or regions within the single focal optical zone of the other portions of the ophthalmic lens.

[0146] In summary, the other portions may provide an increase in retinal ganglion cell activity by stimulating on and / or off pathways excited by an artificially introduced spatial edge profile as light passes through the contact lens or spectacle lens, using a single focus contact lens or a plurality of apertures, non-refractive regions, or non-refractive zones within the optical zone of the spectacle lens.

[0147] Furthermore, this use of excitatory zones, non-refractive regions, or a plurality of apertures within a single focus contact lens or spectacle lens may provide temporal contrast variations supplemented by eye movements and / or eyelid blinking movements using the contact lens and spectacle lens embodiments disclosed herein.

[0148] Schematic eye and simulated retinal image To calculate the wide-field simulated retinal images and wide-field optical performance of one or more exemplary embodiments disclosed herein, an advanced schematic model eye may be used.

[0149] A general prescription for a schematic model eye used to obtain a retinal image that serves as an input to a virtual retinal platform used to simulate the action of embodiments of the present disclosure is provided in Table 1 below. The parameters described in Table 1 do not necessarily indicate the described effects obtained by embodiments of the present disclosure. This should be considered one of many ways to obtain a retinal image to facilitate emulation of retinal processing performed by the virtual retinal platform described herein. For example, in other exemplary embodiments, other model eyes in the literature may be used instead of the model eye described in Table 1. The general parameters of the schematic model eye used are based on the prescription shown in Table 1. In this example, the general prescription of Table 1 provides a schematic model eye with a refractive anomaly at a distance with myopia of 1D without any astigmatism, configured in an uncorrected state, and the distance prescription of this model eye is defined with a pupil diameter of 6 mm and a principal wavelength of 589 nm.

[0150]

Table 1

[0151] In various other exemplary embodiments disclosed herein, various modifications may be considered to evaluate the performance of other embodiments of the ophthalmic lenses described herein. Further, the individual parameters of the schematic model eye, such as the anterior cornea, posterior cornea, corneal thickness, anterior lens, posterior lens, lens thickness, refractive index of the ocular media, retinal curvature, or combinations thereof, may be varied to demonstrate the action of the present disclosure at various levels of myopia with or without astigmatism, as well as for modeling various myopic eyes in the relaxed and accommodated states.

[0152] To obtain a wide - field simulated retinal image using a schematic model eye adapted to various embodiments of the present disclosure, as disclosed herein, the source image file was convolved with an array of point - spread functions over the desired field of view, taking into account the non - linear projection from the visual scene to the wide - angle model eye. Three source image files used in one or more embodiments are shown in FIGS. 14, 15, and 16. The first source image shown in the left portion of FIG. 14 is a source image file of a mobile phone screen display against a white - background screen. This mobile phone screen display is composed of several legible characters, and the viewing angle of the source scene is configured to capture a 15 - degree field of view at a viewing distance of 50 cm.

[0153] FIG. 14 represents a source image file of a wide - field visual scene (1401) projected onto the retina of a wide - angle model eye using a non - linear projection routine. The virtual retina is modeled by a neuron bundle arranged in a circular pattern (1402). The frames representing the wide - field visual scene (1401) of the mobile phone and the virtual retina (1402) against a white background are both for approximately 5°, 15°, or 20° of the retinal field in various embodiments. The second source image shown in the left portion of FIG. 15 is a source image file of another mobile phone screen display against a white - background screen. This mobile phone screen display is composed of several legible characters, and the viewing angle of the source scene is configured to capture a 15 - degree field of view at a viewing distance of 1 meter.

[0154] Figure 15 represents a source image file of a wide - field visual scene (1501) projected onto the retina of a wide - angle model eye using a non - linear projection routine. The virtual retina is modeled by neuron bundles arranged in a circular pattern (1502). Frames representing the wide - field visual scene (1501) of a mobile phone against a white background and the virtual retina (1502) are both for approximately 5°, 15°, or 20° of the retinal field in various embodiments. The third source image file shown in the left part of Figure 16 is a source image file of an 8 - bit grayscale Lena image, and the Lena image could be configured into two deformations for any of the visual fields of 5 degrees or 15 degrees or 20 degrees at a viewing distance of 6 meters.

[0155] Figure 16 represents a source image file of a wide - field visual scene (1601) projected onto the retina of a wide - angle model eye using a non - linear projection routine. The virtual retina is modeled by neuron bundles arranged in a circular pattern (1602). Frames representing the wide - field visual scene (1601) of a standard Lena test image presented in 8 - bit grayscale and the virtual retina (1602) are both for approximately 5°, 15°, or 20° of the retinal field in various embodiments.

[0156] The array of point - spread functions is interpolated for all pixels of the modified image file. At each pixel, an effective point - spread function is convolved with the modified source image file.

[0157] In the present disclosure, the principle of Huygens is applied to calculate the point - spread function in the desired visual field because the modeling effect of relatively small non - refractive features may be compromised by Fourier estimation, which is often used for increased computational efficiency.

[0158] The calculation of the array of point spread functions over the desired field of view includes the effects of diffraction and aberrations. The resulting simulated retinal image is scaled down and up taking into account the detected distortion levels. 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 considered for the convolution operation disclosed herein.

[0159] In various embodiments of the present disclosure, the setting of the various parameters required for the simulation of the virtual retinal image is changed to capture various real-life scenarios that can be experienced by an individual.

[0160] In certain embodiments, since the accuracy of the retinal image simulation is limited by the resolution of the input source image, sufficient care is taken to maintain at least a 512×512 pixel input image resolution to avoid the apparent pixel discretization of the output image often revealed by the aliasing effect, and if necessary, oversampling of the input source is considered to minimize such effects at the expense of a relatively long computation time.

[0161] Contact lens embodiments FIG. 7 shows a front view and a cross-sectional view of an exemplary contact lens embodiment, not to scale. The front view of the exemplary contact lens embodiment further shows an optical zone (701), a lens diameter (702), and a plurality of non-refractive features (703) of the contemplated design.

[0162] In this exemplary example, the lens diameter is about 14 mm, the optical zone is designed with a substantially single focal power and has a diameter of about 8 mm, and the non-refractive features are arranged in the form of the boundaries of a plurality of circular apertures within the optical zone, each having a diameter of about 1 mm. The boundaries of these non-refractive features (703) arranged in the form of a plurality of circular apertures may be configured to be between completely opaque and substantially opaque. For example, in this example, the transmission characteristics of the non-refractive features that are the boundaries of the plurality of circular apertures may be configured such that >95% of the light incident on the non-refractive features or boundaries is absorbed or not transmitted.

[0163] In FIG. 7, the width of the boundaries of the plurality of circular apertures, i.e., the non-refractive features, contemplated is about 50 μm (704). To show this feature and improve its visibility, the boundaries are enlarged relative to the size of the contact lens disclosed herein. The remaining portion of the optical zone without the contemplated non-refractive features, including the transparent regions within the plurality of apertures, includes a single focal design that matches the wearer's basic prescription.

[0164] FIG. 8 shows a front view and a cross-sectional view of another exemplary contact lens embodiment, not to scale. The front view of the exemplary contact lens embodiment further shows an optical zone (801), a lens diameter (802), and a plurality of joined hexagonal non-refractive features (803) of the contemplated design. In this exemplary example, the lens diameter is about 14.2 mm, the optical zone designed with a substantially single focal power has a diameter of about 9 mm, and the non-refractive features arranged in the form of the boundaries of a plurality of hexagonal apertures within the optical zone each have a maximum diameter of about 1 mm.

[0165] The boundaries of these non-refractive features (803) arranged in the form of a plurality of hexagonal apertures may be configured to be between completely opaque and semi-transparent. For example, the transmission characteristics may be configured such that >90% of the light incident on the non-refractive features or boundaries is absorbed or not transmitted.

[0166] In FIG. 8, the width of the boundaries of the plurality of hexagonal apertures, i.e., the non-refractive features, is about 25 μm (804). To show this feature and improve its visibility, its width is enlarged relative to the size of the contact lens described herein. The remaining portion of the optical zone without the intended non-refractive features, including the transparent regions within the plurality of apertures, includes a single-focus design that matches the wearer's basic prescription.

[0167] In yet another embodiment of a contact lens, the plurality of non-refractive features may be arranged as the boundaries of a plurality of circular, semi-circular, elliptical, or hexagonal, or any other polygonal-shaped apertures, where the plurality includes at least 2, 3, 5, 7, 9, 12, or 15 non-refractive features.

[0168] In some other embodiments of a contact lens, the number of non-refractive design features arranged in the form of the boundaries of a plurality of polygonal-shaped apertures may be 4 - 7, or 3 - 9, or 2 - 12, or 3 - 15. In some embodiments, the non-refractive design features arranged in the form of the boundaries of the plurality of apertures may be separated, while in other embodiments, they may be joined or combined.

[0169] In yet another embodiment of a contact lens, the non-refractive features configured as the boundaries of a plurality of apertures, or a plurality of regions, or a plurality of zones, or a plurality of segments may be arranged within 1, 2, 3, 4, 5, or 6 mm of the center of the optical zone of the contact lens. In yet another embodiment of a contact lens, the non-refractive features configured as the boundaries of a plurality of apertures, or a plurality of regions, or a plurality of zones, or a plurality of segments may be arranged between 1 mm and 3 mm from the center of the optical zone of the contact lens, or between 2 mm and 4 mm from the center, or between 3 mm and 5 mm from the center, or between 2 mm and 6 mm from the center, as disclosed herein.

[0170] In certain embodiments of a contact lens, the width of the boundary of an intended non-refractive design feature within the optical zone of the contact lens may be at least 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm wide, and may be completely opaque, substantially opaque, or translucent. In certain embodiments of a contact lens, the width of the opaque boundary of an intended design feature within the optical zone of the contact lens may be between 5-15 μm, 15-25 μm, or 10-50 μm wide.

[0171] In some other embodiments, the boundary of an intended design feature within the optical zone of the contact lens may be opaque, and in still some other embodiments, the boundary of the intended design feature may be translucent. In some embodiments, the width of the boundary or design feature may not be constant across a plurality of apertures. The shape of the plurality of apertures may also vary within one embodiment of the present disclosure.

[0172] FIG. 9 shows a front view and a cross-sectional view of another exemplary embodiment of a contact lens, not to scale. The front view of the exemplary embodiment of the contact lens further shows an optical zone (901), a lens diameter (902), and a plurality of non-refractive features (903) of the intended design.

[0173] In this exemplary example, the lens diameter is about 14.5 mm, the optical zone designed with a substantially single focal power is about 8 mm in diameter, and the non-refractive features configured as line segments or streaks are about 2 mm in length. These non-refractive features (903) may be substantially opaque, such that 95% of the light incident on the non-refractive features is not transmitted or is absorbed.

[0174] In FIG. 9, the width (904) of the contemplated non-refractive feature is from about 25 μm to 50 μm, and in the drawing, the width is enlarged only to show the feature relative to the size of the contact lens described herein. In a preferred embodiment, the maximum width of the non-refractive feature is 100 μm, 150 μm, or 200 μm or less to avoid an undesired impact on resolution characteristics. The remaining portion of the optical zone that does not include the contemplated non-refractive feature, including the clear range within the plurality of apertures, includes a single focus design that matches the wearer's basic prescription.

[0175] FIG. 10 shows a front view and a cross-sectional view of another exemplary contact lens embodiment, not to scale. The front view of the exemplary contact lens embodiment further shows an optical zone (1001), a lens diameter (1002), and a non-refractive feature (1003).

[0176] In this example, the lens diameter is a diameter of about 14 mm, and the single focus power and substantially designed optical zone is a diameter of about 8 mm. The contemplated design feature of this embodiment is a grid pattern centered on the contact lens and spanning a height and width of about 3 mm. The boundaries of these grid lines (1003) may be configured to be completely opaque or substantially opaque. The width (1004) of the contemplated non-refractive feature in FIG. 10 is from about 50 μm to 100 μm, and in the drawing, the width is enlarged only to show the feature relative to the size of the contact lens described herein.

[0177] The embodiment of FIG. 10 may be configured in other variations as well. For example, the intended non-refractive design feature within the optical zone may have a width of at least 5μm, 10μm, 20μm, 30μm, 40μm, or 50μm. The embodiment of FIG. 10 may be configured in other variations as well. For example, the intended non-refractive design feature within the optical zone may have a width between 5 - 15μm, 15 - 25μm, or 10 - 50μm. In a preferred variation of the embodiment of FIG. 10, the maximum width of the non-refractive feature, i.e., the width of the lines forming the lattice pattern, is made 150μm, 200μm, or 250μm or less in order to avoid an unguaranteed resultant effect on the resolution characteristics of the eye.

[0178] In other embodiments, the intended non-refractive design feature may be located (in the located) and arranged around the periphery of the optical zone. In yet another embodiment of a contact lens, the number of fine lines or ribs forming the lattice pattern may be at least 5, 9, 15, or 25. In some other embodiments of contact lenses, the number of design features, lines, or ribs forming the lattice pattern may be between 5 - 9, or 9 - 15, or 9 - 15, or 5 - 25. In another embodiment, it may be contemplated that just one long substantially continuous curve or zigzag line passes through the optical zone with a length of at least 3mm, 6mm, 9mm, or 12mm.

[0179] In yet another embodiment of a contact lens, one or more stripes may be arranged in a symmetric or random manner, and they may be centered on the optical axis or eccentric. Additionally, the stripes may consist of straight or curved lines, and those lines may touch or cross each other, or all may be arranged separately, or a combination thereof. The width and length of the stripes may vary. Different patterns may be applied to the lenses worn in the left and right eyes.

[0180] In yet another embodiment of a contact lens, the intended design features (i.e., multiple striations or moiré patterns) within the optical zone of the contact lens may be spaced apart from each other. In yet another embodiment, the multiple non-refractive features intended may be configured to be adjacent to each other or combined.

[0181] By the natural blinking facilitated by the combined action of the upper and lower eyelids, the contact lens may move freely relative to the wearer's pupil. This may result in temporally varying stimuli, thereby further enhancing the non-uniformity artificially introduced into the visual image and reducing the progression rate in myopic wearers.

[0182] FIG. 11 shows a front view of three additional exemplary embodiments of contact lenses, not to scale. The front view of the exemplary contact lens embodiments shows only a zoomed-in view of the optical zone (1101) and three intended non-refractive design features (1103a, 1103b, and 1103c). In this example, the non-refractive design feature (1103a) is a representative example of an intended moiré pattern configured away from the center of the contact lens embodiment.

[0183] The non-refractive design feature (1103b) shows another representation of an intended curved pattern across the optical zone, which is considered a helical pattern. The non-refractive design feature (1103c) shows a Memphis pattern centered on the optical center of the contact lens. The optical zone is designed with a substantially single focal power and has a diameter of about 8 mm. The width of the design features ranges from 5 to 100 μm, and the substantially opaque features in the drawings are emphasized to show the features relative to the size of the contact lens described herein.

