Freeform contact lens solution for myopia

Abstract

To provide contact lenses to be put on eyes experiencing axial-length related disorders, such as myopia.SOLUTION: This invention relates to a contact lens for managing myopia, where the contact lens comprises an optical zone about an optical axis and a non-optical peripheral carrier zone about the optical zone; where the optical zone is configured with a substantially single-vision power profile providing correction for an eye, and a decentered second region configured with an astigmatic, or toric, or asymmetric power distribution, the second region located substantially away from the optical center and configured to provide at least in part a regional conoid or interval of Sturm producing an optical stop signal for the eye; and where the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric to further provide a temporally and spatially varying stop signals to reduce myopia progression.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] cross reference This application claims priority to Australian Provisional Patent Application No. 2019 / 903582, filed on September 25, 2019, entitled "Rotationally Asymmetric Lens for Myopia", and Australian Provisional Patent Application No. 2020 / 900414, filed on February 14, 2020, entitled "Freeform Lens Design", both of which are incorporated herein by reference.

[0002] The present disclosure generally relates to contact lenses for wear on eyes exhibiting axial length-related disorders such as myopia. The present invention relates to contact lenses for managing myopia, comprising an optical zone about an optical axis and a non-optical peripheral carrier zone about the optical zone, the optical zone being configured with a substantially monofocal power profile providing substantial correction to the eye, and a decentered second region configured with an astigmatism or toric or asymmetric power distribution, the second region being located substantially away from the optical center and configured to provide a directional cue in the form of a regional cone or interval of the star generating an optical stop signal at least partially on the retina, the non-optical peripheral carrier zone being configured with a substantially rotationally symmetric thickness profile to further provide a time- and spatially varying stop signal for slowing, improving, controlling, inhibiting or reducing the rate of myopia progression over time. [Background technology]

[0003] At birth, the human eye is hyperopic, with the ocular length being too short for the eye's total refractive power. As an individual develops from childhood into adulthood, the eye continues to grow and the eye's refractive state stabilizes. Eye growth is understood to be controlled by feedback mechanisms to match the eye's optics to the axial length and maintain homeostasis, and is primarily regulated by visual experience. This process is called emmetropization.

[0004] The signals that guide the emmetropization process begin with the modulation of the light energy received at the retina. The characteristics of the retinal image are monitored by biological processes that modulate the signals to start or stop, accelerate or decelerate eye growth. This process adjusts the optics and axial length to achieve or maintain emmetropia. Deviations from this emmetropization process result in refractive disorders such as myopia.

[0005] The incidence of myopia is increasing at an alarming rate in many parts of the world, especially in East Asia. In myopic individuals, the axial length of the eye does not match the overall ocular power, causing distant objects to be focused in front of the retina.

[0006] A simple pair of negative monofocal lenses may correct myopia. Although such devices may optically correct the refractive error associated with axial length, they do not address the underlying cause of excessive eye growth in myopic progression.

[0007] Excessive axial length in high myopia is associated with serious vision-compromising conditions such as cataracts, glaucoma, myopic maculopathy, and retinal detachment. Thus, there remains a need for specific optical devices for such individuals that not only correct the underlying refractive error, but also prevent substantial consistent excessive ocular elongation or myopic progression over time.

[0008] To date, numerous contact lens optical designs have been proposed to control the rate of eye growth, i.e., myopia progression. The following prior art is incorporated by reference: Collins et al., in U.S. Pat. No. 5,399,433, proposed the introduction of positive spherical aberration at the foveal surface to provide a stimulus to control the rate of myopia progression. Aller, in U.S. Pat. No. 5,399,433, proposed the use of bifocal contact lenses in myopic patients with near point esophoria. Smith et al., in U.S. Pat. No. 5,399,433, proposed the use of lenses that shift the peripheral focal plane in front of the peripheral retina.

[0009] To et al. proposed a method for generating a secondary myopic image using a Fresnel optical system in Patent Document 4. Legerton proposed another method using positive spherical aberration in Patent Document 5.

[0010] Phillips, in U.S. Patent No. 6, proposes a method of simultaneous vision where one portion of the lens corrects existing myopia and another portion generates a simultaneous myopic defocus signal. Thorn et al., in U.S. Patent No. 6,333,513, propose the correction of all optical aberrations, including higher order aberrations, to reduce the rate of myopia progression.

[0011] Menezes, in U.S. Patent No. 5,399,633, proposes the use of a fixed distance vision power zone in the center of the optic zone surrounded by a zone providing positive vertical spherical aberration. Holden et al., in U.S. Patent No. 5,399,633, propose a method for treating myopic eyes with inner and outer optic zones that add refractive power to the baseline prescription power. Tse et al., in U.S. Patent No. 5,399,633, propose a method for slowing the progression of myopia with concentric annular multizone refractive lenses. Bakarju et al., in U.S. Patent No. 5,399,633, propose a lens with multiple modes of higher order spherical aberration to control myopic progression.

[0012] In summary, contact lens design options for slowing the rate of myopia progression include simultaneous defocus areas on the lens, lenses with positive spherical aberration that may also be referred to as peripheral plus lenses, lenses modified to include both central and peripheral plus areas, and lenses that contain a specific set of higher order aberrations.

[0013] definition The terms used herein are those commonly used by those of ordinary skill in the art unless otherwise defined below.

[0014] The term "myopic eye" refers to an eye that has either already developed myopia, is at a pre-myopic stage, is at risk for becoming myopic, or has been diagnosed as having a refractive condition progressing towards myopia, and has an astigmatism of less than 1 DC. The term "progressing myopic eye" refers to an eye with established myopia that is diagnosed as progressing, as determined by either 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.

[0015] The term "eye at risk of becoming myopic" refers to an eye that may currently be emmetropic or low-hyperopic, but that has been identified as being at high risk of becoming myopic based on genetic factors (e.g., parents who are myopic) and / or age (e.g., low hyperopia at an early age) and / or environmental factors (e.g., time spent outdoors) and / or behavioral factors (e.g., time spent doing close work).

[0016] The term "light stop signal" or "stop signal" refers to a light signal or directional cue that can promote slowing, reversing, arresting, retarding, inhibiting or controlling eye growth and / or the refractive condition of the eye.

[0017] 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.

[0018] The term "time-varying optical stop signal" refers to an optical signal or directional cue provided at the retina that changes over time.

[0019] The term "spatially and temporally varying optical stop signal" refers to an optical signal or directional cue provided at the retina that varies both in time and in space across the retina of the eye.

[0020] The term "contact lens" refers to a finished contact lens, usually packaged in a vial, blister pack, or the like, intended to be placed on a wearer's cornea to affect the optical performance of the eye.

[0021] The term "optical zone" or "optical zone" refers to the area on a contact lens that has a prescribed optical effect, including the correction of refractive error, as well as a second area that provides optical stimulation to slow myopia progression. The optical zone may be further differentiated by front and back optical zones, which refer to the anterior and posterior surface areas of the contact lens that contribute to the prescribed optical effect, respectively. The optical zone of a contact lens may be circular or elliptical or another irregular shape. The optical zone of a spherically only powered contact lens is generally circular in shape. However, the introduction of toricity may result in an elliptical optical zone in some embodiments.

[0022] The term "optical center" or "optical center" means the geometric center of the optical zone of a contact lens. The terms geometrical and geometric are essentially the same.

[0023] The term "optical axis" means a line passing through the optical center and substantially perpendicular to a plane containing the edge of the contact lens.

[0024] The term "blend zone" is a zone that connects or lies between the optic zone and the peripheral carrier zone of a contact lens. The term "blending zone" is synonymous with "blend zone" in some embodiments and can be on the front or back surface of a contact lens or on both surfaces. A blend zone can be a polished, smoothed interface between two different adjacent surface curvatures. The thickness of the blending zone can also be referred to as the interface thickness.

[0025] The term "through focus" refers to an area that is substantially in front of or behind the retina, in other words, approximately in front of and / or approximately behind the retina.

[0026] The term "carrier zone" is a non-optical zone that connects or lies between the blend zone and the edge of the contact lens.

[0027] The terms "peripheral zone" or "peripheral carrier zone" are synonymous with a "carrier zone" that is free of prescribed optical effects.

[0028] The term or phrase "spherical optical zone" may mean that the optical zone has a uniform optical power distribution without a substantial amount of primary spherical aberration.

[0029] The term or phrase "aspheric optical zone" may mean that the optical zone does not have a uniform optical power distribution. The aspheric optical zone may be further classified in some embodiments into lower order aberrations such as astigmatism or toricity. The term or phrase "astigmatic optical zone" or "toric optical zone" may mean that the optical zone has a sphero-cylindrical optical power distribution.

[0030] The term "ballast" refers to a rotationally asymmetric distribution of the thickness profile within the carrier zone that influences the rotational orientation of the contact lens when placed on the eye.

[0031] The term "prism ballast" refers to a vertical prism used to create a wedge design that helps stabilize the rotation and orientation of a toric contact lens on the eye.

[0032] The term "slab-off" refers to the intentional thinning of a contact lens toward the upper and lower peripheral edges of the contact lens in one or more discrete areas to achieve desired contact lens rotational stabilization.

[0033] The term "truncation" refers to a lower edge of a contact lens that is designed with a nearly straight line to provide control over rotational stabilization of the contact lens.

[0034] The terms "negative," "planar," or "positive" carrier refer to contact lenses having edge thicknesses greater than, equal to, and less than the junction thickness, respectively, as measured approximately 0.1 mm away from the lens diameter.

[0035] The term "eye model" may refer to a schematic eye model, a ray tracing eye model, or a physical eye model.

[0036] As used herein, the term "Diopter", "Dioptre" or "D" is a unit of refractive power defined as the reciprocal of the focal length of a lens or optical system in meters along the optical axis. Typically, the letter "D" denotes spherical refractive power and the letter "DC" denotes cylindrical refractive power.

[0037] The term "posterior vertex power" means the inverse of the posterior vertex focal length across the optical zone, expressed in diopters (D). The term "SPH" or "spherical" power means a substantially uniform power across all meridians of the optical zone.

[0038] The terms "second region" or "second region within the optic zone" refer to another distinct region within the optic zone of a contact lens having a desired or prescribed optical effect that is substantially decentered from the optical center or axis.

[0039] The term "base prescription" or "base prescription for correcting refractive error" refers to the standard contact lens prescription required to correct the underlying myopia of an individual with or without astigmatism.

[0040] The term "Sturm's regional cone" or "Sturm's regional interval" refers to the resultant off-axis regional through-focus image profile formed on or around the retina due to an astigmatism, toricity or asymmetric refractive power profile configured within the second region of the optical zone, represented by a regional elliptical blur pattern including regional sagittal and tangential planes and a circle of least confusion.

[0041] The term "optical power profile" refers to the one-dimensional optical power distribution across an optical zone as a function of radial distance at a given azimuth angle relative to the optical center, or as a function of azimuth angle measured at a given radial distance.

[0042] The term "power map" refers to a two-dimensional power distribution across the optical zone diameter in Cartesian or polar coordinates.

[0043] The term "radial" in the context of describing the entire optic zone means a direction radiating outward from the optical center of the contact lens, defined along an azimuth angle. The term "azimuth" in the context of describing the entire optic zone means a circumferential direction about the optical center of the optic zone, defined at a radial distance.

[0044] The term "power profile of the second region" means the distribution of localized optical power as a function of radial distance and azimuth angle measured from the geometric center of the second region as a reference. The power profile of the second region can be configured over a circular or elliptical region.

[0045] The term "power map of the second region" refers to a two-dimensional power distribution over the second region within the optical zone in Cartesian or polar coordinates, which may be circular or elliptical in shape.

[0046] The term "radial" in the context of describing a second region means directions radiating outward from the geometric center of the second region, defined along an azimuth angle.

[0047] The term "azimuth" in the context of describing the second region means a circumferential direction along the geometric center of the second region of the optical zone defined by a certain radial distance.

[0048] The term "astigmatic or toric second region" means a power profile distribution having at least two principal power meridians defined over the second region, the two principal power meridians being configured differently from the base prescription of the optical zone, and the difference between the two principal power meridians determining the magnitude of the astigmatic or toric power of the second region.

[0049] The term "asymmetric second region" refers to a variation in localized refractive power along an azimuth direction about the geometric center of the second region while maintaining mirror symmetry along an arbitrarily selected meridian within the second region.

[0050] 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.

[0051] The specific conformance referred to in this invention means that the non-optical peripheral carrier zone is configured with a thickness profile that is substantially free of ballast, or prisms, or truncations.

