Free-form contact lenses for myopia

Abstract

The present invention relates to a contact lens for treating myopia, wherein the contact lens comprises an optical zone around an optical axis and a non-optical peripheral carrier zone around the optical zone. Wherein the optical zone is configured with a substantially single-vision luminance profile to provide correction for the eye; an eccentric second zone is configured with one or more meridional and azimuthal varying luminance profiles, wherein at least one of the meridional and azimuthal varying luminance profiles lacks mirror symmetry, the second zone is substantially away from the optical center, and is configured to at least partially provide a region conic of local blur, thereby generating an optical stop signal for the eye; wherein the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric to further provide a stop signal that varies with time and space to reduce progression of myopia.

Description

[0001] Cross-references

[0002] This application claims priority to Australian Provisional Application No. 2020 / 900414, filed on February 14, 2020, entitled “A Freeform Lens Design”, and is a continuation of PCT / AU2020 / 051006, filed on September 23, 2020, entitled “A Freeform Contact Lens Solution for Myopia”; both are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to the use of contact lenses for conditions related to axial length, such as myopia. The invention relates to a contact lens for treating myopia, wherein the contact lens includes an optical region surrounding an optical axis; and a non-optical peripheral carrier region surrounding the optical region; wherein the optical region is configured with a substantially monochromatic brightness distribution that provides basic correction to the eye; and an off-center second region configured with one or more meridional and azimuth-varying brightness distributions, wherein at least one of the meridional and azimuth-varying brightness distributions is substantially remote from the optical center due to the lack of mirror symmetry, and is configured to at least partially provide directional cues in the form of regional cones or partially blurred intervals, thereby generating an optical stopping signal on the retina. The non-optical peripheral carrier region is configured with substantially rotationally symmetric thickness characteristics and / or configured with at least one rotational aid feature to further provide a stopping signal that varies with time and space to slow, improve, control, inhibit, or reduce the rate of myopia progression over time. Background Technology

[0004] Humans are farsighted at birth because the length of the eyeball is too short for the eye's total refractive power. As a person grows from childhood to adulthood, the eyeball continues to grow until the eye's refractive state stabilizes.

[0005] Eye growth is understood to be controlled by feedback mechanisms and primarily regulated by visual experience to ensure that the eye's optics match its length and maintain homeostasis. This process is called emmetropization.

[0006] The process of emmetropia is initiated by the modulation of light energy received at the retina. Retinal imaging features are monitored by biological processes that modulate these signals to initiate or halt, accelerate or slow eye growth. This process coordinates between the optics and the length of the eyeball to achieve or maintain emmetropia. Derailment from this process leads to refractive errors such as myopia.

[0007] The incidence of myopia is increasing at an alarming rate in many parts of the world, particularly in the East Asian region. In myopic individuals, the axial length of the eye does not match the overall power of the eye, resulting in the focus of distant objects in front of the retina.

[0008] Simple negative single-vision lenses can correct myopia. While such devices can correct the refractive error associated with eye length optically, they do not address the underlying cause of the excessive eye growth in myopia development.

[0009] The excessive eye length in high myopia is associated with significant sight-threatening conditions such as cataract, glaucoma, myopic maculopathy and retinal detachment. Therefore, there remains a need for specific optical devices for such individuals that not only correct the underlying refractive error, but also prevent excessive eye lengthening or myopia development over time.

[0010] To date, a number of contact lens optical designs have been proposed to control the rate of eye growth, i.e. myopia progression. The following prior art is incorporated herein by reference. Collins et al. in US Patent 6045578 proposed adding positive spherical aberration at the foveal plane to provide a stimulus to control the rate of myopia progression. Aller in US Patent 6752499 suggested the use of bifocal contact lenses for myopic participants who exhibit a near point esophoria. Smith et al. in US Patent 7025460 proposed a method using a lens that moves the peripheral image shell in front of the peripheral retina.

[0011] To et al. in US Patent 7506983 proposed a method of producing a secondary myopic image by using Fresnel optics. Legerton in US Patent 7401922 proposed another method using positive spherical aberration.

[0012] Phillips in US Patent 7997725 proposed a method of simultaneous vision where one part of the lens corrects the original myopia and another part produces a simultaneous myopic defocus signal. Thorn et al. in US Patent 7803153 proposed correction of all optical aberrations, including higher order aberrations, to reduce the rate of myopia progression.

[0013] Menezes in US Patent 8690319 suggests the use of a constant distance of vision magnification zone in the center of the optical zone surrounded by a zone that provides positive longitudinal spherical aberration. Holden et al. in US Patent 8931897 suggest a method for treating myopic eyes having an inner vision zone and an outer vision zone and having an additional optical power relative to the base prescription optical power. Tse et al. in US Patent 8950860 suggest a method for retarding myopia progression using a concentric ring multi-zone refractive lens. Bakaraju et al. in US Patent 9532563 suggest a lens with multiple modes of higher order spherical aberration to control myopia.

[0014] In summary, the contact lens design options for retarding the rate of myopia progression include: simultaneous defocus zones on the lens, lenses with positive spherical aberration (also known as peripheral addition), and lenses with additional modifications including central and peripheral addition zones, and lenses including a specific set of higher order aberrations.

[0015] Definitions

[0016] Unless otherwise defined herein, the terms used herein are to be interpreted as follows:

[0017] The term "myopic eye" refers to an eye that is already myopic, is in a pre-myopic stage, is at risk of becoming myopic, is diagnosed with a refractive condition that is progressing towards myopia and has astigmatism, with a lower than 1 DC of refraction.

[0018] The term "progressive myopic eye" refers to an eye that has been diagnosed as being in the process of developing myopia, as measured by a change in refractive error of at least -0.25 D / year, or a change in axial length of at least 0.1 mm / year.

[0019] The term "pre-myopic eye" or "eye at risk of myopia" refers to an eye that can be emmetropic or hyperopic at the time, but has been determined to have a high risk of myopia according to genetic factors (e.g. both parents are myopic) and / or age (e.g. was hyperopic in youth) and / or environmental factors (e.g. time spent outdoors) and / or behavioral factors (e.g. time spent working at close range).

[0020] The term "optical stop signal" or "stop signal" refers to an optical signal or directional cue that can promote slowing, reversing, stalling, retarding, inhibiting or controlling the growth of an eye and / or the refractive condition of an eye.

[0021] The term "spatially varying optical stop signal" refers to an optical signal or directional cue that is provided on the retina, spatially varying across the entire retina of the eye.

[0022] The term“time-varying optical stop signal” refers to a time-varying optical signal or directional cue provided on the retina.

[0023] The term“spatially and temporally varying optical stop signal” refers to an optical signal or directional cue provided on the retina that varies in time and space across the eye’s retina.

[0024] The term“contact lens” refers to a finished contact lens that is worn on a wearer’s cornea to affect the optical performance of the eye.

[0025] The term“optical zone” or“optical zone” refers to a region on a contact lens having a prescribed optical effect, which includes correcting refractive errors, and a second region that provides an optical stimulus to slow the progression rate of myopia. The optical zone can be further distinguished by an anterior optical zone and a posterior optical zone. The anterior and posterior optical zones refer to the regions of the anterior and posterior surfaces of the contact lens, respectively, that contribute to the prescribed optical effect. The optical zone of a contact lens can be circular or elliptical or irregular in shape.

[0026] The term“second region within the optical zone” or“second region” refers to another distinct region within the optical zone of a contact lens having a desired or prescribed optical effect that is substantially offset from the optical center or optical axis. As disclosed herein, the introduction of meridional and azimuthal varying luminance profiles within the second region can result in the second region having a circular or irregular shape.

[0027] The term“optical center of a contact lens” or“optical center of a contact lens” refers to the geometric center of the optical zone of a contact lens. As disclosed herein, the terms geometric and geometric are substantially the same.

[0028] The term“optical axis” refers to a line passing through the optical center and substantially perpendicular to a plane containing the edge of the contact lens.

[0029] The term“hybrid region” refers to a region that connects or is located between the optical zone and the non-optical peripheral carrier region, or a region that connects between the second region and the remainder of the surrounding optical zone. The hybrid region can be on the anterior or posterior surface or both surfaces, and can be polished or smoothed between the two different adjacent surface curvatures as disclosed herein.

[0030] The term“through-focus point” generally refers to a spatial dimension in front of and / or behind the retina, typically in millimeters in image space. However, in some embodiments, as disclosed herein, an alternative measure of the term“through-focus point” that is referenced in object space and measured in diopters or power generally refers to the same thing.

[0031] The term“non-optical peripheral carrier region” is a non-optical region that connects or is located between the optical region and the edge of the contact lens. In some embodiments, as disclosed herein, a hybrid region can be used between the optical region and the peripheral carrier region.

[0032] In the context of describing the second region, the term“radial” refers to a direction that radiates outward from the geometric center to the edge of the second region along an azimuthal definition. The term“radial spoke” refers to a spoke that radiates outward from the geometric center of the second region to the end of the second region at a predetermined azimuthal angle.

[0033] In the context of describing the second region, the phrase“radial luminance profile” as disclosed herein refers to a one-dimensional luminance profile of the local luminance across an arbitrary radial spoke.

[0034] In the context of describing the second region, the phrase“radially invariant luminance profile” as disclosed herein refers to an arbitrary radial spoke that has a substantially uniform luminance profile.

[0035] In the context of describing the second region, the phrase“radially varying luminance profile” as disclosed herein refers to an arbitrary radial spoke that has a substantially non-uniform luminance profile.

[0036] In the context of describing the second region, the term“meridian” as disclosed herein refers to two opposite radial spokes that are distributed along a predetermined azimuthal angle that is defined around the geometric center of the second region.

[0037] In the context of describing the second region, the phrase“meridional luminance profile” as disclosed herein refers to a one-dimensional luminance profile of the local luminance across an arbitrary meridian.

[0038] In the context of describing the second region, the phrase“meridionally invariant luminance profile” as disclosed herein refers to an arbitrary meridian that has a substantially uniform luminance profile.

[0039] In the context of describing the second region, the phrase“meridionally varying luminance profile” as disclosed herein refers to an arbitrary meridian that has a substantially non-uniform luminance profile.

[0040] In the context of describing the second region, the phrase“meridional luminance profile with mirror symmetry” refers to an arbitrary meridian that has substantially the same luminance profile on its two opposite radial spokes.

[0041] In the context of describing the second region, the phrase“meridional luminance profile without mirror symmetry” refers to an arbitrary meridian that has two substantially different luminance profiles on its two opposite radial spokes.

[0042] In the context of describing the second region, the term "azimuthal angle or azimuthal angle" refers to a direction along the circumference of the second region around the geometric center of the second region, defined as any radial distance from the geometric center of the second region.

[0043] In the context of describing the second region, the phrase "azimuthal brightness distribution" refers to a one-dimensional brightness distribution of the local optical power across any azimuthal angle measured at a given radial distance around the geometric center of the second region.

[0044] As disclosed herein, in the context of describing the second region, the phrase "azimuthally invariant brightness distribution" refers to an azimuthal brightness distribution having a substantially uniform brightness distribution.

[0045] As disclosed herein, in the context of describing the second region, the phrase "azimuthally varying brightness distribution" refers to an azimuthal brightness distribution having a substantially non-uniform brightness distribution.

[0046] In the context of describing the second region, the phrase "azimuthal brightness distribution having mirror symmetry" refers to an azimuthal brightness distribution between 0 and π radians substantially similar to an azimuthal brightness distribution between π and 2π radians, as disclosed herein.

[0047] As disclosed herein, in the context of describing the second region, the phrase "azimuthal brightness distribution having no mirror symmetry" indicates an azimuthal brightness distribution between 0 and π radians substantially different from an azimuthal brightness distribution between π and 2π radians.

[0048] The phrase "azimuthal thickness distribution" refers to a one-dimensional thickness distribution of the local lens thickness across any azimuthal angle measured or defined at any radial distance in the non-optical peripheral carrier region.

[0049] The phrase "azimuthally invariant thickness distribution" refers to an azimuthal thickness distribution having a substantially uniform thickness distribution, as disclosed herein.

[0050] As disclosed herein, the phrase "azimuthally varying thickness distribution" refers to an azimuthal thickness distribution having a substantially non-uniform thickness distribution.

[0051] The phrase "periodic azimuthal thickness distribution" refers to an azimuthal thickness distribution following a periodic function or repeating pattern.

[0052] The phrase "azimuthal thickness distribution having mirror symmetry" refers to an azimuthal thickness distribution between 0 and π radians substantially similar to an azimuthal thickness distribution between π and 2π radians, as disclosed herein.

[0053] The phrase "azimuthal thickness profile without mirror symmetry" means that the azimuthal thickness profile as disclosed herein is substantially different between 0 and π radians from the azimuthal thickness profile between π and 2π radians.

[0054] The phrase "peak to valley (PTV) in the azimuthal thickness profile" means the difference between the thickest point and the thinnest point along the azimuthal thickness profile between 0 and 2π radians, defined at an arbitrary radial distance in non-optical distance, of the peripheral zone.

[0055] The term "ballast" means an azimuthal variation in thickness without mirror symmetry within the carrier zone, with the purpose of maintaining the rotational orientation of the contact lens when worn on the eye.

[0056] The term "prismatic ballast" means a vertical prism used to form a wedge design that will help stabilize the rotational and orientation of a toric contact lens on the eye.

[0057] The term "delamination" means purposefully thinning the contact lens towards the edges of the superior and inferior edges of the contact lens in one or more discrete zones to achieve a desired rotational stability of the contact lens.

[0058] The term "truncation" means the inferior edge of the contact lens designed to have an approximately straight shape to control the rotational stability of the contact lens.

[0059] The term "model eye" can mean an iconic, ray-traced or physical model eye.

[0060] The term "power" as used herein means the reciprocal of the focal length of a lens or optical system along the optical axis, in meters. In general, the letter "DS" means the spherical power, and the letter "DC" means the cylindrical power. The term "Sturm's region conic" or "Sturm's region interval" means the distribution of astigmatism or toricity configured within a second region of the retina, the resulting off-axis region formed on or around the retina by the focusing image distribution. The visual zone, represented by the region elliptical blur pattern, includes the region sagittal and tangential planes, as well as a minimum confusion circle. The term "back vertex power" means the reciprocal of the back vertex focal length on the optical region, expressed in diopters (D).

[0061] The term "SPH" or "spherical" power means the substantially uniform power between all meridians of the optical zone. The term "CYL" or "cylinder" power means the difference in back vertex power between two principal meridians within the optical zone.

[0062] The term "brightness difference" refers to the difference between the maximum and minimum brightness in a meridional varying brightness distribution across the optical zone and in an azimuthally varying brightness distribution around the optical axis.

[0063] The term "base prescription for correcting refractive errors" or "standard contact lens prescription required for the base myopia of an individual to correct refractive errors" refers to a standard contact lens prescription.

