Contact lenses for myopia with or without astigmatism

Abstract

The present disclosure relates to contact lenses for eyes with eye length abnormalities, such as myopia with or without astigmatism. The present invention relates to a contact lens for managing myopia with or without astigmatism; wherein the contact lens is configured with an optical zone defined substantially centered around an optical axis to provide a meridional and azimuthally varying brightness distribution, at least partially resulting in foveal correction of the myopic eye, and at least partially resulting in a partially blurred cone signal at the retina of the myopic eye, serving as a directional cue or optical stop signal; and a non-optical peripheral carrier zone surrounding the optical zone, the non-optical peripheral carrier zone being configured with a constant azimuth thickness distribution, with or without a rotational assist feature, to further provide a temporally and spatially varying stop signal to decelerate, control, inhibit or reduce the rate of myopia progression, and remain substantially consistent over time.

Description

[0001] Cross-references

[0002] 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 are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure relates to contact lenses for eyes having abnormalities related to the ocular axis, such as myopia with or without astigmatism. Background Art

[0004] At birth, most people's eyes are farsighted. As we age, the eye tends to become more emmetropic. The growth of the eye is controlled by a visual feedback mechanism called emmetropization. The signals that direct the emmetropization process are initiated at the level of the retina. Retinal image characteristics are monitored by biological processes to modulate signals that start or stop, speed up or slow down eye growth. Derailment from the emmetropization process can result in refractive errors such as myopia and / or astigmatism.

[0005] The problem of myopia is increasing at an alarming rate, and it is predicted that by 2050, half of 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 the overgrowth of the eye.

[0006] Excessive growth is associated with serious vision-threatening conditions such as glaucoma, myopic maculopathy, and retinal detachment. For such individuals, specific optical devices are required that not only correct the underlying refractive error but also prevent excessive eye lengthening or progressive myopia.

[0007] definition

[0008] Unless otherwise defined below, the terms used herein are commonly used by those skilled in the art.

[0009] The term "myopic eye" refers to an eye that has experienced myopia, has been diagnosed with a refractive condition that is progressing toward greater myopia, and has an astigmatism of less than 1 DC.

[0010] The term "myopic astigmatism eye" refers to an eye that has experienced myopia, has been diagnosed as having a refractive condition that is progressing toward myopia, and has an astigmatism equal to or greater than 1 DC.

[0011] 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.

[0012] The term "premyopic eye" or "eye at risk for myopia" refers to an eye that may be an emmetropic eye 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 child) and / or environmental factors (e.g. time spent outdoors) and / or behavioral factors (e.g. time spent completing near vision tasks).

[0013] 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.

[0014] 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.

[0015] 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.

[0016] The term "optical zone" or "optical zone" refers to the area on a contact lens that has a defined optical effect. The optical zone can be distinguished as a distribution of brightness that varies around an 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 anterior and posterior surface areas of the contact lens, respectively, that contribute to the defined optical effect.

[0017] The optical zone of the contact lens can be circular or oval or other irregular shapes. The optical zone of a contact lens with a spherical power is usually circular. However, as disclosed herein, in certain embodiments, the introduction of a meridian and azimuthally varying brightness distribution may result in a non-circular optical zone.

[0018] 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 substantially the same.

[0019] 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.

[0020] The term "blending zone" or "connecting zone" is a zone 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 front surface or the back surface or both surfaces and can be polished or smoothed between two different adjacent surface curvatures as disclosed herein.

[0021] 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, a hybrid region may be used between the optic zone and the peripheral carrier region as disclosed herein.

[0022] The term "through focus" generally refers to a dimension of space in front of and / or behind the retina, typically in millimeters in image space. However, in some embodiments, as disclosed herein, alternative measures of the term "through focus" that are referenced in object space and measured in diopter or brightness generally refer to the same thing.

[0023] The term "radial" refers to a direction defined along an azimuth angle along a radiating direction from the optical center to the edge of the optical zone. The term "radial spokes" refers to spokes radiating outward from the center of the optical zone at a predetermined azimuth angle.

[0024] As disclosed herein, the phrase "radial brightness distribution" refers to a one-dimensional brightness distribution of local light intensity across any radial spoke.

[0025] As disclosed herein, the phrase "radially constant brightness distribution" refers to any radial spoke having a substantially uniform brightness distribution.

[0026] As disclosed herein, the phrase "radially varying brightness distribution" refers to any radial spoke having a substantially non-uniform brightness distribution.

[0027] As disclosed herein, the term "meridian" refers to two opposing radial spokes distributed at predetermined azimuth angles on an optical zone.

[0028] As disclosed herein, the phrase "meridional brightness distribution" refers to a one-dimensional brightness distribution of local brightness across an arbitrary meridian line on an optical zone.

[0029] As disclosed herein, the phrase "meridian-invariant brightness distribution" refers to any meridian having a substantially uniform brightness distribution.

[0030] As disclosed herein, the phrase "meridionally varying brightness distribution" refers to any meridian having a substantially non-uniform brightness distribution.

[0031] The phrase "meridian brightness distribution having mirror symmetry" refers to any meridian having substantially the same brightness distribution on its two opposite radial spokes.

[0032] The phrase "a meridional brightness distribution without mirror symmetry" refers to any meridian having two substantially different brightness distributions on its two opposing radial spokes.

[0033] 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.

[0034] 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.

[0035] As disclosed herein, the phrase "azimuthally invariant brightness distribution" means that the azimuth brightness distribution has a substantially uniform brightness distribution.

[0036] As disclosed herein, the phrase "azimuthally varying brightness distribution" means that the azimuth brightness distribution has a substantially non-uniform brightness distribution.

[0037] 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.

[0038] As disclosed herein, the phrase "azimuthal brightness distribution without 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.

[0039] The phrase "azimuthal thickness profile" refers to the one-dimensional thickness distribution of local lens thickness at any azimuth angle measured or defined at any radial distance in a non-optical peripheral carrier region.

[0040] As disclosed herein, the phrase "azimuthally invariant thickness profile" means that the azimuthally thickness profile has a substantially uniform thickness distribution.

[0041] As disclosed herein, the phrase "azimuthally varying thickness distribution" means that the azimuth thickness distribution has a substantially non-uniform thickness distribution.

[0042] The phrase "periodic azimuthal thickness distribution" means that the azimuthal thickness distribution follows a periodic function or a repeating pattern.

[0043] 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.

[0044] As disclosed herein, the phrase "azimuthal thickness distribution without 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.

[0045] 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.

[0046] The term "ballast" refers to an azimuthally varying thickness profile without mirror symmetry in the carrier region for the purpose of maintaining the rotational orientation of the contact lens when worn on the eye.

[0047] 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.

[0048] The term "thinning" refers to the purposeful thinning of a contact lens in one or more discrete areas toward the edge of the upper and lower edges of the contact lens to achieve a desired rotational stability of the contact lens.

[0049] The term "cut-off" 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.

[0050] The term "model eye" may refer to a schematic, ray-traced, or physically model eye.

[0051] As used herein, the terms "diopter," "brightness," or "D" are unit measures 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.

[0052] 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.

[0053] The term "partially blurred cone" or "partially blurred interval" refers to the retinal image through focus that is represented by an irregular blur pattern with sagittal and tangential planes due to the introduction of meridional and azimuthal variations in the brightness distribution within the optical zone.

[0054] The term "brightness map" refers to the two-dimensional distribution of brightness over an optical area in Cartesian or polar coordinates.

[0055] The term "back power" refers to the reciprocal of the back focal length over the entire or specified area of ​​the optical zone, expressed in diopters (D).

[0056] The term "SPH" or "spherical" brightness refers to substantially uniform brightness across all meridians of the optical zone.

[0057] The term "CYL", "cylindrical" brightness refers to the difference in post-vertex brightness between the two principal meridians within the optical zone.

[0058] The term "delta brightness" refers to the difference between the maximum and minimum brightness in multiple meridional varying brightness distributions across the optical zone and the azimuth varying brightness distribution about the optical axis.

[0059] The term or phrase "astigmatic brightness distribution" or "torsional brightness distribution" may mean that the optical zone has a spherical cylindrical brightness distribution.

[0060] 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.

[0061] The term "foveal correction" refers to correction in at least the fovea region of the retina of the eye. The term "foveal perifoveal region" refers to the region immediately adjacent to the fovea of ​​the retina of the eye. The term "perifoveal region" refers to the region immediately adjacent to the central pit of the retina of the eye. The term "macular perifoveal region" refers to the region within the macular region of the retina of the eye. The term "perifoveal region" refers to the region immediately adjacent to the macular region of the retina of the eye.

[0062] The phrase "rotational assist feature" refers to an azimuthal thickness periodic distribution having a specific periodicity.

[0063] The term "specific fit" means that the non-optical peripheral carrier region includes 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 a rotational assist feature. For the avoidance of doubt, specific fit in the present invention means that the non-optical peripheral carrier region is configured with a thickness profile that is substantially free of any ballast, or prisms, or any truncated features found in standard toric or toric contact lenses of the prior art. Summary of the invention

[0064] A detailed discussion of the prior art and topics of general interest is provided herein as a background to the present disclosure, to illustrate the context of the disclosed embodiments and further to distinguish the present disclosure from the prior art as desired. Nothing herein submitted 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 priority of the claims is previously disclosed, known or part of the common general knowledge.

[0065] Briefly, all contact lens designs proposed for myopia involve applying some degree of defocus to the central or peripheral regions of the retina. See examples in 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 intended to control myopia with no or low degrees of astigmatism. Furthermore, while some designs show an initial burst of treatment or efficacy in combating myopia progression, the observed therapeutic benefits typically wane and disappear over time. Therefore, in order to advance the field, there is a need for a lens that can provide a stable therapeutic benefit over time while catering to myopia with and without astigmatism. More specifically, the lens can minimize, reduce or eliminate the decay, reduction, decline, diminution, attenuation or weakening of the therapeutic benefit over time, resulting in a greater cumulative absolute reduction in axial elongation for a myopic wearer.

[0066] The present disclosure relates to a contact lens for managing myopia; wherein the contact lens is configured with an optical zone substantially defined around its optical axis, the optical zone being characterized by the use of one or more meridian and azimuthally varying brightness distributions, wherein at least one of the meridian 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 decelerate, improve, control, inhibit or reduce the rate of progression of myopia and maintain a substantially constant therapeutic effect over time.

[0067] In some embodiments of the present disclosure, the myopic eye may be a myopic astigmatism eye. In some embodiments, one or more azimuthal thickness distributions may be configured with or without a rotational assist feature. In some embodiments, the rotational assist feature further comprises a periodic thickness distribution with a desired periodicity around the optical axis.

[0068] Certain embodiments are directed to contact lenses for altering the wavefront properties of incident light entering a person's eye in order to correct myopia and simultaneously provide a signal to arrest further eye growth.

[0069] Certain embodiments relate to contact lenses for correcting and treating refractive errors, particularly myopia, astigmatic myopia, progressive myopia or astigmatic progressive myopia.

[0070] According to certain embodiments, the disclosed contact lenses overcome the limitations of the prior art by minimizing the significant changes in visual performance that may occur in astigmatic myopic individuals.

[0071] 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 efficacy of myopia management with or without astigmatism, the efficacy of myopia prevention and control, or the efficacy of treatment of progressive myopia by introducing an optical stimulus or direction that varies in time and space, without burdening the wearer with wearing different lenses to achieve pulsed treatment.

[0072] According to certain other embodiments, the introduction of the spatiotemporally varying optical stimuli described herein is facilitated by the use of a non-optical peripheral carrier region that is configured without any dedicated stabilization platform used in prior art astigmatic or toric lenses. For the avoidance of doubt, the lenses of the present disclosure are free of any kind of stabilization platform, including but not limited to ballasting, thinning, truncation, or the like. Instead, the non-optical peripheral carrier region of the present disclosure is configured with a substantially constant azimuthal thickness profile, with or without an auxiliary rotation feature, allowing for substantial free rotation, which allows the contact lens to be easily increased on the eye.

[0073] 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 meridian and azimuthally varying brightness distributions, wherein at least one of the meridian and azimuthally varying brightness distributions lacks mirror symmetry, and wherein the optical zone at least partially provides foveal correction and produces at least partially blurred intervals 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.

[0074] 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 foveal periphery, fovea, macula, or perimacular region.

[0075] The present disclosure postulates 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 a myopia treatment.

[0076] Certain embodiments are configured with a brightness map 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.

[0077] Certain other embodiments are configured with a brightness map featuring a brightness distribution having multiple meridian and azimuthal variations within the optical zone, the purpose of which is to further minimize significant changes in visual performance that may occur due to contact lens rotation in myopic patients with high astigmatism, such as -0.75DC, -1.00DC, -1.25DC, -1.50DC, -1.75DC or -2DC.

[0078] Certain other embodiments are configured with a brightness map that provides at least partial correction for the myopic eye and at least partially provides a partially blurred cone on the retina to act as a directional cue to reduce the rate of progression of myopia.

[0079] The non-optical peripheral carrier region of some embodiments is configured to have a plurality of azimuthal thickness distributions such that a plurality of azimuthal thickness distribution 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 may 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.

[0080] 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 attenuation, decline or diminishing effect of the efficacy of treating myopia progression over time by providing a spatiotemporally varying stop signal that overcomes the limitations of the prior art.