[0052] The term "subfoveal region" refers to the region immediately adjacent to the fovea of ​​the wearer's retina. The term "parafoveal region" refers to the region immediately adjacent to the foveal region of the wearer's retina. The term "submacular region" refers to the region within the macular region of the wearer's retina. The term "paramacular region" refers to the region immediately adjacent to the macular region of the wearer's retina. [Prior art documents] [Patent documents]

[0053] [Patent Document 1] U.S. Patent No. 6,045,578 [Patent Document 2] U.S. Patent No. 6,752,499 [Patent Document 3] U.S. Patent No. 7,025,460 [Patent Document 4] U.S. Patent No. 7,506,983 [Patent Document 5] U.S. Patent No. 7,401,922 [Patent Document 6] U.S. Patent No. 7,997,725 [Patent Document 7] U.S. Patent No. 7,803,153 [Patent Document 8] U.S. Patent No. 8,690,319 [Patent Document 9] U.S. Patent No. 8,931,897 [Patent Document 10] U.S. Patent No. 8,950,860 [Patent Document 11] U.S. Patent No. 9,535,263 Summary of the Invention [Means for solving the problem]

[0054] Certain disclosed embodiments include contact lenses for altering the wavefront characteristics of incident light entering a human eye. Certain disclosed embodiments are directed to contact lens configurations for correcting, managing, and treating refractive error.

[0055] One proposed embodiment of the invention aims to both correct myopic refractive error and at the same time provide an optical signal that prevents further eye growth or myopia progression.

[0056] The proposed optical device provides a substantially continuously varying stark regional cone (i.e., light stopping signal) that is applied to the peripheral retinal region. The present disclosure includes contact lenses with a decentered astigmatic or toric second region within the optical zone that is purposefully configured without a stabilized carrier zone to provide a substantially continuously varying (or time- and spatially varying) myopic blur signal on the peripheral retina.

[0057] Another proposed contact lens embodiment includes a substantially monofocal optic zone with a second region within the optic zone configured with an astigmatic or toric power profile, where the monofocal portion of the optic zone is used to correct myopic refractive error and the second region provides a regional cone of starm (i.e., a light stop signal) that inhibits or slows the rate of further ocular growth in the peripheral retina.

[0058] The refractive power map of the second region is arranged to be rotationally asymmetric about its geometric center. Another feature of the proposed embodiment may include blending between the rotationally asymmetric second region and the remainder of the optical zone, which may be circular or elliptical in shape.

[0059] Certain embodiments configured with a decentered astigmatic, toric or rotationally asymmetric second region within an otherwise monofocal optical zone configured on a rotationally symmetric peripheral non-optical carrier zone may overcome limitations of the prior art by providing a time- and space-varying stop signal, allowing for minimal saturation of the therapeutic effect on myopia progression.

[0060] In another embodiment, the present invention is directed to a contact lens for at least one of slowing, stopping, or preventing myopia progression. Another embodiment of the present disclosure is a contact lens including a front surface, a back surface, an optic zone, an optical center, the optic zone including a base prescription about the optical center, an eccentric second region having a rotationally asymmetric astigmatic or toric power profile about the geometric center, and a non-optical peripheral carrier zone symmetrically configured about the optic zone, a substantial portion of the optic zone configured to at least partially provide adequate foveal correction, the second region configured to provide a regional cone or interval of starm as a directional cue to reduce the rate of myopia progression, the non-optical peripheral carrier zone configured to provide a temporally and spatially variable optical stop signal, and wherein the therapeutic efficacy of reducing the progression of eye growth remains substantially consistent over time.

[0061] Another embodiment of the present disclosure is a contact lens for an eye comprising an optical zone with an optical center, a decentered second region with a geometric center within the optical zone, and a non-optical peripheral carrier zone around the optical zone, a substantial portion of the optical zone being configured substantially with a base prescription providing a substantial foveal correction to the eye, the decentered second region configured with an asymmetric power distribution located substantially away from the optical center providing a directional cue in the form of at least a partial Sturm's regional cone (i.e., a light stop signal) on the peripheral retina of the eye, and the non-optical peripheral carrier zone being configured substantially without ballast to provide substantial temporal and spatial variation in the directional cue or otherwise configured to allow rotation of the contact lens when on the eye.

[0062] According to one embodiment, the present disclosure is directed to a contact lens for myopic eyes, the contact lens having a front surface, a back surface, an optical axis, and an optical zone about the optical axis, the optical zone including a base prescription about the optical axis and a second region with an asymmetric power profile defined about its geometric center, the base prescription configured to correct the refractive error of the eye, the second region configured to provide a directional cue by the regional cones of Sturm at the peripheral retina, the contact lens further configured with a rotationally symmetric peripheral carrier zone to provide a temporally and spatially variable light stop signal, the therapeutic efficacy of reducing the progression of eye growth remains substantially consistent over time. The present disclosure is directed to modifying the incoming light through the contact lens utilizing a stop signal to slow down the rate of myopic progression. The present disclosure is directed to a contact lens device configured with a decentered second region in the optical zone, the decentered second region including an astigmatic or toric or asymmetric power profile defined about the geometric center of the second region to provide a light stop signal at the retina of the eye. Additionally, the light stopping signal provided at the retina of the eye is configured to be temporally (time) and spatially (location) variable. In particular, the present disclosure relates to contact lenses purposefully configured without any stabilization in the non-optical peripheral carrier zone that can facilitate a temporally and spatially varying light stopping signal to inhibit, reduce, or control progressive myopic refractive error.

[0063] Certain embodiments of the present disclosure are directed to a contact lens for a myopic eye, the contact lens including an optical zone about an optical center and a non-optical peripheral carrier zone about the optical zone, the optical zone being configured with a substantially monofocal optical power providing a substantial correction to the eye and a second region having an asymmetric optical power distribution about its geometric center, the second region being configured substantially away from the optical center and providing at least in part a regional cone of starm that generates a stop signal to the eye, the non-optical peripheral carrier zone being configured substantially without ballast to provide substantial temporal and spatial variation in the optical stop signal or otherwise configured to allow rotation of the lens when on the eye.

[0064] The embodiments presented in this disclosure address the ongoing need for enhanced optical designs and contact lenses that can inhibit the progression of myopia while providing the wearer with reasonable and adequate visual performance for the range of activities the wearer may engage in on a daily basis. Various aspects of the disclosure of embodiments of the present invention address such needs of the wearer. [Brief description of the drawings]

[0065] [Figure 1] 1 shows a front view and a cross-sectional view of an embodiment of a contact lens, the front view further showing an optical center, an optic zone, a second region within the optic zone, a geometric center of the second region, a blend zone, and a carrier zone, according to an embodiment. [Diagram 2]1 shows a front view and a cross-sectional view of another contact lens embodiment. The optic zone of this embodiment substantially comprises a base prescription and a decentered second region configured with an astigmatic or toric or asymmetric power profile about its geometric center. The front view further shows a radial cross-section of a substantially similar thickness of the carrier zone of the embodiment, according to an embodiment. A substantial portion of the optic zone, excluding the second region, is configured with a base prescription, the base prescription including a prescription that corrects the wearer's foveal refractive error. The power distribution within the decentered second region of the optic zone determines the magnitude, position, location and orientation of the directional cue that is provided on or around the peripheral retina. [Diagram 3] 1 shows a front view of yet another contact lens embodiment disclosed herein, further illustrating the potential for substantially free rotation of the contact lens about its optical center due to the configuration of the carrier zone design. According to an embodiment, substantially free rotation of the contact lens is facilitated by its carrier zone designed with a substantially similar radial thickness profile. [Figure 4] FIG. 1 shows a schematic diagram of on-axis geometric spot analysis at the retinal plane when incident light with 0D vergence of visible wavelength (e.g., 589 nm) enters an uncorrected 3D myopic model eye. [Diagram 5] FIG. 1 shows a schematic diagram of an on-axis geometric spot analysis at the retinal plane when incident light of 0D vergence at visible wavelength (e.g., 589 nm) is incident on a 3D myopic model eye corrected with a prior art monofocal contact lens. [Figure 6A] 1 shows a schematic diagram of an on-axis through-focus geometric spot analysis at the retinal plane when incident light of 0D vergence at visible wavelength (589 nm) is incident on a 3D myopic model eye corrected with one of the embodiments of the contact lens disclosed herein. The figure further shows the spatially variable Starm's regional cones at the retinal level caused by the rotationally asymmetric decentered second region configured in the optical zone. The illustrated Starm's regional cones can also be configured to be spatially and temporally variable according to other embodiments. [Figure 6B]1 shows a schematic diagram of an enlarged section of only the second region of the optical zone of one of the embodiments of a contact lens disclosed herein, in which the power profile distribution within the second region of the optical zone of this embodiment is constructed using radial and azimuth power distribution functions relative to the geometric center of the second region as disclosed herein. [Figure 7] 13 illustrates a power map of an entire optical zone of an exemplary embodiment of the present disclosure, including a power map of a decentered second region. [Figure 8] FIG. 8 shows the temporally and spatially varying optical signal due to contact lens rotation, plotted as an on-axis point spread function at the retinal plane when incident light of 0D vergence at visible wavelength (589 nm) is incident on a -3D myopic model eye corrected with the contact lens embodiment described in FIG. [Figure 9] FIG. 8 shows the temporally and spatially varying optical signal due to contact lens rotation, plotted as a through-focus geometric spot analysis when incident light of 0D vergence at visible wavelength (589 nm) is incident on a -3D myopic model eye corrected with the contact lens embodiment described in FIG. [Figure 10] 13 illustrates a power map of the entire optic zone of another exemplary embodiment of the present disclosure, including a power map of a decentered second region. [Figure 11] FIG. 11 shows the temporally and spatially varying optical signal due to contact lens rotation, plotted as an on-axis point spread function at the retinal plane when incident light of 0D vergence at visible wavelength (589 nm) is incident on a -3D myopic model eye corrected with the contact lens embodiment described in FIG. [Figure 12] FIG. 11 shows the temporally and spatially varying signal due to contact lens rotation, plotted as a through-focus geometric spot analysis when incident light of 0D vergence at visible wavelength (589 nm) is incident on a -3D myopic model eye corrected with the contact lens embodiment described in FIG. [Figure 13] 13 illustrates a power map of the entire optic zone of another exemplary embodiment of the present disclosure, including a power map of a decentered second region. [Figure 14] FIG. 14 shows the temporally and spatially varying optical signal due to contact lens rotation, plotted as an on-axis point spread function at the retinal plane when incident light of 0D vergence at visible wavelength (589 nm) is incident on a -3D myopic model eye corrected with the contact lens embodiment described in FIG. [Figure 15] FIG. 14 shows the temporally and spatially varying signal due to contact lens rotation, plotted as a through-focus geometric spot analysis when incident light of 0D vergence at visible wavelength (589 nm) is incident on a -3D myopic model eye corrected with the contact lens embodiment described in FIG. [Figure 16a] 8 shows measured thickness profiles for two perpendicular meridians of one prototype contact lens (Lens #1), which is a variation of the contact lens embodiment illustrated in FIG. [Figure 16b] 1 shows the measured thickness profile for two perpendicular meridians of one commercially available toric contact lens (Control #1). [Figure 17] The power distribution in the second region is shown, measured with a commercially available power mapping device (NIMOevo, Lambda‐X, Belgium) using a 5 mm aperture and a 2.5 mm aperture, when the 2.5 mm aperture is aligned with the geometric center of the second region. [Figure 18] 8 shows the measured and cosine fitted relative power profile as a function of azimuth angle of the second region of the optic zone of one prototype contact lens (Lens #1), which is a variation of the contact lens embodiment described in FIG. 7. [Figure 19] 1 shows a photograph of the device used to measure contact lens rotation over time. [Figure 20] 1 shows a front view of an embodiment of a contact lens disclosed herein, which further illustrates how the azimuth angle position of a prototype contact lens (Lens #1) on eye over time can be used to measure the amount of rotation using two radial marks on the contact lens. [Figure 21] 1 shows the measured azimuth position of one prototype contact lens (Lens #1) over time, i.e., after approximately 30 minutes of lens wear. [Figure 22] 1 shows the measured azimuth position of one commercially available toric contact lens (Control #1) over time, i.e., after approximately 30 minutes of lens wear. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0066] Recent designs that have been added to the prior art include some relatively positive refractive power associated with the prescription power of the lens, usually distributed rotationally symmetrically about the optical axis of the contact lens.

[0067] Each of these options has its own advantages and disadvantages with respect to slowing the rate of myopia progression in an individual.

[0068] Some of the disadvantages are described herein. For example, a problem with some existing optical designs based on simultaneous images is that they impair the quality of vision at various other distances by introducing significant visual disturbances. This side effect is mainly due to a significant level of simultaneous defocus, the use of a significant amount of spherical aberration, or a significant change in refractive power within the optical zone.