[0064] The term "brightness distribution" refers to a one-dimensional brightness distribution of the local light brightness over the entire optical zone as a function of the radial distance from the optical center at a given azimuthal angle; or as a function of the azimuthal angle measured at a given radial distance.

[0065] The term "brightness map" refers to a two-dimensional brightness distribution in Cartesian or polar coordinates over the optical zone diameter.

[0066] The term "brightness distribution map of the second zone" refers to the brightness distribution of the local light zone as a function of the radial distance and the azimuthal angle measured from the geometric center of the second zone. The brightness distribution of the second zone can be configured on a circular, elliptical or irregular zone.

[0067] The term "brightness map of the second zone" refers to a two-dimensional brightness distribution of the entire second zone within the optical zone, which can be circular, elliptical or irregular in Cartesian or polar coordinates.

[0068] The term "astigmatism or toric second zone" refers to a brightness distribution having at least two main brightness meridians defined on the second zone, wherein the configuration of the two main brightness meridians is different from the base prescription of the optical zone, and the difference between the two main power meridians determines the size of the astigmatism or toric power of the second zone.

[0069] The term "partial correction" or "local correction of the eye" refers to the correction of the eye in at least one specific zone.

[0070] The term "foveal correction" refers to the correction of the eye in at least the foveal region of the retina of the eye. The term "perifoveal region" refers to the region of the eye's retina adjacent to the foveal region. The term "perimacular region" refers to the region of the eye's retina adjacent to the macular region. The term "macular edge" refers to the region within the macular region of the eye's retina. The term "perimacular region" refers to the region of the eye's retina adjacent to the macular region.

[0071] The phrase "rotationally auxiliary feature" refers to a periodic azimuthal thickness distribution with a specific periodicity.

[0072] The term "specific fit" refers to a non-optical peripheral carrier region that includes an azimuthal thickness profile about the optical axis that is configured to be substantially invariant to facilitate substantial freedom of rotation of the contact lens within the eye over time. In some examples, the term "specific fit" includes an azimuthal thickness profile with rotational assist features. For the avoidance of doubt, the specific fit in the present invention refers to a thickness profile of the non-optical peripheral carrier region of a standard astigmatic or toric contact lens in the prior art that is substantially free of or devoid of any ballast or prism, or devoid of any truncation features. SUMMARY

[0073] Certain disclosed embodiments are directed to the construction of contact lenses for the correction, management and treatment of refractive errors. One embodiment of the invention is presented to correct myopic refractive errors and simultaneously provide a light signal that prevents further eye growth or myopia progression. The presented optical device provides a substantially continuously varying area cone of partial blur (i.e., an optical stop signal) imposed on the peripheral retinal area. The present disclosure includes a contact lens comprising an eccentric second region within the optical zone, wherein the second region is characterized by one or more meridional and azimuthal varying power profiles, wherein at least one of the meridional and azimuthal varying power profiles is not mirror symmetric, and wherein the contact lens is intentionally configured without a stable carrier region to provide a substantially continuously varying (or temporally and spatially varying) blur signal on the peripheral retina.

[0074] Another contact lens embodiment consists of a substantially single vision region of a second region within the optical zone, wherein the second region is described by one or more meridional and azimuthal varying power profiles, wherein at least one of the meridional and azimuthal varying power profiles is not mirror symmetric; wherein the single vision portion of the optic zone is used to correct myopic refractive errors, and wherein the second region provides a local cone of partial blur (i.e., an optical stop signal) in the peripheral retina that can inhibit further eye growth or slow the rate of growth. The power profile of the second region varies meridionally and azimuthally around its geometric center. Another feature of the presented embodiment can include a blend between the second region and the rest of the optical zone, which can be circular or elliptical in shape.

[0075] Certain embodiments configured with an eccentric second region characterized by meridional and azimuthal varying power profiles within a non-single vision zone configured on a rotationally symmetric peripheral non-optical carrier region overcome the limitations of the prior art by providing a temporally and spatially varying stop signal. As a result, the saturation of the therapeutic effect on myopia progression is minimized.

[0076] In another embodiment, the present invention is directed to a contact lens for at least one of slowing, delaying or preventing progression of myopia. Another embodiment of the present disclosure is a contact lens comprising an anterior surface, a posterior surface, an optical zone, an optical center, the optical zone comprising: a primary prescription about the optical center, an eccentric second zone having one or more meridional and azimuthal varying power profiles, wherein at least one of the meridional and azimuthal varying power profiles is not mirror symmetric, and a non-optical peripheral carrier zone symmetrically disposed about the optical zone; wherein a substantial portion of the optical zone is at least partially configured to provide an appropriate central foveal correction; the second zone is configured to provide a local conical or local blur spacing as a directional cue to reduce the rate of progression of myopia; the non-optical peripheral carrier zone is configured to provide a temporally and spatially varying optical stop signal; whereby the therapeutic efficacy of reducing ocular growth progression is substantially maintained over time.

[0077] Another embodiment of the present disclosure is a contact lens for an eye, the contact lens comprising an optical zone having an optical center, an eccentric second zone having a geometric center within the optical zone, and a non-optical peripheral carrier zone surrounding the optical zone, wherein a substantial portion of the optical zone is configured with a primary prescription to provide an appropriate central foveal correction for the eye; the eccentric second zone is configured with meridional and azimuthal varying power profiles positioned substantially away from the optical center to at least partially provide a directional cue in the form of a local blur (i.e., an optical stop signal) on a peripheral retina of the eye, and wherein the non-optical peripheral carrier zone is configured to be substantially free of ballast or otherwise configured to allow the contact lens to provide the directional cue (i.e., the optical stop signal) as the contact lens rotates on the eye.

[0078] According to one of the embodiments, the present disclosure is directed to a contact lens for an eye with myopia. The contact lens comprises an anterior surface, a posterior surface, an optical axis, an optical zone about the optical axis, the optical zone comprising a primary prescription about the optical axis and a second zone, a meridional and azimuthal varying power profile defined about a geometric center of the second zone, the primary prescription configured to correct a refractive error of the eye, the second zone configured to provide a directional cue in the form of a local blur region on a peripheral retina; wherein the contact lens is further configured with a rotationally symmetric peripheral carrier zone to provide a temporally and spatially varying optical stop signal; whereby the therapeutic efficacy of reducing ocular growth progression is substantially maintained over time.

[0079] The present disclosure is directed to modifying incident light by a contact lens that utilizes a stop signal to slow the rate of myopia progression. The present disclosure is directed to a contact lens device configured with an eccentric second zone within an optical zone, comprising a meridional and azimuthal varying power profile defined about a geometric center of the second zone to impose a stop signal on the retina.

[0080] Further, the optical stop signal applied at the retina is configured to be temporally (time) and spatially (space) varying. More specifically, the present invention relates to a contact lens which is purposefully designed to be devoid of any stabilizing configuration in the non-optical peripheral carrier zone, which can contribute to the temporal and spatial varying optical stop signal to inhibit, reduce or control the progression of myopic refractive error.

[0081] Certain embodiments of the present disclosure are directed to a contact lens for myopic eye, the contact lens comprising an optical zone surrounding an optical center and a non-optical peripheral carrier zone surrounding the optical zone, wherein the optical zone is configured with a substantially single vision to provide a base correction to the eye, a second zone having a longitude and azimuth varying luminance profile around its geometric center, which is configured to provide at least partially a partial obscuration zone substantially away from the optical center, generating an optical stop signal acting on the eye, and wherein the non-optical peripheral carrier zone is configured to be substantially devoid of stabilizers, or configured to allow lens rotation, thereby providing a substantial temporal and spatial varying stop signal to the optical device.

[0082] Embodiments presented in the present disclosure are directed to a continuous need for an optimized optical design and a contact lens which can inhibit the progression of myopia while providing reasonable and adequate visual performance to the wearer for a range of activities, daily work, which the wearer can perform. Various aspects of the embodiments disclosed in the present invention address such needs of the wearer. BRIEF DESCRIPTION OF DRAWINGS

[0083] Figure 1 A front view and a cross-sectional view of a contact lens embodiment are shown. The front view further shows an optical center, an optical zone, a second zone within the optical zone, a geometric center of the second zone, a blending zone and a carrier zone according to certain embodiments.

[0084] Figure 2A A front view and a cross-sectional view of a contact lens embodiment of the present disclosure are shown. The optical zone of the embodiment substantially comprises a base prescription and an eccentric second zone configured with a varying luminance profile around its geometric center in azimuth and meridian directions. The front view also shows an optical center, an optical zone, a blending zone and a non-optical peripheral carrier zone, which comprises at least eight (8) cross-sections along any semi-meridian, whose cross-sectional thicknesses are substantially the same, as previously described in PCT / AU2020 / 051006.

[0085] Figure 2BA front view and cross-sectional view of another contact lens embodiment of the present disclosure is shown. The optical zone of the embodiment comprises substantially a base prescription and an eccentric second zone configured with a luminance profile that varies in azimuth and meridian directions about its geometric center. The front view also shows the optical center, the optical zone with the eccentric second zone, the blending zone, and the non-optical peripheral carrier zone comprising the rotation-aiding features disclosed herein.

[0086] Figure 3A A front view of another contact lens embodiment of the present disclosure is shown, comprising an eccentric second zone configured with a refractive profile that varies in azimuth and meridian about its geometric center, showing a natural blinking-induced substantially free rotation possibility, resulting from a non-optical peripheral carrier zone comprising at least eight (8) cross-sections along any semi-meridian and configured to have substantially similar thicknesses.

[0087] Figure 3B A front view of another contact lens embodiment of the present disclosure is shown, comprising an eccentric second zone configured with a refractive profile that varies in azimuth and meridian about its geometric center, showing a contact lens rotation-aiding substantially around the optical center, a non-optical peripheral carrier zone consisting of an azimuth thickness profile configured substantially to be invariant, or configured to have periodically defined periodic features, according to certain embodiments disclosed, thereby imparting the non-optical peripheral carrier zone with a preconfigured or aided contact lens rotation.

[0088] Figure 4 A schematic diagram of an on-axis geometric point analysis on the retinal plane is shown when incident light having a visible wavelength (e.g. 589 nm) and a vergence of 0 D is incident on the retina of an uncorrected -3 DS myopic model eye.

[0089] Figure 5 A schematic diagram of an on-axis geometric point analysis on the retinal plane is shown when incident light having a visible wavelength (e.g. 589 nm) and a vergence of 0 D is incident on the retina of a -3 DS myopic model eye corrected by one of the contact lens embodiments disclosed previously in PCT / AU2020 / 051006.

[0090] Figure 6A A schematic diagram of an on-axis through-focus geometric point analysis on the retinal plane is shown when incident light having a visible wavelength (589 nm) and a vergence of 0 D is incident on the retina of a -3 DS myopic model eye corrected by a contact lens having an eccentric toric second zone as disclosed previously in PCT / AU2020 / 051006.

[0091] Figure 6BA schematic diagram showing the planar on-axis through focus geometric point analysis of one of the contact lens embodiments of the present disclosure with an eccentric second region configured with azimuthal and meridional varying power profiles is shown when incident light with a visible wavelength (589 nm) and a vergence of 0 D is incident on the retina of a -3 DS myopic model eye with one of the contact lenses as disclosed herein.

[0092] Figure 6C A schematic diagram of one of the contact lens embodiments of the present disclosure is shown along with a magnified portion of the second eccentric region of the optical zone, where the second region of the optical zone uses an azimuthal and meridional varying power profile referenced to the geometric center of the second region.

[0093] Figure 7A A power map of the entire optical zone of one of the contact lenses as previously disclosed in PCT / AU2020 / 051006 is shown, including the power map of the eccentric toric second region (base power: -3 DS, second region power: -3 DS / +1.75 DC).

[0094] Figure 7B The power profile (e.g., power map, diameter function power, and azimuth function power) of the second region only within the eccentric second region of the optical zone of the contact lens configured with a standard spherical cylindrical power profile (base power: -3 DS, second region power: -3 DS / +1.75 DC) as previously disclosed in PCT / AU2020 / 051006 is shown.

[0095] Figure 8 The spatio-temporal varying signal due to contact lens rotation (i.e., 0°, 120°, and 240°) is shown for incident light incident on the retina of a -3 DS myopic model eye with one of the contact lenses as previously disclosed in PCT / AU2020 / 051006. Figure 7A and 7B The on-axis through focus geometric point analysis and the on-axis point spread function of the varying power profile of the second region only within the eccentric second region of the optical zone of the contact lens as previously disclosed in PCT / AU2020 / 051006 is expressed in terms of the contact lens.

[0096] Figure 9A A power map of the entire optical zone of one of the contact lens embodiments of the present disclosure is shown, including the power map of the eccentric second region with an azimuthal and meridional varying power profile (base power: -3 DS, second region (hemispherical) power -3 DS / 1.75 D).

[0097] Figure 9B The power profile (e.g., power, diameter function power, and azimuth function power) of the second region only within the eccentric second region of the optical zone of an exemplary contact lens embodiment of the present disclosure configured with an azimuthal and meridional varying power profile (base power: -3 DS, second region (hemisphere) power -3 DS / 1.75 D) is shown.

[0098] Figure 10The signal of the spatio-temporal changes due to the contact lens rotation (i.e., 0°, 120°, and 240°) is shown in terms of the through-focus geometric point analysis and the on-axis point spread function at the retinal plane of a -1 DS myopic model eye corrected with the contact lens described in Figure 9A and 9B .

[0099] Figure 11A The luminance map of the entire optical zone of one of the contact lens embodiments of the present disclosure is shown, including the luminance map of the eccentric second zone, with azimuthal and meridional varying luminance profiles (base power: -1 DS, luminance of the second zone (cosine transformation I) -1 DS / 1.25 D).

[0100] Figure 11B The power profiles (e.g., luminance, diameter function luminance, and azimuthal function luminance) of the only eccentric second zone within the optical zone configured with azimuthal and meridional varying luminance profiles (base power: -1 DS, luminance of the second zone (cosine transformation I) -1 DS / 1.25 D) in an exemplary contact lens embodiment of the present disclosure are shown.

[0101] Figure 12 The signal of the spatio-temporal changes due to the contact lens rotation (i.e., 0°, 120°, and 240°) is shown in terms of the through-focus geometric point analysis and the on-axis point spread function at the retinal plane of a -1 DS myopic model eye corrected with the contact lens described in Figure 11A and 11B .

[0102] Figure 13A The luminance map of the entire optical zone of one of the contact lens embodiments of the present disclosure is shown, including the luminance map of the eccentric second zone, with azimuthal and meridional varying luminance profiles (base power: -3 DS, luminance of the second zone (cosine transformation II) -3 DS / 1.75 D).

