Contact lens for myopic eye, method, contact lens for eye and method of slowing myopic progression in eye

Abstract

The present disclosure relates to a contact lens for a myopic eye, a method, a contact lens for an eye, and a method of slowing myopia progression in an eye. The contact lens is provided with a front surface, a rear surface, an optical center, an optical region, a mixing region and a non-optical peripheral carrier region; the optical zone comprises at least a base region configured with a substantially toroidal or astigmatic power distribution configured to substantially surround the optical center, at least partially provide meridian correction, at least partially introduce meridian astigmatism, thereby producing a stop signal; the power distribution adopts a cos2 (m theta) form, and m is an integer between 1 and 6; the non-optical peripheral carrier region is configured with a thickness profile that is substantially rotationally symmetric about the optical center to allow substantially free rotation of the contact lens; the substantially free rotation of the contact lens is measured as follows: the contact lens rotates 180 degrees at least three times per 8 hours of wearing the lens, and rotates at least 15 degrees within 1 hour of wearing the lens.

Description

[0001] This application is a divisional application of an invention patent application with an application date of September 23, 2020, application number 202080067307.7 (PCT / AU2020 / 051004), and invention name “Contact lens solution for myopia management”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to Australian provisional application serial number 2019 / 903580 filed on September 25, 2019 and entitled “A contact lens for myopia” and another Australian provisional application serial number 2020 / 900412 filed on February 14, 2020 and entitled “Contact lens”, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure relates to contact lenses for use with eyes suffering from axial length related diseases such as myopia. The present invention relates to contact lenses for managing myopia in an eye; wherein the contact lens is configured with: an optical zone, the optical zone is defined as being substantially centered about the optical axis of the contact lens, the optical zone is used to provide a substantially toric or astigmatic directional cue to the eye; and a non-optical peripheral carrier zone surrounding the optical zone, the non-optical peripheral carrier zone is configured with a substantially rotationally symmetric thickness profile to further provide a temporally and spatially varying directional cue or optical stop signal to thereby slow, improve, control, inhibit or reduce the rate of progression of myopia over time. Background Art

[0005] The human eye is hyperopic at birth, where the length of the eyeball is too short for the total optical power of the eye. As a person progresses from childhood to adulthood, the eyeball continues to grow until the refractive state of the eye stabilizes. The growth of the eye is understood to be controlled by feedback mechanisms and regulated primarily by visual experience so that the optics of the eye match the axial length and maintain homeostasis. This process is called emmetropization.

[0006] The signal directing the emmetropization process is initiated by modulating the light energy received at the retina. Retinal image features are monitored by a biological process that modulates the signal to start or stop, speed up or slow down eye growth. This process is coordinated between optics and eyeball length to achieve or maintain emmetropia. Derailment from this emmetropization process can lead to refractive disorders such as myopia. It is hypothesized that increased retinal activity inhibits eye growth and vice versa.

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

[0008] A simple pair of negative single vision lenses can correct myopia. Although such devices can optically correct the refractive error associated with axial length, these devices do not address the underlying cause of excessive eye growth in myopia progression.

[0009] Excessive axial length in high myopia is associated with serious vision-threatening conditions such as cataracts, glaucoma, myopic maculopathy, and retinal detachment. Therefore, there remains a need for specific optical devices for such individuals that not only correct the underlying refractive error, but also prevent excessive eye lengthening or excessive myopia progression, whereby the therapeutic effect remains substantially consistent over time.

[0010] definition

[0011] Unless otherwise defined below, the terms used herein are commonly used by those skilled in the art.

[0012] The term "myopic eye" refers to an eye that has experienced myopia, is in the pre-myopic stage, is at risk of developing myopia, has been diagnosed as having a refractive condition that is progressing toward myopia, and has an astigmatism of less than 1 DC.

[0013] The term "progressive myopic eye" refers to an eye with established diagnosed progressive myopia measured as 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.

[0014] The term "eye at risk for developing myopia" refers to an eye that may be emmetropic or low hyperopic at the time, but which has been identified as having an increased risk of becoming myopic based on genetic factors (e.g., both parents are myopic) and / or age (e.g., low hyperopia when young) and / or environmental factors (e.g., time spent outdoors) and / or behavioral factors (e.g., time spent performing near tasks).

[0015] The term "optical stop sign" or "stop signal" refers to an optical signal or directional cue that can be useful in slowing, reversing, arresting, delaying, inhibiting or controlling the growth of the eye and / or the refractive condition of the eye.

[0016] The term "spatially varying optical stop signal" refers to an optical signal or directional cue provided at the retina that varies spatially across the retina of the eye.

[0017] The term "temporally varying optical stop signal" refers to an optical signal or directional cue provided at the retina that changes over time.

[0018] The term "spatially and temporally varying optical stop signal" refers to an optical signal or directional cue provided at the retina that changes over time and spatially across the retina of the eye.

[0019] The term "contact lens" refers to a finished contact lens that is intended to fit onto the cornea of ​​a wearer to affect the optical properties of the eye, and is typically packaged in a vial, blister pack, or the like.

[0020] The term "optical zone" or "optical zone" refers to an area on a contact lens that has an optical effect as specified by the prescription. The optical zone can also be distinguished into areas with varying power distributions around an optical center or optical axis. The optical zone can also be distinguished by an anterior optical zone and a posterior optical zone. The anterior optical zone and the posterior optical zone refer to the front surface area and the back surface area of ​​the contact lens, each of which contributes to the prescribed optical effect. The optical zone of a contact lens can be circular or elliptical or other irregular shapes. The optical zone of a contact lens that has only spherical power is usually circular. However, in certain embodiments, the introduction of a toric surface may result in an elliptical optical zone.

[0021] The term "optical center" or "optical center" refers to the geometric center of the optic zone of a contact lens. The terms "geometric" and "geometrical" are essentially the same.

[0022] 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.

[0023] The term "blending zone" is a zone connecting or between the optical zone and the peripheral carrier zone of a contact lens. The terms "blending zone" and "blending zone" are synonymous in certain embodiments and can be located on the anterior surface or the posterior surface or both surfaces of a contact lens. The blending zone can be a polished, smooth junction between two different adjacent surface curvatures. The thickness of the blending zone can also be referred to as the junction thickness.

[0024] The term "through focus" refers to an area substantially in front of and behind the retina. In other words, an area approximately just in front of the retina and / or approximately just behind the retina.

[0025] The term "carrier zone" is the non-optical zone connecting the blending zone and the edge of a contact lens or the non-optical zone located between the blending zone and the edge of a contact lens. In certain embodiments, the term "peripheral zone" or "peripheral carrier zone" is synonymous with "carrier zone" and has no optical effect as prescribed.

[0026] The term or phrase "spherical optical zone" may refer to an optical zone having a uniform power profile without substantial primary spherical aberration.

[0027] The term or phrase "aspheric optical zone" may refer to an optical zone that does not have a uniform power distribution. In certain embodiments, an aspheric optical zone may also be classified as a low-order aberration, such as astigmatism or toric surface. The term or phrase "astigmatic optical zone" or "toric optical zone" may refer to an optical zone that has a sphero-cylindrical power distribution.

[0028] The term "ballast" refers to a rotationally asymmetric distribution of thickness profiles within a carrier region that serves to influence the rotational orientation of a contact lens when placed on an eye.

[0029] The term "prismatic ballasting" refers to the vertical prisms used to create a wedge-shaped design that will help stabilize the rotation and orientation of a toric contact lens on the eye.

[0030] The term "slab-off" refers to the purposeful thinning of a contact lens in one or more discrete areas near the edges of the lower and upper peripheries of the contact lens to achieve a desired rotational stability of the contact lens.

[0031] The term "cut-off" refers to the lower edge of a contact lens that is designed to be nearly straight in order to control the rotational stability of the contact lens.

[0032] The terms "negative," "flat," or "positive" carrier refer to contact lenses having an edge thickness greater than the bond thickness, an edge thickness equal to the bond thickness, and an edge thickness less than the bond thickness, respectively, as measured at a distance of approximately 0.1 mm from the lens diameter.

[0033] The term "model eye" may refer to a conceptual, ray-traced, or physical model eye.

[0034] The terms "diopter," "focal power," or "D" as used herein are unit measures of optical power, defined as the reciprocal of the focal length in meters of a lens or optical system along the optical axis. Typically, the letters "D" represent spherical diopter, and the letters "DC" represent cylindrical diopter.

[0035] The term "Sturm's cone-like" or "Sturm's distance" refers to the resultant substantially on-axis defocused image formed on or about the retina due to an astigmatism, toric or asymmetric power profile configured to be substantially centered about the optical center or optical axis, which is represented by an elliptical blur pattern that includes tangential and sagittal planes and has a circle of minimum confusion.

[0036] The term "power profile" refers to the one-dimensional power profile of local optical power across an optical zone as a function of radial distance at a given azimuthal angle referenced to the optical center, or as a function of azimuthal angle measured at a given radial distance.

[0037] The term "power map" refers to the two-dimensional power distribution in a Cartesian or polar coordinate system across an optical zone. The term "radial" refers to directions radiating from the optical center to the edge of the optical zone along an azimuthal angle definition. The term "azimuthal" refers to directions along a defined circle at radial distances about a defined optical axis or optical center.

[0038] The term "back vertex power" refers to the reciprocal of the back vertex focal length over the entire area or a specific area on the optical zone, expressed in diopters (D). The term "meridian of the optical zone" refers to any meridian around the visual center along any azimuth angle.

[0039] The term "SPH" or "spherical" power refers to the substantially uniform power between all meridians of the optical zone. The term "CYL", "cylindrical" power refers to the difference in back vertex power between two principal meridians in the optical zone.

[0040] The term "asymmetric optical zone" refers to the variation in local power in the azimuthal direction about the visual center while maintaining mirror symmetry along an arbitrarily chosen meridian.

[0041] The term "meridian correction" or "meridian correction of the eye" refers to partial correction of the eye along at least one meridian on the retina of the eye. The term "meridian astigmatism" or "meridian astigmatism of the eye" refers to astigmatism introduced or induced along at least one meridian of the eye.

[0042] The term "specific fit" means that the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric about the optical center to facilitate substantially free rotation of the contact lens over time. The specific fit referred to in the present invention means that the non-optical peripheral carrier zone is configured with a thickness profile that is substantially free of ballast or prisms or any truncation.

[0043] The term "foveal sub-region" refers to the region immediately adjacent to the central pit of the retina of the eye. The term "parafoveal region" refers to the region immediately adjacent to the foveal region of the retina of the eye.

[0044] The term "macular subregion" refers to the region within the macular region of the retina of the eye. The term "paramacular region" refers to the region immediately adjacent to the macular region of the retina of the eye. Summary of the invention

[0045] Certain disclosed embodiments include contact lenses for modifying the wavefront properties of incident light entering a human eye. Certain disclosed embodiments relate to configurations of contact lenses for correcting, managing, and treating refractive errors.

[0046] One of the embodiments of the proposed invention is intended to not only correct myopic refractive error but also simultaneously provide an optical stop signal that prevents further eye growth or myopia progression. The proposed optical device provides a substantially continuously changing astigmatic blur (i.e., an optical stop signal) imposed on the central and peripheral retinal regions.

[0047] The present disclosure includes astigmatic contact lenses or toric contact lenses that are purposefully designed without a stable carrier zone to provide temporally and spatially varying astigmatic blur stop signals on the central and peripheral retina.

[0048] Another proposed embodiment is an asymmetric contact lens for correcting myopic refractive error and also providing an optical stop signal that inhibits further eye growth or slows the rate of eye growth. Another feature of the proposed embodiment may include a blend between a rotationally asymmetric optical zone and a rotationally symmetric carrier zone of the proposed contact lens. The blend zone may be circular or elliptical.

[0049] Certain embodiments configured with a toric correction substantially centered about the optical center or optical axis can overcome limitations of the prior art by providing a stop signal that varies in time and space. Thus, allowing for minimization of saturation of the therapeutic effect of myopia progression. In another embodiment, the invention is directed to a contact lens for at least one of slowing, delaying, or preventing myopia progression.

[0050] Another embodiment of the present disclosure is a contact lens, which includes a front surface, a back surface, an optical center, an optical zone around the optical center, and a toric or astigmatic focal power profile substantially defined around the optical center, wherein the toric or astigmatic profile is configured to at least partially provide adequate foveal correction and at least partially provide an optical stop signal for reducing the rate of myopia progression; the contact lens is also configured with a rotationally symmetric peripheral carrier zone to provide an optical stop signal that varies in time and space; so that the therapeutic effect of slowing the progression of eye growth remains substantially consistent over time.

[0051] According to one of the various embodiments, the present disclosure relates to a contact lens for myopic eyes. The contact lens comprises a front surface, a back surface, an optical axis, an optical zone around the optical axis, and an asymmetric power profile around the optical axis, wherein the asymmetric profile is configured to at least partially provide adequate meridian correction and at least partially provide an optical stop signal for reducing the rate of myopia progression; the contact lens is also configured with a rotationally symmetric peripheral carrier zone to provide an optical stop signal that varies in time and space; so that the therapeutic effect of slowing the progression of eye growth remains substantially consistent over time.

[0052] The embodiments presented in this disclosure are directed to the continuing need for improved optical designs and contact lenses that can inhibit the progression of myopia while providing the wearer with reasonable and adequate visual performance to carry out a range of activities that the wearer can undertake as part of their daily lives. Various aspects of the various embodiments of the present disclosure address such needs of the wearer. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 A front view and a cross-sectional view of a contact lens embodiment are illustrated. According to certain embodiments, the front view also illustrates the optic center, the optical zone, the mixing zone, and the carrier zone.

[0054] Figure 2 A front view and a cross-sectional view of another contact lens embodiment are illustrated. The sphero-cylindrical correction in the optical zone of an embodiment can result in an elliptical optical zone. According to certain embodiments, the front view also illustrates that a radial cross-section of the carrier zone of the embodiment has a substantially similar thickness.

[0055] Figure 3 A front view of yet another contact lens embodiment disclosed herein is illustrated. The front view also illustrates the potential free rotation of the contact lens substantially about the optical center due to the configuration of the carrier zone design. According to certain embodiments, the substantially free rotation of the contact lens is facilitated by designing the carrier zone of the contact lens with a substantially approximate radial thickness profile.

