Contact lenses for myopic eyes and methods of providing directional cues for myopic eyes to reduce myopic progression

Abstract

The present invention relates to contact lenses for myopic eyes and methods of providing directional cues for myopic eyes to reduce myopia progression. In one aspect, a contact lens for myopia is provided. The lens comprises: an optical zone having an optical axis and an azimuthal and meridian varying brightness profile that provides both partial correction for the myopic eye and a blurred signal for use as a direction prompt over the macular region of the myopic eye to reduce myopia progression, and an optical zone having an azimuthal and meridian varying brightness profile that provides both partial correction for the myopic eye and a blurred signal for use as a direction prompt over the macular region of the myopic eye to reduce myopia progression; and a peripheral region surrounding the optical region, the peripheral region including a substantially constant thickness profile about the optical axis that facilitates substantially free on-eye rotation of the contact lens over time, or a thickness profile that facilitates rotation of the contact lens over time.

Description

This application is a divisional application of the invention patent application with the application date of December 11, 2020, application number 202080096497.5 (PCT / AU2020 / 051361), and invention name “Contact lenses for myopia with or without astigmatism”. Cross-references

[0001] This application claims priority to Australian provisional application serial number 2020 / 900412 filed on February 14, 2020, entitled “Contact lens”, and is a continuation of PCT / AU2020 / 051004 filed on September 23, 2020, entitled “Contact lens solution for myopia treatment”, both of which are incorporated herein by reference in their entirety. Technical Field

[0002] The present disclosure relates to contact lenses for eyes having abnormalities related to the eye's axis, such as myopia with or without astigmatism. Background Art

[0003] Most people are born with farsighted eyes. With aging, the eye tends to become more emmetropic. Eye growth is controlled by a visual feedback mechanism called emmetropization. Signals guiding the emmetropization process are initiated at the retinal level. Retinal image characteristics are monitored biologically to modulate signals that start or stop, accelerate or slow eye growth. Derailment from emmetropization can lead to refractive errors such as myopia and / or astigmatism.

[0004] The problem of myopia is increasing at an alarming rate, and it is predicted that by 2050, half the world's population may be myopic. Myopia can be corrected with a simple pair of standard single-vision lenses. While such devices can correct refractive errors, they do not address the underlying cause of excessive eye growth.

[0005] Excessive growth is associated with serious vision-threatening conditions such as glaucoma, myopic maculopathy, and retinal detachment. For such individuals, specific optical devices are needed that can not only correct the underlying refractive error but also prevent excessive eye lengthening or progressive myopia. definition

[0006] Unless otherwise defined below, the terms used herein are commonly used by those skilled in the art.

[0007] The term "myopic eye" refers to an eye that has experienced myopia, has been diagnosed with a refractive condition that is progressing towards greater myopia, and has an astigmatism of less than 1 DC.

[0008] The term "myopic astigmatism" refers to an eye that has experienced myopia, has been diagnosed as having a refractive condition that is progressing towards myopia, and has an astigmatism equal to or greater than 1 DC.

[0009] The terms "progressive myopia" or "progressive myopic astigmatism" refer to an eye that has been diagnosed as developing myopia with or without astigmatism, 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.

[0010] The term "near-myopic eye" or "eye at risk for myopia" refers to an eye that may be emmetropic or have low distance vision at the time, but has been determined to be at increased risk for myopia based on factors such as genetic factors (e.g., both parents are myopic) and / or age (e.g., being hyperopic as a young person) and / or environmental factors (e.g., time spent outdoors) and / or behavioral factors (e.g., time spent completing near vision tasks).

[0011] The term "optical stop sign" or "stop signal" refers to a light signal or directional cue that can promote growth, reverse, arrest, delay, inhibit or control the growth of the eye and / or the refractive condition of the eye.

[0012] The term "spatially varying optical stop signal" refers to an optical signal or directional cue provided on the retina that varies spatially across the retina of the eye. The term "temporally varying optical stop signal" refers to an optical signal or directional cue provided on the retina that varies over time. The term "temporally and spatially varying optical stop signal" refers to an optical signal or directional cue provided on the retina that varies over time and space across the retina of the eye.

[0013] The term "contact lens" refers to a finished contact lens that is worn on the wearer's cornea to affect the optical properties of the eye.

[0014] The term "optical zone" or "optical zone" refers to the area of a contact lens that provides a defined optical effect. The optical zone can be distinguished by a varying brightness distribution around the optical center or axis. The optical zone can be divided into an anterior optical zone and a posterior optical zone. The anterior optical zone and the posterior optical zone refer to the areas of the front and back surfaces of the contact lens, respectively, that contribute to the defined optical effect.

[0015] The optical zone of a contact lens can be circular, elliptical, or other irregular shapes. The optical zone of a contact lens with a spherical power is typically circular. However, as disclosed herein, in certain embodiments, the introduction of a meridional and azimuthal variation in brightness distribution can result in a non-circular optical zone.

[0016] The term "optical center" or "optical center" refers to the geometric center of the optic zone of a contact lens. As disclosed herein, the terms geometric and geometrically are essentially the same.

[0017] As disclosed herein, the term "optical axis" refers to a line passing through the optical center and substantially perpendicular to a plane containing the edge of a contact lens.

[0018] The term "blending zone" or "connecting zone" is a region connecting or located between the optical zone and the non-optical peripheral carrier region of the contact lens. The blending zone can be on the anterior surface or the posterior surface or both surfaces and can be polished or smoothed between two different adjacent surface curvatures as disclosed herein.

[0019] The term "non-optical peripheral carrier region" is a non-optical region connected to or located between the optic zone and the edge of the contact lens. In some embodiments, as disclosed herein, a hybrid region can be used between the optic zone and the peripheral carrier region.

[0020] The term "through focus" generally refers to the spatial dimension in front of and / or behind the retina, typically measured in millimeters in image space. However, in some embodiments, as disclosed herein, alternative metrics to the term "through focus" that are referenced in object space and measured in diopter or brightness generally refer to the same thing.

[0021] The term "radial" refers to directions radiating from the optical center to the edge of the optical zone, along directions defined by azimuth angles. The term "radial spokes" refers to spokes radiating outward from the center of the optical zone at predetermined azimuth angles.

[0022] As disclosed herein, the phrase "radial brightness distribution" refers to a one-dimensional brightness distribution of local light intensity across any radial spoke.

[0023] As disclosed herein, the phrase "radially constant brightness distribution" refers to any radial spoke having a substantially uniform brightness distribution.

[0024] As disclosed herein, the phrase "radially varying brightness distribution" refers to any radial spoke having a substantially non-uniform brightness distribution.

[0025] As disclosed herein, the term "meridian" refers to two opposing radial spokes distributed at predetermined azimuth angles across the optical zone.

[0026] As disclosed herein, the phrase "meridional brightness distribution" refers to a one-dimensional brightness distribution of local light brightness across an arbitrary meridian line on the optical zone.

[0027] As disclosed herein, the phrase "meridionally invariant brightness distribution" refers to any meridian having a substantially uniform brightness distribution.

[0028] As disclosed herein, the phrase "meridionally varying brightness distribution" refers to any meridian having a substantially non-uniform brightness distribution.

[0029] The phrase "meridian brightness distribution having mirror symmetry" refers to any meridian having substantially the same brightness distribution on its two opposing radial spokes.

[0030] The phrase "a meridional brightness distribution having no mirror symmetry" refers to any meridian having two substantially different brightness distributions on its two opposing radial spokes.

[0031] The term "azimuth or azimuth angle" refers to a direction along the circumference of the optical zone around the optical axis, defined at any radial distance.

[0032] The phrase "azimuthal brightness distribution" refers to the one-dimensional brightness distribution of the local brightness across arbitrary azimuth angles, measured at a given radial distance around the optical axis.

[0033] As disclosed herein, the phrase "azimuthally invariant brightness distribution" means that the azimuth brightness distribution has a substantially uniform brightness distribution.

[0034] As disclosed herein, the phrase "azimuthally varying brightness distribution" means that the azimuth brightness distribution has a substantially non-uniform brightness distribution.

[0035] As disclosed herein, the phrase "azimuthal brightness distribution having mirror symmetry" refers to an azimuthal brightness distribution between 0 and π radians that is substantially similar to an azimuthal brightness distribution between π and 2π radians.

[0036] As disclosed herein, the phrase "azimuthal brightness distribution lacking mirror symmetry" means that the azimuthal brightness distribution between 0 and π radians is substantially different from the azimuthal brightness distribution between π and 2π radians.

[0037] The phrase "azimuthal thickness distribution" refers to the one-dimensional thickness distribution of local lens thickness at any azimuthal angle measured or defined at any radial distance in a non-optical peripheral carrier region.

[0038] As disclosed herein, the phrase "azimuthally invariant thickness profile" means that the azimuthally thickness profile has a substantially uniform thickness distribution.

[0039] As disclosed herein, the phrase "azimuthally varying thickness distribution" means that the azimuth thickness distribution has a substantially non-uniform thickness distribution.

[0040] The phrase "periodic azimuthal thickness distribution" means that the azimuthal thickness distribution follows a periodic function or a repeating pattern.

[0041] As disclosed herein, the phrase "azimuthal thickness distribution having mirror symmetry" refers to an azimuthal thickness distribution between 0 and π radians that is substantially similar to an azimuthal thickness distribution between π and 2π radians.

[0042] As disclosed herein, the phrase "azimuthal thickness distribution having no mirror symmetry" refers to an azimuthal thickness distribution between 0 and π radians that is substantially different from an azimuthal thickness distribution between π and 2π radians.

[0043] The phrase "peak-to-valley (PTV) in the azimuthal thickness distribution" refers to the difference between the thickest and thinnest points along the azimuthal thickness distribution between 0 and 2π radians, defining the peripheral carrier region at an arbitrary radial distance in non-optical distances.

[0044] The term "ballast" refers to an azimuthally varying thickness profile without mirror symmetry within the carrier region for the purpose of maintaining the rotational orientation of the contact lens when worn on the eye.

[0045] The term "prismatic ballast" refers to the vertical prisms used to create a wedge-shaped design that will help stabilize the rotation and orientation of a traditional toric contact lens on the eye.

[0046] The term "thinning" refers to the purposeful thinning of a contact lens in one or more discrete areas towards the edge of the upper and lower edges of the contact lens to achieve a desired rotational stability of the contact lens.

[0047] The term "truncation" refers to the lower edge of a contact lens that is designed to have an approximately straight line shape to control the rotational stability of the contact lens.

[0048] The term "model eye" can mean a schematic, ray traced, or physical model eye.

[0049] As used herein, the terms "diopter," "brightness," or "D" are unit measurements of diopter, which are defined as the reciprocal of the focal length (in meters) of a lens or optical system along the optical axis. The term "DS" refers to spherical power, and the term "DC" refers to cylindrical power.

[0050] The term "Sturm's cone" or "Sturm's interval" refers to the resultant all-focus retinal image formed due to the introduction of astigmatism or cylindrical refractive power within the optical zone, which is represented by an elliptical blur pattern with sagittal and tangential planes.

[0051] The term "partially blurred cone" or "partially blurred interval" refers to the irregular blur pattern of the retinal image through focus, with sagittal and tangential planes, resulting from the introduction of meridional and azimuthal variations in the brightness distribution within the optical zone.

[0052] The term "brightness map" refers to the two-dimensional distribution of brightness over an optical area in Cartesian or polar coordinates.

[0053] The term "back power" refers to the reciprocal of the back focal length over all or a specified area of the optical zone, expressed in diopters (D).

[0054] The term "SPH" or "spherical" brightness refers to substantially uniform brightness across all meridians of the optical zone.

[0055] The term "CYL," "cylindrical" brightness, refers to the difference in posterior vertex brightness between the two principal meridians within the optical zone.

[0056] The term "delta brightness" refers to the difference between the maximum and minimum brightness in the multiple meridional varying brightness distributions across the optical zone and the azimuthal varying brightness distributions about the optical axis.

[0057] The term or phrase "astigmatic brightness distribution" or "torsional brightness distribution" may mean that the optical zone has a spherical cylindrical brightness distribution.

[0058] The term "local correction of the eye" or "partial correction of the eye" refers to the correction of the eye in at least one specific area on the retina of the eye, or in at least one meridian or at least one semi-meridian.

[0059] The term "foveal correction" refers to correction in at least the fovea area of the retina of the eye. The term "foveal perifoveal area" refers to the area immediately adjacent to the fovea of the retina of the eye. The term "perifoveal area" refers to the area immediately adjacent to the fovea of the retina of the eye. The term "macular perifoveal area" refers to the area within the macula of the retina of the eye. The term "perifoveal area" refers to the area immediately adjacent to the macula of the retina of the eye.

[0060] The phrase "rotational assist feature" refers to an azimuthal thickness periodic distribution having a specific periodicity.

[0061] The term "specific fit" refers to a non-optical peripheral carrier region comprising an azimuthal thickness profile about the optical axis, wherein the azimuthal thickness profile is configured to be substantially constant to facilitate substantially free intraocular rotation of the contact lens over time. In some examples, the term "specific fit" includes an azimuthal thickness profile having rotation-assisting features. For the avoidance of doubt, specific fit as used herein refers to a thickness profile configured in the non-optical peripheral carrier region that is substantially free of any ballast, prisms, or truncation features found in standard toric or toric contact lenses of the prior art. Summary of the Invention

[0062] A detailed discussion of the prior art and subjects of general interest is provided herein as background to the present disclosure, to illustrate the context of the disclosed embodiments, and further to distinguish the desired advances over the prior art. Nothing herein should be taken as an admission that the material referred to in connection with the various embodiments set out in the present disclosure and / or claim priority is previously disclosed, known, or part of the common general knowledge.

[0063] In simple terms, all contact lens designs proposed for myopia involve applying some degree of defocus to the central or peripheral regions of the retina. See, for example, U.S. Patents 6,045,578, 7,025,460, 7,509,683, 7,401,922, 7,999,972, 7,803,153, 8,969,019, 8,931,897, 8,950,860, 8,998,408, and 9,535,263. Prior art designs are primarily aimed at controlling myopia with no or low levels of astigmatism. Furthermore, while some designs demonstrate an initial burst of treatment or efficacy in combating myopia progression, the observed therapeutic benefit typically diminishes and disappears over time. Therefore, to advance the field, there is a need for a lens that can address myopia with and without astigmatism while providing a stable therapeutic benefit over time. More specifically, the lenses can minimize, reduce or eliminate the decay, reduction, decline, diminution, weakening or attenuation of the therapeutic benefit over time, resulting in a greater cumulative absolute reduction in axial elongation in myopic wearers.

[0064] The present disclosure relates to a contact lens for managing myopia; wherein the contact lens is configured with an optical zone defined substantially around its optical axis, the optical zone being characterized by the use of one or more meridional and azimuthally varying brightness distributions, wherein at least one of the meridional and azimuthally varying brightness distributions lacks mirror symmetry, at least partially resulting in foveal correction of the myopic eye, and at least partially resulting in a partially blurred cone of vision at the retina of the myopic eye, serving as a directional cue or optical stop signal; a non-optical peripheral carrier region surrounding the optical zone, which is configured with one or more azimuth thickness distributions; wherein at least one azimuth thickness distribution is substantially constant to allow substantially free rotation on the eye, thereby further providing a directional cue or optical stop signal that varies in time and space to slow down, improve, control, inhibit or reduce the rate of progression of myopia and maintain a substantially constant therapeutic effect over time.

[0065] In some embodiments of the present disclosure, the myopic eye may be a myopic astigmatism eye. In some embodiments, one or more azimuthal thickness profiles may be configured with or without a rotational assist feature. In some embodiments, the rotational assist feature further comprises a periodic thickness profile with a desired periodicity around the optical axis.

[0066] Certain embodiments are directed to contact lenses for altering the wavefront properties of incident light entering a person's eye, with the intent of correcting myopia and simultaneously providing a signal to prevent further eye growth.

[0067] Certain embodiments relate to contact lenses for correcting and treating refractive errors, particularly myopia, astigmatic myopia, progressive myopia, or astigmatic progressive myopia.

[0068] According to certain embodiments, the contact lenses of the present disclosure overcome the limitations of the prior art by minimizing the significant changes in visual performance that can occur in astigmatic myopic individuals.

[0069] According to certain embodiments, the contact lenses of the present disclosure are intended to minimize the effects of a loss, attenuation, decline, decrement, reduction, or weakening of the efficacy of treatment and / or the effectiveness of myopia management with or without astigmatism, the effectiveness of myopia prevention and control, or the effectiveness of treatment of progressive myopia by introducing an optical stimulus or direction that varies in time and space, without burdening the wearer with different lenses to achieve pulsed treatment.

[0070] According to certain other embodiments, the introduction of the spatiotemporally varying optical stimuli described herein is facilitated by utilizing a non-optical peripheral carrier region that is configured without any dedicated stabilization platform utilized in prior art astigmatic or toric lenses. For the avoidance of doubt, the lenses of the present disclosure are devoid of any type of stabilization platform, including, but not limited to, ballast, thinning, truncation, or the like. Instead, the presently disclosed non-optical peripheral carrier region is configured with a substantially constant azimuthal thickness profile, with or without an assistive rotation feature, allowing for substantial free rotation, which facilitates increased rotation of the contact lens on the eye.

[0071] According to the present disclosure, certain other embodiments are directed to contact lenses for myopic eyes with or without astigmatism, wherein the contact lens is characterized by a front surface, a back surface, an optical center, an optical zone surrounding the optical center, a hybrid zone, and a non-optical peripheral carrier zone surrounding the optical zone; the optical zone is characterized by multiple meridianally and azimuthally varying brightness distributions, wherein at least one of the meridianally and azimuthally varying brightness distributions lacks mirror symmetry, and wherein the optical zone at least partially provides foveal correction and produces at least a partially blurred interval on a retinal area of the myopic eye as an optical stop signal for the myopic eye; wherein the non-optical peripheral carrier zone is configured to be substantially free of any specialized stabilization to facilitate substantially free rotation of the contact lens on the myopic eye, providing a continuously varying or spatially and temporally varying optical stop signal on the central and / or peripheral retina of the myopic eye with or without astigmatism.

[0072] In some embodiments, the spatially and temporally varying optical stop signal or directional cue includes the introduction of cones or intervals of partial blurring. The introduction of partially blurred cones can be in the perifoveal, foveal, macula, or perimacular regions.

[0073] The present disclosure hypothesizes that a continuously varying optical stop signal or directional cue at the retina of a myopic eye may help reduce diminishing effects on the efficacy and / or effectiveness of myopia treatments.

[0074] Certain embodiments are configured with a brightness diagram characterized by multiple meridional and azimuthally varying brightness distributions within an optical region, wherein only one of the multiple meridional varying brightness distributions is configured with mirror symmetry and all azimuthally varying brightness distributions are not configured with mirror symmetry.

[0075] Certain other embodiments are configured with a brightness map characterized by a brightness distribution having multiple meridional and azimuthal variations within the optical zone, the purpose of which is to further minimize the significant changes in visual performance that may occur due to contact lens rotation in myopic patients with high astigmatism, for example -0.75DC, -1.00DC, -1.25DC, -1.50DC, -1.75DC or -2DC.

[0076] Certain other embodiments are configured with a brightness map that provides at least partial correction for the myopic eye and at least in part provides a partially blurred cone on the retina to act as a directional cue to reduce the rate of progression of myopia.

[0077] The non-optical peripheral carrier region of some embodiments is configured to have a plurality of azimuthal thickness profiles such that the plurality of azimuthal thickness profile regions defining a desired width across any range of radial distances in the non-optical peripheral carrier are configured to be constant to facilitate free rotation of the eye. In some examples, the desired width across the range of any radial distances in the non-optical peripheral carrier region can be between 4 mm and 6 mm, between 4 mm and 7.5 mm, between 4.5 mm and 6.5 mm, between 4.25 mm and 7 mm, or between 4.5 mm and 7.25 mm.

[0078] Certain other embodiments are configured with meridional and azimuthally varying brightness maps within the optical zone, combined with an azimuthally invariant thickness profile within the non-optical peripheral carrier zone, such that the contact lens can minimize the diminishing, declining, or diminishing effect of its efficacy in treating myopia progression over time by providing a spatiotemporally varying stop signal that overcomes the limitations of the prior art.

[0079] In some other embodiments of the present disclosure, a hybrid region can be configured between the optical zone and the non-optical peripheral region of the contact lens. In other embodiments, the hybrid region between the optical zone and the non-optical peripheral region can be configured as a circle, an ellipse, or an oval. In other embodiments, it can be configured as any other shape.

[0080] In some other embodiments of the present disclosure, the blended area between the optical zone and the non-optical peripheral area can be at least 0.1 mm, 0.25 mm, 0.5 mm, or 0.75 mm, measured as a semi-diameter of the contact lens. In some other embodiments of the present disclosure, the blended area between the optical zone and the non-optical peripheral area can be between 0.05 mm and 0.1 mm, between 0.1 mm and 0.25 mm, between 0.1 mm and 0.5 mm, or between 0.25 mm and 0.75 mm, measured as a semi-diameter of the contact lens.