[0103] Figure 13B The power profiles (e.g., luminance, diameter function luminance, and azimuthal function luminance) of the only eccentric second zone within the optical zone configured with azimuthal and meridional varying luminance profiles (base power: -3 DS, luminance of the second zone (cosine transformation II) -3 DS / 1.75 D) in an exemplary contact lens embodiment of the present disclosure are shown.

[0104] Figure 14 The signal of the spatio-temporal changes due to the contact lens rotation (i.e., 0°, 120°, and 240°) is shown in terms of the through-focus geometric point analysis and the on-axis point spread function at the retinal plane of a -1 DS myopic model eye corrected with the contact lens described in Figure 13A and 13BThe through-focus point spread function analysis and on-axis point spread function analysis at the retinal plane of a -3 DS myopic model eye corrected with the contact lens described in

[0105] Figure 15A A luminance map of the entire optic zone of one of the contact lens embodiments of the present disclosure is shown, including a luminance map of the eccentric second zone, having azimuthal, radial and meridional varying luminance profiles (base power: -3 DS, luminance of the second zone (cosine transformation III) -3 DS / 1.25 D).

[0106] Figure 15B The power profile (e.g., luminance, diameter function luminance and azimuth function luminance) of the only eccentric second zone within the optic zone configured with azimuthal and meridional varying luminance profiles (base power: -3 DS, luminance of the second zone (cosine transformation III) -3 DS / 1.25 D) in an exemplary contact lens embodiment of the present disclosure is shown.

[0107] Figure 16 The spatio-temporal variation signals due to contact lens rotation (i.e., 0°, 120° and 240°) are illustrated for the incident light incident to the model eye with the contact lens described in Figure 15A and 15B The through-focus point spread function analysis and on-axis point spread function analysis at the retinal plane of a -3 DS myopic model eye corrected with the contact lens described in

[0108] Figure 17 The thickness profile of the non-optical peripheral carrier zone is shown for the contact lens as described in Figure 2A with the azimuthal function of the contact lens along the radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm.

[0109] Figure 18 The thickness profile of the non-optical peripheral carrier zone is shown for the contact lens as described in Figure 2B with the azimuthal function of the contact lens along the radial distance of 5.5 mm.

[0110] Figure 19 The thickness profile of the non-optical peripheral carrier zone is shown for another contact lens as described in Figure 2B with the azimuthal function of the contact lens along the radial distance of 5.5 mm. DETAILED DESCRIPTION

[0111] The state-of-the-art designs added to the prior art have a certain degree of relative positive power associated with the lens prescription power luminance, which is typically distributed rotationally symmetrically along the optical axis of the contact lens.

[0112] The speed of myopia progression delay in these individuals has its own advantages and disadvantages.

[0113] Some weaknesses are described herein. For example, some problems with existing optical designs based on simultaneous images are that they compromise visual quality at various distances by introducing significant visual disturbances. This side effect is mainly attributed to significant levels of simultaneous defocus, use of large amounts of spherical aberration, or significant variations in luminance across the optical zone.

[0114] In view of the impact of compliance with contact lens wear on the efficacy of such lenses, significant reductions in visual performance lead to poorer compliance, and thus poorer efficacy. Therefore, there is a need for an optical design for the correction of myopia and delay of progression that does not cause at least one or more of the disadvantages discussed herein. As discussed herein, other solutions will become apparent.

[0115] The effectiveness of most contact lens designs in the prior art is determined by randomized controlled clinical trials. The duration of these clinical trials with prior art lenses is between 6 months and 3 years, with single vision contact lenses as a control group, and the reported effectiveness of using prior art contact lenses is between 25% and 75%.

[0116] The simple linear model of emmetropization suggests that the amount of stop signal accumulates over time. In other words, the accumulated stop signal depends on the total amount of exposure and not its temporal distribution. However, the inventors have observed from reports of clinical trials of multiple optical designs that a disproportionate large percentage of the effectiveness, or slowing effect on myopia progression rate, occurs in the first 6 to 12 months.

[0117] After the initial peak of treatment, the effectiveness is observed to diminish over time. Therefore, a more faithful model of emmetropization that is consistent with clinical observations suggests that there can be a delay before the stop signal is established, then saturation occurs over time, and can lead to a reduction in the effectiveness of the stop signal.

[0118] There is a need in the art for a contact lens technology that minimizes this saturation of treatment effect by providing a stop signal that varies over time and space to delay the rate of eye growth, such as myopia progression. There is no need for the wearer to burden switching between different optical designs of contact lenses over a given period of time.

[0119] Therefore, there is a need for an optical design that has a substantially greater and / or substantially consistent mechanism of effectiveness in reducing and / or slowing myopia progression that does not significantly compromise visual performance over time. In one or more examples, the substantially consistent effectiveness over time can be considered to be at least 6, 12, 18, 24, 36, 48, or 60 months.

[0120] In this section, the present disclosure will be described in detail with reference to one or more embodiments, some of which are illustrated in the accompanying drawings. Examples and embodiments are provided by way of explanation and should not be construed as limiting the scope of the present disclosure.

[0121] The following description provides in relation to several embodiments, which can share common features and characteristics of the present disclosure. It should be understood that one or more features of one embodiment can be combined with one or more features of any other embodiment constituting additional embodiments.

[0122] The functional and structural information disclosed herein should not be interpreted in any way as limiting, but should be interpreted only as representative for teaching the skilled person in various ways to employ the disclosed embodiments and variations of the embodiments.

[0123] Subheadings and related subject matter headings are used in the detailed description section merely for ease of reference by the reader and are not to be used to limit the subject matter found throughout the disclosure of the invention or claims. Subheadings and related subject matter headings should not be used in construing the limitations of the claims or claims.

[0124] The risk of progressing myopia or pathologic myopia can be based on one or more of the following factors: genetics, race, lifestyle, environment, excessive near work, etc. Certain embodiments of the present disclosure are directed to people at risk of progressing myopia or pathologic myopia.

[0125] One or more of the following advantages are found in one or more disclosed optical devices and / or contact lens design methods. A contact lens device or method provides a stop signal based on an eccentric second zone within an optical zone to slow the growth rate of an eye or stop ocular axial elongation or refractive error status of a wearer’s eye, the second zone having a meridional and azimuthal varying luminance profile. Certain embodiments include a contact lens device or method that provides a stop signal that varies over time and space to increase the effectiveness of managing progressing myopia. But such contact lens devices or methods based on rotationally symmetric, or simultaneously defocused, positive spherical aberration, which are primarily configured along the optical axis or optical center, have a significant risk of visual performance degradation for the wearer.

[0126] The following example embodiments are directed to a method of modifying incident light by a contact lens system that provides an optical stop signal at the retinal plane of a corrective eye. This can be achieved by using an eccentric second zone within an optical zone, the eccentric second zone characterized by using one or more meridional and azimuthal varying luminance profiles, wherein at least one of the meridional and azimuthal varying luminance profiles lacks mirror symmetry.

[0127] In brief, the use of an eccentric second zone with meridional and azimuthal varying luminance profiles within a contact lens can be used to reduce the incidence of myopia, and to slow the progression of myopia by introducing a spatiotemporal varying stop signal with the aid of a peripheral non-optically symmetric carrier zone, and substantially consistent with the temporal variation.

[0128] Figure 1 An exemplary contact lens embodiment (100) is shown in plan view (100a) and cross-section (100b) to scale. The plan view of the exemplary contact lens embodiment (100) further shows an optical centre (101), an optical zone (102), a blending zone (103), a peripheral carrier zone (104), a lens diameter (107) and an eccentric second zone within an optical zone (105) with a geometric centre (106). In this exemplary contact lens embodiment, the lens diameter is approximately 14 mm, the diameter of the optical zone is approximately 8 mm, the width of the blending zone is approximately 0.1 mm, the width of the symmetric carrier zone (104) is approximately 2.75 mm, and the width of the second zone (105) is approximately 1.5 mm x 1.5 mm. The geometric centre (106) of the eccentric second zone (105) is 3 mm from the optical centre (101).

[0129] Figure 2A A plan view and cross-section of an exemplary contact lens embodiment (200a) is shown not to scale. The plan view of the exemplary contact lens embodiment further shows an optical centre (201a), an optical zone (202a), a blending zone (203a), a peripheral carrier zone (204a) and a second zone (205a) within the optical zone (202a) with a geometric centre (206a).

[0130] In this exemplary contact lens embodiment, the lens diameter is approximately 14 mm, and the distance correcting portion of the optical zone (202a) is rotationally symmetric along the optical axis. The second zone (205a) within the optical zone (202a) is circular with a diameter of approximately 1.5 mm. The blending zone (203a) is approximately 0.1 mm in diameter, and the width of the symmetric peripheral carrier zone (204a) is approximately 2.75 mm. As previously disclosed in PCT / AU2020 / 051006, the radial cross-sections (2041 to 2048) of the symmetric peripheral carrier zone (204a) have substantially similar thickness profiles. As disclosed herein, the second zone (205a) is configured with a luminance profile that varies azimuthally and meridionally along the geometric centre (206a), thereby providing a stop signal.

[0131] In this exemplary example, the base prescription of the optic zone (202a) of the contact lens embodiment (200a) is -3D spherical power to correct a -3D myopic eye, and the eccentric second zone (205a) is configured to introduce a regional conic of local blur at the eye’s retina with a +1.25D azimuthal and meridional varying power profile to increase luminosity. In some other examples of the present disclosure, the spherical power of the contact lens for correcting and managing myopic eyes can be between -0.5D to -12D, and the required incremental power in the eccentric second zone introducing a required regional conic of local blur at the myopic eye’s retina can be between 0.75D to 2.5D.

[0132] Except for the second zone, a substantial portion of the optic zone is configured with a base prescription; wherein the base prescription comprises a prescription to correct the central visual field refractive error of the contact lens wearer. The power profile in the optic nerve region within the eccentric second zone determines the size, location, position, and direction of the peripheral directional cues imposed on the peripheral retina.

[0133] By maintaining peripheral thickness profiles rotationally symmetric across all meridional sections, preferred eye rotation can be achieved. For example, as disclosed in PCT / AU2020 / 051006, the radial thickness profiles (e.g. 204a to 204h) can be configured to be substantially the same as any other radial cross-sectional thickness profile, or to allow a deviation of within 4%, 6%, 8% or 10% at any given distance from the lens centre.

[0134] In one example as disclosed in PCT / AU2020 / 051006, the radial thickness profile 204a is within 5%, 8% or 10% of the radial thickness profile 204e for any given distance from the lens centre. In another example, the radial thickness profile 204c is within 4%, 6% or 8% of the radial thickness profile 204g for any given distance from the lens centre.

[0135] In yet another example as disclosed in PCT / AU2020 / 051006, the radial thickness profile, e.g. 204a to 204h, can be configured to be within 4%, 6%, 8% or 10% of the average of all radial cross-sectional thickness profiles for any given distance from the lens centre.

[0136] To determine whether the manufactured radial thickness profile of the non-optical peripheral carrier zone (e.g. as disclosed in PCT / AU2020 / 051006 204a to 204h) conforms to its nominal profile, cross-sectional measurements of the azimuthal thickness can need to be adjusted to a maximum at a defined radial distance. In some other examples, the peak thickness measured in one radial cross-section can be compared to the peak thickness measured in another radial cross-section of the non-optical peripheral carrier zone.

[0137] In some embodiments, the difference in peak thickness between one or more radial cross-sections can be no more than 20 pm, 30 pm, 40 pm, 50 pm or 60 pm. In some embodiments, the difference in peak thickness between one or more vertical radial cross-sections can be no more than 20 pm, 30 pm, 40 pm, 50 pm or 60 pm.

[0138] Figure 2B A front view and a cross-sectional view of an example contact lens embodiment (200b) is shown not to scale. The front view of the example contact lens embodiment further shows an optical centre (201b), an optical zone (202b), a blending zone (203b), a peripheral carrier zone (204b) and a second zone (205b) within the optical zone (202b) having a geometric centre (206b).

[0139] In this example contact lens embodiment, the lens diameter is approximately 15 mm, and the distance correcting portion of the optical zone (202b) is rotationally symmetric along the optical axis. The second zone (205b) within the optical zone (202b) is circular, i.e. has a diameter of approximately 1.75 mm. The blending zone (203b) has a diameter of approximately 0.15 mm, and the peripheral carrier zone (204b) has a width of approximately 3 mm, which zone is configured with a rotational aid (2041b) comprising a substantially constant azimuthal thickness profile, or according to certain embodiments of the disclosure, a periodic profile with a defined period, to make the non-optical peripheral carrier zone easy or aid rotation of the contact lens. The rotational aid feature (2041b) can be configured to enhance the desired intraocular rotation about the lens optical centre. The second zone (205b) is configured with an azimuthal and meridional varying luminance profile along the geometric centre (206b) to provide a stop signal, as disclosed herein.

[0140] In this example example, the base prescription of the optical zone (202b) of the contact lens embodiment (200b) is -3D spherical power to correct a -3D myopic eye, and the eccentric second zone (205b) is configured with an azimuthal and meridional varying luminance profile of +1.5D to introduce a regional conic of local blur at the eye’s retina.

[0141] In the non-optical peripheral carrier region, the thickness profile of the manufactured lens is measured using perpendicular lines drawn from the tangent at each point on the rear surface of the contact lens to each point on the front surface of the contact lens. The thickness distribution measured at each point in the non-optical peripheral carrier region can also be plotted as a function of the azimuth angle defined at any radial distance within the non-optical peripheral carrier region to provide an azimuth thickness distribution.

[0142] In some examples, the azimuth thickness distribution can be measured or compared at any arbitrary radial distance within the non-optical peripheral carrier region. In other examples, the azimuth thickness morphology can be measured or compared by averaging measurements over an arbitrary radial distance range within the non-optical peripheral carrier region.

[0143] exist Figure 2B In some examples of variants, one or more azimuth thickness distributions around the optical axis, defined at arbitrary radial distances in the non-optical peripheral carrier region, are configured to be substantially constant. In this case, substantially constant means that the azimuth thickness distribution varies in peak-to-valley ranges between 5 μm and 50 μm, 10 μm and 40 μm, or 15 μm and 35 μm.

[0144] Figure 3A It shows Figure 2A The figure shows a front view of an exemplary contact lens embodiment. This figure attempts to further illustrate the influence of the lower (309a) and upper (308a) portions of the eyelid on the positioning (303a) of the optical zone (302a) of the contact lens of embodiment (300a), particularly the optical zone (302a) configured with an eccentric second region (305a) of brightness distribution with azimuth and meridional variations.

[0145] The natural blinking facilitated by the combined action of the upper eyelid (308a) and lower eyelid (309a) allows the contact lens (300a) to rotate freely on or around the optical center (301a). The orientation and position of the locally blurred cone applied within the eccentric second region (305a) of the optical region (302a), altered by blinking (essentially free rotation and / or eccentricity), result in temporally and spatially varying stimuli that reduce the rate of myopia progression in the wearer, with an effect largely consistent with temporal variation.