[0056] Figure 4 A schematic diagram of on-axis geometric spot analysis at the retinal plane when incident light having a certain visible wavelength (e.g., 589 nm) and a vergence of 0D is incident on an uncorrected-3D myopic model eye.

[0057] Figure 5 A schematic diagram of on-axis geometric spot analysis at the retinal plane is illustrated when incident light having a certain visible wavelength (e.g., 589 nm) and a vergence of 0D is incident on a -3D myopic model eye corrected using a single-vision contact lens of the prior art.

[0058] Figure 6 A schematic diagram of the on-axis defocused geometric spot analysis at the retinal plane is illustrated when incident light having a certain visible wavelength (589 nm) and a vergence of 0D is incident on a -3D myopia model eye corrected using one of the contact lens embodiments disclosed herein.

[0059] Figure 7 A schematic diagram of an enlarged cross-section of only the optical zone of one of the contact lens embodiments having a toric or spherocylindrical prescription disclosed herein is illustrated. The power profile distribution within the optical zone of this embodiment is configured using the radial power distribution function and the azimuthal power distribution function as disclosed herein.

[0060] Figure 8 A power map distribution within the optical zone of an exemplary embodiment of the present disclosure is shown.

[0061] Fig. 9 The radial thickness distribution of an entire contact lens of an exemplary embodiment of the present disclosure is shown.

[0062] Fig.10 The diagram shows that when incident light having a certain visible wavelength (e.g., 589 nm) and a vergence of 0D is incident on a Figure 8 and Fig. 9 The temporally and spatially varying signal due to contact lens rotation is depicted as an on-axis point spread function at the retinal plane on a 3D myopia model eye corrected by the contact lens embodiment described in FIG.

[0063] Fig.11 The diagram shows that when incident light having a certain visible wavelength (e.g., 589 nm) and a vergence of 0D is incident on a Figure 8 and Fig. 9 The -3D myopia corrected by the contact lens embodiment described in the -3D myopia model eye is depicted as a signal that varies temporally and spatially due to contact lens rotation as analyzed by a wide field of view through-focus geometry.

[0064] Fig.12 The diagram shows the contact lens being rotated as depicted Fig.10 The retinal signal of the modulus of the optical transfer function for the defocus on the axis of the principal meridian and the perpendicular meridian of the temporally and spatially varying point spread function, which is incident on the retinal signal with a certain visible wavelength (for example, 589nm) and a vergence of 0D incident on the optical system using Figure 8 and Fig. 9 The -3D myopia corrected by the contact lens embodiments described in the drawings is calculated when viewed on a 3D model eye.

[0065] Fig.13 A focus map distribution within a light zone of another exemplary embodiment of the present disclosure is shown.

[0066] Fig.14 The radial thickness distribution of a prior art contact lens as a whole is shown.

[0067] Fig.15 Shows Fig.13 The radial thickness distribution of the entire contact lens of the presently disclosed exemplary embodiment is shown in .

[0068] Fig.16 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.13 and Fig.15 The temporally and spatially varying signal due to contact lens rotation is depicted as an on-axis point spread function at the retinal plane on a 3D myopia model eye corrected by the contact lens embodiment described in FIG.

[0069] Fig.17 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.13 and Fig.15 The -3D myopia corrected by the contact lens embodiment described in the -3D myopia model eye is depicted as a signal that varies temporally and spatially due to contact lens rotation as analyzed by a wide field of view through-focus geometry.

[0070] Fig.18 The diagram shows the contact lens being rotated as depicted Fig.16 The retinal signal of the modulus of the optical transfer function on the axis of the principal meridian and the perpendicular meridian, the defocus of the point spread function that varies in time and space, when the incident light with a certain visible wavelength (for example, 589nm) and a vergence of 0D is incident on the lens using Fig.13 and Fig.15 The -3D myopia corrected by the contact lens embodiments described in the drawings is calculated when viewed on a 3D model eye.

[0071] Fig.19 A focus map distribution within a light zone of another exemplary embodiment of the present disclosure is shown.

[0072] Fig. 20 The radial thickness distribution of an entire contact lens of another exemplary embodiment of the present disclosure is shown.

[0073] Fig.21 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.19 and Fig. 20The temporally and spatially varying signal due to contact lens rotation at the retinal plane, described as an on-axis point spread function, when on a 3D myopia model eye corrected by the contact lens embodiment described in FIG.

[0074] Fig. 22 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.19 and Fig. 20 The -3D myopia corrected by the contact lens embodiment described in the -3D myopia model eye is depicted as a signal that varies temporally and spatially due to contact lens rotation as analyzed by a wide field of view through-focus geometry.

[0075] Fig.23 The diagram shows the contact lens being rotated as depicted Fig.21 The retinal signal of the modulus of the optical transfer function on the axis of the principal meridian and the perpendicular meridian, the defocus of the point spread function that varies in time and space, when the incident light with a certain visible wavelength (for example, 589nm) and a vergence of 0D is incident on the lens with Fig.19 and Fig. 20 The -3D myopia corrected by the contact lens embodiments described in the drawings is calculated when viewed on a 3D model eye.

[0076] Fig.24 A focus map distribution within a light zone of another exemplary embodiment of the present disclosure is shown.

[0077] Fig.25 The radial thickness distribution of an entire contact lens of another exemplary embodiment of the present disclosure is shown.

[0078] Fig.26 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.24 and Fig.25 The temporally and spatially varying signal due to contact lens rotation is depicted as an on-axis point spread function at the retinal plane on a 3D myopia model eye corrected by the contact lens embodiment described in FIG.

[0079] Fig. 27 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.24 and Fig.25 The -3D myopia corrected by the contact lens embodiment described in the -3D myopia model eye is depicted as a signal that varies temporally and spatially due to contact lens rotation as analyzed by a wide field of view through-focus geometry.

[0080] Fig.28 The diagram shows the contact lens being rotated as depicted Fig.26 The retinal signal of the modulus of the optical transfer function on the axis of the principal meridian and the perpendicular meridian, the defocus of the point spread function that varies in time and space, when the incident light with a certain visible wavelength (for example, 589nm) and a vergence of 0D is incident on the optical system using Fig.24 and Fig.25 The -3D myopia corrected by the contact lens embodiments described in the drawings is calculated when viewed on a 3D model eye.

[0081] Fig.29 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.13 and Fig.15 The temporally and spatially varying signal due to contact lens decentration at the retinal plane when on a 3D myopia model eye corrected by the contact lens embodiment described in FIG. 5 is depicted as an on-axis point spread function.

[0082] Fig.30 The diagram shows that when incident light with a certain visible wavelength (589nm) and a vergence of 0D is incident on the Fig.13 and Fig.15 The -3D myopia corrected by the contact lens embodiment described in the -3D myopia model eye is depicted as a signal that varies temporally and spatially due to contact lens decentration for a wide field of view through-focus geometry analysis.

[0083] Fig.31 The diagram shows the contact lens being depicted as being eccentric. Fig.29 The retinal signal of the modulus of the optical transfer function on the axis of the principal meridian and the perpendicular meridian, the defocus of the point spread function that varies in time and space, when the incident light with a certain visible wavelength (for example, 589nm) and a vergence of 0D is incident on the lens using Fig.13 and Fig.15 The -3D myopia corrected by the contact lens embodiments described in the drawings is calculated when viewed on a 3D model eye.

[0084] Fig.32a The diagram shows Fig.19 Measured thickness profile of a prototype contact lens (Lens #1) of a variation of the contact lens embodiment described in .

[0085] Figure 32b The diagram shows Fig.19 Measured thickness profile of a prototype contact lens (lens #2) of a variation of the contact lens embodiment described in .

[0086] Fig.33a The diagram shows Fig.19The measured relative meridian power of the optic zone of a prototype contact lens (lens #1) of a variation of the contact lens embodiment described in .

[0087] Figure 33b The diagram shows Fig.19 Measured relative meridian powers of the optic zone of a prototype contact lens of a variation of the contact lens embodiment described in .

[0088] Fig.34a The measured thickness profiles of the two principal meridians (vertical and horizontal) of a commercially available toric contact lens (Control #1) are shown.

[0089] Fig.34b Shown are the measured thickness profiles for the two principal meridians (vertical and horizontal) of a commercially available toric contact lens (Control #2).

[0090] Fig.35 A picture showing a device for measuring the rotation of a contact lens over time.

[0091] Fig.36 A front view of a contact lens embodiment disclosed herein is shown. The front view also illustrates a method by which the azimuthal position, rotation, or number of revolutions about the optical axis of two prototype contact lenses (Lens #1 and Lens #2) can be measured over time using two markings on the contact lens.

[0092] Fig.37a Shown is the azimuthal orientation of a prototype contact lens (Lens #1) measured over time, ie, over approximately 30 minutes of lens wear.

[0093] Fig.37b Shown is the azimuthal orientation of a commercially available toric contact lens (Control #1) measured over time, ie, over approximately 30 minutes of lens wear. DETAILED DESCRIPTION

[0094] 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. The examples and embodiments are provided by way of illustration and should not be construed as limiting the scope of the present disclosure.

[0095] The following description is provided with respect to several embodiments that may share common characteristics and features of the present disclosure. It should be understood that one or more features of one embodiment may be combined with one or more features of any other embodiment that may constitute an additional embodiment.

[0096] The functional and structural information disclosed herein should not be construed as limiting in any way, and should merely be construed as a representative basis for teaching one skilled in the art to variously employ the disclosed embodiments and variations of such embodiments.

[0097] The subheadings and related subject headings included in the detailed description are for the convenience of the reader's reference only and should in no way be used to limit the subject matter found in the entire invention or the claims disclosed. The subheadings and related subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0098] The risk of developing myopia or progressive myopia may be based on one or more of the following factors: genetics, ethnicity, lifestyle, environment, excessive near work, etc. Certain embodiments of the present disclosure are directed to persons at risk of developing myopia or progressive myopia.

[0099] To date, many contact lens optical designs have been proposed to control the growth rate of the eye, i.e. myopia progression. Some contact lens design options with features for slowing the rate of myopia progression include designs with a certain degree of relative positive power associated with prescription powers of the lens that are typically distributed rotationally symmetrically about the optical axis of the contact lens.

[0100] Some problems with existing optical designs based on synchronous images are that they impair visual quality at various other distances by introducing considerable visual disturbances. This side effect is mainly due to: quite high levels of synchronous defocus, the use of considerable amounts of spherical aberration, or drastic changes in focus within the optical zone.

[0101] Given the impact of compliance with contact lens wear on the efficacy of such lenses, a significant reduction in visual performance may result in poorer compliance and, therefore, poorer efficacy.

[0102] A simple linear model of emmetropization suggests that the magnitude of the stop signal accumulates over time. In other words, the cumulative stop signal depends on the total magnitude of the exposure rather than its temporal distribution. However, the inventors have observed from clinical trial reports of various optical designs that, unevenly, the proportion of efficacy achieved or slowing of the progression rate is greater in the first 6 to 12 months.

[0103] After the initial abrupt initiation of treatment, a decrease in efficacy may be observed over time. Therefore, given the clinical observations, a more faithful model of emmetropization consistent with the clinical findings suggests that there may be a delay before the stop signal accumulates, and then saturation occurs over time, and the effectiveness of the stop signal may decay.

[0104] There is a need in the art for a contact lens that slows the rate of eye growth, e.g., myopia progression, by providing a temporally and spatially varying stopping signal to minimize such saturation of the therapeutic effect without placing the burden on the wearer to switch between contact lenses with different optical designs during a given period of time.

[0105] Therefore, there is a need for an optical design having the following mechanisms: achieving substantially greater and / or substantially consistent efficacy over time in reducing and / or slowing myopia progression without significantly compromising visual performance. In one or more examples, the extended period of time over which efficacy is substantially consistent can be considered to be at least 6, 12, 18, 24, 36, 48, or 60 months.

[0106] Various embodiments of the present disclosure are directed to an optical intervention that utilizes the effect of purposefully configured astigmatic blur on the visual system to inhibit or slow the rate of myopia progression. More specifically, some embodiments are directed to a toric contact lens that is purposefully designed to not have any stability or substantial stability in a non-optical peripheral carrier zone and that has optical properties for slowing or stopping the rate of progressive myopic refractive error.

[0107] The optical properties may include, at least in part, the introduction of an astigmatic blur at the level of the retina of the wearer's eye in combination with a rotationally symmetric peripheral carrier zone to serve as a temporally and spatially varying stop signal for a myopic eye or an eye that may be progressing toward myopia.

[0108] The present disclosure also relates to apparatus, methods and / or systems for modifying incident light through contact lenses that utilize astigmatism cues to slow the rate of myopia progression.

[0109] In some embodiments, a contact lens device or method provides a stop signal based on an astigmatism blur signal to slow the rate of eye growth or stop eye growth or ametropia in a wearer's eye. In some embodiments, the contact lens device configured with a rotationally symmetric peripheral carrier zone provides a stop signal that varies in time and space for improving the effectiveness of managing progressive myopia.

[0110] In some embodiments, a contact lens device or method is not based solely on positive spherical aberration or synchronous defocus, which is subject to potential visual performance degradation for the wearer.

[0111] The following exemplary embodiments relate to a method of modifying incident light by a contact lens that provides a synchronous astigmatism cue at the retinal plane of the eye being corrected. This can be achieved by using a toric optical zone of the contact lens to at least partially provide meridian correction for myopia.

[0112] The use of a toric optical zone of a contact lens can be configured with properties designed to reduce the rate of myopia progression by introducing a directional cue of astigmatism at the level of the retina. In certain embodiments, the use of directional cues of astigmatism obtained with a toric contact lens can be configured to be variable both spatially and temporally.

[0113] Certain other embodiments of the present disclosure are directed to an optical intervention that utilizes the action of a purposefully configured asymmetric zone in a contact lens to provide directional cues to the visual system to inhibit or slow down the rate of myopia progression. More specifically, some embodiments are directed to contact lenses that are purposefully designed to not have any stability or substantial stability in a non-optical peripheral carrier zone and that have optical properties for slowing down or stopping the rate of progressive myopic refractive error.