[0081] In some other embodiments of the present disclosure, a hybrid area can be configured between the optical area and the non-optical peripheral area of ​​the contact lens. In other embodiments, the hybrid area between the optical area and the non-optical peripheral area can be configured as a circle, an ellipse, or an ellipse. In other embodiments, it can be configured as any other shape.

[0082] In some other embodiments of the present disclosure, the mixed area between the optical zone and the non-optical peripheral zone can be at least 0.1 mm, 0.25 mm, 0.5 mm or 0.75 mm, measured with the semi-diameter of the contact lens. In some other embodiments of the present disclosure, the mixed area between the optical zone and the non-optical peripheral zone 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, between 0.25 mm and 0.75 mm, measured with the semi-diameter of the contact lens.

[0083] Another embodiment of the present disclosure is directed to a contact lens for use in at least one of slowing, delaying, or preventing myopia progression, the contact lens comprising an anterior surface of the lens, a posterior surface, an optical zone, an optical center surrounding the optical zone, a non-optical peripheral zone surrounding the optical zone, the optical zone configured with a brightness map characterized by one or more meridian and azimuthally varying brightness distributions, wherein at least one of the meridian and azimuthally varying brightness distributions is configured to have no mirror symmetry, wherein the brightness map at least partially provides foveal correction for a myopic eye or a myopic astigmatic eye, and is also configured to at least partially provide at least one partial cone of blur to the myopic eye or the myopic astigmatic eye. The invention relates to a contact lens having a septum, which is used as an optical signal or directional cue on the central and / or peripheral retina; the non-optical peripheral carrier zone is also configured with a rotational assist feature, which includes a periodic function and a periodic azimuthal thickness change; wherein the periodic function includes a sawtooth profile, a sinusoidal profile, a sum of sinusoidal profiles or a quasi-sinusoidal profile, and the periodicity is not less than 6 changes in 360° azimuth, that is, from 0 to 2π radians; wherein the rotational assist feature helps to increase the tendency of the contact lens to rotate on the eye, so that the continuously changing, spatially and temporally changing optical stop signal can change over time to provide consistent therapeutic benefits for myopic eyes or astigmatic myopic eyes.

[0084] In some embodiments, the periodicity may be configured such that it has no less than 6 changes over 180° azimuth, i.e., from 0 to π radians. In some embodiments, the periodicity function may 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.

[0085] In some embodiments, the brightness distribution within the optical zone can be configured to vary meridionally and azimuthally, but radially invariantly, wherein the brightness distribution along 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 along the radial direction is substantially non-uniform.

[0086] In other embodiments, the meridional variation is such that the brightness distribution has substantially no mirror symmetry about the optical axis. In other embodiments, the azimuth variation is such that the brightness distribution has substantially no mirror symmetry 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 is configured to be symmetrical.

[0087] In some other embodiments, the brightness distribution within the optical zone can be configured to vary in meridian and azimuth as well as radially, wherein the brightness distribution along the radial direction can be such that it decreases from the center of the optical zone to the edge of the optical zone, and the brightness distribution along the azimuth direction can be such that it decreases or increases from 0 to 2π radians. In some embodiments, a linear, curvilinear, or quadratic function can be used to describe the decrease in the brightness distribution along the radial direction. In certain other embodiments, the decrease in the brightness distribution along the radial direction can be different for different azimuth positions on the optical zone.

[0088] In other embodiments, the decrease in the brightness distribution along the azimuth direction may follow a cosine distribution with a reduced 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 brightness distribution along the azimuth direction may be different for different radial positions on the optical zone.

[0089] According to one of the embodiments, the present disclosure is directed to a contact lens for myopic eyes with or without astigmatism. The contact lens includes a front surface, a back surface, an optical zone around an optical axis, and a plurality of meridian and azimuth-varying brightness distributions around the optical axis, wherein at least one of the meridian and azimuth-varying brightness distributions is configured to provide at least partially appropriate correction for myopic eyes with or without astigmatism, and is also configured to at least partially provide a stop signal that varies with time and space; therefore, over time, the therapeutic efficacy of reducing the rate of myopia progression remains substantially consistent.

[0090] 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 azimuthal varying profiles is configured to lack mirror symmetry, and at least one of at least some of the longitudinal varying profiles is configured to lack mirror symmetry. 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 particular fit on the eye.

[0091] 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 varying brightness distribution across 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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 a myopic eye.

[0096] In some embodiments, the brightness profile spans at least 3 mm, 4 mm, 5 mm, 6 mm, or 8 mm of the central zone 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.

[0097] Certain embodiments of the present disclosure are directed to contact lenses; wherein the non-optical peripheral carrier region of the contact lens includes a thickness profile that is substantially constant, which is defined as 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% of any other semi-meridian. The thickness profile of the contact lens across the semi-meridians can be obtained by using a perpendicular line drawn from a tangent at each point on the posterior surface of the contact lens to a tangent to the anterior surface of the contact lens.

[0098] 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 one semi-meridian is within a maximum variation range of 5μm, 10μm, 15μm, 20μm, 25μm, 30μm, 35μm, 40μm, 45μm from the thickest peripheral point of 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. Wherein, the non-optical peripheral carrier region includes one or more azimuthal thickness distributions around the optical axis, which are defined at arbitrary radial distances in the non-optical peripheral carrier region and are substantially invariant. Wherein, substantial invariance refers to a variation in the azimuthal thickness distribution, whose peaks and valleys are between 5μm and 45μm, or between 10μm and 45μm, or between 1μm and 45μm.

[0099] Certain embodiments of the present disclosure are directed to contact lenses; wherein the brightness map at least partially provides foveal correction for a myopic eye and at least partially produces at least partially locally blurred cones or intervals as directional cues at the retina of the myopic eye. In addition, the specific fit provides a stop signal that varies in time and space for the myopic eye to substantially control the eye growth of the myopic eye.

[0100] Certain embodiments of the present disclosure are directed to contact lenses; wherein the feature fitting allows the eye to rotate substantially freely; wherein substantially free rotation is measured as the lens rotating 180 degrees at least three times every 8 hours of wear, wherein the lens rotates at least 15 degrees every 1 hour of wear. In some other embodiments, substantially free rotation is measured as the lens rotating 180 degrees at least three times every 12 hours of wear, wherein the lens rotates at least 15 degrees every 2 hours of wear.

[0101] 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 at least one rotational assist feature includes an azimuthal thickness distribution represented by a periodic function having periodicity; wherein the periodic function is a sawtooth profile, a sinusoidal profile, a sum of sinusoidal profiles, or a quasi-sinusoidal profile, and the period of the periodic function over 360° azimuthal angles (from 0 to 2π) is not less than 6. The increase and decrease in the thickness variation rate are different; wherein the maximum thickness variation within at least one rotational assist feature is between 5 μm and 40 μm.

[0102] 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: the contact lens is rotated 180 degrees at least three times for every 4 hours of wear, and is rotated at least 15 degrees within 30 minutes of wearing the lens.

[0103] 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 stop signal for a myopic eye that varies over time and space such that effectiveness remains substantially consistent over time.

[0104] Other embodiments presented in the present disclosure are directed to the continuing 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 to carry out a range of activities that the wearer may engage in. Various aspects of the embodiments disclosed herein address this need of the wearer. BRIEF DESCRIPTION OF THE DRAWINGS

[0105] Figure 1a A front view and a cross-sectional view of an embodiment of a contact lens of the present disclosure are shown. According to an embodiment of the present disclosure, the front view also shows an optical center, an optical zone, a hybrid zone, and a non-optical peripheral carrier zone, which includes at least eight (8) cross-sections along any semi-meridian, configured with substantially similar thickness.

[0106] Figure 1b A front 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 front view also shows an optical center, an optical zone, a hybrid zone, and a non-optical peripheral carrier zone, including an azimuthal thickness distribution that is substantially constant or configured to have a periodic profile, so that the non-optical peripheral carrier zone facilitates or assists the rotation of the contact lens.

[0107] Figure 2aA front view of another contact lens embodiment of the present disclosure is shown, which illustrates the possibility of substantially free rotation of the lens during natural blinking action, which, according to certain embodiments of the present disclosure, 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.

[0108] Figure 2b A front view of another contact lens embodiment of the present disclosure is shown, illustrating the possibility of substantially free rotation or rotation-assisted contact lens substantially around the optical center, which, according to certain embodiments of the present disclosure, is due to the configuration of a non-optical peripheral carrier zone including 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 to rotate.

[0109] 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) of a standard toric or astigmatic contact lens configured using a standard spherocylindrical brightness distribution (brightness: -1DS / +1.5DC) is shown.

[0110] Figure 4a Shows Figure 3 The thickness distribution of the entire contact lens as described in , and the astigmatism distribution along four representative meridians, namely 0°, 45°, 90°, and 135°.

[0111] Figure 4b The thickness distribution of the entire contact lens of a prior art toric contact lens having a brightness distribution with astigmatism along two principal meridians 0° and 90° is shown.

[0112] Figure 4c Shown 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 in the non-optical peripheral region.

[0113] 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 5.5 mm radial distance in the non-optical peripheral region

[0114] Figure 5 The temporal and spatial variations of the signals due to the rotation of the contact lens (i.e., 0°, 90°, 180°, and 270°) are shown, and these signals are described as when a parallel beam of visible light (589 nm) is incident on the Figure 3 , 4aand the on-axis point spread function in the retinal plane when on a -1DS myopia model eye corrected by contact lenses as described in 4c.

[0115] Figure 6a and 6b Figure 1 shows the temporal and spatial variations of the optical signals due to the rotation of the contact lens (i.e., 0° and 90°). These signals are described as the incident light of a visible wavelength (589 nm) incident on the Figure 3 , 4a Geometric point analysis of wide-angle through focus at the retinal plane when on a contact lens-corrected -1DS myopia model eye as described in 4c.

[0116] Figure 7 Figure 1 shows the retinal signal (Sturm's cone) plotted as the on-axis, through-focus, modulation transfer function of the tangential and sagittal meridians for incident light at a visible wavelength (589 nm) incident on the Figure 3 , 4a Calculated for a model eye with -1DS myopia corrected by contact lenses as described in 4c, where the principal meridians of the contact lens plane are located at 0° and 90°.

[0117] 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) of another standard toric or astigmatic contact lens (brightness: -3.5DS / +1.25DC) is shown, which is configured using a standard spherocylindrical brightness distribution.

[0118] Figure 9a Shows Figure 8 The thickness distribution of the entire contact lens as described in , and the astigmatism distribution along four representative meridians, namely 0°, 45°, 90°, and 135°.

[0119] Figure 9b Shows 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 in the non-optical peripheral region.

[0120] Fig.9c The thickness distribution of a prior art toric contact lens stabilized by prismatic ballasting is shown as a function of azimuth angle along a 5.5 mm radial distance in the non-optical peripheral region.

[0121] Fig.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 9b is corrected with an on-axis point spread function at the plane.

[0122] Fig.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 9b is corrected with an on-axis point spread function at the plane.

[0123] Fig.12 The retinal signal (Sturm's cone) is shown when collimated 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, where the flat principal meridians of the contact lens are located at 0° and 90°.

[0124] Fig.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 constant, meridional and azimuthally varying (brightness: -1DS / +1.5D, half lens).

[0125] Fig.14a Shown in Fig.13 The embodiment described in the invention has a thickness distribution throughout the contact lens, which has a refractive distribution that is substantially radially constant and that varies in the meridional and azimuthal directions along four representative meridians, namely 0°, 45°, 90° and 135°.

[0126] Fig.14b Shows Fig.13 and Fig.14a The thickness distribution of the contact lens as a function of the azimuthal angle is 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.

[0127] Fig.15 The signal varying with time and space due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) is shown, which is described as follows: when parallel light of visible wavelength (589nm) is incident on a lens having Fig.13 The on-axis point spread function at the retinal plane when the myopia is corrected for a model eye with -1DS using the contact lens embodiment described in Figure 14.

[0128] Fig.16a and 16b The signal due to the rotation of the contact lens (i.e. 0° and 270°) over time and space is shown, which is described as follows: when parallel light of visible light wavelength (589nm) is incident on the lens with Fig.13 14 and wide angle through-focus geometry analysis of the myopia corrected by the contact lens embodiment described in FIG. 14 on a model eye of -1DS.

[0129] Fig.17 The retinal signal (Sturm's cone) is shown when collimated light of visible wavelength (589 nm) is incident on a -1DS myopic model eye using Fig.13 14, the calculated on-axis modulation transfer functions of the tangential meridian and sagittal meridian through the focus, where the meridians of the contact lens are located at 0° and 90°.

[0130] Fig.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 the optical zone diameter and brightness as a function of the azimuth angle) is shown, which has a brightness distribution that is basically radially unchanged, and varies in the meridional and azimuth directions (brightness: -3.5DS / +1.25D, half lens).

[0131] Fig.19a Shown in Fig.18 The embodiment described in has a thickness distribution across the contact lens having substantially radially invariant, meridional and azimuthal varying brightness distributions along four example representative meridians (i.e., 0°, 45°, 90° and 135°).

[0132] Fig.19b Shows Fig.18 and Fig.19a Thickness distribution of the contact lens described in FIG. 1 as a function of azimuth 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.

[0133] Fig. 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: when parallel light with a visible wavelength (589 nm) is incident on a lens with Fig.18 19 and 19 are exemplary contact lens embodiments described on a model eye correcting -4DS myopia and +1DC×90° astigmatism, with the on-axis point spread function on the retinal plane.