[0081] Another embodiment of the present disclosure is directed to a contact lens for at least one of slowing, delaying, or preventing myopia progression, the contact lens comprising an anterior surface, a posterior surface, an optic zone surrounding the lens, an optical center surrounding the optic zone, a non-optical peripheral zone surrounding the optic zone, the optic zone configured with a brightness map characterized by one or more meridional and azimuthally varying brightness distributions, wherein at least one of the meridional and azimuthally varying brightness distributions is configured without mirror symmetry, wherein the brightness map at least partially provides foveal correction for a myopic eye or a myopic astigmatic eye, and is further configured to at least partially provide at least one partial cone of blur or an interstitial blur to the myopic eye or the myopic astigmatic eye. a septum, serving as an optical signal or directional cue on the central and / or peripheral retina; the non-optical peripheral carrier zone is further configured with a rotational assist feature, the rotational assist feature comprising a thickness variation following a periodic function and a periodic azimuthal thickness variation; wherein the periodic function comprises a sawtooth profile, a sinusoidal profile, a sum of sinusoidal profiles or a quasi-sinusoidal profile, and the periodicity is not less than 6 variations over 360° azimuth, i.e., from 0 to 2π radians; wherein the rotational assist feature helps to increase the propensity of the contact lens to rotate on the eye, so that the continuously varying, spatially and temporally varying optical stop signal can vary over time to provide consistent therapeutic benefits to myopic eyes or astigmatic myopic eyes.

[0082] In some embodiments, the periodicity can be configured such that it has no fewer than 6 variations over 180° azimuth, i.e., from 0 to π radians. In some embodiments, the periodicity function can be arranged differently for lenses suitable for the right eye and the left eye, taking into account the position of the eyelids, the action and direction of the forces acting on the lens due to the wearer's eyelids.

[0083] In some embodiments, the brightness distribution within the optical zone can be configured to vary meridionally and azimuthally, but be radially invariant, wherein the brightness distribution in the radial direction remains substantially the same. In some other embodiments, the brightness distribution within the optical zone can be configured both meridionally and azimuthally, as well as radially, wherein the brightness distribution in the radial direction is substantially non-uniform.

[0084] In other embodiments, the meridional variation is such that the brightness distribution is not substantially mirror-symmetric about the optical axis. In other embodiments, the azimuth variation is such that the brightness distribution is not substantially mirror-symmetric about the optical axis. In some variations of the disclosed embodiments, only one of the multiple meridional variation brightness distributions is configured to be symmetrical, and none of the azimuth variation distributions are configured to be symmetrical.

[0085] In some other embodiments, the brightness distribution within the optical zone can be configured to vary in both the meridional and azimuth directions, as well as in the radial direction. The brightness distribution along the radial direction can decrease from the center of the optical zone to the edge of the optical zone, and the brightness distribution along the azimuth direction can decrease or increase from 0 to 2π radians. In some embodiments, the decrease in the brightness distribution along the radial direction can be described using a linear, curved, or quadratic function. In certain other embodiments, the decrease in the brightness distribution along the radial direction can be different for different azimuth positions within the optical zone.

[0086] In other embodiments, the decrease in the azimuth luminance distribution may follow a cosine distribution with a decreasing frequency, such as one-sixth (1 / 6), one-fifth (1 / 5), one-quarter (1 / 4), one-third (1 / 3), or one-half (1 / 2) of the normal frequency, typically defined by two cosine periods of 360° or 2π radians. In other embodiments, the decrease or increase in the azimuth luminance distribution may be different for different radial positions on the optical zone.

[0087] According to one embodiment, the present disclosure is directed to a contact lens for myopia with or without astigmatism. The contact lens comprises a front surface, a back surface, an optical zone around an optical axis, and a plurality of meridional and azimuthally varying brightness profiles around the optical axis, wherein at least one of the meridional and azimuthally varying brightness profiles is configured to provide at least partial correction for myopia with or without astigmatism and further configured to at least partially provide a stop signal that varies in time and space; thereby, the therapeutic efficacy of reducing the rate of myopia progression remains substantially consistent over time.

[0088] Certain embodiments are directed to a contact lens for at least one of slowing, delaying, or preventing myopia progression, the contact lens comprising: a front surface; a back surface; an optical center; an optical axis; an optical zone surrounding the optical center, the optical zone comprising at least a brightness map; wherein the brightness map is further characterized by a plurality of meridional brightness profiles across the optical zone and a plurality of azimuthal brightness profiles about the optical axis; wherein at least one azimuthal brightness profile is configured to at least partially vary, and at least one meridional brightness profile is configured to at least partially vary; wherein at least one of at least some of the azimuthally varying profiles is configured to lack mirror symmetry, and at least one of at least some of the longitudinally varying profiles is configured to lack mirror symmetry; and a non-optical peripheral carrier region surrounding the optical zone, wherein the non-optical peripheral carrier region comprises one or more azimuthal thickness profiles about the optical axis; wherein the one or more azimuthal thickness profiles are configured to be substantially constant to facilitate a specific fit on the eye.

[0089] Certain embodiments are directed to a contact lens for at least one of slowing, delaying, or preventing myopia progression, the contact lens comprising a brightness map within an optical zone characterized by a brightness distribution that varies across multiple meridians and azimuths, wherein changes in the brightness distribution across the multiple meridians and azimuths result in incremental brightness within the optical zone that is described as the difference between maximum and minimum optical brightness changes that occur within the optical zone.

[0090] Certain embodiments of the present disclosure are directed to contact lenses; wherein the incremental brightness within the brightness map is at least +1.25D, at least +1.5D, at least +1.75D, at least +2D, at least +2.25D, at least +2.5D, or at least +2.75D.

[0091] In some embodiments of the present disclosure; the incremental brightness in the brightness map is between 0.5D and 3.5D, between 0.75D and 3D, between 1D and 2.5D, between 1.25D and 2.25D, between 1.25D and 1.75D or between 1.2D and 2.75D.

[0092] In some embodiments of the present disclosure, the brightness map is at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% of the optical zone, while the remainder of the optical zone is configured to have substantially spherical correction for a myopic eye.

[0093] In some embodiments of the present disclosure, the brightness map is at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% of the optical zone, while the remainder of the optical zone is configured to have basic astigmatism correction for myopia.

[0094] In some embodiments, the brightness profile spans at least 3 mm, 4 mm, 5 mm, 6 mm, or 8 mm of the central region of the optical zone. In some other embodiments, the brightness profile can be achieved using the anterior, posterior, or both surfaces of the contact lens. In other embodiments, at least one of the partially varying meridian profiles can be configured to be radially varying or constant.

[0095] Certain embodiments of the present disclosure are directed to contact lenses wherein the non-optical peripheral carrier region of the contact lens comprises a thickness profile that is substantially constant within a selected region along one or more semi-meridians. Wherein substantial invariance means that the thickness profile along any semi-meridian varies by less than 3%, 5%, or 8% along any other semi-meridian. The thickness profile of the contact lens across the semi-meridians can be obtained by drawing a perpendicular line from a tangent at each point on the posterior surface of the contact lens to a tangent at the anterior surface of the contact lens.

[0096] Certain embodiments of the present disclosure are directed to contact lenses; wherein the substantial invariance of the thickness distribution is configured such that the thickest point within the non-optical peripheral carrier region across any semi-meridian is within a maximum variation range of 5μm, 10μm, 15μm, 20μm, 25μm, 30μm, 35μm, 40μm, or 45μm from the thickest peripheral point across any other semi-meridian within the non-optical peripheral carrier region. However, certain embodiments of the present disclosure are directed to contact lenses and are not limited thereto. The non-optical peripheral carrier region includes one or more azimuthal thickness distributions around the optical axis, the thickness distributions being defined at any radial distance within the non-optical peripheral carrier region and being substantially invariant. The substantial invariance refers to variations in the azimuthal thickness distribution having peaks and valleys between 5μm and 45μm, or between 10μm and 45μm, or between 1μm and 45μm.

[0097] Certain embodiments of the present disclosure are directed to contact lenses wherein the luminance map at least partially provides foveal correction for a myopic eye and at least partially generates at least partially locally blurred cones or spaces as an orientation cue at the retina of the myopic eye. Furthermore, the specific fit provides a temporally and spatially varying stop signal for the myopic eye to substantially control ocular growth.

[0098] Certain embodiments of the present disclosure are directed to contact lenses wherein the feature allows for substantially free rotation of the eye, wherein substantially free rotation is measured as the lens rotating 180 degrees at least three times every eight hours of wear, with at least 15 degrees of rotation occurring within one hour of wear. In some other embodiments, substantially free rotation is measured as the lens rotating 180 degrees at least three times every twelve hours of wear, with at least 15 degrees of rotation occurring within two hours of wear.

[0099] Certain embodiments of the present disclosure are directed to contact lenses; wherein the specific fit includes an azimuthal thickness distribution configured with at least one rotational assist feature; wherein the at least one rotational assist feature includes an azimuthal thickness distribution represented by a periodic function; wherein the periodic function is a sawtooth profile, a sinusoidal profile, a sum of sinusoidal profiles, or a quasi-sinusoidal profile, and wherein the period of the periodic function over 360° azimuth (from 0 to 2π) is not less than 6. The rate of thickness variation varies between increases and decreases; and wherein the maximum thickness variation within the at least one rotational assist feature is between 5 μm and 40 μm.

[0100] Certain embodiments of the present disclosure are directed to contact lenses; wherein, at least one rotational assist feature of the contact lens allows for increased rotation of the contact lens on a myopic eye, as measured by at least three rotations of 180 degrees for every four hours of wear of the contact lens and at least 15 degrees within 30 minutes of wearing the lens.

[0101] In some examples, contact lenses of the present disclosure can be configured such that at least one rotational assist feature is configured to increase rotation of the lens on the eye, and in combination with at least partially varying meridian and azimuthal brightness distributions, the lens can provide a temporally and spatially varying stop signal for a myopic eye such that effectiveness remains substantially consistent over time.

[0102] Other embodiments presented in this disclosure address the ongoing need for improved optical designs and contact lenses that can inhibit the progression of myopia while providing reasonable and appropriate visual performance for the wearer's daily activities for the range of activities the wearer may engage in. Various aspects of the embodiments disclosed herein address this need for wearers. BRIEF DESCRIPTION OF THE DRAWINGS

[0103] Figure 1a An elevational view and a cross-sectional view of an embodiment of a contact lens of the present disclosure are shown. The elevational view also shows an optical center, an optical zone, a hybrid zone, and a non-optical peripheral carrier zone, including at least eight (8) cross-sections along any semi-meridian, configured with substantially similar thicknesses, according to an embodiment of the present disclosure.

[0104] Figure 1b An elevational view and a cross-sectional view of another contact lens embodiment of the present disclosure are shown. According to certain embodiments of the present disclosure, the elevational view also shows an optical center, an optical zone, a hybrid zone, and a non-optical peripheral carrier region, including an azimuthal thickness profile that is substantially constant or configured to have a periodic profile such that the non-optical peripheral carrier region facilitates or assists in rotation of the contact lens.

[0105] Figure 2aA front view of another contact lens embodiment of the present disclosure is shown, illustrating the possibility of substantially free rotation of the lens during natural blinking action, which is due to the non-optical peripheral carrier region being configured with substantially similar thickness in at least eight (8) cross sections along any semi-meridian according to certain embodiments of the present disclosure.

[0106] Figure 2b A front view of another contact lens embodiment of the present disclosure is shown, illustrating the possibility of essentially free rotation or rotation-assisted contact lens substantially about the optical center, according to certain embodiments of the present disclosure, this is due to the configuration of a non-optical peripheral carrier zone having a substantially constant azimuthal thickness distribution, or configured as a periodic distribution with a defined periodicity, so that the non-optical peripheral carrier zone tends to or assists the contact lens in rotation.

[0107] Figure 3 The power distribution within the optical zone (i.e., brightness distribution, brightness as a function of optical zone diameter and brightness as a function of azimuth angle) of a standard toric or astigmatic contact lens configured using a standard spherocylindrical brightness distribution (brightness: -1DS / +1.5DC) is shown.

[0108] Figure 4a Shown Figure 3 Thickness distribution of the entire contact lens as described in , and astigmatism distribution along four representative meridians, namely 0°, 45°, 90°, and 135°.

[0109] Figure 4b The thickness distribution of the entire contact lens of a prior art toric contact lens is shown, the lens having an astigmatic brightness distribution along two principal meridians, 0° and 90°.

[0110] Figure 4c Shown with Figure 3 and Figure 4a Thickness distribution as a function of azimuthal angle for the contact lens described in , obtained along four example radial distances of 5 mm, 5.5 mm, 6 mm and 6.5 mm within the non-optical peripheral region.

[0111] Figure 4d Thickness distribution as a function of azimuth angle for a prior art toric contact lens with prismatic ballast stabilization is shown along a radial distance of 5.5 mm within the non-optical peripheral region.

[0112] Figure 5 The temporal and spatial variations of the signals due to contact lens rotation (i.e., 0°, 90°, 180°, and 270°) are shown. These signals are described as the time-varying signals when a parallel beam of visible light (589 nm) is incident on the lens. Figure 3 、 4aOn-axis point spread function in the retinal plane when on a -1DS myopia model eye corrected with contact lenses as described in 4c.

[0113] Figure 6a and 6b The time- and space-varying optical signals due to contact lens rotation (i.e., 0° and 90°) are shown. These signals are described as the time-varying optical signals due to contact lens rotation (i.e., 0° and 90°) when parallel light of visible wavelength (589 nm) is incident on the lens. Figure 3 、 4a Geometric point analysis of wide-angle through focus at the retinal plane when on a -1DS myopic model eye corrected by contact lenses as described in 4c and 4c.

[0114] Figure 7 The retinal signal (Sturm's cone) is shown as the on-axis, through-focus, modulation transfer function plotted as tangential and sagittal meridians, resulting from a collimated incident light incident on the retina at a visible wavelength (589 nm). Figure 3 、 4a Calculated for a model eye with -1DS myopia corrected with contact lenses as described in 4c, where the principal meridians of the contact lens plane are located at 0° and 90°.

[0115] Figure 8 The brightness distribution within the optical zone (i.e., brightness distribution, brightness as a function of optical zone diameter and brightness as a function of azimuth angle) of another standard toric or astigmatic contact lens (brightness: -3.5DS / +1.25DC) is shown, which is configured using a standard spherocylinder brightness distribution.

[0116] Figure 9a Shown Figure 8 Thickness distribution of the entire contact lens as described in , and astigmatism distribution along four representative meridians, namely 0°, 45°, 90°, and 135°.

[0117] Figure 9b Shown Figure 8 and Figure 9a Thickness distribution as a function of azimuthal angle of the contact lens described in , obtained at radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm along four examples within the non-optical peripheral region.

[0118] Figure 9c Shown is the thickness distribution as a function of azimuth angle along a 5.5 mm radial distance within the non-optical peripheral region for a prior art toric contact lens stabilized using prismatic ballasting.

[0119] Figure 10The temporal and spatial variations of the signal due to contact lens rotation (i.e., 0°, 90°, 180°, and 270°) are illustrated as follows: parallel incident light of visible wavelength (589 nm) is incident on a model eye with -4DS myopia and +1DC×90° astigmatism, using Figure 8 、 9a The contact lens embodiment described in and 9b is corrected for the on-axis point spread function at the plane.

[0120] Figure 11a and 11b The temporal and spatial variations of the signal due to contact lens rotation (i.e., 0° and 90°) are shown, described as follows: parallel incident light of visible wavelength (589 nm) is incident on a model eye with -4DS myopia and +1DC × 90° astigmatism, using Figure 8 、 9a The contact lens embodiment described in and 9b is corrected for the on-axis point spread function at the plane.

[0121] Figure 12 The retinal signal (Sturm's cone) is shown when parallel incident light of visible wavelength (589 nm) is incident on a model eye with -4DS myopia and +1DC×90° astigmatism using Figure 8 、 9a The contact lens embodiment described in 9b is corrected by having a modulation transfer function that is on-axis through the focus of its tangential meridian and sagittal meridian, with the flat principal meridians of the contact lens located at 0° and 90°.

[0122] Figure 13 The brightness distribution within the optical zone of an embodiment of the contact lens of the present disclosure (i.e., a brightness diagram, brightness as a function of the optical zone diameter and brightness as a function of the azimuth angle) is shown, which has a brightness distribution that is essentially radially invariant, meridional and azimuthally varying (brightness: -1DS / +1.5D, half lens).

[0123] Figure 14a Shown in Figure 13 The embodiment described in the present invention has a thickness distribution throughout the contact lens, which has a refractive distribution that is substantially radially constant and varies in the meridional and azimuthal directions along four representative meridians, namely 0°, 45°, 90° and 135°.

[0124] Figure 14b Shown Figure 13 and Figure 14a Thickness distribution of the contact lens as a function of azimuthal angle, obtained in the non-optical peripheral region along four example radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm.

[0125] Figure 15 The temporal and spatial variations of the signal due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) are shown, which are described as follows: when parallel light of visible wavelength (589 nm) is incident on a lens having Figure 13 The on-axis point spread function at the retinal plane when the myopia is corrected for a model eye with a -1DS as described with the contact lens embodiment described in Figure 14.

[0126] Figure 16a and 16b The time- and space-varying signals due to the rotation of the contact lens (i.e., 0° and 270°) are shown. The signal is described as follows: when parallel light of visible wavelength (589 nm) is incident on a lens having Figure 13 Wide angle through focus geometry analysis of the contact lens embodiment as corrected for myopia on a -1DS model eye as shown in FIG. 14 .

[0127] Figure 17 The retinal signal (Sturm's cone) is shown when parallel light of visible wavelength (589 nm) is incident on the -1DS myopic model eye using Figure 13 The on-axis modulation transfer functions of the tangential meridian and the sagittal meridian through the focus are calculated for the contact lens embodiment described in 14, where the meridians of the contact lens are located at 0° and 90°.

[0128] Figure 18 The brightness distribution within the optical zone of another contact lens embodiment of the present invention (i.e., brightness distribution diagram, brightness as a function of optical zone diameter and brightness as a function of azimuth angle) is shown, which has a brightness distribution that is basically radially unchanged, meridional and azimuth-changing (brightness: -3.5DS / +1.25D, half lens).

[0129] Figure 19a Shown in Figure 18 The embodiment described in has a thickness distribution across the entire contact lens with substantially radially invariant, meridional and azimuthally varying brightness distributions along four exemplary representative meridians (i.e., 0°, 45°, 90°, and 135°).

[0130] Figure 19b Shown Figure 18 and Figure 19a Thickness distribution of the contact lens described in FIG. 5 as a function of azimuthal angle along four example radial distances of 4.25 mm, 4.75 mm, 5.5 mm and 6.5 mm in the non-optical peripheral region.

[0131] Figure 20The temporal and spatial variations of the signals due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) are shown. These signals are described as follows: Figure 18 On-axis point spread function at the retinal plane when the exemplary contact lens embodiments described in and 19 are corrected for a model eye with -4DS myopia and +1DC×90° astigmatism.

[0132] Figure 21a and 21b The time- and space-varying signals due to contact lens rotation (i.e., 0° and 90°) are shown. The signal is described as follows: when parallel incident light with a visible wavelength (589 nm) is incident on a lens with a Figure 18 Analysis of wide-angle through-focus geometry when the contact lens embodiment described in 19 is applied to a model eye correcting -4DS myopia and +1DC×90° astigmatism

[0133] Figure 22 The retinal signal (partially blurred cone) is shown, which is described as follows: when parallel incident light of visible wavelength (589 nm) is incident on the Figure 18 The modulation transfer functions of the on-axis through-focus of the tangential meridian and sagittal meridian were calculated for the model eye corrected for -4DS myopia and +1DC×90° of the contact lens embodiment described in 19, where the meridians of the -3.5D contact lens are located at 0° and 90°.

[0134] Figure 23 The brightness distribution within the optical zone of an embodiment of a contact lens of the present invention (i.e., a brightness diagram, brightness as a function of the optical zone diameter and brightness as a function of the azimuth angle) is shown, which has a substantially radially invariant, meridional and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, half-frequency cosine lens (1)).

[0135] Figure 24a Shown Figure 23 The thickness distribution of the entire contact lens of the embodiment described in the embodiment, which is along four representative meridians, namely 0°, 45°, 90° and 135°, has a substantially radially invariant, meridional and azimuthal varying brightness distribution.

[0136] Figure 24b Shown Figure 23 and Figure 24a Thickness distribution of the contact lens described in FIG. 1 as a function of azimuth angle along four example radial distances of 4.25 mm, 4.75 mm, 5.5 mm and 6.5 mm in the non-optical peripheral region.

[0137] Figure 25The temporal and spatial variations of the signals due to contact lens rotations (i.e., 0°, 90°, 180°, and 270°) are shown. These signals are described as follows: Figure 23 The on-axis point spread function in the retinal plane when used on a -1DS myopic model eye corrected by the contact lens embodiment shown in Figure 24.

[0138] Figure 26a and 26b The time- and space-varying signals due to contact lens rotations (i.e., 90° and 180°) are shown. These signals are described as follows: Figure 23 Wide angle through focus geometry analysis on a -1DS myopic model eye corrected by the contact lens embodiment shown in Figure 24.