[0184] In yet another embodiment of a contact lens, the designed features (i.e., multiple non-refractive stripes or moiré patterns) may be included within 1, 2, 3, 4, 5, or 6 mm of the center of the optical zone of the contact lens. In yet another embodiment of a contact lens, the design features (i.e., multiple non-refractive stripes or moiré patterns) may be included between 1 mm and 3 mm from the center of the optical zone of the contact lens, or between 2 mm and 4 mm from the center, or between 3 mm and 5 mm from the center, or between 2 mm and 6 mm from the center. In yet another embodiment of a contact lens, the intended design features (i.e., multiple stripes or moiré patterns) within the optical zone of the contact lens may be separated from each other. In yet another embodiment, the multiple non-refractive features intended may be configured to be adjacent to each other or combined. In a particular embodiment of a contact lens, the width of the intended design features (i.e., multiple stripes or moiré patterns) within the optical zone of the contact lens may be at least 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm wide.

[0185] In a particular embodiment of a contact lens, the width of the intended design features within the optical zone of the contact lens may be between 5 and 15 μm, between 15 and 25 μm, or between 10 and 50 μm wide. In some other embodiments, the boundaries of the intended design features within the optical zone of the contact lens may be opaque, and in still 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 features.

[0186] FIG. 12 shows a schematic diagram showing incident light of a visible wavelength such as 555 nm and a vergence of 0 D from a wide-angle view (1201) entering a 2D myopic model eye (1200) corrected with a prior art standard single-focus lens (1202).

[0187] The retinal ganglion cell activity recorded by the on-center / off-surround and off-center / on-surround circuits (1203) demonstrates or shows minimal or baseline retinal activity when a prior art standard single focal lens (1202) moves over the front of the eye by natural blinking movements, or habitual eye movements, or combinations thereof. The relative differences in the temporal integration of on receptive field and off receptive field activity determine further eye growth.

[0188] This disclosure assumes that an inactive retina causes eye growth and that an active retina decreases that growth or causes a stop signal. This disclosure further anticipates that prior art standard single focal contact lenses or spectacle lenses and / or spatially homogeneous visual images contribute to a homogeneous and substantially edge-free visual image that keeps the retina in a baseline state (i.e., the baseline or constant firing pattern of retinal ganglion cells) and thus promotes further eye growth leading to more advanced myopia.

[0189] FIG. 13 shows a schematic diagram of a beam of incident light of a visible wavelength such as 555 nm and a vergence of 0 D from a wide-angle field of view (1301) entering a 2D myopic model eye (1300) corrected in one of the exemplary embodiments (1302) disclosed herein. The retinal ganglion cell activity recorded by the on-center / off-surround and off-center / on-surround circuits (1303) demonstrates or shows an increase in retinal activity compared to the baseline state when the exemplary embodiment (1302) moves over the front of the eye by natural blinking movements, or habitual eye movements, or combinations thereof.

[0190] In FIGS. 12 and 13, a simple model eye was selected for illustrative purposes. However, in other embodiments, schematic ray-tracing model eyes such as Liou-Brennan, Escudero-Navarro, and others may be used instead. In the examples provided herein, the present invention was disclosed using a 2D myopic model eye, but the same disclosure can be extended to other degrees of myopia, namely -1D, -3D, -5D, or -6D. Furthermore, it is understood that it can be extended to eyes having various degrees of myopia with astigmatism. In an embodiment, a specific wavelength of 555 nm was mentioned, but it is understood that it can also be extended to other visible wavelengths between 420 nm and 760 nm.

[0191] Modeling of various exemplary contact lens embodiments (D1 - D7) shows that the intended non-refractive features used with a single-focus optical profile provide an increase in retinal ganglion cell activity, as measured by an increase in the average retinal spike rate obtained using the virtual retinal platform disclosed herein.

[0192] In other embodiments, various other surrogate measures of retinal ganglion cell activity may be considered, such as examination of spike train analysis of selected neuron bundles.

[0193] To show the action of contact lens embodiments according to the present invention, as described herein, for each test case (i.e., Examples 1 - 7), an experiment of advanced optical modeling was performed using two different types of contact lenses. The first type included single-focus control contact lenses (C1 - C7) that matched the basic prescription of a schematic model eye to provide correction of refractive anomalies mimicking standard treatment. The second type included various exemplary contact lens embodiments (D1 - D7) that were essentially the same single-focus standard treatment control contact lenses (C1 - C7) but were configured with additional non-refractive features designed according to the present invention.

[0194] To demonstrate the operation of the present invention, contact lenses of the control (C1 to C7) and exemplary embodiments (D1 to D7) were each mounted on a modified schematic model eye as described in each of Examples 1 to 7 and tested / evaluated. For the purpose of demonstrating the operation of these Examples 1 to 7, only the optical zone (8 mm) of the contact lens was modeled. In other examples, the entire contact lens including the peripheral zone and the edge may be modeled as desired.

[0195] The surface transmission characteristics of the front surface of the contact lens were modified to design the features of Examples 1 to 7. The transmittance is calculated as a percentage of 100%, where 100% means that all light is transmitted as if there were no absorption, reflection, or aperture loss. In certain embodiments of the present disclosure, the surface transmittance is defined as any relative percentage of the intensity with which light passes through its surface. In some other embodiments of the present disclosure, any relative percentage of the intensity may be configured to be wavelength-dependent. In certain other embodiments of the present disclosure, any percentage of the intensity may be configured to be polarization-sensitive.

[0196] To evaluate the simulated retinal ganglion cell activity, the contact lens was slid on the anterior corneal surface at various eccentric positions that mimic the relative lens movement that can be caused by vertical blinking-induced lens movement over the eye and / or horizontal saccadic eye movements. The movement of the contact lens relative to the center of the anterior corneal surface was included between + / −1 mm in both the horizontal and vertical directions. To mimic the movement of the contact lens over the eye, both a dispersion function and a tilt function were used in the modeling device.

[0197] At each position of the eccentric lens, a wide - field retinal image simulation was performed. The 48 retinal images thus simulated constituted an input stream to a virtual retinal platform that gives rise to retinal ganglion cell activity. In this example, each of the 48 image frames was configured to be 50 milliseconds, which constitutes a 2.4 - second real - time stimulus presentation to the virtual retinal model. Each frame of the input stream was configured over 512×512 pixels, and each frame covered the entire diameter of a circular neuron region that encompasses an area of approximately 5°×5° (fovea) or 15°×15° (macula) of the retina of the virtual retinal platform. The bit depth of each pixel in the input stream was digitized in the range of 0 - 255 (i.e., 8 bits). The specific retinal settings and configurations described in Equations 1 - 9, which are used to show the operation of the contact lens embodiments of the present disclosure, are considered in the following sections.

[0198] In all of Examples 1 - 7, the outer plexiform layer was configured to have a central region for approximately 1.5° (i.e., σC in Equation 2) and a surrounding region for approximately 4.75° (i.e., σS in Equation 3). The temporal scales of the center and the surround of the outer plexiform layer were set to approximately 1 millisecond, which were represented by the variables τC and τS in Equations 2 and 3, respectively. The variables that govern the integrated center - surround signal, as described in Equation 1 herein, were selected such that w 0PL = 1 and λ 0PL = 10. The static non - linear coefficients of bipolar and ganglion cell synapses were fixed throughout Examples 1 - 7. The bipolar linear threshold was set to 0, the linear threshold was maintained at a constant 80, and the bipolar amplification value was maintained at 100.

[0199] The values for the neuron model were maintained across all of Examples 1 - 7, where a leak of 0.75, neuron noise of 20, a membrane capacitance of 150, and a firing threshold of 2.4 were used for the simulations of Examples 1 - 7. The postsynaptic pooling variable sigma was ignored. Options for the contrast gain control mechanism, the utility of the replenishing high - pass filter in the outer plexiform layer, and the utility of the horizontal connections of amacrine cells were kept variable across Examples 1 - 7. Further details of the specific settings used are disclosed herein.

Example

[0200] Control (C1) and exemplary embodiment (D1) designs In this example, the following parameters of the schematic model eye of Table 1 were changed to constitute a 1D myopic eye (i.e., a basic prescription Rx of - 1D) in a 2D adjustment state. (1) The anterior lens curvature radius (R = 8.22 mm), and (2) the anterior lens conic constant (Q = - 2.314). The model was configured to focus on an object near about 50 cm from the eye. The modified myopic model eye was corrected one by one with the control (C1) and exemplary embodiment (D1) contact lenses. The control contact lens C1 was modeled using a front radius (R = 7.936 mm, Q = - 0.221), a central thickness (0.135 mm), a back radius (R = 7.75 mm, Q = - 0.25), and a refractive index of 1.42. The control contact lens C1 has no / lacks any non - refractive features contemplated in this present disclosure.

[0201] The exemplary embodiment (D1) contact lens is a single - focus contact lens having the same optical design as the control (C1), and is further configured with the additional non - refractive features disclosed in FIG. 17.

[0202] FIG. 17 shows a front view and a cross-sectional view of an exemplary contact lens embodiment D1 that is not to scale. The front view of the exemplary contact lens embodiment further shows an optical zone (1701), a lens diameter (1702), and a plurality of non-refractive features (1703) including non-refractive features of the combined circular shape of the contemplated design (D1). The total number of circular openings is 7. The overall dimension of the non-refractive feature including the plurality of openings is a diameter of about 3.75 mm. The dimension of each opening is a diameter of about 1.25 mm. The width of the boundary of each opening is about 100 μm (1704).

[0203] The non-refractive features are enlarged relative to other features of the contact lens for identification and visibility. The remaining portion of the optical zone (1701) without the non-refractive features of the exemplary embodiment D1 is composed of basic single-focus prescription parameters that match the basic prescription of the eye.

[0204] In this exemplary example D1, the lens diameter is about 14.2 mm, the optical zone designed with a substantially single-focus refractive power is about 8 mm in diameter, and the non-refractive features arranged in the form of a plurality of circular openings within the optical zone each have a diameter of about 1 mm. According to the steps disclosed in paragraphs

[0196] to

[0198] , the simulated retinal images were calculated and analyzed when the contact lens designs of control C1 and embodiment D1 were each worn on the schematic model eye of Example 1.

[0205] In this Example 1, additional variables of the virtual retinal platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were used with the following input parameter values. (i) Outer retinal amplification λ of 150 Hz per normalized luminance unit OPL value, (ii) bipolar inactivity leak of 5 Hz

[0206]

Number

[0207] (iii) Feedback amplification λ of 100 Hz A , (iv) Spatial scale σA of 2.5°, and (v) Temporal scale τA of 0.01 milliseconds. The arrangement of the neuron bundle (1402) was a circular arrangement spreading over a 15° × 15° visual field.

[0208] The sparse lateral connectivity mode of the virtual retina was used with 10 presynaptic neurons having a positive weight of 10% and a weight variance of 0.01. Further, the supplementary high-pass filter options of the outer plexiform layer described in Equations 2 and 3 were not used. The option of postsynaptic pooling was removed.

[0209] As considered herein, the post-processing of the calculated simulated retinal images of the control (C1) contact lens design of Example 1 using the virtual retina platform results in a spike train as a function of time (Figure 18) and a peristimulus histogram (Figure 19) emphasizing the average spike rate as a function of time for cells having both on-polarity and off-polarity. The upper and lower subgraphs of Figures 18 and 19 represent data for on-cells and off-cells, respectively.

[0210] As considered herein, the post-processing of the calculated simulated retinal images of the embodiment (D1) contact lens design of Example 1 using the virtual retina platform results in a spike train as a function of time (Figure 20) and a peristimulus histogram (Figure 21) emphasizing the average spike rate as a function of time for cells having both on-polarity and off-polarity. The upper and lower subgraphs of Figures 20 and 21 represent data for on-cells and off-cells, respectively.

[0211] The neuron activity by the control (C1) contact lens is invariant with time or monotonic as a function of time for cells having both on and off types of polarity, as shown by the spike train in Figure 18.

[0212] On the other hand, as shown by the spike trains in FIG. 20, the neuronal activity by the contact lens of Embodiment (D1) varies with time or is non-monotonic as a function of time for cells with both on and off types of polarities.

[0213] In Example 1, the neuronal activity by the control (C1) contact lens follows a monotonic profile following the first 100 milliseconds showing signal stabilization, as shown by the average spike rate in FIG. 19. This observed pattern is similar for cells with both on and off types of polarities. In Example 1, the average spike rate by the control (C1) contact lens following the first 100 - millisecond stabilization period is about one - quarter (1 / 4) the magnitude of that obtained by off - type cells for on - type cells, as disclosed herein (FIG. 19). On the other hand, the neuronal activity by the contact lens of Embodiment (D1) varies with time or is non - monotonic as a function of time, as shown by the average spike rate in FIG. 21.

[0214] In this Example 1, the average spike rate for on - type cells obtained by the contact lens of Embodiment (D1) is generally at least 3 - 4 times the average spike rate for on - type cells obtained by the control (C1) contact lens. In this example, the average spike rate as a function of time obtained by the contact lens of Embodiment (D1) follows a quasi - sine - wave pattern for both on - type and off - type cells, as depicted in FIG. 21.

[0215] The non - stationarity and non - linearity in the spike responses obtained by the lenses of the embodiments are due to artificial edges or light contrast profiles in the retinal image or temporal variations of artificial edges.

[0216] In this Example 1, the on-axis and off-axis evaluations of the optical performance were modeled in the multi-color mode over 470 nm to 650 nm using a luminosity function that describes the average spectral sensitivity of human vision for brightness under bright vision conditions with a pupil analysis diameter of 4 mm.

[0217] As described in FIGS. 22 and 23 herein, the wide-field optical performance was measured using a modulation transfer function as a function of spatial frequency at a pupil diameter of 4 mm, and was significantly similar between the control (C1) and exemplary embodiment (D1) contact lenses, i.e., the variation in the area under the curves represented by the solid black line and the dashed black line was less than 5%. For the off-axis performance in Example 1, the visual field considered for performance evaluation was 15°, which is ±7.5° from the center.

Example

[0218] Control (C2) and Exemplary Embodiment (D2) Designs In this example, the following parameters of the schematic model eye in Table 1 were changed to represent a 2D myopic eye with 1D astigmatism (i.e., a basic prescription Rx of -2D / -1DC) in the 2D adjustment state. (i) The anterior corneal radius (R x = 7.829 mm) along the X-axis, (ii) the anterior corneal conic constant (Q x = -0.604) along the X-axis, (iii) the vitreous chamber depth of 17.339 mm, (iv) the anterior lens radius (R = 8.22 mm), and (v) the anterior lens conic constant (Q = -2.314). The model was configured to focus on an object near about 50 cm from the eye. The modified myopic model eye was corrected one by one with the control (C2) and exemplary embodiment (D2) contact lenses.

[0219] The control (C2) contact lens represents a single-focus toric modeled using the following parameters. Front surface (R = 8.226 mm, Q = -0.392), central thickness (0.135 mm), toric back surface (R y = 7.75 mm, Q y = -0.25; R x = 7.829 mm, Qx =-0.604), and a refractive index of 1.38. The control contact lens C2 has no / lacks any non-refractive features contemplated in this disclosure.