[0114] Figure 1 The general structure of an exemplary contact lens embodiment (100) to which embodiments of the present invention may be applied is shown, the lens being shown in a not-to-scale front view (100a) and a cross-sectional view (100b). The front view of the exemplary contact lens embodiment (100) also illustrates a substrate including an optical center (101), an optical zone (102), a blending zone (103), a symmetrical non-optical peripheral carrier zone (104), and a lens diameter (105). In this exemplary example, the lens diameter is approximately 14 mm, the optical zone diameter is approximately 8 mm, the blending zone width is approximately 0.25 mm, and the carrier zone width is approximately 2.75 mm.

[0115] Figure 2 A not-to-scale front view (200a) and cross-sectional view (200b) of another exemplary contact lens embodiment are shown. The front view of the exemplary contact lens embodiment also illustrates a substrate including an optical center (201), an optical zone (202), a blending zone (203), and a non-optical peripheral carrier zone (204). In this exemplary example, the lens diameter is about 14 mm in diameter, the optical zone (202) is spherocylindrical, or astigmatic, or toric, or asymmetric, the optical zone is elliptical and has a horizontal diameter of about 8 mm and a vertical diameter of about 7.5 mm, the blending zone has a width along the horizontal meridian of about 0.25 mm and a width along the vertical meridian of about 0.38 mm, and the symmetrical peripheral carrier zone has a width of about 2.75 mm. The radial cross-sections (204a to 204h) of the symmetrical peripheral carrier zone (204) have the same or substantially similar thickness profiles.

[0116] In certain embodiments, the differences in thickness profiles along different radial cross-sections (204a-204h) can be configured to achieve a desired supra-ocular rotation about the optical center of the lens. Preferred supra-ocular rotation can be achieved by maintaining rotational symmetry of the peripheral thickness profile across all semi-meridians.

[0117] For example, the radial thickness profiles (e.g., 204a to 204h) can be configured such that for any given distance from the center of the lens, the thickness profiles of any of the other radial cross sections are substantially the same or within a variation range of 4%, 6%, 8%, or 10%.

[0118] In one example, for any given distance from the center of the lens, radial thickness profile 204a is within 5%, 8%, or 10% of radial thickness profile 204e. In another example, for any given distance from the center of the lens, radial thickness profile 204c is within 4%, 6%, or 8% of radial thickness profile 204g.

[0119] In yet another example, the radial thickness profiles (e.g., 204a to 204h) can be configured such that for any given distance from the center of the lens, the thickness profile of any of the radial cross sections is within 4%, 6%, 8%, or 10% of the average of all radial cross sections. In order to determine whether the radial thickness profiles of the manufactured non-optical peripheral carrier regions, such as 204a to 204h, meet their nominal profiles, it may be necessary to perform cross-sectional measurements of the thickness at defined radial distances along the azimuthal direction of the contact lens. In some other examples, the peak thickness measured in one radial cross section may be compared to the peak thickness measured in another radial cross section of the non-optical peripheral carrier region.

[0120] In some embodiments, the difference in peak thickness between one or more radial cross sections may be no greater than 20 μm, 30 μm, 40 μm, 50 μm, or 60 μm. In some embodiments, the difference in peak thickness between one or more perpendicular radial cross sections may be no greater than 20 μm, 30 μm, 40 μm, 50 μm, or 60 μm.

[0121] In this exemplary example, the spherical power of the sphero-cylindrical or astigmatic or toric optical zone (202) of the contact lens embodiment (200) has a spherical power of -3D to correct a -3D myopic eye and has a cylindrical power of +1.25DC to induce or introduce meridian astigmatism at the retina of the eye. In some other examples of the present disclosure, the spherical power of a contact lens for correcting and managing myopic eyes can be between -0.5D and -12D, and the desirable astigmatic or toric or cylindrical power range for inducing or introducing the desired meridian astigmatism at the retina of the myopic eye can be between +0.75DC to +2.5DC.

[0122] Figure 3 Shows Figure 2 A front view of an exemplary contact lens (300) embodiment is shown in FIG. The figure schematically illustrates the effect of the lower eyelid (303) and the upper eyelid (304) on the orientation of the contact lens embodiment (300), and in particular on the orientation of the optical zone (302) defined about the visual center (301).

[0123] Due to natural blinking facilitated by the combined action of the lower eyelid (303) and the upper eyelid (304), the contact lens (300) may rotate on or about the visual center (301). This may cause the orientation and position of the astigmatic or toric or asymmetric stimulus applied by the optical zone (302) defined as being substantially centered about the optical center or optical axis to change with blinking, thereby providing substantially free rotation and / or decentration, thereby resulting in temporally and spatially varying stimulus to reduce the progression rate of myopic wearers; wherein the effectiveness of managing myopia remains substantially consistent over time.

[0124] In some embodiments, for example, as described in reference Figure 2 and Figure 3 As described, the contact lens is designed to exhibit substantially free rotation at least under the influence of the natural blinking action. For example, with full-day lens wear, preferably over 6 to 12 hours, eyelid interaction will allow the contact lens to be easily oriented on the eye in a large number of different orientations or configurations. Due to the astigmatic or toric or asymmetric optics configured substantially around the optical center of the contact lens, the directional cue used to control the eye growth rate can be configured to vary in space and time.

[0125] In some embodiments, surface parameters of contact lens embodiments, such as posterior surface radius and / or asphericity, can be adjusted for an individual eye so that a desired supra-ocular rotation of the contact lens can be achieved. For example, the contact lens can be configured to be at least 0.3 mm flatter than the radius of curvature of the flattest meridian of the cornea of ​​the eye to increase the occurrence of supra-ocular rotation during wear of the lens.

[0126] In 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 per day of wear. It should be understood that the contact lens is still capable of generating a temporally and spatially varying stop signal simply by the random orientation of the lens, which is dictated by the orientation of the contact lens at the time of insertion.

[0127] Figure 4 An uncorrected 3D myopic model eye (400) is shown. When incident light (401) of a certain visible wavelength (e.g., 589 nm) with a vergence of 0D is incident on the uncorrected myopic eye, the synthetic image on the retina has a symmetrical blur (402) caused by defocus. The schematic diagram represents the on-axis geometric spot analysis at the retinal plane.

[0128] Figure 5 Shows when Figure 4 Schematic diagram of on-axis geometric spot analysis at the retinal plane of a 3D myopic model eye (500) corrected with a prior art single vision spherical contact lens (501). Here, in this example, when incident light (502) of a visible wavelength (e.g., 589 nm) with a vergence of 0D is incident on the corrected myopic eye, the synthetic image on the retina has a symmetrical sharp focus (503).

[0129] Figure 6 Shows when Figure 4 Schematic diagram of on-axis, through-focus, geometric spot analysis at the retinal plane of a 3D myopic model eye (600) corrected with a contact lens (602) of one of the exemplary embodiments disclosed herein. Here, in this example, when incident light (601) of a visible wavelength (e.g., 589 nm) with a vergence of 0D is incident on the corrected myopic eye (600), the synthetic through-focus image on the retina forms a Sturm-like cone or pitch (603) with a minimum confusion circle (605) and an elliptical blur pattern about the tangential plane (604) and the sagittal plane (606). The images (607 and 608) behind the retina are both out of focus. In this example, the exemplary embodiments of the present disclosure are configured so that the sagittal plane is on the retina and the tangential plane and the minimum confusion circle are both in front of the retina. The graphic dimension of the blur circle size is 200 μm.

[0130] The elliptical blur pattern in the tangential plane (604) located in front of the retina is called meridian astigmatism, while the elliptical blur pattern in the sagittal plane (606) is called meridian correction.

[0131] In another example, the contact lens embodiment (602) can be specified such that the elliptical blur pattern in the tangential plane (604) is located in front of the retina and the elliptical blur pattern in the sagittal plane (606) is not located behind the retina. The depth of Sturm's cone-like or pitch, i.e., the defocus distance between the sagittal plane and the tangential plane, can be configured to be between about +0.5DC and +3DC. The location of the elliptical blur pattern in the tangential plane (604) can be located between 0.6mm and 0.13mm in front of the retina. The location of the elliptical blur pattern in the sagittal plane (606) can be located between about 0.13mm and 0mm in front of the retina.

[0132] In some examples, the meridian correction can be limited to a foveal subregion, a foveal region, a macular subregion, a macular region, or a paramacular region; while in other examples, the meridian correction can extend to a wider field of view angle on the retina, such as including at least 10 degrees, 20 degrees, or 30 degrees.

[0133] In some examples, the meridian astigmatism can be limited to a foveal subregion, a foveal region, a macular subregion, a macular region, or a paramacular region; while in other examples, the meridian astigmatism can extend to a wider field of view angle on the retina, such as including at least 10 degrees, 20 degrees, or 30 degrees.

[0134] The lateral extent of the optical stop signal on the retina is determined by the amplitude of the astigmatic or toric or asymmetric power distribution, or by the surface area of ​​the astigmatic or toric or asymmetric power distribution within the optical zone.

[0135] Furthermore, due to the rotationally symmetric peripheral carrier zone, the orientation and position of the optical stop stimulus, i.e. the elliptical blur pattern, in front of the retina varies substantially over time due to the natural blinking action. The supraocular rotation and decentration of the contact lens provide a signal that varies spatially and temporally.

[0136] The specific structural and functional details disclosed in these figures and examples are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to employ the disclosed embodiments in numerous other variations.

[0137] exist Figures 4 to 6A schematic model eye (Table 1) is selected for illustrative purposes. However, in other exemplary embodiments, a schematic ray tracing model eye such as Liou-Brennan, Escu Dero-Navarro, etc. may be used instead of the simple model eye described above. Parameters of the cornea, lens, retina, ocular media, or a combination thereof may also be altered to help further simulate the embodiments disclosed herein.

[0138] The examples provided herein have used a -3D myopic model eye to disclose the present invention, however, the present disclosure can be extended to other degrees of myopia, such as -1D, -2D, -5D or -6D. In addition, it should be understood that one skilled in the art can extend to eyes with varying degrees of myopia combined with astigmatism up to 1DC. In the example embodiments, reference is made to a specific wavelength of 589nm, however, it should be understood that one skilled in the art can extend to other visible wavelengths between 420nm and 760nm.

[0139] Certain embodiments of the present disclosure are directed to contact lenses that can provide a temporally and spatially varying, in other words substantially time-varying, stop signal to a progressive myopic eye with the aid of the natural on-eye rotation and decentration of the contact lens that occurs due to the natural blinking action. Such a temporally and spatially varying stop signal can minimize the implicit saturation effect of the efficacy observed in the prior art.

[0140] Certain embodiments of the present disclosure are directed to contact lenses that can provide a spatially and temporally varying stop signal for a progressively myopic eye, regardless of the orientation in which the contact lens is worn or inserted by the wearer.

[0141] In some embodiments of the present disclosure, a stop signal may be configured using an astigmatic or toric, asymmetric power profile that is defined to be substantially centered about the visual center or optical axis. An astigmatic or toric power profile may be configured using a radial and / or azimuthal power profile along the visual center.

[0142] Figure 7 A schematic diagram (700) of an enlarged cross section of only the optic zone (702) of one contact lens embodiment of a contact lens embodiment having an astigmatic, toric or spherocylindrical prescription (701) of a contact lens embodiment disclosed herein is illustrated. The power profile distribution within the optic zone of this embodiment is configured using a radial power distribution function (703) and an azimuthal (704) power distribution function as disclosed herein.

[0143] In certain embodiments of the present disclosure, an astigmatic or toric or asymmetric power distribution may be configured using the following expression: Power distribution of toric embodiment = spherical + cylindrical / 2 * (radial) power distribution function * (azimuthal) power distribution function. In some embodiments, the radial distribution function may take the following form: Radial power distribution = Cρ 2 , where C is the expansion coefficient and Rho(ρ) (703) is the normalized radial coordinate ρ0 / ρ 最大 Rho(ρ0) is the radial coordinate at a given point, and ρ 最大 is the maximum radial coordinate or semi-diameter of the optical zone (705). In some embodiments, the azimuthal power distribution function may take the following form: azimuthal power distribution = cos mθ, where, in some embodiments, m may be any integer between 1 and 6, and Theta(θ) is the azimuthal angle (704).

[0144] In certain embodiments of the present disclosure, it may be necessary to deal with the fact that most corneas have some astigmatism or may have sufficiently high eye astigmatism that requires correction. Corneal astigmatism or eye astigmatism may combine favorably or unfavorably with contact lens cylinder power, and this combination may result in different visual performances of the contemplated embodiments.

[0145] While this change in performance may be beneficial for treatment or management effectiveness as measured in terms of efficacy on myopia progression, the change in performance may be noticeable or in some cases troublesome to the wearer. Some methods of reducing this change in visual performance may be achieved by using toric lenses to correct eye astigmatism.

[0146] In such a case, a stable lens may be required for the person's eye and multiple contact lenses may be prescribed, or multiple contact lenses with different cylindrical powers and / or axes may be applied to the person's eye with the lenses rotated over time according to specific instructions.

[0147] For example, different lens pairs may be worn on different days, weeks, or months. When two or more lenses are worn for each eye under specific instructions, the variation in design allows for a similar therapeutic effect to be achieved both spatially and temporally to slow the progression of myopia; wherein the slowing of myopia progression is substantially consistent over time.

[0148] Multiple contact lenses may not be a preferred embodiment of the present disclosure due to the inconveniences that contact lenses present to the wearer and eye care practitioner; however, alternative methods of use of the present invention are contemplated and noted herein to those skilled in the art.

[0149] In another embodiment of the present disclosure, in order to address higher amounts of astigmatism that require correction, such as at least +1.25DC, +1.5DC, +1.75DC or +2DC, a spectacle lens may be prescribed to be worn to account for the sphero-cylindrical error of the affected eye, and a dedicated contact lens may be prescribed to be worn simultaneously with the spectacle lens, and simultaneously with a contact lens configured to induce a desired level of astigmatism or toricity to serve as a stop signal that varies in time and space.