[0134] Fig.21a and 21b The signal due to the rotation of the contact lens (i.e. 0° and 90°) over time and space is shown, which is described as follows: when parallel incident light with a visible wavelength (589nm) is incident on the lens with Fig.18 The contact lens embodiment described in 19 corrects -4DS myopia and +1DC×90° astigmatism on a model eye, and its wide-angle through-focus geometric point analysis

[0135] Fig. 22 The retinal signal (partially blurred cone) is shown, which is described as follows: when parallel incident light at a visible wavelength (589 nm) is incident on a Fig.18 The modulation transfer functions of the on-axis through-focus of the tangential meridian and sagittal meridian were calculated for the contact lens embodiments described in 19 on a model eye corrected for -4DS myopia and +1DC×90°, where the meridians of the -3.5D contact lens are located at 0° and 90°.

[0136] Fig.23 The brightness distribution within the optical zone of an embodiment of the 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 brightness distribution that is basically radially invariant, meridional and azimuthally varying (brightness: -1DS / +1.5D, half-frequency cosine lens (1)).

[0137] Fig.24a Shows Fig.23 The thickness distribution of the entire contact lens of the embodiment described in, which is represented along four meridians, namely 0°, 45°, 90° and 135°, has a substantially radially invariant, meridional and azimuthal brightness distribution.

[0138] Figure 24b Shows Fig.23 and Fig.24a The contact lens described in FIG. 1 has a thickness distribution as a function of azimuth angle in the non-optical peripheral region along four example radial distances of 4.25 mm, 4.75 mm, 5.5 mm and 6.5 mm.

[0139] Fig.25The 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: when parallel incident light with a visible wavelength (589 nm) is incident on a lens with a Fig.23 The on-axis point spread function on the retinal plane when the contact lens embodiment shown in Figure 24 is corrected on a -1DS myopic model eye.

[0140] Fig.26a and 26b The time- and space-dependent signals due to contact lens rotations (i.e., 90° and 180°) are shown. These signals are described as follows: Fig.23 Wide angle through focus geometry analysis when corrected on a -1DS myopic model eye using the contact lens embodiment shown in Figure 24.

[0141] Fig. 27 The retinal signal (partially blurred cones) is shown, which is described as: when parallel incident light with a visible wavelength (589nm) is incident on a Fig.23 The modulation transfer functions of the on-axis tangential meridian and sagittal meridian through the focus are calculated when the contact lens embodiment described in Figure 24 is corrected on a -1DS myopia model eye, and wherein the meridians of the -0.25D contact lens are located at 0° and 90°.

[0142] Fig.28 The brightness distribution within the optical zone of an embodiment of a contact lens of the present invention (i.e., brightness diagram, brightness as a function of the diameter of the optical zone and brightness as a function of the azimuth angle) is shown, which has a substantially radially invariant, meridian and azimuthally varying distribution (brightness: -3.5DS / +1.25D, half

[0143] Fig.29a Shown in Fig.28 The thickness distribution of the entire contact lens of the embodiment described in, which is represented along four meridians, namely 0°, 45°, 90° and 135°, has a substantially radially invariant, meridional and azimuthal brightness distribution.

[0144] Fig.29b Shows Fig.28 and Fig.29a The contact lens described in FIG. 1 has a thickness distribution as a function of azimuth 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.

[0145] Fig.30The time- and space-dependent signals due to contact lens rotations (i.e., 0°, 90°, 180°, and 270°) are shown. These signals are described as follows: Fig.28 29 and the on-axis point spread function on the retinal plane for a model eye with -4DS myopia and +1DC x 90° astigmatism corrected by the exemplary contact lens embodiment described in FIG. 29 .

[0146] Fig.31a and 31b The signal due to the rotation of the contact lens (i.e. 0° and 90°) over time and space is shown, which is described as follows: when parallel incident light with a visible wavelength (589nm) is incident on the lens with Fig.28 Wide angle through-focus geometry analysis of the contact lens embodiments described in and 29 on a model eye with -4DS myopia and +1DC x 90° astigmatism corrected.

[0147] Fig.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 Fig.28 When the contact lens embodiment described in 29 is used on a model eye corrected for -4DS myopia and +1DC×90° astigmatism, the modulation transfer function of the on-axis through-focus of the tangential meridian and the sagittal meridian is calculated, and wherein the meridians of the -2.9D refractive contact lens are located at 0° and 90°.

[0148] Fig.33 The brightness distribution within the optical zone of an embodiment of the 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 brightness distribution that is essentially radially invariant, meridianally and azimuthally varying (brightness: -1DS / +1.5D, inverse half-cosine lens (1)).

[0149] Fig.34a Shown in Fig.33 The embodiments described in the drawings have thickness profiles along four exemplary representative meridians, namely 0°, 45°, 90° and 135°, across the entire contact lens, with substantially radially invariant, meridional and azimuthally varying brightness profiles.

[0150] Fig.34b Shows Fig.33 and Fig.34a Thickness distribution of the contact lens described in FIG. 5 as a function of azimuth angle in the non-optical peripheral region along a radial distance of 5.5 mm.

[0151] Fig.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, which is described as follows: when parallel incident light with a visible wavelength (589 nm) is incident on a lens with a Fig.33 The on-axis point spread function at the retinal plane when the contact lens embodiments described in 34 are used to correct -1DS myopia in a model eye.

[0152] Fig.36a and 36b The signal due to the rotation of the contact lens (i.e. 0° and 270°) is shown as a function of time and space. The signal is described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens with Fig.33 Analysis of wide angle through-focus geometry when the contact lens embodiment described in Figure 34 is corrected in a model eye with -1DS myopia.

[0153] Fig.37 The retinal signal (partially blurred cone) is shown, which is described as follows: when parallel incident light at a visible wavelength (589 nm) is incident on a Fig.33 The modulation transfer functions of the on-axis tangential meridian and sagittal meridian through the focus are calculated for a model eye with -1DS myopia corrected by the contact lens embodiment described in Figure 34, and wherein the meridians of the contact lens with a refractive power of -0.25D are located at 0° and 90°.

[0154] Fig.38 The brightness distribution within the optical zone of an embodiment of the contact lens of the present invention (i.e., 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, meridianally and azimuthally varying (brightness: -3.5DS / +1.25D, flipped half-cosine lens (2)).

[0155] Fig.39a Shown in Fig.38 The embodiments described herein have thickness distributions across the entire contact lens along four examples representing meridians 0°, 45°, 90° and 135°, with substantially radially invariant, meridional and azimuthal varying brightness distributions.

[0156] Fig.39b Shows Fig.38 and Fig.39a Thickness distribution of the contact lens described in FIG. 5 as a function of azimuth angle along a radial distance of 5.8 mm in the non-optical peripheral region.

[0157] Fig.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, which is described as follows: when parallel incident light with a visible wavelength (589 nm) is incident on a lens with a Fig.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° astigmatism corrected.

[0158] Fig.41a and 41b The signal due to the rotation of the contact lens (i.e. 0° and 90°) is shown as time and space varying. The signal is described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens with Fig.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.

[0159] Fig.42 The retinal signal is shown, which is described as follows: when a flat incident light with a visible wavelength (589 nm) is incident on the Fig.38 The modulation transfer functions of the on-axis tangential meridian and sagittal meridian through the focus are calculated when the contact lens embodiment described in 39 is 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 are located at 0° and 90°.

[0160] Fig.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 the optical zone diameter and brightness as a function of the 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)).

[0161] Fig.44 The signal due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) over time and space is shown, which is described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens with Fig.43 The on-axis point spread function in the retinal plane when the contact lens embodiment described in the embodiment is corrected in a -1DS myopic model eye.

[0162] Fig.45a and 45b The signal due to the rotation of the contact lens (i.e. 0° and 270°) is shown as a function of time and space. The signal is described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens with Fig.43The contact lens embodiments described in the present invention are corrected for wide angle through focus geometry in a 1DS myopic model eye.

[0163] Fig.46 The retinal signal is shown, which is described as: when parallel incident light with a visible wavelength (589 nm) is incident on Fig.43 The modulation transfer functions of the on-axis through-focus for the tangential meridian and sagittal meridian were calculated for the contact lens embodiment described in the embodiment on a model eye correcting -1DS myopia, where the meridians are located at 0° and 90° at a radial distance of ±4mm for a -0.65D diopter contact lens.

[0164] Fig.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 the optical zone diameter and brightness as a function of the azimuth angle) is shown, which has a brightness distribution that is basically radially unchanged, and varies in the meridional and azimuth directions (brightness: -3.5DS / +1.25D, inverse semi-cosine lens (negative spherical aberration) (2)).

[0165] Fig.48 The signal due to the rotation of the contact lens (i.e. 0°, 90°, 180° and 270°) over time and space is shown, which is described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens with Fig.47 The on-axis point spread function at the retinal plane when the contact lens embodiment described in the embodiment corrects -4DS myopia and +1DC×90° astigmatism in a model eye.

[0166] Fig.49a and 49b The signal due to the rotation of the contact lens (i.e. 0° and 90°) is shown as time and space varying. The signal is described as follows: when parallel incident light with a visible wavelength (589) is incident on the lens with Fig.47 The contact lens embodiments described herein correct for -4DS myopia and +1DC x 90° astigmatism in a model eye with wide angle through focus geometry analysis.

[0167] Fig.50 The retinal signal is shown, which is described as follows: when parallel incident light with a visible wavelength (589nm) is incident on the Fig.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 correction model of -4DS myopia and +1DC×90° astigmatism, where the contact lens with a diopter of -3.3D is located at the meridians of 0° and 90° at a radial distance of ±4mm.

[0168] Fig.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. Fig.13 A variation of the contact lens embodiment described in .

[0169] Fig.52 The measured azimuth angle characteristics of a half-area sample contact lens (HA lens #2) of another disclosed embodiment with a label or prescription of -2DS / +2D are shown. The produced lens HA lens 2 is the disclosed Fig.13 and 47 Another variation of the combination of the contact lens embodiments described in .

[0170] Fig.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. The produced lens F2 Lens #1 is Fig.23 A variation of the contact lens embodiment described in .

[0171] Fig.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).

[0172] Fig.55 The measured thickness distribution of the sample contact lens HA lens #1 is shown. Fig.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.

[0173] Fig.56 The measured thickness distribution of the sample contact lens HA lens #2 is shown in FIG. Fig.13 and 47 A variation of the combination of contact lens embodiments described in . The thickness distribution of HA lens #2 is described as a function of lens diameter.

[0174] Fig.57 The measured thickness distribution of the sample contact lens F2 lens #1 is shown, which is Fig.23 A variation of the contact lens embodiment described in . F2 The thickness distribution of lens #1 is described as a function of lens diameter.

[0175] Fig.58The azimuthal position of F2 lens #1 measured after a period of wear on the eye, i.e., approximately 60 minutes of lens wear, is shown.Contact Lens Example F2 lens #1 is designed to have a substantially constant azimuthal thickness profile in the non-optical peripheral carrier region, thereby allowing substantially free rotation of the contact lens on the eye.

[0176] Fig.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 in the non-optical peripheral carrier region, thereby allowing substantially free rotation of the contact lens on the eye.

[0177] Fig.60 The azimuthal position measured after a period of wear of a prior art commercial toric contact lens (Control #1) is shown, i.e., after about 30 minutes of wear. The control prior art toric contact lens is designed with a dedicated stabilization zone in the non-optical peripheral carrier region to allow minimal rotation of the lens when worn on the eye. This is in stark contrast to all the embodiments of the present disclosure. DETAILED DESCRIPTION

[0178] 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 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 an embodiment may be combined with one or more features of any other embodiment constituting an additional embodiment.

[0179] The functional and structural information disclosed herein should not be interpreted as limiting in any way, but should only be interpreted as a representative basis for teaching those skilled in the art to use the disclosed implementations and their variations in various ways. Subheadings and related subject headings are used in the detailed description section only for the convenience of the reader's reference and should not be used to limit the subject matter throughout the invention or the claims of this disclosure. In addition, subheadings and related subject headings should not be used when interpreting claims or the scope of claims.

[0180] 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).

[0181] To date, several optical designs have been proposed to control the rate of myopia progression. Some features of designs used to retard the rate of myopia progression include a certain degree of relative positivity related to the prescription power, usually distributed rotationally symmetrically with respect to the optical axis of the contact lens. This article describes some inherent weaknesses of the prior art. Existing designs based on simultaneous images usually show a loss of visual quality at different distances. This side effect is attributed to the significance of simultaneous defocus, large amounts of spherical aberration or sharp changes in brightness.

[0182] Given the impact of contact lens wear compliance on efficacy, a significant reduction in visual performance can promote poor compliance, leading to poor efficacy. Therefore, a design for correcting myopia and delaying progression is needed without incurring at least one or more of the disadvantages discussed herein. As discussed herein, other solutions will become apparent.

[0183] The efficacy of prior art designs was determined in randomized controlled clinical trials. The duration of these clinical trials ranged from 6 months to 3 years, and reported efficacy of prior art lenses ranged from 20% to 50% compared to control single vision lenses.

[0184] Simple linear models of emmetropization suggest that the magnitude of the stop signal will accumulate over time. In other words, the cumulative stop signal depends on the total exposure rather than its temporal distribution. A striking finding in all clinical trials is that almost all of the reduction in the rate of myopia progression occurs within the first 6 to 12 months.

[0185] 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 need to switch between different lenses.