[0146] In some embodiments, for example, as referenced Figure 2A and 3BAs described, due to the substantially invariant azimuthal thickness profile within the non-optical peripheral carrier zone, as previously disclosed in PCT / AU2020 / 051006, the contact lens is designed to exhibit substantially free rotation at least under the influence of natural blinking action. For example, over the course of a day of lens wear, preferably in excess of 6 to 12 hours, the interaction of the eyelids will cause the contact lens to orient in a number of different orientations or configurations on the eye. Due to the azimuthal and meridional varying luminance profile configured within the eccentric second zone within the optical zone about the optical centre, the directional cues (i.e. the region of blur conoid) that control the rate of eye growth can be configured to vary spatially and temporally.

[0147] In some embodiments, the surface parameters, such as back surface radius and / or asphericity, of the contact lens embodiment can be tailored for a single eye such that the desired on-eye rotation of the contact lens can be achieved. For example, the contact lens can be configured to be at least 0.3 mm flatter than the radius of curvature of the corneal meridian at the flattest point of the eye to increase the rotational nature on the eye during wear.

[0148] It will be appreciated that in certain embodiments, the substantially free rotation of the contact lens embodiment of the present disclosure is merely a desired outcome of one aspect of the invention. However, in the event that the substantially free rotation achieved is less than the desired rotation, for example, less than 20 degrees of rotation within 1 hour of lens wear, and less than 360 degrees of rotation per day, the invention of the present disclosure is still capable of producing a stop signal that varies spatially and temporally merely by the random orientation of the lens, and controlled by the orientation of the contact lens at insertion.

[0149] In some embodiments, for example, as described with reference to Figure 2B and 3B the contact lens is designed to exhibit substantially free rotation at least under the influence of natural blinking action, or has a propensity to increase rotation due to rotation assisting features. For example, over the course of a day of lens wear, preferably in excess of 6 to 12 hours, the interaction of the eyelids will cause the contact lens to orient in a number of different orientations or configurations on the eye. This results in a light signal or stimulus that varies spatially and temporally, thereby reducing the rate of myopia progression of the myopic wearer. Wherein the benefits of the stimulus that varies spatially and temporally provide an ideal effect of controlling myopia that is substantially consistent over time.

[0150] As described, due to the azimuthal and meridional varying luminance profile configured within the eccentric second zone within the optical zone about the optical centre, in combination with the rotation assisting features in the non-optical peripheral carrier zone, the local conoid or partial blur spacing produced at the retinal level of the wearer of the contact lens can be configured to vary spatially and temporally, which can maximise the reduction in the decrease in the therapeutic effect as a function of time.

[0151] In some embodiments, the surface parameters of the contact lens embodiment, such as the back surface radius and / or the degree of asphericity, can be tailored for a single eye such that a desired on-eye rotation of the contact lens can be achieved. For example, the contact lens can be configured to be at least 0.1 mm, 0.2 mm, or 0.3 mm flatter than the radius of curvature of the flattest meridian of the cornea of the eye to further increase the rotational nature of the lens on the eye.

[0152] In Figure 2B and 3B In other examples or variations of the above, the azimuthal thickness profile of the non-optical peripheral carrier region can be configured using a sawtooth profile to assist in the rotation of the contact lens. For example, the number of teeth across the full 2p radians can be at least 6, at least 8, at least 10, at least 12, or at least 14. The number of teeth should be no less than 6 to avoid preferential orientation. In some examples, the amplitude of any single tooth in the selected tooth set can be selected to provide at least 10%, 20%, 30%, 40%, or 50% more rotation than a design configured with a substantially constant azimuthal thickness profile configured within the non-optical peripheral carrier region (i.e., examples or variations of the above). Figure 2A and 3A In some variations of the above, the azimuthal thickness profile of the non-optical peripheral carrier region can follow a sinusoidal profile or a quasi-sinusoidal profile. Figure 2B 3B For such profiles, the azimuthal thickness profile within the non-optical peripheral carrier region is non-uniform. Furthermore, the azimuthal thickness variation can also vary as a function of radial distance within the non-optical peripheral carrier region despite the rotation assisting features of the present disclosure. For example, towards the outer edge of the contact lens and towards the front optical zone diameter, the considered sawtooth pattern can be reduced to blend with a uniform edge thickness. In some other embodiments, the contact lens can be designed to have less than 20 degrees of rotation over 1 hour of lens wear, and less than 180 degrees of rotation per day. It will be appreciated that the contact lens can still be able to control the random positioning of the contact lens through the positioning of the contact lens upon insertion at any given day to produce a stop signal that varies over time and space.

[0153] An uncorrected -3D myopic model eye (400) is shown. When incoming light (401) of a visible wavelength (e.g., 555 nm) of 0D vergence is incident on the uncorrected myopic eye, the resultant image on the retina is symmetrically blurred due to defocus (402). This schematic represents an on-axis point analysis on the retinal plane.

[0154] Figure 4 An uncorrected -3D myopic model eye (400) is shown. When incoming light (401) of a visible wavelength (e.g., 555 nm) of 0D vergence is incident on the uncorrected myopic eye, the resultant image on the retina is symmetrically blurred due to defocus (402). This schematic represents an on-axis point analysis on the retinal plane.

[0155] ​Figure 5 shows the on-axis geometric spot analysis on the retinal plane when a -3D myopic model eye (500) is corrected with a single vision spherical contact lens configured with an eccentric second zone of astigmatism distribution as previously disclosed in PCT / AU2020 / 051006 (501). Figure 4 The schematic diagram of on-axis geometric spot analysis on the retinal plane when a -3D myopic model eye (500) is corrected with a single vision spherical contact lens configured with an eccentric second zone of astigmatism distribution as previously disclosed in PCT / AU2020 / 051006 (501). In this example, when incoming light (502) of visible wavelength (e.g. 555nm) with a vergence of 0D is incident on the corrected myopic eye, the resultant image on the retina has a sharp point from the symmetry of the lens single vision portion, and an elliptical blur pattern (503) from the eccentric astigmatic second zone.

[0156] Figure 6A shows the on-axis geometric spot analysis on the retinal plane when a -3D myopic model eye (600a) is corrected with a contact lens (602a) whose optical zone is configured with an eccentric second zone (603a) of astigmatism distribution as previously disclosed in PCT / AU2020 / 051006. Figure 4 The schematic diagram of on-axis geometric spot analysis on the retinal plane when a -3D myopic model eye (600a) is corrected with a contact lens (602a) whose optical zone is configured with an eccentric second zone (603a) of astigmatism distribution as previously disclosed in PCT / AU2020 / 051006. In this example, when incoming light (601a) of visible wavelength (e.g. 589nm) with a vergence of 0D is incident on the myopic eye (600a) through the contact lens (602a), the resultant through-focus image morphology, including the series of geometric point distributions depicted from 606a to 610a. The astigmatism or toricity power distribution configured within the eccentric second zone (603a) of the optical zone (602a) results in the appearance of Sturm’s (606a) local conic or interval substantially in front of the retina within the through-focus image morphology (606a to 608a).

[0157] As can be seen in Figure 6A The local conic or Sturm’s (605a) interval around the retinal plane formed by the eccentric second zone (603a) within the contact lens optical zone (602a) can be observed by examining the through-focus plots (606a, 607a and 608a). Each of the three (3) point plots spreads light or optical energy over a central region of approximately 200pm of the retina (606a, 607a and 608a). In each through-focus plot, there is at least one distinct region that forms a minimum spread of rays or optical energy that can be seen as an ellipse, which contains Sturm’s conic or interval (605a). The size of the three through-focus point plots of minimum confusion circle (612a) and sagittal blur pattern (613a) around the tangential plane (611a) gradually decreases as they approach the retina.

[0158] Figure 6B shows the on-axis geometric spot analysis on the retinal plane when a -3D myopic model eye (600a) is corrected with a contact lens (602a) whose optical zone is configured with an eccentric second zone (603a) of astigmatism distribution as previously disclosed in PCT / AU2020 / 051006. Figure 4A schematic of the on-axis through-focus point geometry analysis around the retinal plane when an exemplary contact lens embodiment (602b) is corrected for a -3D myopic model eye (600b) configured with azimuthally and meridionally varying luminance profiles within the eccentric second zone (603b) of the optic zone of the exemplary embodiment (602b). In this example, when incoming light (601b) of visible wavelengths (e.g., 589 nm) with a luminance of 0 D is incident on the myopic eye (600b) through the exemplary contact lens embodiment (602b), the resulting through-focus image morphology, including the series of geometric point profiles depicted from 606b to 610b. The azimuthal and meridional variation of luminance profiles configured within the eccentric second zone (603b) of the optic zone (602b) results in the appearance of local conic or interval (606b) of blur within the through-focus image morphology (606b to 608b) that essentially forms in front of the retina.

[0159] As can be seen in Figure 6B The local conic or Sturm (605b) interval around the retinal plane formed by the exemplary contact lens optic zone (602b) within the eccentric second zone (603b) can be observed by examining the through-focus maps (606b, 607b, and 608b). Each of the three (3) point maps spreads light or optical energy over a central region of approximately 200 pm of the retina (606b, 607b, and 608b). In each through-focus map, at least one distinct region forms a minimum spread of rays or optical energy that can be seen as an irregular blur pattern that contains a conic or interval (605b). The size of the three through-focus point maps around the tangent plane (611b), the minimum confusion circle (612b), and the sagittal irregular blur pattern (613b) gradually decreases as they approach the retina.

[0160] The through-focus image morphology in front of the retina (606b to 608b) contains the tangential irregular blur pattern (611b), the minimum confusion circle (612b), and the sagittal irregular blur pattern (613b), which are sub-regions of the series of geometric spot profiles depicted in the central foveal or parafoveal regions. As seen in its magnified version (613b), the resulting image (604b) on the foveal region is depicted as a minimum irregular blur pattern. It can be seen that the portion of the through-focus image morphology formed behind the retina (609b and 610b) is not in focus.

[0161] In this example, the contact lens embodiment (602b) has a second region (603b) of partial conic or partial blur spacing (605b) configured on or in front of the retinal plane. However, in other example embodiments, the partial blur region spacing can be configured in such a way as to be entirely in front of the retina, on or around the retinal plane, or entirely behind the retina. In some embodiments, the partial blur region conic or spacing can be at least 0.3, 0.4, 0.5, 0.6, or 0.75 mm in depth.

[0162] In other embodiments, the region conic or partial blur spacing can be configured to be at least 1 D, 1.25 D, 1.5 D, 1.75 D, or at least 2 D. In some embodiments, the region conic or partial blur spacing can be configured to be in front of or behind the retina. Furthermore, due to the rotational assist features and / or the substantially constant azimuthal thickness profile configured in the peripheral carrier region, the orientation and position of the regional conic of partial blur (stop signal) imparted on the retina substantially changes over time due to the rotation and decentration of the contact lens. As a result, the stop signal varies temporally and spatially due to the rotation and decentration of the contact lens.

[0163] In some examples, the partial blur region conic is configured to be further away from the foveal edge, fovea, macular edge, macular region, or perimacular region. In some examples, the partial blur region conic can be configured on the retina with a wider field of view angle, such as at least 5 degrees, at least 10 degrees, at least 20 degrees, or at least 30 degrees.

[0164] The specific structural and functional details disclosed in these figures and examples should not be construed as limiting, but merely as representative of the embodiments disclosed as a representative basis for a skilled artisan to employ the disclosed embodiments in a variety of other variations.

[0165] For illustrative purposes, a schematic model eye (Table 1) was chosen in Figure 4 to Figure 6B However, in other example embodiments, a schematic ray tracing model eye such as Liou-Brennan, Escudero-Navarro, etc. can be used instead of the simple model eye described above. The parameters of the cornea, lens, retina, ocular media, or combinations thereof can also be changed to assist in further simulation of the embodiments disclosed herein.

[0166] The examples provided herein have disclosed the present invention using a -3 D myopic model eye, however, the same disclosure can be extended to other myopic degrees, such as -1 D, -2 D, -5 D, or -6 D. Furthermore, it should be appreciated that a skilled artisan can extend the astigmatism variation of a myopic eye with astigmatism up to 1 DC.

[0167] In example embodiments, reference is made to a specific wavelength of 555 nm, but it will be appreciated that the skilled person can extend the range to other visible wavelengths between 420 nm and 760 nm. Certain embodiments of the disclosure are directed to contact lenses that emit a stop signal to progressive myopic eyes that varies in time and in space, in other words substantially varies over time at the retinal location, which is achieved by means of a natural eye-up rotation. The contact lens is decentered due to the natural blinking action. This stop signal that varies in time and in space can minimize the implicit saturation effect of the effectiveness observed in the prior art.

[0168] Certain embodiments of the disclosure are directed to a contact lens that can provide a stop signal to progressive myopic eyes that varies in space and time, no matter in which orientation the wearer wears or puts in the contact lens. In some embodiments of the disclosure, the stop signal in the decentered second region of the optical zone can be configured along an azimuthal and meridional varying luminance profile of the geometric center of said second region.

[0169] Figure 6C A schematic representation of a magnified portion of a second region (602cb) within the optical zone of one of the contact lens embodiments (600c) is shown, which is defined with an azimuthal and meridional varying luminance profile as disclosed herein. As mentioned within the disclosure, the distance between the optical center (601c) and the geometric center of the second region (602c) is the decentering amount (603c). Furthermore, the azimuthal and meridional varying luminance profile of the second region can be described with the following variables: a radial coordinate (604c), an azimuthal angle Θ(θ) (605c) and a semi-diameter (606c).

[0170] Table 1 distinguishes between the designs I and II of the present disclosure and the designs of the in-vivo second astigmatic region within the optic zone of the contact lens previously disclosed in PCT / AU2020 / 051006. The abbreviations VAR and SYM in Table 1 stand for variance and symmetry, respectively. As can be seen from the table, the two distinguishing components that separate the disclosed designs from the previously disclosed designs depend largely on the meridional and azimuthal variation characteristics of the luminance profile in the in-vivo second region. While the previously disclosed contact lens (PCT / AU2020 / 051006) features an astigmatic or toric second region within the optic zone with a luminance profile that varies in azimuth but not in meridian, the designs of the second region of the present disclosure are all configured with one or more meridional and azimuthal varying luminance profiles, wherein at least one of the meridional and azimuthal varying luminance profiles lacks mirror symmetry. The examples provided in this specification have disclosed the present invention using model eyes with -1 DS and -3 DS of myopia. The same disclosure can be extended to other myopia powers, for example, -2 DS, -4 DS or -6 DS of myopia. In example embodiments, reference is made to a specific monochromatic wavelength of 589 nm. In other examples, the designer of the contact lens can extend the range to other visible wavelengths between 420 nm and 760 nm.