[0150] Schematic model eye used to simulate the optical performance results of the exemplary embodiments of the present disclosure ( Figures 8 to 31 ). The prescription parameters of the schematic model eye used for optical modeling and performance simulation are listed in Table 1.

[0151] The prescription provides a -3D myopic eye defined for a monochromatic wavelength of 589 nm. The prescription described in Table 1 should not be construed as a necessary method to demonstrate the effects of the contemplated exemplary embodiments. The prescription is only one of many methods that can be used by those skilled in the art for optical simulation purposes. The prescriptions for four (4) exemplary contact lens embodiments are provided in Table 2.

[0152]

[0153] Table 1: Schematic of the 3D myopic model eye. Prescriptions for the model eye.

[0154] The parameters of the exemplary embodiment of the model contact lens simulated only the optical zone for performance effects. To demonstrate performance changes as a function of time, decentration / tilt functions on the surface have been used to mimic the translation and rotation that would occur physiologically in vivo. For simulation of optical performance results, the exemplary embodiment was rotated along the horizontal and vertical meridians by 0°, 45°, 90° and 135° or decentration ±0.75 mm.

[0155] Figure 8 A two-dimensional power diagram (in D) of an exemplary embodiment (Example #1) across an 8 mm optical zone diameter is illustrated. The lens is configured with a spherical power of -3D and a cylindrical power of +1DC; when the power profile is decomposed into two principal meridians, the power of one principal meridian (vertical solid line, 801) is approximately -3D, and the power of the other principal meridian (horizontal dashed line, 802) is approximately -2D.

[0156] The variation in power across azimuth about the optical center - the intersection of the dashed and solid lines - follows a simple cosine distribution as described herein. Figure 8The contact lens described in is configured to at least partially provide foveal correction or at least partially provide meridian correction for a 3D myopic model eye and further provide an induced or introduced meridian stop signal at the retina of the model eye.

[0157] In this example, the principal meridian (801) at least partially provides meridian correction and the principal meridian (802) provides a meridian stop signal at the retina of the model eye.

[0158] Fig. 9 The cross-sectional thickness profile of an exemplary embodiment of the present invention is illustrated. For contact lens example #1 ( Figure 8 ), showing two thickness profiles of a steep section (901) and a flat section (902) along the optical zone perpendicular to the meridian.

[0159] Figure 8 The sphero-cylindrical power profile of the contact lens embodiment depicted in yields an elliptical optical zone having a major axis (902, flat meridian) and a minor axis (901, steep meridian). In this exemplary embodiment, the zone between the minor axis (901, steep meridian) and the non-optical peripheral carrier zone (903) results in a stepped transition or blending region (904).

[0160] In this exemplary embodiment, the power variation across the principal meridians of the exemplary embodiment (Example #1) is designed to be minimal (i.e., a flat power profile). However, in some other embodiments of the present disclosure, power variation across the principal meridians is contemplated. Fig. 9 As observed in FIG, the peripheral non-optical zone of the lens has a substantially rotationally symmetric carrier zone. This design facilitates substantially free rotation at or about the optical center of the contact lens embodiment (embodiment #1) due to natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn causes the astigmatic stimulus imposed by the optical zone to vary with blinking, thereby resulting in a temporally and spatially varying stimulus to reduce the rate of myopia progression; so that the directional cue and efficacy to reduce the progression of eye growth remain substantially consistent over time.

[0161] When incident light of a visible wavelength (589 nm) with a vergence of 0D is incident on a myopic eye corrected by an exemplary embodiment (Example #1) of Table 1, the temporally and spatially varying point spread function on the axis synthesized at the retinal plane is as follows: Fig.10 As shown in , where the principal meridians of the lens are located at 0° (1001), 45° (1002), 90° (1003) and 135° (1104).

[0162] The rotationally symmetric peripheral carrier zone of the exemplary embodiment (Example #1) facilitates that the astigmatic stimulus described as the point spread function of the sagittal plane on the retina changes with the natural blinking action due to contact lens rotation, thereby providing a temporally and spatially varying signal to the eye.

[0163] Fig.11 Temporally and spatially varying signals are illustrated for a wide angle (ie, ±10° field of view) where the principal meridians of a contact lens embodiment are rotated 0°, 45°, 90°, and 135° about the optical center to simulate rotation of the contact lens over time.

[0164] Fig.11 The through-focus geometric spot diagram represents the time integral of the optical stop signal, which is obtained by integrating the synthesized response when the contact lens implementation is fitted on a -3D myopic model eye and further rotated in 4 different configurations (0°, 45°, 90° and 135°) to simulate the on-eye rotation of the contact lens to produce an optical stop signal that varies in space and time.

[0165]

[0166] Table 2: Optic zone prescriptions for four exemplary contact lens embodiments of the present disclosure.

[0167] The through-focus geometric spot analysis about the retinal plane is calculated at five (5) positions 1101 to 1105; wherein columns 1101 and 1102 represent retinal positions located at -0.3 mm and -0.1 mm in front of the retina; column 1103 represents a position at 0 mm on the retina; and columns 1104 and 1105 represent retinal positions located at +0.3 mm and +0.1 mm behind the retina.

[0168] As can be observed, the through-focus image montage about the retina forms a Sturm's cone-like or pitch (1100) having an elliptical blur pattern that includes a tangential plane (1101) and a sagittal plane (1103) and a circle of least confusion (1102). Behind the retina, the elliptical blur pattern (1104, 1105) keeps increasing in size. In a preferred configuration, the contact lens embodiment is provided such that one of the elliptical foci (tangential) is located in front of the retina and the other elliptical focus (sagittal) is located on the retina.

[0169] An elliptical blur pattern in the tangential plane (1101) located in front of the retina is referred to as meridian astigmatism, while an elliptical blur pattern in the sagittal plane (1103) is referred to as meridian correction. In other examples of the present disclosure, a contact lens embodiment may be specified such that both elliptical foci (tangential and sagittal) are located in front of the retina; in this example, the position of the sagittal plane is configured to at least partially provide meridian correction to the eye. In yet another configuration, a contact lens embodiment may be specified such that one of the elliptical foci (tangential) is located in front of the retina and the circle of least confusion is located on the retina. Furthermore, in each of these contemplated configurations, by virtue of the rotationally symmetric peripheral carrier zone configured into the contemplated embodiments, the optical stimulus of the astigmatism or toric surface located in front of or on the retina changes with the natural blinking action due to the rotation of the contact lens on the eye, thereby providing an optical signal that varies in time and space.

[0170] Fig.12 The retinal signal is illustrated, which is described as the modulus of the on-axis, through-focus, optical transfer function for the principal meridian and the perpendicular meridian of the point spread function that varies in time and space; when incident light with a visible wavelength (589nm) and 0D vergence is incident on the -3D myopic model eye of Table 1, which is corrected using the contact lens embodiment described herein (Example #1).

[0171] In this exemplary embodiment, the peaks of the optical transfer functions for the principal meridians are located at or slightly in front of the retinal plane, which provides at least partial foveal correction or at least partial meridian correction for a -3D myopic eye.

[0172] The peak of the optical transfer function for the vertical meridian is about 0.38 mm in front of the retina, which provides the induced or introduced meridian stop signal. In this example, the peaks for the cardinal meridian and the vertical meridian are synonymous with the elliptical blur patterns in the sagittal and tangential planes, respectively.

[0173] In some other embodiments, the peak of the optical transfer function for the principal meridian can be on the retina and no more than 0.1 mm in front of the retina. In some other embodiments, the peak of the optical transfer function for the perpendicular meridian can be approximately 0.25 mm, 0.35 mm, 0.45 mm, or 0.6 mm in front of the retina. In some embodiments, the distance between the peak of the principal meridian and the peak of the perpendicular meridian can be optimized to improve visual performance while achieving a desired level of induced meridian astigmatism that contributes to the optical stop signal.

[0174] Fig.13A two-dimensional power diagram (in D) across an 8 mm optical zone diameter for an exemplary embodiment (Example #2) is illustrated. The lens is configured with a spherical power of -3D and a cylindrical power of +1.5DC; when the power profile is decomposed into two principal meridians, one principal meridian (vertical solid line, 1301) has a power of approximately -3D, while the other principal meridian (horizontal dashed line, 1302) has a power of approximately -1.5D. As described herein, the variation in power across azimuth about the optical center, i.e., about the intersection of the dashed and solid lines, follows a simple cosine distribution.

[0175] The lens has a spherical power of -3D along one principal meridian, which is used to provide at least partial foveal correction or at least partial meridian correction for the -3D myopic model eye described in Table 1, and an astigmatic or toric or cylindrical power of +1.5DC provides an induced meridian stop signal at the retina of the model eye.

[0176] Fig.14 The thickness profile of a prior art lens having a toric optical zone is illustrated. Fig.14 The prior art lens has a prismatic ballast stabilization zone. Upon close examination of the radial thickness profiles of the vertical meridian and the horizontal meridian of the prismatic ballast lens, the prismatic ballast lens is a typical lens of the prior art having a prescription of -3.00 / +1.50 x 90°.

[0177] The horizontal section (1401) is symmetrical, while the vertical section has a thick lower (1402) section and a thin upper (1403) section to provide a stable orientation when fitted to the eye. The steep thickness curvature in the vertical section and the flat thickness curvature in the horizontal meridian match the desired corneal astigmatism, and this provides good vision along any meridian.

[0178] On the contrary, Fig.15 Thickness profiles of an exemplary embodiment (Example #2) of the present invention are illustrated. Two thickness profiles along the perpendicular meridians of the steep and flat portions of the optical zone of a contact lens embodiment (Example #2) are shown. Fig.13 The sphero-cylindrical power profile of the contact lens embodiment depicted in results in an elliptical optical zone having a major axis (1501, flat meridian) and a minor axis (1502, steep meridian).

[0179] In this exemplary embodiment, the region between the minor axis (1502, steep meridian) and the non-optical peripheral carrier region (1503) results in a stepped transition or blending region (1504). In this exemplary embodiment, the power variation across the principal meridians of the exemplary embodiment (Example #2) is designed to be minimal (i.e., flat power profile).

[0180] like Fig.15 , the peripheral non-optical zone of the lens has a substantially rotationally symmetric carrier zone. This design facilitates the contact lens embodiment (Example #2) to rotate substantially freely on or about the optical center due to natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn causes the astigmatic stimulus applied by the optical zone to vary with blinking, thereby resulting in a temporally and spatially varying stimulus to reduce the rate of myopia progression in a myopic wearer; wherein the directional cue and efficacy of reducing the rate of eye growth remain substantially consistent over time.

[0181] When incident light of a visible wavelength (589 nm) with a vergence of 0D is incident on a myopic eye corrected using the exemplary embodiment (Example #2) of Table 1, the temporally and spatially varying point spread function on the axis synthesized at the retinal plane is Fig.16 , where the principal meridians of the lens are located at 0° (1601), 45° (1602), 90° (1603) and 135° (1604). It can be noted that when compared with Example 1 ( Fig.10 ) compared to the results obtained in Example 2 ( Fig.16 ) increases in the length of the on-axis point spread function captured at the retina due to the increased cylindrical power of this contact lens embodiment (Example #2).

[0182] The rotationally symmetric peripheral carrier zone of an exemplary embodiment (Example #2) facilitates that the astigmatic stimulus described as the point spread function of the sagittal plane on the retina changes with the natural blinking action due to rotation of the contact lens, thereby providing a temporally and spatially varying signal to the eye.

[0183] Fig.17 Wide-angle (i.e., ±10° field of view), temporally and spatially varying signals are illustrated, where the principal meridians of a contact lens embodiment (Example #2) are rotated 0°, 45°, 90°, and 135° about the optical center to simulate rotation of the contact lens over time. Fig.17 The through-focus geometric spot diagram represents the time integral of the optical stop signal, which is obtained by integrating the synthesized response when the contact lens implementation is fitted on a -3D myopia model eye and further rotated in 4 different configurations (0°, 45°, 90° and 135°) to simulate the rotation of the contact lens on the eye to produce an optical stop signal that varies in space and time.

[0184] The through-focus geometric spot analysis about the retinal plane is calculated at five (5) positions 1701 to 1705; wherein columns 1701 and 1702 represent retinal positions located at -0.3 mm and -0.15 mm in front of the retina; column 1703 represents a position at 0 mm on the retina; and columns 1704 and 1705 represent retinal positions located at +0.3 mm and +0.15 mm behind the retina.

[0185] It can be seen that the mosaic of defocused images about the retina forms a Sturm's cone-like or spacing (1700) with an elliptical blur pattern, which includes a tangential plane (1701) and a sagittal plane (1703) and a circle of least confusion (1702). Behind the retina, the size of the elliptical blur pattern (1704, 1705) continues to increase. In a preferred configuration, the contact lens embodiment is specified so that one of the elliptical foci (tangential) is located in front of the retina and the other elliptical focus (sagittal) is located on the retina.

[0186] When compared with Example 1 ( Fig.11 ) compared to Example 2 ( Fig.17 ) The length of the depicted sagittal and tangential planes in the through-focus image obtained by ) increases due to the increased cylindrical power of this lens embodiment (Example #2). The scale of each spot diagram is marked as 300 μm.

[0187] In other examples of the present disclosure, contact lens embodiments may be specified such that both elliptical foci (tangential and sagittal) are located in front of the retina. In yet another configuration, contact lens embodiments may be specified such that one of the elliptical foci (tangential) is located in front of the retina and the circle of least confusion is located on the retina.

[0188] Furthermore, in each of these contemplated configurations, by virtue of the rotationally symmetric peripheral carrier zone configured into the contemplated embodiments, the astigmatic or toric optical stimulus located in front of or on the retina changes with the natural blinking action due to rotation of the contact lens on the eye, thereby providing a temporally and spatially varying optical signal.

[0189] Fig.18 The retinal signals are illustrated, which are described as the modulus of the on-axis, through-focus, optical transfer functions of the principal meridians and perpendicular meridians of the point spread functions that vary in time and space; when incident light with a visible wavelength (589nm) and 0D vergence is incident on the -3D myopic model eye of Table 1, which is corrected with the contact lens embodiment described herein (Example #2).