[0186] Patents PCT / AU2020 / 051004 and PCT / AU2020 / 051006 have considered some designs to overcome this limitation regarding the reduction in stop signal effectiveness observed with prior art lenses.

[0187] 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.

[0188] 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 a wearer's eye or stop the growth of the eye (or the state of refractive error). 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 cause potential visual performance degradation to the wearer. A contact lens device that has a rotationally symmetric optical power distribution across the entire optical zone that overcomes the limitations of existing lens technology by minimizing the significant changes that may occur in visual performance when worn on myopic eyes with and without astigmatism.

[0189] 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.

[0190] This can be accomplished 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 disclosed embodiments can be configured with or without additional rotational aid features to facilitate the directional cue obtained by the contact lens to remain substantially constant in space and time.

[0191] Figure 1a The front view (100a) and cross-sectional view (110a) of an exemplary contact lens embodiment are not shown 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).

[0192] Meridian (106a) and azimuthal (107a) brightness distribution functions are used to configure meridian and azimuthal varying brightness distribution within an optical zone (102a) of a contact lens embodiment (100a).

[0193] In this exemplary example, the carrier region (104a) is further described as eight (8) cross sections along arbitrary semi-meridians 1041 to 1048. In this exemplary example, the lens diameter is approximately 14 mm, i.e., the optical zone (102a) is elliptical, approximately 8 mm in diameter along the horizontal, approximately 7.5 mm in diameter along the vertical, the blending zone (103a) is approximately 0.25 mm in the horizontal meridian, approximately 0.38 mm in the vertical meridian, and the width of the symmetrical non-optical peripheral carrier region (104a) is approximately 2.75 mm.

[0194] 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 distribution that facilitates rotation of the contact lens.

[0195] In certain embodiments, the difference in thickness profiles of eight (8) sections along any semi-meridian (1041-1048) 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.

[0196] For example, the thickness distributions of the eight (8) representative cross-sections (1041 to 1048) can be configured such that each of the thickness distributions of the eight (8) representative cross-sections is substantially the same. 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 arbitrary representative cross-section differs from any other representative cross-section by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10%.

[0197] 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 a 3%, 5%, 7%, or 9% variation 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 a 4%, 6%, or 8% variation of the thickness distribution of the representative cross-section 1046.

[0198] 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%, 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.

[0199] 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 across 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.

[0200] In some examples, the peak thickness measured in one cross section at any semi-meridian may be compared to the peak thickness measured at a corresponding point in another cross section at another semi-meridian of the non-optical peripheral carrier region. In some examples, the peak thickness measured at a series of points in one cross section along any semi-meridian may be compared to the peak thickness measured within a series of ranges of corresponding points in another cross section along the non-optical peripheral carrier region. In some embodiments, the difference in peak thickness between one or more representative cross sections may 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 may be no greater than 10 μm, 20 μm, 30 μm, 40 μm, or 50 μm.

[0201] 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.

[0202] In this exemplary contact lens embodiment (100a), the optical zone has a meridional and azimuthally varying brightness distribution, wherein the meridional varying brightness distribution has no mirror symmetry, which at least partially provides correction for -3DS myopia, wherein the meridional and azimuthally varying brightness distribution with at least 1.25D of incremental brightness at least partially induces or introduces partially blurred cones or intervals 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 used to correct and manage myopia can be between -0.5DS and -12DS and the required incremental power to induce or introduce the required cones or partially blurred intervals, such as the range of directional cues or stop signals for the retina of the myopic eye can be between +0.75D and +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.

[0203] 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 so that the non-optical peripheral carrier region has a defined period or periodic feature to facilitate or assist 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.

[0204] The thickness distribution of the produced lens can be measured by the perpendicular line from the tangent line at each point on the back surface in the non-optical peripheral carrier area of ​​the contact lens to each point on the front surface. The thickness distribution measured at each point in the non-optical peripheral carrier area can also be plotted as a function of the azimuthal angle defined at any radial distance in the non-optical peripheral carrier area to provide an azimuthal thickness distribution.

[0205] In some examples, the azimuthal thickness distribution may be measured or compared at any arbitrary radial distance within the non-optical peripheral carrier region. In other examples, the azimuthal thickness distribution may be measured or compared by an average value within an arbitrary range of radial distances within the non-optical peripheral carrier region.

[0206] 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-trough 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.

[0207] Figure 2a A front view of an exemplary contact lens embodiment (200a) is shown. The diagrammatic illustration shows the effect of the lower (201a) and upper (202a) portions of the eyelid positioned in 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 zone is approximately 0.125 mm (horizontally) and 0.25 mm (vertically), and the symmetrical carrier region width is approximately 2.9 mm (horizontally) and 2.75 mm (vertically).

[0208] 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 zone blur or partial blur, applied by the optical zone (203a), which is substantially defined by the optical center or optical axis, and the change of blinking provides 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, which effect is substantially consistent over time.

[0209] Figure 2b A front view of another contact lens embodiment (200b) of the present disclosure is shown. The figure graphically illustrates the effect of positioning the eyelid, lower portion (201b) and upper portion (202b) of the contact lens embodiment (200a), which illustrates substantially free rotation or assisting rotation of the contact lens substantially about the optical center (201b), which, according to certain embodiments of the present disclosure, is due to a non-optical peripheral carrier region (204b) configured with a substantially constant azimuthal thickness distribution (2040), (defined by periodic characteristics with or without a particular periodicity), which can facilitate configuration or assist rotation of the contact lens (203a and 203b).

[0210] In some embodiments, for example, as described with reference to FIGS. 1 and 2 , the contact lens is designed to exhibit at least substantial free rotation under the influence of natural blinking movements, or to facilitate increased rotational tendency due to rotational assist features. For example, over a full day of lens wear, preferably over 6 to 12 hours, the interaction of the eyelids will cause the contact lens to be in a large number of different orientations or configurations on the eye 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. Among other things, the advantage of temporally and spatially varying stimulus provides a desirable effect of controlling myopia that is substantially consistent over time.

[0211] Due to the basically meridian and azimuthally varying brightness distribution configured in the optical zone around the optical center of the contact lens, combined with the basically constant azimuth thickness distribution configured in the non-optical peripheral zone, the intervals of regional vision cones or local blur produced at the level of the wearer's retina can be configured with spatial and temporal variations, so as to minimize the reduction of therapeutic efficacy over time.

[0212] In some embodiments, the surface parameters of the contact lens embodiments can be customized to the individual eye, such as the back surface radius and / or asphericity, so that the desired supra-ocular rotation of the contact lens can be achieved. 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 the lens rotating during wear.

[0213] 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 expected 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 as compared to a design having a substantially constant azimuthal thickness distribution configured 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.

[0214] For this distribution feature, the azimuthal thickness distribution within the non-optical peripheral carrier region is non-uniform. In addition, 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 features may be reduced to a point where they may blend with the uniform edge thickness. In some other embodiments, the contact lens may be designed to have less than 20 degrees of rotation within 1 hour of lens wear, and less than 180 degrees of rotation once per day. It should be understood that the contact lens is still capable of producing 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.

[0215] 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.

[0216]

[0217]

[0218] Table 1: Description of the power and thickness of various contact lens designs.

[0219] All rotationally symmetric lens designs, such as single vision, bifocal and multifocal designs, feature meridional and azimuthally invariant brightness profiles in their optical zones and are also configured with azimuthally invariant thickness profiles (<10 microns) in the non-optical peripheral carrier zones.

[0220] Unlike the rotationally symmetric single vision, bifocal and multifocal designs of Table 1, the optic zone of a conventional / standard toric or toric lens is characterized by an azimuthally varying but meridianally invariant brightness profile, and an optic peripheral carrier zone having an azimuthally varying thickness profile (>100 μm). The presence of at least 100 μm or greater peaks and valleys in the azimuth thickness profile of a standard toric or toric lens is an advantage of the 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, and further, the lens should not rotate significantly on the eye to avoid any potential impairment of visual quality. In order to not allow free rotation on the eye, prior art standard toric or toric lenses are designed with dedicated stabilization zones, such as ballast, prism, slab or truncated designs. These dedicated stabilization zones are the reason for the large magnitude of the peaks and valleys (>100 μm) observed in toric or toric contact lenses.

[0221] 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 auxiliary rotation features, thereby allowing substantially free rotation, which makes the contact lens more susceptible to increased rotation on the eye.

[0222] 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 may 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 may be changed to assist in further simulation of the embodiments disclosed herein or variations thereof.

[0223] The examples provided in this specification have used -1DS and -4DS myopia, model eyes with and without +1DC astigmatism to disclose the invention. The same disclosure can be extended to other degrees of myopia and / or astigmatism, for example, myopia of -2DS, -3DS or -6DS, and / or astigmatism of 0.5DC, 0.75DC or 1.25DC. Astigmatism can be expressed using positive cylinder signs (e.g., +1.25DC) or using negative cylinder signs (e.g., -1.25DC). In the example embodiment, reference is made to a specific monochromatic wavelength of 589nm. In other examples, the lens designer can extend the range to other visible wavelengths between 420nm and 760nm.

[0224] Certain embodiments of the present disclosure are directed to a contact lens that can vary temporally and spatially, in other words, substantially vary in retinal position over time, to provide a stop signal to an eye with progressive myopia by causing the contact lens to naturally rotate on the eye due to the natural blinking motion. Such temporally and spatially varying stop signals can minimize the potential effects of therapeutic saturation and / or wear-off observed with prior art lenses.

[0225] 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 in which the wearer wears or inserts the contact lens. In some embodiments of the present disclosure, a stop signal can be configured using a brightness distribution that varies in the meridian and azimuth directions. The brightness distribution that varies in the meridian and azimuth directions can be further configured using a brightness distribution that is invariant in the meridian direction around the optical center of the contact lens. In some other embodiments, the brightness distribution that varies in the meridian and azimuth directions can be configured using a brightness distribution that is substantially invariant in the meridian direction. In certain embodiments of the present disclosure, the brightness distribution that varies in the meridian and azimuth directions within the optical zone of the contact lens can be configured using a radially invariant, meridianally 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.

[0226] In some embodiments, the expected 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 expected 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.

[0227] In certain embodiments of the present disclosure, a meridian and azimuthally varying brightness distribution within the optical zone of a contact lens can be configured using a radially varying brightness distribution over substantially the entire optical zone; wherein the radial size variation is configured such that the brightness increases or decreases from the center of the optical zone to the edge of the optical zone, and the azimuth size variation is configured such that the brightness decreases from 0 to 2π radians.

[0228] 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.

[0229] 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.

[0230] 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 quarter (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 expected normal frequencies for toric or astigmatic lenses in the prior art can be observed or seen.

[0231] 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.

[0232] In some embodiments, the meridional and azimuthal varying brightness distribution may be configured such that the brightness distribution is the sum of the spherical prescription, and the product of the radial or meridional and azimuthal brightness distribution functions. In some embodiments, the brightness distribution function of the optical zone may be radially constant, but meridional and azimuthal 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, for 10%, 20%, 30%, 40% or 50% of the area of ​​the optical zone of the contact lens, its brightness distribution function may be radially and azimuthal constant, and vary in azimuth over the remaining area of ​​the optical zone.

[0233] The schematic model eye was used to simulate the optical performance results of the 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.

[0234]

[0235] Table 2: Schematic diagram of myopic model eye with a prescription of -1DS.

[0236] The prescription provides two model eyes, one with myopia of -1DS without astigmatism, and the other with myopia of -4DS with +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 a necessary method for demonstrating the effects of the intended exemplary embodiments. It is merely one of many methods that a person skilled in the art may use for optical simulation purposes. In other examples, the lens designer may also vary the parameters of various parameters of the model eye; for example, the shape of the lens, the cornea, the lens, the retina, the media, or a combination thereof, to illustrate a better simulation of the described effects.

[0237] 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.

[0238]

[0239]

[0240] Table 3: Schematic diagram of myopia model with prescription of -4DS / +1DC×90.

[0241] Figure 3 A brightness diagram distribution (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 at radial distances of 0.5, 1.5, 2.5 and 3.5 mm, respectively, for four representative examples radial positions R1, R2, R3 and R4 (303).

[0242] A toric or astigmatic lens is configured using a standard sphero-cylindrical brightness distribution function, with one principal meridian (vertical meridian, 90°) having approximately +0.5D of brightness, the other principal meridian (horizontal meridian, 0°) having approximately -1D of brightness, and the oblique meridians 45° and 135° having approximately -0.25D of brightness. The difference between the two principal meridians is the cylindrical brightness, which is 1.5DC in this contact lens example. The brightness distribution of a toric or astigmatic lens is mirror-symmetric in that it has a radially and meridionally invariant brightness distribution that follows a cosine function with normal frequency (i.e., there are two cosine cycles over 360°). Figure 3The normal frequency of observing or seeing a standard toric or astigmatic lens of the prior art.

[0243] Figure 4a Shows coverage Figure 3 The toric or astigmatic contact lens diameters described in the figure are plotted along 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.

[0244] As previously disclosed in PCT Application No. PCT / AU2020 / 051004, the design facilitates substantially free rotation on or about the optical center of the contact lens due to the combination of up and down eyelid motions that promote natural blinking. This in turn results in blink-dependent astigmatism or linear stimulation applied by the optical zone, thereby producing temporally and spatially varying stimulation to reduce the rate of myopia progression. As a result, the efficacy of astigmatism direction cues and reduced eye growth progression remains substantially consistent over time.