[0069] Considering the impact of compliance of contact lenses on the effectiveness of such lenses, a significant reduction in visual performance may promote poor compliance, resulting in reduced effectiveness. Thus, there is a need for optical designs to correct and slow myopia progression without causing at least one or more of the disadvantages discussed herein. Other solutions will become apparent as discussed herein.

[0070] Efficacy rates for most prior art contact lens designs are established through randomized controlled clinical trials. The duration of these clinical trials with prior art lenses ranges between 6 months and 3 years, with reported efficacy rates for prior art contact lenses ranging between 25% and 75% when compared to monofocal control lenses.

[0071] Simple linear models of emmetropization suggest that the magnitude of the stop signal accumulates over time. In other words, the accumulated stop signal depends on the total magnitude, not the time distribution of exposure. However, we have observed from reported clinical trials of various optical designs that a disproportionate proportion of the efficacy or slowing effect achieved on progression rate occurs in the first 6-12 months.

[0072] After an initial burst of treatment, efficacy is observed to wane over time. Thus, in light of clinical observations, a more faithful model of emmetropization consistent with clinical outcomes would suggest a delay in the strengthening of the stop signal, followed by saturation and perhaps a decline in the effectiveness of the stop signal over time.

[0073] There is a need in the art for contact lenses that minimize such saturation of therapeutic effect by providing a time- and spatially-varying stopping signal for slowing the rate of ocular growth, e.g., myopia progression, without requiring the wearer to burden switching between contact lenses of different optical designs during a given period of time.

[0074] Thus, there is a need for optical designs with mechanisms for achieving substantially greater and / or substantially consistent effectiveness over time in reducing and / or slowing myopia progression without significantly compromising visual performance. In one or more examples, substantially consistent effectiveness over time may be considered to last for at least 6, 12, 18, 24, 36, 48, or 60 months.

[0075] 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 for illustrative purposes and should not be construed as limiting the scope of the present disclosure.

[0076] The following description is provided with respect to several embodiments that may share common characteristics and features of the present disclosure, and it should be understood that one or more features of one embodiment may be combined with one or more features of any other embodiment to form an additional embodiment.

[0077] The functional and structural information disclosed herein should not be read as limiting in any way, but should be interpreted merely as a representative basis to teach those skilled in the art how to employ the disclosed embodiments and variations of those embodiments in various ways.

[0078] The subheadings and associated headings used in the Detailed Description section are included for ease of reference to the reader only and should not be used in any way to limit the invention or subject matter found throughout the claims of this disclosure. The subheadings and associated headings should not be used to construe the scope of the claims or limitations of the claims.

[0079] The risk of developing myopia or progressive myopia may be based on one or more factors such as genetics, ethnicity, lifestyle, environment, excessive close work, etc. Certain embodiments of the present disclosure are directed to individuals at risk of developing myopia or progressive myopia.

[0080] One or more of the following advantages are found in one or more of the disclosed optical devices and / or methods of contact lens design: A contact lens device or method that provides a stop signal to slow the wearer's eye growth or stop the condition of eye growth or refractive error based on a decentered second region in the optical zone configured with an astigmatic, toric, or asymmetric power profile. Some embodiments include a contact lens device or method that provides a time- and space-varying stop signal to enhance the effectiveness of managing progressive myopia. A contact lens device or method that is not based solely on either rotationally symmetric positive spherical aberration or simultaneous defocus configured primarily along the optical axis or optical center, which suffer from the potential for significant visual performance degradation for the wearer.

[0081] The following exemplary embodiments are directed to a method of modifying incident light through a contact lens system to present a light stopping signal at the retinal plane of a corrected eye. This may be accomplished by using a decentered second region in the optical zone configured with an optical power profile that is rotationally asymmetrically defined about the geometric center of the second region.

[0082] In short, the use of a rotationally asymmetric decentered second region of a contact lens can be used to reduce the rate of myopia progression, and the reduction in myopia progression can be maintained substantially consistently over time by introducing a spatially and temporally varying stop signal by virtue of the peripheral non-optically symmetric carrier zone.

[0083] FIG. 1 illustrates an exemplary contact lens embodiment (100) in a front view (100a) and a cross-sectional view (100b), not to scale. The front view of the exemplary contact lens embodiment (100) further illustrates the optical center (101), the optical zone (102), the blend zone (103), the carrier zone (104), the lens diameter (105), and the decentered second region (106) with a geometric center (107) within the optical zone. In this representative example, the lens diameter is approximately 14 mm, the optical zone diameter is approximately 8 mm, the blend zone width is approximately 0.25 mm, the symmetric carrier zone width is approximately 2.75 mm, and the second region (106) width within the optical zone is approximately 1.5 mm by 2 mm. The geometric center (107) of the decentered second region (106) is 3 mm away from the optical center (101).

[0084] 2 shows a front view and a cross-sectional view, not to scale, of an exemplary contact lens embodiment (200). The front view of the exemplary contact lens embodiment further shows an optical center (201), an optic zone (202), a blend zone (203), a peripheral carrier zone (204), and a second region (205) with a geometric center (206) within the optic zone.

[0085] In this representative example, the lens has a diameter of approximately 14 mm and the distance correcting portion of the optical zone is rotationally symmetrical along the optical axis. The second region (205) within the optical zone is elliptical, i.e., approximately 2 mm wide at the horizontal meridian and approximately 1.5 mm wide at the vertical meridian. The blend zone (203) is approximately 0.1 mm wide and the symmetric peripheral carrier zone (204) is approximately 2.75 mm wide. The radial cross sections (204a-204h) of the symmetric peripheral carrier zone (204) have substantially similar thickness profiles. The second region (205) is configured with a toric or astigmatic power distribution along a geometric center (206) that provides a stop signal.

[0086] In some embodiments, the difference in thickness profile along the different radial cross sections (204a-204h) can be configured to achieve a desired on-ocular rotation about the optical center of the lens.

[0087] A favorable on-eye rotation can be achieved by keeping the peripheral thickness profile rotationally symmetric across all semi-meridians. For example, the radial thickness profiles (e.g., 204a-204h) can be configured such that the thickness profile of any other radial cross section is substantially identical or within 4%, 6%, 8%, or 10% variation at any given distance from the center of the lens.

[0088] In one example, radial thickness profile 204a is within 5%, 8% or 10% variation of radial thickness profile 204e at any given distance from the center of the lens. In another example, radial thickness profile 204c is within 4%, 6% or 8% variation of radial thickness profile 204g at any given distance from the center of the lens.

[0089] In yet another example, the radial thickness profiles, e.g., 204a-204h, can be configured such that the thickness profile of any cross section is within 4%, 6%, 8%, or 10% variation from the average of all radial cross sections at any given distance from the center of the lens.

[0090] To verify that the manufactured radial thickness profiles of the non-optical peripheral carrier zones, e.g., 204a-204h, match their nominal profiles, cross-sectional measurements of the thickness along the azimuth direction of the contact lens at defined radial distances may be desired.

[0091] In some other examples, the peak thickness measured at one radial cross-section of the non-optical peripheral carrier zone may be compared to the peak thickness measured at another radial cross-section.

[0092] In some embodiments, the difference in peak thickness between one or more radial cross sections can 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 orthogonal radial cross sections can be no greater than 20 μm, 30 μm, 40 μm, 50 μm, or 60 μm.

[0093] In this representative example, the spherical power of the base prescription of the optical zone (202) of the contact lens embodiment (200) has a spherical power of -3D for correcting -3D myopia, and the decentered second region is configured with a toric or astigmatic power of +1.25DC for introducing a Sturm's areal cone at the retina of the eye. In some other examples of the present disclosure, the spherical power of the contact lens for correcting and managing myopia can be between -0.5D and -12D, and the desired astigmatic or toric power in the decentered second region for introducing a desired Sturm's areal cone at the retina of the myopic eye can range between +0.75DC and +2.5DC.

[0094] Figure 3 illustrates a front view of the exemplary contact lens embodiment shown in Figure 2. This figure seeks to further illustrate the influence of the lower (302) and upper (303) eyelids on the orientation of the contact lens embodiment (300), particularly the optical zone (302) configured with a rotationally asymmetric second region (304) of an astigmatic or toric or asymmetric optical power profile.

[0095] Due to natural blinking facilitated by the combined movement of the upper (304) and lower (303) eyelids, the contact lens (300) may freely rotate on or around the optical center (301). The orientation and location of the astigmatic stimulus provided by the rotationally asymmetric second region (304) within this optical zone (302) varies with blinking (substantially free rotation and / or decentration), resulting in a temporally and spatially varying stimulus for reducing the wearer's rate of progression of myopia that is substantially consistent over time.

[0096] In some embodiments, the contact lens is designed to exhibit substantially free rotation at least under the influence of natural blinking motion, as described with reference to Figures 2 and 3. For example, throughout a day of lens wear, preferably over a period of 6-12 hours, eyelid interaction will position the contact lens to be oriented on the eye in a number of different orientations or configurations. Directional cues for controlling the rate of eye growth may be configured to vary spatially and temporally due to astigmatic or toric or asymmetric optics configured within the decentered second region of the contact lens.

[0097] In some embodiments, the surface parameters of the contact lens embodiments, such as the back surface radius and / or asphericity, can be tailored to an individual eye so that a desired on-eye rotation of the contact lens can be achieved. For example, the contact lens can be configured to be at least 0.3 mm flatter than the radius of curvature of the flattest meridian of the cornea of ​​the eye to increase the occurrence of on-eye rotation during lens wear.

[0098] It is understood that in some embodiments, substantially free rotation of the contact lens embodiments of the present disclosure is merely a desired outcome of one aspect of the present invention, but when substantially free rotation is achieved that is less than desired, e.g., less than 20 degrees within one hour of lens insertion and less than 360 degrees once per day, the disclosed invention can still generate a stop signal that varies in time and space with the merely random orientation of the lens depending on the orientation of the contact lens at the time of insertion.

[0099] Figure 4 shows an uncorrected 3D myopic model eye (400). When incident light (401) of visible wavelength (e.g. 555 nm) with 0D vergence enters an uncorrected myopic eye, the resulting image on the retina has a symmetric blur (402) caused by defocus. This schematic diagram represents an on-axis geometric spot analysis at the retinal plane.

[0100] Figure 5 shows a schematic diagram of an on-axis geometric spot analysis at the retinal plane when the -3D myopic model eye (500) of Figure 4 is corrected with a prior art monofocal spherical contact lens (501). In this example here, when incident light (502) of visible wavelength (e.g. 555 nm) with 0D vergence is incident on the corrected myopic eye, the resulting image on the retina has a symmetric sharp focus (503).

[0101] FIG. 6A shows a schematic diagram of an on-axis through-focus geometric spot analysis around the retinal surface when the 3D myopic model eye (600a) of the exemplary embodiment of FIG. 4 is corrected with one of the exemplary embodiments (602a) configured with an astigmatic power distribution in the decentered second region (603a) of the optical zone of the exemplary embodiment (602a). In this example, when an incident light (601a) of visible wavelength (e.g., 589 nm) with 0D vergence enters the myopic eye (600a) through the exemplary contact lens embodiment (602a), the incident light produces a through-focus image profile that includes a series of geometric spot distributions depicted in 607a-612a. The astigmatic or toric power distribution configured in the decentered second region (603a) of the optical zone (602a) produces a stern areal cone or interval (606a) in the through-focus image profile (607a-609a) that is formed substantially in front of the retina.

[0102] As can be seen in FIG. 6A, the regional cones or intervals of Sturm around the retinal surface formed by the decentered second region within the optical zone can be observed by examining the through-focus spot figures (607a, 608a, and 609a). Each of the three (3) spot figures has a spread of light rays or light energy diffusion over a central region of about 200 μm of the retina (607a, 608a, and 609a). Within each of the through-focus spot figures, there is at least one distinct region formed of a minimum spread of light rays or light energy that can be seen as a white ellipse that contains the cones or intervals of Sturm (613a, 614a, and 615a). The size of the three white ellipses that encompass each of the tangential plane (613a), the circle of least confusion (614a), and the sagittal blur pattern (615a) gradually decreases as one approaches the retina. The length, orientation, and position of the star's cones or spaces, particularly the tangential and sagittal blur patterns, constitute directional cues that act as the optical stop signals of the present invention as disclosed herein.

[0103] The through-focus image profile (607a-609a) in front of the retina includes a tangential elliptical blur pattern (613a), a circle of least confusion (614a) and a sagittal elliptical blur pattern (615a) as depicted within a series of sub-regions of the geometric spot distribution formed in the parafoveal or paramacular region. The resulting image (604a) on the foveal region is depicted as a minimum elliptical blur pattern as seen in its enlarged version (610a). As can be seen, the sections (611a and 612a) of the through-focus image profile formed behind the retina are out of focus.