[0139] Figure 27 The retinal signal (partially blurred cones) is shown, which is described as follows: when parallel incident light of visible wavelength (589 nm) is incident on the Figure 23 The modulation transfer functions of the on-axis through-focus of the tangential meridian and sagittal meridian were calculated when the contact lens embodiment described in Figure 24 was corrected on a -1DS myopic model eye, and where the meridians of the -0.25D contact lens are located at 0° and 90°.

[0140] Figure 28 The brightness distribution within the optical zone of an embodiment of a contact lens of the present invention (i.e., brightness plots, brightness as a function of optical zone diameter and brightness as a function of azimuth angle) is shown, which has a substantially radially invariant, meridional and azimuthally varying distribution (brightness: -3.5DS / +1.25D, half

[0141] Figure 29a Shown in Figure 28 The thickness distribution of the entire contact lens of the embodiment described in the embodiment, which is along four representative meridians, namely 0°, 45°, 90° and 135°, has a substantially radially invariant, meridional and azimuthal varying brightness distribution.

[0142] Figure 29b Shown Figure 28 and Figure 29a Thickness distribution of the contact lens described in FIG. 5 as a function of azimuth along four example radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm in the non-optical peripheral region.

[0143] Figure 30The time- and space-varying signals due to contact lens rotations (i.e., 0°, 90°, 180°, and 270°) are shown. These signals are described as follows: Figure 28 29 , and the on-axis point spread function at the retinal plane when viewed on a model eye with -4DS myopia and +1DC x 90° astigmatism corrected by the exemplary contact lens embodiment described in FIG. 29 .

[0144] Figure 31a and 31b The time- and space-varying signals due to contact lens rotation (i.e., 0° and 90°) are shown. The signal is described as follows: when parallel incident light with a visible wavelength (589 nm) is incident on a lens with a Figure 28 Wide angle through focus geometry analysis on a model eye with -4DS myopia and +1DC x 90° astigmatism corrected by the contact lens embodiments described in and 29.

[0145] Figure 32 The retinal signal (partially blurred cone) is shown and is described as follows: when parallel incident light with a visible wavelength (589 nm) is incident on the Figure 28 The modulation transfer functions of the on-axis through-focus of the tangential meridian and the sagittal meridian are calculated for the contact lens embodiments described in 29 for a model eye corrected for -4DS myopia and +1DC×90° astigmatism, and wherein the meridians of the -2.9D diopter contact lens are located at 0° and 90°.

[0146] Figure 33 The brightness distribution within the optical zone of an embodiment of a contact lens of the present invention (i.e., a brightness diagram, brightness as a function of the optical zone diameter and brightness as a function of the azimuth angle) is shown, which has a substantially radially invariant, meridional and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, inverse semi-cosine lens (1)).

[0147] Figure 34a Shown in Figure 33 The embodiment described in the drawings has a thickness distribution along four representative meridians, namely 0°, 45°, 90° and 135°, across the entire contact lens, which has a substantially radially invariant, meridional and azimuthally varying brightness distribution.

[0148] Figure 34b Shown Figure 33 and Figure 34a Thickness distribution of the contact lens described in as a function of azimuthal angle along a radial distance of 5.5 mm in the non-optical peripheral region.

[0149] Figure 35The temporal and spatial variations of the signal due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) are shown. The signal is described as follows: when parallel incident light of visible wavelength (589 nm) is incident on the lens with Figure 33 The on-axis point spread function at the retinal plane in a model eye with -1DS myopia corrected by the contact lens embodiments described in 34.

[0150] Figure 36a and 36b The time- and space-varying signals due to the rotation of the contact lens (i.e., 0° and 270°) are shown. The signals are described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens Figure 33 Wide-angle through-focus geometry analysis of the contact lens embodiment described in Figure 34 when correcting -1DS myopia in a model eye.

[0151] Figure 37 The retinal signal (partially blurred cone) is shown, which is described as follows: when parallel incident light of visible wavelength (589 nm) is incident on the Figure 33 The modulation transfer functions of the on-axis through-focus of the tangential meridian and sagittal meridian were calculated for a model eye corrected for -1DS myopia using the contact lens embodiment described in Figure 34, where the meridians of the contact lens with a refractive power of -0.25D are located at 0° and 90°.

[0152] Figure 38 The brightness distribution within the optical zone of an embodiment of a contact lens of the present invention (i.e., a brightness diagram, brightness as a function of the optical zone diameter and brightness as a function of the azimuth angle) is shown, which has a substantially radially invariant, meridional and azimuthally varying brightness distribution (brightness: -3.5DS / +1.25D, flipped half-cosine lens (2)).

[0153] Figure 39a Shown in Figure 38 The embodiments described herein have thickness distributions across the entire contact lens along four representative meridians, 0°, 45°, 90°, and 135°, with substantially radially invariant, meridional, and azimuthal variations in brightness distribution.

[0154] Figure 39b Shown Figure 38 and Figure 39a Thickness distribution of the contact lens described in as a function of azimuthal angle along a radial distance of 5.8 mm in the non-optical peripheral region.

[0155] Figure 40The temporal and spatial variations of the signal due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) are shown. The signal is described as follows: when parallel incident light of visible wavelength (589 nm) is incident on the lens with Figure 38 The on-axis point spread function at the retinal plane when the exemplary contact lens embodiments described in 39 are in a model eye with -4DS and +1DC×90° myopia corrected.

[0156] Figure 41a and 41b The time- and space-varying signals due to contact lens rotation (i.e., 0° and 90°) are shown. The signals are described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens Figure 38 Wide angle through-focus geometry analysis of the contact lens embodiment described in Figure 39 when correcting -4DS myopia and +1DC×90° astigmatism in a model eye.

[0157] Figure 42 The retinal signal is shown, which is described as follows: when the incident light with a visible wavelength (589nm) is incident on the Figure 38 The modulation transfer functions of the on-axis through-focus of the tangential meridian and sagittal meridian were calculated when the contact lens embodiment described in 39 was used on a model eye with -4DS myopia and +1DC×90° astigmatism corrected, where the meridians of the contact lens with a refractive power of -2.9D were located at 0° and 90°.

[0158] Figure 43 The brightness distribution within the optical zone of another contact lens embodiment of the present invention (i.e., brightness diagram, brightness as a function of optical zone diameter and brightness as a function of azimuth angle) is shown, which has a brightness distribution that is basically radially unchanged and varies in the meridional and azimuth directions (brightness: -1DS / +1.5D, inverse semi-cosine lens (negative spherical aberration) (1)).

[0159] Figure 44 The time- and space-varying signals due to contact lens rotations (i.e., 0°, 90°, 180°, and 270°) are shown. The signals are described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens Figure 43 On-axis point spread function at the retinal plane when the contact lens embodiment described in the embodiment is corrected in a myopic model eye with -1DS.

[0160] Figure 45a and 45b The time- and space-varying signals due to the rotation of the contact lens (i.e., 0° and 270°) are shown. The signals are described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens Figure 43Analysis of the geometric points of wide-angle through-focus when the contact lens embodiment described in the invention corrects the myopia in a model eye of -1DS.

[0161] Figure 46 The retinal signal is shown, which is described as follows: when parallel incident light of visible wavelength (589 nm) is incident on Figure 43 The modulation transfer functions of the on-axis through-focus for the tangential and sagittal meridians were calculated for a model eye corrected for -1DS myopia using the contact lens embodiment described in the Figure 1 , where the meridians are located at 0° and 90° at a radial distance of ±4 mm for a -0.65D contact lens.

[0162] Figure 47 The brightness distribution within the optical zone of another contact lens embodiment of the present invention (i.e., brightness diagram, brightness as a function of optical zone diameter and brightness as a function of azimuth angle) is shown, which has a brightness distribution that is essentially radially invariant, meridional and azimuthally varying (brightness: -3.5DS / +1.25D, inverse semi-cosine lens (negative spherical aberration) (2)).

[0163] Figure 48 The time- and space-varying signals due to contact lens rotations (i.e., 0°, 90°, 180°, and 270°) are shown. The signals are described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens Figure 47 The on-axis point spread function at the retinal plane when the contact lens embodiment described in corrects -4DS myopia and +1DC×90° astigmatism in a model eye.

[0164] Figure 49a and 49b The time- and space-varying signals due to contact lens rotation (i.e., 0° and 90°) are shown. The signals are described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens Figure 47 Wide-angle through-focal geometry analysis of the contact lens embodiments described in the figure correcting -4DS myopia and +1DC x 90° astigmatism in a model eye.

[0165] Figure 50 The retinal signal is shown, which is described as follows: when the parallel incident light with a visible wavelength (589nm) is incident on the Figure 47 The modulation transfer functions of the on-axis through-focus of the tangential meridian and sagittal meridian were calculated for the contact lens embodiment described in the figure for correction of -4DS myopia and +1DC×90° astigmatism, where the meridians of the -3.3D refractive power contact lens are located at 0° and 90° at a radial distance of ±4mm.

[0166] Figure 51The azimuth angle characteristics of the half-area sample contact lens (HA lens #1) of the embodiment of the present disclosure with a measured label or prescription power of -5.5DS / +2D are shown. The produced lens HA lens #1 is the embodiment of the present disclosure. Figure 13 A variation of the contact lens embodiment described in .

[0167] Figure 52 The azimuth angle characteristics of a half-area sample contact lens (HA lens #2) of another disclosed embodiment with a measured label or prescription of -2DS / +2D are shown. The produced lens HA lens 2 is the embodiment of the present disclosure. Figure 13 and 47 Another variation of the combination of contact lens embodiments described in .

[0168] Figure 53 The azimuthal brightness characteristics of a half-frequency cosine sample contact lens (F2 Lens #1) of another embodiment of the present disclosure with a measured brightness of -5.5DS / +1.5D are shown. Figure 23 A variation of the contact lens embodiment described in .

[0169] Figure 54 Shown is the thickness distribution of a commercially available toric contact lens having a prior art dedicated stabilization arrangement, measured along the lens diameter (Control #1) at two principal meridians (vertical and horizontal).

[0170] Figure 55 The measured thickness distribution of the sample contact lens HA lens #1 is shown. Figure 13 A variation of the contact lens embodiment described in . The thickness distribution of HA lens #1 is described as a function of lens diameter.

[0171] Figure 56 The measured thickness distribution of the sample contact lens HA lens #2 is shown. Figure 13 and 47 The thickness distribution of HA lens #2 is described as a function of lens diameter.

[0172] Figure 57 The measured thickness distribution of the sample contact lens F2 lens #1 is shown. Figure 23 A variation of the contact lens embodiment described in . The thickness distribution of F2 lens #1 is described as a function of lens diameter.

[0173] Figure 58The azimuthal position of F2 lens #1 measured after a period of time on the eye, i.e., approximately 60 minutes of lens wear, is shown. Contact lens embodiment F2 lens #1 is designed to have a substantially constant azimuthal thickness profile within the non-optical peripheral carrier region, thereby allowing substantially free rotation of the contact lens on the eye.

[0174] Figure 59 The azimuthal position of HA lens #2 measured after a period of time on the eye, i.e., approximately 60 minutes of lens wear, is shown. Contact Lens Example HA lens #2 is designed to have a substantially constant azimuthal thickness profile within the non-optical peripheral carrier region, thereby allowing for substantially free rotation of the contact lens on the eye.

[0175] Figure 60 The azimuthal angle position of a prior art commercially available toric contact lens (Control #1) measured after a period of wear, i.e., approximately 30 minutes of wear, is shown. This prior art toric contact lens is designed with a dedicated stabilization zone within the non-optical peripheral carrier region, thereby allowing minimal lens rotation when worn on the eye. This is in stark contrast to all of the embodiments disclosed herein. DETAILED DESCRIPTION

[0176] In this section, the present disclosure will be described in detail with reference to one or more embodiments, some of which are illustrated and supported by 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. The following description is provided by way of several related embodiments, and the common features and characteristics of these embodiments may be shared. It should be understood that one or more features of one embodiment may be combined with one or more features of any other embodiment to form additional embodiments.

[0177] The functional and structural information disclosed herein should not be construed as limiting in any way, but rather as a representative basis for teaching those skilled in the art how to variously employ the disclosed embodiments and their variations. Subheadings and related subject headings are used in the detailed description section solely for the convenience of the reader and should in no way be used to limit the subject matter of the invention or the claims herein. Furthermore, subheadings and related subject headings should not be used when interpreting the claims or the scope of the claims.

[0178] The risk of developing myopia or progressive myopia may be based on one or more of the following factors: genetics, ethnicity, lifestyle, excessive near work, etc. Certain embodiments of the present disclosure are directed to persons at risk of developing myopia or progressive myopia (with or without astigmatism).

[0179] To date, several optical designs have been proposed to control the rate of myopia progression. Some features of designs used to slow myopia progression include a degree of relative positivity relative to the prescription power, typically distributed rotationally symmetrically about the optical axis of the contact lens. This article describes some inherent weaknesses of the prior art. Existing designs based on simultaneous images often exhibit a loss of visual quality at different distances. This side effect has been attributed to significant simultaneous defocus, significant spherical aberration, or abrupt changes in brightness.

[0180] Given the impact of contact lens wear compliance on efficacy, a significant reduction in visual performance can contribute to poor compliance, leading to poor efficacy. Therefore, a design for correcting myopia and delaying progression that does not incur at least one or more of the disadvantages discussed herein is needed. As discussed herein, other solutions will become apparent.

[0181] The efficacy of prior art designs was determined in randomized controlled clinical trials. These clinical trials lasted between 6 months and 3 years and reported efficacy of prior art lenses ranging from 20% to 50% compared to control single vision lenses.

[0182] Simple linear models of emmetropization suggest that the magnitude of the stopping signal accumulates over time. In other words, the cumulative stopping signal depends on the total amount of light exposure, not its temporal distribution. A striking finding across all clinical trials is that nearly all of the reduction in myopia progression occurs within the first 6 to 12 months.

[0183] Therefore, a more realistic emmetropization model consistent with clinical findings suggests that there may be a delay before the stop signal is established, then saturation occurs over time, and then the effectiveness of the stop signal fades. Based on this clinical observation, there is a clear need in the art for a contact lens that avoids or minimizes this saturation effect by providing a stop signal that varies in time and space to delay the rate of myopia progression without requiring the wearer to undertake the task of switching between different lenses.

[0184] Patents PCT / AU2020 / 051004 and PCT / AU2020 / 051006 have considered designs to overcome this limitation regarding the reduced effectiveness of the stop signal observed with prior art lenses.

[0185] While the lenses proposed in patents PCT / AU2020 / 051004 and PCT / AU2020 / 051006 are suitable for eyes with simple myopic refractive errors, they are also less restrictive for eyes with myopia and astigmatism.

[0186] One or more of the following advantages are found in one or more devices and / or methods of the disclosed contact lens designs. A contact lens device or method that provides a stop signal that is based on a spatially and temporally varying directional cue or optical signal to delay the growth rate of or stop the growth (or state of refractive error) of a wearer's eye. A contact lens device that provides a stop signal that varies in time and space to increase the effectiveness of managing progressive myopia with or without astigmatism. A contact lens device that is not based solely on positive spherical aberration, which can potentially result in decreased visual performance for the wearer. A contact lens device that has a rotationally symmetric power distribution across the optical zone that overcomes the limitations of existing lens technology by minimizing the potential for significant changes in visual performance when worn on myopic eyes with and without astigmatism.

[0187] The following exemplary embodiments are directed to methods of modifying incident light through a contact lens to provide spatially and temporally varying directional cues or optical stop signals at the retinal plane of a corrected eye.

[0188] This can be achieved by using a meridional and azimuthally varying brightness profile within the optical zone, the brightness profile being configured to be substantially free of mirror symmetry, and using a substantially constant azimuth thickness profile within the non-optical peripheral zone of the contact lens; providing at least partial foveal correction for myopia with or without astigmatism, and further providing at least partially locally blurred cones of vision as a directional cue or optical stop signal at the retinal level to reduce the incidence of myopia progression. The substantially constant azimuth thickness profile of the non-optical peripheral zone of the contact lens of the presently disclosed embodiments can be configured with or without additional rotational aid features to facilitate maintaining the directional cue obtained by the contact lens substantially constant in space and time.

[0189] Figure 1a A front view (100a) and a cross-sectional view (110a) of an exemplary contact lens embodiment are shown, not to scale. The front view of the exemplary contact lens embodiment further illustrates an optical center (101a), an optical zone (102a), a hybrid zone (103a), a non-optical peripheral carrier zone (104a), and a lens diameter (105a).

[0190] Meridian (106a) and azimuthal (107a) brightness distribution functions are used to configure meridional and azimuthal varying brightness distributions within an optical zone (102a) of a contact lens embodiment (100a).

[0191] In this illustrative example, the carrier region (104a) is further depicted as eight (8) cross sections along arbitrary semi-meridians 1041 through 1048. In this illustrative example, the lens diameter is approximately 14 mm, i.e., the optical zone (102a) is elliptical, approximately 8 mm in diameter along the horizontal and approximately 7.5 mm in diameter along the vertical, the blending zone (103a) is approximately 0.25 mm in the horizontal meridian and approximately 0.38 mm in the vertical meridian, and the width of the symmetric non-optical peripheral carrier region (104a) is approximately 2.75 mm.

[0192] Eight (8) cross sections along any semi-meridian (1041-1048) of the peripheral carrier region (104a) have the same or substantially similar thickness distribution. Figure 1a In another variation, according to certain embodiments of the present disclosure, the non-optical peripheral carrier region is configured to have a thickness profile that facilitates rotation of the contact lens.

[0193] In certain embodiments, the differences in thickness profiles of eight (8) sections along any semi-meridian (1041 to 1048) can be configured to achieve a desired supra-ocular rotation about the optical center of the lens. For example, a preferred supra-ocular rotation can be achieved by maintaining a substantially constant thickness profile across all semi-meridians within the non-optical peripheral carrier region.

[0194] For example, the thickness distributions of the eight (8) representative cross-sections (1041 to 1048) can be configured such that each of the eight (8) representative cross-sections has a substantially identical thickness distribution. In another example, the representative cross-sections (1041 to 1048) at any given distance from the center of the lens can be configured such that the thickness distribution of any one arbitrary representative cross-section differs from any other representative cross-section by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, or 10%.

[0195] In one example, the thickness distribution of the representative cross-section 1041, measured at any given distance from the center of the lens, is within 3%, 5%, 7%, or 9% of the thickness distribution of the radial cross-section 1047. In another example, the thickness distribution of the representative cross-section 1043, measured at any given distance from the center of the lens, is within 4%, 6%, or 8% of the thickness distribution of the representative cross-section 1046.

[0196] In yet another example, the thickness distribution of representative cross-sections (e.g., 1041 to 1048) can be configured such that the thickness distribution of any representative cross-section is within 4%, 6%, 8%, or 10% of the average value of all representative cross-sections, measured over a width defined across any radial distance range in the non-optical peripheral carrier region.

[0197] To determine whether the thickness distribution of a manufactured lens is close to its nominal value, e.g., 1041 to 1048, the thickness distribution of the contact lens through the semi-meridian can be obtained by using a perpendicular line from a tangent at each point on the back of the contact lens to the front of the contact lens.

[0198] In some examples, the peak thickness measured in one cross section along any semi-meridian can be compared to the peak thickness measured at a corresponding point in another cross section along another semi-meridian of the non-optical peripheral carrier area. In some examples, the peak thickness measured at a range of points in one cross section along any semi-meridian can be compared to the peak thickness measured over a range of corresponding points in another cross section along the non-optical peripheral carrier area. In some embodiments, the difference in peak thickness between one or more representative cross sections can be no greater than 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm. In some embodiments, the difference in peak thickness between one or more perpendicular radial cross sections can be no greater than 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm.

[0199] In some examples, the number of representative cross-sectional examples used to characterize the non-optical peripheral carrier region of the contact lenses of the present disclosure can be at least 4, at least 6, at least 8, at least 10, at least 12, at least 16, at least 18, at least 24, at least 32, or at least 36.

[0200] In this exemplary contact lens embodiment (100a), the optical zone has a meridional and azimuthally varying brightness profile, wherein the meridional varying brightness profile lacks mirror symmetry, which at least partially provides correction for -3DS myopia, wherein the meridional and azimuthally varying brightness profiles having at least 1.25D of incremental brightness at least partially induce or introduce partially blurred cones or spaces that serve as directional cues or optical stop signals on the retina of the eye. In some other examples of the present disclosure, the spherical power of the contact lens for correcting and managing myopia can be between -0.5DS and -12DS and the desired incremental power to induce or introduce the desired cones or partially blurred spaces, such as the directional cue or stop signal on the retina of the myopic eye can range from +0.75D to +2.5D. In some embodiments, the myopic eye may or may not have a significant amount of astigmatism, such as -0.75DC, -1DC, -1.25DC, -1.5DC, -1.75DC, or -2DC.