[0245] Figure 4b The overall lens thickness distribution of a prior art toric contact lens with astigmatism distribution along two principal meridians 0° and 90° is shown. Figure 4b The prior art toric lens has a prism-ballast stabilization zone. The thickness distribution of the vertical meridian and horizontal meridian of the prismatic ballast lens, which is a typical lens in the prior art, has a cylindrical refractive power of about 1.5 DC.

[0246] The horizontal section (401b) is symmetrical, while the vertical section has a thicker lower (402b) and thinner upper (403b) portion, so that it provides 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, which provides good vision for astigmatic eyes along any meridian.

[0247] Figure 4c Shows Figure 3 and Figure 4a The contact lens described in FIG. 1 shows the thickness distribution 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 each representative radial position within the non-optical peripheral region is approximately 0.07 mm.

[0248] on the contrary, Figure 4dThe thickness distribution of the prior art complex curved contact lens as a function of the azimuth angle is shown, which shows a basically asymmetric azimuth 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 azimuth thickness distribution is approximately 0.155 mm, thereby achieving the desired stability of the complex prior art contact lens.

[0249] 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 figure is used for correction, and the prescription is described in Table 2. The point spread function of the axial time and space 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.

[0250] In this example Figure 5 In other examples within the present invention, visual performance is 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.

[0251] Figure 6a and 6b FIG. 4 shows the wide-angle (i.e., ±10° visual field) spatiotemporal variation signals of two different azimuth eyeglass positions when the contact lens is worn on the eye, 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 focus simulates the supraocular rotation of the contact lens, resulting in an optical stop signal that varies in time and space.

[0252] The through-focus geometric point analysis around the retinal plane was calculated at five positions, namely from -0.4 to +0.4 mm in 0.2 mm steps; where 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. 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.

[0253] In this example, Figure 6a and 6b In the present invention, an off-axis angle of 10° for the upper and lower fields of view has been used to describe the 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° fields of view 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 can extend the simulation to other wavelengths, including but not limited to 555 nm, 586 nm, or 591 nm. In certain other examples, multiple wavelengths can be used to demonstrate the chromatic effect of such contact lenses. All of these extensions are considered to be within the scope and intent of the present invention.

[0254] The incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with -1DS myopia. Figure 3 , 4a and 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, such as Figure 7 To evaluate the differences in contact lens rotational performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, i.e., 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 cones or Sturm's spacing remains constant as a function of rotation of the contact lens on the eye.

[0255] 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 desired spatiotemporal variation signal can be achieved through this design. Figure 3 , 4aThe intended design described in and 4c provides the desired temporally and spatially varying stimulus when worn on a purely myopic eye, but this may not be the case when such a lens is worn on 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 effect of this interaction.

[0256] Figure 8 A 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 of meridians 0°, 45°, 90°, 135° (802); 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 (803).

[0257] A toric or astigmatic lens is configured using a standard sphero-cylindrical power distribution function with one principal meridian (vertical meridian, 90°) having approximately -2.25D of power, the other principal meridian (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 meridionally invariant power distribution that follows a cosine function with normal frequency, which results in a power distribution that varies in azimuth about two mirror-symmetric axes (i.e., two cosine cycles over 360°). Figure 8 The normal frequencies expected from standard toric or astigmatic lenses in the prior art can be observed or seen.

[0258] Figure 9a Shown Figure 8 9, and the astigmatism distribution along four representative example meridians 0°, 45°, 90° and 135°. As can be seen in cross-sections 901a and 902a of Figure 9, 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 because the combined action of the upper and lower eyelids promotes natural blinking.

[0259] This in turn results in a blink-varying astigmatism or linear stimulus applied by the optical zone, resulting in a temporally and spatially varying stimulus to reduce the wearer's rate of myopia progression; thus, the directional cueing of the astigmatism and the efficacy of reducing the progression of eye growth remain essentially consistent over time.

[0260] Figure 9b The thickness distribution along the radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm for four examples is shown. Figure 9b It can be seen that, regardless of the radial distance, the thickness of the contact lens remains essentially constant as a function of the azimuth angle, with a peak-to-valley value of <10 μm. In addition, the maximum thickness difference between different radii is approximately 0.04 mm.

[0261] On the contrary, Fig.9c The thickness distribution as a function of the azimuth angle of another example of a complex curved contact lens of the prior art is shown, which shows a sinusoidal thickness variation as a function of the 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 a stable complex surface of the prior art contact lens.

[0262] 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, Fig.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.

[0263] Fig.11a and 11b The temporal and spatial variations of the signal for wide angle (i.e., ±10° field of view) for two different azimuth contact lens positions are shown, i.e., the contact lens embodiment ( Figure 8 and 9) have their angles of the flat principal meridian (-3.5D) located at 0° and 90°, respectively. Fig.11a and 11b The geometric point 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. The geometric point analysis of the through focus is calculated around the retinal plane at five positions, from -0.6 to +0.6 mm, in 0.3 mm steps; where 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.

[0264] It can be seen that in this example, the use of a 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), Figure 8 and Figure 9a and b) with a toric lens correction, the retinal signal is described as the modulation transfer function through the focus on the axis of the tangential and sagittal meridians, as Fig.12 .

[0265] To evaluate the performance differences of the contact lens with time-varying rotation, 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 on the eye. These two scenarios provide the best and worst combinations for evaluating the interaction between the astigmatism of the eye and the cylindrical power of the contact lens.

[0266] 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.

[0267] 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.

[0268] The expansion or contraction of cone depth or Sturm's interval 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 the expansion and contraction of cone depth or Sturm's interval as a function of on-eye rotation of the lens.

[0269] from Fig.12As can be seen from the simulations described in , the difference in distance between the tangent and sagittal meridians for the two azimuth 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 to combat progressive myopia as disclosed herein, significant visual changes may cause poor compliance issues, which are often observed in other existing lens designs.

[0270] Such limitations can be overcome, especially for eyes with myopia and astigmatism. Various disclosed embodiments of the present invention solve this problem by an intended design that minimizes visual changes when worn by people with myopia and astigmatism, and this effect can be shown by the following embodiment examples.

[0271] Fig.13 The brightness diagram distribution (1301) within the optical zone of the contact lens of an embodiment of the present disclosure is shown, and for four representative examples of meridians 0°, 45°, 90°, 135° (1302), the corresponding brightness distribution is as a function of the optical zone diameter; and, for four representative examples of radial positions R1, R2, R3 and R4 (1303), the corresponding brightness distribution is as a function of the azimuth angle at radial distances of 0.5, 1.5, 2.5 and 3.5 mm respectively.

[0272] Although the contact lens embodiment of the present invention has a radially constant and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, half-area lens) in one half-area region of the optical zone, it has a spherical brightness distribution (-1DS) in the other half-area region of the optical zone. As can be seen from 1302 and 1303, the brightness distribution of the half-area region defined by the azimuth angles of 0° to 180°, corresponding to the 0°, 45° / 135° and 90° meridians, varies between approximately -1D, -0.25D and +0.5D, respectively, and produces an incremental brightness of approximately 1.5D. The brightness in the other half-area region remains constant at -1D.

[0273] Fig.14a Shown Fig.13 Thickness distribution of the half-area lens example described in , which has radially constant, meridional and azimuthally varying brightness distribution along four representative meridians 0°, 45°, 90° and 135°. Fig.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 zone.

[0274] Since the combined action of the upper and lower eyelids promotes natural blinking, the design facilitates generally free rotation on or about the optical center of the contact lens. This, in turn, causes the stimulus applied by the optical zone of the half-area design to vary with blinking, resulting in temporally varying stimulation to reduce the wearer's rate of myopia progression. As a result, the efficacy of reducing ocular growth remains substantially consistent over time.

[0275] Fig.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. Fig.13 and Fig.14a as a function of the azimuth angle of the contact lens.

[0276] from Fig.14b It can be seen that, regardless of radial distance, the thickness of the contact lens is essentially a function of the azimuth angle, with a peak-to-valley value of less than 5 μm. In addition, the maximum thickness difference between different radii is about 0.04 mm.

[0277] When the incident light of parallel visible wavelength (589nm) is incident on the -1DS myopic simulated eye, the prescription is shown in Table 2, and the Fig.13 and Fig.14b The exemplary contact lens described in is corrected to obtain an on-axis point spread function that varies in time and space on the retinal plane, wherein the lens is rotated on the eye by 0° (1501), 90° (1502), 180° (1503) and 270° (1504) over time, see Fig.15 .

[0278] Fig.16a and 16b FIG. 1 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 contact lens embodiment ( FIG. 1 ) with brightness of -1D (as shown in 1302 along 0°) Fig.13 and 14) have meridians located at 0° and 90° respectively.

[0279] Fig.16a and 16b The through-focus geometric spot diagram simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time. The resulting through-focus retinal image is called a locally blurred cone or interval, providing at least partial correction for myopia and at least partially providing an optical stop signal or stimulus that varies in space and time.

[0280] Geometric point analysis of the through focus around the retinal plane was calculated in 0.2 mm jumps at five positions, from -0.4 to +0.4 mm; 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.

[0281] 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 azimuth contact lens positions. Fig.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.

[0282] When incident light of parallel visible wavelength (589nm) is incident on the -1D myopic schematic model eye, the myopic prescription is shown in Table 2. Fig.13 and Fig.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 Fig.17 .

[0283] To evaluate differences in contact lens rotational performance over time, modulation transfer functions were calculated for two azimuthal contact lens positions, i.e., with the principal meridian (-1D along 0°, as shown at 1302) at 0° (1701) and 90° (1702) when the contact lens is worn on the eye.

[0284] 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 for the half-area lens has less impact on visual performance than for the prior art toric lenses. In this example, the depth of the cone of vision or the spacing of the partial blur as a function of rotation of the lens on the eye remains constant.

[0285] Fig.18The brightness diagram distribution (1801) within the optical zone of the contact lens of an embodiment of the present disclosure is shown, and for four representative examples of meridians 0°, 45°, 90°, 135° (1802), the corresponding brightness distribution is as a function of the optical zone diameter; and, for four representative examples of radial positions R1, R2, R3 and R4 (1803), the corresponding brightness distribution is as a function of the azimuth angle at radial distances of 0.5, 1.5, 2.5 and 3.5 mm respectively.

[0286] 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).

[0287] As can be seen from 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.

[0288] Fig.19a Shown Fig.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°. Fig.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 zone.

[0289] Since the combined action of the upper and lower eyelids promotes natural blinking, the design facilitates generally free rotation at or about 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 varying stimulus that reduces the wearer's rate of myopia progression. Thus, the efficacy of reducing ocular growth progression remains substantially consistent over time.

[0290] Fig.19b Shows Fig.18 and Fig.19a Thickness distribution of the contact lens described in FIG. 5 as a function of azimuth 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.

[0291] from Fig.19bIt can be seen that, regardless of radial distance, the thickness of the contact lens as a function of azimuth is essentially constant, with a peak-to-valley value of <10 μm. In addition, the maximum thickness difference between different radii is approximately 0.06 mm.

[0292] With incident light of parallel visible wavelength (589nm) incident on a schematic model eye with a prescription of -4DS / +1DC×90° (Table 3), by way of example Fig.18 and Fig.19a Correction with the contact lens described in b yields a spatiotemporally varying on-axis point spread function in the retinal plane, such as Fig. 20 As shown, the glasses are rotated on the eye by 0° (2001), 90° (2002), 180° (2003) and 270° (2004) over time.

[0293] Fig.21a and 21b FIG. 4 shows the spatiotemporal variation signals of wide angles (i.e., ±10° visual field) at two different azimuth positions when the contact lens is worn on the eye, wherein the contact lens embodiment ( Fig.18 and 19) with a meridian of -3.5D (along 0°, as shown in 1802) located at 0° and 90° respectively.

[0294] Fig.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.

[0295] The through-focus geometric point analysis around the retinal plane was calculated at five positions, i.e., from -0.6 to +0.6 mm, in 0.3 mm steps; wherein 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.

[0296] Fig.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 azimuth contact lens positions. Fig.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.

[0297] The incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription of -4DS / +1DC×90° (Table 3). Fig.18 as well as Fig.19aThe retinal signal is described as the modulation transfer function of the tangential and sagittal meridians through the focus on the axis, see Fig. 22 .

[0298] 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).

[0299] In this example, the modulation transfer functions 2201 and 2202 show that the difference between the tangential meridian and the sagittal meridian (i.e., 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 effect on visual performance for the half-area zone lens than for the toric lens.

[0300] 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. Fig.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.

[0301] Fig.23 The brightness distribution diagram (2301) within the optical zone of the contact lens of the embodiment of the present disclosure is shown, and for four representative examples of meridians 0°, 45°, 90°, 135° (2302), the corresponding brightness distribution as a function of the diameter of the optical zone; and for four representative examples of radial positions R1, R2, R3 and R4 (2303), 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. The contact lens embodiment of the present invention has a radially invariant, meridian 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, and varies 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, and varies between approximately -0.25D, -0.75D and -1D, and produces an incremental brightness of approximately 1.5D.

[0302] Fig.24ashows the thickness distribution of an example of a half-frequency cosine lens (1) with Fig.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°. Fig.24a As can be seen in cross-sections 2401a and 2402a of the lens, the non-optical zone of the lens has a substantially rotationally symmetrical peripheral carrier zone. 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 causes the stimulus applied by the optical zone of the half-frequency cosine lens (1) design to vary with blinking, resulting in a temporally and spatially varying stimulus that reduces the rate of progression of myopia in the wearer; therefore, the efficacy of reducing the progression of ocular growth remains substantially consistent over time.