[0190] In this exemplary embodiment, the peaks of the optical transfer functions for the principal meridians are located at or slightly in front of the retinal plane, which provides at least partial foveal correction or at least partial meridian correction for a -3D myopic eye.

[0191] The peak of the optical transfer function for the vertical meridian is about 0.64 mm in front of the retina, which provides the induced or introduced meridian stop signal. In this example, the peaks for the cardinal meridian and the vertical meridian are synonymous with the elliptical blur patterns in the sagittal and tangential planes, respectively.

[0192] In some other embodiments, the peak of the optical transfer function for the principal meridian can be on the retina and no more than 0.1 mm in front of the retina. In some other embodiments, the peak of the optical transfer function for the perpendicular meridian can be approximately 0.25 mm, 0.35 mm, 0.45 mm, or 0.6 mm in front of the retina. In some embodiments, the distance between the peak of the principal meridian and the peak of the perpendicular meridian can be optimized to improve visual performance while achieving a desired level of induced meridian astigmatism that contributes to the optical stop signal.

[0193] Fig.19 A two-dimensional power diagram (in D) across an 8 mm optical zone diameter is illustrated for an exemplary embodiment (Example #3). The lens is configured with a spherical power of -3D and a cylindrical power of +1.5DC; in addition to the sphero-cylindrical power profile, the lens is also configured to have a primary spherical aberration of -0.75D defined at the end of the optical zone.

[0194] When the power diagram is decomposed into two principal meridians, the power of one principal meridian (vertical solid line, 1901) is approximately -3D, where the magnitude of the negative primary spherical aberration defined above is defined over the entire optical zone; and the power of the other principal meridian (horizontal dashed line, 1902) is approximately -1.5D, where the magnitude of the negative primary spherical aberration defined above is defined over the entire optical zone. As described herein, the power variation across the azimuth angle around the optical center, i.e., around the intersection of the dashed and solid lines, follows a complex cosine distribution.

[0195] In some exemplary embodiments, the substantially asymmetric power distribution is represented using a power distribution function described by the following expression: spherical + azimuthal component, where spherical refers to the distance spherical prescription power used to correct the eye, and the azimuthal component of the power distribution function is described as C a *cos(mθ), where C a is the azimuth coefficient, m is an integer between 1 and 6, and Theta (θ) is the azimuth angle of a given point in the light zone.

[0196] In some other exemplary embodiments, the substantially asymmetric power distribution is represented using a power distribution function described by the following expression: spherical + (radial component) * (azimuthal component), where spherical refers to the distance spherical prescription power for correcting myopia, and the radial component of the power distribution function is described as C r *ρ, where C r is the expansion coefficient, and Rho(ρ) is the normalized radial coordinate (ρ0 / ρ 最大 ); the azimuthal component of the focal power distribution function is described as C a *cos(mθ), where m can be any integer between 1 and 6, and Theta(θ) is the azimuthal angle, where Rho(ρ0) is the radial coordinate of a given point, where ρ 最大 is the maximum radial coordinate or radius of the optic zone. The contact lens embodiment of Example #3 is configured to provide at least partial foveal correction or at least partial meridian correction for the -3D myopic model eye described in Table 1, and an asymmetric power profile substantially centered about the optical axis (which is defined as a complex cosine distribution with respect to the azimuth) provides an induced meridian stop signal at the retina of the model eye. In other embodiments of the present disclosure, it may be more desirable to change other magnitudes of the primary spherical aberration, such as -0.5D, -1D, -1.25D defined over the entire optical zone of the contact lens. In some other embodiments of the present disclosure, the desired magnitude of the positive spherical aberration can be configured as, for example, 5mm, 6mm, or 7mm over a small area of ​​the optical zone.

[0197] Fig. 20 The cross-sectional thickness profiles of an exemplary embodiment of the present invention (Example #3) are illustrated. For contact lens Example #3, two thickness profiles along the perpendicular meridians of the steep portion (2001) and the flat portion (2002) of the optical zone are shown. In this exemplary embodiment, the thickness profiles along the perpendicular meridians of the steep portion (2001) and the flat portion (2002) of the optical zone are shown. Fig.19 The asymmetric power distribution defined in the azimuthal direction of the contact lens embodiment depicted in , results in an elliptical optical zone having a major axis (2002, a flat meridian) and a minor axis (2001, a steep meridian), which can be represented as a complex cosine distribution around the optical center.

[0198] In this exemplary embodiment, the region between the minor axis (2001, the steep meridian) and the non-optical peripheral carrier region (2003) creates a stepped transition or blending region (2004). Fig. 20, the peripheral non-optical zone of the lens has a substantially rotationally symmetric carrier zone. This design facilitates the contact lens embodiment (Example #3) to rotate substantially freely on or about the optical center due to natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn causes the astigmatism stimulus applied by the optical zone to vary with blinking, thereby resulting in a temporally and spatially varying stimulus to reduce the progression rate of myopic wearers, wherein the directional cue and efficacy of reducing eye growth progression remain substantially consistent over time.

[0199] When incident light of a visible wavelength (589 nm) with a vergence of 0D is incident on a myopic eye corrected using an exemplary embodiment (Example #3) of Table 1, the temporally and spatially varying point spread function on the axis synthesized at the retinal plane is Fig.21 , where the principal meridians of the lens are located at 0° (2101), 45° (2202), 90° (2203) and 135° (2204).

[0200] It can be noted that when compared with Example 1 and Example 2 ( Fig.10 and Fig.16 ) compared with the results obtained in Example 3 ( Fig.21 ) is reduced in length of the on-axis point spread function captured at the retina due to the introduction of negative primary spherical aberration in this contact lens embodiment (Example #3).

[0201] The rotationally symmetric peripheral carrier zone of an exemplary embodiment (Example #3) facilitates that the astigmatic stimulus described as the point spread function of the sagittal plane on the retina changes with the natural blinking action due to rotation of the contact lens, thereby providing a temporally and spatially varying signal to the eye.

[0202] Fig. 22 Wide-angle (i.e., ±10° field of view), temporally and spatially varying signals are illustrated, wherein the principal meridian of a contact lens embodiment (Example #3) is rotated 0°, 45°, 90°, and 135° about the optical center to simulate rotation of the contact lens over time.

[0203] Fig. 22 The through-focus geometric spot diagram represents the time integral of the optical stop signal, which is obtained by integrating the synthesized response when the contact lens implementation is fitted on a -3D myopia model eye and further rotated in 4 different configurations (0°, 45°, 90° and 135°) to simulate the rotation of the contact lens on the eye to produce an optical stop signal that varies in space and time.

[0204] The through-focus geometric spot analysis about the retinal plane is calculated at five (5) positions 2201 to 2205; wherein columns 2201 and 2202 represent retinal positions located -0.3 mm and -0.15 mm in front of the retina; column 2203 represents a position located at 0 mm on the retina; and columns 2204 and 2205 represent retinal positions located +0.3 mm and +0.15 mm behind the retina.

[0205] It can be seen that the mosaic of defocused images about the retina forms a Sturm's cone-like or spacing (2200) with an elliptical blur pattern, which includes a tangential plane (2201) and a sagittal plane (2203) and a circle of least confusion (2202). Behind the retina, the size of the elliptical blur pattern (2204, 2205) continues to increase. In a preferred configuration, the contact lens embodiment is specified so that one of the elliptical foci (tangential) is located in front of the retina and the other elliptical focus (sagittal) is located on the retina.

[0206] When compared with Example 1 and Example 2 ( Fig.11 and Fig.17 ) compared to Example 2 ( Fig.17 ) is reduced in length in the sagittal and tangential planes depicted in the through-focus image obtained by the lens embodiment (Example #2) because of the negative primary spherical aberration introduced in this lens embodiment (Example #2). The scale of each spot diagram is marked as 300 μm. In other examples of the present disclosure, the contact lens embodiment can be specified so that both elliptical foci (tangential and sagittal) are located in front of the retina. In yet another configuration, the contact lens embodiment can be specified so that one of the elliptical foci (tangential) is located in front of the retina and the circle of minimum confusion is located on the retina. In addition, in each of these contemplated configurations, by virtue of the rotationally symmetric peripheral carrier zone configured into the contemplated embodiments, the asymmetric blur stimulus located in front of the retina or on the retina changes with the natural blinking action due to the rotation of the contact lens on the eye, thereby providing an optical signal that changes in time and space.

[0207] Fig.23 The retinal signals of the modulus of the on-axis, through-focus, optical transfer functions for the principal meridians and perpendicular meridians, described as temporally and spatially varying point spread functions, are illustrated when incident light having a visible wavelength (589 nm) and 0D vergence is incident on a -3D myopic model eye of Table 1, which is corrected using a contact lens embodiment described herein (Example #3).

[0208] In this exemplary embodiment, the peak of the optical transfer function for the principal meridian is located at or slightly in front of the retinal plane, which provides at least partial foveal correction or at least partial meridian correction for a -3D myopic eye. The peak of the optical transfer function for the vertical meridian is about 0.42 mm in front of the retina, which provides a stop signal for the induced or introduced meridian. In this example, the peaks of the principal meridian and the vertical meridian are synonymous with the elliptical blur patterns in the sagittal plane and the tangential plane, respectively.

[0209] In some other embodiments, the peak of the optical transfer function for the principal meridian can be on the retina and no more than 0.1 mm in front of the retina. In some other embodiments, the peak of the optical transfer function for the perpendicular meridian can be approximately 0.25 mm, 0.35 mm, 0.45 mm, or 0.6 mm in front of the retina. In some embodiments, the distance between the peak of the principal meridian and the peak of the perpendicular meridian can be optimized to improve visual performance while achieving a desired level of induced meridian astigmatism that contributes to the optical stop signal.

[0210] Fig.24 A two-dimensional power diagram (in D) across an 8 mm optical zone diameter for an exemplary embodiment (Example #4) is illustrated. The lens is configured with a spherical power of -3D and a cylindrical power of +1.5DC; in addition to the sphero-cylindrical power profile, the lens is configured to have a primary spherical aberration of +0.75D defined at the end of the optical zone. When the power diagram is decomposed into two principal meridians, one principal meridian (vertical solid line, 2401) has a power of approximately -3D, wherein the magnitude of the positive primary spherical aberration defined above is defined across the optical zone; and the other principal meridian (horizontal dashed line, 2402) has a power of approximately -1.5D, wherein the magnitude of the positive primary spherical aberration defined above is defined across the optical zone. As described herein, the power variation across the azimuth angle about the optical center, i.e., about the intersection of the dashed and solid lines, follows a complex cosine profile.

[0211] In some exemplary embodiments, the substantially asymmetric power distribution is represented using a power distribution function that is described at least in part using at least one or more of the terms of a Bessel loop function of the first kind having the general expression (n, m); wherein at least one or more of the terms of the Bessel loop function are obtained when n is 1, 2, 3 and m is ±2. In some other exemplary embodiments, the azimuthal power distribution function is cos 2 (mθ) where m is an integer between 1 and 6, inclusive.

[0212] The contact lens embodiment of Example #4 is configured to provide at least partial foveal correction or at least partial meridian correction to the -3D myopic model eye described in Table 1, and an asymmetric power distribution about the optical axis (which is defined as a complex cosine distribution with respect to the azimuth) provides an induced meridian stop signal at the retina of the model eye.

[0213] In other embodiments of the present disclosure, it may be more desirable to vary other magnitudes of primary spherical aberration, such as +0.5D, +1D, +1.25D defined over the entire optical zone of a contact lens. In some other embodiments of the present disclosure, the desired magnitude of positive spherical aberration may be configured over a small area of ​​the optical zone, such as 5mm, 6mm, or 7mm.

[0214] Fig.25 The cross-sectional thickness profiles of an exemplary embodiment of the present invention (Example #4) are illustrated. For contact lens Example #4, two thickness profiles along the perpendicular meridians of the steep portion (2501) and the flat portion (2502) of the optical zone are shown. In this exemplary embodiment, the thickness profiles along the perpendicular meridians of the steep portion (2501) and the flat portion (2502) of the optical zone are shown. Fig.24 The asymmetric power distribution defined by the azimuthal direction of the contact lens embodiment depicted in the embodiment of FIG. 2 , which can be represented as a complex cosine distribution around the optical center, results in an elliptical optical zone having a major axis (2502, a flat meridian) and a minor axis (2501, a steep meridian). In this exemplary embodiment, the zone between the minor axis (2501, a steep meridian) and the non-optical peripheral carrier zone (2503) produces a stepped transition zone or blending zone (2504).

[0215] like Fig.25 , the peripheral non-optical zone of the lens has a substantially rotationally symmetric carrier zone. This design facilitates the contact lens embodiment (Example #4) to rotate substantially freely on or about the optical center due to natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn results in an asymmetric stimulus applied by the optical zone that varies with blinking, thereby resulting in a temporally and spatially varying stimulus to reduce the progression rate of myopic wearers, wherein the directional cue and efficacy of reducing eye growth progression remain substantially consistent over time.

[0216] When incident light of a visible wavelength (589 nm) with a vergence of 0D is incident on a myopic eye corrected using an exemplary embodiment (Example #4) of Table 1, the temporally and spatially varying point spread function on the axis synthesized at the retinal plane is Fig.26 , where the principal meridians of the lens are located at 0° (2601), 45° (2602), 90° (2603) and 135° (2604).

[0217] It can be noted that when compared with Example 3 ( Fig.21 ) compared to the results obtained in Example 4 ( Fig.26 ) is slightly sharper at the retina due to the introduction of positive primary spherical aberration in this contact lens embodiment (Example #4). The rotationally symmetric peripheral carrier zone of the exemplary embodiment (Example #4) facilitates the astigmatism stimulus depicted as a point spread function in the sagittal plane on the retina to change with the natural blinking action due to contact lens rotation, thereby providing the eye with a temporally and spatially varying signal.