[0201] Figure 1bA front view (100b) and a cross-sectional view (110b) of another contact lens embodiment of the present disclosure are shown. The front view further shows an optical center (101b) having an azimuthal thickness distribution (1040), an optical zone (102b), a hybrid zone (103b), a lens diameter (105b), and a substantially constant non-optical peripheral carrier region (104b) configured such that the non-optical peripheral carrier region has a defined period or periodic feature that facilitates or assists rotation of the contact lens according to certain embodiments of the present disclosure. The meridional and azimuthal brightness distribution within the optical zone of the contact lens embodiment (100b) is configured using the meridional (106b) and azimuthal (107b) brightness distribution functions described herein.

[0202] The thickness distribution of the produced lens can be measured by taking a tangent line at each point on the back surface of the contact lens in the non-optical peripheral carrier region and a perpendicular line at each point on the front surface. The thickness distribution measured at each point in the non-optical peripheral carrier region can also be plotted as a function of the azimuthal angle defined at any radial distance within the non-optical peripheral carrier region to provide an azimuthal thickness distribution.

[0203] In some examples, the azimuthal thickness distribution can be measured or compared at any arbitrary radial distance within the non-optical peripheral carrier region. In other examples, the azimuthal thickness distribution can be measured or compared as an average over a range of arbitrary radial distances within the non-optical peripheral carrier region.

[0204] exist Figure 1b In some examples of variations, one or more azimuthal thickness profiles about the optical axis (defined at arbitrary radial distances in the non-optical peripheral carrier region) can be configured to be substantially constant. In this case, substantially constant means that the peak-to-valley value of the azimuthal thickness profile variation is between 5 μm and 50 μm, 10 μm and 40 μm, or 15 μm and 35 μm.

[0205] Figure 2a A front view of an exemplary contact lens embodiment (200a) is shown. The diagrammatic illustration shows the effect of the eyelid positioning the lower portion (201a) and the upper portion (202a) of the contact lens embodiment (200a), particularly the optical zone (203a) defined around the optical center (201a). In this iconic example, the non-optical peripheral carrier region is depicted as eight (8) representative cross-sections (2041 to 2048) of arbitrary semi-meridians. In this example, the lens diameter is approximately 14.2 mm, the diameter of the optical zone is approximately 8 mm, the width of the hybrid region is approximately 0.125 mm (horizontally) and 0.25 mm (vertically), and the width of the symmetrical carrier region is approximately 2.9 mm (horizontally) and 2.75 mm (vertically).

[0206] As the combined action of the lower eyelid (201a) and the upper eyelid (202a) promotes natural blinking, the contact lens (200a) can be rotated on or around the optical center (201a). This may result in the orientation and positioning of the light signal or stimulus, i.e., the interval of regional blur or partial blur, applied by the optical zone (203a), which is substantially defined by the optical center or optical axis, and the changes in blinking provide a substantially free or assisted rotation (204a), thereby resulting in a stimulus that varies in time and space to reduce the rate of progression of myopia or astigmatic myopia in the wearer; wherein the advantage of the stimulus that varies in time and space provides a desired effect of controlling myopia that is substantially consistent over time.

[0207] Figure 2b A front view of another contact lens embodiment (200b) of the present disclosure is shown. The figure diagrammatically illustrates the effect of positioning the eyelid, lower portion (201b) and upper portion (202b) of the contact lens embodiment (200a), showing substantially free rotation or facilitating contact lens rotation substantially about the optical center (201b), according to certain embodiments of the present disclosure, due to a non-optical peripheral carrier region (204b) configured with a substantially constant azimuthal thickness profile (2040), (defined as a periodic characteristic with or without a specific periodicity), which can facilitate or facilitate contact lens rotation (203a and 203b).

[0208] In some embodiments, for example, as described with reference to Figures 1 and 2, the contact lens is designed to exhibit at least substantial free rotation under the influence of natural blinking, or to facilitate increased rotational tendency due to rotation-assistance features. For example, over a full day of lens wear, preferably exceeding 6 to 12 hours, eyelid interaction can cause the contact lens to be positioned on the eye in a variety of different orientations or configurations, resulting in a temporally and spatially varying optical signal or stimulus, thereby reducing the rate of progression of myopia or astigmatic myopia in the wearer. The advantage of temporally and spatially varying stimulus provides a desirable myopia control effect that remains substantially consistent over time.

[0209] Due to the essentially meridional and azimuthally varying brightness distribution configured in the optical zone around the optical center of the contact lens, combined with the essentially constant azimuth thickness distribution configured in the non-optical peripheral zone, the intervals of regional cones or local blur produced at the level of the wearer's retina can be configured to vary in space and time, thereby minimizing the loss of therapeutic efficacy over time.

[0210] In some embodiments, surface parameters of contact lens embodiments can be customized to the individual eye, such as the back surface radius and / or asphericity, to achieve a desired supra-ocular rotation of the contact lens. For example, the radius of curvature of the contact lens can be configured to be 0.1 mm, 0.2 mm, or 0.3 mm flatter than the flattest meridian of the cornea to increase the chance of lens rotation during wear.

[0211] exist Figure 2b In other examples or variations of , a sawtooth profile can be used to configure the azimuthal thickness distribution of the non-optical peripheral carrier region to assist in rotation of the contact lens on the eye. For example, the number of teeth over the intended full 2π 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 biased positioning on the eye. In some examples, the amplitude of any single tooth in the selected array of teeth, the angle of the tooth, and / or the orientation of the tooth can provide at least 10%, 20%, 30%, 40%, or 50% more rotation than a design configured with a substantially constant azimuthal thickness distribution in the non-optical peripheral carrier region. Figure 2b In some variations, the azimuthal thickness distribution of the non-optical peripheral carrier region may follow a sinusoidal or quasi-sinusoidal distribution.

[0212] With this distribution characteristic, the azimuthal thickness distribution within the non-optical peripheral carrier region is non-uniform. Furthermore, while the rotational assist features of the present disclosure are contemplated, the azimuthal thickness variation may also vary as a function of radial distance within the non-optical peripheral carrier region. For example, toward the outer edge of the contact lens and toward the anterior optical zone diameter, the expected sawtooth characteristics may be reduced to blend with the uniform edge thickness. In some other embodiments, the contact lens may be designed to rotate less than 20 degrees within one hour of lens wear and less than 180 degrees once per day. It should be understood that the contact lens is still capable of generating a stop signal that varies in time and space through random lens orientation, depending on the orientation in which the contact lens is worn on any given day.

[0213] Table 1 distinguishes the disclosed designs I and II from a range of prior art contact lens designs, including commercially available designs, including single vision, bifocal, multifocal, and standard toric or astigmatic lenses. The abbreviations VAR, SYM, and PTV in Table 1 stand for variance, symmetry, and peak-to-valley, respectively. As can be seen from the table, the two differentiating elements that distinguish the disclosed designs from the prior art rely heavily on the meridional and azimuthal variations in the brightness distribution of the optical zone, and the azimuthal invariance of the thickness distribution of the non-optical peripheral carrier zone. Table 1: Description of the power and thickness of various contact lens designs.

[0214] All rotationally symmetric lens designs, such as single vision, bifocal and multifocal designs, feature a meridional and azimuthally invariant brightness distribution in their optical zones and are also configured with an azimuthally invariant thickness distribution (<10 μm) in the non-optical peripheral carrier zone.

[0215] Unlike the rotationally symmetric single vision, bifocal, and multifocal designs in Table 1, the optic zone of conventional / standard toric or toric lenses is characterized by an azimuthally varying but meridionally constant brightness distribution, and an optic peripheral carrier zone with an azimuthally varying thickness distribution (>100 μm). The presence of peaks and valleys of at least 100 μm or greater in the azimuth thickness distribution of standard toric or toric lenses is an advantage of this design. In order for a toric or toric lens to correct the eye's primary astigmatism, the toric or toric portion of the optic zone should be aligned with the eye's astigmatic axis. Furthermore, the lens should not rotate significantly on the eye to avoid any potential loss of visual quality. To prevent free rotation on the eye, conventional standard toric or toric lenses are designed with dedicated stabilization zones, such as ballast, prisms, slabs, or truncated designs. These dedicated stabilization zones are responsible for the large peaks and valleys (>100 μm) observed in toric or toric contact lenses.

[0216] For the avoidance of doubt, the lenses of the present disclosure do not have any kind of stabilizing platform, including but not limited to ballast, thinning, truncation, or the like. Instead, the non-optical peripheral carrier region of the present disclosure is configured to have a substantially constant azimuthal thickness profile, with or without rotation-assisting features, thereby allowing substantially free rotation, which makes the contact lens more susceptible to increased on-eye rotation.

[0217] The specific structural and functional details disclosed in these figures and examples should not be interpreted as limiting, but merely as a representative basis for teaching those skilled in the art to use a variety of other variations of the disclosed embodiments. The specific schematic model eye selected for illustrative purposes is to demonstrate the effects of the embodiments of the present disclosure. This should not be interpreted as limiting the scope of the invention. For example, those skilled in the art can use other schematic ray tracing model eyes such as Liou-Brennan, Escudero-Navarro, etc. instead of the model eye configuration used in the current disclosure. For example, the parameters of the cornea, lens, retina, ocular media or a combination thereof can be changed to assist in further simulation of the embodiments disclosed herein or their variations.

[0218] The examples provided in this specification have used model eyes with -1 DS and -4 DS myopia, with and without +1 DC astigmatism to disclose the present invention. The same disclosure can be extended to other degrees of myopia and / or astigmatism, for example, -2 DS, -3 DS, or -6 DS myopia, and / or astigmatism of 0.5 DC, 0.75 DC, or 1.25 DC. Astigmatism can be expressed using positive cylindrical notation (e.g., +1.25 DC) or using negative cylindrical notation (e.g., -1.25 DC). In the example embodiment, reference is made to a specific monochromatic wavelength of 589 nm. In other examples, the lens designer can extend the range to other visible wavelengths between 420 nm and 760 nm.

[0219] Certain embodiments of the present disclosure are directed to a contact lens that can be temporally and spatially variable, in other words, substantially change in retinal position over time, to provide a stopping signal to an eye with progressive myopia by allowing the contact lens to naturally rotate on the eye due to the natural blinking motion. This temporally and spatially variable stopping signal can minimize the potential effects of therapeutic saturation and / or wear-off observed with prior art lenses.

[0220] Certain embodiments of the present disclosure are directed to a contact lens that can provide a spatiotemporally varying stop signal to a progressive myopic eye with or without astigmatism, regardless of the orientation of the wearer wearing or inserting the contact lens. In some embodiments of the present disclosure, the stop signal can be configured using a meridional and azimuthally varying brightness distribution. The meridional and azimuthally varying brightness distribution can be further configured using a meridionally invariant brightness distribution around the optical center of the contact lens. In some other embodiments, the meridional and azimuthally varying brightness distribution can be configured using a substantially meridionally invariant brightness distribution. In certain embodiments of the present disclosure, the meridional and azimuthally varying brightness distribution within the optical zone of the contact lens can be configured using a radially invariant, meridionally varying distribution across the entire optical zone and an azimuthally varying distribution across a selected substantial portion of the optical zone of the contact lens, while the remainder of the zone is configured with an azimuthally invariant brightness distribution.

[0221] In some embodiments, the desired or selected local area of azimuthal variation distribution may be 25%, 30%, 35%, 40%, 45%, or 50% of the total area of the optical zone on the contact lens. In some other embodiments, the desired or selected local area of azimuthal variation distribution may be between 20% and 30%, 30% and 50%, or 15% and 45% of the total area of the optical zone on the contact lens.

[0222] In certain embodiments of the present disclosure, a meridional and azimuthally varying brightness distribution within the optical zone of a contact lens can be configured using a radially varying brightness distribution across substantially the entire optical zone; wherein the radial magnitude variation is configured to increase or decrease the brightness from the center of the optical zone to the edge of the optical zone, and the azimuth magnitude variation is configured to decrease the brightness from 0 to 2π radians.

[0223] In some contact lens embodiments of the present disclosure, a linear, curvilinear, or quadratic function may be used to describe the drop in brightness distribution along the radial direction.

[0224] In certain other embodiments of the present disclosure, the reduction in brightness distribution along the radial direction may be different for different azimuthal positions on the optical zone.

[0225] In other embodiments, the reduction in brightness distribution along the azimuthal direction may follow a cosine distribution with a decreasing frequency, for example, in some embodiments it may be one sixth (1 / 6), one fifth (1 / 5), one fourth (1 / 4), one third (1 / 3), or one half (1 / 2) of the normal expected frequency for prior art toric or astigmatic lenses. Figure 3 and Figure 8 The normal frequencies expected for toric or astigmatic lenses in the prior art can be observed or seen.

[0226] In other embodiments of the present disclosure, the reduction in brightness distribution along the azimuth direction may be different for different radial positions on the optical zone. In yet another embodiment of the present disclosure, the reduction in brightness distribution along the azimuth direction may be the same at substantially all radial positions on the optical zone.

[0227] In certain embodiments, the meridional and azimuthally varying brightness distribution can be configured such that the brightness distribution is the sum of the spherical prescription and the product of the radial or meridional and azimuth brightness distribution functions. In some embodiments, the brightness distribution function of the optical zone can be radially constant but meridionally and azimuthally variable. In some embodiments, the brightness distribution of the optical zone varies meridionally and azimuthally and is also configured to vary radially. In some other embodiments, the brightness distribution function can be radially and azimuthally constant for 10%, 20%, 30%, 40%, or 50% of the area of the contact lens' optical zone and vary azimuthally over the remainder of the optical zone.

[0228] A schematic model eye was used to simulate the optical performance results of exemplary embodiments of the present disclosure. Tables 2 and 3 list the prescription parameters of the schematic model eye used for optical modeling and performance simulation. Table 2: Schematic diagram of the myopic model eye with a prescription of -1DS.

[0229] The prescriptions provide two model eyes, one with -1DS myopia and no astigmatism, and the other with -4DS myopia and +1DC x 90° astigmatism, measured at a 6mm pupil and 589nm wavelength. The prescriptions described in Tables 2 and 3 should not be construed as necessarily demonstrating the effects of the intended exemplary embodiments. They are merely one of many methods that a person skilled in the art could employ for optical simulation purposes. In other examples, the lens designer could also vary various parameters of the model eye; for example, the lens shape, cornea, lens, retina, media, or a combination thereof, to better simulate the described effects.

[0230] To demonstrate the effects of other embodiments, other schematic model eyes such as Atchison, Escudero-Navarro, Liou-Brennan, Polans, Goncharov-Dainty may also be used instead. Table 3: Schematic diagram of the myopia model with a prescription of -4DS / +1DC×90.

[0231] Figure 3 The brightness distribution diagram (301) within the optical zone of a standard toric or astigmatic contact lens is shown, with the corresponding brightness distribution as a function of the optical zone diameter for four representative examples meridians 0°, 45°, 90°, 135° (302); and the corresponding brightness distribution as a function of the azimuth angle for four representative examples radial positions R1, R2, R3 and R4 (303) at radial distances of 0.5, 1.5, 2.5 and 3.5 mm respectively.

[0232] A toric or astigmatic lens is configured using a standard sphero-cylindrical brightness distribution function, with approximately +0.5D of brightness along one principal meridian (the vertical meridian, 90°), approximately -1D of brightness along the other principal meridian (the horizontal meridian, 0°), and approximately -0.25D of brightness along the oblique meridians of 45° and 135°. The difference between the two principal meridians is the cylindrical brightness, which in this contact lens example is 1.5DC. The brightness distribution of a toric or astigmatic lens is mirror-symmetric in that it has a radially and meridional-invariant brightness distribution that follows a cosine function with a normal frequency (i.e., two cosine cycles over 360°). Figure 3 The normal frequency of observing or seeing in standard toric or astigmatic lenses of the prior art.

[0233] Figure 4a Shows coverage Figure 3The diameter of the toric or astigmatic contact lens described in the figure is plotted along the four representative meridians (i.e., 0°, 45°, 90°, and 135°). Figure 4a As can be seen in cross sections 401a and 402a, the non-optical peripheral carrier region of the contact lens has a substantial rotational symmetry.

[0234] As previously disclosed in PCT application number PCT / AU2020 / 051004, the design facilitates substantially free rotation on or around the optical center of the contact lens due to the combination of up and down eyelid motion that promotes natural blinking. This, in turn, results in blink-dependent astigmatism or linear stimulation applied to the optical zone, thereby producing temporally and spatially varying stimulation to reduce the rate of myopia progression. Consequently, the efficacy of astigmatism cues and reduced eye growth remains substantially consistent over time.

[0235] Figure 4b The thickness distribution of the entire lens of a prior art toric contact lens is shown with astigmatism distribution along two principal meridians, 0° and 90°. Figure 4b The prior art toric lens has a prism-ballast stabilization zone. The thickness distribution of the prism-ballast lens in the vertical meridian and the horizontal meridian is typical of the prior art lens, and the cylindrical refractive index is about 1.5DC.

[0236] The horizontal section (401b) is symmetrical, while the vertical section has a thicker lower section (402b) and a thinner upper section (403b) to provide a stable orientation when worn on the eye. The steep thickness curvature in the vertical section and the flat thickness curvature in the horizontal meridian match the desired corneal astigmatism, providing good vision for astigmatism along any meridian.

[0237] Figure 4c Shown Figure 3 and Figure 4a Thickness distribution of the contact lens described in FIG as a function of azimuth along four example radial distances of 5 mm, 5.5 mm, 6 mm and 6.5 mm within the non-optical peripheral region. Figure 4c As can be seen in the figure, the thickness of the contact lens as a function of azimuth angle is essentially constant, with peak-to-valley values of <5 μm, regardless of radial distance. In addition, the maximum thickness difference observed at various representative radial positions within the non-optical peripheral region is approximately 0.07 mm.

[0238] on the contrary, Figure 4dThe thickness distribution of a prior art toric contact lens as a function of azimuth angle is shown, which shows a basically asymmetric azimuthal thickness distribution, wherein the thickness difference between the 90° and 270° azimuth angles at a radial distance of 5.5 mm, i.e., the peak-to-valley value (PTV) of the azimuthal thickness distribution is approximately 0.155 mm, thereby achieving the desired stability of the toric prior art contact lens.

[0239] The incident light of visible wavelength (589nm) was incident on the schematic model eye of -1DS myopia, and the Figure 3 、 Figure 4a and 4c The toric lens described in the correction is used, and the prescription is described in Table 2. The point spread function of the on-axis temporal and spatial variation on the retinal plane is as follows Figure 5 As shown, the lens is rotated on the eye by 0° (501), 90° (502), 180° (503) and 270° (504) over time.

[0240] In this example Figure 5 As in other examples within the present invention, visual performance was analyzed at a 6 mm pupil. The proposed method can be extended to obtain such simulations at other pupils, including but not limited to 2, 3, 4, 5, 6 mm, or any other pupil between 2 and 7 mm, or including but not limited to 30°, 60°, 120°, 150°, or any other lens rotation.

[0241] Figure 6a and 6b The wide-angle (i.e., ±10° visual field) spatiotemporal variation signals for two different azimuth eyeglass positions when the contact lens is worn on the eye are shown, wherein the embodiment of the contact lens ( Figure 3 、 4a and 4c) have their flat principal meridians located at 0° and 90°, respectively. Figure 6a and 6b The geometric spot diagram across the focal point simulates the supraocular rotation of the contact lens, resulting in an optical stop signal that varies in time and space.

[0242] Through-focus geometric point analysis was calculated around the retinal plane at five locations, from -0.4 to +0.4 mm in 0.2 mm increments; retinal locations -0.4 mm and -0.2 mm were in front of the retina; retinal location 0 mm was on the retina; and retinal locations +0.2 mm and +0.4 mm were behind the retina. It can be seen that the through-focus mosaic image between -0.4 mm and 0 mm forms a Sturm's cone or interval, which contains an elliptical blur pattern in the tangential and sagittal planes and a circle of least confusion. Behind the retina (+0.2 and +0.4 mm), the size of the elliptical blur pattern increases.

[0243] In this example, Figure 6a and 6b In the above examples, an off-axis angle of 10° for the upper and lower fields of view has been used to describe visual performance over a wider range of fields of view. Lens designers can extend the simulation to other fields of view, including but not limited to 5°, 10°, 15°, or 20° for horizontal, vertical, or any oblique field of view. In addition, those skilled in the art can extend the simulation to other lens rotations, including but not limited to 20°, 50°, 130°, 160°, or any other lens rotation. Figure 6a and 6b In other examples within the present invention, the visual performance is analyzed at a monochromatic wavelength of 589 nm. Lens designers may extend the simulation to other wavelengths, including but not limited to 555 nm, 586 nm, or 591 nm. In certain other examples, multiple wavelengths may be used to demonstrate the chromatic effects of the contact lens. All such extensions are considered within the scope and intent of the present invention.

[0244] The incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with -1DS myopia. Figure 3 、 4a and the exemplary contact lens embodiment described in 4c, the myopia prescription is described in Table 2, and the retinal signal is described as: the modulation transfer function of the tangential and sagittal meridians through the focus on the axis, as Figure 7 As shown. To evaluate the differences in contact lens rotation performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, namely, when the contact lens is worn on the eye with the flat principal meridian (-1D) at 0° (701) and 90° (702). In this example, the modulation transfer functions 701 and 702 show that the differences between the tangential meridian and the sagittal meridian are independent of the position of the azimuthal contact lens with a difference in focus shift of approximately 0.6 mm. In other words, the depth of the cone of vision, or Sturm's spacing, remains constant as a function of contact lens rotation on the eye.