[0220] The exemplary embodiment contact lens (D2) is a single-focus toric having the same optical design as the control C2, and is further configured with additional non-refractive features disclosed in FIG. 24.

[0221] The non-refractive features of the exemplary embodiment D2 include a dot pattern (2403) including a plurality of dots arranged in a hexagonal pattern. This random pattern (2403) is located within the optical zone (2401) around the optical center of the contact lens (2402). The total number of dots is 7. The total dimension of the dot pattern is a diameter of about 3.5 mm. The dimension of each dot in the dot pattern is a diameter of about 125 μm (2404).

[0222] The non-refractive features are magnified relative to other features of the contact lens for identification and visibility. The remaining portion of the optical zone (2401) without the non-refractive features of the exemplary embodiment D2 is configured with basic single-focus prescription parameters that match the basic prescription of the eye.

[0223] In accordance with the steps disclosed in paragraphs

[0196] to

[0198] , the simulated retinal images were calculated and analyzed when the contact lens designs of the control C2 and the embodiment D2 were each mounted on the schematic model eye of Example 2.

[0224] In this Example 2, additional variables of the virtual retinal platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were used with the following input parameter values. (i) Outer retinal amplification λ of 150 Hz per normalized luminance unit OPL value, (ii) bipolar inactivity leak of 5 Hz

[0225]

Number

[0226] (iii) A feedback amplification λ of 100 Hz A , (iv) a spatial scale σA of 2.5°, and (v) a temporal scale τA of 0.01 milliseconds. The arrangement of the neuron bundles (1402) was a circular arrangement extending over a 15° × 15° visual field.

[0227] The sparse lateral connectivity mode of the virtual retina was used with 10 presynaptic neurons having a positive weight of 10% and a weight variance of 0.01. Further, the replenishing high-pass filter options of the outer plexiform layer described in Equations 2 and 3 were used with the following parameter values. A temporal scale of 0.2 milliseconds and a spatial scale of half a degree. The option of postsynaptic pooling was removed.

[0228] As considered herein, the post-processing of the computed simulated retinal images of the control (C2) contact lens design of Example 2 using the virtual retina platform results in a spike train as a function of time (Figure 25) and a peri-stimulus histogram emphasizing the average spike rate as a function of time (Figure 26) for cells having both on-polarity and off-polarity. The upper and lower subgraphs of Figures 25 and 26 represent data for on-cells and off-cells, respectively.

[0229] As considered herein, the post-processing of the computed simulated retinal images of the embodiment (D2) contact lens design of Example 2 using the virtual retina platform results in a spike train as a function of time (Figure 27) and a peri-stimulus histogram emphasizing the average spike rate as a function of time (Figure 28) for cells having both on-polarity and off-polarity. The upper and lower subgraphs of Figures 27 and 28 represent data for on-cells and off-cells, respectively.

[0230] The neuronal activity by the control (C2) contact lens, as shown by the spike trains in FIG. 25, is invariant over time or monotonic as a function of time for cells with both on and off types of polarities. On the other hand, the neuronal activity by the embodiment (D1) contact lens, as shown by the spike trains in FIG. 26, varies over time or is non-monotonic as a function of time.

[0231] In Example 2, the neuronal activity by the control (C2) contact lens follows a linear profile excluding the data for the first 150 milliseconds showing signal stabilization, as shown by the average spike rate in FIG. 26. This observed pattern is similar for cells with both on and off types of polarities.

[0232] In Example 2, the average spike rate following the first 150 - millisecond stabilization period is about one - third (1 / 3) to one - fourth the magnitude of that obtained by off - type cells for on - type cells, as disclosed herein.

[0233] On the other hand, the neuronal activity by the embodiment (D1) contact lens, as shown by the average spike rate in FIG. 28, varies over time or is non - monotonic as a function of time. However, the variation within the spike rate as a function of time obtained in embodiment D2 of Example 2 is lower in both amplitude and frequency when compared to the results obtained in embodiment D1 of Example 1.

[0234] In this Example 2, the average spike rate for on-cells obtained with the Embodiment (D2) contact lens is generally at least 1.5 times the average spike rate for on-cells obtained with the control (D2) contact lens. In this example, the average spike rate as a function of time obtained with the Embodiment (D2) contact lens follows a temporal variation pattern for both on- and off-cells, as described in FIG. 28. The non-stationarity and non-linearity in the spike responses obtained with the lenses of the embodiments are due to artificial edges or light contrast profiles in the retinal image, or temporal variations of the artificial edges.

[0235] In this Example 2, the on-axis and off-axis evaluations of the optical performance were modeled at a monochromatic mode (589 nm) and a pupil analysis diameter of 4 mm. As described herein in FIGS. 29 and 30, the wide-field optical performance cannot be virtually distinguished between the control (C2) and exemplary embodiment (D2) contact lenses when measured using the modulation transfer function as a function of spatial frequency at a pupil diameter of 4 mm. For the off-axis performance in Example 2, the field of view considered for the evaluation of the performance was 15°, which is ±7.5° from the center.

Example

[0236] Control C3 and Exemplary Embodiment Design D3 In this Example 3, the following parameters of the schematic model eye of Table 1 were changed to represent a 3D myopic eye (i.e., a basic prescription Rx of -3D) in an uncorrected state. (i) The vitreous chamber depth of 17.65 mm, and (ii) the retinal radius of curvature of 13.5 mm.

[0237] The model was configured to focus on a distant object approximately at optical infinity from the eye. The modified myopic model eye was corrected one by one with the control (C3) and exemplary embodiment (D3) contact lenses. The control (C3) contact lens represents a single - focus lens modeled using the following parameters: front surface (R = 8.262 mm, Q = - 0.137), central thickness (0.135 mm), back surface (R = 7.75 mm, Q = - 0.25), and refractive index 1.42. The control contact lens C3 has no / lacks any non - refractive features contemplated in this disclosure.

[0238] The second lens D3 represents an exemplary embodiment that is also a single - focus contact lens having the same parameters as the control C3, and is further configured with non - refractive features disclosed in FIG. 31.

[0239] The non - refractive features of the exemplary embodiment D3 (FIG. 31) include a random pattern (3103) of bars or thick lines, including a plurality of bars. This random pattern is located optically within the optical zone (3101) around the optical center of the contact lens (3102). The total number of bars is 7. The total dimensions of the grid pattern are approximately 4 mm in diameter. The dimensions of each bar in the random bar pattern are between approximately 50 μm×1.25 mm (3104).

[0240] The non - refractive features are magnified relative to the other features of the contact lens for identification and visibility. The remaining portion of the optical zone (3101) without the non - refractive features of the exemplary embodiment D3 is configured with basic single - focus prescription parameters that match the basic prescription of the eye.

[0241] In accordance with the steps disclosed in paragraphs

[0196] -

[0198] , the retinal images simulated when the contact lens designs of control C3 and embodiment D3 were worn one by one on the model eye of Example 3 were calculated and analyzed.

[0242] In this Example 3, additional variables of the virtual retina platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were used with the following input parameter values. (i) Outer plexiform amplification λ of 150 Hz per normalized luminance unit OPL value, (ii) bipolar inactivity leak of 5 Hz

[0243]

Number

[0244] (iii) feedback amplification λ of 100 Hz A , (iv) spatial scale σA of 2.5°, and (v) temporal scale τA of 0.01 milliseconds. The arrangement of the neuron bundle (1602) was a circular arrangement extending over a 5°×5° visual field. The sparse lateral connectivity mode of the virtual retina was not used. Furthermore, the outer plexiform layer replenishment high-pass filter options described in Equations 2 and 3 were used with the following parameter values. A temporal scale of 0.2 milliseconds and a spatial scale of 0.5°. The option of postsynaptic pooling was removed.

[0245] As discussed herein, the post - processing of the computed simulated retinal images for the control (C3) contact lens design of Example 3 using the virtual retinal platform yields a spike train as a function of time (Figure 32) and a peristimulus histogram (Figure 33) that emphasizes the average spike rate as a function of time for cells with both on - polarity and off - polarity. The upper and lower sub - graphs of Figures 32 and 33 represent data for on - cells and off - cells, respectively. As discussed herein, the post - processing of the computed simulated retinal images for the embodiment (D3) contact lens design of Example 3 using the virtual retinal platform yields a spike train as a function of time (Figure 34) and a peristimulus histogram (Figure 35) that emphasizes the average spike rate as a function of time for cells with both on - polarity and off - polarity. The upper and lower sub - graphs of Figures 34 and 35 represent data for on - cells and off - cells, respectively.

[0246] Neuronal activity with the control (C3) contact lens, as shown by the spike train in Figure 32, is relatively time - invariant or has minimal variation or fluctuation as a function of time for cells with both on - and off - type polarities. On the other hand, neuronal activity with the embodiment (D1) contact lens, as shown by the spike train in Figure 34, is relatively time - varying or has greater variation or fluctuation as a function of time.

[0247] In Example 3, neuronal activity with the control (C3) contact lens follows a relatively monotonic profile following an initial 100 - millisecond period of signal stabilization, as shown by the average spike rate in Figure 33. This observed pattern is similar for cells with both on - and off - type polarities. In Example 3, the average spike rate with the control (C3) contact lens, as disclosed herein, is approximately four times greater for on - type cells than that obtained by off - type cells, excluding the initial 100 - millisecond stabilization period.

[0248] On the other hand, the neuron activity by the contact lens of Embodiment (D3) varies with time or is non-monotonic as a function of time, as shown by the average spike rate in FIG. 34. In this Example 3, the cumulative average spike rate as a function of time obtained in Embodiment D3 is lower for both on-type and off-type cells as compared to the results obtained in Control C3 of Example 3.

[0249] The non-stationarity and non-linearity in the spike response obtained by the lens of the embodiment are due to artificial edges or light contrast profiles in the retinal image, or temporal variations of the artificial edges.

[0250] In this example, the average spike rate as a function of time described in FIG. 28 obtained by the contact lens of Embodiment (D2) follows the temporal variation pattern for both on-type and off-type cells. The control (C3) contact lens in this Example 3 shows some temporal variation in both on-type and off-type average spike rates, as shown in FIG. 33, but the temporal variation observed within the average spike rate obtained by the contact lens of Embodiment (D3) is much larger than that of the control (C3) contact lens.

[0251] In this Example 3, the on-axis and off-axis evaluations of the optical performance were modeled in a multi-color mode over 470 nm to 650 nm using a photometric function that describes the average spectral sensitivity of human vision for brightness under photopic conditions with a 6 mm pupil analysis diameter.

[0252] In this example, the photoreceptor cell density as a function of retinal eccentricity was kept constant for simplicity, but other variations in the retinal model including changes in photoreceptor cell density may be expected.

[0253] As described in FIGS. 36 and 37 herein, the wide-field optical performance is virtually indistinguishable between the control (C3) and exemplary embodiment (D3) contact lenses when measured using the modulation transfer function as a function of spatial frequency at a pupil diameter of 6 mm. For the off-axis performance in Example 3, the field of view considered for performance evaluation was 5°, which is ±2.5° from the center.

Example

[0254] Control C4 and exemplary embodiment design D4 In this Example 4, the following parameters of the schematic model eye in Table 1 were changed to represent a 3D myopic eye (i.e., a basic prescription Rx of -3D) in an uncorrected state. (i) A vitreous chamber depth of 17.65 mm, and (ii) a retinal curvature radius of 13.5 mm. The model was configured to focus on an object approximately at optical infinity from the eye.

[0255] The modified myopic model eye was corrected one by one with the control (C4) and exemplary embodiment (D4) contact lenses. The control (C4) contact lens represents a single-focus lens modeled using the following parameters. Front surface (R = 8.262 mm, Q = -0.137), center thickness (0.135 mm), back surface (R = 7.75 mm, Q = -0.25), and refractive index 1.42. The control contact lens C4 has no / missing any non-refractive features contemplated in this present disclosure.

[0256] The second lens D4 represents an exemplary embodiment that is also a single-focus contact lens having the same parameters as the control C4, and is further configured with the non-refractive features disclosed in FIG. 38.

[0257] The non-refractive feature of Example D4 of the exemplary embodiment includes a grating pattern (3803) including a plurality of line or streak features. This grating pattern (3803) is located optically within the optics around the optical center of the optical zone (3801) of the contact lens (3802). The total number of linear or streak features is six, three in the horizontal direction and three in the vertical direction. The total dimension of the grating pattern is about 3 mm in diameter. The dimension of each line or streak in the grating pattern is between about 75 μm and 1 mm (3804). The non-refractive feature is magnified relative to other features of the contact lens for identification and visibility. The remaining portion of the optical zone (3801) without the non-refractive feature of exemplary embodiment D4 is composed of basic single-focus prescription parameters that match the basic prescription of the eye.

[0258] According to the steps disclosed in paragraphs

[0196] to

[0198] , the simulated retinal images were calculated and analyzed when the contact lens designs of Control C4 and Embodiment D4 were worn on the model eye of Example 4.

[0259] In this Example 4, additional variables of the virtual retina platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were removed. The arrangement of the neuron bundles (1602) was a circular arrangement extending over a 15° × 15° field of view. The sparse lateral connectivity mode of the virtual retina was not used.

[0260] Furthermore, the outer plexiform layer replenishment high-pass filter options described in Equations 2 and 3 were removed. The option of postsynaptic pooling was also removed.

[0261] As discussed herein, the post - processing of the calculated simulated retinal images of the control (C4) contact lens design of Example 4 using the virtual retinal platform results in a spike train as a function of time (Figure 39) and a peristimulus histogram (Figure 40) highlighting the average spike rate as a function of time for cells having both on - polarity and off - polarity. The upper and lower sub - graphs of Figures 39 and 40 represent data for on - cells and off - cells, respectively.

[0262] As discussed herein, the post - processing of the calculated simulated retinal images of the embodiment (D4) contact lens design of Example 4 using the virtual retinal platform results in a spike train as a function of time (Figure 41) and a peristimulus histogram (Figure 42) highlighting the average spike rate as a function of time for cells having both on - polarity and off - polarity. The upper and lower sub - graphs of Figures 41 and 42 represent data for on - cells and off - cells, respectively.

[0263] Neuronal activity with the control (C4) contact lens, as shown by the spike train in Figure 39, is relatively time - invariant or has minimal variation or jitter as a function of time for cells having both on - and off - type polarities. On the other hand, neuronal activity with the embodiment (D1) contact lens, as shown by the spike train in Figure 41, is relatively time - varying or has greater variation or jitter as a function of time.

[0264] In Example 4, neuronal activity with the control (C4) contact lens follows a relatively monotonic profile following the first 100 milliseconds indicative of signal stabilization, as shown by the average spike rate in Figure 40. This observed pattern is similar for cells having both on - and off - type polarities.

[0265] In Example 4, the average spike rate by the control (C4) contact lens, as disclosed herein, excluding the first 100 milliseconds stabilization period, is about twice as large for on-type cells as that obtained by off-type cells.

[0266] On the other hand, the neuron activity by the contact lens of Embodiment (D4) varies with time as a function of time as shown by the average spike rate in FIG. 41.