[0171]

[0172] Table 1: Luminance description of the second region for different contact lens designs.

[0173] Certain embodiments of the present disclosure are directed to a contact lens that can provide a stop signal to a progressive myopia eye that varies in time and space, in other words, substantially varies in time and substantially varies in position on the retina, by rotating naturally on the eye due to the natural blinking action of the eye. Such prior art lenses can be observed to minimize saturation of the implicit effect and / or minimize the reduction of the stop signal.

[0174] Certain embodiments of the present disclosure are directed to a contact lens that can provide a stop signal to a progressive myopia eye that varies in time and space, in other words, substantially varies in time and substantially varies in position on the retina, by rotating naturally on the eye due to the natural blinking action of the eye. Such prior art lenses can be observed to minimize saturation of the implicit effect and / or minimize the reduction of the stop signal.

[0175] In some other embodiments, a substantially radially invariant luminance profile can be used to configure the meridional and azimuthal varying luminance profiles. In certain embodiments of the disclosure, the meridional and azimuthal varying luminance profiles within the second region of the optical zone of the contact lens can be configured using a radially varying luminance profile across substantially the entire second region of the optical zone and an azimuthal varying feature across a selected portion of the second region of the optical zone, while the remaining portion of the selected region is configured with an azimuthally invariant luminance profile.

[0176] In some embodiments, the intended or selected portion area of the azimuthal varying feature can be 25%, 30%, 35%, 40%, 45% or 50% of the total area of the second region of the optical zone thereon. In some other embodiments, the intended or selected portion area of the azimuthal varying feature can be between 20% to 30%, 30% to 50%, 15% to 45% of the total area of the second region of the optical zone of the contact lens.

[0177] In certain embodiments of the disclosure, the meridional and azimuthal varying luminance profiles within the second region of the optical zone of the contact lens can be configured using a radially varying luminance profile across substantially the entire second region of the optical zone; wherein the variation in the radial dimension is configured such that the luminance increases or decreases from the geometric centre of the second region of the optical zone to the edge of the second region of the optical zone, and the variation in the azimuthal dimension is configured such that the luminance decreases from 0 radian to 2p radian.

[0178] In some contact lens embodiments of the disclosure, a linear, curvilinear or quadratic function can be used to describe the decrease in luminance profile along the radial direction. In certain other embodiments of the disclosure, the decrease in luminance profile along the radial direction within the second region of the optical zone can be different for different azimuthal positions within the second region of the optical zone.

[0179] In other embodiments, the decrease in luminance profile along the azimuthal direction within the second region of the optical zone can follow a cosine profile with decreasing frequency, for example, in some embodiments, one sixth (1 / 6), one fifth (1 / 5), one fourth (1 / 4), one third (1 / 3) or one half (1 / 2) of the normal frequency expected in a toric or multifocal lens as previously disclosed in PCT / AU2020 / 051006. The decrease in luminance profile along the azimuthal direction within the second region of the optical zone can be observed or seen in Figures 7B and 8. Figure 7A The term “normal frequency” expected in a toric or multifocal luminance profile of the second region within the optical zone can be observed or seen in Figures 7B and 8.

[0180] In other embodiments of the disclosure, the decrease in luminance profile along the azimuthal direction can be different for different radial locations within the second region of the optical zone. In yet another embodiment of the disclosure, the decrease in luminance profile along the azimuthal direction can be the same for substantially all radial locations within the second region of the optical zone.

[0181] In certain embodiments, the meridional and azimuthal varying luminance profile within the second region of the optical zone can be configured as a sum of luminance profiles, i.e., a base sphere plus a sum of the product of a radial or meridional and azimuthal luminance profile function. In some embodiments, the luminance profile function within the second region of the optical zone can be radially invariant but meridionally and azimuthally varying. In some embodiments, the luminance profile within the second region of the optical zone is varying in meridional and azimuthal and further configured to be invariant in radial. In some other embodiments, the luminance profile function within the second region of the contact lens optical zone can be radially and azimuthally invariant over approximately 10%, 20%, 30%, 40% or 50% area of the second zone of the lens and azimuthally varying over the rest of the second region.

[0182] In certain embodiments of the contact lens, the primary portion of the optical zone provides substantial central foveal correction for myopic eyes and the eccentric second region within the optical zone provides at least partially a regional conic or a partially blurred region that acts as an orientation cue to reduce the rate of myopia progression; the contact lens is further configured to provide a spatially and temporally varying stop signal with a reduced rate of myopia progression that is substantially uniform over time. In certain other embodiments, the optical stop signal configured using the eccentric second region in the optical zone provides a regional conic or a partially blurred interval on the retina or the surrounding retina; wherein the depth of the regional conic or the partially blurred interval is at least 0.5D, 0.75D, ID, 1.25D, 1.5D, 1.75D or 2D.

[0183] In certain other embodiments, the optical stop signal configured using the eccentric second region in the optical zone that is rotationally asymmetric about the optical axis or the optical center provides a regional conic or a partially blurred interval on the retina or the surrounding retina; wherein the depth of the local conic or the partially blurred interval is in the range of 0.5D and 1.25D, 0.75D and 1.25D, 0.5D and 1.5D, ID and 1.75D or 1.5D and 2D.

[0184] In certain other embodiments, the second region can be defined to have an azimuthal and meridional varying luminance profile defined about a geometric center of the second region; wherein the azimuthal and meridional varying luminance profile of the second region is different from the base prescription of the contact lens.

[0185] In certain other embodiments, the optical stop signal configured by the second zone within the optical zone is rotationally asymmetric about the optical axis or optical center, thereby providing a regional conoid or partial blur interval on or around the retina; wherein the depth of the local conoid or partial blur interval is in the range between -0.5 DC and +1.25 DC, -0.75 DC and +1.25 DC, -0.5 DC and +1.5 DC, -0.75 DC and +0.75 DC, or -1 DC and +1 DC.

[0186] In other embodiments of the present disclosure, the stop signal configured by the second zone within the optical zone can use only the luminance profile varying along the azimuth and the meridian.

[0187] An schematic model eye was used to simulate the optical performance results of the presently disclosed exemplary embodiments (Figures 7 to Figure 16 ) The prescription parameters of the schematic model eye used for optical modeling and performance simulation are listed in Table 2. The prescription provides a -3D myopic eye defined for a monochromatic wavelength of 589 nm.

[0188]

[0189] Table 3: Prescription of the schematic model eye providing a -3D myopic model eye.

[0190] The prescription described in Table 2 should not be interpreted as the necessary method to prove the effect of the contemplated exemplary embodiments.

[0191] This is only one of the many methods that a person skilled in the art can use for optical simulation purposes. To prove the effect of other embodiments, other schematic model eyes such as Atchison, Escudero-Navarro, Liou-Brennan, Polans, Goncharov-Dainty can be used instead of the above-mentioned schematic model eyes.

[0192] It is described herein that a person skilled in the art can also vary the individual parameters of the model eye; for example, cornea, lens, retina, media or a combination thereof to help better simulate the effect. The parameters of the model contact lens exemplary embodiments only simulate the performance effect of the optical zone.

[0193] To express the performance change as a function of time, a surface tilt function has been used to mimic the rotation that occurs physiologically in vivo. To simulate the optical performance results, the exemplary embodiments were rotated 0°, 120° and 240° for point spread function and through focus geometric spot analysis.

[0194] Figure 7A ​A two-dimensional power map (in D) of a contact lens on an optical zone diameter (700a) of 8mm is shown as previously disclosed in PCT / AU2020 / 051006. As disclosed in PCT / AU2020 / 051006, the optical zone (700a) of the contact lens is intended to be grafted onto a substantially rotationally symmetrical non-optical peripheral carrier zone. The contact lens has a spherical power of -3DS in the optical zone (700a) to correct a -3DS myopic eye, and a toric or astigmatic power profile in the second zone (702a) of the optical zone (700a) defined by two main meridional powers (not to scale).

[0195] In Figure 7A the second zone, one main power meridian (-3DS) of the second zone is perpendicular to the optical center (701a) of the optical zone (700a), and a second main power meridian (-1.25DS) of the second zone is configured to be parallel to the optical center (701a) of the optical zone (700a).

[0196] As previously disclosed in PCT / AU2020 / 051006, the difference in the main power meridian (+1.25DC) is the astigmatic power of the second zone (702a) for imposing a stop signal. The second zone (702a) within the optical zone (700a) has a diameter of 1.5mm x 1.75mm, and its geometric center (703a) is decentered by 1.25mm with respect to the optical center (701a) of the optical zone (700a). The blending width is 0.1mm. However, this contact lens example is not meant to be interpreted as limiting the scope of the present disclosure.

[0197] Figure 7B A power map profile (700b) of the second zone (702a) within the optical zone (700a) of a contact lens is shown as previously disclosed in PCT / AU2020 / 051006, and the power varies along an azimuthal angle (705b) and along a meridian (706b) in the power map. Figure 7B The corresponding power curves of the four representative sample meridians 0°, 45°, 90° and 135° (707b) are also shown in relation to the second zone diameter, and the corresponding power curves of the four representative sample meridians in relation to the azimuthal angle positions R1, R2, R3 and R4 (708b) are 0.15, 0.3, 0.45 and 0.6 millimeters in radial distance, respectively.

[0198] The second zone (702a) of the optical zone (700a) of the contact lens is configured using a standard sphero-cylindrical power profile where one principle meridian (vertical meridian 90°) has a power of approximately -3.00D and the other principle meridian (horizontal meridian, 0°) has a power of approximately -1.25D and the oblique meridians 45° and 135° have a power of approximately -2.12D. The difference between the two principle meridians in this example embodiment is a cylinder of 1.75 DC. The power profile of the toric or astigmatic second zone is symmetric in that it has a power profile that is invariant along the radial and meridional directions that follows a cosine function of normal frequency which results in an azimuthally varying power profile cosine period that exceeds 360° with two axes of mirror symmetry (i.e., two axes). In Figure 7B The term "normal frequency" can be observed or seen in the second zone with a toric or astigmatic power profile in

[0199] Figure 8 Geometric spot analysis through focus and the corresponding on-axis point spread functions (804) are shown for the -3D myopic model eye of Table 1 when corrected with the contact lenses described in Figure 7A and 7B Geometric spot analysis through focus and the corresponding on-axis point spread functions (804) are shown for the -3D myopic model eye of Table 1 when corrected with the contact lenses described in

[0200] On-eye rotation of the contact lens embodiment over time results in three configurations that provide signals over time and space on the retina. In this example, the three configurations represent test cases where the principle power meridian of the contact lens is at 0°, 120° and 240° azimuthal positions as the contact lens rotates over time. In this example, each contact lens configuration is described in rows and the configuration of the astigmatic or toric power profile within the second zone of the optical zone results in a zone conic or Sturm (801, 802, 803) interval that is essentially formed in the pre-retinal portion of the through focus image morphology, parafovea, or perimacular region.

[0201] As can be seen in Figure 8 By examining the defocused spot diagram with scatter, it can be observed that the contact lens with the Figure 7BThe Sturm's region conic or interval of the retinal plane formed by the second region within the optical zone of the optic is eccentric. The light rays or light energy spread out at about 120 pm from the centre of the retina. In the through-focus map, there is a distinct region where the minimum light rays or light energy spread out, which contains the elliptical blur pattern of the conic or interval of Sturm (801 and 803). As previously described in PCT / AU2020 / 051006, the direction of the elliptical blur pattern (801 and 803) and the corresponding point spread function (804) varies with the direction of the contact lens on the eye, thereby providing directional cues to the eye that vary with time and space.

[0202] Figure 9A A two-dimensional power map (in D) of a contact lens embodiment of the present disclosure is shown over an 8 mm optical zone diameter (900a). The optical zone (900a) of the contact lens is intended to be grafted onto a non-optical peripheral carrier zone with rotational assist functionality. The contact lens has a spherical power of -3 DS in the optical zone (900a) to correct a -3 DS myopic eye, and a power distribution that varies along the azimuth and meridian in a second region (902a) within the optical zone (900a). The second region (902a) within the optical zone (900a) has a diameter of 1.5 mm, and its geometric centre (903a) is eccentric to the optical centre (901a) of the optical zone (900a) by 1.25 mm. The blending width is 0.1 mm. However, this contact lens example is not meant to be interpreted as limiting the scope of the present disclosure.

[0203] Figure 9B The power map distribution (900b) of the second region (902a) is shown, which includes a power distribution (hemisphere region) that varies along the azimuth and meridian, and along one azimuth (905b) and one meridian (906b distribution within the power map). Figure 9B The radial distance of the corresponding power curves of the four representative sample meridians 0°, 45°, 90° and 135° (907b) from the second region diameter, and the radial distance of the corresponding power curves of the four representative sample meridians from the azimuthal position R1, R2, R3 and R4 (908b) are 0.15, 0.3, 0.45 and 0.6 mm, respectively.

[0204] The second zone (902a) of the optical zone (900a) of the contact lens is configured with a substantially radially invariant, meridional and azimuthal varying, luminance profile (luminance: -3 DS / +1.75 D, semi- zone), where the flattest semi-meridional has a power of about -1.25 DS, the steepest semi-meridional has a power of about -3.00 DS, and the oblique meridional has a power of about -2.12 DS at 45° and 135°. The difference between the flattest and steepest semi-meridional is the delta power, which in this example embodiment is 1.75 D.

[0205] Figure 10 It is shown that when the contact lens of Figure 9A and 9B is configured to correct the -3 D myopic model eye of Table 2, the through-focus geometric spot analysis and corresponding on-axis point spread functions (1004) are provided. In this example, the through-focus geometric spot analysis was performed at the following locations: pre-retinal -0.5 mm and -0.25 mm, on the retina, and post-retinal +0.25 mm and +0.5 mm.

[0206] The on-eye rotation of the contact lens embodiment over time results in three configurations that provide a signal that varies over time and space on the retina. In this example, the three configurations represent test cases where the power -1.25 DS meridional line is located at 0°, 120°, and 240° azimuthal locations as the contact lens rotates over time. In this example, described in rows, the luminance profile of the azimuthal and meridional power variation configured within the second zone of the optical zone (i.e., cosine-variation I zone) of each contact lens configuration results in a zone conic or partial blur interval (1001, 1002, 1003) that is formed substantially within the through-focus image morphology, around the fovea, or pre-retinal to the macula.