[0303] Figure 24b Shown in Fig.23 and Fig.24a Described in FIG. 1 is the thickness distribution as a function of the 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.

[0304] from Figure 24b It can be seen that, regardless of the radial distance, the thickness of the contact lens as a function of the azimuth angle is essentially constant, with a peak-to-valley value of less than 10 μm. In addition, the maximum thickness difference between different radii is about 0.06 mm.

[0305] The incident light of parallel visible wavelength (589nm) is incident on the -1D myopic schematic simulated eye (myopia prescription see Table 2), Fig.23 and Fig.24a The exemplary contact lens described in a and b is used to correct for the spatio-temporal variation of the point spread function on the axis in the retinal plane, as shown in Fig.25 As shown, where the lens is rotated on the eye by 0° (2501), 90° (2502), 180° (2503) and 270° (2504) over time.

[0306] Fig.26a and 26b 1 shows the wide angle (i.e., ±10° field of view) spatiotemporal variation signals for two different azimuth positions when the contact lens is worn on the eye, i.e., the contact lens embodiment with a diopter of -0.25D ( Fig.23 as well as Fig.24a and b) have meridians (along 0°, as shown in FIG. 2302 ) located at 90° and 180°, respectively.

[0307] Fig.26a and 26bThe through-focus geometry plot 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 geometry plot was calculated around the retinal plane at five positions, i.e., from -0.4 to +0.4 mm in 0.2 mm steps; retinal positions -0.4 mm and -0.2 mm in front of the retina; retinal position 0 mm on the retina; and retinal positions +0.2 mm and +0.4 mm behind the retina.

[0308] 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 azimuth contact lens positions, Fig.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 a toric lens.

[0309] 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 Fig.23 and Fig.24a The exemplary contact lenses described in a and b are used to correct for retinal irradiation, and the retinal signal is described by the modulation transfer function of the tangential and sagittal meridians through the focus, as shown in Fig. 27 To evaluate 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, when the principal meridian (-0.25D, along 0°, as shown at 2302) was located at 0° (2701) and 90° (2702).

[0310] 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 azimuth 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 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.

[0311] Fig.28The brightness distribution diagram (2801) within the optical zone of the contact lens of the embodiment of the present disclosure is shown, and the corresponding brightness distribution is a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, 135° (2802); and the corresponding brightness distribution is 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 (2803). The contact lens embodiment of the present invention has a radially invariant, meridian and azimuthally varying brightness distribution (brightness: -3.5DS / +1.25D, half-frequency cosine lens (2)).

[0312] 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.

[0313] Fig.29a Shown Fig.28 The thickness distribution of the half-frequency cosine lens example (2) described in FIG. 1 has a radially invariant brightness distribution along the four representative meridians of 0°, 45°, 90° and 135°, and a meridional and azimuthally varying brightness distribution.

[0314] from Fig.29a As can be seen in cross-sections 2901a and 2902a of the lens, the non-optical region of the lens 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 eye growth remains substantially consistent over time.

[0315] Fig.29b The thickness distribution along the radial distances of 4.5 mm, 5.25 mm, 5.75 mm and 6.25 mm for four examples is shown. Fig.28 and Fig.29a as a function of the azimuth angle of the contact lens.

[0316] from Fig.29bIt can be seen that the thickness of the contact lens is essentially constant regardless of the radial distance, with a peak-to-valley variation of less than 5 μm as a function of the azimuth angle. In addition, the maximum thickness difference between different radii is approximately 0.04 mm.

[0317] When incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with a prescription of -4DS / +1D×90 (Table 3), Fig.28 and Fig.29a and b) are corrected by the exemplary contact lenses described in the examples, resulting in Fig.30 The on-axis point spread function over time and space in the retinal plane is shown, where the glasses change over time as the eye is rotated 0° (3001), 90° (3002), 180° (3003) and 270° (3004).

[0318] Fig.31a and 31b 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 are shown, i.e., the brightness is -2.9D contact lens embodiment ( Fig.28 and Fig.29a and b) have meridians (along 0°, as shown in FIG. 2802 ) located at 0° and 90°, respectively.

[0319] Fig.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.

[0320] The 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 jumps; 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.

[0321] Fig.11a and 11b Unlike the toric lens through-focus mosaic image seen in , where the blurred image varies significantly more in size (i.e., focus) and direction between the two azimuthal contact lens positions, Fig.31a and 31b The image of the example half-frequency cosine lens (2) embodiment has only a small change. Therefore, compared with a toric lens, the rotation of the half-frequency cosine (2) contact lens has less impact on visual performance.

[0322] When incident light of parallel visible wavelength (589nm) is incident on the schematic model eye of -4DS / +1D×90° prescription (Table 3), Fig.28 and Fig.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 through the focus, as Fig.32 Shown

[0323] To evaluate differences in contact lens rotational performance over time, modulation transfer functions were calculated for two azimuthal contact lens positions, with the principal meridian (along 0°, -2.9D, as shown in 2802) at 0° (3201) and 90° (3202) when the contact lens was worn on the eye.

[0324] 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 less variation than the 0.8 mm for the toric contact lens shown, 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.

[0325] 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). This focus shift is Figure 8 The toric contact lens shown is smaller at 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.

[0326] 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. Fig.12 Compared to Sturm's cone depth for the toric contact lens example, the expansion or contraction of the cone depth or partial blur interval as a function of contact lens rotation is minimal.

[0327] Fig.33The brightness distribution diagram (3301) in the optical zone of the contact lens of the embodiment of the present disclosure is shown, and the corresponding brightness distribution is a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, 135° (3302); and the corresponding brightness distribution is 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 (3303). The contact lens embodiment of the present invention has a radially invariant, meridian and azimuthally variable brightness distribution (brightness: -1DS / +1.5D, flipped semi-quasi-cosine lens (1)).

[0328] 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.

[0329] Fig.23 The contact lens embodiment of the invention has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Fig.33 The brightness distribution of the example has a horizontal plateau feature between 170° and 190°.

[0330] Fig.34a Shown Fig.23 The thickness distribution of the example of the flipped half-cosine lens (1) shown in FIG. 1 has radially invariant, meridian and azimuthally varying brightness distributions along four representative example meridians (i.e., 0°, 45°, 90° and 135°).

[0331] from Fig.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.

[0332] also, Fig.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 (ie, down-the-nasal) of the contact lens on the eye.

[0333] The thickness of the lens periphery varies in a sawtooth pattern having about 6 teeth in total and wherein the amplitude of each sawtooth is about 0.02 mm, ie, the thickness varies between about 0.18 and 0.2 mm.

[0334] 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 optical zone and the outer edge can be blended.

[0335] Such a peripheral thickness profile may assist rotation at or about the optical center of the contact lens as the combined action of the upper and lower eyelids promotes natural blinking.

[0336] 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.

[0337] To support the natural rotational orientation of the lens on the eye, mirrored lenses can be worn in the left and right eyes. When incident light of parallel visible wavelength (589nm) is incident on the myopic schematic eye of -1DS, the prescription is shown in Table 2, with Fig.33 and Fig.34a and b) for correction with the exemplary contact lens described in a, resulting in a spatiotemporal variation point spread function on an axis in the retinal plane, where the lens changes over time and is rotated on the eye by 0° (3501), 90° (3502), 180° (3503) and 270° (3504), as shown in FIG. Fig.35 shown.

[0338] Fig.36a and 36b 3302) shows the spatiotemporal variation signal of a wide angle (i.e., ±10° field of view) at two different azimuth positions when the contact lens is worn on the eye, i.e., a contact lens embodiment in which the diopter is -0.25D (along 0°, as shown in FIG. 3303 ). Fig.33 as well as Fig.34a and b) have meridians located at 0° and 270° respectively.

[0339] Fig.36a and 36b The geometric spot diagram of the interfocal point simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time.

[0340] Geometric point analysis of the through focus around the retinal plane was calculated in 0.2 mm jumps at five positions, from -0.4 to +0.4 mm; 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.

[0341] Figure 6a and 6bUnlike the toric lens interfocus mosaic image seen in , the blurred image varies in size (i.e., focus) and direction between the two azimuth contact lens positions. Fig.36a and 36b The image of the example flipped half-cosine lens (1) embodiment in FIG. 1 only changes in direction. Therefore, compared with a toric lens, the rotation of the flipped half-cosine lens (1) has less impact on visual performance.

[0342] When the incident light of parallel visible wavelength (589nm) is incident on the -1DS myopic schematic model eye, the prescription is shown in Table 2, and the Fig.33 and Fig.34a and Fig.34b The exemplary contact lens described herein is corrected such that the retinal signal is described by a modulation transfer function through the focus on the axis of the tangential meridian and the sagittal meridian, as Fig.37 shown.

[0343] To evaluate the differences in contact lens rotation performance over time, the modulation transfer functions were calculated for two azimuthal contact lens positions, i.e., a 0.25D contact lens at 0° (3701) and 90° (3702) on 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 1 has a smaller focus shift of approximately 0.6 mm, indicating that rotation of the flipped half-cosine lens (1) has less effect on visual performance than a 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.

[0344] Fig.38 The brightness diagram distribution (3801) within the optical zone of the contact lens of an embodiment of the present disclosure is shown, and for four representative examples of meridians 0°, 45°, 90°, 135° (3802), the corresponding brightness distribution is as a function of the optical zone diameter; and, for four representative examples of radial positions R1, R2, R3 and R4 (3803), the corresponding brightness distribution is as a function of the azimuth angle at radial distances of 0.5, 1.5, 2.5 and 3.5 mm respectively.

[0345] The contact lens embodiment of the present invention has a radially invariant, meridional and azimuthal brightness distribution (brightness: -3.5DS / +1.25D, flipped semi-cosine lens (2)).

[0346] 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.

[0347] Fig.28 The contact lens embodiment of the invention has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Fig.38 The brightness distribution of the example has a horizontal plateau feature between 0° and 180°.

[0348] Fig.39a Shown Fig.38 The thickness distribution of the example of the flipped half-cosine lens (2) shown in FIG. 1 has radially invariant, meridian and azimuthally varying brightness distributions along four representative meridians (i.e., 0°, 45°, 90° and 135°).

[0349] from Fig.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.

[0350] also, Fig.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 (ie, down-the-nasal) of the contact lens on the eye.

[0351] The thickness of the lens periphery varies in a sawtooth pattern having about 12 teeth in total and wherein the amplitude of each sawtooth is about 0.02 mm, i.e., the thickness varies between about 0.19 and 0.21 mm. A suitable amplitude of the pattern of teeth may vary between 0.05 mm and 0.05 mm, wherein the amplitude generally decreases toward the optical zone and lens diameter.

[0352] The variation in thickness may preferably be added to the anterior peripheral region to promote interaction with the eyelid. Such azimuthal peripheral thickness distribution may account for rotation at or about the optical center of the contact lens due to natural blinking promoted by the combined action of the upper and lower eyelids. This, in turn, causes the stimulus applied by the optical zone of the flipped semi-cosine lens (2) design to vary with blinking, thereby resulting in a spatiotemporally varying optical signal or stimulus to reduce the rate of progression of astigmatic myopia. Thus, such efficacy in reducing ocular growth remains substantially consistent over time.

[0353] When incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription -4DS / +1DC×90° (Table 3), Fig.38 and Fig.39a Correction with the exemplary contact lens described in b and b results in a time-space varying point spread function on axis in the retinal plane, such as Fig.40 As shown, the glasses are rotated on the eyes by 0° (4001), 90° (4002), 180° (4003) and 270° (4004) over time.

[0354] Fig.41a and 41b FIG. 4 shows the spatiotemporal variation signals of wide angles (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 power of -2.9D ( Fig.38 and 39) have meridians (along 0°, as shown in FIG. 3802) located at 0° and 90°, respectively. Fig.41a and 41b The through focus geometry plot simulates the rotation of the contact lens on the eye, resulting in optical stop signals that vary in space and time. 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; retinal positions +0.3 mm and +0.6 mm are behind the retina. Fig.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, Fig.36a and 36b The image variation of the flipped semi-cosine lens (2) of the example in the embodiment is small. Therefore, compared with a toric lens, the rotation of the flipped semi-cosine lens (2) has less impact on visual performance.

[0355] When the incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription -4DS / +1DC×90° (Table 3), Fig.38 and Fig.39a The exemplary contact lens correction described in b and c results in the retinal signal being described by the modulation transfer function on axis through the focal point in the tangential and sagittal meridians, as Fig.42 shown.

[0356] To evaluate 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 (brightness -2.9D along 0°, as shown at 3302) at 0° (3801) and 90° (3802).

[0357] 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), and the difference in focus shift is 0.1 mm. Figure 8 The toric contact lens shown in is about 0.8 mm smaller, which indicates that the rotation of the flipped half-cosine lens (2) has less impact on visual performance than that of a toric lens.

[0358] In this example, the cone depth or 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. Fig.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 rotation of the contact lens.

[0359] Fig.43 The brightness distribution diagram (4301) within the optical zone of the contact lens of the embodiment of the present disclosure is shown, and the corresponding brightness distribution is a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, 135° (4302); and the corresponding brightness distribution is 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 (4303). The contact lens embodiment of the present invention has a radially invariant, meridian and azimuthally varying brightness distribution (brightness: -1DS / +1.5D, flipped semi-quasi-cosine lens (with negative spherical aberration) (1)).