[0267] In this example, the average spike rate as a function of time described in FIG. 42 obtained by the contact lens of Embodiment (D4) follows the time variation for both on-type and off-type cells. The amplitude or magnitude of the time variation observed within the average spike rate obtained by the contact lens of Embodiment (D4) is smaller than that of the contact lenses of other embodiments of the present disclosure.

[0268] In this Example 4, the on-axis and off-axis evaluations of the optical performance were modeled at a single color mode (589 nm) and a pupil analysis diameter of 4 mm. As described herein in FIGS. 43 and 44, the wide-field optical performance cannot be virtually distinguished between the control (C4) and exemplary embodiment (D4) contact lenses when measured using the modulation transfer function as a function of the spatial frequency at a pupil diameter of 6 mm. For the off-axis performance in Example 4, the visual field considered for the performance evaluation was 15°, which was ±7.5°.

Example

[0269] Control C5 and Exemplary Embodiment Design D5 In this Example 5, the following parameters of the schematic model eye in Table 1 were changed to represent a 3D myopic eye (Rx: -3D) in a 1D adjustment state. (i) The vitreous chamber depth of 17.65 mm, (ii) the retinal radius of curvature of 13.5 mm, and (iii) the anterior lens radius (R = 9.081 mm) and the conic constant (Q = -4.123).

[0270] The model was configured to focus on an object near about 1 meter from the eye. The modified myopic model eye was corrected one by one with the control (C5) and exemplary embodiment (D5) contact lenses.

[0271] The control (C5) contact lens represents a single - focus lens modeled using the following parameters. Front surface (R = 8.262 mm, Q = - 0.137), central thickness (0.135 mm), back surface (R = 7.75 mm, Q = - 0.25), and refractive index 1.42. The control contact lens C5 has no / lacks any non - refractive features contemplated in this disclosure.

[0272] The second lens D5 represents an exemplary embodiment that is also a single - focus contact lens having the same parameters as the control C5, and is further configured with non - refractive features disclosed in FIG. 45.

[0273] The non - refractive features of the exemplary embodiment example D5 (FIG. 45) include a spoke pattern (4503) including a plurality of line features. This spoke pattern (4503) is located within the optical zone (4501) of the contact lens (4502). The total number of spoke features is 8. The total dimension of the spoke pattern is a diameter of about 4 mm. The dimension of each line in the spoke pattern is between about 100 μm×1 mm (4504).

[0274] The non - refractive features are enlarged relative to other features of the contact lens for identification and visibility. The remaining portion of the optical zone (4501) without the non - refractive features of the exemplary embodiment D5 is configured with basic single - focus prescription parameters that match the basic prescription of the eye.

[0275] In accordance with the steps disclosed in paragraphs

[0196] -

[0198] , the simulated retinal images were calculated and analyzed when the control C5 and the contact lens design of embodiment D5 were worn on the model eye of Example 5.

[0276] In this Example 5, additional variables of the virtual retina platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were used with the following input parameter values. (i) Outer plexiform layer amplification λ of 150 Hz per normalized luminance unit OPL value, (ii) bipolar inactivity leak of 5 Hz

[0277]

Number

[0278] (iii) Feedback amplification λ of 100 Hz A , (iv) Spatial scale σA of 2.5°, and (v) Temporal scale τA of 0.01 milliseconds. The arrangement of the neuron bundle (1602) was a circular arrangement extending over a 5° × 5° visual field. The sparse horizontal connectivity mode of the virtual retina was not used. Furthermore, the outer plexiform layer replenishment high-pass filter options described in Equations 2 and 3 were removed. The option of postsynaptic pooling was also removed.

[0279] As discussed herein, post - processing of the computed simulated retinal images of the control (C5) contact lens design of Example 5 using the virtual retina platform results in a spike train as a function of time (FIG. 46) and a peristimulus histogram (FIG. 47) that emphasizes the average spike rate as a function of time for cells having both on - polarity and off - polarity. The upper and lower sub - graphs of FIGS. 46 and 47 represent data for on - cells and off - cells, respectively. As discussed herein, post - processing of the computed simulated retinal images of the embodiment (D5) contact lens design of Example 5 using the virtual retina platform results in a spike train as a function of time (FIG. 48) and a peristimulus histogram (FIG. 49) that emphasizes the average spike rate as a function of time for cells having both on - polarity and off - polarity. The upper and lower sub - graphs of FIGS. 48 and 49 represent data for on - cells and off - cells, respectively. The neuronal activity by the control (C5) contact lens is relatively time - invariant or has minimal variation or fluctuation as a function of time for cells having both on and off types of polarity, as shown by the spike train of FIG. 46. On the other hand, the neuronal activity by the embodiment (D5) contact lens varies relatively with time and decreases or increases monotonically as a function of time, as shown by the spike train of FIG. 48.

[0280] In Example 5, the neuronal activity by the control (C5) contact lens follows a relatively monotonic profile following an initial 100 milliseconds of signal stabilization, as shown by the average spike rate of FIG. 47. This observed pattern is similar for cells having both on and off types of polarity. In Example 5, the average spike rate by the control (C5) contact lens, as disclosed herein, is approximately three times as large for on - type cells as that obtained by off - type cells, except for an initial 100 - millisecond stabilization period.

[0281] On the other hand, the neuronal activity by the contact lens of Embodiment (D5) varies with time as a function of time as shown by the average spike rate in FIG. 49. In this example, the average spike rate as a function of time described in FIG. 49 obtained by the contact lens of Embodiment (D5) follows the time variation for both on-type and off-type cells. The non-stationarity and non-linearity in the spike response obtained by the lens of the embodiment are due to artificial edges or light contrast profiles in the retinal image, or temporal variations of the artificial edges.

[0282] In this Example 5, the on-axis and off-axis evaluations of the optical performance were modeled in the multi-color mode using a photometric function that describes the average spectral sensitivity of human vision for brightness under photopic conditions with a 5 mm pupil analysis diameter.

[0283] As described in FIGS. 50 and 51 herein, the wide-field optical performance is significantly similar between the control (C5) and the exemplary embodiment (D5) contact lenses when measured using a modulation transfer function as a function of spatial frequency at a 5 mm pupil diameter, that is, the variation in the area under the curves represented by the solid black line and the dashed black line was less than 5%. For the off-axis performance in Example 5, the field of view considered for the performance evaluation was 15°, which was ±7.5°.

Example

[0284] Control C6 and Exemplary Embodiment Design D6 In this Example 6, the following parameters of the schematic model eye in Table 1 were changed to represent a 4D myopic eye (i.e., a basic prescription Rx of -4D) in a 2D adjusted state. (i) The vitreous chamber depth of 18.04 mm, (ii) the retinal radius of curvature of 13.5 mm, and (iii) the anterior lens radius (R = 7.794 mm) and conic constant (Q = -3.959) parameters.

[0285] The model was configured to focus on an object located approximately 50 cm from the eye. The modified myopic model eye was corrected one by one with the control (C6) and exemplary embodiment (D6) contact lenses. The control (C6) contact lens represents a single - focus lens modeled using the following parameters: front surface (R = 8.41 mm, Q = - 0.112), center thickness (0.135 mm), back surface (R = 7.75 mm, Q = - 0.25), and refractive index 1.42. The control contact lens C6 has no / lacks any non - refractive features contemplated in this disclosure.

[0286] The second lens D6 represents an exemplary embodiment that is also a single - focus contact lens having the same parameters as the control C6, and is further configured with non - refractive features disclosed in FIG. 45.

[0287] The non - refractive features of the exemplary embodiment example D6 include a random pattern (5203) including a plurality of elliptical dot - like features slightly elongated in the horizontal direction. This random pattern is located within the optical zone (5201) around the optical center of the contact lens (5202) of the exemplary embodiment. The total number of elliptical dot - like features in (5202) is 18. The total dimension of the random pattern is about 3 mm in diameter. The dimension of each elliptical dot - like feature is between about 125 μm×200 μm (5204).

[0288] The non - refractive features are magnified relative to other features of the contact lens for identification and visibility. The remaining portion of the optical zone (5201) without the non - refractive features of the exemplary embodiment D8 is configured with basic single - focus prescription parameters that match the basic prescription of the eye.

[0289] Following the steps disclosed in paragraphs

[0196] to

[0198] , simulated retinal images were calculated and analyzed when the contact lens designs of control C6 and embodiment D6 were worn on the schematic model eye of Example 6. In this Example 6, additional variables of the virtual retina platform were considered with the following settings. The options for the contrast gain control mechanism described in Equations 1, 5, and 6 were removed. The arrangement of the neuron bundles (1602) was a circular arrangement extending over a 15°×15° visual field.

[0290] The sparse lateral connectivity mode of the virtual retina was used with 10 presynaptic neurons having a positive weight of 10% and a weight variance of 0.01. The options for the replenishing high-pass filter of the outer plexiform layer described in Equations 2 and 3 were removed. The option for postsynaptic pooling was also removed.

[0291] As considered herein, the post-processing of the calculated simulated retinal images of the control (C6) contact lens design of Example 6 using the virtual retina platform results in a spike train as a function of time (Figure 53) and a peri-stimulus time histogram (Figure 54) highlighting the average spike rate as a function of time for cells having both on-polarity and off-polarity. The upper and lower subgraphs of Figures 53 and 54 represent data for on-cells and off-cells, respectively.

[0292] As considered herein, the post-processing of the calculated simulated retinal images of the embodiment (D6) contact lens design of Example 6 using the virtual retina platform results in a spike train as a function of time (Figure 55) and a peri-stimulus time histogram (Figure 56) highlighting the average spike rate as a function of time for cells having both on-polarity and off-polarity. The upper and lower subgraphs of Figures 55 and 56 represent data for on-cells and off-cells, respectively.

[0293] Neuron activity by the control (C6) contact lens, as shown as the spike train in FIG. 53, is relatively invariant over time or has minimal variation or fluctuation as a function of time for cells with both on and off types of polarities. On the other hand, neuron activity by the embodiment (D6) contact lens, as shown as the spike train in FIG. 55, varies relatively over time and monotonically decreases or increases as a function of time. The non-stationarity and non-linearity in the spike responses obtained by the lenses of the embodiments are due to artificial edges or light contrast profiles in the retinal image, or temporal variations of the artificial edges.

[0294] In Example 6, neuron activity by the control (C6) contact lens follows a relatively monotonic profile following the first 100 milliseconds showing signal stabilization, as shown as the average spike rate in FIG. 54. This observed pattern is similar for cells with both on and off types of polarities. In Example 6, the average spike rate by the control (C6) contact lens, as disclosed herein, is approximately three times as large for on-type cells as that obtained by off-type cells, excluding the first 100 millisecond stabilization period.

[0295] On the other hand, neuron activity by the embodiment (D6) contact lens varies over time as a function of time, as shown as the average spike rate in FIG. 56. In this example, the average spike rate as a function of time obtained with the embodiment (D6) contact lens, described in FIG. 56, follows a time-varying pattern for both on-type and off-type cells.

[0296] In this Example 6, the on-axis and off-axis evaluations of the optical performance were modeled at a monochromatic mode (589 nm) and a pupil analysis diameter of 4 mm.

[0297] As described in FIGS. 57 and 58 in this specification, when the wide field optical performance is measured using the modulation transfer function as a function of the spatial frequency at a pupil diameter of 4 mm, it was virtually indistinguishable between the control (C6) and the exemplary embodiment (D6) contact lenses, as represented by the solid black line and the dashed black line. For the off-axis performance in Example 6, the field of view considered for the evaluation of the performance was 15°, which was ±7.5°.

Example

[0298] Control C7 and Exemplary Embodiment Design D7 In this Example 7, the following parameters of the schematic model eye in Table 1 were changed to represent a 4D myopic eye (i.e., a basic prescription Rx of -4D) in the unadjusted state. (i) The vitreous chamber depth of the eye of 18.04 mm, and (ii) the retinal radius of curvature of 13.5 mm. The model was configured to focus on a distant object that is optically infinitely far from the eye. The modified myopic model eye was corrected one by one with the control (C7) and the exemplary embodiment (D7) contact lenses. The control (C7) contact lens represents a single focus lens modeled using the following parameters. Front surface (R = 8.41 mm, Q = -0.112), center thickness (0.135 mm), back surface (R = 7.75 mm, Q = -0.25), and refractive index 1.42. The control contact lens C7 has no / lacks any non-refractive features contemplated in this present disclosure. The second lens D7 represents an exemplary embodiment that is also a single focus contact lens having the same parameters as the control C7, and is further configured with the non-refractive features disclosed in FIG. 59.

[0299] The non-refractive feature of Example D7 of the exemplary embodiment includes a helical pattern (5903) including a plurality of dot features. The helical pattern is located within the optical zone (5901) of the contact lens (5902). The total number of dot features in each arm is 49. The total dimension of the helical pattern is a diameter of about 6 mm. The width of each dot feature is between about 125 μm (5904). The non-refractive feature is enlarged relative to other features of the contact lens for identification and visibility. The remaining portion of the optical zone (5901) without the non-refractive feature of the exemplary embodiment D7 is composed of basic single-focus prescription parameters that match the basic prescription of the eye.

[0300] In accordance with the steps disclosed in paragraphs

[0196] to

[0198] , the simulated retinal images were calculated and analyzed when the contact lens designs of Control C7 and Embodiment D7 were worn on the model eye of Example 7.

[0301] In this Example 7, additional variables of the virtual retinal platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were used with the following input parameter values. (i) Outer plexiform layer amplification λ of 150 Hz per normalized luminance unit OPL value, (ii) bipolar inactivity leak of 5 Hz

[0302]

Number

[0303] (iii) feedback amplification λ of 100 Hz A, (iv) a spatial scale σA of 2.5°, and (v) a temporal scale τA of 0.01 milliseconds. The arrangement of the neuron bundles (1602) was a circular arrangement extending over a 5° × 5° visual field. The sparse lateral connectivity mode of the virtual retina was turned off. The outer plexiform layer replenishment high-pass filter option described in Equations 2 and 3 was turned off. The postsynaptic pooling option was also turned off. As discussed herein, the post-processing of the computed simulated retinal images of the control (C7) contact lens design of Example 7 using the virtual retina platform results in a spike train as a function of time (Figure 60) and a peristimulus histogram (Figure 61) emphasizing the average spike rate as a function of time for cells with both on and off polarities. The upper and lower subgraphs of Figures 60 and 61 represent data for on and off cells, respectively. As discussed herein, the post-processing of the computed simulated retinal images of the embodiment (D7) contact lens design of Example 7 using the virtual retina platform results in a spike train as a function of time (Figure 62) and a peristimulus histogram (Figure 63) emphasizing the average spike rate as a function of time for cells with both on and off polarities. The upper and lower subgraphs of Figures 62 and 63 represent data for on and off cells, respectively.

[0304] Neuron activity with the control (C7) contact lens is relatively time-invariant or has minimal variation or fluctuation as a function of time for cells with both on and off types of polarities, as shown by the spike train in Figure 60. On the other hand, neuron activity with the embodiment (D7) contact lens fluctuates relatively with time and sways with periodicity that varies as a function of time, as shown by the spike train in Figure 62.

