Ophthalmic lens with optically non-coaxial zone for myopia control

Abstract

To provide ophthalmic devices such as ophthalmic lenses.SOLUTION: An ophthalmic device may comprise an ophthalmic lens for at least one of slowing, retardation and prevention of myopia progression. The ophthalmic lens may comprise a center zone with negative power for myopic vision correction, and at least one treatment zone surrounding the center zone. The at least one treatment zone has a power profile comprising ADD power, has a surface shape comprising a portion of a generally toroidal shape, and is arranged to form a continuous surface with the center zone.SELECTED DRAWING: Figure 5A

Description

[Technical field]

[0001] The present disclosure relates to ophthalmic devices, such as wearable lenses, including contact lenses, implantable lenses, including inlays and onlays, and any other type of device comprising an optical component, and more specifically, to ophthalmic devices designed to slow, retard, or prevent the progression of myopia. The ophthalmic lenses of the present disclosure include at least one treatment zone having a non-coaxial focal point with an add power, thereby preventing and / or slowing the progression of myopia. [Background technology]

[0002] Ophthalmic devices such as contact lenses are currently used to correct vision defects such as myopia (nearsightedness), hyperopia (farsightedness), presbyopia, and astigmatism. However, properly designed lenses can be used to improve vision as well as correct vision defects.

[0003] Common conditions that lead to reduced vision are myopia and hyperopia, for which corrective lenses in the form of glasses or hard or soft contact lenses are prescribed. These conditions are generally described as an imbalance between the length of the eye and the focus of the optical components of the eye. Myopic eyes focus in front of the retinal plane, while hyperopic eyes focus behind the retinal plane. Myopia typically occurs because the axial length of the eye is longer than the focal length of the optical components of the eye, i.e. the eye is overstretched. Hyperopia typically occurs because the axial length of the eye is too short compared to the focal length of the optical components of the eye, i.e. the eye is not stretched enough.

[0004] Myopia has a high prevalence in many parts of the world. The most worrying aspect of this condition is the possibility of progression to high myopia, for example, more than 5 or 6 diopters (i.e., <-5.00 or -6.00D according to the sign convention), which dramatically affects the ability to function without visual aids. As used herein, the measure D is the diopter power, which is defined as the reciprocal of the focal length of a lens or optical system in meters. High myopia is also associated with an increased risk of retinal disease, cataracts, and glaucoma.

[0005] Corrective lenses are used to change the gross focus of the eye to project a clearer image onto the retinal surface by shifting the focal point from in front of the retinal surface to correct myopia or from behind the retinal surface to correct hyperopia, respectively. However, corrective approaches to the above conditions are merely prosthetic, i.e., they only address the symptoms rather than addressing the cause of the condition.

[0006] Most eyes do not have simple myopia or simple hyperopia, but rather myopic astigmatism or hyperopic astigmatism. Astigmatic error of focus causes the image of a point source to form as two mutually perpendicular lines at different focal lengths. In the preceding discussion, the terms "myopia" and "hyperopia" are used to include simple myopia or myopic astigmatism, as well as hyperopia and hyperopic astigmatism, or mixed astigmatism (combinations thereof), respectively.

[0007] Emmetropia describes a state of clear vision in which objects at infinity are in relatively sharp focus with the lens relaxed. In an adult normal or emmetropic eye, light from both distant and near objects passes through the central or paraxial region of the aperture or pupil and is focused by the cornea and lens close to the retinal plane where the inverted image is perceived. However, it has been observed that most normal eyes generally exhibit positive vertical spherical aberration with a magnitude of about +0.50D for a 5.00mm aperture, which means that when the eye is focused at infinity, light rays passing through the aperture or pupil at its periphery are focused at +0.50D in front of the retinal plane.

[0008] Spherical aberration in a normal eye is not constant: for example, accommodation (mainly induced changes in the refractive power of the eye, but also changes to the internal lens) causes a change in spherical aberration from positive to negative.