[0218] Fig. 27 Wide-angle (i.e., ±10° field of view), temporally and spatially varying signals are illustrated, wherein the principal meridians of a contact lens embodiment (Example #4) are rotated 0°, 45°, 90°, and 135° about the optical center to simulate rotation of the contact lens over time. Fig. 27 The through-focus geometric spot diagram represents the time integral of the optical stop signal obtained by integrating the synthesized response when the contact lens embodiment is fitted on a -3D myopic model eye and further rotated in 4 different configurations (rotated 0°, 45°, 90°, and 135°) to simulate the rotation of the contact lens on the eye to produce a spatially and temporally varying optical stop signal. The through-focus geometric spot analysis is calculated about the retinal plane at five (5) locations 2701 to 2705; wherein columns 2701 and 2702 represent retinal locations located at -0.3 mm and -0.15 mm in front of the retina; column 2703 represents a location at 0 mm on the retina; and columns 2704 and 2705 represent retinal locations located at +0.3 mm and +0.15 mm behind the retina. It can be seen that the mosaic of defocused images about the retina forms a Sturm's cone-like or spacing (2700) with an elliptical blur pattern, which includes a tangential plane (2701) and a sagittal plane (2703) and a circle of least confusion (2702). Behind the retina, the size of the elliptical blur pattern (2704, 2705) continues to increase. In a preferred configuration, the contact lens embodiment is specified so that one of the elliptical foci (tangential) is located in front of the retina and the other elliptical focus (sagittal) is located on the retina. When compared with Example 2 ( Fig.17 ) compared to Example 4 ( Fig. 27 ) is slightly enlarged due to the negative spherical aberration of the lens. The scale of each spot diagram is marked as 300 μm.

[0219] In other examples of the present disclosure, contact lens embodiments may be provided such that both elliptical foci (tangential and sagittal) are located in front of the retina. In yet another configuration, contact lens embodiments may be provided such that one of the elliptical foci (tangential) is located in front of the retina and the circle of least confusion is located on the retina. Furthermore, in each of these contemplated configurations, by virtue of the rotationally symmetric peripheral carrier zone configured into the contemplated embodiments, the asymmetric blur stimulus located in front of or on the retina changes with the natural blinking action due to the rotation of the contact lens on the eye, thereby providing an optical signal that varies in time and space.

[0220] Fig.28 The retinal signals of the modulus of the on-axis, through-focus, optical transfer functions for the principal meridians and the perpendicular meridians described as temporally and spatially varying point spread functions are illustrated; when incident light having a visible wavelength (589 nm) and 0D vergence is incident on the -3D myopic model eye of Table 1, which is corrected using a contact lens embodiment (Example #4) described herein. In this exemplary embodiment, the peak of the optical transfer function for the principal meridian is located at or slightly in front of the retinal plane, which provides at least partial foveal correction or at least partial meridian correction for the -3D myopic eye. The peak of the optical transfer function for the perpendicular meridian is about 0.45 mm in front of the retina, which provides a stop signal for the induced or introduced meridian. In this example, the peaks of the principal meridian and the perpendicular meridian are synonymous with the elliptical blur patterns of the sagittal plane and the tangential plane, respectively. In some other embodiments, the peak of the optical transfer function for the principal meridian can be on the retina and no more than 0.1 mm in front of the retina. In some other embodiments, the peak of the optical transfer function for the perpendicular meridian can be approximately 0.25 mm, 0.35 mm, 0.45 mm, or 0.6 mm in front of the retina. In some embodiments, the distance between the peak of the principal meridian and the peak of the perpendicular meridian can be optimized to improve visual performance while achieving a desired level of induced meridian astigmatism that contributes to the optical stop signal. When incident light of a visible wavelength (589 nm) with a vergence of 0D is incident on a myopic eye corrected using an exemplary embodiment (Example #2) of Table 1, the on-axis eccentric point spread function obtained at the retinal plane by the lens eccentricated along the x-axis by 0.75 mm (2901) and -0.75 mm (2902) and along the y-axis by 0.75 mm (2903) and -0.75 mm (2904) is Fig.29 Medium picture.

[0221] Fig.30The illustration shows a wide-angle (i.e., ±10° field of view), temporally and spatially varying (i.e., ±0.75 mm decentration of the lens along the x- and y-axes over time) geometric spot analysis about the retinal plane; when the -3D myopic model eye of Table 1 is corrected using one of the exemplary embodiments disclosed herein (Example #2). Fig.30 The through-focus geometric spot diagram represents the spatial integral of the optical stop signal, which is obtained by integrating the responses obtained when the contact lens implementation is fitted on a -3D myopic model eye and further eccentricated in two different configurations (±0.75 mm eccentricity along the x-axis and y-axis) to simulate the on-eye rotation of the contact lens to produce an optical stop signal that varies in space and time.

[0222] It can be seen that the mosaic of defocused images about the retina forms a Sturm-like cone or pitch (3000) with an elliptical blur pattern, which has a sagittal (3002) plane and a tangential plane (3003) and a circle of minimum confusion (3001). Behind the retina, the size of the blur pattern (3004, 3005) increases continuously. The contact lens embodiment is provided so that one of the elliptical foci is located in front of the retina. In addition, due to the rotationally symmetric peripheral carrier area, the stimulus in front of the retina changes with the natural blinking action, that is, in this exemplary embodiment, the stimulus in front of the retina changes due to the decentration of the lens (a signal that changes in time and space).

[0223] Fig.31 The retinal signals of the modulus of the on-axis, through-focus, optical transfer functions for the principal meridians and perpendicular meridians, described as temporally and spatially varying point spread functions, are illustrated when the lens is decentered; when incident light having a visible wavelength (589 nm) and 0D vergence is incident on the -3D myopic model eye of Table 1, which is corrected using the contact lens embodiment described herein (Example #2). The peaks of the optical transfer functions for the principal meridians are located at or slightly in front of the retinal plane, which provides meridian correction for the -3D myopic eye. The peak of the optical transfer function for the perpendicular meridian is approximately 0.64 mm in front of the retina, which provides the induced meridian stop signal.

[0224] In certain other embodiments, the variation or predominant variation of the optical signal received by the on-axis region and the off-axis region on the retina is configured by a Sturm's cone-like or spacing, wherein the optical stop signal refers to a portion of the Sturm's cone-like or spacing falling in front of the retina and the remainder of the Sturm's cone-like or spacing being at the periphery of the retina. The proportion of the Sturm's cone-like or spacing providing the meridian stop signal may be about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or 100%.

[0225] In certain embodiments, the astigmatism portion or toric portion of the optical zone of the contact lens embodiment at least partially provides meridian correction for myopic eyes and at least partially provides a meridian stop signal to reduce the rate of myopia progression. The introduced or induced astigmatism, optical stop signal may be at least +0.5DC, +0.75DC, +1DC, +1.25DC, +1.5DC, +1.75DC, +2DC, +2.25DC or +2.5DC.

[0226] In certain embodiments, the surface extent defined by the minor and major axes of the astigmatic portion or toric portion of the optical zone of a contact lens embodiment that at least partially provides meridian correction for a myopic eye and at least partially provides a meridian stop signal to reduce the rate of myopia progression can be at least 30%, 40%, 50%, 60%, 70% or 80%.

[0227] In certain other embodiments, the desired prescription for the introduced or induced astigmatism, optical stop signal, may be expressed in negative cylinder form. For example, a prescription in the form of negative cylinder intended to correct and manage a -3D myopic model eye for an embodiment of the present disclosure would be -2D of spherical power and -1DC of cylindrical power; in this example, the embodiment would provide partial foveal correction or at least partial meridian correction for the myopic model eye, and also provide at least 1DC of astigmatic blur (i.e., a stop signal) for the myopic eye.

[0228] In certain embodiments, the astigmatism induced in the toric optical zone of the contact lens can be at least +0.5DC, +0.75DC, +1DC, +1.25DC, +1.5DC, +1.75DC, +2DC, +2.25DC, or +2.5DC. In certain embodiments, the astigmatism induced in the toric optical zone of the contact lens can be between +0.50DC and +0.75DC, between +0.5DC and +1DC, and between +0.5DC and +1.25DC, between +0.5DC and 1.5DC, between 0.5DC and 1.75DC, between 0.5DC and 2DC, between 0.5DC and 2.25DC, or between 0.5DC and 2.5DC.

[0229] In certain embodiments, the diameter of the toric optical zone of a contact lens can be at least 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, or 9 mm. In certain embodiments, the diameter of the toric optical zone of a contact lens can be between 6 mm and 7 mm, between 7 mm and 8 mm, between 7.5 mm and 8.5 mm, or between 7 mm and 9 mm.

[0230] In certain embodiments, the width of the blending or mixing zone of the contact lens can be at least 0.05 mm, 0.1 mm, 0.15 mm, 0.25 mm, 0.35 mm, or 0.5 mm. In certain embodiments, the width of the blending or mixing zone 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 mixing zone can be symmetrical, while in some other embodiments, the mixing zone can be asymmetrical, such as elliptical. In certain other embodiments, one skilled in the art can contemplate practicing the present invention without the use of a blending or mixing zone.

[0231] In certain embodiments, the major portion of the optical zone of a contact lens comprised of toric correction, defined as being substantially concentric about the optical axis or optical center, may be understood to represent at least 50%, 60%, 70%, 80%, 90%, 95%, 98%, or 100% of the optical zone of the contact lens. In certain embodiments, the major portion of the optical zone of a contact lens comprised of toric correction, defined as being substantially concentric about the optical axis or optical center, may be understood to represent between 50% and 70%, between 60% and 80%, between 60% and 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.

[0232] 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 radial thickness profile across the horizontal meridian, the vertical meridian, and other oblique meridians.

[0233] In certain embodiments, a peripheral zone or carrier zone of a contact lens is substantially symmetrical and has substantially similar radial thickness profiles across horizontal meridians, vertical meridians, and other oblique meridians, which can mean that the thickness profile of the peripheral carrier zone across any of the semi-meridians is within 7%, 9%, 11%, 13%, or 15% of the thickness profile of any other semi-meridian, wherein the radial thickness profiles compared between any different ones of the meridians are measured at radial distances.

[0234] In certain embodiments, the peripheral or carrier zone of a contact lens is substantially symmetrical and has a substantially similar radial thickness profile across the horizontal meridian, the vertical meridian, and other oblique meridians, which may mean that the thickness profile of the peripheral carrier zone across any of the meridians is within 7%, 9%, 11%, 13%, or 15% of the thickness profile of any other meridian. Wherein the radial thickness profile compared between any different meridians in the meridians is measured at the radial distance. In certain embodiments, the peripheral or carrier zone of a contact lens is substantially rotationally symmetrical and has a substantially similar radial thickness profile across the horizontal meridian, the vertical meridian, and other oblique meridians, which may mean that the thickest point in the peripheral carrier zone across any of the semi-meridians is within a maximum variation of 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, or 40 μm of the thickest peripheral point in any other semi-meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0235] In certain embodiments, the peripheral zone or carrier zone of the contact lens is substantially rotationally symmetric and has a substantially similar radial thickness profile across the horizontal meridian, the vertical meridian, and other oblique meridians, which can mean that the thickest point within the peripheral carrier zone across any of the meridians is within a maximum variation of 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, or 40 μm of the thickest peripheral point of any other meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction. In certain embodiments, the peripheral zone or non-optical carrier zone of the contact lens is configured to be substantially free of ballast, free of any optical prism, free of prismatic ballast, free of thinned design, or free of truncated design, which is commonly used in conventional toric contact lenses or asymmetric contact lenses, intended to stabilize the orientation of the contact lens on the eye.

[0236] In certain embodiments, the contact lens can be substantially free to rotate over time by 180 degrees at least once, twice, three times, four times, five times, or ten times per day, and by at least 10, 15, 20, or 25 degrees within 1 hour of wearing the lens. In other embodiments, the contact lens can be substantially free to rotate over time by 90 degrees at least once, twice, three times, four times, five times, or ten times per day, and by at least 10, 15, 20, or 25 degrees within 2 hours of wearing the lens. In some embodiments, the toric portion of the contact lens can be positioned, formed, or disposed on the anterior surface, the posterior surface, or a combination thereof. In some embodiments, the toric portion of the contact lens defined as being substantially concentric about the optical axis or optical center of the contact lens is used to generate a specific feature of a stop signal, such as an induced astigmatism having a sagittal focal line or a tangential focal line substantially in front of the retina.

[0237] In certain other examples, the contact lens may be positioned, formed, or disposed on one of the two surfaces of the contact lens and the toric portion on the other surface may have other features to further slow eye growth. For example, additional optical features such as coma, trefoil, or primary spherical aberration may be used to improve the visual performance of an embodiment while providing a directional cue or stop signal for slowing the rate of eye growth.

[0238] In certain 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 asphericity, an extended odd polynomial, an extended even polynomial, a conic section, a biconic section, a toric surface, or a Zernike polynomial.

[0239] In some other embodiments, the radial and / or azimuthal power distribution across the optical center can be described by appropriate Bessel functions, Jacobi polynomials, Taylor polynomials, Fourier expansions, or combinations thereof. In one embodiment of the present disclosure, the stop signal can be configured using only astigmatism, astigmatism, or toric power profiles. However, in other embodiments, higher-order aberrations such as primary spherical aberration, coma, and trefoil aberrations can be combined with the configured astigmatism, toric, or asymmetric blur. As will be appreciated by those skilled in the art, the present invention can be used in conjunction with any of the devices / methods that may affect myopia progression. These may include, but are not limited to, various designs of eyeglass lenses, color filters, pharmaceutical preparations, behavioral changes, and environmental conditions.

[0240] Prototype Contact Lenses Lens #1 and Lens #2: Design, Metrology, and Clinical Data

[0241] Two toric contact lenses with rotationally symmetric peripheral carrier zones were manufactured according to the prescriptions for the right and left eyes of one subject to evaluate visual performance and measure the amount of rotation of the lenses over time when worn on the eyes.

[0242] As disclosed herein, Lens #1 and Lens #2 are exemplary embodiments of the present invention. The spherical power of these two lenses (Lens #1 and Lens #2) is -2.00D and the cylindrical power is +1.50DC. However, the contact lens embodiment contains meridian negative spherical aberration, wherein the magnitude of the spherical aberration is selected such that the principal meridians configured with positive cylinders blend into the sphere at the ends of the optical zone. This approach reduces the average cylindrical power over the 8mm optical zone to approximately +0.8DC. Both lenses provide clinically acceptable visual performance when compared to monovision correction.