[0207] As can be seen in Figure 10 , the through-focus spot pattern with the following characteristics can be observed by examining the through-focus spot pattern: Figure 9Ba local conic or partial blur around the retinal plane. Diffusion of scattered light rays or optical energy at about 120 pm from the center of the retina. In the full focus map, there is a distinct region formed with minimal light ray or optical energy spread, which contains an irregular blur pattern or partial blur interval of the foveal surface (1001 and 1003). The direction of the irregular blur pattern (1001 and 1003) and the corresponding point spread function (1004) changes with the direction of the contact lens on the eye, thereby providing directional cues to the eye that vary with time and space. The area around the graft of the second region off-center on the optical zone can be smoothed to minimize any optical jumps in luminance and to minimize any visual performance degradation due to significant changes in luminance due to sudden changes in surface curvature at the junctions of the graft of the second region. In some examples, the blending of the second region off-center with the rest of the optical zone can be achieved by turning the lathe to rotate at a desired or optimal speed while the lens is being manufactured. In some other example embodiments, the blending of the second region off-center with the optic zone can not be the desired outcome.

[0208] Figure 11A A two-dimensional power map (in D) of a contact lens embodiment of the present disclosure is shown on an optical zone diameter of 8 mm (1100a). The optical zone of the contact lens (1100a) is intended to be grafted onto a non-optical peripheral carrier zone with or without rotational assist features. The contact lens has a spherical power of -1 DS in the optical zone (1100a) to correct a -1 DS myopic eye and a luminance profile that varies along the azimuth and meridian in a second region (1102a) within the optical zone (1100a). The second region (1102a) within the optical zone (1100a) has a diameter of 1.75 mm and its geometric center (1103a) is off-center by 1 mm relative to the optical center (1101a) of the optical zone (1100a). The blending width is 0.05 mm.

[0209] Figure 11B A luminance profile map (1100b) of the second region (1102a) is shown, which includes an azimuth and meridian varying luminance profile (cosine- variable star I region) and the luminance varies along one azimuth (1105b) and along one meridian (1106b) in the luminance map. Figure 11BThe corresponding luminance profiles of the four representative sample meridians 0°, 45°, 90° and 135° (1107b) as a function of the second zone diameter, and the corresponding luminance profiles of the four representative sample meridians as a function of azimuthal position R1, R2, R3 and R4 (1108b) at radial distances of 0.15, 0.3, 0.45 and 0.6 mm, respectively, are also shown. The second zone (1102a) of the optical zone (1100a) of the contact lens is configured to have a substantially radially invariant, meridional and azimuthal luminance profile (luminance: -1 DS / +1.25 D, cosine-variant Zone I). As can be seen from 1107b and 1108b, the luminance profile in the region defined by 0° to 180° azimuthal angle is approximately between -0.4 D, -0.7 D and -1 D for the range of 0°, 45° / 135° and 90° meridians, respectively. In the region defined by 180° to 360° azimuthal angle, the luminance varies between approximately -0.4 D, 0 D and +0.2 D for the range of 0°, 45° / 135° and 90° meridians, respectively, resulting in a luminance difference of approximately 1.2 D, respectively.

[0210] In some other embodiments, the azimuthal varying luminance profile of the second zone can be configured such that it resembles a sawtooth or triangular morphology. That is, the azimuthal luminance variation at an arbitrary radial distance from the geometric center of the second zone will have a linear increase in luminance as a function of azimuthal angle until a peak or a desired or threshold value is reached, and then linearly return to the starting phase.

[0211] Figure 12 Full focus geometric spot analysis and corresponding on-axis point spread functions (1204) are shown when the contact lens described in Figure 11A and 11B Example 2 is described in correcting a -1 D myopic model eye. In this example, the geometric spot analysis through focus was performed at the following locations: pre-retinal -0.4 mm and -0.2 mm, on the retina and post-retinal +0.2 mm and +0.4 mm.

[0212] The on-eye rotation of the contact lens embodiment over time results in three configurations that provide a spatially and temporally varying signal on the retina. In this example, the three configurations represent test cases in which the semi-meridional line of -0.4 DS of semi-meridional power is located at 0°, 120° and 240° azimuthal positions over time as the contact lens rotates. In this example, for each contact lens configuration depicted as a row, the azimuthally and meridionally varying luminance profile (i.e., cosine-variant Zone I) configured within the second zone of the optical zone results in a zonally conical or partial blur interval (1201, 1202, 1203) in front of the retina within the full focus image morphology in the foveal or macular edge region.

[0213] As in Figure 12 As can be seen in the diagram, one can observe the effect of examining the point map passing through the focal point. Figure 11B An off-center second region within the optical region forms locally conical or partially blurred intervals around the retinal plane. This diffuses light or energy at approximately 100 μm from the center of the retina. In the total focal map, there exists a distinct region formed with minimal ray or energy dispersion, containing irregularly blurred patterns of cones or partially blurred intervals (1201 and 1203). The orientation of the irregular blurred patterns (1201 and 1203) and the corresponding point spread function (1204) vary with the orientation of the contact lens on the eye, thus providing the eye with temporal and spatial directional cues.

[0214] Figure 13A A two-dimensional refractive power map (denoted by D) of an 8 mm optical region diameter (1300a) of the contact lens embodiment of this disclosure is shown. The optical region (1300a) of the contact lens is disposed on a non-optical peripheral carrier region with rotational assistance. The corneal contact lens has a spherical power of -3DS in the optical region (1300a) to correct -3DS myopia (Table 2), and has a refractive power distribution varying along azimuth and longitude in a second region (1302a) within the optical region (1302a). The diameter of the second region (1302a) within the optical region (1300a) is 1.75 mm, and its geometric center (1303a) is 1.25 mm off-center from the optical center (1301a) of the optical region (1300a). The blending width is 0.075 mm.

[0215] Figure 13B The brightness distribution (1300b) of the second region (1302a) is shown, which includes brightness distributions that vary along azimuth and meridian (cosine-variable star II region), and brightness varies along an azimuth (1305b) and along a meridian (1306b) in the brightness diagram. Figure 13BThe corresponding luminance profiles of the four representative sample meridians 0°, 45°, 90° and 135° (1307b) versus the second zone diameter, and the corresponding luminance profiles of the four representative sample meridians versus the azimuthal position R1, R2, R3 and R4 (1308b) at radial distances of 0.15, 0.3, 0.45 and 0.6 mm, respectively, are also shown. The second zone (1302a) of the optical zone (1300a) of the contact lens is configured with a substantially radially invariant, meridional and azimuthal varying power profile (Luminance: -3DS / +1.75D, Cosine-variant Zone II). As can be seen from 1307b and 1308b, the luminance profile in the region defined by the 0° to 180° azimuthal position varies between approximately -2.12D, -2.6D and -3D for the 0°, 45° / 135° and 90° meridians, respectively. In the region defined by the 180° to 360° azimuthal position, the luminance for the 0°, 45° / 135° and 90° meridians varies between approximately -2.12D, -1.7D and -1.25D, respectively, resulting in a luminance difference of approximately 1.75D.

[0216] Figure 14 The on-axis point spread function (PSF) analysis and corresponding on-axis point spread function (1404) is shown for the contact lens described in Figure 13A and 13B correcting a -3D myopic model eye. In this example, the through-focus geometric spot analysis was performed at the following locations: pre-retinal -0.5 mm and -0.25 mm, on the retina and post-retinal +0.25 mm and +0.5 mm.

[0217] The on-axis point spread function (PSF) analysis and corresponding on-axis point spread function (1404) is shown for the contact lens described in Figure 13A and 13B correcting a -3D myopic model eye. In this example, the through-focus geometric spot analysis was performed at the following locations: pre-retinal -0.5 mm and -0.25 mm, on the retina and post-retinal +0.25 mm and +0.5 mm.

[0218] As in Figure 14As can be seen, the spread of light rays or optical energy at about 140 pm from the center of the retina can form different areas of minimal light ray or optical energy spread in the through-focus map, including irregularly blurred patterns or partially blurred intervals of the cone (1401 and 1403) by the spread of light rays or optical energy. The direction of the irregularly blurred patterns (1401 and 1403) and the corresponding point spread function (1404) vary with the direction of the contact lens on the eye, thereby providing the eye with directional cues that vary in time and space.

[0219] Figure 15A A two-dimensional power map (in D) of a contact lens embodiment of the present disclosure is shown over an optical zone diameter of 8 mm (1500a). The optical zone of the contact lens (1500a) is configured onto a non-optical peripheral carrier zone with rotational auxiliary functionality. The contact lens has a spherical power of -3 DS in the optical zone (1500a) to correct a -3 DS myopic eye (Table 2), and a luminance profile in the second zone (1502a) within the optical zone (1500a) that varies along the azimuth, meridian, and radial directions. The second zone (1502a) within the optical zone (1500a) has a diameter of 1.75 mm, and its geometric center (1503a) is decentered by 1.25 mm from the optical center (1501a) of the optical zone (1500a). The blending width is 0.075 mm.

[0220] Figure 15B A luminance profile of the second zone (1502a) is shown (1500b), which includes a luminance profile that varies along the azimuth, meridian, and radial directions (cosine- Varin III zone), and the luminance is along one azimuth (1505b) and along one meridian line in the luminance map (1506b). Figure 15BThe corresponding luminance profiles of the four representative sample meridians 0°, 45°, 90° and 135° (1507b) versus the second zone diameter, and the radial distance of the corresponding luminance profiles of the four representative sample meridians from the position R1, R2, R3 and R4 (1508b) are also shown, which are 0.15, 0.3, 0.45 and 0.6 mm, respectively. The second zone (1502a) of the optical zone (1500a) of the contact lens is configured to have a generally radially variable meridional and azimuthal luminance profile (luminance: -3DS / +1.25D, cosine-variant III zone). As can be seen from 1507b and 1508b, the luminance profile varies between -2.4 to -2.6D, -2.7 to -3.2D and -2.8 to -3.25D at the 0°, 45° / 135° and 90° meridians, respectively, in the zone defined by the 0° to 180° azimuthal angle. And in the zone defined by the 180° to 360° azimuthal angle, the luminance varies between -2.7 to -2.4D, -2.2 to -2.1D and -2 to -1.9D at the 0°, 45° / 135° and 90° meridians, respectively, resulting in a luminance difference of about 1.25D.

[0221] Figure 16 Full focus point analysis and corresponding on-axis point spread functions (1604) are shown for the contact lens described in Figure 15A and 15B correcting a -3D myopic model eye. In this example, the through-focus point analysis was performed at the following locations: pre-retinal -0.4 mm and -0.2 mm, on the retina and post-retinal +0.2 mm and +0.4 mm.

[0222] On-eye rotation of the contact lens embodiment over time results in three configurations that provide a spatially and temporally varying signal on the retina. In this example, the three configurations represent test cases in which the meridians of the contact lens are positioned at 0°, 120° and 240° azimuthal locations with a luminance of -3DS as the contact lens rotates over time. In this example, for each contact lens configuration configured as a row, the azimuthally, meridionally and azimuthally varying luminance profile (i.e. cosine-variant III zone) configured within the second zone of the optical zone results in a zone conic or partial focus blur in the near-foveal or macular edge region (1601, 1602, 1603) substantially in front of the retinal through-focus point image morphology.

[0223] As can be seen in Figure 16 , the point spread by the contact lens can be observed by the point spread through the focus (1605a, 1605b, 1605c). Figure 15Ba second region of decentration within the optical zone of the contact lens forms a local conic or partial blur around the retinal plane. Diffusion of light rays or light energy at about 120 μm from the center of the retina. In the full focus map, there is a distinct region formed with minimal light ray or light energy spread, which contains an irregularly blurred pattern of cones or partial blur intervals (1501 and 1503). The direction of the irregularly blurred pattern (1501 and 1503) and the corresponding point spread function (1504) changes with the orientation of the contact lens on the eye, thereby providing directional cues to the eye that vary with time and space.

[0224] Figure 17 The thickness profile along the four sample radial distances 4.5 mm, 5.25 mm, 5.75 mm, and 6.25 mm in the non-optical peripheral region is shown as a function of the azimuthal angle of the contact lens described in Figure 2A and 3A It can be seen from Figure 17 that the thickness of the contact lens is essentially a function of the azimuthal angle, with a peak-to-valley of less than 5 μm, independent of the radial distance. Furthermore, the maximum thickness difference between different radii is about 0.04 mm.

[0225] Figure 18 The thickness as a function of the azimuthal angle along the periphery carrier region of the left contact lens at an average radial distance of about 5 mm is shown for the exemplary contact lens described in Figure 2B and 3B The contact lens on the eye is assisted to rotate in a counter-clockwise direction (i.e., under the nasal wing). The thickness of the peripheral lens varies in the form of a sawtooth pattern, which has a total of about 6 teeth, and the amplitude of each sawtooth is about 0.04 mm, i.e., the thickness varies between about 0.14 mm and 0.18 mm. The number of teeth can be increased by up to 20 to minimize potential discomfort. In some embodiments, a sharp connection between the sawtooth pattern and the optical region on the inner side and the edge on the outer side can also be mixed.

[0226] In some other examples of the present disclosure, the preferred embodiments of the sawtooth pattern can be configured such that the angle of the sawtooth can be optimized and configured, taking into account the differences between the right and left eyes. The interaction of the eyelids when wearing the contact lens can generate forces on the lens, which can be in different directions for the right and left eyes. In some examples, the preferred embodiments include a rotation assistance feature that is complementary to and does not counteract the natural rotation direction.

[0227] Figure 19 The thickness profile along the four sample radial distances 4.5 mm, 5.25 mm, 5.75 mm, and 6.25 mm in the non-optical peripheral region is shown as a function of the azimuthal angle of the contact lens described in Figure 2B and 3BThe exemplary contact lens described in the middle, at an average radial distance of about 5.5 mm, the thickness varies as a function of the azimuth angle along the peripheral carrier region of the other left contact lens, assists the contact lens on the eye to rotate in a counter-clockwise direction (i.e., under the nasal wing). The thickness of the peripheral lens varies in the form of a sawtooth pattern having a total of about 12 teeth, and wherein the amplitude of each sawtooth is about 0.02 mm, i.e., the thickness varies between about 0.2 mm and 0.18 mm.

[0228] Natural blinking facilitated by the combined action of the upper and lower eyelids, as Figure 18 and 19 The peripheral thickness pattern shown can account for rotation on or around the optical center of the contact lens.

[0229] In certain embodiments, the second region within the optical region of the contact lens that is eccentric can have a diameter of at least 0.5 mm, 0.75 mm, 1 mm, 1.5 mm, or 2.5 mm, in the shape of a circle or a regular or another irregular shape along the axis of the second region.

[0230] In certain embodiments, the major or minor axis of the second region within the optical region of the contact lens that is eccentric in the shape of a circle or an irregular shape can have a diameter between 0.5 mm and 1.25 mm, 0.5 mm and 1.75 mm, 0.75 mm and 2.5 mm, or 0.5 mm and 3.5 mm.

[0231] In certain embodiments, the second region within the optical region of the contact lens that is eccentric can have a surface area between 0.5 and 5 square millimeters, 2.5 and 7.5 square millimeters, 5 and 10 square millimeters, or 1 square millimeter and 25 square millimeters.