[0104] In this example, a contact lens embodiment (602a) with a rotationally asymmetric decentered second region (603a) in the optical zone is configured such that the Starm's areal cone or space (606a) is entirely in front of the retinal plane. However, in other exemplary embodiments, the Starm's space may be configured to be on or around the retinal plane or entirely behind the retina. In some embodiments, the depth of the Starm's areal cone or space may be at least 0.3, 0.4, 0.5, 0.6, or 0.75 mm.

[0105] In other embodiments, the regional cones or spacing of the Starm may be configured to be at least +1 DC, +1.25 DC, +1.5 DC, +1.75 DC, or at least +2 DC. In some embodiments, the placement of the regional cones or spacing of the Starm may be configured to be in front of or behind the retina. Furthermore, due to the rotational symmetry configured in the peripheral carrier zone, the orientation and position of the astigmatic stimulus (stop signal) of the decentered second region (603) presented to the retina varies substantially over time with the natural blinking motion, resulting in a stop signal that varies in time and space due to the rotation and decentering of the contact lens.

[0106] In some instances, the regional cones of the Starm are located further away from the subfoveal, foveal, submacular, macular, or paramacular regions, hi some instances, the regional cones of the Starm can be located over a wider field of view on the retina, for example at least 5 degrees, at least 10 degrees, at least 20 degrees, or at least 30 degrees.

[0107] The specific structural and functional details disclosed in these figures and examples should not be read as limiting, but merely as a representative basis for teaching those skilled in the art to employ the disclosed embodiments in numerous other variations.

[0108] A schematic model eye (Table 1) was chosen for illustration in Figures 4-6. However, in other exemplary embodiments, a schematic ray tracing model eye such as Liou-Brennan, Escudero-Navarro, and others may be used in place of the above simple model eye. Parameters of the cornea, lens, retina, optic body, or combinations thereof may be varied to aid in further simulation of the embodiments disclosed herein.

[0109] Although the examples provided herein use a -3D myopic model eye to disclose the present invention, the disclosure may be extended to other degrees of myopia, such as -1D, -2D, -5D, or -6D. Furthermore, it is understood that one skilled in the art may derive the extension to eyes with various degrees of myopia together with astigmatism up to 1DC.

[0110] Although the specific wavelength of 555 nm is mentioned in the exemplary embodiment, it is understood that one skilled in the art may derive the extension to other visible wavelengths between 420 nm and 760 nm. Certain embodiments of the present disclosure are directed to contact lenses that can provide a time- and space-varying stop signal to an ongoing myopic eye, in other words, a stop signal whose retinal position varies substantially over time, achieved with the help of the natural on-eye rotation and decentration of the contact lens caused by the natural blinking action. This time- and space-varying stop signal can minimize the potential saturation effect of efficacy observed in the prior art.

[0111] Certain embodiments of the present disclosure are directed to contact lenses that may provide a spatially and temporally varying stop signal to an ongoing myopic eye, regardless of which orientation the contact lens is worn or inserted by the wearer. In some embodiments of the present disclosure, the stop signal of the decentered second region of the optical zone may be configured using an astigmatic or toric or asymmetric power profile. The astigmatic or toric or asymmetric power profile in the second region of the optical zone may be configured using a radial and / or azimuthal power distribution along the geometric center of said second region.

[0112] FIG. 6B shows a schematic diagram of an enlarged section of a second region (601b) within the optical zone (600b) of one of the contact lens embodiments defined with a toric or astigmatic asymmetric power distribution as disclosed herein.

[0113] In certain embodiments of the present disclosure, the astigmatic or toric or asymmetric power distribution of the second region in the optical zone is (radial) * (azimuth) function. In some embodiments, the radial function is the radial power distribution=Cρ 2 where C is the expansion coefficient and rho(ρ) (602b) is the normalized radial coordinate ρ0 / ρ max rho(ρ0) is the radial coordinate at a given point, while ρ max is the maximum radial coordinate or semi-diameter (604b) of the second region (601b) within the optical zone. In some embodiments, the azimuth power distribution function can be of the form Azimuth Power Distribution = cos mθ, where m can be any integer between 1 and 6 in some embodiments, and theta (θ) is the azimuth angle (603b).

[0114] In some contact lens embodiments, a substantial portion of the optical zone provides a foveal correction for substantially myopic eyes, and a decentered second region within the optical zone provides a Sturm's regional cone that acts at least in part as a directional cue to reduce the rate of myopia progression, and the contact lens is further configured to provide a temporally and spatially varying stop signal to reduce the rate of myopia progression that is substantially consistent over time. In some other embodiments, the optical stop signal configured with the decentered second region of the optical zone defined rotationally asymmetrically about the geometric center of the second region provides a Sturm's regional cone or space on or around the peripheral retina, and the depth of the Sturm's regional cone or space is at least +0.5DC, +0.75DC, +1DC, +1.25DC, +1.5DC, +1.75DC, or +2DC.

[0115] In certain other embodiments, the light stopping signal configured with an eccentric second region of the optical zone defined rotationally asymmetrically about the geometric center of the second region provides a stark regional cone or space on or around the peripheral retina, the stark regional cone or space having a depth in the range of between +0.5DC to +1.25DC, +0.75DC to +1.25DC, +0.5DC to +1.5DC, +1DC to +1.75DC or +1.5DC to +2DC.

[0116] In some other embodiments, the second region can be defined by a spherocylindrical prescription, the spherocylindrical prescription of the second region being substantially different from the base prescription of the contact lens. In some other embodiments, the second region can be defined by two principal meridians about a geometric center of the second region, the power profile of the principal meridians of the second region being different from the base prescription of the contact lens. In some other embodiments, the second region can be defined by an asymmetric power map defined about a geometric center of the second region, the asymmetric power map of the second region being different from the base prescription of the contact lens.

[0117] In some other embodiments, the light stopping signal is configured with an eccentric second region of the optical zone defined rotationally asymmetrically around the geometric center of the second region to provide a star's regional cone or spacing on or around the peripheral retina, the star's regional cone or spacing depth is at least -0.5DC, -0.75DC, -1DC, -1.25DC, -1.5DC, -1.75DC, or -2DC. In some other embodiments, the light stopping signal is configured with an eccentric second region of the optical zone defined rotationally asymmetrically around the geometric center of the second region to provide a star's regional cone or spacing on or around the peripheral retina, the star's regional cone or spacing depth is in the range between -0.5DC to -1.25DC, -0.75DC to -1.25DC, -0.5DC to -1.5DC, -1DC to -1.75DC, or -1.5DC to -2DC.

[0118] In certain other embodiments, the light stopping signal configured with an eccentric second region of the optical zone defined rotationally asymmetrically about the geometric center of the second region provides a stark regional cone or space on or around the peripheral retina, the stark regional cone or space having a depth in the range between -0.5DC to +1.25DC, -0.75DC to +1.25DC, -0.5DC to +1.5DC, -0.75DC to +0.75DC or -1DC to +1DC.

[0119] In certain other embodiments, a stop signal configured with a second region of the optical zone that is rotationally asymmetric about the optical axis or optical center can be achieved through the use of a more complex optical power profile using a combination of radial and azimuth power variations across the second region of interest.

[0120] In some other embodiments, the radial and / or azimuthal power distribution across the optical center may be described by appropriate Zernike polynomials, Bessel functions, Jacobi polynomials, Taylor polynomials, Fourier expansions, or combinations thereof. In other embodiments of the present disclosure, the stop signal configured through the second region in the optical zone may exclusively use astigmatic or toric asymmetric power profiles.

[0121] A schematic model eye was used for simulation of the optical performance results of exemplary embodiments of the present disclosure (FIGS. 7-15). The prescription parameters of the schematic model eye used for optical modeling and performance simulation are summarized in Table 1. This prescription represents a -3D myopic eye defined for a monochromatic wavelength of 589 nm.

[0122] [Table 1]

[0123] The formulations set forth in Table 1 should not be construed as a required method for demonstrating the effectiveness of the exemplary embodiments contemplated.

[0124] This is just one of many methods that may be used by one skilled in the art for optical simulation purposes. Other schematic model eyes, such as those of Atchison, Escudero-Navarro, Liou-Brennan, Polans, Goncharov-Dainty, may be used in place of the above schematic model eye to demonstrate the effectiveness of other embodiments.

[0125] One skilled in the art may vary individual parameters of the model eye, such as parameters of the cornea, crystalline lens, retina, optic body, or combinations thereof, to help better simulate the effect. The parameters of the exemplary embodiment of the model contact lens only simulate the optical zone with respect to performance effects.

[0126] To demonstrate performance variation as a function of time, a tilt function on the surface is used to replicate the rotation that would occur physiologically in vivo. In simulating the optical performance results, the exemplary embodiment was rotated 0°, 45°, 90°, and 135° for the point spread function, and 0°, 120°, and 240° for the through-focus geometric spot analysis.

[0127] Figure 7 shows a two-dimensional power map (unit D) of an exemplary embodiment (Example #1) over an 8 mm diameter optic zone. The optic zone of the exemplary embodiment is intended to be grafted onto a substantially rotationally symmetric non-optical peripheral carrier zone. The contact lens has a -3D spherical power in the optic zone for correcting -3D myopia and a toric or astigmatic power distribution in a second region within the optic zone defined by two principal power meridians (not to scale).

[0128] The area surrounding the decentered second region graft on the optic zone may be smoothed to minimize optical abrupt changes in refractive power and minimize visual performance loss caused by a significant change in refractive power caused by a sudden change in surface curvature at the junction of the second region graft. In some examples, blending of the decentered second region with the remainder of the optic zone may be achieved by spinning a lathe at a desired or optimal speed during manufacturing of the lens. In some other exemplary embodiments, blending of the decentered second region with the optic zone may not be the desired result.

[0129] In FIG. 7, one principal power meridian (-1D) of the second region is aligned perpendicular to the optical center of the optic zone, and a second principal power meridian (-2.5D) of the second region is configured to be parallel to the optical center of the optic zone.

[0130] The difference between the principal power meridians (+1.5DC) is the cylindrical power of the second region used to provide the light stop signal as disclosed herein. The geometric center of the second region in the optical zone is decentered by 1.5mm. However, this contact lens example is not intended to be construed as limiting the scope of the present disclosure. The two-dimensional power map of the exemplary embodiment only represents the optical zone section of the contemplated embodiment, i.e., zone 102 in FIG. 1 or zone 202 in FIG. 2.

[0131] A substantially symmetric non-optical peripheral carrier zone (e.g., zone 104 in FIG. 1 or zones 204a-h in FIG. 2) facilitates substantially free rotation on or around the optical center of the proposed contact lens embodiments as a result of natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn causes the regional cone of starm (light stopping signal) provided by a second region within the optical zone to vary with blinking, resulting in a temporally and spatially varying stimulus for reducing the rate of progression in myopic wearers that is substantially consistent over time. When incident light of visible wavelength (589 nm) with a vergence of 0D enters a myopic eye corrected with an optical zone of the exemplary embodiment depicted in FIG. 7 prescribed according to Table 1 and configured on a substantially rotationally symmetric non-optical peripheral carrier zone (e.g., zone 104 in FIG. 1 or zones 204a-h in FIG. 2), the resulting on-axis, temporally and spatially varying point spread functions at the retinal plane for the second region within the optical zone with the principal power meridian at 0° (801), 45° (802), 90° (803) and 135° (804) are shown in FIG. 8.

[0132] The rotationally symmetric non-optical peripheral carrier zone of the exemplary embodiment promotes Sturm's regional cone as a light-stopping stimulus to vary with natural blinking behavior (a temporally and spatially varying signal).

[0133] 9 shows the through-focus geometric spot analysis of the 3D myopic model eye of Table 1 when corrected in three configurations with one of the exemplary embodiments (Example #1). In this example, the through-focus geometric spot analysis was performed at locations 0.7 mm and 0.35 mm in front of the retina, on the retina, and 0.35 mm and 0.7 mm behind the retina.

[0134] On-eye rotation of the contact lens embodiment over time results in three configurations that provide a temporally and spatially varying signal on the retina. In this example, the three configurations represent test cases where the lens' principal power meridian is located at 0°, 120°, and 240° azimuth positions over time due to contact lens rotation. In this example, for each contact lens configuration depicted as a row, an astigmatism or toric power distribution (Example #1) configured in the second region of the optical zone results in a regional cone or space (900) of starm formed in the through-focus image profile substantially in the parafoveal or paramacular region in front of the retina.