[0243] The measured base curve, lens diameter and center thickness values ​​for the two lenses manufactured, lens #1 for the right eye and lens #2 for the left eye, are shown in Table 4. The contact lens material was Contaflex 42 (Contamac, UK) with a measured refractive index of 1.432.

[0244]

[0245] Table 4: Measured base curve, diameter, and center thickness values ​​for Lens #1 and Lens #2.

[0246] Fig.32a and Figure 32b Two prototype contact lenses are shown, Lens #1 ( Fig.32a ) and lens #2( Figure 32b ) of the two perpendicular meridians, the two lenses are Fig.19 A variation of the contact lens embodiment described in .

[0247] The thickness profile was measured using an Optimec is830 (Optimec Ltd., UK) and a peripheral prism, i.e., the thickness difference between the two peripheral peaks of the meridian of each lens was determined. In lens #1 (3201), the thickness difference for meridian 1 and meridian 2 was 32.5 μm and 2.3 μm, respectively. Similarly, in lens #2 (3020), the thickness difference for meridian 1 and meridian 2 was 22.9 μm and 0.4 μm, respectively.

[0248] As expected from the design of the peripheral rotationally symmetric carrier zone of these prototype contact lenses, the peripheral thickness difference across the two meridians was minimal, thereby providing a non-rotationally stable peripheral carrier zone.

[0249] While the Optimec is830 allowed reliable measurements of peripheral thickness profiles, the instrument's measurement variability increased in the central optical zone, and the expected thickness differences between the vertical meridian and the horizontal meridian of the annular optical zone of Lens #1 and Lens #2 could not be derived from these measurements. Instead, a power mapping instrument, NIMOevo (Lamb Da-X, Belgium), was used to measure and confirm the cylindrical power of the central optical zone of Lens #1 and Lens #2.

[0250] Fig.33a and Figure 33b The relative meridian power measured by NIMOevo after cosine fitting of the data of two prototype contact lenses, lens #1 (3301) and lens #2 (3302), is shown. Fig.19 A variation of the contact lens embodiment described in . For an aperture of 8 mm, the measured cylindrical powers of Lens #1 and Lens #2 are 0.78 DC and 0.74 DC, respectively, which is consistent with the expected cylindrical power (i.e., cylindrical power plus negative spherical aberration in the meridian).

[0251] Fig.34a and Fig.34b The measured thickness profiles of the vertical meridian and the horizontal meridian of two commercially available toric contact lenses (Control #1 and Control #2) are shown. For the avoidance of doubt, Control #1 and Control #2 are examples of prior art lenses. These lenses are Biofinity Toric lenses (CooperVision, USA) with a cylindrical power of -1.25 DC (material: comfilcon A).

[0252] In this example, an Optimec is830 (Optimec Ltd., UK) and peripheral prisms were used to measure the thickness profile, i.e., determine the thickness difference between the two peripheral peaks of the meridian of each lens. In Control #1 (3401), the thickness difference for meridian 1 (vertical) and meridian 2 (horizontal) was 197.5 μm and 28 μm, respectively. In Control #2 (3402), the thickness difference for meridian 1 and meridian 2 was 198.5 μm and 0.03 μm, respectively. Unlike the thickness profile and thickness difference of the prototype contact lenses, lens #1 (3201) and lens #2 (3202), which are similar for both meridians, these two commercially available toric contact lenses, Control #1 (3401) and Control #2 (3402), show significant peripheral prisms along meridian 2. The purpose of these peripheral prisms is to stabilize the toric contact lenses (prior art).

[0253] Fig.35A picture of a device (3500) for measuring rotation of a contact lens over time is shown. The device (3500) comprises a simple eyeglass frame (3501) to which is attached a mounting arm with a small camera (3503) (SQ11 micro HD camera). The camera is positioned so that when worn on the eye, a video of the contact lens can be taken over time to assess the rotation of the contact lens embodiments disclosed herein, i.e., spatially and temporally varying stimuli.

[0254] Fig.36 A front view of a contact lens embodiment (3600) disclosed herein is shown, the contact lens embodiment (3600) including a symmetrical non-optical peripheral carrier zone (3601) that allows the contact lens embodiment to rotate freely on or about its optical center under the influence of the lower eyelid (3603) and the upper eyelid (3604). The front view also illustrates a method that can use two different marks (3605a and 3605b) along the same meridian on the contact lens embodiment in combination with the device (3500) to measure the azimuthal position (3602), i.e., the amount of rotation, of the contact lens over time. In this exemplary embodiment (3600), the contact lens mark (3605b) is located along the 45° meridian. In other embodiments, the mark can have different shapes, sizes, or colors, and the number of marks can be more than 2 to provide additional convenience in detecting the azimuthal position of the contact lens over time.

[0255] Fig.37a and Fig.37b The measured azimuthal position of a prototype contact lens #1 (3701) and a commercially available toric contact lens control #1 (3702) over time, i.e., over about 30 minutes of lens wear when wearing the described apparatus (3500) and following the described method (3600), is shown. Unlike the commercially available toric contact lens control #1, which only showed a small amount of lens rotation, the prototype contact lens #1 rotated about 250° after about 25 minutes of lens wear. In some embodiments, the contact lens can be configured with a specific fit that allows the contact lens to rotate substantially freely on a myopic eye; wherein substantially free rotation of the contact lens is measured as the contact lens rotating 180 degrees at least once, twice, three times, four times, or five times per day, and rotating at least 15 degrees, 20 degrees, 25 degrees, 30 degrees, or 35 degrees within 1 hour of lens wear. Several other exemplary embodiments are described in the following example groups.

[0256] Example Group "A" - Astigmatism Power Distribution

[0257] A contact lens for an eye, the contact lens comprising an optical zone surrounding an optical center and a non-optical peripheral carrier zone surrounding the optical zone; wherein the optical zone is configured with a substantially toric or astigmatic power profile substantially centered about the optical center, at least partially provides meridian correction for the eye, and at least partially provides meridian astigmatism, thereby generating a directional cue to serve as a stop signal for the eye; and wherein the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric about the optical center.

[0258] The contact lens of one or more claims of Example Group A, wherein the range of the optical zone configured with a substantially toric or astigmatic power profile comprises at least 50% of the optical zone, and the remainder of the optic zone is configured with a spherical correction for the eye.

[0259] The contact lens of one or more claims of Example Group A, wherein meridian correction and meridian astigmatism are provided by an area of ​​the optical zone configured with a substantially toric or astigmatic power profile that extends across at least 4 mm of a central region of the contact lens.

[0260] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile of the optical zone is configured on the front surface of the contact lens.

[0261] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile of the optical zone is configured on the posterior surface of the contact lens.

[0262] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile of the optical zone is configured partially by the front surface of the contact lens and partially by the back surface of the contact lens.

[0263] The contact lens of one or more claims of Example Group A, wherein the thickest point across any one semi-meridian in the non-optical peripheral carrier zone is within a maximum variation of 30 μm of the thickest peripheral point at any other semi-meridian.

[0264] A contact lens according to one or more claims of Example Group A, wherein the thickness profile of the substantially rotationally symmetric region of the non-optical peripheral carrier zone in any meridian is within at least 6% of the average thickness profile of the non-optical peripheral carrier zone measured around the optical center of the contact lens.

[0265] The contact lens of one or more claims of Example Group A comprises a spherical blending zone between the optical zone and the non-optical peripheral carrier zone, wherein the width of the spherical blending zone spans at least 0.1 mm, as measured on a semi-chord diameter across the optical center of the contact lens.

[0266] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile has an effective astigmatism or toricity of at least +0.75D cylindrical power.

[0267] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile has an effective astigmatism or toric power of at least +1.25D cylindrical power.

[0268] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile has an effective astigmatism or toric power of at least +1.75D cylindrical power.

[0269] The contact lens of one or more claims of Example Group A, wherein the substantially toric or astigmatic power profile has an effective astigmatism or toric power of at least +2.25D cylindrical power.

[0270] The contact lens of one or more claims of Example Group A, wherein a substantially toric or astigmatic power profile is combined with a primary spherical aberration of at least +1D defined over the entire optical zone.

[0271] The contact lens of one or more claims of Example Group A, wherein a substantially toric or astigmatic power profile is combined with a primary spherical aberration of at least -1D defined over the entire optical zone.

[0272] The contact lens according to one or more claims of Example Group A, wherein the shape of the elementary area configured with the substantially toric or astigmatic power distribution is arranged within a substantially circular or elliptical area of ​​the optical zone.

[0273] A contact lens as described in one or more claims of Example Group A, wherein the non-optical peripheral carrier zone provides a specific fit that provides a temporally and spatially varying optical stop signal to the wearer's eye to provide a directional signal for substantially controlling growth of the eye.

[0274] A contact lens according to one or more claims of Example Group A, wherein the non-optical peripheral carrier area is configured to allow at least one of the following: rotation of the contact lens by at least 15 degrees during one hour of wear on a myopic eye; and rotation of the contact lens by 180 degrees at least three times during eight hours of wear.

[0275] A contact lens as described in one or more claims of Example Group A, wherein the non-optical peripheral carrier zone provides a specific fit to provide a temporally and spatially varying optical stop signal to the wearer's eye, wherein the varying optical signal provides a substantially consistent directional stimulus or directional cue to inhibit or slow growth of the eye over time.

[0276] The contact lens of one or more claims of Example Group A, wherein the contact lens is configured for a myopic eye having no astigmatism or a cylindrical power with astigmatism less than 1D.

[0277] The contact lens of one or more claims of Example Group A, wherein the contact lens is capable of providing a wearer with visual performance substantially comparable to that obtained using an appropriately fitted commercial single-vision contact lens.

[0278] A contact lens according to one or more claims in Example Group A, wherein the contact lens is configured with an astigmatic or toric power zone substantially covering the optical zone, wherein the radial power profile is described by a standard conic section, a biconic section, an even or odd extended polynomial, or a combination thereof.

[0279] The contact lens of one or more claims of Example Group A, wherein the contact lens is configured for an eye at risk of developing myopia.

[0280] A contact lens as described in one or more claims of Example Group A, wherein the optical zone is configured to at least partially provide adequate foveal correction for the eye and is also configured to at least partially provide a temporally and spatially varying stop signal to reduce the rate of eye growth.

[0281] A contact lens as described in one or more claims of Example Group A, wherein the optical zone is configured to at least partially provide adequate foveal correction for the eye and is also configured to at least partially provide a stop signal that varies in time and space to reduce the rate of eye growth substantially uniformly over time.

[0282] The contact lens of one or more claims of Example Group A, wherein the contact lens is capable of altering incident light and utilizing directional cues provided by induced astigmatism incorporated at least in part by the central optical zone to slow the rate of myopia progression.

[0283] A contact lens according to one or more claims of Example Group A, wherein the contact lens provides a temporally and spatially variable stop signal to the wearer by means of rotation of the contact lens on the eye facilitated at least in part by a rotationally symmetric non-optical peripheral carrier zone.

[0284] A method comprising: applying a contact lens to a myopic eye or prescribing a contact lens for a myopic eye, the contact lens comprising a configuration effective for the myopic eye to: provide spherical correction to at least reduce the myopic error of the eye; and introduce astigmatic error into the myopic eye; and rotate on the eye during wear of the contact lens, whereby the astigmatic error is temporally and spatially variable.

[0285] The method according to the above claims, wherein the contact lens is a contact lens according to any one or more of the above claims of Example Group A.

[0286] Example Group "B" - Asymmetric Distribution Defined by Other Power Profile Variations

[0287] A contact lens for an eye, the contact lens comprising an optical zone surrounding an optical center and a non-optical peripheral carrier zone surrounding the optical zone; wherein the optical zone is configured with an asymmetric power distribution substantially centered about the optical center, at least partially provides meridian correction for the eye, and at least partially provides a meridian stop signal for the eye, and wherein the non-optical peripheral carrier zone is configured to be substantially unballasted or otherwise configured to allow the lens to rotate when on the eye to provide primarily temporal and spatial variations to the meridian stop signal.

[0288] The contact lens of one or more claims of Example Group B, wherein the range of the optical zone configured with a power distribution that is substantially asymmetric about the optical center includes at least 50% of the optical zone, and the remainder of the optical zone is configured with spherical correction for a myopic eye.

[0289] The contact lens of one or more claims of Example Group B, wherein the meridian correction and meridian stop signal are provided by an area of ​​the optical zone configured with a substantially asymmetrical distribution extending across at least 4 mm of a central region of the contact lens.

[0290] The contact lens of one or more claims of Example Group B, wherein the substantially asymmetric power profile of the optical zone is configured on the front surface of the contact lens.

[0291] The contact lens of one or more claims of Example Group B, wherein the substantially asymmetric power profile of the optical zone is configured on the posterior surface of the contact lens.

[0292] The contact lens of one or more claims of Example Group B, wherein the substantially asymmetric power profile of the optical zone is configured in part by the anterior surface of the contact lens and in part by the posterior surface of the contact lens.

[0293] The contact lens of one or more claims of Example Group B, wherein the thickest point across any one meridian in the non-optical peripheral carrier zone is within a maximum variation of 30 μm of the thickest peripheral point on any other meridian.

[0294] A contact lens according to one or more claims of Example Group B, wherein the thickness profile of the substantially rotationally symmetric region of the non-optical peripheral carrier zone in any meridian is within 6% of the average thickness profile of the non-optical peripheral carrier zone measured about the optical center of the contact lens.

[0295] The contact lens of one or more claims of Example Group B comprises a spherical blending zone between the optical zone and the non-optical peripheral carrier zone, wherein the width of the spherical blending zone spans at least 0.1 mm, as measured on a semi-chord diameter across the optical center of the contact lens.

[0296] The contact lens of one or more claims of Example Group B, wherein the difference between the minimum power and the maximum power across the substantially asymmetric power profile is at least +1.25D.