[0305] In Example 7, the neuron activity by the control (C7) contact lens follows a relatively monotonic profile following the first 100 milliseconds showing signal stabilization, as shown as the average spike rate in FIG. 61. This observed pattern is similar for cells with both on and off types of polarities.

[0306] On the other hand, the neuron activity by the embodiment (D6) contact lens varies as a function of time, as shown as the average spike rate in FIG. 62. In this example, the average spike rate as a function of time obtained with the embodiment (D7) contact lens, described in FIG. 63, follows a time-varying pattern for both on-type and off-type cells.

[0307] In this Example 7, the on-axis and off-axis evaluations of the optical performance were modeled in the monochromatic mode (589 nm) and at a pupil analysis diameter of 6 mm. As described herein in FIGS. 64 and 65, the wide-field optical performance is virtually indistinguishable between the control (C7) and the exemplary embodiment (D7) contact lenses when measured using the modulation transfer function as a function of spatial frequency at a pupil diameter of 6 mm, as represented by the solid black and dashed black lines.

[0308] For the off-axis performance in Example 7, the field of view considered for the evaluation of the performance was 15°, which was ±7.5°. The simulation technique described herein is one of many ways to show that a single-focus contact lens having the intended non-refractive features disclosed herein provides an increase in retinal ganglion cell activity compared to a standard treatment single-focus contact lens.

[0309] Embodiments of spectacle lenses When a non-refractive feature used with a single-focus optical profile is measured by a surrogate measure of an increase in the average retinal ganglion cell spike rate by a virtual retinal platform that mimics the performance in the wearer's eye, various eyeglass lens embodiments are modeled to show an increase in retinal ganglion cell activity.

[0310] FIG. 66 shows a front view of a prior art spectacle lens (6601), not to scale, and an exemplary embodiment of a spectacle lens (6602). The dimensions of the spectacle lens are approximately 40 mm × 50 mm. In both cases, the entire spectacle lens area constitutes its optical zone. The embodiment of the spectacle lens (6602) is configured with a non-refractive feature (6603) that includes a grid pattern of four horizontal lines or ribs and four vertical lines or ribs. The optical zone is substantially designed around an optical center (6605) having a single focal power that matches the basic prescription of the eye. The grid pattern located at the center of the spectacle lens embodiment spans a height and width of approximately 25 mm. The boundaries of these grid lines (6603) are configured to be completely opaque or substantially opaque. The width of the non-refractive feature (6604) is between approximately 50 μm and 100 μm, and in the drawing, its width is enlarged only to show the feature relative to the size of the contact lens disclosed herein. Additionally, the embodiment of FIG. 66 may be configured with other variations. For example, the width of the intended non-refractive design feature within the optical zone may be at least 125 μm, 150 μm, 175 μm, 200 μm, or 250 μm. Additionally, the embodiment of FIG. 66 may be configured with other variations. For example, the intended non-refractive design feature may include a random pattern, a plurality of circles, ellipses, triangles, rectangles, hexagons, regular polygons, or irregular polygons, where the width of the boundaries defining the plurality of apertures may be between 50 - 125 μm, 150 - 250 μm, or 100 - 300 μm. In a preferred variation of the embodiment of FIG. 66, the maximum width of the non-refractive feature, i.e., the width of the lines or ribs forming the grid pattern or any other pattern, is 150 μm, 200 μm, or 250 μm or less to avoid an unguaranteed resulting impact on the resolution characteristics of the wearer's eye. In other embodiments, the intended non-refractive design feature may be located (in the located) disposed at the periphery of the optical zone of the spectacle design. In yet another embodiment of the spectacle lens, the number of fine lines or ribs forming the grid pattern may be at least 5, 9, 15, or 25.In some other embodiments of the spectacle lens, the number of design features, lines, or streaks forming the grid pattern may be between 5 and 9, or 9 and 15, or 9 and 15, or 5 and 25. In another embodiment, it may be contemplated that just one long substantially continuous curve or zigzag line passes through the optical zone with a length of at least 3 mm, 6 mm, 9 mm, or 12 mm.

[0311] In yet another embodiment of the spectacle lens, one or more stripes may be arranged in a symmetric or random manner, and they may be positioned concentrically with the optical axis or may be eccentric with respect to the optical center. Additionally, the stripes may consist of straight or curved lines, and those lines may contact or intersect each other, or all may be separated and configured, or a combination thereof. The width and length of the stripes may vary. Different patterns may be applied to the lenses for the left and right eyes.

[0312] In yet another embodiment of the spectacle lens, the intended design features (i.e., multiple stripes or moiré patterns) within the spectacle lens may be spaced apart from each other. In yet another embodiment, the multiple non-refractive features intended may be configured to be adjacent to each other or combined.

[0313] The natural impulsive eye movements of a spectacle wearer may introduce temporal fluctuations in the stimuli, which may further enhance the inhomogeneities artificially introduced into the visual image, which in turn may enhance the therapeutic benefits to the wearer, such as a greater reduction in the progression rate of myopia of the wearer. FIG. 67 shows a schematic diagram of incident light of a visible wavelength such as 555 nm and a vergence of 0 D from a wide-angle field of view (6701) entering a 2D myopic model eye (6700) corrected with a prior art standard single-focus lens (6702). Retinal ganglion cell activity was recorded by on-center / off-surround and off-center / on-surround circuits (6703). The retinal ganglion cell activity associated with the prior art standard single-focus lens (6702) was captured on the retinal surface facilitated by simulated habitual impulsive eye movements, showing minimal retinal activity, or baseline retinal activity, or minimal temporal fluctuations in retinal activity. The relative difference in the temporal integration of on receptive field and off receptive field activity determines further eye growth.

[0314] The present disclosure assumes that an inactive retina causes eye growth, and an active retina reduces that growth or triggers a stop signal. The present disclosure further anticipates that prior art standard single-focus or spectacle lenses and / or spatially homogeneous visual images contribute to a homogeneous and substantially edge-free visual image that keeps the retina in a baseline state (i.e., the baseline or constant firing pattern of retinal ganglion cells), thus promoting further eye growth leading to more advanced myopia.

[0315] FIG. 68 shows a schematic diagram showing incident light of a visible wavelength such as 555 nm and a vergence of 0 D from a wide-angle field of view (6801) entering a 2D myopic model eye (6800) corrected with an embodiment of glasses (6802). Retinal ganglion cell activity recorded by an on-center / off-surround and off-center / on-surround circuit (6803) with a standard glasses embodiment (6802) was captured on the retinal surface facilitated by simulated habitual saccadic eye movements, demonstrating or showing an increase in retinal activity compared to the baseline state.

[0316] In FIGS. 67 and 68, simple model eyes were selected for illustrative purposes. However, in other embodiments, schematic ray-tracing model eyes such as those of Liu-Brennan, Escudero-Navarro, and others may be used instead. In the examples provided herein, a 2D myopic model eye was used to disclose the present disclosure, but the same disclosure can be extended to other degrees of myopia, namely -1D, -3D, -5D, or -6D. Furthermore, it is understood that it can be extended to eyes with various degrees of myopia with astigmatism. In embodiments, a specific wavelength of 555 nm was mentioned, but it is understood that it can also be extended to other visible wavelengths between 420 nm and 760 nm.

[0317] Modeling of various exemplary glasses lens embodiments (D8 - D10) shows that the intended non-refractive features used with a single-focus design provide an increase in retinal ganglion cell activity measured by an increase in the average retinal spike rate obtained using the virtual retinal platform disclosed herein. In other embodiments, various other surrogate measures of retinal ganglion cell activity may be considered, such as examination of spike train analysis of selected neuron bundles.

[0318] To show the effect of embodiments of glasses lenses according to the present disclosure, as described herein, advanced optical modeling experiments were performed for each test case (i.e., Examples 8 - 10) using two different types of glasses.

[0319] The first type included single - focus spectacle lenses (C8 - C10) that corresponded to the basic prescription of a schematic model eye to provide correction of refractive errors mimicking standard treatment.

[0320] The second type included various exemplary spectacle lens embodiments (D8 - D10) that were essentially the same single - focus standard therapeutic control spectacle lenses (C8 - C10), further configured with additional non - refractive features designed according to the present invention. To demonstrate the action of the present invention, the control (C8 - C10) and exemplary embodiment spectacle lenses (D8 - D10) were each mounted on a modified schematic model eye as described in each of Examples 8 - 10 and tested / evaluated. The front - surface transmission characteristics of the spectacle lenses were modified to design the features of Examples 8 - 10. The transmittance was calculated as a percentage of 100%, where 100% means that all light transmits as if there were no absorption, reflection, or aperture losses. In certain embodiments of the present disclosure, the surface transmittance is defined as any relative percentage of the intensity with which light transmits through that surface. In some other embodiments of the present disclosure, any relative percentage of intensity may be configured to be wavelength - dependent. In certain other specific embodiments of the present disclosure, any percentage of intensity may be configured to be polarization - sensitive. To evaluate the simulated retinal ganglion cell activity, the spectacle lenses were horizontally eccentric with respect to the optical axis of the model eye at various dispersion positions that mimic saccadic eye movements. The movement of the spectacle lens with respect to the optical center of the model eye was included between ±5 mm in the horizontal direction. A wide - field retinal image simulation was performed at each of the eccentric spectacle positions. The 101 retinal images thus simulated constituted an input stream for a virtual retinal platform for generating retinal ganglion cell activity. In this example, each of the 101 image frames was configured to be 50 milliseconds, which constitutes a 5.05 - second real - time stimulus presentation to the virtual retinal model. Each frame of the input stream was configured over 512×512 pixels, and each frame covered the entire diameter of a circular neuron region that included an area of approximately 15°×15° (macula) or 20°×20° (near - macula) of the retina of the virtual retinal platform. The bit depth of each pixel in the input stream was digitized in the range of 0 - 255 (i.e., 8 bits).The specific retinal settings and configurations described in Equations 1-9, which are used to illustrate the operation of the contact lens embodiments of the present disclosure, are considered in the following sections.

[0321] In all of Examples 8-10, the outer plexiform layer was configured to have a central region for about 1.5° (i.e., σC of Equation 2) and a peripheral region for about 4.75° (i.e., σS of Equation 3). The temporal scales of the center and periphery of the outer plexiform layer were set to about 1 millisecond, which were represented by the variables τC and τS of Equations 2 and 3, respectively. The variables governing the integrated center-surround signal, as described in Equation 1 herein, were w 0PL = 1 and λ 0PL = 10 were selected. The static nonlinear coefficients of bipolar cell and ganglion cell synapses were fixed throughout Examples 8-10. The bipolar linear threshold was set to 0, the linear threshold was kept at a constant 80, and the bipolar amplification value was kept at 100. The values for the neuron model were maintained throughout Examples 8-10, where a leak of 0.75, neuron noise of 20, membrane capacitance of 150, and firing threshold of 2.4 were used for the simulations of Examples 8-10. The postsynaptic pooling variable sigma was ignored. Options for the contrast gain control mechanism, the utility of the replenishing high-pass filter of the outer plexiform layer, and the utility of the lateral connections of amacrine cells were kept variable throughout Examples 8-10. Further details of the specific settings used are disclosed herein.

[0322] For each of the exemplary embodiments described herein, advanced optical modeling experiments were performed using the following two types of spectacle lenses. (1) A single-focus spectacle lens that matches the basic prescription of a model eye for correcting refractive anomalies, which simulates standard treatment, (2) The same standard single-focus spectacle lens as above, having additional non-refractive features designed in accordance with the present invention to provide an increase in retinal ganglion cell activity as compared to the single-focus spectacle lens of standard treatment.

[0323] In certain embodiments of the spectacle lens, the opaque or translucent or absorptive boundary of the intended design feature (i.e., the aperture) within the optical zone of the spectacle lens may be at least 15 μm, 25 μm, 35 μm, 50 μm, 75 μm, 100 μm, 150 μm, 200 μm, or 250 μm in width.

[0324] In certain embodiments of the spectacle lens, the opaque or translucent or absorptive boundary of the intended design feature (i.e., the aperture) within the optical zone of the spectacle lens is configured to be 300 μm, 325 μm, 350 μm, 375 μm, or 400 μm or less in width in order to avoid potential degradation of the resolution ability of the corrected eye and / or to maintain an appropriate amount of light transmission under all viewing conditions, for example, in response to the 2 - 7 mm change in the normal pupil over the conditions of dim light, ambient light, and high - level light that the wearer may experience.

[0325] For the cosmetic appearance of the spectacle lens, a translucent or absorptive / colored boundary may sometimes be preferred over an opaque boundary as a design feature. In certain embodiments of the spectacle lens, the translucent boundary of the intended design feature on the spectacle lens may be between 15 - 30 μm, 25 - 50 μm, or 30 - 75 μm, or 15 - 100 μm in width. In some embodiments, the width of the design feature may not be constant across multiple apertures.

[0326] In yet another embodiment of the spectacle, the plurality of apertures intended within the optical zone may be used only when the wearer is performing a particular near - viewing task, such as reading a book, writing, playing a video game, using a mobile phone, using a tablet, or using a computer.

[0327] Regarding the realization of the intended design features in spectacle lenses, in certain embodiments, a plurality of boundaries may be introduced using a material having polarization selectivity. The use of such a polarization-sensitive material may further provide a desirable edge effect for providing a stop signal while enhancing the aesthetics for the wearer. When using a plurality of apertures formed of a polarization-sensitive material, selective test cases may be considered (use of a liquid crystal display (LCD) or a light emitting diode display).

Example

[0328] Control (C8) and exemplary embodiment (D8) designs In this Example 8, the following parameters of the schematic model eye of Table 1 were changed to represent a 3D myopic eye (i.e., a basic prescription Rx of -3D) in an unadjusted state. (i) A vitreous chamber depth of 17.63 mm, and (ii) a retinal radius of curvature of 13.5 mm.

[0329] The model was configured to focus on a distant object that is optically infinitely far from the eye. The modified myopic model eye was corrected one by one with the control (C8) and exemplary embodiment (D8) spectacle lenses. The control (C8) spectacle lens represents a single-focus lens modeled using the following parameters. Refractive index 1.5 with a front surface (R = 2000 mm), center thickness (1.5 mm), back surface (R = 144.2 mm), and overall blank diameter of 50 mm. The control spectacle lens C8 has no / missing any non-refractive features contemplated in this disclosure. The second lens D8 represents an exemplary embodiment that is also a single-focus spectacle lens having the same parameters as the control C8, and is further configured with non-refractive features disclosed in FIG. 69. The non-refractive features of the exemplary embodiment D8 (6900) include a spiral pattern having six arms (6902), each arm further including a plurality of dot-like features. The spiral pattern is located around the optical center of the spectacle lens (6901). The total number of dot-like features in each arm (6902) is about 10. The total dimension of the spiral pattern is about 5 mm in diameter. The width of the dot-like features is between about 75 μm (6904). The remaining portion (6905) of the exemplary embodiment D8 is configured with single-focus parameters that match the basic prescription of the eye. The non-refractive features of the exemplary embodiment D8 are configured to absorb at least 90% of the light incident on the non-refractive features. According to the steps disclosed in paragraphs

[0320] to

[0322] , the simulated retinal images were calculated and analyzed when the control C8 and the spectacle lens design of the embodiment D8 were worn on the model eye of Example 8.