[0009] As mentioned, myopia typically occurs due to excessive axial elongation, or elongation, of the eye. It is now generally accepted, primarily from animal studies, that axial elongation of the eye can be influenced by retinal image quality and focus. Experiments conducted on a variety of different animal species utilizing several different experimental paradigms have demonstrated that retinal image quality can be altered to produce consistent and predictable changes in ocular elongation.

[0010] Furthermore, it has been shown that defocusing the retinal image in both chick and primate animal models through a positive lens (myopic defocus) or a negative lens (hyperopic defocus) leads to predictable changes in ocular elongation (in terms of direction and magnitude) consistent with the eye elongating to compensate for the imposed defocus. The changes in ocular length associated with optical blur have been shown to vary with both scleral elongation and choroidal thickness changes. Positive lens blurring creates myopic blurring, thickens the choroid, and decreases the rate of scleral elongation, resulting in hyperopic refractive error. Negative lens blurring creates hyperopic blurring, thins the choroid, and increases the rate of scleral elongation, resulting in myopic refractive error. It has been demonstrated that these changes in eye elongation in response to defocus of the retinal image are mediated broadly through local retinal mechanisms, and when the optic nerve is damaged, eye length changes still occur, resulting in the appearance of defocus and altered eye elongation localized to that particular retinal region.

[0011] In humans, there is both indirect and direct evidence supporting the notion that retinal image quality can affect eye elongation. A variety of different eye pathologies, all of which result in the disruption of visual form, such as ptosis, congenital cataracts, corneal opacities, vitreous hemorrhage, and other eye diseases, have been found to be associated with abnormal eye elongation in young people, suggesting that relatively large retinal image quality changes affect eye elongation in human subjects. The influence of more subtle retinal image changes on human eye elongation has also been hypothesized based on optical errors in the human focusing mechanism, which may stimulate human eye elongation and the development of myopia.

[0012] One of the risk factors for the development of myopia is precision work. The accommodative lag or negative spherical aberration associated with the accommodation during such precision work may cause the eye to experience hyperopic blur, which stimulates the progression of myopia as described above. Moreover, this accommodative system is an actively adapting optical system, which constantly responds to the convergence of the input optical system, and is affected by the optical device and working distance. With conventional single vision optical designs for myopia correction, young people's eyes may exhibit accommodative lag or negative spherical aberration, and therefore may have hyperopic defocus. With conventional multifocal designs incorporating coaxial add power in the treatment zone, which have been used for presbyopia correction and more recently for the purpose of myopia control, young people's eyes may utilize add power for near objects and are susceptible to hyperopic defocus through the distance portion for the image of such objects. Myopia control is most effective when the user adjusts through the distance correction zone for near vision, directing the image plane at or in front of the retina (see http: / / www.gslsymposium.com / getattachment / Posters / Cheng,-Xu-et-al-Impact-of-SCL-for-Myopia-Progression.pdf.aspx).

[0013] Both the monovision and multifocal cases mentioned above lead to continued myopia progression. One way to design an optical system that slows down the rate of myopia progression is to utilize a high plus signal to the retina through the use of high add power. Add power is the difference between the zone of the optical device with a dedicated purpose, such as correcting presbyopia or controlling myopia, and the myopia correction zone. For myopia control, the add power in the treatment zone of the optical device is more positive (more plus) or more negative compared to the power of the myopia correction zone.

[0014] US Patent No. 6,045,578 discloses that adding positive spherical aberration to contact lenses reduces or inhibits the progression of myopia. This method involves modifying the spherical aberration of the visual system in a direction and angle related to changing the elongation of the eye, in other words, emmetropia can be adjusted by spherical aberration. In this process, the cornea of ​​a myopic eye is fitted with a lens having a diopter power that increases away from the center of the lens. Paraxial rays that enter the central portion of the lens are focused on the retina of the eye, producing a sharp image of the object. Peripheral rays that enter the peripheral portion of the pupil are focused in a plane between the cornea and the retina, producing a positive spherical aberration of that image on the retina. This positive spherical aberration reduces the tendency of the myopic eye to elongate more by exerting a physiological effect on the eye that tends to prevent the eye from elongating.