[0135] The Sturm's regional cone or spacing (900) results in an elliptical blur pattern with sagittal and tangential planes formed approximately between 901 and 903. The spot images formed behind the retina are out of focus (904 and 905).

[0136] As can be seen in Figure 9, the regional Sturm's cones or intervals around the retinal surface formed by the decentered second region in the optical zone of Figure 7 can be observed by examining a through-focus spot diagram (901) having a spread of light rays or light energy diffusion over a central region of about 250 μm of the retina. Within the through-focus spot diagram, there is a distinct region formed with minimal light rays or light energy spread that can be seen as a white ellipse that contains the tangential blur of the Sturm's cones or intervals. The orientation of the tangential blur pattern changes with the orientation of the contact lens on the eye, providing a temporally and spatially varying directional cue to the eye as disclosed herein.

[0137] 10 shows a two-dimensional refractive power map (units D) of an exemplary embodiment (Example #2) over an 8 mm diameter optic zone. The optic zone of the exemplary embodiment is intended to be grafted onto a substantially rotationally symmetric non-optical peripheral carrier zone.

[0138] The contact lens has a -3D spherical power in the optic zone for correcting -3D myopia and a toric or astigmatic power distribution in a second region within the optic zone defined by two principal power meridians.

[0139] 10 further illustrates that one principal power meridian of the second region (-2.5D) is aligned at 135° to the optical center of the optic zone and a second principal power meridian of the second region (-0.5D) is configured to be at 45° to the optical center of the optic zone. The difference between the principal power meridians (+2DC) is the astigmatic power of the second region used to provide the light stop signal as disclosed herein.

[0140] The geometric center of the decentered second region in the optical zone is decentered by 1.5 mm. However, this contact lens example is not intended to be construed as limiting the scope of the present disclosure. The two-dimensional refractive power map of the exemplary embodiment only represents the optical zone section of the contemplated embodiment, i.e., zone 102 in FIG. 1 or zone 202 in FIG. 2.

[0141] In this example, a substantially symmetric peripheral non-optical carrier zone (e.g., zone 104 of FIG. 1 or zones 204a-h of FIG. 2) facilitates substantially free rotation on or around the optical center of the contact lens embodiment as a result of natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn causes the regional cone or spacing of the stark as a light stopping signal provided by the second region of the optical zone to vary with blinking, resulting in a temporally and spatially varying stimulus for reducing the rate of myopia progression in a myopic wearer that is substantially consistent over time.

[0142] When incident light of visible wavelength (589 nm) with 0D vergence is incident on a myopic eye corrected with an optical zone of the exemplary embodiment depicted in FIG. 10, which is formulated according to Table 1 and configured on a substantially rotationally symmetric non-optical peripheral carrier zone (e.g., zone 104 of FIG. 1 or zones 204a-h of FIG. 2), the resulting on-axis, temporally and spatially varying point spread functions at the retinal plane are shown in FIG. 11, with the principal power meridian of the second region in the optical zone at 45° (1101), 90° (1102), 135° (1103) and 210° (1104). The rotationally symmetric non-optical peripheral carrier zone of the exemplary embodiment promotes the regional cones or spacing of the star (light stopping stimuli) to vary with the natural blinking behavior (temporally and spatially varying signals).

[0143] 12 shows the through-focus geometric spot analysis of the 3D myopic model eye of Table 1 when corrected in three configurations with one of the exemplary embodiments (Example #2). In this example, the through-focus geometric spot analysis was performed at locations 0.7 mm and 0.35 mm in front of the retina, on the retina, and 0.35 mm and 0.7 mm behind the retina.

[0144] On-eye rotation of a contact lens embodiment over time results in three configurations that provide a temporally and spatially varying signal on the retina, in this example, the three configurations represent test cases where the lens' principal power meridian is located at 0°, 120° and 240° azimuth positions over time due to contact lens rotation.

[0145] In this example, with the configuration of each contact lens depicted as a row, the astigmatic or toric refractive power distribution (Example #2) configured within the second region of the optical zone results in a regional cone or space (1200) of starm formed in the parafoveal or paramacular region substantially in front of the retina in the through-focus image profile.

[0146] The Sturm's regional cone or spacing (1200) results in an elliptical blur pattern with sagittal and tangential planes formed approximately between 1201 and 1203. The spot images formed behind the retina are out of focus (1204 and 1205).

[0147] As seen in FIG. 12, the Sturm's regional cones around the retinal surface formed by the decentered second region in the optical zone of FIG. 10 can be observed by examining a through-focus spot diagram (1201) having a diffuse spread of light rays over a central retinal region of approximately 250 μm.

[0148] Within the through-focus spot diagram, there is a distinct region formed by the minimum beam spread seen as a white ellipse that contains the tangential blur of Sturm's cone. The orientation of the tangential blur pattern changes with the orientation of the contact lens on the eye, providing a temporally and spatially varying directional cue to the eye as disclosed herein.

[0149] Figure 13 shows a two-dimensional power map (unit D) of an exemplary embodiment (Example #3) over an 8 mm diameter optic zone. The optic zone of the exemplary embodiment is intended to be grafted onto a substantially rotationally symmetric non-optical peripheral carrier zone. The contact lens has a -3D spherical power in the optic zone for correcting -3D myopia and a toric or astigmatic power distribution in a second region within the optic zone defined by two principal power meridians.

[0150] In this example, one principal power meridian (-5D) of the second region is aligned perpendicular to the optical center of the optical zone, and a second principal power meridian (-3.5D) of the second region is configured to be parallel to the optical center of the optical zone. The difference between the principal power meridians (-1.5DC) is the cylindrical power of the second region used to provide the optical stop signal as disclosed herein. The geometric center of the second region within the optical zone is decentered by 1.5 mm.

[0151] However, this contact lens example is not intended to be construed as limiting the scope of the present disclosure. The two-dimensional refractive power maps of the exemplary embodiments only represent the optical zone sections of the contemplated embodiments, i.e., zone 102 of FIG. 1 or zone 202 of FIG. 2.

[0152] A substantially symmetrical non-optical peripheral carrier zone, for example similar to zone 104 of FIG. 1 or zones 204a-h of FIG. 2, facilitates substantially free rotation on or around the optical center of the proposed contact lens embodiments as a result of natural blinking facilitated by the combined action of the upper and lower eyelids, which in turn causes the regional cone or spacing of the starm by the second region within the optical zone to vary with blinking, resulting in a temporally and spatially varying stimulus for reducing the rate of progression in myopic wearers that is substantially consistent over time.

[0153] When incident light of visible wavelength (589 nm) with 0D vergence is incident on a myopic eye corrected with an optical zone of the exemplary embodiment depicted in FIG. 13, prescribed according to Table 1 and configured on a substantially rotationally symmetric non-optical peripheral carrier zone, such as depicted in zone 104 of FIG. 1 or zones 204a-h of FIG. 2. The resulting on-axis, temporally and spatially varying point spread functions at the retinal plane for the second region in the optical zone with the principal power meridian at 0° (1401), 45° (1402), 90° (1403) and 135° (1404) are shown in FIG.

[0154] The rotationally symmetric non-optical peripheral carrier zone of the exemplary embodiment encourages the regional cones or spacing of the star (light stopping stimuli) to vary with natural blinking behavior (a temporally and spatially varying signal).

[0155] FIG. 15 shows the through-focus geometric spot analysis when the -3D myopic model eye of Table 1 was corrected with one of the exemplary embodiments (Example #3) in three configurations. In this example, the through-focus geometric spot analysis was performed at positions 0.7 mm (1501) and 0.35 mm (1502) in front of the retina, on the retina (1503), and 0.35 mm (1504) and 0.7 mm (1505) behind the retina. On-eye rotation of the contact lens embodiment over time results in three configurations that provide temporally and spatially varying signals on the retina. In this FIG. 15 example, the three configurations represent test cases where the lens' principal power meridian is located at 0°, 120°, and 240° azimuth positions over time due to contact lens rotation.

[0156] In this example of Figure 15, with the configuration of each contact lens depicted as a row, the astigmatic or toric refractive power distribution (Example #3) configured within the second region of the optical zone results in Starm's regional cones or spaces (1500) formed substantially around the retina, with at least some portion of the Starm's regional cones or spaces being behind the retina, as seen in a through-focus image profile encompassing the parafoveal or paramacular regions, as described herein.

[0157] Sturm's areal cones or spacing (1500) result in an elliptical blur pattern with sagittal and tangential planes formed approximately between 901-903. The spot image formed in front of the retina is blurred and out of focus (1501 and 1502). As seen in FIG. 15, Sturm's areal cones around the retinal plane formed by the decentered second region in the optical zone of FIG. 13 can be observed by examining a through-focus spot diagram (1505) with a spread of light beams over a central retinal area of ​​about 250 μm. Within the through-focus spot diagram, there is a clear region formed with minimal spread of light beams seen as a white ellipse that contains the sagittal blur of Sturm's cones. The position and orientation of the sagittal blur pattern changes with the orientation of the contact lens on the eye, providing a temporally and spatially varying directional cue to the eye as disclosed herein.

[0158] In certain embodiments, a decentered second region within the optic zone of a contact lens that is configured rotationally asymmetric about its geometric center can be at least 0.5 mm, 0.75 mm, 1 mm, 1.5 mm, or 2.5 mm wide along the minor axis of the elliptical second region.

[0159] In certain embodiments, a decentered second region within the optic zone of a contact lens that is configured rotationally asymmetric about its geometric center can be at least 0.75 mm, 1.5 mm, 2.5 mm, or 3.5 mm wide along the major axis of the elliptical second region.

[0160] In certain embodiments, the decentered second region within the optic zone of the contact lens, configured rotationally asymmetrically about its geometric center, can be between 0.5 mm and 1.25 mm, 0.5 mm and 1.75 mm, 0.75 mm and 2.5 mm, or 0.5 mm and 3.5 mm in diameter along the minor or major axis.

[0161] In one embodiment, the surface area of ​​a decentered second region within the optic zone of the contact lens that is rotationally asymmetrically configured about its geometric center is less than or equal to 0.5 mm in diameter along the minor or major axis. 2 ~5mm 2 , 2.5mm 2 ~7.5mm 2 , 5mm 2 ~10mm 2 , or 1 mm 2 ~25mm 2 It can be anywhere between.

[0162] In some embodiments, the surface area of ​​the decentered second region is at least 10% and no more than 35% of the surface area of ​​the optical zone. In some embodiments, the surface area of ​​the decentered second region is at least 5% and no more than 30% of the surface area of ​​the optical zone. In some embodiments, the surface area of ​​the decentered second region is at least 3% and no more than 20% of the surface area of ​​the optical zone. In some embodiments, the surface area of ​​the decentered second region is at least 5% and no more than 40% of the surface area of ​​the optical zone.

[0163] In certain embodiments, the geometric center of a decentered second region within the optical zone that is configured rotationally asymmetric about its geometric center can be spaced at least 0.75 mm, 1 mm, 1.5 mm, 2 mm, or 2.5 mm away from the optical center.

[0164] In certain embodiments, the distance between the geometric centers of second regions within the optical zone that are configured rotationally asymmetric about their geometric centers can be between 0.75 mm and 1.25 mm, 0.75 mm and 1.75 mm, 1 mm and 2 mm, or 0.75 mm and 2.5 mm.

[0165] In some embodiments, the optic zone of a contact lens may be at least 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, or 9 mm in diameter. In some embodiments, the optic zone of a contact lens may be between 6 mm and 7 mm, 7 mm and 8 mm, 7.5 mm and 8.5 mm, or between 7 and 9 mm in diameter.

[0166] In some embodiments, the blend zone or blending zone of a contact lens may be at least 0.05 mm, 0.1 mm, 0.15 mm, 0.25 mm, 0.35, or 0.5 mm in width. In some embodiments, the blend zone or blending zone of a contact lens may be between 0.05 mm and 0.15 mm, 0.1 mm and 0.3 mm, or 0.25 mm and 0.5 mm in width.

[0167] In some embodiments, the blending zone may be symmetrical, while in some other embodiments, the blending zone may be asymmetrical, e.g., elliptical, hi other embodiments, the width of the blending zone may be reduced to zero and thus non-existent.

[0168] In exemplary embodiments, the shape of the second region within the optical zone can be circular, semicircular, noncircular, oval, rectangular, hexagonal, square, or combinations thereof to introduce a desired stop signal to the developing myopic eye. In certain embodiments, the area of ​​the second region within the optical zone configured asymmetrically rotationally about the optical axis can be at least 5%, 10%, 15%, 20%, 25%, 30%, or 35% of the optical zone.

[0169] In some embodiments, the area of ​​the second region within the optical zone configured asymmetrically rotationally about the optical axis can be between 5% and 10%, 10% and 20%, 10% and 25%, 5% and 20%, 5% and 25%, 10% and 30%, or 5% and 35% of the optical zone.