[0360] 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).

[0361] Fig.23The contact lens embodiment of the invention has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Fig.43 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.

[0362] 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. Fig.43 The exemplary contact lens described herein is used to correct the retinal angle, and the time- and space-dependent point spread function of the axis is obtained on the retinal plane, see Fig.44 , where the lens is rotated on the eye by 0° (4401), 90° (4402), 180° (4403) and 270° (4404) over time.

[0363] Fig.45a and 45b The wide-angle (i.e., ±10° visual field) temporal and spatial variation signals at two different azimuth positions when the contact lens is worn on the eye are shown, wherein the contact lens embodiment ( Fig.43 )'s refractive index changes from ±0.65D at the periphery to -0.25D at the center (as shown in FIG. 4302 , along 0°) with meridians located at 0° and 270° respectively. Fig.45a and 45b 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.

[0364] The 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.

[0365] 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 azimuth contact lens positions, Fig.45a and 45b The exemplary inverse semi-cosine lens (with negative spherical aberration) (1) embodiment changes only in direction. Therefore, the rotational property of the inverse semi-cosine lens (with negative spherical aberration) (1) has less impact on visual performance than a toric lens.

[0366] 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 Fig.43The retinal signal is described by the modulation transfer function through the focus on the axis of the tangential and sagittal meridians, as Fig.46 shown.

[0367] To evaluate 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 worn on the eye (with power 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).

[0368] 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 azimuth contact lens, and the difference in focus shift is approximately 0.3 mm, which is 1.3 mm. Figure 7 The toric contact lens shown in FIG. 1 is about 0.6 mm smaller than the toric contact lens, indicating that the rotation of the flipped half-cosine lens (negative spherical aberration) (1) has less effect on visual performance than the toric lens. In this example, the depth of the cone of vision or the interval of partial blur as a function of the rotation of the contact lens on the eye remains constant.

[0369] Fig.47 A brightness diagram distribution (4701) within the optical zone of a contact lens of an embodiment of the present disclosure is shown, with corresponding brightness distribution as a function of the optical zone diameter for four representative examples of meridians 0°, 45°, 90°, 135° (4702); and corresponding brightness distribution as a function of 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 (4703). The contact lens embodiment of the present invention has radial, meridian and azimuth varying brightness distribution (brightness: -3.5DS / +1.25D, flipped semi-quasi-cosine lens (with negative spherical aberration) (2)).

[0370] 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).

[0371] Fig.28The contact lens embodiment of the invention has a brightness distribution as a function of azimuth angle that follows a half-frequency cosine function, unlike Fig.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.

[0372] When the incident light of parallel visible wavelength (589nm) is incident on the -4DS / +1DC×90° (Table 3) schematic diagram model eye, Fig.47 The 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 Fig.48 shown.

[0373] Fig.49a and 49b The spatiotemporal variation signal of a wide angle (i.e., ±10° field of view) at two different azimuth positions when the contact lens is worn on the eye is shown, where the refractive power ranges from ±3.25D in the periphery to -2.9D in the center (as shown by 4702 along 0°) with meridians located at 0° and 90°, respectively. Fig.49a and 49b The geometric spot diagram of the interfocal point simulates the rotation of the contact lens on the eye, resulting in an optical stop signal that varies in space and time.

[0374] The 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.

[0375] Fig.11a and 11b Unlike the toric lens through-focus mosaic image seen in , where the blurred image has significantly greater variation in size (i.e., focus) and direction between the two azimuthal contact lens positions, Fig.49a and 49b The exemplary inverted half-cosine lens (with negative spherical aberration) (2) embodiment has less variation. Therefore, the rotational properties of the inverted half-cosine lens (with negative spherical aberration) (2) have less impact on visual performance than a toric lens.

[0376] When incident light of parallel visible wavelength (589nm) is incident on the schematic model eye with prescription -4DS / +1DC×90° (Table 3), Fig.47With the exemplary contact lens correction described in , the retinal signal is described as the modulation transfer function through the focus on axis for the tangential and sagittal meridians, as Fig.50 as shown in .

[0377] To evaluate 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 worn on the eye (with 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).

[0378] 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 their focal displacement is Figure 8 The 0.8 mm for the toric contact lens shown is smaller, 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).

[0379] In this example, the cone depth or 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 power of the contact lens and the astigmatism of the eye.

[0380] When with Fig.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.

[0381] 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 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.

[0382] In certain embodiments, a substantial portion of the optical zone of the contact lens consists of meridional and azimuthal varying brightness distribution functions, which may be understood to be at least 50%, 60%, 70%, 80%, 90%, 95%, 98% or 100% of the optical zone of the contact lens.

[0383] In certain embodiments, the substantial portion of the optical zone of the contact lens comprised of the meridional and azimuthal varying brightness distribution functions may be understood to be between 50% and 70%, between 60% and 80%, between 60% and 50%, between 90%, between 50% and 95%, between 80% and 95%, between 85% and 98%, or between 50% and 100% of the optical zone of the contact lens.

[0384] 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 zone 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 zone or carrier zone of the contact lens is substantially symmetrical and has a substantially similar thickness distribution in horizontal, vertical, and other oblique meridians.

[0385] In certain embodiments, the peripheral region or carrier region of the contact lens is substantially symmetrical and has 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 doubts in the radial direction).

[0386] 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.

[0387] In some embodiments, the contact lens may be positioned, formed or placed with meridional and azimuthal varying brightness distributions on the anterior surface, the posterior surface or a combination thereof.

[0388] In certain other embodiments, the toric portion positioned, formed or placed on one of the two surfaces of the contact lens and on the other surface may have other features for further reducing eye growth, for example, using other features such as defocus, coma or spherical aberration.

[0389] 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.

[0390] 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.

[0391] These may include, but are not limited to: eyeglass lenses of various designs, color filters, pharmaceutical agents, behavioral changes, and environmental factors.

[0392] Prototype contact lens: design, measurements and clinical data

[0393] 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 the visual performance and the amount of rotation of the lens over time while it is worn on the eye.

[0394]

[0395] Table 4: Refractive index and prescription information of the left eye of S#1 and S#2

[0396] 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.

[0397] Fig.51 The azimuthal brightness distribution of HA lens #1 for S#1 is measured and averaged at 6mm in the optical zone. HA lens #1 is Fig.13 A variation of the contact lens embodiment described in . The measured brightness -5.5DS / +2D is consistent with the lens prescription (Table 4).

[0398] Fig.52 The azimuthal brightness distribution of HA Lens #2 for S#2 is measured and averaged at 6mm in the optical zone. Fig.13 and 47 A variation of the contact lens embodiment combination described in , which has a half-area lens design with negative spherical aberration. The measured brightness -2DS / +2D is consistent with the lens prescription (Table 4), and the brightness of the spherical half area changes, that is, it decreases from about -1.5D to about -2.5D between 180° and 360° azimuth.

[0399] Fig.53 The azimuthal brightness distribution of the F2 lens #1 of S#1 is measured and averaged at 6mm in the optical zone. Fig.23 A variation of the contact lens embodiment described in . The measured brightness -5.5DS / +1.5D is consistent with the lens prescription (Table 4).

[0400] Fig.54The thickness distribution of the vertical and horizontal meridians measured for a commercially available toric contact lens (control group #1) is shown. For the avoidance of doubt, control group #1 is an example of a prior art lens. The lens is Biofinity Toric (CooperVision, USA), (material: comfilcon A), cylindrical power -1.25 DC.

[0401] Thickness distribution was measured using an Optimec is830 (Optimec Ltd, UK). The thickness distribution of the contact lens was measured by a perpendicular line from the tangent at each point on the back of the contact lens to the tangent on the front of the contact lens. Peripheral prism was measured as the thickness difference between the two peripheral peaks of each lens meridian. In control group #1, the thickness difference for meridians 1 (vertical) and 2 (horizontal) was 197.5 μm and 28 μm, respectively. Peripheral prism along meridian 1 is to stabilize toric contact lenses (prior art, commercially available).

[0402] Fig.55 The thickness distribution of two perpendicular meridians of the HA lens #1 prototype contact lens measured is shown. Fig.13 A variation of the contact lens embodiment described in . The peripheral prism was measured as the thickness difference between the two peripheral peaks of each lens meridian. In HA lens #1, the thickness difference of meridians 1 and 2 was 2.6 μm and 30.3 μm, respectively.

[0403] Fig.56 The graph shows the measured thickness distribution of two perpendicular meridians of the HA lens #2 prototype contact lens. Fig.13 and 47 A variation of the contact lens embodiment described in HA lens #2 (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 of each lens meridian. In HA lens #2, the thickness difference of meridians 1 and 2 is 10.7 μm and 34.4 μm, respectively.

[0404] Fig.57 The thickness distribution of the two perpendicular meridians of the F2 lens #1 prototype contact lens measured is shown in FIG. Fig.23 The peripheral prism is measured as the thickness difference between the two peripheral peaks of each lens meridian. In F2 lens #1, the thickness difference of meridians 1 and 2 is 2.9 μm and 14.8 μm, respectively. As expected from the design of the peripheral rotationally symmetric carrier region of the three prototype contact lenses, the peripheral thickness difference of the two meridians is minimized, thereby providing a peripheral carrier region without a stabilizing rotation effect.

[0405] by Fig.35The apparatus and measurement procedures explained in PCT / AU2020 / 051004 in and 36 were used to measure the amount of rotation of the prototype contact lenses F2 lens #1 and HA lens #2 and the control lens #1 lens on the eye.

[0406] Fig.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 counterclockwise (or down the nose) by about 450° (i.e., 1.25 turns).

[0407] Fig.59 The measured azimuthal position of the prototype contact lens HA Lens #2 when S#2 was worn on the left eye is shown. After about one hour of wear, HA Lens #2 rotated approximately 230° counterclockwise (or down the nose) (i.e., 0.6 turns). Based on the measured data points, it can be expected that the lens will rotate one full turn in another hour of lens wear.

[0408] Fig.60 The measured azimuthal position of a commercially available toric contact lens control group #1 is shown, showing only a small amount of lens rotation within 30 minutes of lens wear.

[0409] 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.

[0410] Other exemplary embodiments are described in Example Sets A and B below.

[0411] Example Set A

[0412] 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 partially blurred cones 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.

[0413] A2—The contact lens of example A1, 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;

[0414] A3 - A contact lens according to claim A2, wherein at least one partially varying meridional refractive index distribution varies radially.

[0415] A4—A contact lens according to claim A2, wherein at least one partially varying meridional refractive index distribution is radially invariant.

[0416] A5-Contact lens according to one or more of examples A1 to A4, wherein the at least one azimuthal angle distribution around the optical axis is at least partially variable and has no mirror symmetry around the optical axis;

[0417] A5 - A contact lens according to one or more of examples A1 to A4, wherein 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 a normal frequency; wherein the normal frequency is defined by two cosine periods over 360° or 2π radians.

[0418] A6—A contact lens according to claim A1, wherein only one of the multiple meridional refractive index distributions is mirror-symmetric along the optical zone, and the multiple azimuthal refractive index distributions do not have mirror-symmetry around the optical axis.

[0419] A7 - A contact lens according to one or more of examples A1 to A6 of claims, wherein the eye is a myopic eye with an astigmatism ≤ 0.75DC; wherein the sign of the astigmatism can be specified as a positive cylinder or a negative cylinder.

[0420] A8 - A contact lens according to one or more of examples A1 to A6 of claims, wherein the eye is a myopic astigmatist eye with an astigmatism ≥ 1DC; wherein the sign of the astigmatism can be specified as a positive cylinder or a negative cylinder.

[0421] A9-A contact lens according to one or more of claims in Examples A1 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.

[0422] A10 - A contact lens of one or more of claim examples A1 to A6 and A8, 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, the remainder being configured for basic astigmatism correction for myopic astigmatism ≥ 1DC.

[0423] A11 - A contact lens according to 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 the 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.

[0424] A12-A contact lens according to 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 the central zone of the lens optical zone. The remainder of the optical zone is configured for basic spherical correction of myopic astigmatism with astigmatism ≥ 1 DC.

[0425] 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.

[0426] 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 a meridional varying brightness distribution over the entire optical area and an azimuth varying brightness distribution around the optical axis provides an 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.

[0427] 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.

[0428] A16 - A contact lens according to one or more of claims examples A1 to A15, wherein the local blurred cone depth of the intraocular retina is at least 0.2 mm, 0.5 mm, 0.75 mm or 1 mm.

[0429] A17-A contact lens according to one or more of Examples A1 to A16, wherein the partially blurred cones span at least the foveal edge, fovea, macular edge, macula, or peri-macular region of the retina.

[0430] 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.

[0431] 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.

[0432] A20 - A contact lens according to one or more of claims examples A1 to A19, wherein the partially blurred cone is not a regular Sturm cone but is irregular.

[0433] 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.

[0434] 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.

[0435] A23-A contact lens according to one or more of claims 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, the sagittal plane being substantially close to the retina of the eye.

[0436] 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 measured on the semi-diameter of the entire contact lens optical zone spans at least 0.125 mm, 0.25 mm, 0.5 mm, 0.75 mm or 1 mm.

[0437] A25 - A contact lens according to one or more of claims 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.