[0245] Patent application number PCT / AU2020 / 051004 discloses a toric or astigmatic lens having a substantially rotationally symmetrical peripheral carrier region, such as Figure 3 、 4a and 4c, and the performance of the example lenses, as Figure 5 , 6, 7. From the optical modeling results, it can be seen that the required spatiotemporal variation signal can be achieved through this design. Figure 3 、 4aThe intended design described in [4c] provides the desired temporally and spatially varying stimulation when worn in a purely myopic eye, but this may not be the case when such a lens is worn in an eye with myopia and astigmatism. The interaction of the astigmatism or toric refractive profile in the exemplary contact lens with the inherent astigmatism in the myopic eye is likely to violate the design principles of temporally and spatially varying stop signals. The next example will illustrate the effects of this interaction.

[0246] Figure 8 The brightness diagram distribution (801) within the optical zone of a toric or astigmatic contact lens is shown, with the corresponding brightness distribution as a function of the optical zone diameter for four representative examples meridians 0°, 45°, 90°, 135° (802); and the corresponding brightness distribution as a function of the azimuth angle for four representative examples radial positions R1, R2, R3 and R4 (803) at radial distances of 0.5, 1.5, 2.5 and 3.5 mm respectively.

[0247] The toric or astigmatic lens is configured using a standard spherical cylindrical power distribution function, with one principal meridian (the vertical meridian, 90°) having approximately -2.25D of power, the other principal meridian (the horizontal meridian, 0°) having approximately -3.5D of power, and the oblique meridians 45° and 135° having approximately -2.9D of power. The difference between the two principal meridians is the cylindrical power, which in this exemplary embodiment is 1.25DC. The power distribution of the toric or astigmatic lens is symmetrical in that it has a radially and meridional invariant power distribution that follows a cosine function with normal frequency, which results in a power distribution that varies in azimuth about two mirror-image axes of symmetry (i.e., two cosine cycles over 360°). In Figure 8 The normal frequencies expected from standard toric or astigmatic lenses in the prior art can be observed or seen.

[0248] Figure 9a Shown Figure 8 Thickness distribution across the diameter of the example contact lens described in FIG, as well as astigmatism distribution along four representative example meridians at 0°, 45°, 90°, and 135°. As can be seen in cross-sections 901a and 902a of FIG9 , the non-optical zone of the lens has a substantially rotationally symmetrical peripheral carrier zone. As previously disclosed in patent application number PCT / AU2020 / 051004, this design facilitates substantially free rotation at or about the optical center of the contact lens, as the combined action of the upper and lower eyelids promotes natural blinking.

[0249] This in turn results in blink-varying astigmatism or linear stimulation applied by the optical zone, resulting in a stimulation that varies in time and space to reduce the wearer's rate of myopia progression; thus, the directional cueing of astigmatism and the efficacy of reducing eye growth remain essentially consistent over time.

[0250] Figure 9b The thickness distribution along the radial distance of 4.5mm, 5.25mm, 5.75mm and 6.25mm for four examples is shown. Figure 9b As can be seen in the figure, the thickness of the contact lens remains essentially constant as a function of azimuth angle, independent of radial distance, with peak-to-valley values <10 μm. Furthermore, the maximum thickness difference between different radii is approximately 0.04 mm.

[0251] On the contrary, Figure 9c The thickness distribution as a function of azimuth angle for another example of a prior art toric contact lens is shown, which shows a sinusoidal thickness variation as a function of azimuth angle, wherein the thickness difference is between 90° and 270° azimuth angles, and the peak-to-valley value (PTV) of the azimuth thickness distribution is approximately 0.19 mm at a radial distance of 5.5 mm, resulting in toric stabilization of the prior art contact lens.

[0252] When incident light of parallel visible wavelength (589nm) is incident on the schematic eye with a prescription of -4DS / +1DC×90, Figure 8 、 Figure 9a and the toric lens described in b for correction, Figure 10 The on-axis point spread functions obtained in the retinal plane over time and space are shown, where the lens is rotated on the eye by 0° (1001), 90° (1002), 180° (1003) and 270° (1004) over time.

[0253] Figure 11a and 11b The temporal and spatial variations of the signals for wide angles (i.e., ±10° field of view) are shown for two different azimuthal contact lens positions, i.e., where the contact lens embodiment ( Figure 8 and 9) have their angles of the flat principal meridian (-3.5D) located at 0° and 90°, respectively. Figure 11a and 11b The through-focus geometric point diagram simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time. The through-focus geometric point analysis is calculated around the retinal plane at five positions, from -0.6 to +0.6 mm, in 0.3 mm increments; retinal positions -0.6 mm and -0.3 mm are in front of the retina; retinal position 0 mm is on the retina; and retinal positions +0.3 mm and +0.6 mm are behind the retina.

[0254] It can be seen that in this example, the toric contact lens ( Figure 8 as well as Figure 9a and b) correcting myopic astigmatism, the size and shape of the elliptical blur pattern changes with lens rotation. When the contact lens is rotated, it will cause changes in visual performance. When the incident light of parallel visible wavelength (589nm) is incident on the schematic model eye of -4DS / +1DC×90 (Table 3), the Figure 8 and Figure 9a and b) with the toric lens correction, the retinal signal is described as the modulation transfer function of the tangential and sagittal meridians through the focus on axis, as Figure 12 .

[0255] To evaluate the performance differences of contact lens rotation over time, modulation transfer functions were calculated for two azimuthal contact lens positions: 0° (1201) and 90° (1202) at the flat principal meridian (-3.5D) when the contact lens is worn. These two scenarios provide the best and worst combinations for evaluating the interaction between the eye's astigmatism and the contact lens's cylindrical power.

[0256] In this example, modulation transfer functions 1201 and 1202 show that the distance between the tangential meridian and the sagittal meridian is different at two azimuth contact lens positions. When the contact lens is worn on the eye with the flat principal meridian (-3.5D) at 0° (1201s), the eye's astigmatism is substantially corrected because the distance between the tangential meridian and the sagittal meridian is only about 0.1 mm. However, when the contact lens is worn on the eye (1202) with the flat principal meridian (-3.5D) at 90°, the eye's astigmatism increases, and the distance between the tangential meridian and the sagittal meridian is about 0.9 mm.

[0257] In other words, the cone depth or Sturm interval varies as a function of the rotation of the contact lens on the eye due to the interaction between the cylindrical power of the contact lens and the astigmatism of the eye.

[0258] The expansion or contraction of cone depth or Sturm's distance as a function of contact lens rotation can cause significant visual impairment for astigmatic myopic wearers. It is therefore desirable to minimize significant changes in cone depth or Sturm's distance as a function of lens rotation on the eye.

[0259] from Figure 12As can be seen from the simulations described in , the difference in distance between the tangential and sagittal meridians for the two azimuthal contact lens positions 1201 and 1202 is approximately 0.8 mm. This is quite large and may result in significant changes in the visual performance of the lens wearer. Although temporal changes are fundamental to strategies for combating progressive myopia, as disclosed herein, significant visual changes may cause poor compliance, which is often observed in other existing lens designs.

[0260] Such limitations can be overcome, especially for eyes with myopia and astigmatism. The various disclosed embodiments of the present invention solve this problem by anticipating the design to minimize visual changes when worn by people with myopia and astigmatism, as shown in the following examples.

[0261] Figure 13 The brightness diagram distribution (1301) within the optical zone of the contact lens of an embodiment of the present disclosure is shown, with the corresponding brightness distribution as a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, and 135° (1302); and the corresponding brightness distribution as a function of the azimuth angle at radial distances of 0.5, 1.5, 2.5, and 3.5 mm, respectively, for four representative examples of radial positions R1, R2, R3, and R4 (1303).

[0262] While embodiments of the contact lens of the present invention have a radially constant, azimuthally varying brightness distribution (brightness: -1DS / +1.5D, half-area lens) in one half-area of the optical zone, the other half-area of the optical zone has a spherical brightness distribution (-1DS). As can be seen in 1302 and 1303, the brightness distribution of the half-area defined by the azimuth angles of 0° to 180° varies between approximately -1D, -0.25D, and +0.5D at the 0°, 45° / 135°, and 90° meridians, respectively, resulting in an incremental brightness of approximately 1.5D. The brightness in the other half-area remains constant at -1D.

[0263] Figure 14a Shown Figure 13 The thickness distribution of the half-area lens example described in has a radially constant, meridional and azimuthal brightness distribution along the four representative meridians 0°, 45°, 90° and 135°. Figure 14a As can be seen in cross-sections 1401a and 1402a, the non-optical zone of the lens has a substantially rotationally symmetric peripheral carrier region.

[0264] Because the combined action of the upper and lower eyelids promotes natural blinking, this design facilitates approximately free rotation on or around the optical center of the contact lens. This, in turn, causes the stimulation applied by the optical zone of the half-area design to vary with blinking, resulting in temporally and spatially varying stimulation to reduce the wearer's rate of myopia progression. Consequently, the efficacy of reducing ocular growth remains essentially consistent over time.

[0265] Figure 14b The thickness distribution along four example radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm in the non-optical peripheral region is shown. Figure 13 and Figure 14a as a function of the azimuth angle of the contact lens.

[0266] from Figure 14b It can be seen that, regardless of radial distance, the thickness of the contact lens is essentially a function of the azimuthal angle, with a peak-to-valley variation of less than 5 μm. In addition, the maximum thickness difference between different radii is approximately 0.04 mm.

[0267] When the incident light of parallel visible wavelength (589nm) is incident on the myopic simulated eye of -1DS, the prescription is shown in Table 2, and the Figure 13 and Figure 14b The exemplary contact lens described in the present invention is corrected to obtain a time- and space-varying on-axis point spread function in the retinal plane, wherein the lens is rotated on the eye by 0° (1501), 90° (1502), 180° (1503) and 270° (1504) over time, see Figure 15 .

[0268] Figure 16a and 16b FIG1 shows the spatiotemporal variation signals of wide angle (i.e., ±10° field of view) at two different azimuth positions when the contact lens is worn on the eye, wherein the brightness is -1D (as shown in 1302 along 0° in FIG1 ) of the contact lens embodiment ( Figure 13 and 14) are located at 0° and 90° respectively.

[0269] Figure 16a and 16b The through-focus geometric spot diagram simulates rotation of the contact lens on the eye, resulting in a spatially and temporally varying optical stop signal. The resulting through-focus retinal image, referred to as a locally blurred cone or space, provides at least partial correction for myopia and at least partially provides a spatially and temporally varying optical stop signal or stimulus.

[0270] Geometric point analysis of through-focus around the retinal plane was calculated at five positions, from -0.4 to +0.4 mm, in 0.2 mm steps; retinal positions -0.4 mm and -0.2 mm were in front of the retina; retinal position 0 mm was on the retina; and retinal positions +0.2 mm and +0.4 mm were behind the retina.

[0271] Figure 6a and 6b Unlike the toric lens seen in , which focuses the mosaic image through, the blurred image varies in size (i.e., focus) and direction between the two azimuthal contact lens positions. Figure 16a and 16b The image of the example half-area contact lens embodiment in FIG. 1 changes only in direction. Compared with a toric lens, the rotational properties of the half-area contact lens have less impact on visual performance.

[0272] When the incident light of parallel visible wavelength (589nm) is incident on the -1D myopic schematic model eye, the myopic prescription is shown in Table 2. Figure 13 and Figure 14b For the exemplary contact lens correction described, the retinal signal is described as the modulation transfer function of the tangential and sagittal meridians on axis through the focus, see Figure 17 .

[0273] To evaluate the differences in contact lens rotational performance over time, modulation transfer functions were calculated for two azimuthal contact lens positions, i.e., when the contact lens is worn on the eye, with the principal meridian (-1D along 0°, as shown in 1302) at 0° (1701) and 90° (1702).

[0274] In this example, the modulation transfer functions 1701 and 1702 show that the difference between the tangential meridian and the sagittal meridian is independent of the position of the azimuthal contact lens (the difference in focus shift is approximately 0.5 mm). Figure 7 The toric contact lens shown is smaller, again demonstrating that contact lens rotation has less of an impact on visual performance for the half-area lens than for the prior art toric lenses. In this example, the cone depth, or the separation of the partial blur, remains constant as a function of on-eye lens rotation.

[0275] Figure 18The brightness diagram distribution (1801) within the optical zone of the contact lens of an embodiment of the present disclosure is shown, with the corresponding brightness distribution as a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, 135° (1802); and the corresponding brightness distribution as a function of the azimuth angle at radial distances of 0.5, 1.5, 2.5 and 3.5 mm for four representative examples of radial positions R1, R2, R3 and R4 (1803).

[0276] In one half-area area of the optical zone of the contact lens embodiment of the present invention, there is a radially constant and azimuthally varying brightness distribution (brightness: -3.5DS / +1.25D, half-area lens), while in the other half-area area of the optical zone, there is a spherical brightness distribution (-3.5DS).

[0277] As can be seen from Figures 1802 and 1803, the brightness distribution of the half-area defined by the azimuth angle of 0° to 180°, corresponding to the 0°, 45° / 135° and 90° meridians, varies between approximately -3.5D, -2.9D and -2.25D, respectively, and produces an incremental brightness of approximately 1.25D. The brightness in the other half-area remains constant at -3.5DS.

[0278] Figure 19a Shown Figure 18 Thickness distribution of the half-area example described in , with radially invariant, meridional and azimuthally varying brightness distributions along the meridians of four representative examples at 0°, 45°, 90° and 135°. Figure 19a As can be seen in cross-sections 1901a and 1902a, the non-optical zone of the lens has a substantially rotationally symmetric peripheral carrier region.

[0279] Because the combined action of the upper and lower eyelids promotes natural blinking, the design facilitates approximately free rotation at or around the optical center of the contact lens. This, in turn, causes the stimulus applied by the optical zone of the half-area lens design to vary with blinking, resulting in a temporally and spatially varying stimulus that reduces the wearer's rate of myopia progression. Consequently, the efficacy of reducing ocular growth progression remains essentially consistent over time.

[0280] Figure 19b Shown Figure 18 and Figure 19a Thickness distribution of the contact lens described in FIG. 5 as a function of azimuthal angle in the non-optical peripheral region at radial distances of 4.25 mm, 4.75 mm, 5.5 mm, and 6.5 mm for four examples.

[0281] from Figure 19bIt can be seen that the thickness of the contact lens is essentially constant as a function of azimuth angle, regardless of radial distance, with a peak-to-valley value of <10 μm. In addition, the maximum thickness difference between different radii is approximately 0.06 mm.

[0282] The incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with a prescription of -4DS / +1DC×90° (Table 3). Figure 18 and Figure 19a Correction with the contact lens described in b yields a spatiotemporally varying on-axis point spread function on the retinal plane, as Figure 20 As shown, the glasses are rotated on the eyes by 0° (2001), 90° (2002), 180° (2003) and 270° (2004) over time.

[0283] Figure 21a and 21b FIG1 shows the spatiotemporal variation signals of wide angle (i.e., ±10° visual field) at two different azimuth positions when the contact lens is worn on the eye, wherein the contact lens embodiment ( Figure 18 and 19) have meridians of degrees -3.5D (along 0°, as shown in 1802) located at 0° and 90° respectively.

[0284] Figure 21a and 21b The geometric spot diagram through the focus simulates the rotation of the contact lens on the eye, thereby generating an optical stop signal that varies in space and time.

[0285] Through-focus geometric point analysis around the retinal plane was calculated at five positions, from -0.6 to +0.6 mm, in 0.3 mm steps; retinal positions -0.6 mm and -0.3 mm were in front of the retina; retinal position 0 mm was on the retina; and retinal positions +0.3 mm and +0.6 mm were behind the retina.

[0286] Figure 11a and 11b Unlike the toric lens seen in , which focuses the mosaic image through, the blurred image varies in size (i.e., focus) and direction between the two azimuthal contact lens positions. Figure 21a and 21b The image of the example half-area contact lens embodiment in FIG. 1 changes only in direction. Compared with a toric lens, the rotational properties of the half-area contact lens have less impact on visual performance.

[0287] The incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with a prescription of -4DS / +1DC×90° (Table 3). Figure 18 as well as Figure 19aThe retinal signal is described as the modulation transfer function of the tangential and sagittal meridians through the focus. Figure 22 .

[0288] To evaluate differences in contact lens rotational performance over time, modulation transfer functions were calculated for two azimuthal contact lens positions, at 0° (2201) and 90° (2202) on the principal meridian (-3.5D along 0°, as shown in 1802).

[0289] In this example, the modulation transfer functions 2201 and 2202 show that the difference between the tangential meridian and the sagittal meridian (ie, the peak closest to the retina) is approximately 0.4 mm in 2201 and 2202. Figure 8 This difference is smaller than the 0.8 mm focus shift for the toric contact lens shown, again indicating that lens rotation has less of an impact on visual performance with the half-area lens than with the toric lens.

[0290] In this example, the cone depth or partial blur interval varies as a function of the rotation of the lens on the eye, due to the interaction between the brightness increment of the contact lens and the astigmatism of the eye. Figure 12 Compared to the Sturm cone depth of the toric contact lens example, the expansion or contraction of the cone depth or the partial blur interval as a function of contact lens rotation is minimized.

[0291] Figure 23 A brightness distribution diagram (2301) within the optical zone of a contact lens of an embodiment of the present disclosure is shown, with corresponding brightness distributions as a function of optical zone diameter for four representative examples of meridians 0°, 45°, 90°, and 135° (2302); and corresponding brightness distributions as a function of azimuth angle for four representative examples of radial positions R1, R2, R3, and R4 (2303) at radial distances of 0.5, 1.5, 2.5, and 3.5 mm, respectively. The contact lens embodiment of the present invention has a radially invariant, meridional, and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, half-frequency cosine lens (1)). It can be seen from 2302 and 2303 that the brightness distribution of the half-area area defined by the azimuth angle of 0° to 180° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -0.25D, 0.25D and 0.5D; the brightness distribution of the half-area area defined by the azimuth angle of 180° to 360° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -0.25D, -0.75D and -1D, and produces an incremental brightness of approximately 1.5D.

[0292] Figure 24ashows the thickness distribution of an example of a half-frequency cosine lens (1) with Figure 23 Depicted are the radially invariant, meridional, and azimuthally varying brightness distributions along the meridians of four representative examples at 0°, 45°, 90°, and 135°. Figure 24a As can be seen in cross-sections 2401a and 2402a of the lens, the non-optical zone has a substantially rotationally symmetrical peripheral carrier zone. This design facilitates substantially free rotation on or about the optical center of the contact lens, as the combined action of the upper and lower eyelids promotes natural blinking. This, in turn, results in the stimulus applied by the optical zone of the half-frequency cosine lens (1) design varying with blinking, thereby resulting in a spatiotemporally varying stimulus that reduces the rate of myopia progression in the wearer; thus, the efficacy of reducing ocular growth progression remains substantially consistent over time.

[0293] Figure 24b Shown in Figure 23 and Figure 24a Described in Figure 3 are the thickness distributions as a function of azimuth angle along four example radial distances of 4.25 mm, 4.75 mm, 5.5 mm and 6.5 mm within the non-optical peripheral region of the contact lens.

[0294] from Figure 24b It can be seen that the thickness of the contact lens is essentially constant as a function of azimuth angle, regardless of radial distance, with a peak-to-valley value of less than 10 μm. In addition, the maximum thickness difference between different radii is approximately 0.06 mm.

[0295] The incident light of parallel visible wavelength (589nm) is incident on the -1D myopic simulated eye (myopia prescription see Table 2), Figure 23 and Figure 24a The exemplary contact lenses described in a and b are used for correction, resulting in an on-axis spatiotemporal variation of the point spread function on the retinal plane, such as Figure 25 As shown, where the lens is rotated on the eye by 0° (2501), 90° (2502), 180° (2503) and 270° (2504) over time.

[0296] Figure 26a and 26b The wide-angle (i.e., ±10° visual field) spatiotemporal variation signals for two different azimuth positions when the contact lens is worn on the eye are shown, i.e., the contact lens embodiment with a refractive index of -0.25D ( Figure 23 as well as Figure 24a and b) have meridians (along 0°, as shown in Figure 2302) located at 90° and 180°, respectively.

[0297] Figure 26a and 26bThe through-focus geometry plot simulates the rotation of the contact lens on the eye, resulting in a spatially and temporally varying optical stop signal. The through-focus geometry plot was calculated around the retinal plane at five positions, from -0.4 to +0.4 mm in 0.2 mm increments; retinal positions -0.4 mm and -0.2 mm are in front of the retina; retinal position 0 mm is on the retina; and retinal positions +0.2 mm and +0.4 mm are behind the retina.

[0298] Figure 6a and 6b Unlike the toric lens through-focus mosaic image seen in , where the blurred image varies in size (i.e., focus) and direction between the two azimuthal contact lens positions, Figure 26a and 26b The image of the example half-frequency cosine lens (1) embodiment changes only in direction. Therefore, the rotational properties of the half-frequency cosine (1) contact lens have less impact on visual performance than those of a toric lens.