[0330] In this Example 8, additional variables of the virtual retina platform were considered with the following settings. The options of the contrast gain control mechanism described in Equations 1, 5, and 6 were used with the following input parameter values. (i) Outer plexiform layer amplification λ of 150 Hz per normalized luminance unit OPL value, (ii) bipolar inactivity leak of 5 Hz

[0331] [Number]

[0332] (iii) A feedback amplification λ of 100 Hz A , (iv) a spatial scale σA of 2.5°, and (v) a temporal scale τA of 0.01 milliseconds. The arrangement of the neuron bundles (1602) was a circular arrangement extending over a 15° × 15° visual field.

[0333] The sparse lateral connectivity mode of the virtual retina was used with 10 presynaptic neurons having a positive weight of 10% and a weight variance of 0.01. Further, the supplementary high-pass filter options of the outer plexiform layer described in Equations 2 and 3 were used with the following parameter values. A temporal scale of 0.2 milliseconds and a spatial scale of 0.5°. The option of postsynaptic pooling was also removed. As discussed herein, the post-processing of the calculated simulated retinal images of the control (C8) eyeglass design of Example 8 using the virtual retina platform results in a spike train as a function of time (Figure 70) and a peri-stimulus histogram (Figure 71) that emphasizes the average spike rate as a function of time for cells having both on and off polarities. The upper and lower subgraphs of Figures 70 and 71 represent data for on-cells and off-cells, respectively.

[0334] As discussed herein, the post-processing of the calculated simulated retinal images of the embodiment (D8) eyeglass design of Example 8 using the virtual retina platform results in a spike train as a function of time (Figure 72) and a peri-stimulus histogram (Figure 73) that emphasizes the average spike rate as a function of time for cells having both on and off polarities. The upper and lower subgraphs of Figures 72 and 73 represent data for on-cells and off-cells, respectively.

[0335] The neuronal activity by the control (C8) spectacle lens, as shown as the spike train in FIG. 70, is relatively invariant over time, or has minimal variation as a function of time, or has no variation, or has no fluctuation. This observation was the same for cells with both on-type and off-type polarities. On the other hand, the neuronal activity by the embodiment (D8) spectacle lens, as shown as the spike train in FIG. 72, varies relatively over time and shows fluctuations over time. The fluctuations observed as a function of time are aperiodic with a small amplitude of the observed fluctuations. The non-stationarity and non-linearity in the spike response obtained by the lenses of the embodiments are due to artificial edges or light contrast profiles in the retinal image, or temporal variations of artificial edges.

[0336] In Example 8, the neuronal activity by the control (C8) spectacle lens follows a relatively monotonic profile following the first 100 milliseconds showing signal stabilization, as shown as the average spike rate in FIG. 71. This observed pattern is similar for cells with both on and off types of polarities.

[0337] On the other hand, the neuronal activity by the embodiment (D8) spectacle lens follows a time-varying pattern for both on-type and off-type cells, as shown as the average spike rate in FIG. 73. In this Example 8, the on-axis and off-axis evaluations of the optical performance were modeled in a multi-color mode over a wavelength range of 470 nm to 650 nm using a photometric function that describes the average spectral sensitivity of human vision for brightness under photopic conditions with a pupil analysis diameter of 6 mm.

[0338] As described in FIGS. 74 and 75 herein, when the wide-field optical performance is measured using the modulation transfer function as a function of the spatial frequency at a pupil diameter of 6 mm, it is virtually indistinguishable between the control (C8) and exemplary embodiment (D8) spectacle lenses, as represented by the solid black and dashed black lines. For the off-axis performance in Example 8, the field of view considered for the evaluation of the performance was 20°, which is ±10° from the center.

Example

[0339] Control (C9) and Exemplary Embodiment (D9) Designs In this Example 9, the following parameters of the schematic model eye in Table 1 were changed to represent a 1D myopic eye (i.e., a basic prescription Rx of -3D) in a 1D adjustment state. (i) The vitreous chamber depth of the eye of 16.92 mm, (ii) the retinal radius of curvature of 12 mm, and (iii) the anterior lens radius (R = 9.34 mm) and conic constant (Q = -3.2) parameters.

[0340] The model was configured to focus on a distant object 1 meter away from the eye. The modified myopic model eye was corrected one by one with the control (C9) and exemplary embodiment (D9) spectacle lenses. The control (C8) spectacle lens represents a single-focus lens modeled using the following parameters. Refractive index 1.5 with a front surface (R = 2000 mm), center thickness (1.5 mm), back surface (R = 379.1 mm), and overall blank diameter of 50 mm. The control spectacle lens C9 has no / lacks any non-refractive features contemplated in this present disclosure.

[0341] The second lens D9 represents an exemplary embodiment that is also a single-focus spectacle lens having the same parameters as the control C9, and is further configured with the non-refractive features disclosed in FIG. 76.

[0342] The non-refractive feature of Example D9 of the exemplary embodiment includes a square grid pattern (7602), which further includes a plurality of square openings located around the optical center of the spectacle lens (7601). The total number of openings designed within the pattern (7602) is about 16. The total dimensions of the square grid are about 3×3 mm. The width of the lines or boundaries forming the square openings is between about 50 μm (7604). The remaining portion (7605) of the exemplary embodiment D9 is composed of single focus parameters that match the basic prescription of the eye. The non-refractive feature of the exemplary embodiment D9 is configured to absorb at least 85% of the light incident on the non-refractive feature.

[0343] Following the steps disclosed in paragraphs

[0320] to

[0322] , the simulated retinal images were calculated and analyzed when the spectacle designs of Control C9 and Embodiment D9 were worn on the model eye of Example 9. In this Example 9, additional variables of the virtual retina platform were considered with the following settings. Options for the contrast gain control mechanism described in Equations 1, 5, and 6. The arrangement of the neuron bundles (1602) was a circular arrangement extending over a 20°×20° visual field.

[0344] The sparse lateral connectivity mode of the virtual retina was used with 10 presynaptic neurons having a positive weight of 10% and a weight variance of 0.01. The supplementary high-pass filter options for the outer plexiform layer described in Equations 2 and 3 were turned off. The options for postsynaptic pooling were also turned off.

[0345] As considered herein, the post-processing of the calculated simulated retinal images of the Control (C9) spectacle design of Example 9 using the virtual retina platform results in a spike train (Figure 77) as a function of time and a peristimulus time histogram (Figure 78) emphasizing the average spike rate as a function of time for cells having both on-type and off-type polarities. The upper and lower subgraphs of Figures 77 and 78 represent data for on-cells and off-cells, respectively.

[0346] As considered in this specification, post - processing of the calculated simulated retinal images for the embodiment (D9) eyeglass design using the virtual retinal platform results in a spike train (Figure 79) as a function of time and a peristimulus histogram (Figure 80) emphasizing the average spike rate as a function of time for cells having both on - type and off - type polarities. The upper and lower sub - graphs of Figures 79 and 80 represent data for on - type cells and off - type cells, respectively.

[0347] Neuronal activity by the control (C9) eyeglass lens is relatively time - invariant or has minimal variation or fluctuation as a function of time for cells having both on and off types of polarities, as shown by the spike train of Figure 77. On the other hand, neuronal activity by the embodiment (D9) eyeglass lens fluctuates relatively with time and sways with periodicity that varies as a function of time, as shown by the spike train of Figure 79. In Example 9, neuronal activity by the control (C9) eyeglass lens follows a relatively monotonic profile following the first 50 milliseconds showing signal stabilization, as shown by the average spike rate of Figure 78. This observed pattern is similar for cells having both on - type and off - type types of polarities. The off - type cell response did show some variability in the average spike rate as a function of time, but the magnitude of that change was small. On the other hand, neuronal activity by the embodiment (D9) eyeglass lens follows a time - varying pattern for both on - type and off - type cells, as shown by the average spike rate as a function of time obtained by the embodiment (D9) eyeglass lens described in Figure 80. Neuronal activity by the control (C9) eyeglass lens is relatively time - invariant for both types of polarities, as shown by the spike train of Figure 77. The non - stationarity and non - linearity in the spike response obtained by the lens of the embodiment are due to artificial edges or light contrast profiles in the retinal image or temporal variations of artificial edges.

[0348] As can be seen from the responses of the discrete neuron bundles, the number of active discrete off-type neuron bundles is 3 to 4 times less than the number of corresponding active discrete on-type neuron bundles. On the other hand, the neuron activity by the spectacle lens in Embodiment (D9) varies relatively with time for both types of polarities, as shown as the spike trains in FIG. 79. Furthermore, the total number of active off-type discrete neuron bundles was comparable to the number of active on-type discrete neuron bundles.

[0349] In this Example 9, the on-axis and off-axis evaluations of the optical performance were modeled in the monochromatic mode (589 nm) and at a pupil analysis diameter of 5 mm. As described herein in FIGS. 81 and 82, the wide-field optical performance cannot be virtually distinguished between the control (C9) and the exemplary embodiment (D9) spectacle lenses when measured using the modulation transfer function as a function of the spatial frequency at a pupil diameter of 5 mm. For the off-axis performance in Example 9, the field of view considered for the evaluation of the performance was 20°, which is ±10° from the center.

Example

[0350] Control (C10) and Exemplary Embodiment (D10) Designs In this Example 10, the following parameters of the schematic model eye in Table 1 were changed to represent a 4D myopic eye (i.e., a basic prescription Rx of -4D) in a 2D adjustment state. (i) The vitreous chamber depth of the eye of 18 mm, (ii) the retinal radius of curvature of 12 mm, and (iii) the anterior lens radius (R = 7.934 mm) and conic constant (Q = -1.962) parameters.

[0351] The model was configured to focus on a distant object 50 cm away from the eye. The modified myopic model eye was corrected one by one with the control (C10) and exemplary embodiment (D10) spectacle lenses. The control (C10) spectacle lens represents a single-focus lens modeled using the following parameters: refractive index 1.5 with a front surface (R = 2000 mm), a central thickness (1.5 mm), a back surface (R = 102.26 mm), and an overall blank diameter of 50 mm. The control spectacle lens C10 has no / missing any non-refractive features contemplated in this disclosure.

[0352] The second lens D10 represents an exemplary embodiment that is also a single-focus spectacle lens having the same parameters as the control C10, and is further configured with non-refractive features disclosed in FIG. 83. The non-refractive feature of the exemplary embodiment D10 includes a non-refractive feature configured as a random pattern (8302) further including a series of lines or streaks located around the optical center of the spectacle lens (8301). The total number of designed lines or streaks within the pattern (8302) is about 16. The length (8306) of the line or streak is about 0.75 mm to 1.25 mm.

[0353] The width (8304) of the line or streak is about 25 μm to 75 μm. The remaining portion (8305) of the exemplary embodiment D10 is configured with single-focus parameters that match the basic prescription of the eye. The non-refractive feature of the exemplary embodiment D10 is configured to absorb at least 80% of the light incident on the non-refractive feature.

[0354] Following the steps disclosed in paragraphs

[0320] to

[0322] , the simulated retinal images were calculated and analyzed when the control C10 and the eyeglass design of embodiment D10 were each worn on the schematic model eye of Example 10. In this Example 10, additional variables of the virtual retina platform were considered with the following settings. Options for the contrast gain control mechanism described in Equations 1, 5, and 6. The arrangement of the neuron bundles (1602) was a circular arrangement extending over a 20° × 20° visual field. The sparse lateral connectivity mode of the virtual retina was turned off. The outer plexiform layer replenishment high-pass filter options described in Equations 2 and 3 were turned off. The option for postsynaptic pooling was also turned off. As discussed herein, the post-processing of the calculated simulated retinal images of the control (C10) eyeglass design of Example 10 using the virtual retina platform resulted in spike trains as a function of time (Figure 84) and peristimulus histograms emphasizing the average spike rate as a function of time (Figure 85) for cells having both on-type and off-type polarities. The upper and lower subgraphs of Figures 84 and 85 represent data for on-type and off-type cells, respectively. As discussed herein, the post-processing of the calculated simulated retinal images of the embodiment (D10) eyeglass design of Example 10 using the virtual retina platform resulted in spike trains as a function of time (Figure 86) and peristimulus histograms emphasizing the average spike rate as a function of time (Figure 87) for cells having both on-type and off-type polarities.

[0355] The upper and lower subgraphs of Figures 86 and 87 represent data for on-type and off-type cells, respectively. The neuronal activity by the control (C10) eyeglass lens is relatively invariant over time for both types of polarities, i.e., on-type (upper subgraph of Figure 84) and off-type cells (lower subgraph of Figure 84), as shown by the spike trains in Figure 84. The Y-axis of the subgraph represents the response of discrete neuron bundles.

[0356] As can be seen, the number of active discrete off-type neuron bundles is 3 to 4 times less than the number of corresponding active discrete on-type neuron bundles. On the other hand, in the embodiment (D10), the neuron activity by the spectacle lens varies relatively with time for both types of polarities, that is, the on-type (the upper sub-graph in FIG. 86) and the off-type (the lower sub-graph in FIG. 86), as shown as the spike trains in FIG. 86. However, the total number of active off-type discrete neuron bundles by the spectacle lens example of the embodiment (D10) is comparable to the number of active on-type discrete neuron bundles.

[0357] In Example 10, the neuron activity by the control (C10) spectacle lens, as shown as the average spike rate in FIG. 85, follows a relatively monotonic profile for on-type cells following the first 50 milliseconds showing signal stabilization (the upper graph in FIG. 85). On the other hand, off-type cells showed small variations in the average spike rate as a function of time, but the magnitude of these variations was small.

[0358] In contrast, the discrete neuron activity by the spectacle lens of the embodiment (D10) is variable as a function of time, as shown as the average spike rate in FIG. 87. The time-varying pattern is observed in both on-type and off-type cells, but the magnitude is larger in off-type cells. In the pattern observed in off-type cells at the 2000 - 3000 millisecond time point (the lower graph in FIG. 87), the average spike rate follows a quasi-sinusoidal pattern. At various other time points of the off-type cell response, the amplitude of the quasi-sinusoidal pattern decreases. The on-type cell response also shows variations in the average spike rate as a function of time, but the magnitude of the variations is less.

[0359] The non-stationarity and non-linearity in the spike response obtained with the lens of the embodiment are due to artificial edges or light contrast profiles in the retinal image, or temporal fluctuations of artificial edges. In Example 10, the on-axis and off-axis evaluations of the optical performance were modeled in a multi-color mode over wavelengths from 470 nm to 650 nm using a photometric function that describes the average spectral sensitivity of human vision to brightness under photopic conditions with a pupil analysis diameter of 4 mm.

[0360] As described in FIGS. 88 and 89 herein, when the wide-field optical performance is measured using a modulation transfer function as a function of spatial frequency at a pupil diameter of 4 mm, it is substantially similar between the control (C10) and exemplary embodiment (D10) spectacle lenses, as represented by the solid black and dashed black lines. For the off-axis performance in Example 10, the field of view considered for the evaluation of performance was 20°, which is ±10° from the center.