[0170] In some embodiments, the peripheral non-optical or carrier zone of a contact lens may be at least 2.25 mm, 2.5 mm, 2.75 mm, or 3 mm in width. In some embodiments, the peripheral or carrier zone of a contact lens may be between 2.25 mm and 2.75 mm, 2.5 mm and 3 mm, or 2 mm and 3.5 mm in width.

[0171] In certain embodiments, the peripheral or carrier zone of the contact lens is substantially symmetrical, with a radial thickness profile that is substantially similar across horizontal, vertical and other oblique meridians.

[0172] In certain embodiments, the peripheral or carrier zone of the contact lens is substantially symmetrical and has a radial thickness profile that is substantially similar across the horizontal, vertical and other oblique meridians, which may mean that the maximum thickness of the peripheral carrier zone across any meridian is within 5%, 6%, 7%, 8%, 9%, or 10% variation of the maximum thickness of any other meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0173] In certain embodiments, the peripheral or carrier zone of the contact lens is substantially symmetrical, with a radial thickness profile that is substantially similar across the horizontal, vertical and other oblique meridians, which may mean that the maximum thickness of the peripheral carrier zone across any semi-meridian is within 5%, 6%, 7%, 8%, 9%, or 10% variation of the maximum thickness of any other semi-meridian.

[0174] In certain embodiments, the peripheral or carrier zone of the contact lens is substantially rotationally symmetric and the radial thickness profile is substantially similar across horizontal, vertical and other oblique meridians, which may mean that the thickest point in the peripheral carrier zone across any meridian is within a maximum of 5, 10, 15, 20, 25, 30, 35, or 40 μm variation of the thickest peripheral point of any other meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0175] In certain embodiments, the peripheral or carrier zone of the contact lens is substantially rotationally symmetric and the radial thickness profile is substantially similar across the horizontal, vertical and other oblique meridians, which may mean that the thickest point in the peripheral carrier zone across any semi-meridian is within a maximum of 5, 10, 15, 20, 25, 30, 35, or 40 μm variation of the thickest peripheral point of any other semi-meridian. For the avoidance of doubt, the thickness profile is measured in the radial direction.

[0176] In certain embodiments, the peripheral zone or non-optical carrier zone of the contact lens is configured to be substantially free of ballast, prism ballast, peripheral ballast, slab-off, truncation, or combinations thereof, commonly used in conventional toric contact lenses to stabilize the orientation of the contact lens on the eye.

[0177] In certain embodiments, substantially free rotation of a contact lens over time can be 360 ​​degree rotation at least 1, 2, 3, 4, 5, or 10 times per day, and at least 10 degrees, 15 degrees, 20 degrees, or 25 degrees within one hour of lens wear.

[0178] In other embodiments, the substantially free rotation of the contact lens over time can be at least 1, 2, 3, 4, 5 or 10 rotations of 90 degrees per day, and at least 10 degrees, 15 degrees, 20 degrees, or 25 degrees within 2 hours of lens wear. In some embodiments, the rotationally asymmetric decentered second region of the contact lens can be located, formed or disposed on the anterior surface, the posterior surface, or a combination thereof.

[0179] In some embodiments, the rotationally asymmetric decentered second region of the contact lens may be located, formed, or positioned at least partially on the anterior surface, at least partially on the posterior surface, or at least partially on the anterior surface and at least partially on the posterior surface.

[0180] In some embodiments, an astigmatic, toric or asymmetric second region of the contact lens is dedicated to generating a particular characteristic of the stop signal, such as the regional cone or spacing arrangement of the elicited starm at a desired location in the peripheral retina.

[0181] In some examples, the optics of the decentered second region of the contact lens can be configured to provide a Starm's regional cone or spacing substantially in front of, approximately on, or substantially behind the retinal plane.

[0182] In certain other embodiments, the base prescription of the contact lens is located, formed or placed on one of the two surfaces of the contact lens, and the other surface may have other features to further reduce eye growth.

[0183] In certain embodiments, the shapes of the decentered second region within the optical zone, the blending zone between the decentered second region and the remainder of the optical zone, the blending zone of the optical zone, and the peripheral carrier zone may be described by one or more of a sphere, an aspheric surface, an extended odd polynomial, an extended even polynomial, a conic section, a biconic section, or a Zernike surface polynomial.

[0184] In certain other embodiments, the decentered second region within the optic zone can have a combination of astigmatism and coma, or a combination of astigmatism and spherical aberration, or a combination thereof.

[0185] In some embodiments, there may be distinct advantages to combining the contact lens embodiments of the present disclosure with prescription eyeglass lenses, and only a single stock holding unit may be required with a second region having a preferred astigmatic or toric or asymmetric power profile of the desired or preferred size and shape or other device characteristics to achieve the desired optical effect on the retina. Only one contact lens may be worn alternating between the left and right eyes each day to enhance wearability and fluctuating therapeutic signals.

[0186] Another distinct advantage of combining the inventive contact lens embodiments of the present disclosure with prescription spectacle lenses is that they accommodate eyes that are naturally astigmatic, and the astigmatism or cylinder correction can be built into the spectacle lenses.

[0187] Again, in such cases, a single stock holding unit can be worn as a contact lens without concern for the overlapping refractive powers of cylinder and / or induced astigmatism of the decentered second region or any other contemplated device feature.

[0188] As one of ordinary skill in the art will appreciate, the present invention may be used in combination with any device / method that may affect the progression of myopia.

[0189] These include, but are not limited to, various designs of eyeglass lenses, color filters, medications, behavioral changes, and environmental conditions.

[0190] Prototype Contact Lens Lens #1: Design, Measurements, and Clinical Data To evaluate manufacturability, visual performance of the prototype contact lens, and also to determine the amount of rotation of the contact lens embodiment over time when worn on the eye, one prototype contact lens, Lens #1, comprised of an optic zone having a spherical power of 0 D with a decentered second region comprised of a toric or astigmatic power of +1.5 DC and a rotationally symmetric non-optical peripheral carrier zone, was fabricated for the right eye of one consenting study participant.

[0191] The lenses provided clinically acceptable visual performance when compared to monofocal correction. The measured base curve, lens diameter and central thickness values ​​of Lens #1 were 8.51 mm, 13.73 mm and 0.148 mm, respectively. The contact lens material was Contaflex 42 (Contamac, UK) with a measured refractive index of 1.432.

[0192] FIG. 16a shows the measured thickness profile of a prototype contact lens embodiment (Lens #1), which is a variation of the contact lens embodiment illustrated in FIG.

[0193] Figure 16b shows the measured thickness profile of one commercially available toric contact lens, Control #1. The thickness profile was measured with an Optimec is830 (Optimec Ltd, UK) and the peripheral prism, defined as the difference in thickness between the two peripheral peaks of the meridian of each lens, was determined.

[0194] In this example, the data for two perpendicular meridians for Lens #1 (1601) is plotted in Figure 16a, and the data for Control #1 (1602) is plotted in Figure 16b. The thickness difference for Lens #1 was 27.3 μm and 15.7 μm for meridians 1 and 2, respectively.

[0195] As expected from the nominal design of the peripheral rotationally symmetric non-optical carrier zone of this prototype contact lens, the peripheral thickness difference across both meridians was minimal, providing a peripheral carrier zone configured with essentially no rotational stabilization.

[0196] In this example, the thickness difference observed in Control #1 (1602) was 198.5 μm and 30 μm at meridians 1 and 2, respectively. Unlike the thickness profile and difference of Lens #1 (1601) of the prototype contact lens embodiment, Control #1 had significant peripheral prism along meridian 2. This peripheral prism has the purpose of stabilizing toric contact lenses (prior art). While the Optimec is830 allows for reliable measurement of the peripheral thickness profile, the measurement variability of the instrument increases in the central optic zone, and the expected thickness difference between the perpendicular meridians and the horizontal meridians of the toric second region in the optic zone of Lens #1 cannot be properly evaluated from these measurements. Instead, the toricity of the second region of Lens #1 was measured and confirmed using a power mapping instrument NIMOevo (Lambda-X, Belgium).

[0197] 17 shows two power maps obtained with a commercially available power mapping instrument NIMOevo (Lambda-X, Belgium) with a 5 mm aperture (1701) and a 2.5 mm aperture (1702) when the instrument was aligned with the geometric center of the second region of prototype contact lens embodiment Lens #1. The power map obtained with the 5 mm aperture shows the expected elliptical shape of the second region (1703) within the optic zone.

[0198] When the diameter of the measurement zone (1704) was changed to 2.5 mm, which is the minor axis of the elliptical second region of Lens #1, the toric power profile of the second region is shown in 1702. The relative powers were then obtained in steps of 10° from the power map (1702). Figure 18 shows the measured and cosine fitted cylinder power of Lens #1 of about 1.4 DC, which matches the expected cylinder power of this lens.

[0199] Figure 19 shows a photograph of the device (1900) used to measure contact lens rotation over time. The device (1900) consists of a small camera (1903) (SQ11 Mini HD Camera) attached to a simple eyeglass frame (1901) using a mounting arm. The camera was positioned such that video of the contact lens when worn on the eye could be taken over time to assess the rotation of the contact lens embodiments disclosed herein, i.e., spatially and temporally varying stimuli.

[0200] FIG. 20 shows a front view of a contact lens embodiment (2000) disclosed herein. The front view further illustrates a method, i.e., two different markings (2006a and 2006b) along the same meridian on a contact lens embodiment, which, in conjunction with a device (1900), may be used to measure the azimuth position or amount of rotation (2002) of a particular contact lens meridian over time. In this exemplary embodiment (2000), the contact lens marking (2006b) was located along the 45° meridian. In other embodiments, the markings may be of different shapes, sizes, or colors, and the number of markings may be greater than two to further facilitate detection of the azimuth position of a particular contact lens meridian over time.

[0201] In this example, the measured azimuth positions of the prototype contact lens #1 and the commercial toric contact lens control #1 are shown as a function of time in Figures 21 and 22. In this example, the described contact lens monitoring device (1900) was worn by consenting study participants who wore both the embodiment and control contact lenses in the manner described. In this example, the lenses were worn for approximately 30 minutes on two different occasions. As can be seen from Figures 21 and 22, unlike the commercial stabilized toric contact lens control #1, the prototype contact lens #1 rotated nearly four revolutions on the eye within 30 minutes of lens wear. In contrast to the embodiments of the present disclosure, the control lens showed only a small amount of lens rotation over the 30 minutes of lens wear.

[0202] Some other illustrative embodiments are described in the following example set. EXAMPLES

[0203] Example Set "A" - Astigmatism Profiles Within the Second Region 1. An ophthalmic contact lens comprising an optical zone about an optical center and a non-optical peripheral carrier zone about the optical zone, the optical zone being configured with a substantially monofocal power distribution providing a substantial correction to the eye and a decentered second region having an astigmatic or toric power distribution located substantially away from the optical center providing at least in part a Sturm's areal cone on the retina of the eye, the non-optical peripheral carrier zone being configured with a substantially rotationally symmetric thickness profile about the optical center.

[0204] A contact lens according to one or more of the claims in Example Set A, wherein the surface area of ​​the second region within the optical zone, configured with a substantially toric or astigmatic optical power distribution, comprises at least 10% and no more than 35% of the optical zone.

[0205] A contact lens according to one or more of the claims in Example Set A, wherein at least the regional cones of the star on the retina are configured to provide a directional signal for substantially controlling ocular growth of the eye.

[0206] A contact lens according to one or more of the claims in Example Set A, wherein at least the regional cones of the retina are configured substantially away from the macula.

[0207] A contact lens according to one or more of the claims in embodiment set A, wherein at least the regional cones of the retina are configured substantially in front of the peripheral retina.

[0208] A contact lens according to one or more of the claims in embodiment set A, wherein at least the regional cones of the star on the retina are configured substantially behind the peripheral retina.

[0209] A contact lens according to one or more of the claims in Example Set A, wherein the substantially toric or astigmatic power distribution of the second region within the optical zone is configured on the anterior surface of the contact lens.

[0210] A contact lens according to one or more of the claims in Example Set A, wherein the substantially toric or astigmatic power distribution of the second region within the optical zone is configured on a posterior surface of the contact lens.

[0211] A contact lens according to one or more of the claims in Example Set A, wherein the substantially toric or astigmatic power distribution within the second region of the optical zone is constituted in part by the anterior surface of the contact lens and in part by the posterior surface of the contact lens.

[0212] A contact lens according to one or more of the claims in Example Set A, wherein the thickest point within the non-optical peripheral carrier zone across any semi-meridian is within a maximum variation of 30 μm of the thickest peripheral point of any other semi-meridian.