[0015] Although the level of positive spherical aberration and / or the amount of plus power required to achieve optimal slowing of myopia progression is unclear, researchers in the field have attempted to use multi-zone devices with areas of positive add power of about +1.50 up to about +4.00 D in an attempt to slow myopia progression. For the purposes of distinguishing these multi-zone designs in the present disclosure, the add zones of these devices generate a focal point of light that is coincident with the axis of myopic correction (principal axis, common axis, optical axis or geometric axis) and therefore may be considered to be "coaxial" by design. (e.g., U.S. Pat. Nos. US5929969, US7506983, US7832859, US8240847).

[0016] This method generally gives less than about 50% treatment results.Cure is defined as the relative axial length change and / or spherical equivalent from baseline for test group compared with the axial length change and / or spherical equivalent of control group over a year or a given time.There remains a need for myopia control treatment with efficacy of more than 50% and close to 100%.Intuitively, adding high plus power treatment zone will provide better treatment because the response of eye growth in animals is proportional to the power of optical stimulation (as reported by Wildsoet, Vision Research 1995).

[0017] However, conventional wisdom in the field of bifocal or multifocal ophthalmic lenses assumes that lenses with high plus or high add powers may have detrimental effects on visual acuity and contrast sensitivity (as reported by Ardaya et al. (Optometry 2004)). Furthermore, Smith et al. (US7025460) argue against out-of-range powers typically found in bifocal or multifocal lenses for presbyopia. Smith et al. write: "While the appropriate type of refractive defocus can affect ocular elongation (or ocular de-elongation) to result in myopia (or re-myopia) in the phenomenon of lens correction, it is important to note that when the amount of refractive error is large, there is a large degradation of such image quality due to severe defocus, which may alter the optical state and thus produce myopia." It further teaches that "the greatest amount of relative curvature of field occurs before significant visual acuity deterioration occurs at the spherical equivalent periphery of +3.50D to +4.00D, which corresponds to the upper limit of negative curvature of field for effective treatment of myopia, resulting in form deprivation myopia." This opinion has discouraged researchers from pursuing high-plus treatment zones for myopia control.

[0018] On the contrary, Applicant's research shows that using designs with a central distance zone and a high-add treatment zone with an add power of more than about 3.00D versus traditional low-add type designs reduces visual acuity loss and has no significant additional impact on contrast sensitivity. This is also supported by a study by De Gracia et al. (OVS 2013), who only investigated add powers up to 4.00D and did not relate this study to potential benefits in controlling myopia progression. This breakthrough allows ophthalmic field designs to achieve a significant slowing of myopia progression by more than 50% without further adversely affecting visual acuity.

[0019] Moreover, it is clear that a significantly higher plus power relative to the power for providing clear distance vision is not expected to result in a reduction in accommodation as occurs with a lower add power design, and subjects may rely to some extent on that add power for clear vision during precision work activities, as was observed during applicant's studies. This reduced accommodation can lead to hyperopic defocus as a result of light rays passing through the optical zone of the device that is intended to provide clear distance vision (the distance portion of the device or near correction zone). In the present disclosure, subjects must accommodate to the distance portion of the lens for near vision correction, and objects imaged through the high add treatment zone cannot be sharpened by the accommodative convergence system if they are sufficiently out of focus.

[0020] Other attempts to slow down the progression of myopia may include power profiles that show gradients of several zones of the lens. Various methodologies have been applied. Some treatment zones are progressive zones in which a systematically varying coaxial focus is configured, see for example US8240847, US8662664. Still other designs are configured to generate more peripheral retinal myopic defocus (see for example US7665842, US8684520). Furthermore, the zones of some designs may be called blend zones or transition zones, since they are in effect zones with no functional optical purpose designed to connect the treatment zones and the correction zones (see for example US8240847, US8684520). These designs do not include a portion of a nearly toroidal surface to generate a ring focus when following the present disclosure.