[0299] When the incident light of parallel visible wavelength (589nm) is incident on the schematic model eye of -1D myopia, the prescription is shown in Table 2, and the Figure 23 and Figure 24a The retinal signal is described by the modulation transfer function of the tangential and sagittal meridians through the focus axis, as shown in FIG. Figure 27 To evaluate the performance differences with time-varying contact lens rotation, the modulation transfer functions for two azimuthal contact lens positions were calculated when the contact lens was worn on the eye and when the principal meridian (-0.25D, along 0°, as shown in 2302) was located at 0° (2701) and 90° (2702).

[0300] In this example, the modulation transfer functions 2701 and 2702 show that the difference between the tangential meridian and the sagittal meridian (i.e., the peak closest to the retina) is independent of the position of the azimuthal contact lens, with the difference in focus shift being approximately 0.24 mm. Figure 7 The difference is smaller than the approximately 0.6 mm focus shift for the toric contact lens shown, indicating that lens rotation has less of an impact on visual performance using a half-frequency cosine lens (1) than a toric contact lens. In this example, the cone depth or partial blur interval remains constant as a function of lens rotation.

[0301] Figure 28The brightness distribution diagram (2801) of the contact lens of the present disclosure is shown, with the corresponding brightness distribution as a function of the diameter of the optical zone for four representative examples of meridians 0°, 45°, 90°, and 135° (2802); and the corresponding brightness distribution as a function of the azimuth angle for four representative examples of radial positions R1, R2, R3, and R4 (2803) at radial distances of 0.5, 1.5, 2.5, and 3.5 mm, respectively. The contact lens embodiment of the present disclosure has a radially invariant, meridional, and azimuthally varying brightness distribution (brightness: -3.5DS / +1.25D, half-frequency cosine lens (2)).

[0302] It can be seen from 2802 and 2803 that the brightness distribution of the area defined by the azimuth angle of 0° to 180° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -2.9D, 2.5D and -2.25D respectively; the brightness distribution of the area defined by the azimuth angle of 180° to 360° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -2.9D, -3.3D and -3.5D respectively, resulting in an incremental brightness of approximately 1.25D.

[0303] Figure 29a Shown Figure 28 Thickness distribution of the half-frequency cosine lens (2) example described in FIG, which has radially invariant, meridional and azimuthal brightness distributions along the four representative meridians of 0°, 45°, 90° and 135°.

[0304] from Figure 29a As can be seen in cross-sections 2901a and 2902a of the lens, the non-optical region has a substantially rotationally symmetrical peripheral carrier region. Since the combined action of the upper and lower eyelids promotes natural blinking, this design facilitates substantially free rotation on or around the optical center of the contact lens. In turn, this results in the stimulus applied by the optical region designed by the half-frequency cosine lens (2) varying with blinking, thereby resulting in a temporally and spatially varying stimulus that reduces the rate of progression of myopia in the wearer. As a result, the efficacy of reducing ocular growth remains substantially consistent over time.

[0305] Figure 29b The thickness distribution along the radial distance of 4.5mm, 5.25mm, 5.75mm and 6.25mm for four examples is shown. Figure 28 and Figure 29a as a function of the azimuth angle of the contact lens.

[0306] from Figure 29bIt can be seen that the thickness of the contact lens remains essentially constant regardless of radial distance, with peaks and valleys less than 5 μm as a function of azimuth angle. In addition, the maximum thickness difference between different radii is approximately 0.04 mm.

[0307] When incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with a prescription of -4DS / +1D×90 (Table 3), Figure 28 and Figure 29a and the exemplary contact lenses described in b are corrected to obtain Figure 30 The on-axis point spread function of the retinal plane is shown as a function of time and space, where the glasses are rotated on the eye by 0° (3001), 90° (3002), 180° (3003) and 270° (3004) over time.

[0308] Figure 31a and 31b The spatiotemporal variation signals of wide angle (i.e., ±10° visual field) at two different azimuth positions when the contact lens is worn on the eye are shown, i.e., the brightness is -2.9D contact lens embodiment ( Figure 28 and Figure 29a and b) have meridians (along 0°, as shown in Figure 2802) located at 0° and 90°, respectively.

[0309] Figure 31a and 31b The geometric spot diagram through the focus simulates the rotation of the contact lens on the eye, which produces an optical stop signal that varies in space and time.

[0310] Through-focus geometric point analysis around the retinal plane was calculated at five positions, from -0.6 to +0.6 mm, in 0.3 mm steps; retinal positions -0.6 mm and -0.3 mm were in front of the retina; retinal position 0 mm was on the retina; and retinal positions +0.3 mm and +0.6 mm were behind the retina.

[0311] Figure 11a and 11b Unlike the toric lens through-focus mosaic image seen in , the blurred image varies significantly more in size (i.e., focus) and direction between the two azimuthal contact lens positions. Figure 31a and 31b The image of the example half-frequency cosine lens (2) embodiment has only a small change. Therefore, the rotation of the half-frequency cosine (2) contact lens has less impact on visual performance than that of a toric lens.

[0312] When the incident light of parallel visible wavelength (589nm) is incident on the schematic model eye of -4DS / +1D×90° prescription (Table 3), Figure 28 and Figure 29a With the exemplary contact lens correction described in b and c, the retinal signal is described by the modulation transfer function of the tangential and sagittal meridians on axis through the focus, as Figure 32 shown

[0313] To evaluate the differences in contact lens rotational performance over time, modulation transfer functions were calculated for two azimuthal contact lens positions, with the contact lens positioned at 0° (3201) and 90° (3202) with its principal meridian (along 0°, -2.9D, as shown in 2802) when the contact lens was worn on the eye.

[0314] In this example, the modulation transfer functions 3201 and 3202 show that the difference between the tangential meridian and the sagittal meridian (i.e., the peak closest to the retina) is approximately 0.2 mm at 2201 and approximately 0.6 at 2202. Figure 8 This is shown to have a smaller variation compared to the 0.8 mm of the toric contact lens, indicating that the visual performance produced by contact lens rotation using the half frequency cosine lens (2) is less than that of the toric prior art lens. In this example, the modulation transfer functions 3201 and 3202 show that the difference between the tangential meridian and the sagittal meridian (i.e., the peak closest to the retina) is approximately 0.2 mm (2201) and 0.6 mm (2202), which is a focus shift of approximately 0.2 mm. Figure 8 The toric contact lens shown is smaller by approximately 0.8 mm, indicating that contact lens rotation using a half-frequency cosine lens (2) has less impact on visual performance than prior art toric contact lenses.

[0315] In this example, the cone depth or partially blurred interval varies as a function of the rotation of the contact lens on the eye, due to the interaction between the incremental brightness of the contact lens and the astigmatism of the eye. Figure 12 Compared to the Sturm's cone depth for the toric contact lens example, the expansion or contraction of the cone depth or the partially blurred interval as a function of contact lens rotation is minimal.

[0316] Figure 33 The brightness distribution diagram (3301) within the optical zone of a contact lens of an embodiment of the present disclosure is shown, with the corresponding brightness distribution as a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, and 135° (3302); and the corresponding brightness distribution as a function of the azimuth angle for four representative examples of radial positions R1, R2, R3, and R4 (3303) at radial distances of 0.5, 1.5, 2.5, and 3.5 mm, respectively. The contact lens embodiment of the present invention has a radially invariant, meridional, and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, flipped half-quasi-cosine lens (1)).

[0317] It can be seen from 3302 and 3303 that the regional brightness distribution defined by the azimuth angle of 0° to 180° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -0.25D, 0.12D and 0.5D respectively; the regional brightness distribution defined by the azimuth angle of 180° to 360° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -0.25D, -0.63D and -1D respectively, and produces an incremental brightness of approximately 1.5D.

[0318] Figure 23 The contact lens embodiment has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Figure 33 The brightness distribution of the example has a horizontal plateau feature between 170° and 190°.

[0319] Figure 34a Shown Figure 23 The thickness distribution of the example of the flipped half-quasi-cosine lens (1) shown in FIG, has radially invariant, meridian and azimuthally varying brightness distributions along four representative meridians (i.e., 0°, 45°, 90°, and 135°).

[0320] from Figure 34a As can be seen in cross sections 3401a and 3402a, the non-optical region of the lens has a substantially rotationally symmetric peripheral carrier region with a peak thickness of approximately 0.18 mm.

[0321] also, Figure 34b The thickness of an exemplary contact lens as a function of azimuthal angle is shown for the left lens peripheral carrier region at an average radial distance of about 5 mm, which results in an auxiliary counterclockwise rotation of the contact lens on the eye (ie, down the nose).

[0322] The thickness of the lens periphery varies in a sawtooth pattern having approximately 6 teeth in total and wherein the amplitude of each sawtooth is approximately 0.02 mm, ie, the thickness varies between approximately 0.18 and 0.2 mm.

[0323] The number of teeth can be increased up to 20 to minimize potential discomfort. In some embodiments, within the toothed morphology, sharp junctions between the teeth and the inner optic zone and the outer edge can be blended.

[0324] Such a peripheral thickness profile can assist in rotation at or about the optical center of the contact lens as the combined action of the upper and lower eyelids promotes natural blinking.

[0325] This, in turn, results in the stimulus applied by the optical zone of the flipped semi-quasi-cosine lens (1) design changing with blinking, resulting in a spatiotemporally varying optical signal or stimulus that reduces the wearer's rate of myopia progression; thus, the efficacy of reducing eye growth remains essentially consistent over time.

[0326] In order to support the natural rotation direction of the lens on the eye, a mirrored lens can be worn in the left and right eyes. When the incident light of parallel visible wavelength (589nm) is incident on the myopic schematic eye of -1DS, the prescription is shown in Table 2, and the Figure 33 and Figure 34a and b) for correction with the exemplary contact lens described in a, b) and b) resulting in a spatiotemporal point spread function on an axis in the retinal plane, wherein the lens is varied over time and rotated on the eye by 0° (3501), 90° (3502), 180° (3503) and 270° (3504), as shown in FIG. Figure 35 shown.

[0327] Figure 36a and 36b The spatiotemporal variation signals for wide angle (i.e., ±10° field of view) at two different azimuthal positions when the contact lens is worn on the eye are shown, i.e., the contact lens embodiment in which the diopter is -0.25D (along 0°, as shown in FIG. 3302 ). Figure 33 as well as Figure 34a and b) have meridians at 0° and 270°, respectively.

[0328] Figure 36a and 36b The geometric spot diagram through the focus simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time.

[0329] Geometric point analysis of through-focus around the retinal plane was calculated at five positions, from -0.4 to +0.4 mm, in 0.2 mm steps; retinal positions -0.4 mm and -0.2 mm were in front of the retina; retinal position 0 mm was on the retina; and retinal positions +0.2 mm and +0.4 mm were behind the retina.

[0330] Figure 6a and 6b Unlike the toric lens seen in the figure, which intersects the focal mosaic image, the blurred image varies in size (i.e., focus) and direction between the two azimuth contact lens positions. Figure 36a and 36b The image of the flipped semi-cosine lens (1) embodiment shown in the example only changes in direction. Therefore, the rotational property of the flipped semi-cosine lens (1) has less influence on the visual performance than that of a toric lens.

[0331] When the incident light of parallel visible wavelength (589nm) is incident on the myopic model eye of -1DS, the prescription is shown in Table 2, and the Figure 33 and Figure 34a and Figure 34b The exemplary contact lens described herein is corrected, and the retinal signal is described by the modulation transfer function of the tangential meridian and the sagittal meridian through the focus on axis, as shown in FIG. Figure 37 shown.

[0332] To evaluate the differences in contact lens rotation performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, namely, a 0.25D contact lens at 0° (3701) and 90° (3702) along the principal meridians (along 0°, as shown in 3302). In this example, the modulation transfer functions 3701 and 3702 show that the difference between the tangential meridian and the sagittal meridian (i.e., the peak closest to the retina) is independent of the position of the azimuthal contact lens, and the difference in focus shift is approximately 0.27 mm, which is greater than Figure 7 The toric contact lens shown in Figure 2 has a smaller focus shift of approximately 0.6 mm, indicating that the rotation of the flipped half-cosine lens (1) has less effect on visual performance than the toric lens. In this example, the cone depth or the interval between partial blurs remains constant as a function of on-eye contact lens rotation.

[0333] Figure 38 The brightness diagram distribution (3801) within the optical zone of the contact lens of an embodiment of the present disclosure is shown, with the corresponding brightness distribution as a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, 135° (3802); and the corresponding brightness distribution as a function of the azimuth angle at radial distances of 0.5, 1.5, 2.5 and 3.5 mm for four representative examples of radial positions R1, R2, R3 and R4 (3803).

[0334] The contact lens embodiment of the present invention has a radially invariant, meridional and azimuthal brightness distribution (diopter: -3.5DS / +1.25D, flipped semi-cosine lens (2)).

[0335] It can be seen from 3802 and 3803 that the regional brightness distribution defined by the azimuth angle of 0° to 180° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -2.9D, -2.5D and -2.25D respectively; the regional brightness distribution defined by the azimuth angle of 180° to 360° corresponds to the 0°, 45° / 135° and 90° meridians, varying between approximately -2.9D, -3.2D and -3.5D respectively, resulting in an incremental brightness of approximately 1.25D respectively.

[0336] Figure 28The contact lens embodiment has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Figure 38 The brightness distribution of the example has a horizontal plateau feature between 0° and 180°.

[0337] Figure 39a Shown Figure 38 The thickness distribution of the example of the flipped half-cosine lens (2) shown in FIG, has radially invariant, meridian and azimuthally varying brightness distributions along four representative meridians (i.e., 0°, 45°, 90°, and 135°).

[0338] from Figure 39a As can be seen in cross sections 3901a and 3902a, the non-optical region of the lens has a substantially rotationally symmetric peripheral carrier region with a peak thickness of approximately 0.20 mm.

[0339] also, Figure 39b The thickness of an exemplary contact lens as a function of azimuthal angle is shown for the left lens peripheral carrier region at an average radial distance of about 5 mm, which results in an auxiliary counterclockwise rotation of the contact lens on the eye (ie, down the nose).

[0340] The thickness of the lens periphery varies in a sawtooth pattern having approximately 12 teeth in total and wherein the amplitude of each sawtooth is approximately 0.02 mm, i.e., the thickness varies between approximately 0.19 and 0.21 mm. A suitable amplitude of the tooth pattern may vary between 0.05 mm and 0.05 mm, with the amplitude generally decreasing towards the optical zone and lens diameter.

[0341] The thickness variation can preferably be added to the anterior peripheral region to promote interaction with the eyelid. Due to natural blinking promoted by the combined action of the upper and lower eyelids, this azimuthal peripheral thickness distribution can account for rotation at or about the optical center of the contact lens. In turn, this causes the stimulus applied by the optical zone of the flipped semi-cosine lens (2) design to vary with blinking, resulting in a spatiotemporally varying optical signal or stimulus to reduce the rate of progression of astigmatic myopia. Thus, the efficacy of such reduction in ocular growth remains substantially consistent over time.

[0342] When the incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription -4DS / +1DC×90° (Table 3), Figure 38 and Figure 39a Correction with the exemplary contact lens described in b and c results in an on-axis time-space varying point spread function on the retinal plane, such as Figure 40As shown, the glasses are rotated on the eyes by 0° (4001), 90° (4002), 180° (4003) and 270° (4004) over time.

[0343] Figure 41a and 41b FIG1 shows the spatiotemporal variation signals of wide angle (i.e., ±10° visual field) at two different azimuth positions when the contact lens is worn on the eye, wherein the contact lens embodiment with a refractive index of -2.9D ( Figure 38 and 39) have meridians (along 0°, as shown in FIG. 3802) located at 0° and 90°, respectively. Figure 41a and 41b The through-focus geometry plot simulates the rotation of the contact lens on the eye, resulting in a spatially and temporally varying optical stop signal. The through-focus geometry analysis around the retinal plane was calculated at five positions, from -0.6 to +0.6 mm, in 0.3 mm steps; retinal positions -0.6 mm and -0.3 mm are in front of the retina; retinal position 0 mm is on the retina; and retinal positions +0.3 mm and +0.6 mm are behind the retina. Figure 11a and 11b Unlike the toric lens through-focus mosaic image seen in , where the blurred image changes significantly in size (i.e., focus) and direction between the two azimuth contact lens positions, Figure 36a and 36b The image variation of the flipped semi-cosine lens (2) of the example in FIG is smaller. Therefore, the rotation of the flipped semi-cosine lens (2) has less influence on the visual performance than that of a toric lens.

[0344] When the incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription -4DS / +1DC×90° (Table 3), Figure 38 and Figure 39a The exemplary contact lens corrections described in a and b result in retinal signals described by modulation transfer functions on-axis through the focus in the tangential and sagittal meridians, as Figure 42 shown.

[0345] To evaluate the differences in contact lens rotational performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, with the principal meridian of the contact lens (luminance -2.9D along 0°, as shown in 3302) at 0° (3801) and 90° (3802).

[0346] In this example, the modulation transfer functions 3801 and 3802 show that the difference between the tangential meridian and the sagittal meridian (i.e., the peak closest to the retina) is 0.2 mm (4201) and 0.7 mm (4202), which is a difference in focus shift. Figure 8 The toric contact lens shown in FIG is about 0.8 mm smaller, which indicates that the rotation of the flipped half-cosine lens (2) has less effect on visual performance than that of the toric lens.

[0347] In this example, the cone depth or the interval of partial blur varies as a function of the rotation of the contact lens on the eye due to the interaction between the refraction of the contact lens and the astigmatism of the eye. Figure 12 Sturm cone depth comparison for a toric contact lens example, with minimal expansion or contraction of the cone depth or partially blurred interval depth as a function of contact lens rotation.

[0348] Figure 43 The brightness distribution diagram (4301) within the optical zone of a contact lens of an embodiment of the present disclosure is shown, with the corresponding brightness distribution as a function of the diameter of the optical zone for four representative examples of meridians 0°, 45°, 90°, and 135° (4302); and the corresponding brightness distribution as a function of the azimuth angle for four representative examples of radial positions R1, R2, R3, and R4 (4303) at radial distances of 0.5, 1.5, 2.5, and 3.5 mm, respectively. The contact lens embodiment of the present invention has a radially invariant, meridional, and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, flipped semi-quasi-cosine lens (with negative spherical aberration) (1)).

[0349] As can be seen in 4302 and 4303, the brightness distribution of the area defined by the azimuth angle of 0° to 180° corresponds to the meridians of 0°, 45° / 135° and 90°, varying between approximately -0.65 to -0.25D, -0.25 to -0.1D and 0.1 to 0.5D, respectively; the brightness distribution in the area defined by the azimuth angle of 180° to 360° corresponds to the meridians of 0°, 45° / 135° and 90°, varying between approximately -0.65 to -0.25D, -1 to -0.63D, -1.4 to -1D, respectively, resulting in an incremental brightness of approximately 1.5D (at a radial distance of approximately 0.6mm).

[0350] Figure 23 The contact lens embodiment has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Figure 43 The brightness distribution of the example has a horizontal plateau feature between 170° and 190°, and a negative spherical aberration feature of about 0.5D.

[0351] When the incident light of parallel visible wavelength (589nm) is incident on the myopic eye of schematic -1D, the prescription is shown in Table 2. Figure 43 The exemplary contact lens described is used to correct the eye, and the time- and space-varying point spread function on the axis obtained on the retinal plane is shown in FIG. Figure 44 , where the lens is rotated on the eye by 0° (4401), 90° (4402), 180° (4403) and 270° (4404) over time.

[0352] Figure 45a and 45b The wide-angle (i.e., ±10° visual field) spatiotemporal variation signals at two different azimuth positions when the contact lens is worn on the eye are shown, wherein the contact lens embodiment ( Figure 43 ) with the refractive index varying from ±0.65D at the periphery to -0.25D at the center (as shown in FIG. 4302 , along 0°) at meridians located at 0° and 270°, respectively. Figure 45a and 45b The geometric spot diagram through the focus simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time.

[0353] Through-focus geometric point analysis around the retinal plane was calculated at five positions, from -0.4 to +0.4 mm, in 0.2 mm steps; retinal positions -0.4 mm and -0.2 mm were in front of the retina; retinal position 0 mm was on the retina; and retinal positions +0.2 mm and +0.4 mm were behind the retina.

[0354] Figure 6a and 6b Unlike the toric lens through-focus mosaic image seen in , where the blurred image varies in size (i.e., focus) and direction between the two azimuthal contact lens positions, Figure 45a and 45b The exemplary embodiment of the inverse semi-cosine lens (with negative spherical aberration) (1) changes only in direction. Therefore, the rotational properties of the inverse semi-cosine lens (with negative spherical aberration) (1) have less impact on visual performance than a toric lens.

[0355] When incident light of parallel visible wavelength (589 nm) is incident on the schematic model eye with -1D myopia, the prescription is shown in Table 2, and the Figure 43 The retinal signal is described by the modulation transfer function of the tangential and sagittal meridians through the focus axis, as shown in Figure 2. Figure 46 shown.