[0297] The contact lens of one or more claims of Example Group B, wherein the substantially asymmetric power profile is represented using a power profile function described by the following expression: spherical + azimuthal component, wherein spherical refers to the distance spherical prescription power used to correct the eye, and the azimuthal component of the power profile function is described as C a *cos(mθ), where C a is the azimuth coefficient, m is an integer between 1 and 6, and Theta (θ) is the azimuth angle of a given point in the optical zone.

[0298] The contact lens of one or more claims of Example Group B, wherein the substantially asymmetric power profile is represented using a power distribution function described by the following expression: sphere+(radial component)*(azimuthal component), wherein sphere refers to the distance spherical prescription power for correcting myopia, and the radial component of the power distribution function is described as C r *ρ, where C r is the expansion coefficient, and Rho(ρ) is the normalized radial coordinate (ρ0 / ρ 最大 ); the azimuthal component of the focal power distribution function is described as C a*cos(mθ), where m can be any integer between 1 and 6, and Theta(θ) is the azimuthal angle, where Rho(ρ0) is the radial coordinate of a given point, where ρ 最大 is the maximum radial coordinate or radius of the light zone.

[0299] A contact lens according to one or more claims of Example Group B, wherein the substantially asymmetric power distribution is represented using a power distribution function that is at least partially described using at least one or more of the terms of a first-class Bessel cycle function having a general expression (n, m); wherein at least one or more of the terms of the Bessel cycle function is obtained when n takes a value of 1, 2, 3 and m takes a value of ±2.

[0300] The contact lens of one or more claims according to Example Group B, wherein the azimuthal power distribution function is cos 2 (mθ) where m is an integer between 1 and 6, inclusive.

[0301] The contact lens of one or more claims of Example Group B, wherein the shape of the elementary region configured with the substantially asymmetric power distribution is arranged within a substantially circular or elliptical region of the optical zone.

[0302] A contact lens as described in one or more claims of Example Group B, wherein the non-optical peripheral carrier zone provides a specific fit that provides a temporally and spatially varying optical stop signal to the wearer's eye to provide a directional signal for substantially controlling growth of the eye.

[0303] A contact lens according to one or more claims of Example Group B, wherein the non-optical peripheral carrier area is configured to allow at least one of the following: the contact lens to rotate at least 15 degrees during one hour of wear on a myopic eye; or the contact lens to rotate 180 degrees at least three times during eight hours of wear.

[0304] A contact lens as described in one or more claims of Example Group B, wherein the non-optical peripheral carrier zone provides a specific fit that provides a temporally and spatially varying optical stop signal to the wearer's eye to provide a directional signal for substantially controlling ocular growth of the eye.

[0305] A contact lens as described in one or more claims of Example Group B, wherein the non-optical peripheral carrier zone provides a specific fit that provides a temporally and spatially varying optical stop signal to the wearer's eye to provide a directional signal to control ocular growth of the eye substantially consistently over time.

[0306] The contact lens of one or more claims according to Example Group B, wherein the contact lens is configured for a myopic eye having no astigmatism or a cylindrical power with astigmatism less than 1D.

[0307] The contact lens of one or more claims of Example Group B, wherein the contact lens is capable of providing a wearer with visual performance substantially comparable to that obtained using a commercial single-vision contact lens.

[0308] A contact lens according to one or more claims of Example Group B, wherein the contact lens is configured with an astigmatic or toric power profile substantially across the optical zone, the power profile being described by a Bessel function, a Jacobi polynomial, a Taylor polynomial, a Fourier expansion, or a combination thereof.

[0309] The contact lens of one or more claims according to Example Group B, wherein the contact lens is configured for an eye at risk of developing myopia.

[0310] A contact lens as described in one or more claims of Example Group B, wherein the optical zone is configured to at least partially provide adequate foveal correction for the eye and is also configured to at least partially provide a temporally and spatially varying stop signal to reduce the rate of eye growth.

[0311] A contact lens as described in one or more claims of Example Group B, wherein the optical zone is configured, at least in part, to provide adequate foveal correction to the eye and is also configured, at least in part, to provide a temporally and spatially varying stop signal to reduce the rate of eye growth, wherein the efficacy of the treatment or management of eye growth is substantially consistent over time.

[0312] The contact lens of one or more claims of Example Group B, wherein the contact lens is capable of altering incident light and utilizing directional cues provided by an induced astigmatism optical signal at least partially incorporated by the central optical zone to slow the rate of myopia progression.

[0313] A method comprising: applying a contact lens to a myopic eye or prescribing a contact lens for a myopic eye, the contact lens comprising a configuration effective for the myopic eye to: provide spherical correction to at least reduce the myopic error of the myopic eye; and introduce a stop signal into the myopic eye; and rotate on the eye during wear of the contact lens, whereby the stop signal is temporally and spatially variable.

[0314] The method according to the above claims, wherein the contact lens is a contact lens according to any one or more of the above claims of Example Group B.

Claims

1. A contact lens for myopic eyes, characterized in that: The contact lens has a front surface, a back surface, an optical center, an optical zone around the optical center, a hybrid zone, and a non-optical peripheral carrier zone; the optical zone includes at least a basic area configured with a substantially toric or astigmatic power distribution, wherein the substantially toric or astigmatic power distribution is configured to substantially surround the optical center, at least partially provide meridian correction for the myopic eye, and at least partially introduce meridian astigmatism to generate a stop signal for the myopic eye; wherein the power distribution adopts cos 2 (mθ), wherein m can be an integer between 1 and 6; and wherein the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric about the optical center to allow substantially free rotation of the contact lens on the myopic eye; wherein the substantially free rotation of the contact lens is measured as: the contact lens rotates 180 degrees at least three times for every 8 hours of wearing the lens, and at least 15 degrees within 1 hour of wearing the lens.

2. The contact lens according to claim 1, wherein The extent of the primary area configured with the substantially toric or astigmatic power profile comprises at least 60% of the optical zone, and the remainder of the optical zone is configured with a spherical correction for the myopic eye.

3. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile substantially across the optical zone has an effective astigmatism or toricity of at least +1.25 DC.

4. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile substantially across the optical zone is represented using a power distribution function described by the following expression: sphere + (cylinder / 2) * (azimuthal component), wherein sphere refers to the distance spherical prescription power used to correct the myopic eye, cylinder refers to the magnitude of the induced astigmatism or toric, wherein the azimuthal component of the power distribution function is described as C a *cos(mθ), where C a is the azimuthal coefficient, m is an integer between 2 and 6, and θ is the azimuthal angle of a given point of the optical zone.

5. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile substantially across the optical zone is represented using a power distribution function described by the following expression: sphere + (cylinder / 2)*(radial component)*(azimuthal component), wherein sphere refers to the distance spherical prescription power used to correct the myopic eye, cylinder refers to the magnitude of the induced astigmatism or toric, and the radial component of the power distribution function is described as C r *ρ, where C r is the expansion coefficient and ρ is the normalized radial coordinate ρ0 / ρ 最大 ; and wherein the azimuthal component of the focal power distribution function is described as C a *cos(mθ), where m can be any integer between 2 and 6, and θ is the azimuthal angle, where ρ0 is the radial coordinate at a given point, where ρ 最大 is the maximum radial coordinate or semi-diameter of the optical zone.

6. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile substantially across the optical zone is represented by a power profile function that is at least partially described by at least one or more of the terms of a first kind Bessel loop function with the general expression (n, m); wherein the at least one or more of the terms of the Bessel loop function are obtained when n is 1, 2, 3 and m is ±2.

7. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile is combined with a primary spherical aberration of at least +1D defined throughout the optical zone.

8. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile is combined with a primary spherical aberration of at least -1D defined across the optical zone.

9. The contact lens of claim 1, wherein: The substantially toric or astigmatic power profile is combined with a primary spherical aberration of at least -2D defined across the optical zone.

10. The contact lens of claim 1, wherein: The substantially rotationally symmetric region of the non-optical peripheral carrier zone has a thickness profile in any meridian within 6% of a mean thickness profile of the non-optical peripheral carrier zone measured about the optical centre of the contact lens.

11. The contact lens of claim 1 , wherein: The thickest point in the non-optical peripheral carrier zone across any of the meridians is within a maximum variation of 30 μm of the thickest peripheral point in any other meridian.

12. The contact lens of claim 1, wherein: The contact lens is configured to rotate when applied to the myopic eye, whereby the introduced meridian astigmatism provides a temporally and spatially varying optical signal to the myopic eye.

13. The contact lens of claim 1, wherein: Light incident on the myopic eye forms a Sturm's cone-like shape, wherein at least 50% of the Sturm's cone-like shape falls in front of the retina, thereby providing the stop signal to slow the rate of myopia progression; wherein the depth of the Sturm's cone-like shape is the distance between the sagittal image plane and the tangential image plane.

14. The contact lens of claim 13, wherein: The depth of the Sturm's cone-like body is configured to be between approximately +0.5D and +3D.

15. The contact lens of claim 13, wherein: The depth of the Sturm's cone-like body is configured to be between about 0.6 mm and 0 mm.

16. The contact lens of claim 1, wherein: The contact lens is able to alter incident light and slow the rate of myopia progression by utilizing the directional cue provided by the introduced meridian astigmatism.

17. The contact lens of claim 1, wherein: The contact lenses are capable of providing adequate visual performance to wearers with myopic eyes that is comparable to the performance obtained using commercial single-vision contact lenses.

18. A method comprising applying a contact lens to an eye with progressive myopia, wherein: The contact lens is the contact lens according to claim 1.

19. A method comprising prescribing a contact lens for an eye with progressive myopia, wherein: The contact lens is the contact lens according to claim 1.

20. The method according to claim 18 or 19, wherein: The progressive myopic eye has an astigmatism of less than 1DC.

21. A contact lens for an eye, the contact lens comprising: anterior and posterior surfaces, an optical axis, an optical zone surrounding the optical axis, and a non-optical peripheral zone surrounding the optical zone; in: the optical zone being configured with an asymmetric power profile that varies about the optical axis, wherein the asymmetric power profile at least partially provides meridian correction for the eye and at least partially introduces a directional optical stop signal to the eye; The non-optical peripheral zone is configured to be substantially rotationally symmetric about the optical axis to allow the contact lens to rotate freely on the eye so that the directional optical stop signal varies temporally and spatially on the retina of the eye.

22. The contact lens of claim 21, wherein: The contact lens is a contact lens having a prescription for a myopic eye having an astigmatism of 0 to 1 cylindrical diopter.

23. The contact lens of claim 21, wherein: The extent of the substantial area configured with the asymmetric power profile comprises at least 50% of the optical zone, and the remainder of the optical zone is configured with a spherical correction for the eye.

24. The contact lens of claim 21, wherein: The meridian correction and the directional optical stop signal provided by the asymmetric power profile extend across at least 4 mm of a central region of the optic zone.

25. The contact lens of claim 21, wherein: The asymmetric power profile of the optic zone is disposed on the anterior surface of the contact lens.

26. The contact lens of claim 21, wherein: The asymmetric power profile of the optic zone is disposed on the posterior surface of the contact lens.

27. The contact lens of claim 21, wherein: The asymmetric power profile of the optic zone is configured partially on the anterior surface and partially on the posterior surface of the contact lens.

28. The contact lens of claim 21, wherein: The substantially rotationally symmetric region of the non-optical peripheral zone has a thickness profile in any meridian that is within 6% of an average thickness profile of the non-optical peripheral zone measured about the optical axis of the contact lens.

29. The contact lens of claim 21, wherein: The difference between the minimum power and the maximum power across the asymmetric power profile is at least +1.25 diopters.

30. The contact lens of claim 21, wherein: The asymmetric power profile can be represented using a power distribution function having a spherical component and an azimuthal component, wherein the spherical component refers to the distance spherical prescription power used to correct the eye, and the azimuthal component is Ca*cos(mθ), wherein Ca is the azimuthal coefficient, m is an integer between 1 and 6, and θ is the azimuthal angle at a given point in the optical zone.

31. The contact lens of claim 21, wherein: The asymmetric power profile can be represented using a power distribution function having an azimuthal component that can be expressed as Ca*cos(mθ), where Ca is the azimuthal coefficient, m is an integer between 1 and 6, and θ is the azimuthal angle at a given point in the optical zone.

32. The contact lens of claim 21, wherein: The contact lens rotates freely on the eye when the contact lens rotates 180 degrees at least three times for every 8 hours the lens is worn, or at least 15 degrees within 1 hour of wearing the lens on the eye.

33. The contact lens of claim 21, when used or prescribed, for controlling eye growth in a myopic eye.

34. The contact lens of claim 21, wherein: The directional optical stop signal remains substantially consistent over time.

35. A method comprising: Applying to an eye or prescribing a contact lens for an eye, the contact lens comprising a configuration effective for the eye: providing spherical correction to at least reduce the refractive error of the eye; and introducing an asymmetric optical signal into the eye, the asymmetric optical signal at least partially introducing a directional optical stop signal to the eye; and The contact lens is allowed to rotate on the eye during wear, whereby the asymmetric optical signal is temporally and spatially variable.

36. The method of claim 35, wherein: The asymmetric optical signal includes astigmatic blur.

37. The method of claim 35, wherein: The difference between the minimum power and the maximum power across the asymmetric optical signal is at least +1.25 Diopters.

38. The method of claim 35, wherein: The contact lens is configured to be rotated 180 degrees at least three times during an eight hour period of wear on the eye.

39. The method of claim 35, wherein: The asymmetric optical signal provided by the contact lens is effective to at least slow myopia progression in the eye.

40. The method of claim 35, further comprising determining that the eye is a progressive myopic eye or an eye at risk of developing myopia.

41. A method of slowing the progression of myopia in an eye, the method comprising: applying to the eye or prescribing a contact lens for the eye, the contact lens having an optical zone with an asymmetric power profile and a substantially rotationally symmetric non-optical peripheral zone; wherein, due to rotation of the contact lens on the eye, the asymmetric power profile in the optical zone provides a temporally and spatially varying directional optical signal on the retina of the eye, the directional optical signal effectively slowing down axial elongation of the eye and slowing myopia progression.

42. The method according to claim 41, wherein: The asymmetric optical signal includes astigmatic blur.

43. The method of claim 41, wherein: The difference between the minimum power and the maximum power across the asymmetric optical signal is at least +1.25 Diopters.

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