[0021] U.S. Patent Application Publication No. US2017 / 0184875 contemplates that "optical features of the lens body that, when worn on the eye, direct peripheral light to the eye away from the central region of the retina further cause the peripheral light directed away from the central region of the retina to have a focal point that is not on the retina." It specifies that "the optical features may have properties that direct light to the peripheral region of the retina, that focus light precisely on the peripheral region of the retina, that focus light in front of the peripheral region of the retina, that focus light behind the peripheral region of the retina, or a combination thereof." This patent does not contemplate, in accordance with the present disclosure, that the treatment zone includes a portion of a generally toroidal surface to produce a ring focus.

[0022] As another example in the art, International Publication No. WO2012 / 173891 by R. Griffin claims the elimination of accommodation stress that leads to the progression of myopia through the construction of an artificial pinhole that results in increased accommodation lag and depth of focus and depth of field. According to Griffin, "the eye becomes more relaxed in accommodation."

[0023] Referring now to FIG. 1, a graph shows a device with a design incorporating a central distance zone correcting distance vision and a peripheral zone of variable plus power. Visual acuity was measured using a four-alternative forced choice method with progressively smaller Snellen charts. Increasing the peripheral plus power from about +2.00D to +3.00D causes an increase in high contrast vision loss typical of multifocal designs for presbyopes. However, as the peripheral power continues to increase, the relative impact on visual acuity levels off with a surprising improvement, such that above about +4.00D to +5.00D of peripheral plus, vision loss remains relatively constant. This is important for the design of myopia control lenses, since it has been found (in animal models) that higher plus powers have a greater impact on eye growth (as reported in Wildsoet, Vision Research 1995).

[0024] However, further optimization of the ADD design is necessary to optimize image quality. Now referring to FIG. 2, the power profile is depicted with a power of +5.00D or +10.00D beyond the radial position of 2.25mm from the center of the lens. Light rays pass through these high ADD areas and form a tight focus in front of the retina. However, with continued propagation to the retina, these light rays form a ring-shaped defocus on the retina.

[0025] As shown in the point spread function (PSF) cross section of FIG. 3, light rays coming from the +5.00D and +10.00D regions form individual spikes on the retina. Thus, when a person looks at a point source through one of these +5.00D or +10.00D high plus lenses, the person's retina receives a peak signal surrounded by a ring-shaped halo. Normally, this is not a problem when a person reads text or resolves details in an object, because the halo is too blurry for humans to perceive it. Nevertheless, it is a problem because when a person looks at a black / white edge, the presence of the spike in the PSF causes energy from the white background to leak into the black.

[0026] Now referring to FIG. 4, the image cross-sections for the power profiles of +5.00D and +10.00D of FIG. 2, with an entrance pupil diameter of 6.00 mm, are shown by convolving the PSF with the black / white edge in object space. The lens with 0.00D power produces a sharp edge between black and white (at 0.00 mm) and therefore has no ring structure. On the other hand, the lens with +5.00D and +10.00D regions does not have a sharp edge between black and white, thereby resulting in an image where the black background is not completely black and the white background is not completely white.

[0027] Thus, improvements are needed. Summary of the Invention [Means for solving the problem]

[0028] The present disclosure relates to an ophthalmic device for at least one of slowing, retarding, or preventing the progression of myopia that may address one or more shortcomings of the prior art.

[0029] According to one aspect, the present invention relates to an ophthalmic lens for at least one of slowing, retarding or preventing the progression of myopia, the ophthalmic lens comprising a central zone having a negative power for the correction of myopia and at least one treatment zone surrounding the central zone, the at least one treatment zone having a power profile including a positive power relative to the central zone, the at least one treatment zone having a surface shape including a portion of a generally toroidal shape, the at least one treatment zone being disposed to form a continuous surface with the central zone.

[0030] According to another aspect, the present invention is directed to an ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, the ophthalmic lens comprising a central zone having a negative power for the correction of myopia, and at least one treatment zone surrounding the central zone, the at least one treatment zone having a power profile including a positive power relative to the central zone, the at least one treatment zone having an annular configuration having a shared radial center point with the central zone, the at least one treatment zone producing a focal ring, the location of each of the infinity foci on the ring being offset from the geometric axis of the central zone ("non-coaxial"), and the at least one treatment zone being disposed to form a continuous surface with the central zone.