[0213] A contact lens according to one or more of the claims in Example Set A, wherein the thickness profile of the substantially rotationally symmetric region of the non-optical peripheral carrier zone in any meridian is within 6%, 7%, 8%, 9%, or 10% of the average thickness profile of the non-optical peripheral carrier zone measured around the optical center of the contact lens.

[0214] A contact lens as described in one or more of the claims in Example Set A, comprising a spherical blending zone between the optical zone and the non-optical peripheral carrier zone, the width of the spherical blending zone spanning at least 0.1 mm as measured over a semichord diameter across the optical center of the contact lens.

[0215] A contact lens according to one or more of the claims in Example Set A, wherein the substantially toric or astigmatic power distribution in the second region of the optic zone has an effective astigmatism or toricity of at least +1.25 diopters of cylinder power.

[0216] A contact lens according to one or more of the claims in Example Set A, wherein the substantially toric or astigmatic power distribution in the second region of the optic zone has an effective astigmatism or toricity of at least +1.75 diopters of cylinder power.

[0217] A contact lens according to one or more of the claims in Example Set A, wherein the substantially toric or astigmatic power distribution in the second region of the optic zone has an effective astigmatism or toricity of at least +2.25 diopters of cylinder power.

[0218] A contact lens according to one or more of the claims in Example Set A, wherein a substantially toric or astigmatic power distribution is combined with a primary spherical aberration of at least +1D defined across the smallest diameter of the second region.

[0219] A contact lens according to one or more of the claims in Example Set A, wherein a substantially toric or astigmatic power distribution is combined with a primary spherical aberration of at least -1D defined across the smallest diameter of the second region.

[0220] A contact lens according to one or more of the claims in Example Set A, wherein the shape of the second region within the optical zone configured with a substantially toric or astigmatic power distribution is substantially circular or elliptical.

[0221] A contact lens according to one or more of the claims in Example Set A, wherein the non-optical peripheral carrier zone provides specific adaptation to provide a time- and spatially-varying light-stopping signal to the wearer's eye.

[0222] A contact lens as described in one or more of the claims in Example Set A, wherein the non-optical peripheral carrier zone is configured to permit at least one of at least 15 degree rotation of the contact lens during one hour of wear on a myopic eye and at least three 180 degree rotations of the contact lens during eight hours of wear.

[0223] A contact lens as described in one or more of the claims in Example Set A, wherein the non-optical peripheral carrier zone provides specific adaptability to present a temporally and spatially varying light stopping signal to the wearer's eye to provide a directional signal that substantially controls ocular growth of the eye that is substantially consistent over time.

[0224] The contact lens of one or more of the claims in Example Set A, wherein the contact lens is configured for a myopic eye with no astigmatism or with astigmatism of less than 1 diopter of cylinder power.

[0225] A contact lens according to one or more of the claims in Example Set A, wherein the contact lens is capable of providing the wearer with suitable visual performance comparable to that obtained with commercially available single focus contact lenses.

[0226] The contact lens of any one or more of the claims in Example Set A, wherein the contact lens is configured with an astigmatic or toric power profile substantially across a second region within the optic zone that is described by a standard conic section, a biconic, an even or odd expansion polynomial, or a combination thereof.

[0227] The contact lens of one or more of the claims in Example Set A, wherein the contact lens is configured for an eye at risk of developing myopia.

[0228] A contact lens as described in one or more of the claims in Example Set A, wherein the second region within the optical zone is configured to provide at least partially adequate foveal correction to the eye and is further configured to provide at least partially a temporally and spatially varying stop signal for reducing a rate of eye growth.

[0229] A contact lens as described in one or more of the claims in Example Set A, wherein the second region within the optical zone is configured to provide at least partially adequate foveal correction to the eye and is further configured to provide a substantially consistent temporally and spatially varying stop signal over time for at least partially reducing a rate of ocular growth.

[0230] The contact lens of one or more embodiments of Set A, wherein the contact lens utilizes cues presented by induced astigmatism incorporated at least in part by a second region within the optical zone to modify incoming light and slow the rate of myopia progression.

[0231] The contact lens of one or more embodiments of Set A, wherein the contact lens presents a temporally and spatially variable stop signal to the wearer by virtue of rotation of the contact lens on the eye facilitated at least in part by a rotationally symmetric non-optical peripheral carrier zone.

[0232] The contact lens of one or more embodiments of Set A, wherein the regional cones of Sturm formed at least partially on the retina are outside the subfoveal region of the retina but within the macular region.

[0233] The contact lens of one or more embodiments of Set A, wherein the regional cones of Sturm formed at least partially on the retina are outside the foveal region of the retina but within the paramacular region.

[0234] 1. A method comprising applying or prescribing a contact lens to a myopic eye, the contact lens providing a spherical correction to the myopic eye for at least reducing myopic error of the myopic eye, introducing astigmatism error to the myopic eye, and including features effective to rotate on the eye during wear of the contact lens, whereby the astigmatism error is temporally and spatially variable.

[0235] The method according to any one of the preceding claims of Example Set A, wherein the contact lens is a contact lens according to any one or more of the preceding claims of Example Set A.

[0236] Example Set "B" - Asymmetric Power Profile in Second Region 1. An ophthalmic contact lens comprising an optical zone about an optical center and a non-optical peripheral carrier zone about the optical zone, the optical zone being configured with a substantially monofocal refractive power distribution providing a substantial correction to the eye and a second region having an asymmetric refractive power distribution located substantially away from the optical center that at least partially provides a Starm's areal cone on the retina of the eye, the non-optical peripheral carrier zone being configured substantially without ballast to provide substantial temporal and spatial variation in an optical stop signal or otherwise configured to allow rotation of the lens when on the eye.

[0237] A contact lens according to one or more of the claims in Example Set B, wherein the surface area of ​​the second region within the optical zone configured with a substantially asymmetric optical power distribution comprises at least 10% and no more than 35% of the optical zone.

[0238] A contact lens according to one or more of the claims in embodiment set B, wherein at least the regional cones of the star on the retina are configured to provide a directional signal for substantially controlling ocular growth of the eye.

[0239] A contact lens according to one or more of the claims in Example Set B, wherein at least the regional cones of the retina are configured substantially away from the macula.

[0240] A contact lens according to one or more of the claims in embodiment set B, wherein at least the regional cones of the star on the retina are configured substantially in front of the peripheral retina.

[0241] A contact lens according to one or more of the claims in embodiment set B, wherein at least the regional cones of the retina are configured substantially around the peripheral retina.

[0242] A contact lens according to one or more of the claims in embodiment set B, wherein at least the regional cones of the retina are configured substantially in front of the peripheral retina.

[0243] A contact lens according to one or more of the claims in embodiment set B, wherein the substantially toric or astigmatic power distribution of the optical zone is configured on the anterior surface of the contact lens.

[0244] A contact lens according to one or more of the claims in embodiment set B, wherein the substantially toric or astigmatic power distribution of the optical zone is configured on the posterior surface of the contact lens.

[0245] A contact lens according to one or more of the claims in embodiment set B, wherein the substantially toric or astigmatic power distribution of the optical zone is defined partly by the anterior surface of the contact lens and partly by the posterior surface of the contact lens.

[0246] A contact lens according to one or more of the claims in Example Set B, wherein the thickest point within the non-optical peripheral carrier zone across any meridian is within a maximum variation of 30 μm of the thickest peripheral point of any other meridian.

[0247] A contact lens according to one or more of the claims in Example Set B, wherein the thickness profile of the substantially rotationally symmetric region of the non-optical peripheral carrier zone in any meridian is within 5%, 6%, 7%, 8%, 9% or 10% of the average thickness profile of the non-optical peripheral carrier zone measured around the optical center of the contact lens.

[0248] A contact lens according to one or more of the claims in Example Set B, comprising a spherical blending zone between the optical zone and the non-optical peripheral carrier zone, the width of the spherical blending zone spanning at least 0.1 mm as measured over a semichord diameter across the optical center of the contact lens.

[0249] A contact lens according to one or more of the claims in Example Set B, wherein the substantially toric or astigmatic power distribution in the second region of the optic zone has an effective astigmatism or toricity of at least +1.25 diopters of cylinder power.

[0250] A contact lens according to one or more of the claims in Example Set B, wherein the non-optical peripheral carrier zone provides specific adaptability to provide a temporally and spatially varying light stopping signal to the wearer's eye to provide a directional signal that substantially controls ocular growth of the eye.

[0251] The substantially asymmetric refractive power distribution in the second region is C a * cos(mθ) where C a The contact lens of one or more of the claims in Example Set B, wherein m 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.

[0252] The substantially asymmetric refractive power distribution in the second region is (radial component) * (azimuth component), and the radial component of the power distribution function is C r * ρ, where C r are the expansion coefficients, and rho (ρ) is the normalized radial coordinate (ρ0 / ρ max ) and the azimuth component of the refractive power distribution function is C a * cos(mθ), where m can be any integer between 1 and 6, theta (θ) is the azimuth angle, rho (ρ0) is the radial coordinate at a given point, and ρ max The contact lens of one or more of the claims in Example Set B, wherein:

[0253] A contact lens according to one or more of the claims of Example Set B, wherein the substantially asymmetric power distribution is expressed at least in part by a power distribution function described by at least one or more terms of a Bessel circle function of the first kind of the general formula (n,m), where at least one or more of the terms of the Bessel circle function are obtained when n takes on values ​​of 1, 2, 3 and m takes on values ​​of ±2.

[0254] The azimuth power distribution function in the second region of the optical zone is cos 2 A contact lens according to one or more of the claims in Example Set B, having the form (mθ), where m is an integer between 1 and 6, inclusive.

[0255] A contact lens according to one or more of the claims in Example Set B, wherein the shape of the second region within the optical zone configured with a substantially asymmetric optical power distribution is substantially circular or elliptical in shape.

[0256] A contact lens as described in one or more of the claims in Example Set B, wherein the non-optical peripheral carrier zone is configured to allow at least one of at least 15 degree rotation of the contact lens during 1 hour of wear on a myopic eye and at least three 180 degree rotations of the contact lens during 8 hours of wear.

[0257] A contact lens as described in one or more of the claims in Example Set B, wherein the non-optical peripheral carrier zone provides specific adaptability to present a temporally and spatially varying light stopping signal to the wearer's eye to provide a directional signal that substantially controls ocular growth of the eye that is substantially consistent over time.

[0258] The contact lens of one or more of the claims in Example Set B, wherein the contact lens is configured for a myopic eye with no astigmatism or with astigmatism of less than 1 diopter of cylinder power.

[0259] A contact lens according to one or more of the claims in Example Set B, wherein the contact lens is capable of providing the wearer with suitable visual performance comparable to that obtained with commercially available single focus contact lenses.

[0260] The contact lens of any one or more of the claims in Example Set B, wherein the contact lens comprises an asymmetric optical power profile across a second region within the optical zone that is described by a Bessel function, a Jacobi polynomial, a Taylor polynomial, a Fourier expansion, or a combination thereof.

[0261] The contact lens of one or more of the claims in Example Set B, wherein the contact lens is configured for an eye at risk of developing myopia.

[0262] A contact lens as described in one or more of the claims in Example Set B, wherein the second region within the optical zone is configured to provide, at least in part, an appropriate foveal correction to the eye and is further configured to provide, at least in part, a temporally and spatially varying stop signal for reducing a rate of eye growth.

[0263] A contact lens as described in one or more of the claims in Example Set B, wherein the optical zone is configured to provide at least partially adequate foveal correction to the eye and is further configured to provide a substantially consistent, temporally and spatially varying stop signal over time for at least partially reducing a rate of eye growth.

[0264] The contact lens of one or more embodiments of Set B, wherein the contact lens utilizes cues presented by induced asymmetric optical signals incorporated at least in part by a second region within the optical zone to modify incoming light and slow the rate of myopia progression.

[0265] The contact lens of one or more embodiments of Set B, wherein the contact lens presents a temporally and spatially variable stop signal to the wearer by virtue of rotation of the contact lens on the eye facilitated at least in part by a rotationally symmetric non-optical peripheral carrier zone.

[0266] The contact lens of one or more embodiments of Set B, wherein the regional cones of Sturm formed at least partially on the retina are outside the subfoveal region of the retina but within the macular region.

[0267] The contact lens of one or more embodiments of Set B, wherein the regional cones of Starm formed at least partially on the retina are outside the foveal region of the retina but within the paramacular region.

[0268] 1. A method comprising applying or prescribing a contact lens to a myopic eye, the contact lens providing the myopic eye with at least a spherical correction for reducing the myopic error of the eye, and including a structure effective to introduce a stop signal to the myopic eye and rotate on the eye during wear of the contact lens, whereby the stop signal is temporally and spatially variable.