[0232] In certain embodiments, the surface area of the second region that is eccentric is at least 10% of the surface area of the optical zone and no more than 35% of the surface area of the optical region. In certain embodiments, the surface area of the second region that is eccentric is at least 5% of the surface area of the optical zone and no more than 30%. In certain embodiments, the surface area of the second region that is eccentric is at least 3% of the surface area of the optical zone and no more than 20% of the surface area of the optical zone. In certain embodiments, the surface area of the second region that is eccentric is at least 5% of the surface area of the optical zone and no more than 40%.

[0233] In certain embodiments, the distance between the geometric center of the second region within the optical region that is configured to be rotationally asymmetric about its geometric center and the optical center can be at least 0.75 mm, 1 mm, 1.5 mm, 2 mm, or 2.5 mm.

[0234] In certain embodiments, the distance between the geometric center of the second region within the optical zone configured to be rotationally asymmetric about its geometric center and the optical center can be between 0.75 mm to 1.25 mm, 0.75 mm to 1.75 mm, 1 mm to 2 mm, or 0.75 mm to 2.5 mm.

[0235] In certain embodiments, the diameter of the optical zone of the contact lens can be at least 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, or 9 mm. In certain embodiments, the diameter of the optical zone of the contact lens can be between 6 mm to 7 mm, 7 mm to 8 mm, 7.5 mm to 8.5 mm, or 7 mm to 9 mm.

[0236] In certain embodiments, the width of the blending zone or blending zone of the contact lens can be at least 0.05 mm, 0.1 mm, 0.15 mm, 0.25 mm, 0.35 mm, or 0.5 mm. In certain embodiments, the width of the blending zone or blending zone of the contact lens can be between 0.05 mm and 0.15 mm, 0.1 mm and 0.3 mm, or 0.25 mm and 0.5 mm.

[0237] In some embodiments, the blending zone can be symmetric, e.g., circular. While in other embodiments, the blending zone can be asymmetric, e.g., elliptical or irregular. In other embodiments, the width of the blending zone can decrease to zero, and thus be non-existent.

[0238] In exemplary embodiments, the shape of the second region within the optical zone can be circular, semi-circular, non-circular, elliptical, rectangular, hexagonal, square, irregular, or a combination thereof to introduce a stop signal for progression of myopia that can be provided. In certain embodiments, the area of the second region within the optical zone configured to be rotationally asymmetric about the optical axis can be at least 5%, 10%, 15%, 20%, 25%, 30%, or 35% of the optical zone.

[0239] In certain embodiments, the area of the second region within the optical zone configured to be rotationally asymmetric about the optical axis can be between 5% and 10%, 10% and 20%, 10% and 25%, 5% and 20%, 5% to 25%, 10% to 30%, or 5% and 35% of the optical zone.

[0240] In certain embodiments, the width of the peripheral non-optical zone or carrier region of the contact lens can be at least 2.25 mm, 2.5 mm, 2.75 mm, or 3 mm. In certain embodiments, the width of the peripheral region or carrier region of the contact lens can be between 2.25 mm and 2.75 mm, 2.5 mm and 3 mm, or 2 mm and 3.5 mm.

[0241] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially symmetric and has a substantially similar radial thickness profile at the horizontal, vertical and other oblique meridians.

[0242] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially symmetric and has a substantially similar radial thickness profile at the horizontal, vertical and other oblique meridians, which can mean that the maximum thickness of any meridian of the peripheral carrier region is within 5%, 6%, 7%, 8%, 9% or 10% of the maximum thickness of any other meridian at any one of the meridians. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0243] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially symmetric and has a substantially similar radial thickness profile at the horizontal, vertical and other oblique meridians, which can mean that the maximum thickness of any semi-meridian of the peripheral carrier region is within 5%, 6%, 7%, 8%, 9% or 10% of the maximum thickness of any other semi-meridian at any one of the meridians.

[0244] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially rotationally symmetric and has a substantially similar radial thickness profile at the horizontal, vertical and other oblique meridians, which can mean that the maximum amount of change in the thickest point across any one meridian of the peripheral carrier region is 5, 10, 15, 20, 25, 30, 35 or 40 pm of the thickest peripheral point of any other meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0245] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially rotationally symmetric and has a substantially similar radial thickness profile at the horizontal, vertical and other oblique meridians, which can mean that the maximum amount of change in the thickest point across any one semi-meridian of the peripheral carrier region is 5, 10, 15, 20, 25, 30, 35 or 40 pm of the thickest peripheral point of any other semi-meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0246] In certain embodiments, the peripheral region or non-optical carrier region of the contact lens is configured to be substantially free of stabilizing means, prism stabilizing means, edge prism stabilizing means, top and bottom beveling, truncated design or combinations thereof typically used in conventional toric contact lenses intended to stabilize the orientation of the contact lens on the eye.

[0247] In certain embodiments, the substantially free rotation of 360 degrees of the contact lens over time can be at least once, twice, three times, four times, five times or ten times per day and at least 10, 15, 20 or 25 rotations within one hour of lens wear.

[0248] In other embodiments, the substantially free rotation of the contact lens over time can be 90 degrees per day, at least once, twice, three times, four times, five times or ten times per day and at least 10, 15, 20 or 25 degrees of rotation within two hours of lens wear. In some embodiments, the rotationally asymmetric eccentric second region of the contact lens can be located, formed or placed on the front surface, the back surface or a combination thereof.

[0249] In some embodiments, the rotationally asymmetric eccentric second region of the contact lens can be located, formed or placed at least partially on the front surface, at least partially on the back surface or at least partially on the front surface and at least partially on the back surface.

[0250] In some embodiments, the meridional and azimuthal variation in luminance profile within the second region of the contact lens is dedicated to produce specific features of the stop signal, such as positioning the region conically or partially obscuring the interval at the desired retinal periphery location.

[0251] In some examples, the optical design of the eccentric second region of the contact lens can be configured to provide a local field of blur or a local field of blur interval substantially in front of the retinal plane, approximately on the retinal plane or substantially behind the retinal plane.

[0252] In certain other embodiments, the base prescription of the contact lens located, formed or disposed on one and the other of the two surfaces of the contact lens can have other features for further reducing eye growth.

[0253] In certain embodiments, the shape of the eccentric second region within the optical region, the blending region between the eccentric second region and the rest of the optical region, the shape of the blending region of the optical region and the peripheral carrier region can be described by one or more of the following: a sphere, an asphere, an extended odd polynomial, an extended even polynomial, a conic section, a segmented polynomial or a biconic section.

[0254] In certain embodiments, the combination of the contact lens embodiments in the present disclosure with a prescription eyeglass lens can have significant advantages; where only one single inventory unit with a second region having a preferred meridional and azimuthal variation in luminance profile or other device features of the desired or preferred size and shape is required to achieve the desired optical effect on the retina. To improve wearability and variation of the treatment signal, one piece of contact lens can be alternated between the left and right eye each day.

[0255] Another apparent advantage of combining the current contact lens embodiments of the present disclosure with a prescribed spectacle lens is to handle existing astigmatism; wherein the astigmatism or cylinder correction can be incorporated into the pair of spectacle lenses.

[0256] Likewise, in this case, a single inventory unit can be worn as a contact lens without having to worry about the overlapping luminance of the cylinder and / or the meridian and azimuthal varying luminance profile of the second region of decentration or any other intended device functionality.

[0257] As will be appreciated by those skilled in the art, the present invention can be used in conjunction with any device / method that can influence myopia progression.

[0258] These can include, but are not limited to, various designs of spectacle lenses, filters, pharmaceutical agents, behavioral changes, and environmental conditions.

[0259] Other exemplary embodiments are described in the following few sets of examples.

[0260] Set of Examples “A” - Meridian and Azimuthal Luminance Profile within the Second Region

[0261] A contact lens for an eye, the contact lens comprising an optical zone about an optical center and a non-optical peripheral carrier zone about the optical zone; wherein the optical zone is configured with a substantially single vision luminance profile that provides a substantial correction for the eye; and a second region of decentration comprising at least one luminance map characterized by a plurality of meridian luminance profiles across the optical zone and a plurality of azimuthal luminance profiles about the optical axis, resulting in a luminance disparity; wherein at least one of the azimuthal luminance profiles is partially varying and lacks mirror symmetry; wherein at least one of the meridian luminance profiles is partially varying and lacks mirror symmetry; wherein the second region of decentration with a geometric center is substantially away from the optical center, providing a region of local blur at least partially on the retina of the eye; wherein the non-optical peripheral carrier zone comprises a plurality of azimuthal thickness profiles about the optical axis, wherein the azimuthal thickness profiles are configured to facilitate fitting of the lens on the eye.

[0262] The contact lens of one or more claims of Set of Examples A, wherein the at least one azimuthal luminance profile is defined using a cosine profile with a reduced frequency (i.e., one quarter (1 / 4)) or half (1 / 2) of the normal frequency; wherein the normal frequency is defined as two cosine periods over 360° or 2π radians.

[0263] The contact lens of one or more claims of Set of Examples A, wherein only one of the plurality of meridian power profiles has mirror symmetry about the optical zone and none of the plurality of azimuthal power profiles has mirror symmetry about the optical axis.

[0264] The contact lens of one or more claims of Example Set A, wherein at least one of the partially varying meridian power profiles is radially varying.

[0265] The contact lens of one or more claims of Example Set A, wherein at least one of the partially varying meridian power profiles is radially constant.

[0266] The contact lens of one or more claims of Example Set A, wherein the second area within the optical zone has a surface area that is at least 10% and no greater than 35% of the optical zone.

[0267] The contact lens of one or more claims of Example Set A, wherein the second area within the optical zone has a shape that is substantially circular or elliptical.

[0268] The contact lens of one or more claims of Example Set A, wherein the second area has a geometric center located at least 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, or 3 mm from the optical center of the contact lens.

[0269] The contact lens of one or more claims of Example Set A, wherein the power difference is at least +1.25 D, at least +1.5 D, at least +1.75 D, at least +2 D, at least +2.25 D, or at least +2.5 D.

[0270] The contact lens of one or more claims of Example Set A, wherein the power difference is between +0.5 D and +2.75 D, +0.75 D and +2.5 D, +1 D and +2.25 D, +1.25 D and +2 D, or +1.25 D and +2.75 D.

[0271] The contact lens of one or more claims of Example Set A, wherein the second area is combined with at least +0.25 D of primary spherical aberration defined over the smallest diameter of the second area.

[0272] The contact lens of one or more claims of Example Set A, wherein the second area is combined with at least -0.25 D of primary spherical aberration defined over the smallest diameter of the second area.

[0273] The contact lens of one or more claims of Example Set A, wherein the second area within the optical zone is disposed on the front surface or the back surface of the contact lens.

[0274] The contact lens of one or more claims of Example Set A, wherein the second area of the optical zone is partially disposed by the front surface and partially disposed by the back surface of the contact lens.

[0275] The contact lens of one or more claims of Example Set A, wherein a blending zone is configured between the optical zone and the second zone; the blending zone is disposed between the optical zone and the second zone. And wherein the blending zone spans at least 0.025 mm, 0.05 mm, 0.075 mm, or 0.1 mm as measured across the semi-diameter of the optical zone of the contact lens.

[0276] The contact lens of one or more claims of Example Set A, wherein a blending zone is configured between the optical zone and the non-optical peripheral zone; and wherein the blending zone spans at least 0.125 mm, 0.25 mm, 0.5 mm, 0.75 mm, or 1 mm as measured across the semi-diameter of the optical zone of the contact lens.

[0277] The contact lens of one or more claims of Example Set A, wherein the plurality of azimuthal thickness profiles of the non-optical peripheral carrier zone are configured to be substantially invariant about the optical axis.

[0278] The contact lens of one or more claims of Example Set A, wherein the difference between the thickest point and the thinnest point within the plurality of azimuthal thickness profiles of the non-optical peripheral carrier zone about the optical axis provides a peak-to-valley thickness.

[0279] The contact lens of one or more claims of Example Set A, wherein the variation of the substantially invariance is such that the peak-to-valley thickness is between 5 pm and 45 pm, or between 10 pm and 45 pm or between 1 pm and 45 pm.

[0280] The contact lens of one or more claims of Example Set A, wherein the substantially invariance is such that the peak-to-valley thickness does not exceed 5 pm, 10 pm, 15 pm, 20 pm, 25 pm, 30 pm, 35 pm, 40 pm, or 45 pm.

[0281] The contact lens of one or more claims of Example Set A, wherein the plurality of azimuthal thickness profiles are defined to have a desired width spanning a range of any radial distance in the non-optical peripheral carrier zone, wherein the desired width is 3.5 mm to 7.2 mm, 4 mm to 7.5 mm, 4.5 mm to 6.5 mm, 4.25 mm to 7 mm, or 4.5 mm to 7.1 mm of the non-optical peripheral carrier zone.

[0282] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0283] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0284] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0285] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0286] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0287] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0288] The contact lens according to one or more of the set of examples A, wherein the non-optical peripheral carrier zone comprises a thickness profile defined along the selected zone, the thickness profile being substantially invariant along one or more semi-meridians; and wherein the substantial invariance refers to a variation of the thickness profile along any semi-meridian being less than 3%, 5% or 8% of any other semi-meridian.

[0289] The contact lens of one or more claims of the Example Set A, wherein the partially obscured area conic extends at least across the foveal edge, fovea, macular edge, macula, or perimacular region of the retina of the eye.

[0290] The contact lens of one or more claims of the Example Set A, wherein the partially obscured area conic extends at least 2.5 degrees, 5 degrees, 7.5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, or 40 degrees of the visual field of the retina.

[0291] The contact lens of one or more claims of the Example Set A, wherein the partially obscured area conic is positioned on the retina such that it acts as a directional cue or optical stop signal for the myopic eye.

[0292] The contact lens of one or more claims of the Example Set A, wherein the partially obscured area conic is not a regular conic of Sturm, but is irregular.

[0293] The contact lens of one or more claims of the Example Set A, wherein the partially obscured area conic comprises a sagittal plane and a tangential plane; wherein the tangential plane is positioned anterior to the retina of the eye at at least one location within the 40 degree visual field of the retina of the eye.

[0294] The contact lens of one or more claims of the Example Set A, wherein the sagittal plane is positioned anterior to the retina of the eye at at least one location within the 40 degree visual field of the retina of the eye.

[0295] The contact lens of one or more claims of the Example Set A, wherein the sagittal plane is positioned substantially close to the retina of the eye at at least one location within the 40 degree visual field of the retina of the eye.

[0296] The contact lens of one or more claims of the Example Set A, wherein the at least one rotation facilitating feature of the contact lens allows for increased rotation of the contact lens on the myopic eye, rotating 180 degrees at least three times per 4 hours of lens wear, and rotating at least 15 degrees within 30 minutes of lens wear.