[0031] According to yet another aspect, the present invention relates to an ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, the ophthalmic lens comprising a central zone, a myopia correction zone surrounding the central zone, the myopia correction zone exhibiting a negative power for the correction of myopia and the central zone exhibiting an add power relative to the myopia correction zone, and at least one treatment zone surrounding the central zone and disposed radially outward from the myopia correction zone, the at least one treatment zone having a power profile including a positive power relative to the myopia correction zone, the at least one treatment zone having an annular configuration having a shared radial axis with the central zone, the at least one treatment zone producing a focal ring, the location of each of the infinity foci on the ring being offset from the geometric axis of the central zone ("non-coaxial"), and the at least one treatment zone being disposed to form a continuous surface with the central zone.

[0032] According to yet another aspect, the present invention relates to an ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, the ophthalmic lens comprising: a central zone; a myopia correction zone surrounding the central zone, the myopia correction zone exhibiting a negative power for the correction of myopia and the central zone exhibiting an add power relative to the myopia correction zone; and at least one treatment zone surrounding the central zone and disposed radially outward from the myopia correction zone, the at least one treatment zone having a power profile including a positive power, the at least one treatment zone having a surface shape including a portion of a generally toroidal shape, the at least one treatment zone being disposed to form a continuous surface with the central zone.

[0033] According to yet another aspect, the present invention relates to an ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: a central zone having a negative power for the correction of myopia, the central zone having a principal axis perpendicular to its surface and passing through the center of the ophthalmic lens; and at least one treatment zone surrounding the central zone, the at least one treatment zone having a power profile including a positive power relative to the central zone, the at least one treatment zone having a surface shape including a portion of a generally toroidal shape, the at least one treatment zone being disposed to form a continuous surface with the central zone, and the at least one treatment zone having an inclination angle configured to direct an innermost light ray relative to a cross section of the treatment zone to intersect the principal axis at a point at or in front of the retinal plane of a wearer of the ophthalmic lens.

[0034] According to another aspect, the present invention is directed to an ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, the ophthalmic lens including a central zone having negative power and exhibiting an on-axis focus, and at least one treatment zone surrounding the central zone, the at least one treatment zone having a power profile including an add power relative to the central zone, the at least one treatment zone exhibiting a ring focus, and the power profile of the treatment zone including a curved ramp configuration. [Brief description of the drawings]