[0356] To evaluate the differences in contact lens rotational performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, with the principal meridian of the contact lens on the eye (with diopter ranging from ±0.65D at the periphery to -0.25D at the center (as shown by 4302 along 0°) at 0° (4601) and 90° (4602).

[0357] In this example, the modulation transfer functions 4601 and 4602 show that the difference between the tangential meridian and the sagittal meridian (i.e., the peak closest to the retina) is independent of the position of the azimuthal contact lens, with the difference in focus shift being approximately 0.3 mm, which is less than 0.1 mm. Figure 7 The toric contact lens shown in FIG is about 0.6 mm smaller, indicating that the rotation of the flipped semi-cosine lens (negative spherical aberration) (1) has less effect on visual performance than the toric lens. In this example, the cone depth or the interval of partial blur remains constant as a function of on-eye contact lens rotation.

[0358] Figure 47 A brightness distribution diagram (4701) within the optical zone of a contact lens of an embodiment of the present disclosure is shown, with the corresponding brightness distribution as a function of the diameter of the optical zone for four representative examples of meridians 0°, 45°, 90°, and 135° (4702); and the corresponding brightness distribution as a function of the azimuth angle for four representative examples of radial positions R1, R2, R3, and R4 (4703) at radial distances of 0.5, 1.5, 2.5, and 3.5 mm, respectively. The contact lens embodiment of the present invention has a brightness distribution that varies radially, meridionally, and azimuthally (brightness: -3.5DS / +1.25D, flipped semi-quasi-cosine lens (with negative spherical aberration) (2)).

[0359] It can be seen in 4702 and 4703 that the brightness distribution of the area defined by the azimuth angle of 0° to 180° corresponds to the meridians of 0°, 45° / 135° and 90°, varying between approximately -3.3 to -2.9D, -3 to -2.6D and -2.6 to -2.25D, respectively; the brightness distribution in the area defined by the azimuth angle of 180° to 360° corresponds to the meridians of 0°, 45° / 135° and 90°, varying between approximately -3.3 to -2.9D, -3.6 to -3.2D and -4 to -3.5D, respectively, resulting in an incremental brightness of approximately 1.25D (at a radial distance of approximately 0.6mm).

[0360] Figure 28 The contact lens embodiment has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Figure 47 The brightness distribution of the example has a horizontal plateau characteristic between 170° and 190°, and a negative spherical aberration characteristic of about 0.5D.

[0361] When the incident light of parallel visible wavelength (589nm) is incident on the -4DS / +1DC×90° (Table 3) schematic model eye, Figure 47The exemplary contact lens correction shown in , results in a point spread function that varies in time and space on an axis in the retinal plane, where the lens is rotated on the eye through 0° (4801), 90° (4802), 180° (4803) and 270° (4804) over time, as shown in Figure 48 shown.

[0362] Figure 49a and 49b The spatiotemporal variation signals of a wide angle (i.e., ±10° visual field) at two different azimuth positions when the contact lens is worn on the eye are shown, where the refractive index ranges from ±3.25D at the periphery to -2.9D at the center (as shown by 4702 along 0°) with the meridians located at 0° and 90°, respectively. Figure 49a and 49b The geometric spot diagram of the through-focus simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time.

[0363] Through-focus geometric point analysis around the retinal plane was calculated at five positions, from -0.6 to +0.6 mm, in 0.3 mm steps; retinal positions -0.6 mm and -0.3 mm were in front of the retina; retinal position 0 mm was on the retina; and retinal positions +0.3 mm and +0.6 mm were behind the retina.

[0364] Figure 11a and 11b Unlike the toric lens through-focus mosaic image seen in , where the blurred image has significantly greater variations in size (i.e., focus) and direction between the two azimuthal contact lens positions, Figure 49a and 49b The example embodiment of the inverted semi-cosine lens (with negative spherical aberration) (2) has less variation. Therefore, the rotational properties of the inverted semi-cosine lens (with negative spherical aberration) (2) have less impact on visual performance than a toric lens.

[0365] When incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription -4DS / +1DC×90° (Table 3), Figure 47 For the exemplary contact lens correction described in , the retinal signal is described as the modulation transfer function of the on-axis through-focus for the tangential and sagittal meridians, as Figure 50 As shown in .

[0366] To evaluate the differences in contact lens rotational performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, with the principal meridian of the contact lens on the eye (with refractive power ranging from ±3.25D at the edge to -2.9D at the center (along 0°, as shown in 4702) at 0° (5001) and 90° (5002).

[0367] In this example, the modulation transfer functions 5001 and 5002 show that the difference between the tangential and sagittal meridians (i.e., the peak closest to the retina) is approximately 0.13 mm in 5001 and approximately 0.7 mm in 5002. The difference in focus shift is greater than Figure 8 The 0.8 mm is smaller for the toric contact lens shown, indicating that contact lens rotation using a flipped half-cosine lens (negative spherical aberration) has less impact on visual performance than a toric lens (2).

[0368] In this example, the cone depth, or the interval of partial blur, varies as a function of the rotation of the contact lens on the eye due to the interaction between the refractive index of the contact lens and the astigmatism of the eye.

[0369] When with Figure 12 The expansion or contraction of the cone depth or partially blurred interval depth as a function of contact lens rotation is minimal when compared to the Sturm's cone depth for the toric contact lens example.

[0370] In certain embodiments, the width of the blending region or blending area 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 region or blending area of the contact lens can be between 0.05 mm and 0.15 mm, between 0.1 mm and 0.3 mm, or between 0.25 mm and 0.5 mm. In some embodiments, the blending region can be symmetrical, while in other embodiments, the blending region can be asymmetrical, such as an elliptical shape.

[0371] In certain embodiments, a substantial portion of the optical zone of the contact lens is comprised of the meridional and azimuthal varying brightness distribution functions, which can be understood to be at least 50%, 60%, 70%, 80%, 90%, 95%, 98% or 100% of the optical zone of the contact lens.

[0372] In certain embodiments, a substantial portion of the optical zone of the contact lens comprised of the meridional and azimuthal varying brightness distribution functions can be understood to be between 50% and 70%, between 60% and 80%, between 60% and 50%, 90%, 50% to 95%, between 80% and 95%, between 85% and 98%, or between 50% and 100% of the optical zone of the contact lens.

[0373] In certain embodiments, the width of the peripheral non-optical zone or carrier zone 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 zone of the contact lens can be between 2.25 mm and 2.75 mm, between 2.5 mm and 3 mm, or between 2 mm and 3.5 mm. In certain embodiments, the peripheral region or carrier zone of the contact lens is substantially symmetrical and has a substantially similar thickness profile in horizontal, vertical, and other oblique meridians.

[0374] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially symmetrical, having substantially similar thickness distributions in horizontal, vertical and other oblique meridians, meaning that the thickness distribution of the peripheral carrier region in any meridian is within 1%, 3%, 5% or 10% of the variation in the thickness distribution in any meridian (to avoid doubt in the radial direction).

[0375] In certain embodiments, the peripheral region or non-optical carrier region of the contact lens is substantially free of ballast, optical prisms, prismatic ballast, slab-off, truncation, or combinations thereof.

[0376] In some embodiments, the contact lens can be positioned, formed, or placed with meridional and azimuthal varying brightness distributions on the anterior surface, the posterior surface, or a combination thereof.

[0377] In certain other embodiments, the toric surface portion positioned, formed, or placed on one of the two surfaces of the contact lens and on the other surface can have other features to further reduce eye growth, for example, using other features such as defocus, coma, or spherical aberration.

[0378] In some embodiments, the shape of the optical zone, hybrid zone and / or peripheral carrier zone can be described by one or more of: a sphere, an aspheric surface, an extended odd polynomial, an extended even polynomial, a conic section, a hyperbolic section, a complex surface or a Zernike polynomial.

[0379] As will be appreciated by those skilled in the art, the present invention may be used in conjunction with any device / method that may affect the progression of myopia.

[0380] These may include, but are not limited to: various designs of eyeglass lenses, color filters, pharmaceutical agents, behavioral changes, and environmental factors. Prototype contact lens: design, measurements and clinical data

[0381] Table 4 lists the refractive and prescription data for three prototype contact lenses (HA and F2 designs) manufactured for the left eyes of two groups of subjects (S#1 and S#2) to evaluate visual performance and the amount of rotation that the lens experienced over time while worn on the eye. Table 4: Refractive index and prescription information of the left eyes of S#1 and S#2

[0382] Table 4 shows HA Lens #1, HA Lens #2, and F2 Lens #1, which are exemplary embodiments of the present invention, as disclosed herein. All three lenses provide clinically acceptable visual performance compared to single vision correction.

[0383] Figure 51 The azimuthal brightness distribution of HA lens #1 for S#1 is measured and averaged at 6mm in the optical zone. Figure 13 A variation of the contact lens embodiment described in . The measured brightness of -5.5DS / +2D is consistent with the lens prescription (Table 4).

[0384] Figure 52 The azimuthal brightness distribution of HA Lens #2 of S#2 was measured and averaged at 6mm in the optical zone. Figure 13 and 47 A variation of the contact lens embodiment described in [ 1 ] has a half-area lens design with negative spherical aberration. The measured brightness of -2DS / +2D is consistent with the lens prescription (Table 4), and the spherical half-area brightness changes from approximately -1.5D to approximately -2.5D between 180° and 360° azimuths.

[0385] Figure 53 The azimuthal brightness distribution of the F2 lens #1 of S#1 is measured and averaged at 6mm in the optical zone. Figure 23 A variation of the contact lens embodiment described in . The measured brightness of -5.5DS / +1.5D is consistent with the lens prescription (Table 4).

[0386] Figure 54 The vertical and horizontal meridian thickness distributions measured for a commercially available toric contact lens (Control #1) are shown. For the avoidance of doubt, Control #1 is an example of a prior art lens. The lens is a Biofinity Toric (CooperVision, USA) (material: comfilcon A) with a cylinder power of -1.25 DC.

[0387] Thickness distribution was measured using an Optimec is830 (Optimec Ltd, UK). The thickness distribution of the contact lens was measured from a tangent line at each point on the back of the contact lens to a perpendicular line to the tangent line on the front of the contact lens. Peripheral prism was measured as the difference in thickness between the two peripheral peaks of each lens meridian. In control group #1, the thickness difference along meridians 1 (vertical) and 2 (horizontal) was 197.5 μm and 28 μm, respectively. Peripheral prism along meridian 1 is intended to stabilize toric contact lenses (prior art, commercially available).

[0388] Figure 55 The thickness distribution of the two perpendicular meridians of the HA lens #1 prototype contact lens is shown. Figure 13 Peripheral prism was measured as the thickness difference between the two peripheral peaks along the meridian of each lens. In HA lens #1, the thickness difference along meridians 1 and 2 was 2.6 μm and 30.3 μm, respectively.

[0389] Figure 56 The graph shows the measured thickness distribution of two perpendicular meridians of the HA lens #2 prototype contact lens, which is Figure 13 and 47 A variation of the contact lens embodiment described in

[15] (i.e., a half-zone lens design) is combined with negative spherical aberration. Peripheral prism is measured as the thickness difference between the two peripheral peaks along each lens meridian. In HA lens #2, the thickness difference along meridians 1 and 2 is 10.7 μm and 34.4 μm, respectively.

[0390] Figure 57 The thickness distribution of the two perpendicular meridians of the F2 lens #1 prototype contact lens is shown. Figure 23 A variation of the contact lens embodiment described in [ 1 ]. Peripheral prism is measured as the thickness difference between the two peripheral peaks along each lens meridian. In F2 lens #1, the thickness differences along meridians 1 and 2 are 2.9 μm and 14.8 μm, respectively. As expected from the design of the peripheral rotationally symmetric carrier regions of these three prototype contact lenses, the peripheral thickness difference between the two meridians is minimized, thereby providing a peripheral carrier region without a rotationally stabilizing effect.

[0391] by Figure 35 The apparatus and measurement procedures explained in PCT / AU2020 / 051004 in

[36] were used to measure the amount of rotation on the eye of the prototype contact lenses F2 lens #1 and HA lens #2 and the control lens #1.

[0392] Figure 58 The measured azimuth angle of the prototype contact lens F2 lens #1 on the left eye of S#1 is shown. After about one hour of wear, the F2 lens #1 rotated approximately 450 degrees counterclockwise (or downwardly toward the nose) (i.e., 1.25 turns).

[0393] Figure 59 The figure shows the measured azimuthal position of the prototype contact lens, HA Lens #2, when worn on the left eye. After approximately one hour of wear, HA Lens #2 rotated approximately 230° counterclockwise (or downward in the nose), or 0.6 turns. Based on these measured data points, it can be expected that the lens will rotate one full turn within another hour of wear.

[0394] Figure 60 Shown is the measured azimuthal position of a commercially available toric contact lens control group #1, showing only a small amount of lens rotation over 30 minutes of lens wear.

[0395] In some embodiments, the contact lens can be configured to have a specific fit that allows the contact lens to have substantial free rotation on the myopic eye; wherein the substantial free rotation of the contact lens is measured by: rotating 360 degrees at least once, twice, three times, three times, four times or five times per day, and rotating at least 15, 20, 25, 30 or 35 degrees in 1 hour. Further exemplary embodiments are described in Example Sets A and B below. Example Set A

[0396] A1 - A contact lens for an eye, the contact lens comprising an anterior surface, a posterior surface, an optical center, an optical axis, an optical zone about the optical center, and a non-optical peripheral carrier region about the optical center. The optical zone comprises at least one brightness map characterized by a plurality of meridional brightness profiles across the optical zone and a plurality of azimuthal brightness profiles about the optical axis; wherein the brightness map at least partially provides foveal correction to the eye and at least partially provides a partially blurred cone of vision to the retina of the eye; and the non-optical peripheral carrier region comprises a plurality of azimuthal thickness profiles about the optical axis, wherein the azimuthal thickness profiles are configured to facilitate a specific fit on the eye.

[0397] A2-The contact lens of example A1 of claim 1, wherein at least one meridional refractive index profile varies at least partially along the optical zone and has substantially no mirror symmetry along the optical zone;

[0398] A3 - A contact lens according to claim A2, wherein at least one of the partially varying meridional refractive index distributions is radially varying.

[0399] A4—A contact lens according to claim A2, wherein at least one of the partially varying meridional refractive index profiles is radially invariant.

[0400] A5 - The contact lens according to one or more of examples A1 to A4, wherein the at least one azimuthal angle distribution about the optical axis is at least partially variable and has no mirror symmetry about the optical axis;

[0401] A5 - A contact lens according to one or more of examples A1 to A4 of claims, wherein the at least one azimuthal brightness distribution is defined using a cosine distribution with a reduced frequency, i.e., one quarter (1 / 4) or one half (1 / 2) of the normal frequency; wherein the normal frequency is defined as two cosine periods over 360° or 2π radians.

[0402] A6—A contact lens according to claim A1, wherein only one of the plurality of meridional refractive index distributions is mirror-symmetric along the optical zone, and the plurality of azimuthal refractive index distributions do not have mirror-symmetry about the optical axis.

[0403] A7 - A contact lens according to one or more of claims A1 to A6, wherein the eye is a myopic eye with an astigmatism ≤ 0.75DC; wherein the sign of the astigmatism can be specified in terms of a positive cylinder or a negative cylinder.

[0404] A8 - A contact lens according to one or more of claims Examples A1 to A6, wherein the eye is a myopic astigmatic eye with an astigmatism ≥ 1DC; wherein the sign of the astigmatism can be specified in terms of a positive cylinder or a negative cylinder.

[0405] A9 - A contact lens according to one or more of claims 1 to A7, wherein the refractive map is centered on the optical center and spans at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% of the optical zone, and the remainder of the optical zone is configured for basic spherical correction for myopia with astigmatism ≤ 0.75DC.

[0406] A10 - The contact lens of one or more of claim examples A1 to A6 and A8, wherein the refractive map is centered about the optical center and spans at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% of the optical zone, the remainder being configured for basic astigmatism correction for myopic astigmatism ≥ 1DC.

[0407] A11 - The contact lens of one or more of examples A1 to A7 and A9, wherein the refractive map spans at least 3 mm, 4 mm, 5 mm, 6 mm, or 8 mm of a central region of the optical zone. The remainder of the optical zone is configured for substantial spherical correction of myopia with astigmatism ≤ 0.75 DC.

[0408] A12 - The contact lens of one or more of examples A1 to A6 and A8, wherein the refractive map spans at least 3 mm, 4 mm, 5 mm, 6 mm, or 8 mm of a central region of the lens optic zone. The remainder of the optic zone is configured to provide a basic spherical correction for myopic astigmatism with an astigmatism of ≥ 1 DC.

[0409] A13 - A contact lens according to one or more of Examples A1 to A12, wherein the refractive index map can be obtained using the front surface, the back surface or both surfaces of the contact lens.

[0410] A14-A contact lens according to one or more of Examples A1 to A13, wherein the difference between their maximum brightness and minimum brightness within the meridional varying brightness distribution over the entire optical area and the azimuthal varying brightness distribution around the optical axis provides incremental brightness; wherein the incremental brightness is at least +1.25D, at least +1.5D, at least +1.75D, at least +2D, at least +2.25D, or at least +2.5D.

[0411] A15 - A contact lens according to one or more of claims Examples A1 to A13, wherein the difference between their maximum brightness and minimum brightness within the meridian variation on the optical zone or the azimuthal brightness distribution around the optical axis provides incremental brightness; wherein the incremental brightness is between +0.5D and +2.75D, +0.75D and +2.5D, +1D and +2.25D, +1.25D and +2D or +1.25D and +2.75D.

[0412] A16 - A contact lens according to one or more of claims examples A1 to A15, wherein the depth of the local blur cone of the retina within the eye is at least 0.2 mm, 0.5 mm, 0.75 mm or 1 mm.

[0413] A17 - A contact lens according to one or more of Examples A1 to A16, wherein the partially blurred cones span at least the foveal margin, fovea, macular margin, macula, or perimacular region of the retina.

[0414] A18 - A contact lens according to one or more of examples A1 to A16, wherein the locally blurred cones are 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 retinal field of view.

[0415] A19 - A contact lens according to one or more of examples A1 to A18, wherein the partially blurred cones are located on the retina so as to provide a directional cue or optical stop signal for myopic eyes with or without astigmatism.

[0416] A20 - A contact lens according to one or more of examples A1 to A19, wherein the partially blurred cones are not regular Sturm cones but are irregular.

[0417] A21 - A contact lens according to one or more of examples A1 to A20, wherein the partially blurred cone of vision comprises a sagittal plane and a tangential plane; wherein the tangential plane is located at at least one position within a 40 degree field of view of the retina in front of the retina.

[0418] A22 - A contact lens according to one or more of examples A1 to A21, wherein the sagittal plane is located in front of the retina at at least one position within a 40 degree field of view of the retina.

[0419] A23 - A contact lens according to one or more of examples A1 to A22, wherein the sagittal plane is located at at least one position within a 40 degree field of view of the retina that is substantially close to the retina of the eye.

[0420] A24 - A contact lens according to one or more of claims Examples A1 to A23, wherein a mixed zone is configured between the optical zone and the non-optical peripheral zone; and wherein the mixed zone spans at least 0.125 mm, 0.25 mm, 0.5 mm, 0.75 mm or 1 mm as measured over the semi-diameter of the optical zone of the entire contact lens.

[0421] A25 - A contact lens according to one or more of examples A1 to A24, wherein the multiple azimuthal thickness distributions of the non-optical peripheral carrier region are configured to be substantially constant around the optical axis.

[0422] A26 - A contact lens according to one or more of Examples A1 to A25, wherein the difference between the thickest point and the thinnest point within a plurality of azimuthal distributions of a non-optical peripheral carrier region around the optical axis provides a peak-to-valley thickness.

[0423] A27 - A contact lens according to one or more of claims Examples A1 to A26, wherein the substantially constant refers to a peak-to-valley thickness varying between 5 μm and 45 μm, or between 10 μm and 45, or between 1 μm and 45 μm.

[0424] A28 - A contact lens according to one or more of claims Examples A1 to A26, wherein the substantial invariance refers to a peak-to-valley thickness variation of no more than 5 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm or 45 μm.

[0425] A29 - A contact lens according to one or more of claims Examples A1 to A28, wherein the multiple azimuthal thickness distributions are defined as having a desired width across any range of radial distances in the non-optical peripheral carrier region, wherein the desired width is between 3.5 mm and 7.2 mm, 4 mm and 7.5 mm, 4.5 mm and 6.5 mm, 4.25 mm and 7 mm or 4.5 mm and 7.1 mm in the non-optical peripheral carrier region.

[0426] A30 - A contact lens according to one or more of claims Examples A1 to A24, wherein the non-optical peripheral carrier region comprises a thickness distribution defined within a selected region along one or more semi-meridians, the thickness distribution being configured to be substantially invariant; wherein, substantial invariance means that the variation in the thickness distribution along any semi-meridian is less than 3%, 5% or 8% of that along any other semi-meridian.

[0427] A31-A contact lens according to one or more of claims A1 to A24, wherein the non-optical peripheral carrier region comprises a thickness distribution defined within a selected region along one or more semi-meridians, the thickness distribution being configured to be substantially invariant; wherein the substantial invariance of the thickness distribution means that the maximum variation of a thickest point across any semi-meridian is within 5 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 45 μm of the thickest point of any other semi-meridian within the non-optical peripheral carrier region.