[0297] The contact lens of one or more claims of the Example Set A, wherein the at least one rotation facilitating feature is configured to increase rotation on the eye and in combination with the second area of the inner at least partially varying meridional and azimuthal luminance profile provide a time and space varying stop signal for the myopic eye such that the effectiveness of the directional signal remains substantially consistent over time.

[0298] The contact lens of one or more claims in the set of examples A, wherein the power profile provides the eye with temporally and spatially varying local blur of the local prismatic body with lens wear; wherein the spatial variation includes at least the foveal edge, fovea, macular edge, macula, or perimacular region of the eye's retina; and wherein the temporal variation provides the eye with a therapeutic benefit that remains substantially temporally consistent over time.

[0299] The contact lens of one or more claims in the set of examples A, wherein the power profile provides the eye with temporally and spatially varying local blur of the local prismatic body with lens wear; wherein the spatial variation includes at least the foveal edge, fovea, macular edge, macula, or perimacular region of the eye's retina; and wherein the temporal variation provides the eye with a therapeutic benefit that remains substantially temporally consistent over time.

[0300] The contact lens of one or more claims in the set of examples A, wherein the lens wear provides the myopic eye with temporally and spatially varying directional cues or optical stop signals to substantially control the eye growth of the myopic eye.

[0301] The contact lens of one or more claims in the set of examples A, wherein the therapeutic benefit to the eye is myopia control, myopia management, slowing the rate of myopia progression.

[0302] The contact lens of one or more claims in the set of examples A, wherein the visual performance of the contact lens is substantially similar to the visual performance of a single vision contact lens for the eye.

[0303] The contact lens of one or more claims in the set of examples A, wherein the at least one rotation assist feature is selected to allow a desired lens rotation to provide a desired visual performance while maintaining a desired spatial and temporal variation for the optical stop signal for the myopic eye to maintain the efficacy of the directional signal substantially consistent over time.

[0304] Example set "B" - different contact lenses are used for the left and right eyes.

[0305] A pair of contact lenses, one for a right myopic eye, one for a left myopic eye, each contact lens comprising an anterior surface, a posterior surface, an optical center, an optical axis, a second region eccentric to the optical center within an optical zone; wherein the geometric center of the second eccentric region is located substantially away from the optical center; a non-optical peripheral carrier region surrounding the optical zone; the optical zone substantially comprising a single vision to correct the myopic eye; wherein the second eccentric region comprises a luminance map characterized by a plurality of meridional and azimuthal luminance profiles around its geometric center; wherein at least one of the meridional and azimuthal luminance profiles is at least partially varying and has no mirror symmetry; wherein the luminance map at least partially provides proper correction for the myopic eye and at least partially provides a partial blur local cone on the retina of the myopic eye as a directional cue or optical stop signal; the non-optical peripheral carrier region comprises a plurality of azimuthal thickness profiles around the optical axis, wherein at least one of the azimuthal thickness profiles is configured to be substantially invariant to facilitate fitting on the myopic eye.

[0306] The pair of contact lenses of one or more claims of the set of examples B, wherein the plurality of meridional and azimuthal angular number profiles across the geometric center of the second eccentric region are substantially different between the right myopic eye and the left myopic eye.

[0307] The pair of contact lenses of one or more claims of the set of examples B, wherein at least one rotation assistance feature of each contact lens is differentially configurable between the right myopic eye and the left myopic eye.

[0308] The pair of contact lenses of one or more claims of the set of examples B, wherein at least one rotation assistance feature of each contact lens is configured to be symmetrically mirrored between the right myopic eye and the left myopic eye with respect to the nasal side.

[0309] The pair of contact lenses of one or more claims of the set of examples B, wherein at least one rotation assistance feature of each contact lens is configured to be asymmetrically mirrored between the right myopic eye and the left myopic eye with respect to the nasal side.

[0310] The pair of contact lenses of one or more claims of the set of examples B, wherein at least one rotation assistance feature of each contact lens is configured to be asymmetrically mirrored between the right myopic eye and the left myopic eye with respect to the nasal side. This allows each rotation assistance feature to be selected to allow different magnitudes of lens body rotation between the left and right myopic eyes, thereby further increasing the optical stop signal that varies spatially and temporally for the myopic eye, thereby making the directional cue more effective and remaining substantially consistent over time.

[0311] The contact lenses of one or more claims of Example Set B, wherein the at least one rotation-aiding feature of each contact lens is configured to be asymmetrically mirrored between the right myopic eye and the left myopic eye with respect to the nasal side. So as to select each rotation-aiding function to allow the magnitude of lens rotation to differ between the right myopic eye and the left myopic eye, thereby providing the desired visual performance while maintaining the myopic eye's spatially and temporally varying optical stop signal, thereby keeping the myopic eye's efficacy direction signal substantially consistent over time.

[0312] The contact lenses of one or more claims of Example Set B can be combined with one or more of the claim limitations described in one or more claims of Example Set A.

Claims

1. A contact lens, the contact lens comprising: a front surface; a back surface; an optical center; an optical axis; an optical zone, the optical zone comprising: a first zone configured with a single power for correction of myopia; and a second zone configured with a power map featuring a plurality of meridional power profiles and a plurality of azimuthal power profiles centered on a geometric center thereof; wherein the second zone is decentered from the optical center; and a non-optical peripheral carrier zone surrounding the optical zone, the non-optical peripheral carrier zone comprising a plurality of azimuthal thickness profiles surrounding the optical axis; wherein: in the decentered second zone, at least one of the azimuthal power profiles is varied and lacks mirror symmetry; in the decentered second zone, at least one of the meridional power profiles is varied and lacks mirror symmetry; the power map provides foveal correction for myopia and provides a local blur zone cone on the retina of myopia for use as a directional cue, or optical signal, for at least one of slowing, delaying, or reducing myopia progression; and at least one of the azimuthal thickness profiles is substantially uniform to facilitate on-eye rotation of the contact lens on a myopic eye and the contact lens is configured to rotate when on-eye.

2. The contact lens of claim 1, wherein, only one of the plurality of meridional power profiles has mirror symmetry about the geometric center of the decentered second zone; and none of the plurality of azimuthal power profiles has mirror symmetry about the geometric center of the decentered second zone.

3. The contact lens of claim 2, wherein, at least one of the varied meridional power profiles is radially varied.

4. The contact lens of claim 1, wherein, the at least one azimuthal power profile is defined with a half (1 / 2) cosine distribution of frequency, the frequency defined as two cosine periods over 360° or 2π radians.

5. The contact lens of claim 1, wherein, a surface area of the second zone within the optical zone is at least 10% and no greater than 40% of the optical zone, and wherein the surface area of the second zone within the optical zone is between 5 mm2and 25 mm2.

6. The contact lens of claim 1, wherein, a shape of the second zone within the optical zone is substantially elliptical.

7. The contact lens of claim 1, wherein, the geometric center of the second zone is positioned at least 1.5 mm from the optical center of the contact lens.

8. The contact lens of claim 1, wherein, a difference between a maximum power profile and a minimum power profile within the meridional power profiles that vary over the second zone, and the azimuthal power profiles that vary about the geometric center of the second zone, provide a power latitude, and wherein the power latitude difference is between +0.5D to +2.75D.

9. The contact lens of claim 1, wherein, the second zone of the optical zone comprises a spherical aberration between +0.5D to -0.5D determined over a smallest diameter of the second zone.

10. The contact lens of claim 1, wherein, the power map is obtained using the front surface, the back surface, or both surfaces of the contact lens.

11. The contact lens of claim 1, wherein, a difference between a thickest point and a thinnest point within the plurality of azimuthal thickness profiles in the non-optical peripheral carrier zone surrounding the optical axis produces a peak-to-valley thickness; wherein the peak-to-valley thickness is between 5 pm and 45 pm and is substantially constant.

12. The contact lens of claim 1, wherein, The amount of rotation on the eye is measured by the contact lens rotating at least 180 degrees at least three times per 8 hours of wear and rotating at least 15 degrees within 1 hour of wear.

13. The contact lens of claim 1, comprising at least one rotation-aiding feature; wherein, The at least one rotation-assisting feature is represented by a periodic function; wherein the periodic function is a sawtooth feature, a sinusoidal feature, a sum of multiple sinusoidal features, or a quasi-sinusoidal feature; wherein the periodic function is defined over 0 to 2π radians with a period not less than 6 and the rate of thickness change is different with respect to increases than with respect to decreases.

14. The contact lens of claim 12, wherein, The maximum thickness change within the at least one rotation-assisting feature is between 10 μm and 45 μm.

15. The contact lens of claim 1, wherein, The locally obscured area-cone is not a Sturm's regular cone, but is irregular; wherein the locally obscured area-cone has a depth on the retina of at least 0.5 mm.

16. The contact lens of claim 14, wherein, The locally obscured area-cone spans at least the parafoveal, foveal, perimacular, macular, or perimacular region of the retina; wherein the locally obscured area-cone is within at least a 15 degree field of view of the retina.

17. The contact lens of claim 1, wherein, The locally obscured area-cone is located on the retina to provide the directional cue or the optical signal for the myopic eye.

18. The contact lens of claim 1, wherein, The locally obscured area-cone includes a sagittal plane and a tangent plane; wherein the tangent plane is located anterior to the retina in at least one location within a 40 degree field of view of the retina of the myopic eye; wherein the sagittal plane is located anterior to the retina in at least one location within a 40 degree field of view of the retina of the myopic eye; or wherein the sagittal plane is located substantially near the retina of the eye in at least one location within a 40 degree field of view of the retina of the myopic eye.

19. The contact lens of claim 1, comprising at least one rotation-aiding feature, wherein, The at least one rotation-assisting feature of the contact lens allows for increased rotation of the contact lens on the myopic eye, measured by rotation of the contact lens, at least 180 degrees three times per 4 hours of wear and at least 15 degrees within 30 minutes of wear.

20. The contact lens of claim 1, wherein, The at least one rotation-assisting feature is configured to increase rotation on the myopic eye and, in combination with the varying meridional and azimuthal luminance profiles within the second region, provide a stop signal for the myopic eye that varies with time and space such that the effectiveness of the directional cue remains substantially constant with time.

21. The contact lens of claim 1, wherein, The luminance map, in combination with the rotation on the eye, provides a locally obscured area-cone for the eye that varies with time and space when the contact lens is applied to the eye; wherein the spatial variation includes at least the parafoveal, foveal, perimacular, macular, or perimacular region of the retina of the eye; and wherein the temporal variation provides a therapeutic benefit for the eye that remains substantially constant with time.

22. The contact lens of claim 1, wherein, When the contact lens is applied to the eye, the luminance map in combination with the on-eye rotation provides a local blur area conic that varies with time and space for the eye; wherein the spatial variation includes a 15 degree field of view of the retina of the eye; and wherein the temporal variation is provided by the contact lens rotating at least 180 degrees at least three times per 8 hours of wear, and the contact lens rotating at least 15 degrees per 1 hour of wear, thereby promoting a therapeutic effect on the eye and maintaining the efficacy of the directional cue substantially constant over time.

23. The contact lens of claim 1, wherein, The on-eye rotation provides a directional cue or optical stop signal that varies with time and space for the myopic eye to substantially control the eye growth of the myopic eye.

24. The contact lens of claim 21, wherein, The therapeutic benefit to the eye is myopia control, myopia management, slowing the progression of myopia for the myopic eye.

25. The contact lens of claim 1, wherein, The visual performance of the contact lens is substantially similar to the visual performance of a single vision contact lens for the myopic eye.

26. The contact lens of claim 1, comprising at least one rotation assist feature, wherein, The at least one rotation-assisting feature is selected to allow the required rotation of the lens to provide the desired visual performance while maintaining the required temporal and spatial variation of the optical stop signal; the efficacy of the directional cue for the myopic eye is maintained substantially constant over time.

27. The contact lens of claim 1, wherein, The contact lens is one of a pair of contact lenses, and wherein the luminance profile of the plurality of meridians and azimuths that cover the geometric center of the eccentric second zone is substantially different for right myopic eyes and left myopic eyes.

28. The contact lens of claim 1, wherein, The contact lens is one of a pair of contact lenses, and wherein each contact lens further comprises at least one rotation-assisting feature, wherein the at least one rotation-assisting feature of each contact lens is configured differently for right myopic eyes and left myopic eyes.

29. The contact lens of claim 1, wherein, The contact lens is one of a pair of contact lenses, and wherein each contact lens further comprises at least one rotation-assisting feature, wherein the at least one rotation-assisting feature of each contact lens is configured around the nasal side of the wearer of the pair of contact lenses to be mirror-symmetrically between right myopic eyes and left myopic eyes of the wearer.

30. The contact lens of claim 1, wherein, The contact lens is one of a pair of contact lenses, each contact lens further comprising at least one rotation-assisting feature, wherein the at least one rotation-assisting feature of each contact lens is configured around the nasal side of the wearer of the pair of contact lenses to be non-mirror-symmetrically between right myopic eyes and left myopic eyes of the wearer.

31. The contact lens of claim 1, wherein, The contact lens is one of a pair of contact lenses, and wherein each contact lens further comprises at least one rotation-assisting feature, wherein the at least one rotation-assisting feature of each contact lens is configured around the nasal side of the wearer of the pair of contact lenses to be non-mirror-symmetrically between right myopic eyes and left myopic eyes of the wearer, such that each rotation-assisting feature is selected to allow a different degree of lens rotation between right myopic eyes and left myopic eyes, thereby further increasing the optical stop signal that varies with space and time for the myopic eye, thereby maintaining the efficacy of the directional cue substantially constant over time.

32. The contact lens of claim 1, wherein, The contact lens is one contact lens of a pair of contact lenses, and wherein each contact lens further comprises at least one rotation assist feature, wherein the at least one rotation assist feature of each of the contact lenses is configured non-mirror-symmetrically about the nasal side of a wearer of the pair of contact lenses between the right myopic eye and the left myopic eye of the wearer, such that each rotation assist feature can be selected to allow for different magnitudes of lens rotation between the right and left myopic eyes to provide desirable visual performance while maintaining a spatially and temporally varying optical stop signal for the myopic eyes to maintain the efficacy of the directional signal substantially constant over time.

33. The contact lens of claim 1, wherein, At least one of the meridional luminance profiles that varies is radially varying; and wherein the radial luminance variation in at least one of the meridional luminance profiles that varies is between 0 and -1 D.

34. The contact lens of claim 1, wherein, At least one of the plurality of meridional luminance profiles that varies is radially invariant.

35. The contact lens of claim 1, wherein, The plurality of azimuthal thickness profiles are defined as a desired width across any radial distance range in the non-optical peripheral carrier region, wherein the desired width is between 3.5 mm and 7.2 mm of the non-optical peripheral carrier region.

36. The contact lens of claim 2, wherein, At least one of the meridional luminance profiles that varies is radially invariant.

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