[0035] The above and other features and advantages of the present disclosure will become apparent from the following more particular description of preferred embodiments of the present disclosure, as illustrated in the accompanying drawings. [Figure 1] 1 illustrates a graph showing the change in visual acuity as the add power is increased in the peripheral zone. [Diagram 2] Two lens power profiles are illustrated, one with a +5.00D treatment zone and one with a +10.00D treatment zone. [Diagram 3] 3 illustrates a cross-sectional view of the point spread function for the power profile of FIG. 2 with an entrance pupil diameter of 6.00 mm. [Figure 4] 3 illustrates a cross-section of the image intensity produced by the power profile of FIG. 2 with respect to black and white edges. [Figure 5A] 1 illustrates a schematic representation of an example of an ophthalmic device having at least one treatment zone according to the present disclosure. [Figure 5B] 5B illustrates a perspective view of the ophthalmic device of FIG. 5A. [Figure 5C] 1 illustrates a portion of a toroidal shape after the toroidal shape has been cut by a conical surface. [Figure 5D] 1 illustrates a portion of a toroidal shape disposed on an ellipsoidal shape. [Figure 5E] For example, a portion of a toroidal shape is shown disposed on the cap, which may be a portion of the ellipsoidal shape of FIG. 5D. [Figure 5F] Concentric treatment zones resulting in a point focus are illustrated. [Figure 5G] 1 illustrates a treatment zone of the present disclosure resulting in a ring focus. [Figure 6] 1 illustrates an example of an ophthalmic device having a central myopia correction zone and at least one treatment zone according to the present disclosure. [Figure 7] 1 illustrates an example of an ophthalmic device having a central treatment zone, a myopia correction zone, and at least one treatment zone according to the present disclosure. [Figure 8A] 1 illustrates the power profile of an ophthalmic device. [Figure 8B] 8B illustrates an annotated representation of the power profile of FIG. 8A. [Figure 8C] 1 illustrates a ray diagram showing concentric and non-concentric focal points associated with an ophthalmic device of the present disclosure. [Figure 9A] 1 is a diagrammatic representation of a plane wavefront and associated light rays passing through an emmetropic (or perfectly corrected) eye toward the retina. [Figure 9B] 9B is a diagrammatic representation of light rays associated with a wavefront having a spherical wavefront error of +10.00D (relative to that of FIG. 9A) traveling through the eye toward the retina. [Figure 9C] A diagrammatic representation of light rays passing through an optical system (an optical device plus an emmetropic eye) where the optical device has a plano (ie, 0.00D) power at the center and a +10.00D concentric power at the periphery. [Figure 9D] A diagrammatic representation of light rays passing through an optical system (an optical device plus an emmetropic eye) where the optical device has a plano (ie, 0.00D) power at the center and a +10.00D non-coaxial power at the periphery. [Figure 9E] A schematic representation of light rays passing through an optical system (an optical device plus an emmetropic eye) where the optical device has a plano (i.e., 0.00D) power at the center and a +10.00D coaxial power at the periphery, with the center of the light beam from the periphery tilted inward and away from the fovea. [Figure 10A] 1 illustrates a ray diagram showing the focal ring of an ophthalmic device according to the present disclosure. [Figure 10B] 1 illustrates a ray diagram showing the focal rings and a central zone having an add power of an ophthalmic device according to the present disclosure. [Figure 11A] A schematic representation of light rays passing through an optical system (an optical device plus an emmetropic eye) where the optical device has a plano (i.e., 0.00D) power in the center and a +10.00D coaxial power in the periphery, with the center of the light bundle in the peripheral zone tilted inward and away from the fovea in an asymmetric manner. [Figure 11B] A schematic representation of light rays passing through an optical system (an optical device plus an emmetropic eye) where the optical device has a plano (i.e., 0.00D) power in the center and a +10.00D coaxial power in the periphery, with the center of the light bundle in the peripheral zone tilted outward and away from the fovea in a symmetrical manner. [Figure 11C] A schematic representation of light rays passing through an optical system (an optical device plus an emmetropic eye) where the optical device has a plano (i.e., 0.00D) power in the center and a +10.00D coaxial power in the periphery, with the center of the light bundle in the peripheral zone tilted outward and away from the fovea in an asymmetric manner. [Figure 12A] Illustrates a ray diagram showing the focal ring of an ophthalmic device showing light rays passing through the peripheral zone converging to a point behind the retinal surface in accordance with the present disclosure. [Figure 12B] Illustrates a ray diagram showing the focal ring of an ophthalmic device showing light rays passing through the peripheral zone that do not converge to any point behind the retinal surface in accordance with the present disclosure. [Figure 13] 1 illustrates a comparison of two power profiles of respective ophthalmic devices according to the present disclosure. [Figure 14A] 1 illustrates a plot of the change in axial length of a human eye exposed to various sample optical configurations. [Figure 14B] 1 illustrates a plot of the change in axial length of a human eye exposed to various sample optical configurations. [Figure 14C] 1 illustrates a plot of the change in axial length of a human eye exposed to various sample optical configurations. [Figure 14D] 1 illustrates a plot of the change in axial length of a human eye exposed to various sample optical configurations. [Figure 15A] 1 illustrates the power profile of an ophthalmic device having two peripheral treatment zones according to the present disclosure. [Figure 15B] 1 illustrates a power profile for an ophthalmic device having two peripheral treatment zones and a central treatment zone containing add power in accordance with the present disclosure. [Figure 16A]16A illustrates comparative plots of the psychological responses (as measured by Contact Lens User Experience, CLUE™ scores) for comfort, visual acuity, and handling, respectively, between three multizone test lenses and one control lens (a commercially available single vision soft contact lens) after 1-3 days of lens administration; FIG. 16B illustrates the LSM and 95% CI of the CLUE™ scores by lens type. [Figure 16B] FIG. 16B illustrates a comparison plot of the psychological responses (as measured by Contact Lens User Experience, CLUE™ scores) for comfort, visual acuity, and handling between three multizone test lenses and one control lens (a commercially available single vision soft contact lens) after 1-3 days of lens administration, respectively; FIG. 16B shows the LSM difference and 95% CI of the CLUE™ visual acuity scores between each of the three test lenses and the one control lens. [Figure 17A] Illustrated are plots of monocular (A) and binocular (B) logMAR visual acuity comparisons between three multizone test lenses and one control lens (a commercially available single vision soft contact lens) under three different contrast / illumination conditions (LSM and 95% CI). [Figure 17B] Illustrated are plots of monocular (A) and binocular (B) logMAR visual acuity comparisons between three multizone test lenses and one control lens (a commercially available single vision soft contact lens) under three different contrast / illumination conditions (LSM and 95% CI). [Figure 18A] Illustrated are comparison plots of the difference in monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and one control lens under high contrast bright conditions (LSM difference and 95% CI). [Figure 18B] Illustrated are comparison plots of the difference in monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and one control lens under high contrast bright conditions (LSM difference and 95% CI). [Figure 19A] Illustrated are comparison plots of the difference in monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and one control lens under high contrast dark conditions (LSM difference and 95% CI). [Figure 19B] Illustrated are comparison plots of the difference in monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and one control lens under high contrast dark conditions (LSM difference and 95% CI). [Figure 20A] Illustrated are comparison plots of the difference in monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and one control lens under low contrast bright conditions (LSM difference and 95% CI). [Figure 20B] Illustrated are comparison plots of the difference in monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and one control lens under low contrast bright conditions (LSM difference and 95% CI). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] Ophthalmic devices can include implantable devices and / or wearable devices such as contact lenses. Traditional contact lenses include polymer structures having specific shapes that correct various vision problems.