[0428] A32 - The contact lens of one or more of claims Examples A1 to A24, A30 or A31, wherein the selected area along one or more arbitrary semi-meridians is between 3.5 mm and 7.2 mm, 4 mm and 7.1 mm, 3.75 mm and 7 mm, or 4 mm and 7.2 mm of the non-optical peripheral carrier region.

[0429] A33 - The contact lens of one or more of claims examples A1 to A32, wherein the specific fit provides a directional indication or optical stop signal to the myopic eye that varies in time and space to substantially control myopia gain in the myopic eye.

[0430] A34 - The contact lens of one or more of claims Examples A1 to A33, wherein the specific fit allows for substantial free rotation in a myopic eye; wherein substantial free rotation is measured as follows: the contact lens rotates at least 180 degrees at least three times for every 8 hours of wear and at least 15 degrees within 1 hour of wearing the lens.

[0431] A35 - A contact lens according to one or more of examples A1 to A34, wherein the specific fitting configuration has at least one rotational assist feature; wherein at least one rotational assist feature is represented by a periodic periodic function.

[0432] A36 - A contact lens according to example A35, wherein the periodic function is sawtooth, sinusoidal, a sum of sinusoidal shapes, or quasi-sinusoidal.

[0433] A37 - A contact lens according to example A35, wherein the periodic function defined over 0 to 2π radians has a periodicity of not less than 6, and the rate of change of thickness with increase is different from the rate of change of thickness with decrease.

[0434] A38 - A contact lens according to one or more of examples A1 to A37, wherein the maximum thickness variation within the at least one rotational assist feature is between 10 μm and 45 μm.

[0435] A39 - The contact lens of one or more of examples A1 to A38, wherein the at least one rotation assist feature of the contact lens allows for increased rotation of the contact lens on a myopic eye, as measured by rotation of the myopic eye. The contact lens is rotated at least 180 degrees at least three times for every four hours of wear and at least 15 degrees within 30 minutes of wear.

[0436] A40 – A contact lens according to one or more of claims Examples A1 to A39, wherein the at least one rotational assist feature is configured to increase rotation of the eye with at least partially varying meridian and azimuth brightness distributions to provide a stop signal to the myopic eye that varies in time and space such that the effectiveness of the directional signal remains substantially consistent over time.

[0437] A41 - A contact lens according to one or more of claims in Examples A1 to A40, wherein the refractive map is combined with a specific fit to provide the eye with a locally blurred cone that varies in time and space; wherein the spatial variation includes at least the foveal edge, fovea, macular edge, macula or perimacula area of the retina of the eye; wherein the temporal variation provides a therapeutic benefit to the eye that remains substantially constant over time.

[0438] A42 - A contact lens according to one or more of claim examples A1 to A40, wherein the refractive map is combined with a specific fit to provide the eye with a locally blurred cone that varies in time and space; wherein the spatial variation includes 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 retinal field of view of the eye; wherein the temporal variation refers to the contact lens being rotated at least 180 degrees at least three times for every 8 hours of wearing, and at least 15 degrees within 1 hour of wearing the lenses, so that the therapeutic effect on the eye remains basically consistent throughout the wearing process.

[0439] A43 - The contact lens of one or more of claim examples A41 to A42, wherein the therapeutic benefit to the eye is myopia control, myopia management, or slowing of myopia progression in the eye.

[0440] A44 - A contact lens according to one or more of examples A1 to A43, wherein the visual performance of the contact lens is substantially similar to the visual performance of a single vision contact lens.

[0441] A45 - A contact lens according to one or more of claims in Examples A1 to A44, wherein the at least one rotational assist feature is selected because the desired lens rotation can provide the desired visual performance for the myopic eye while maintaining the desired spatial and temporal variation of the optical signal so that the effectiveness of the directional signal remains substantially consistent over time. Example Set B

[0442] B1 - A pair of contact lenses, one right lens and one left lens, for myopic eyes with or without astigmatism, each contact lens comprising a front surface, a back surface, an optical center, an optical axis, an optical zone around the optical center, and a non-optical peripheral carrier area around the optical zone; the optical zone comprising at least one brightness map characterized by a plurality of meridional brightness distributions over the entire optical zone and a plurality of azimuthal brightness distributions around the optical axis; wherein at least one meridional brightness distribution is at least partially variable and has no mirror symmetry; wherein at least one azimuthal brightness distribution is at least partially variable and has no mirror symmetry; wherein the brightness map at least partially provides appropriate correction for the myopic eye and at least partially provides a partially blurred local cone of vision on the retina of the myopic eye, serving as a directional cue or optical stop signal; the non-optical peripheral carrier area comprising a plurality of azimuthal thickness distributions around the optical axis, wherein at least one azimuthal thickness distribution is configured to be substantially constant to facilitate specific fitting on the myopic eye.

[0443] B2 - The contact lens pair according to claim B1, wherein the brightness distribution in multiple meridional directions over the entire optical zone and the brightness distribution in multiple azimuth angles around the optical axis are substantially different for the right myopic eye and the left myopic eye.

[0444] B3 - The contact lens pair of one or more of claims examples B1 to B2, wherein the brightness map of each contact lens is at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% of the optical zone and the remainder of the optical zone is configured to have basic spherical correction for myopia without astigmatism.

[0445] B4 - The contact lens pair of one or more of claim examples B1 to B2, wherein the brightness map of each contact lens is at least 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% of the optical zone and the remainder of the optical zone is configured for basic astigmatism correction for an astigmatic myopic eye.

[0446] B5—The contact lens pair of one or more of claims Bl to B4, wherein the brightness map of each contact lens spans at least 3 mm, 4 mm, 5 mm, 6 mm, or 8 mm of a central region of the optical zone.

[0447] B6 - A pair of contact lenses according to one or more of claims B1 to B5, wherein the brightness map of each contact lens can be obtained using the front surface, the back surface or both surfaces of the contact lens.

[0448] B7—A contact lens pair according to one or more of examples B1 to B6, wherein at least one locally varying meridional brightness distribution of each contact lens can be further configured to be radially varying.

[0449] B8—A contact lens pair according to one or more of examples B1 to B6, wherein at least one locally varying meridional brightness distribution of each contact lens can be further configured to be radially invariant.

[0450] B9 - A contact lens pair according to one or more of examples B1 to B8, wherein the incremental brightness within a meridian brightness distribution that varies at least partially across the entire optical area of each contact lens is +1.25D, at least +1.5D, at least +1.75D, or at least +2D.

[0451] B10 - The contact lens pair of one or more of claim examples B1 to B9, wherein the incremental brightness within the at least partially varying azimuthal brightness distribution about the optical axis of each contact lens is at least +1.25D, at least +1.5D, at least +1.75D, or at least +2D.

[0452] B11 - A contact lens pair according to one or more of examples B1 to B10, wherein a blending zone is configured between the optical zone and the non-optical peripheral zone of each contact lens; wherein the blending zone measured on the semi-diameter of the optical center of each contact lens spans at least 0.125 mm, 0.25 mm, 0.5 mm, 0.75 mm or 1 mm.

[0453] B12—The contact lens pair of one or more of claims examples B1 to B11, wherein the plurality of azimuthal thickness profiles of the non-optical peripheral carrier region are configured to be substantially constant about the contact lens optical axis.

[0454] B13 - A contact lens pair according to one or more of examples B1 to B12, wherein the difference between the thickest point and the thinnest point within the multiple azimuthal distributions of the non-optical peripheral carrier region around the optical axis provides the peak-to-valley thickness of each contact lens.

[0455] B14 - A pair of contact lenses according to one or more of examples B1 to B13, wherein the basic invariance refers to the peak-to-valley thickness of each contact lens varying between 5 μm and 45 μm, between 10 μm and 50 μm, or between 1 μm and 45 μm.

[0456] B15 - A pair of contact lenses according to one or more of examples B1 to B14, wherein the basic invariance means that the peak-to-valley thickness of each contact lens does not exceed 5 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm or 45 μm, respectively.

[0457] B16 - A contact lens pair according to one or more of examples B1 to B15, wherein the multiple azimuthal thickness distributions are defined as having a desired width spanning a range of arbitrary radial distances in the non-optical peripheral carrier region, wherein the desired width is between 3.5 mm and 7.2 mm, 4 mm and 7.5 mm, 4.5 mm and 6.5 mm, 4.25 mm and 7 mm, or 4.5 mm and 7.1 mm in the non-optical peripheral carrier region of each contact lens.

[0458] B17 - A pair of contact lenses according to one or more of claims Examples B1 to B16, wherein the non-optical peripheral carrier zone includes a thickness distribution defined along a selected area, the thickness distribution being configured to be substantially constant along one or more semi-meridians; wherein substantially constant means that the variation in the thickness distribution along any semi-meridian over the entire optical zone of each contact lens is less than 3%, 5% or 8% of that along any other semi-meridian.

[0459] B18 - A pair of contact lenses according to one or more of examples B1 to B17, wherein the substantially constant azimuthal thickness distribution of each contact lens is between 5 μm and 40 μm peak to valley.

[0460] B19 - A contact lens pair according to one or more of claims Examples B1 to B18, wherein the substantially constant azimuthal thickness distribution of each contact lens is configured such that the thickest point within the non-optical peripheral carrier region across any semi-meridian varies within a maximum range of 30 μm of the thickest peripheral point across any other semi-meridian.

[0461] B20 – A contact lens pair according to one or more of examples B1 to B19, wherein the specific fit of each contact lens provides a stop signal to the myopic eye that varies in time and space to substantially control the growth of the myopia.

[0462] B21 - A contact lens pair according to one or more of claims Examples B1 to B20, wherein the specific fit of each contact lens allows for substantially free rotation on a myopic eye; wherein the substantially free rotation is measured as follows: the contact lens rotates at least 180 degrees at least three times for every 8 hours of wear and at least 15 degrees within 1 hour of wearing the lenses.

[0463] B22 - A contact lens pair according to one or more of examples B1 to B22, wherein the specific fit of each contact lens, including the azimuthal thickness distribution, is configured with at least one rotational assist feature; wherein at least one rotational assist feature is represented by a periodic function having a periodicity.

[0464] B23 - A contact lens pair according to example B22, wherein the periodic function of each contact lens is sawtooth, sinusoidal, a sum of sinusoidal shapes, or quasi-sinusoidal.

[0465] B24—The contact lens pair of claims B22 and B23, wherein the periodic function of each contact lens has a period of no less than 6, and the increasing rate of change of thickness is different from the decreasing rate of change.

[0466] B25—The contact lens pair according to examples B22 to B24, wherein the maximum thickness variation within at least one rotation assist feature of each contact lens is between 10 μm and 40 μm.

[0467] B26 - A contact lens pair according to one or more of examples B1 to B25, wherein at least one rotational assist feature of each contact lens allows for increased rotation of the contact lens on a myopic eye, the measurement scheme being as follows: the contact lens is rotated at least 180 degrees at least three times for every 4 hours of wear and at least 15 degrees within 30 minutes of wear.

[0468] B27 - A contact lens pair according to one or more of examples B1 to B26 of claim 1, wherein the at least one rotational assist feature of each contact lens is configured to increase rotation on the eye and, in combination with at least one partially varying meridian and azimuthal brightness distribution, provide a stop signal to the myopic eye that varies in time and space, such that the effectiveness of the directional signal remains substantially consistent over time.

[0469] B28—A contact lens pair according to one or more of examples B1 to B28, wherein at least one rotational assist feature of each contact lens can be configured differently for a right myopic eye and a left myopic eye.

[0470] B29 – A contact lens pair according to one or more of examples B1 to B28, wherein at least one rotational assist feature of each contact lens is configured to be mirror-symmetrical between the right myopic eye and the left myopic eye with the nasal axis as a reference point.

[0471] B30 - A contact lens pair according to one or more of claims examples B1 to B29, wherein at least one rotational assist feature of each contact lens is configured to be mirror asymmetric between the right myopic eye and the left myopic eye with the nasal axis as a reference point.

[0472] B31 - The contact lens pair according to one or more of examples B1 to B30, wherein at least one rotational assist feature of each contact lens is configured to be mirror-asymmetric between the right myopic eye and the left myopic eye with the nasal axis as a reference point, such that each rotational assist feature is selected to allow the lens to rotate at different amplitudes between the left and right myopic eyes, thereby further increasing the spatially and temporally varying optical signal of the myopic eye, thereby maintaining the efficacy of the directional signal substantially consistent over time.

[0473] B32 - The contact lens pair according to one or more of examples B1 to B31, wherein the at least one rotational assist feature of each contact lens is configured to be asymmetric between the right myopic eye and the left myopic eye with the nasal axis as a reference point, such that each rotational assist feature is selected to allow a different magnitude of rotation of the lens between the left and right myopic eyes, thereby providing ideal visual performance for the myopic eye while maintaining spatially and temporally varying optical signals, such that the efficacy of the directional signal remains substantially consistent over time.

[0474] B33 - A contact lens pair according to one or more of examples B1 to B32, wherein multiple meridional brightness distributions across the optical zone, and multiple azimuthal brightness distributions about the optical axis of each contact lens, are selected to allow for providing desired visual performance for a myopic eye while maintaining a spatially and temporally varying optical stop signal such that the effectiveness of the directional signal remains substantially consistent over time.

[0475] B34 - A contact lens pair according to one or more of claim examples B1 to B33, may be combined with one or more limiting rights in one or more of the corresponding claims A1 to A45 of example set A.

Claims

1. A contact lens for myopia, comprising: an optical zone having an optical axis and an azimuthally and meridianally varying brightness distribution that provides both partial correction for the myopic eye and a blur signal serving as a directional cue over the macular region of the myopic eye to reduce myopia progression; as well as A peripheral zone surrounding the optical zone includes a substantially constant thickness profile about the optical axis that facilitates substantially free on-eye rotation of the contact lens over time, or a thickness profile that facilitates rotation of the contact lens over time.

2. The contact lens according to claim 1, wherein The optical zone is configured with at least one meridian brightness profile that is constant across a diameter of the optical zone.

3. The contact lens according to claim 1, wherein: The through-focus geometric spot diagram for the lens has a constant or substantially constant size between azimuthal positions.

4. The contact lens according to claim 1, wherein: The blurred signal extends to the perimacula region of the myopic eye.

5. The contact lens according to claim 1, wherein: The blurred signal is in the fovea area of the myopic eye.

6. The contact lens according to claim 1, wherein: The blurred signal is in the fovea area of the myopic eye.

7. The contact lens according to claim 1, wherein: The blurred signal extends across the fovea, macula, and perimacular regions of the myopic eye.

8. The contact lens according to claim 1, wherein: The blur signal has a shape that is rotationally asymmetric about the optical axis.

9. The contact lens according to claim 1, wherein: The blurred signal has a shape that is elongated along the meridian.

10. The contact lens according to claim 1, wherein The azimuthally and meridionally varying brightness distribution in the optical zone produces a temporally and spatially varying point spread function at the retina of the myopic eye as the contact lens is rotated on the eye.

11. The contact lens according to claim 10, wherein: As the contact lens is rotated on the eye, the temporally and spatially varying point spread functions change in direction but not significantly in magnitude, thereby minimizing changes in visual performance.

12. The contact lens according to claim 10, wherein: The temporally and spatially varying point spread function provides the blur signal, and wherein the position of the blur signal on the retina changes as the contact lens is rotated on the eye, thereby providing a continuously changing directional cue or optical stop signal to the myopic eye.

13. The contact lens according to claim 1, wherein: The peripheral zone includes a substantially constant thickness profile about the optical axis that facilitates substantially free on-eye rotation of the contact lens over time.

14. The contact lens according to claim 1, wherein: The thickness profile includes a periodic azimuthal thickness profile that facilitates time-varying rotation of the contact lens.

15. A method of providing directional cues to a myopic eye to reduce the progression of myopia, the method comprising providing or prescribing a contact lens to the eye, wherein: The contact lens is the contact lens according to any one of claims 1 to 14.

16. A method of providing directional cues to a myopic eye to reduce myopia progression, the method comprising providing a temporally and spatially varying point spread function at the retina of the myopic eye as the contact lens is rotated on the eye by applying the contact lens to the eye and configured to rotate while applied to the eye, wherein: The temporally and spatially varying point spread function is provided to at least the macular region of the myopic eye.

17. The method according to claim 16, wherein The temporally and spatially varying point spread functions maintain a substantially constant magnitude as the contact lens is rotated on the eye.

18. The method according to claim 16, wherein The point spread function varies in azimuth so as to provide temporal and spatial variation of the temporally and spatially varying point spread function as the contact lens is rotated on the eye.

19. The method according to claim 16, wherein The point spread function varies across the meridian to provide temporal and spatial variation of the temporally and spatially varying point spread function as the contact lens is rotated on the eye.

20. The method of claim 15 or claim 16, further comprising providing the temporally and spatially varying point spread function to a perimacular region of the myopic eye.

21. A contact lens for myopia, comprising: the optical zone surrounding the optical center; as well as a non-optical peripheral carrier zone surrounding said optical zone, wherein the optical zone is configured with an azimuthally and meridianally varying brightness distribution that provides partial foveal correction for the myopic eye and an optical stop signal at the retina of the eye, wherein the azimuthally and meridianally varying brightness distribution spans at least 3 mm of a central region of the optical zone, and wherein the non-optical peripheral carrier region is configured to be substantially free of ballast, or otherwise configured to allow the lens to rotate when worn on the eye to provide substantial temporal and spatial variation to the optical stop signal.

22. The contact lens according to claim 21, wherein The optical zone is configured with at least one meridional brightness distribution that is radially invariant.

23. The contact lens according to claim 21, wherein: The through-focus geometric spot diagram for the lens has a constant or substantially constant size between azimuthal positions.

24. The contact lens according to claim 21, wherein The stop signal extends across the foveal region of the myopic eye.

25. The contact lens according to claim 21, wherein The stop signal extends across the macular region of the myopic eye.

26. The contact lens according to claim 21, wherein The stop signal has a shape that is rotationally asymmetric about the optical axis.

27. The contact lens according to claim 21, wherein: The stop sign has a shape that is elongated along the meridian.

28. The contact lens according to claim 21, wherein The azimuthally and meridionally varying brightness distribution in the optical zone produces a temporally and spatially varying point spread function at the retina of the myopic eye as the contact lens is rotated on the eye.

29. The contact lens according to claim 28, wherein As the contact lens is rotated on the eye, the temporally and spatially varying point spread functions change in direction but not significantly in magnitude, thereby minimizing changes in visual performance.

30. The contact lens according to claim 28, wherein The temporally and spatially varying point spread function provides a stop signal, and wherein the location of the stop signal on the retina changes as the contact lens is rotated on the eye, thereby providing a continuously changing directional cue or optical stop signal to the myopic eye.

31. The contact lens according to claim 21, wherein: The peripheral zone includes a substantially constant thickness profile about the optical axis that facilitates substantially free on-eye rotation of the contact lens over time.

32. The contact lens according to claim 21, wherein The peripheral zone thickness profile includes a periodic azimuthal thickness profile that facilitates time-varying rotation of the contact lens.

33. A method of providing directional cues to a myopic eye to reduce the progression of myopia, the method comprising providing or prescribing a contact lens to the eye, wherein: The contact lens is the contact lens according to any one of claims 21 to 32.

34. A method comprising: A contact lens is applied to or prescribed for a myopic eye, the contact lens comprising an optical zone configured with an azimuthally and meridianally varying brightness distribution that provides partial foveal correction for the myopic eye and an optical stop signal at the retina of the eye, wherein the azimuthally and meridianally varying brightness distribution spans at least 3 mm of a central region of the optical zone, and wherein the contact lens is configured to rotate on the myopic eye during wear, whereby the optical stop signal is temporally and spatially variable.

35. The method according to claim 34, wherein Spherical correction is provided at the fovea of the myopic eye.

36. The method according to claim 34 or 15, wherein The stop signal extends across the foveal region of the myopic eye.

37. The contact lens according to claim 34, wherein: The stop signal extends across the macular region of the myopic eye.

38. The contact lens according to claim 34, wherein: The stop signal has a shape that is rotationally asymmetric about the optical axis.

39. The contact lens according to any one of claims 34 to 38, wherein: The stop sign has a shape that is elongated along the meridian.

40. A contact lens for an eye, the contact lens comprising an optical zone and a non-optical peripheral carrier zone surrounding an optical center, the contact lens configured to rotate on the eye during wear, wherein The optical zone has meridian and azimuthal brightness distributions that provide spherical correction of myopic refractive error and an optical stop signal for myopia progression within at least 3 mm of a central region of the optical zone, and the lens is configured such that in one rotational position, a portion of the retina of the eye receives the spherical correction, while in another rotational position, the same portion of the retina receives the optical stop signal for myopia progression.

41. The contact lens according to claim 40, wherein During one rotation, the portion of the retina receiving the spherical correction does not receive the stop signal.

42. The contact lens according to claim 40 or claim 41, wherein: The spherical correction is provided together with correction of astigmatism ≤ 1DC.

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