[0438] A26-A contact lens according to one or more of claims 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.

[0439] A27-A contact lens according to one or more of claims in Examples A1 to A26, wherein the substantially unchanged 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.

[0440] A28-A contact lens according to one or more of claims Examples A1 to A26, wherein the basic invariance refers to a peak-to-valley thickness variation of no more than 5μm, 10μm, 15μm, 20μm, 25μm, 30μm, 35μm, 40μm or 45μm.

[0441] 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 to 7.2 mm, 4 mm to 7.5 mm, 4.5 mm to 6.5 mm, 4.25 mm to 7 mm or 4.5 mm to 7.1 mm in the non-optical peripheral carrier region.

[0442] 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, wherein the thickness distribution is configured to be substantially constant; wherein substantial invariance means that the variation in the thickness distribution along any semi-meridian is less than 3%, 5% or 8% of any other semi-meridian.

[0443] A31-A contact lens according to one or more of claims in Examples A1 to A24, wherein the non-optical peripheral carrier region includes a thickness distribution defined in a selected region along one or more semi-meridians, and the thickness distribution is configured to be substantially constant; wherein the substantial invariance of the thickness distribution means that the maximum variation of a thickest point across any semi-meridian is within 5μm, 10μm, 15μm, 20μm, 25μm, 30μm, 35μm, 40μm, 45μm of the thickest point of any other semi-meridian in the non-optical peripheral carrier region.

[0444] 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 to 7.2 mm, 4 mm to 7.1 mm, 3.75 mm and 7 mm, or 4 mm and 7.2 mm of the non-optical peripheral carrier region.

[0445] A33-The contact lens of one or more of claim 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.

[0446] A34 - A contact lens of one or more of claim examples A1 to A33, wherein the specific fit allows substantial free rotation on a myopic eye; wherein substantial free rotation is measured as follows: the contact lens is rotated 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.

[0447] 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.

[0448] A36-A contact lens according to example A35, wherein the periodic function is sawtooth, sinusoidal, a sum of sinusoids, or quasi-sinusoidal.

[0449] 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 increasing thickness is different from the rate of change of decreasing thickness.

[0450] A38 - A contact lens according to one or more of examples A1 to A37, wherein the maximum thickness variation within at least one rotational assist feature is between 10 μm and 45 μm.

[0451] A39-A contact lens according to one or more of examples A1 to A38, wherein the 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 rotation of the myopic eye. 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.

[0452] A40 – A contact lens according to one or more of claims Examples A1 to A39, wherein at least one rotational assist feature is configured to increase rotation of the eye with at least partially varying meridian and azimuth brightness distributions, providing 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.

[0453] 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 peri-macular area of ​​the retina of the eye; wherein the temporal variation provides a therapeutic benefit to the eye that remains substantially constant over time.

[0454] A42-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 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 eye's retinal field of view; 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.

[0455] 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, slowing of myopia progression of the eye.

[0456] A44-A contact lens according to one or more of claims 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.

[0457] A45-A contact lens according to one or more of claims in Examples A1 to A44, wherein 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 varying optical signals so that the effectiveness of the directional signal remains substantially consistent over time.

[0458] Example Set B

[0459] 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 zone around the optical zone; the optical zone comprises at least one brightness map, the brightness map being 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 zone comprises 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.

[0460] B2 - A contact lens pair according to claim B1, wherein for the right myopic eye and the left myopic eye, the brightness distribution in multiple meridian directions over the entire optical area and the brightness distribution in multiple azimuth angles around the optical axis are substantially different.

[0461] B3 - 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 to have basic spherical correction for myopia without astigmatism.

[0462] 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.

[0463] B5—The contact lens pair of one or more of claim examples B1 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 the central region of the optical zone.

[0464] B6 - A pair of contact lenses according to one or more of claims B1 to B5, wherein a brightness map of each of the contact lenses can be obtained using the front surface, the back surface or both surfaces of the contact lens.

[0465] B7—A contact lens pair according to one or more of examples B1 to B6, wherein at least one locally varying meridian brightness distribution of each contact lens can be further configured to vary radially.

[0466] B8—A contact lens pair according to one or more of examples B1 to B6, wherein at least one locally varying meridian brightness distribution of each contact lens can be further configured to be radially invariant.

[0467] 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.

[0468] B10 - A 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 around the optical axis of each contact lens is at least +1.25D, at least +1.5D, at least +1.75D, or at least +2D.

[0469] B11 - A pair of contact lenses according to one or more of examples B1 to B10, wherein a mixed zone is configured between the optical zone and the non-optical peripheral zone of each contact lens; wherein the mixed 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.

[0470] B12—The contact lens pair of one or more of claim examples B1 to B11, wherein the multiple azimuthal thickness distributions of the non-optical peripheral carrier region are configured to be substantially constant around the contact lens optical axis.

[0471] 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.

[0472] 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.

[0473] 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 5μm, 10μm, 15μm, 20μm, 25μm, 30μm, 35μm, 40μm or 45μm, respectively.

[0474] 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 to 7.2 mm, 4 mm to 7.5 mm, 4.5 mm to 6.5 mm, 4.25 mm to 7 mm, or 4.5 mm to 7.1 mm in the non-optical peripheral carrier region of each contact lens.

[0475] B17-A pair of contact lenses according to one or more of examples B1 to B16, wherein the non-optical peripheral carrier zone includes a thickness distribution defined along a selected area, wherein the thickness distribution is configured to be substantially constant along one or more semi-meridians; wherein substantially constant means that over the entire optical zone of each contact lens, the variation in the thickness distribution along any semi-meridian is less than 3%, 5% or 8% of any other semi-meridian.

[0476] B18 - A contact lens pair according to one or more of examples B1 to B17, wherein the substantially constant azimuthal thickness distribution of each contact lens refers to a peak-to-valley value between 5 μm and 40 μm.

[0477] B19 - A contact lens pair according to one or more of claims Examples B1 to B18, wherein the substantially invariant 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 in any other semi-meridian.

[0478] 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 over time and space to substantially control the growth of the myopic eye.

[0479] B21 - A contact lens pair according to one or more of 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 is 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.

[0480] 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.

[0481] B23-A pair of contact lenses according to example B22, wherein the periodic function of each contact lens is sawtooth, sinusoidal, a sum of sinusoidal shapes, or quasi-sinusoidal.

[0482] B24—The contact lens pair of claims B22 and B23, wherein the period of the periodic function of each contact lens is no less than 6, and the increasing rate of change of thickness is different from the decreasing rate of change.

[0483] B25—A 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.

[0484] B26-A pair of contact lenses 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 wearing and at least 15 degrees within 30 minutes of wearing.

[0485] B27-A contact lens pair according to one or more of examples B1 to B26, 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 with time and space, thereby maintaining substantially consistent effectiveness of the directional signal over time.

[0486] 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.

[0487] 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.

[0488] B30 - A contact lens pair according to one or more of 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.

[0489] B31-A 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, so that each selected rotational assist feature allows the lens to rotate differently between the left and right myopic eyes, thereby further increasing the optical signal of the myopic eye that varies in space and time, so that the efficacy of the directional signal remains substantially consistent over time.

[0490] B32-A contact lens pair according to one or more of examples B1 to B31, wherein 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, so that each selected rotational assist feature allows the lens to rotate differently between the left and right myopic eyes, thereby providing ideal visual performance for the myopic eye, while maintaining spatially and temporally varying optical signals, so that the efficacy of the directional signal remains substantially consistent over time.

[0491] B33 - A contact lens pair according to one or more of examples B1 to B32, wherein multiple meridian brightness distributions across the optical zone, and multiple azimuthal brightness distributions around the optical axis of each contact lens, are selected to allow for providing the desired visual performance for the 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.

[0492] 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, used to slow down, delay or reduce at least one of the progression of myopia, the contact lens comprising: front surface; rear surface; Optical Center; Optical axis; an optical zone surrounding the optical center, the optical zone comprising a brightness map characterized by a plurality of meridional brightness distributions across the optical zone and a plurality of azimuthal brightness distributions about the optical axis; and a non-optical peripheral carrier region surrounding the optical zone, the non-optical peripheral carrier region comprising a plurality of azimuthal thickness profiles about the optical axis; wherein at least one azimuthal brightness distribution is partially variable and lacks mirror symmetry; and wherein at least one meridional brightness distribution is partially variable and lacks mirror symmetry; wherein the brightness map at least partially provides foveal correction for the eye and at least partially provides a partially blurred cone signal for use as a directional cue or optical signal at the retina of the myopic eye; and At least one of the azimuthal thickness profiles is substantially constant such that the azimuthal thickness profile is substantially free of any ballast or prismatic or truncated features.

2. The contact lens of claim 1, wherein only one of the plurality of meridional brightness distributions has mirror symmetry along the optical zone, and none of the plurality of azimuthal degree distributions has mirror symmetry about the optical axis.

3. The contact lens of claim 1 , wherein the brightness map is at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95% or 100% of the optical zone and the remainder of the optical zone is substantially configured with spherical correction for a myopic eye without astigmatism.

4. The contact lens of claim 1, wherein the brightness map is at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95% or 100% of the optical zone and the remainder of the optical zone is substantially configured with astigmatism correction for a myopic eye with astigmatism.

5. The contact lens of claim 1, wherein the brightness map spans at least 3 millimeters of a central region of the optical zone.

6. The contact lens of claim 5, wherein the brightness map is achieved using the front surface, the back surface, or both surfaces of the contact lens.

7. The contact lens of claim 5, wherein at least one of the partially varying meridional brightness distributions is further configured to vary radially.

8. The contact lens of claim 7, wherein at least one radial brightness variation in the partially varying meridional brightness distribution is between 0 and -0.5D, or between 0 and -0.75D, or between 0 and -1D.

9. The contact lens of claim 1, wherein at least one of the partially varying meridional distributions is further configured to be radially invariant.

10. The contact lens of claim 1, wherein the difference between the maximum brightness and the minimum brightness of the brightness distribution that varies longitudinally across the optical zone and the brightness distribution that varies azimuthally around the optical axis provides an 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.

11. A contact lens according to claim 1, wherein the partially blurred cones have a depth of at least 0.5 mm at the retina of the eye; wherein the partially blurred cones span at least the macular region of the retina of the eye; wherein the macular region includes at least 20 degrees of visual field on the retina of a myopic eye.

12. The contact lens of claim 1, wherein the partially blurred cones are irregular and not regular Sturm cones; wherein, The partially blurred cone includes a sagittal plane and a tangential plane; wherein the tangential plane is located in front of the retina at at least one location within a 20 degree field of view of the retina of the eye; wherein, for at least one location within the 20 degree field of view of the retina of the eye, the sagittal plane is located substantially close to the retina of the eye.

13. A contact lens according to claim 1, wherein the substantially unchanged refers to a change in peak-to-valley thickness of no more than 40 μm; wherein the peak-to-valley thickness is defined as the difference between the thickest point and the thinnest point within a plurality of azimuthal angle distributions of a non-optical peripheral carrier region around the optical axis.

14. A contact lens according to claim 1, wherein the multiple azimuthal thickness distributions are defined as having a desired width across any radial distance range in the non-optical peripheral carrier zone, wherein the desired width is between 3.5 mm and 7.2 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 7.1 mm in the non-optical peripheral carrier zone.

15. The contact lens of claim 1, wherein the azimuthal thickness profile is substantially free of any ballast or prismatic or truncation features to permit substantially free rotation on a myopic eye; wherein substantially free rotation is measured as the contact lens rotating at least 180 degrees 3 times for every 8 hours of wear and at least 15 degrees within 1 hour of wearing the lens.

16. The contact lens of claim 1, wherein the azimuthal thickness profiles are substantially free of any ballast or prismatic or truncated features further configured with at least one rotational assist feature within the plurality of azimuthal thickness profiles; wherein at least one rotational assist feature is represented using a periodic function having a periodicity; wherein, The periodic function is a sawtooth curve, or a sine curve, or a sum of sine curves, and / or a quasi-sinusoidal curve; wherein the period of the periodic function is defined as not less than 6 in the range of 0 to 2π radians, and the thickness change rate increases and decreases differently; and wherein the maximum thickness change of at least one rotational auxiliary feature is between 10μm and 40μm.

17. The contact lens of claim 1, wherein the at least one rotational assist feature allows for increased rotation of the contact lens on a myopic eye, measured as at least three rotations of 180 degrees per four hours of wear of the contact lens and at least 15 degrees within 30 minutes of wear.

18. A contact lens according to claim 1, wherein the at least one rotational assist feature is selected to allow a desired lens rotation to provide a desired visual performance while maintaining a desired spatially and temporally varying optical signal for a myopic eye so that the efficacy of the directional signal remains substantially consistent over time.

19. A contact lens according to claim 1, wherein the brightness map combined with the azimuthal thickness distribution substantially free of any ballast or prismatic or truncation features provides a temporally and spatially varying directional cue or optical signal for substantially controlling eye growth in myopia, with efficacy remaining constant over time.

20. The contact lens of claim 1, wherein the visual performance of the contact lens is substantially similar to the visual performance of a single vision contact lens used for myopia correction.

21. A contact lens according to any one of claims 1 to 20, wherein at least one of the azimuthal brightness distributions is defined using a cosine distribution with a reduced frequency, wherein the reduced frequency is half (1 / 2) of a normal frequency, wherein the normal frequency is defined by two cosine periods of 360° or 2π radians.

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