[0269] The method according to any one of the preceding claims of Example Set B, wherein the contact lens is a contact lens according to any one or more of the preceding claims of Example Set B.

[0270] In some instances, the Sturm's regional cones may be located in the paramacular region of the retina, while in other instances, the Sturm's regional cones may be located in peripheral areas on the retina.

Claims

1. 1. An ophthalmic contact lens comprising: an optical zone around the optical center, the optical zone covering a surface area; a first region within the optical zone, the first region covering a substantial portion of the surface area of ​​the optical zone; a decentered second region within the optical zone defining a geometric center that is decentered relative to the optical center; the decentered second region covers a different portion of the surface area of ​​the optical zone than the first region, has a surface area of ​​at least 5% of the surface area of ​​the optical zone, and has a non-optical peripheral carrier zone around the optical zone; At least the first region is comprised of a base prescription that provides refractive correction for the eye; the decentered second region is configured with an asymmetric refractive power distribution that provides at least a partial Sturm's regional cone on the retina of the eye; the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric about an optical axis such that the contact lens is substantially free to rotate over time when on the eye; A contact lens for an eye, wherein in one rotational position of the contact lens on the eye, the contact lens provides a refractive correction other than the Starm's regional cone to a first region of the retina of the eye, and in another rotational position of the contact lens on the eye, the contact lens provides the Starm's regional cone to the first region of the retina.

2. 2. The ophthalmic contact lens of claim 1, wherein a surface area of ​​said decentered second region is less than or equal to 40% of a surface area of ​​said optic zone.

3. 3. An ophthalmic contact lens according to claim 1 or 2, wherein the geometric centre of the decentered second region is at least 0.75 mm away from the optical centre.

4. An ophthalmic contact lens according to any one of claims 1 to 3, wherein the magnitude of the asymmetric power distribution in the decentered second region is at least +1.25 DC.

5. 5. An ophthalmic contact lens according to any one of claims 1 to 4, wherein said asymmetric power distribution is combined with a primary spherical aberration of at least +1D defined over a minimum diameter of said decentered second region.

6. An ophthalmic contact lens according to any one of claims 1 to 4, wherein said asymmetric power distribution is combined with a primary spherical aberration of at least -1D defined over a minimum diameter of said decentered second region.

7. An ophthalmic contact lens according to any one of claims 1 to 6, wherein the shape of the decentered second region is substantially circular or elliptical.

8. An ophthalmic contact lens according to any one of claims 1 to 7, wherein, in the retina of the eye, the regional cones of Starm are arranged substantially in front of the retina.

9. 9. An ophthalmic contact lens according to claim 1 or 8, wherein the regional cone of Starm is partially configured substantially behind the retina.

10. 10. An ophthalmic contact lens according to any one of claims 1 to 9, wherein the thickest point within the non-optical peripheral carrier zone across any semi-meridian is within a maximum variation of 30 μm of the thickest peripheral point of any other semi-meridian.

11. 11. An ophthalmic contact lens according to any one of claims 1 to 10, wherein the thickness profile of the substantially rotationally symmetric region of the non-optical peripheral carrier zone in any meridian is within 7% of the average thickness profile of the non-optical peripheral carrier zone measured around the optical center of the contact lens.

12. An ophthalmic contact lens according to any one of claims 1 to 11, wherein the substantially free rotation of the contact lens over time provides a temporally and spatially varying light stop signal to the wearer's eye to provide a directional cue light signal that substantially controls ocular growth of the eye.

13. 13. An ophthalmic contact lens according to any one of claims 1 to 12, wherein the non-optical peripheral carrier zone is configured to permit at least one of at least 15 degree rotation of the contact lens during 1 hour of wear on a myopic eye, and at least three 180 degree rotations of the contact lens during 8 hours of wear.

14. An ophthalmic contact lens according to any one of claims 1 to 13, wherein the first region and the decentered second region of the contact lens are opposed.

15. 15. An ophthalmic contact lens according to any one of claims 1 to 14, wherein the asymmetric power distribution of the decentered second region has two principal meridians, the power of at least one of the principal meridians being different from the other powers of the optical zone.

16. The asymmetric refractive power distribution in the decentered second region is C ａ ＊ cos(mθ) where C ａ 9. An ophthalmic contact lens according to claim 1 or 8, wherein m 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.

17. The asymmetric refractive power distribution in the decentered second region is (radial component) ＊ (azimuth component), and the radial component of the refractive power distribution function is C ｒ ＊ ρ, where C ｒ are the expansion coefficients, and rho (ρ) is the normalized radial coordinate (ρ ０ / ρ ｍａｘ ) and the azimuth component of the refractive power distribution function is C ａ ＊ cos(mθ), where m can be any integer between 1 and 6, theta (θ) is the azimuth angle, and rho (ρ ０ ) is the radial coordinate at a given point, and ρ ｍａｘ 9. An ophthalmic contact lens according to claim 1 or 8, wherein:

18. 9. An ophthalmic contact lens according to claim 1 or 8, wherein the asymmetric refractive power distribution is at least partially represented by a power distribution function described by at least one or more terms of a Bessel circle function of the first kind of general formula (n, m), the at least one or more terms of the Bessel circle function being obtained when n takes on values ​​of 1, 2, 3 and m takes on values ​​of ±2.

19. The azimuth power distribution function in the decentered second region of the optical zone is cos ２ 9. An ophthalmic contact lens according to claim 1 or 8, having the form (mθ) where m is an integer between 1 and 6 inclusive.

20. 1. A method comprising the step of applying or prescribing a contact lens to a myopic eye, comprising:

20. A method, wherein the contact lens provides for a myopic eye at least a spherical correction for reducing the myopic error of the eye, and includes a structure effective to introduce a stop signal to the myopic eye and rotate on the eye during wear of the contact lens, whereby the stop signal is temporally and spatially variable, the contact lens being as defined in any one of claims 1 to 19.

21. 1. A method comprising the steps of providing or prescribing a contact lens with a prescribed optical effect for an eye having a myopic refractive error, comprising: The contact lens comprises: an optical zone around an optical center, the optical zone covering a surface area and providing the prescribed optical effect, the optical zone having both a base prescription providing a refractive correction of myopic refractive error over a substantial portion of the optical zone, and a Sturm's regional cone acting as a directional cue to reduce the rate of myopia progression, the Sturm's regional cone being provided by a region of the optical zone that is decentered with respect to the optical center and covers at least 5% of the surface area of ​​the optical zone; a non-optical peripheral carrier zone around the optical zone, The method of claim 1, wherein the non-optical peripheral carrier zone has a substantially rotationally symmetric thickness profile and the contact lens is configured to rotate on the eye.

22. 22. The method of claim 21, wherein the thickness profile of the substantially rotationally symmetric region of the non-optical peripheral carrier zone at any meridian is within 10% of the average thickness profile of the non-optical peripheral carrier zone measured about the optical center of the contact lens.

23. 22. The method of claim 21, comprising a spherical blending zone between the optical zone and the non-optical peripheral carrier zone, the width of the spherical blending zone spanning at least 0.1 mm as measured over a half chord diameter across the optical center of the contact lens.

24. 22. The method of claim 21, wherein the regional cones of Starm provide a temporally and spatially varying light stopping signal for the eye as the contact lens rotates on the eye.

25. 22. The method of claim 21, wherein the non-optical peripheral carrier zone is configured to permit at least one of at least 15 degree rotation of the contact lens during one hour of wear on a myopic eye and at least three 180 degree rotations of the contact lens during eight hours of wear.

26. 22. The method of claim 21, wherein the contact lens is configured for a myopic eye with no astigmatism or with less than 1 diopter of cylindrical astigmatism.

27. 22. The method of claim 21, wherein the Sturm's regional cones are formed on the retina and are outside the subfoveal region of the retina but within the macular region.

28. 22. The method of claim 21, wherein the regional cones of Starm are formed on the retina and are outside the subfoveal region of the retina but within the paramacular region.

29. 1. An ophthalmic contact lens comprising: an optical zone about an optical center; a non-optical peripheral carrier zone around the optical zone; the optical zone being comprised of a substantially monofocal power distribution providing a substantial correction to the eye and a second region having an asymmetric power distribution located substantially away from the optical center; configured to provide a light stopping signal at least in part involving a regional cone of the star on the retina of the eye; A contact lens for an eye, wherein the non-optical peripheral carrier zone is configured substantially without ballast to provide substantial temporal and spatial variation to the optical stop signal or is otherwise configured to allow rotation of the contact lens when on the eye.

30. 30. An ophthalmic contact lens as claimed in claim 29, wherein a surface area of ​​said second region within said optical zone that is configured with said substantially asymmetric optical power distribution comprises at least 10% and no more than 35% of said optical zone.

31. 30. An ophthalmic contact lens according to claim 29, wherein the regional cones of Starm on the retina are configured substantially away from the macula.

32. 30. An ophthalmic contact lens according to claim 29, wherein the regional cones of the star on the retina are configured substantially in front of, around, or in front of the peripheral retina.

33. 30. An ophthalmic contact lens according to claim 29, wherein the thickest point within the non-optical peripheral carrier zone across any meridian is within a maximum variation of 30 μm of the thickest peripheral point of any other meridian.

34. 30. An ophthalmic contact lens as described in claim 29, comprising a spherical blending zone between the optical zone and the non-optical peripheral carrier zone, the width of the spherical blending zone spanning at least 0.1 mm as measured over a half chord diameter across the optical center of the contact lens.

35. 30. An ophthalmic contact lens according to claim 29, wherein the contact lens is configured for a myopic eye with no astigmatism or with less than 1 diopter of cylindrical astigmatism.

36. 30. An ophthalmic contact lens as claimed in claim 29, wherein said regional cones of Starm formed on the retina are outside the subfoveal region of the retina but within the macular region.

37. 30. An ophthalmic contact lens according to claim 29, wherein the regional cones of Starm formed on the retina are outside the subfoveal region of the retina but within the paramacular region.

38. 1. A method comprising the step of applying or prescribing a contact lens to a myopic eye, comprising: The contact lens includes features effective to provide a spherical correction for a myopic eye to reduce at least the myopic error of the eye, introduce astigmatism error in the myopic eye, and rotate on the eye during wear of the contact lens, whereby the astigmatism error is temporally and spatially variable.

39. The contact lens includes an optic zone about an optical center and a non-optical peripheral carrier zone about the optic zone; the optical zone being comprised of a substantially monofocal power distribution providing substantial correction to a myopic eye, and a decentered second zone having an astigmatic or toric power distribution located substantially away from the optical center providing at least in part a Sturm's areal cone on the retina of the eye; 40. The method of claim 38, wherein the non-optical peripheral carrier zone is configured with a thickness profile that is substantially rotationally symmetric about the optical center.

40. 40. The method of claim 38, wherein the surface area of ​​the contact lens that introduces the astigmatic error comprises at least 10% and no more than 35% of the optic zone.

41. 40. The method of claim 38, wherein the astigmatism error provides a directional signal for substantially controlling ocular growth of the eye.

42. 39. The method of claim 38, wherein the astigmatic error is provided substantially away from the macula.

43. 40. The method of claim 38, wherein the astigmatism error is provided substantially in front of the retina of the eye.

44. 40. The method of claim 38, wherein the astigmatic error has an effective astigmatism of at least +1.25 diopters of cylinder power.

45. 40. The method of claim 38, wherein the contact lens is configured for a myopic eye with no astigmatism or with less than 1 diopter of cylindrical astigmatism.

46. 39. The method of claim 38, wherein the astigmatic error is outside the subfoveal region of the retina but within the macular region.

47. 39. The method of claim 38, wherein the astigmatic error is outside the subfoveal region of the retina but within the paramacular region.

48. 1. An ophthalmic contact lens comprising: an optical zone about an optical center and a non-optical peripheral carrier zone; configured to rotate on the eye while being worn; the optical zone includes a base prescription that provides a refractive correction of myopic refractive error and a region that introduces decentered astigmatic error; 1. A contact lens for an eye, the contact lens configured such that in one rotational position a portion of the retina receives the base prescription and in another rotational position the portion of the retina receives the astigmatism error.

49. 49. The ophthalmic contact lens of claim 48, wherein the surface area of ​​the contact lens introducing the decentered astigmatism error comprises at least 10% and no more than 35% of the optic zone.

50. 49. An ophthalmic contact lens according to claim 48, wherein the decentered astigmatism error provides a directional signal for substantially controlling ocular growth of the eye.

51. 49. An ophthalmic contact lens according to claim 48, wherein said decentered astigmatic error has an effective astigmatism of at least +1.25 diopters of cylinder power.

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