[0361] Exemplary set of claims A A contact lens for an eye, the contact lens comprising a front surface, a back surface, and an optical zone including a basic prescription that provides substantial correction for refractive anomalies of the eye and a plurality of non-refractive features, and a peripheral zone surrounding the optical zone.

[0362] The contact lens according to the above claim example of set A, wherein the basic prescription for the eye includes at least one of the following: spherical aberration correction, astigmatism correction, or spherical and astigmatism correction.

[0363] One or more of the contact lenses according to the above claim example of set A, wherein the plurality of non-refractive features include at least one of the following: a plurality of substantially opaque boundaries forming a plurality of apertures, each aperture surrounding a substantially transparent region with a boundary line, a substantially opaque boundary, or a plurality of substantially opaque features forming one or more patterns without a substantially distinct boundary.

[0364] One or more contact lenses of the above claim examples of Group A, wherein each substantially transparent region includes a basic prescription for the eye, the contact lens.

[0365] One or more contact lenses of the above claim examples of Group A, wherein the shape of at least one of the plurality of openings is circular, elliptical, oblong, triangular, rectangular, square, pentagonal, hexagonal, octagonal, or any other regular polygon, or an irregular polygon, or a random shape, the contact lens.

[0366] One or more contact lenses of the above claim examples of Group A, wherein the plurality of openings are configured in a circular, hexagonal, radial, helical, regular, irregular, or random arrangement, the contact lens.

[0367] One or more contact lenses of the above claim examples of Group A, wherein the surface area of the transparent region surrounded by at least one boundary line of the plurality of openings is 0.25 square millimeters to 2.5 square millimeters, or 0.5 square millimeters to 5 square millimeters, or 0.75 square millimeters to 7.5 square millimeters, or 0.25 square millimeters to 7.5 square millimeters, the contact lens.

[0368] One or more contact lenses of the above claim examples of Group A, wherein the width of the substantially opaque boundary of any of the plurality of openings is at least 3 times, at least 4 times, or at least 6 times, or at least 8 times, or at least 10 times the average wavelength of the visible spectrum of light (i.e., 555 nm) such that the substantially opaque boundary remains substantially non-diffractive, the contact lens.

[0369] One or more contact lenses of the above claim examples of Group A, wherein the width of the substantially opaque boundary of any of the plurality of openings is 5 μm to 75 μm, or 25 μm to 150 μm, or 50 μm to 250 μm, the contact lens.

[0370] One or more contact lenses of the above claim examples of Group A, wherein the total number of apertures in the plurality of apertures is at least 2, at least 3, at least 4, at least 5, at least 6, or at least 7 apertures.

[0371] One or more contact lenses of the above claim examples of Group A, wherein the plurality of patterns without substantially distinct boundaries includes at least a spoke wheel pattern, a spiral pattern, a vortex pattern, a lattice pattern, a Memphis pattern, a dot pattern, a regular pattern, an irregular pattern, a moiré pattern, an interference pattern, a random pattern with points, a random pattern with straight lines, a random pattern with non-circular points, a random pattern with curves, a random pattern with arcs, a random pattern with zigzag lines, and each pattern of the plurality of patterns is formed by a substantially opaque feature including points, lines, or streaks.

[0372] One or more contact lenses of the above claim examples of Group A, wherein the plurality of patterns without substantially distinct boundaries are centered or decentered within the optical zone.

[0373] One or more contact lenses of the above claim examples of Group A, wherein the total surface area of the plurality of non-refractive features occupies 2.5% to 10%, or 5% to 15%, or 7.5% to 20% of the total surface area of the optical zone.

[0374] One or more contact lenses of the above claim examples of Group A, wherein the plurality of non-refractive features are configured to be within 3 mm, or 4 mm, or 5 mm, or 6 mm from the center of the optical zone.

[0375] One or more contact lenses of the above claim examples of Group A, wherein in a region outside 6.5 mm from the center of the optical zone, or outside 7 mm from the center, or outside 7.5 mm from the center, the contact lens is substantially free of non-refractive features.

[0376] One or more contact lenses of the above claim examples of Group A, wherein the plurality of non-refractive features are applied to the front surface, or the back surface, or both the front and back surfaces.

[0377] One or more contact lenses of the above claim examples of Group A, wherein the plurality of non-refractive features are applied within the base material of the contact lens.

[0378] One or more contact lenses of the above claim examples of Group A, wherein the total light transmittance through the optical zone is 85% to 90%, or 90% to 95%, or 92.5% to 97.5%, or 85% to 99% of the total light transmittance through the optical zone of a similar single-focus lens lacking non-refractive features.

[0379] One or more contact lenses of the above claim examples of Group A, wherein the plurality of non-refractive features are configured to be sensitive to the polarization of incident light at least in part.

[0380] One or more contact lenses of the above claim examples of Group A, wherein the plurality of non-refractive features are activated and become opaque at least in part when the incident light is linearly polarized, or circularly polarized, or elliptically polarized.

[0381] One or more contact lenses among the above claim examples of Group A, wherein the plurality of non-refractive features are at least partially activated and become opaque when incident light comes from an LCD or LED or OLED monitor screen, a TV screen, a tablet screen, or a mobile screen, or a screen of a similar electronic device.

[0382] One or more contact lenses among the above claim examples of Group A, wherein the plurality of non-refractive features are configured to be electronically adjustable at least in part.

[0383] One or more contact lenses among the above claim examples of Group A, wherein the non-refractive features are configured such that the material properties have spectral sensitivity to specific visible wavelengths in the range of 420 to 760 nm.

[0384] One or more contact lenses among the above claim examples of Group A, wherein the lens can provide the wearer with appropriate visual performance substantially similar to that obtained by a single-focus lens lacking non-refractive features.

[0385] One or more contact lenses among the above claim examples of Group A, wherein the non-refractive features are configured such that the material properties have spectral sensitivity to specific visible wavelengths in the range of 420 to 760 nm.

[0386] One or more contact lenses among the above claim examples of Group A, which provide an on-axis modulation transfer function for at least one pupil in the range of 3 mm to 6 mm and at least one wavelength in the range of 420 nm to 760 nm that is substantially equivalent to that obtained by a single-focus contact lens lacking non-refractive features when tested with a model eye configured with a refractive error at a distance substantially matching the basic prescription.

[0387] One or more contact lenses of the above claim examples of Group A, which, when tested with a model eye configured with a refractive error that substantially matches the basic prescription, provides an off-axis wide-field modulation transfer function for at least one pupil in the range of 3 mm to 6 mm and at least one wavelength in the range of 420 nm to 760 nm that is substantially equivalent to that obtained with a single-focus contact lens lacking refractive characteristics.

[0388] One or more contact lenses of the above claim examples of Group A, wherein the wide field of view of the retina includes at least 5°, or 10°, or 15°, or 20°, or 25°, or 30° of the field of view.

[0389] One or more contact lenses of the above claim examples of Group A, which, when tested with a model eye configured with a refractive error that substantially matches the basic prescription, provides substantial correction of the refractive error of the eye and results in an artificial edge or spatial light contrast profile that spreads across the wide field of view of the retina of the model eye.

[0390] One or more contact lenses of the above claim examples of Group A, which, when tested in a model eye configured with a refractive error that substantially matches the basic prescription at various decentered positions to simulate either the on-eye movement of the contact lens, the eye movement of the wearer, or a combination thereof, provides a temporal variation of an artificial edge or spatial light contrast profile that spreads across the wide field of view of the retina of the model eye.

[0391] One or more contact lenses of the above claim examples of Group A, wherein the model eye is a schematic, physical, or bench-top model eye.

[0392] One or more contact lenses of the above claim examples of Group A, which, when tested on a bench top or physical model eye configured with a refractive error substantially matching the basic prescription, provide substantial correction of the refractive error of the model eye.

[0393] One or more contact lenses of the above claim examples of Group A, wherein the retina of a bench top or physical model eye including a camera having a charge coupled device or complementary metal oxide sensor is configured to capture an image of a visual scene projected through the model eye corrected with the contact lens.

[0394] One or more contact lenses of the above claim examples of Group A, wherein the image captured by the retina of the model eye serves as an input stream for a virtual retina simulator that includes at least one of the following three image processing steps: (a) spatio-temporal filtering of the input stream of the image to provide a bandpass current, (b) instantaneous non-linear contrast gain control using variable feedback gate shunting conductivity, and (c) discrete set of noise integration and firing cell models that provide a spike train indicating ganglion cell activity.

[0395] One or more contact lenses of the above claim examples of Group A, wherein the plurality of non-refractive regions are configured to provide an increase in retinal ganglion cell activity as compared to that obtained by a single focus contact lens lacking non-refractive features.

[0396] One or more contact lenses of the above claim examples of Group A, wherein the retinal ganglion cell activity measured as the average retinal spike rate integrated over a particular time frame is at least 1.25 times, 1.5 times, 1.75 times, 2 times, 2.25 times, 2.5 times, 2.75 times, 3 times that of the retinal ganglion cell activity of a single focus contact lens lacking non-refractive features.

[0397] One or more contact lenses among the above claim examples of Group A, wherein the specific time frame over which the average retinal spike rate is integrated may be at least 1 second, or at least 3 seconds, or at least 10 seconds, or at least 30 seconds, or at least 60 seconds, or at least 120 seconds, or at least 180 seconds, the contact lens.

[0398] One or more contact lenses among the above claim examples of Group A, wherein the non-stationarity of retinal ganglion cell activity or neuronal response measured as the average retinal spike rate is observed in an on-center / off-surround retinal field, or an on-surround / off-center retinal field, or both, the contact lens.

[0399] One or more contact lenses among the above claim examples of Group A, wherein the function that describes the overall retinal ganglion cell activity or the non-stationarity in the neuronal response in the retina of a model eye, measured with respect to the average retinal spike rate as a function of time, follows a non-linear, or non-periodic, or sinusoidal, or quasi-sinusoidal, rectangular wave, quasi-rectangular wave, square wave, quasi-square wave, or non-monotonic pattern that exhibits temporal variations in the overall retinal ganglion cell activity, the contact lens.

[0400] One or more contact lenses among the above claim examples of Group A, wherein the plurality of non-refractive regions provide at least one of deceleration, delay, or prevention of the progression of myopia measured by changes in the axial length of the eye or refractive anisometropia, the contact lens.

[0401] One or more contact lenses among the above claim examples of Group A, wherein the contact lens provides appropriate foveal vision correction for the refractive anomaly of the eye, and the non-refractive feature provides a time-varying stop signal and / or a spatially-varying stop signal for reducing the progression rate of myopia, at least in part, the contact lens.

[0402] One or more contact lenses of the above claim examples of Group A, wherein at least one effect of decelerating, delaying, or preventing the progression of myopia is maintained for at least 12, 24, 36, 48, or 60 months of lens wear.

[0403] One or more contact lenses of the above claim examples of Group A, wherein the peripheral region lacks a plurality of substantially opaque features.

[0404] One or more contact lenses of the above claim examples of Group A, wherein the non-refractive features are applied using pad printing, laser etching, photoetching, or laser printing.

[0405] One or more contact lenses of the above claim examples of Group A, which are combined with one or more spectacle lenses of the claim examples of Group B to constitute additional embodiments.

[0406] Exemplary claim set B A spectacle lens for the eye, the spectacle lens including a front convex surface, a back concave surface, and an optical center around which a basic prescription for substantially correcting the distance refractive anomaly of the eye is configured, and further including a plurality of non-refractive features.

[0407] A spectacle lens of the above claim examples of Group B, wherein the basic prescription for the eye includes at least one of the following: spherical aberration correction, astigmatism correction, or spherical and astigmatism correction.

[0408] One or more spectacle lenses of the above claim examples of Group B, wherein the plurality of non-refractive features include at least one of the following: a plurality of substantially opaque boundaries forming a plurality of openings, each opening surrounding a substantially transparent region with a boundary line, a substantially opaque boundary, or a plurality of substantially opaque features forming one or more patterns without a substantially distinct boundary.

[0409] One or more spectacle lenses among the above claim examples of Group B, wherein each substantially transparent region includes a basic prescription for the eye, the spectacle lens.

[0410] One or more spectacle lenses among the above claim examples of Group B, wherein the shape of at least one of the plurality of openings is circular, elliptical, oval, triangular, rectangular, square, pentagonal, hexagonal, octagonal, or any other regular polygon, or an irregular polygon, or a random shape, the spectacle lens.

[0411] One or more spectacle lenses among the above claim examples of Group B, wherein the surface area of the transparent region surrounded by at least one boundary line of the plurality of openings is 0.25 square millimeters to 2.5 square millimeters, or 0.5 square millimeters to 5 square millimeters, or 0.75 square millimeters to 7.5 square millimeters, or 0.25 square millimeters to 7.5 square millimeters, the spectacle lens.

[0412] One or more spectacle lenses among the above claim examples of Group B, wherein the width of the substantially opaque boundary of any of the plurality of openings is at least 3 times, at least 4 times, or at least 6 times, or at least 8 times, or at least 10 times the average wavelength of the visible spectrum of light (i.e., 555 nm) so that the substantially opaque boundary remains substantially non-diffractive, the spectacle lens.

[0413] One or more spectacle lenses among the above claim examples of Group B, wherein the width of the substantially opaque boundary of any of the plurality of openings is 5 μm to 75 μm, or 25 μm to 150 μm, or 50 μm to 250 μm, the spectacle lens.

[0414] One or more spectacle lenses among the above claim examples of Group B, wherein the total number of openings in the plurality of openings is at least 6, at least 9, at least 12, at least 18, at least 24, or at least 30 openings, the spectacle lens.

[0415] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of apertures are formed in a circular, hexagonal, radial, spiral, regular, irregular, or random arrangement.

[0416] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of patterns without substantially distinct boundaries include at least a spoke wheel pattern, a spiral pattern, a vortex pattern, a lattice pattern, a Memphis pattern, a dot pattern, a regular pattern, an irregular pattern, a moiré pattern, an interference pattern, a random pattern with dots, a random pattern with straight lines, a random pattern with curves, a random pattern with arcs, and a random pattern with zigzag lines, and each pattern of the plurality of patterns is formed by substantially opaque features including points, lines, or streaks.

[0417] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of patterns without substantially distinct boundaries are centered or eccentric within the spectacle lens.

[0418] One or more spectacle lenses among the above claim examples of Group B, wherein the total surface area of the plurality of non-refractive features occupies 5% to 15%, or 7.5% to 20%, or 12.5% to 25% of the total surface area of the spectacle lens.

[0419] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive features are configured to be within 10 mm, or 15 mm, or 20 mm, or 30 mm of the center of the spectacle lens.

[0420] One or more spectacle lenses among the above claim examples of Group B, wherein the region outside 30 mm, or 35 mm, or 40 mm of the center of the spectacle lens is substantially free of non-refractive features.

[0421] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive features are applied to the front surface, or the back surface, or both the front and back surfaces.

[0422] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive features are applied within the base material of the contact lens.

[0423] One or more spectacle lenses among the above claim examples of Group B, wherein the substantially opaque boundary or feature is configured to absorb at least 80 percent, at least 90 percent, or at least 99 percent of the light incident on the substantially opaque boundary or feature.

[0424] One or more spectacle lenses among the above claim examples of Group B, wherein the total transmittance of light through the optical zone is 85 percent to 90 percent, or 90 percent to 95 percent, or 92.5 percent to 97.5 percent, or 85 percent to 99 percent of the total transmittance of light through the optical zone of a similar single-focus lens lacking the non-refractive feature.

[0425] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive features are configured to be sensitive to the polarization of incident light at least in part.

[0426] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive features are activated and become opaque at least in part when the incident light is linearly polarized, circularly polarized, or elliptically polarized.

[0427] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive features are activated and become opaque at least in part when the incident light comes from an LCD or LED or OLED monitor screen, a TV screen, a tablet screen, or a mobile screen, or a screen of a similar electronic device.

[0428] One or more spectacle lenses of the above claim examples of Group B, wherein the plurality of non-refractive features are configured to be electronically adjustable at least in part.

[0429] One or more spectacle lenses of the above claim examples of Group B, wherein the non-refractive feature is configured such that the material property has spectral sensitivity to a specific visible wavelength within the range of 420 to 760 nm.

[0430] One or more spectacle lenses of the above claim examples of Group B, wherein the lens can provide a wearer with an appropriate visual performance substantially similar to that obtained by a single-focus lens lacking non-refractive features.

[0431] One or more spectacle lenses of the above claim examples of Group B, which provide an on-axis modulation transfer function for at least one pupil in the range of 3 mm to 6 mm and at least one wavelength in the range of 420 nm to 760 nm that is substantially equivalent to that obtained by a single-focus spectacle lens lacking non-refractive features when tested with a model eye configured with a distance refractive anomaly substantially matching the basic prescription.

[0432] One or more spectacle lenses of the above claim examples of Group B, which provide an off-axis wide-field modulation transfer function for at least one pupil in the range of 3 mm to 6 mm and at least one wavelength in the range of 420 nm to 760 nm that is substantially equivalent to that obtained by a single-focus spectacle lens lacking non-refractive features when tested with a model eye configured with a distance refractive anomaly substantially matching the basic prescription.

[0433] One or more spectacle lenses of the above claim examples of Group B, wherein the wide field of view of the retina includes at least 5°, or 10°, or 15°, or 20°, or 25°, or 30° of the field of view.

[0434] One or more spectacle lenses among the above claim examples of Group B, which, when tested with a model eye configured with a refractive anomaly at a distance substantially matching the basic prescription, provide substantial correction of the refractive anomaly of the eye and result in an artificial edge or a spatial light contrast profile that spreads over a wide field of view of the retina of the model eye.

[0435] One or more spectacle lenses among the above claim examples of Group B, which, when tested at various eccentric positions for mimicking the eye movements of the wearer with a model eye configured with a refractive anomaly at a distance substantially matching the basic prescription, provide temporal variations of an artificial edge or a spatial light contrast profile that spreads over a wide field of view of the retina of the model eye.

[0436] One or more spectacle lenses among the above claim examples of Group B, wherein the model eye is a schematic, physical, or bench-top model eye.

[0437] One or more spectacle lenses among the above claim examples of Group B, which, when tested with a bench-top or physical model eye configured with a refractive anomaly at a distance substantially matching the basic prescription, result in substantial correction of the refractive anomaly of the model eye.

[0438] One or more spectacle lenses among the above claim examples of Group B, wherein the retina of a bench-top or physical model eye including a camera having a charge-coupled device or a complementary metal oxide sensor is configured to capture an image of a visual scene projected through the model eye corrected with the spectacle lens.

[0439] One or more spectacle lenses of the above claim examples of Group B, wherein the image captured by the retina of the model eye serves as an input stream for a virtual retina simulator that includes at least one of the three image processing steps disclosed herein: (a) spatio-temporal filtering of the image input stream that results in a bandpass current, (b) instantaneous non-linear contrast gain control using variable feedback gate shunt conductivity, and (c) discrete set of noise integration and firing cell models that result in a spike train indicative of ganglion cell activity.

[0440] One or more spectacle lenses of the above claim examples of Group B, wherein the plurality of non-refractive regions are configured to provide an increase in retinal ganglion cell activity as compared to that obtained by a single-focus spectacle lens lacking non-refractive features.

[0441] One or more spectacle lenses of the above claim examples of Group B, wherein the retinal ganglion cell activity measured as the average retinal spike rate integrated over a particular time frame is at least 1.25 times, 1.5 times, 1.75 times, 2 times, 2.25 times, 2.5 times, 2.75 times, 3 times that of the retinal ganglion cell activity of a single-focus spectacle lens lacking non-refractive features.

[0442] One or more spectacle lenses of the above claim examples of Group B, wherein the particular time frame over which the average retinal spike rate is integrated may be at least 1 second, or at least 3 seconds, or at least 10 seconds, or at least 30 seconds, or at least 60 seconds, or at least 120 seconds, or at least 180 seconds.

[0443] One or more spectacle lenses of the above claim examples of Group B, wherein the non-stationarity of the retinal ganglion cell activity or neuronal response measured as the average retinal spike rate is observed in an on-center / off-surround retinal field, or an on-surround / off-center retinal field, or both.

[0444] One or more spectacle lenses among the above claim examples of Group B, wherein the function describing the overall retinal ganglion cell activity in the retina of a model eye or the non-stationarity in neuronal response, measured with respect to the average retinal spike rate as a function of time, follows a non-linear, or non-periodic, or sinusoidal, or quasi-sinusoidal, rectangular wave, quasi-rectangular wave, square wave, quasi-square wave, or non-monotonic pattern indicating temporal variations in the overall retinal ganglion cell activity.

[0445] One or more spectacle lenses among the above claim examples of Group B, wherein the plurality of non-refractive regions provide at least one of deceleration, delay, or prevention of the progression of myopia measured by changes in the axial length of the eye or refractive anisometropia.

[0446] One or more spectacle lenses among the above claim examples of Group B, wherein the spectacle lens provides appropriate foveal vision correction for refractive anomalies of the eye at least in part, and the non-refractive feature provides a time-varying stop signal and / or a spatially varying stop signal for reducing the progression rate of myopia at least in part.

[0447] One or more spectacle lenses among the above claim examples of Group B, wherein the effect of at least one of deceleration, delay, or prevention of the progression of myopia is maintained over at least 12, 24, 36, 48, or 60 months of lens wear.

[0448] One or more spectacle lenses among the above claim examples of Group B, wherein the peripheral region lacks a plurality of substantially opaque features.

[0449] One or more spectacle lenses among the above claim examples of Group B, wherein the non-refractive feature is applied using pad printing, laser etching, photoetching, or laser printing.

[0450] One or more spectacle lenses among the above claim examples of Group B, which are combined with one or more contact lenses of the claim examples of Group A to constitute an additional embodiment, the spectacle lens.

Claims

**Claim 1** An ophthalmic lens for an eye with progressive myopia, the ophthalmic lens including a front surface, a back surface, an optical center, and an optical zone around the optical center, the optical zone including a basic prescription for the eye and at least one region providing a total transmittance, the at least one region comprising a plurality of low-transmission non-refractive features in the form of lines or streaks having a plurality of lines or streaks, each of the plurality of lines or streaks having a width of 300 μm or less, the basic prescription including spherical aberration correction, astigmatism correction, or spherical aberration and astigmatism correction, each of the plurality of low-transmission non-refractive features absorbing at least 80% of the light incident on the low-transmission non-refractive feature, The total transmittance of the light passing through the optical zone of the ophthalmic lens is 85% to 99% of the total transmittance of the light passing through the optical zone of a similar single-focus lens having an optical zone including the basic prescription and not including the plurality of low-transmission non-refractive features. An ophthalmic lens. **Claim 2** Each of the plurality of low-transmission non-refractive features has a width between 5 μm and 250 μm, is non-diffractive, and is configured to be at least one of an arc shape, or a straight line, a zigzag line, a curve, or a stripe pattern, the plurality of low-transmission non-refractive features being arranged in at least one pattern, The at least one pattern includes at least one of a moiré pattern, a curve pattern, a spoke wheel pattern, a Memphis pattern, a rectangular grid pattern, a regular pattern, an irregular pattern, a hexagonal pattern, a spiral pattern, a vortex pattern, a radial pattern, an array of lines, a zigzag pattern, a random pattern having a straight line, a random pattern having a curve, a random pattern having an arc, a random pattern having a zigzag line, or a random pattern. The ophthalmic lens according to claim 1. **Claim 3** The total surface area of the plurality of low-transmission non-refractive features occupies 2.5% to 15% of the total surface area of the optical zone, the plurality of low-transmission non-refractive features being configured to be within 5 mm of the center of the optical zone, In the region outside 6 mm of the center of the optical zone, the low-transmission non-refractive feature is missing. The ophthalmic lens according to claim 1 or 2. **Claim 4** The plurality of low-transmission non-refractive features are applied at at least one location among the front surface, the back surface, or within the material of the ophthalmic lens. The ophthalmic lens according to any one of claims 1 to 3, wherein the plurality of low-transmission non-refractive features are configured to be at least one of opaque, translucent, reflective, spectro-sensitive, polarization-sensitive, or absorptive.

5. The plurality of low-transmission non-refractive features are configured such that the material properties have spectral sensitivity to specific visible wavelengths within the range of 420 to 760 nm. The plurality of low-transmission non-refractive features are at least partially electronically adjustable. The ophthalmic lens according to any one of claims 1 to 4, wherein the plurality of low-transmission non-refractive features are at least partially activated when the incident light is linearly polarized, circularly polarized, or elliptically polarized.

6. When the ophthalmic lens is tested with a schematic model eye, a bench-top model eye, or a physical model eye configured with a refractive anomaly at a distance that matches the basic prescription, it provides on-axis and off-axis wide-field optical performance along the optical axis of the ophthalmic lens for at least one pupil in the range of 3 mm to 6 mm and at least one wavelength in the range of 420 nm to 760 nm, with variations within 5% of the optical performance obtained by a single-focus lens lacking the low-transmission non-refractive features. The optical performance is measured as a modulation transfer function as a function of spatial frequency. The off-axis wide field includes at least 5 degrees of the visual field of the schematic model eye, the bench-top model eye, or the physical model eye. The ophthalmic lens according to any one of claims 1 to 5.

7. When the ophthalmic lens is tested with the schematic model eye, the bench-top model eye, or the physical model eye, it provides substantial correction of the refractive anomaly of the model eye and an increase in spike trains indicating retinal ganglion cell activity. The retina of the model eye is configured to capture an image of the visual scene projected through the model eye corrected by the ophthalmic lens. The captured image serves as an input stream for a virtual retina simulator that includes at least one of the following image processing steps: (a) spatio-temporal filtering of the image input stream that results in a bandpass current, (b) instantaneous non-linear contrast gain control using variable feedback gate shunt conductivity, and (c) a discrete set of noise integration and firing cell models that result in a spike train indicative of the retinal ganglion cell activity. The ophthalmic lens according to claim 6, which provides an increase in the spike train indicative of the retinal ganglion cell activity as compared to that obtained by a single focus lens lacking the low transmission non-refractive feature. Claim 8 The captured image of the visual scene results in an artificial edge that spreads across the wide field of view of the retina of the model eye, or a spatial light contrast profile, for the ophthalmic lens according to claim 7. Claim 9 The captured image of the visual scene includes images captured at various eccentric positions to mimic one of the movements above the eye of the ophthalmic lens, the wearer's eye movements, or a combination thereof, and provides a temporal variation of the artificial edge that spreads across the wide field of view of the retina of the model eye, or the spatial light contrast profile, for the ophthalmic lens according to claim 8. Claim 10 The non-stationarity of the retinal ganglion cell activity or neuronal response measured as the average retinal spike rate is observed in at least one of the on-center / off-surround retinal fields and the on-surround / off-center retinal fields, for the ophthalmic lens according to claim 9. Claim 11 The non-stationarity of the retinal ganglion cell activity or the neuronal response measured as the average retinal spike rate integrated over a particular time frame is at least 1.5 times the retinal ganglion cell activity of a single focus lens lacking the low transmission non-refractive feature. The particular time frame over which the average retinal spike rate is integrated is at least 1 second, for the ophthalmic lens according to claim 10. Claim 12 The non-stationarity in the retinal ganglion cell activity or the neuronal response, measured with respect to the average retinal spike rate as a function of time, is non-linear, or aperiodic, or sinusoidal, or quasi-sinusoidal, rectangular, quasi-rectangular, square, quasi-square, or non-monotonic pattern, indicating temporal variation in the overall retinal ganglion cell activity, the ophthalmic lens according to claim 11.

13. The ophthalmic lens according to claim 12, wherein the ophthalmic lens provides visual performance similar to that obtained by a single-focus lens lacking the low-transmission non-refractive feature.

14. The ophthalmic lens provides at least one of deceleration, delay, or prevention of the progression of myopia measured by changes in the axial length of the eye or refractive anomalies over time, wherein the measurement of the change over time is considered after at least 6, 12, or 24 months of lens wear, the ophthalmic lens according to claim 13.

15. The low-transmission non-refractive feature is applied using pad printing, laser etching, photoetching, or laser printing, the ophthalmic lens according to claim 14.

16. The plurality of low-transmission non-refractive features are at least partially activated and become opaque when incident light comes from an LCD or LED or OLED monitor screen, TV screen, tablet screen, or mobile screen, or a screen of a similar electronic device, the ophthalmic lens according to claim 15.

17. The off-axis wide field of view includes at least 15 degrees of the field of view of the model eye, the ophthalmic lens according to claim 16.

18. The movement on the eye is within 1 mm from the lens position located at the center on the eye and is in one of the horizontal, diagonal, vertical, or a combination of these directions, the ophthalmic lens according to claim 9.

19. An ophthalmic lens for an eye with progressive myopia, the ophthalmic lens includes a front surface, a back surface, an optical center, and an optical zone around the optical center, the optical zone includes a basic prescription for the eye and at least one region providing a total transmittance, the at least one region is provided with a plurality of low-transmission non-refractive features in the form of a plurality of lines or streaks having a plurality of lines or streaks, and the width of each of the plurality of lines or streaks is 300 μm or less. The basic prescription includes spherical aberration correction with or without an aspherical aberration correction. The total transmittance of the optical zone of the ophthalmic lens is at least 85% of the total transmittance of light passing through the optical zone around the optical center of a single - focus lens that includes the basic prescription, the optical zone around the optical center, and that lacks the plurality of low - transmittance non - refractive features. Claim 20 The ophthalmic lens according to any one of claims 1 to 19, wherein the width of each of the lines or the streaks is 50 μm or less. Claim 21 The ophthalmic lens according to any one of claims 1 to 19, wherein the width of each of the lines or the streaks is 100 μm or less. Claim 22 The ophthalmic lens according to any one of claims 1 to 19, wherein the width of each of the lines or the streaks is 150 μm or less. Claim 23 The ophthalmic lens according to any one of claims 1 to 19, wherein the width of each of the lines or the streaks is 200 μm or less.

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