[0037] As part of a typical eye exam, the eye care professional may determine the contact lens prescription needed to correct the patient's refractive error. This prescription may specify the power, cylinder, and / or cylinder axis of the contact lens, and may be used to determine or select a contact lens design.

[0038] The optical function of radially concentric multi-zone ophthalmic lenses, which serve at least the purpose of spherical correction, most commonly comes from the anterior and posterior surfaces. One of these surfaces may be essentially spherical or ellipsoidal. The other surface is typically a spherical or ellipsoidal cap, followed by a frustum of a spherical or ellipsoidal cap, each of which has one or more curved portions, each of which is symmetrically arranged to form a continuous surface ("zone"). The zones may be radially concentric and optically coaxial about a common axis.

[0039] In one aspect, each frustum can be made by segmenting a sphere or ellipsoid of appropriate size and shape to achieve the desired optical power, perpendicular to the principal axis of such sphere or ellipsoid. In some cases, transition regions (e.g., optically dysfunctional) may be required to allow the individual zones to form a continuous surface. For myopia treatment, some zones generally generate a more positive wavefront derivative than the zones dedicated to correcting distance vision, and the wavefront derivative is taken with respect to the radial distance from the principal axis (dW / dr). Light rays parallel to a common axis and passing through the zones will enter the principal focus of each zone, and these foci will be located on the same axis for the rotationally symmetric zones. When an ophthalmic lens is used to correct vision, and one or more of the zones have principal foci with different focal lengths, the image formed at the retina of the eye may be blurred or have ghosts or halos, leading to a decrease in vision.

[0040] In certain embodiments, satisfactory visual results can be achieved by preparing a zone (or replacing a designed zone of a lens) with a surface shape derived from a toroidal shape (e.g., a spherical torus) or, in the case of replacing multiple zones, from one or more tori. As an example, the portion of the toroidal shape to be utilized can be derived from a torus after making a slice of the surface shape of a right circular cone through the surface of the torus (e.g., a spherical torus), with the main axis of the cone coinciding with the axis of rotation around which the torus is generated. The portion of the torus-forming portion of the lens surface is arranged so that it forms a continuous surface with other zones of the lens or is joined by transition regions that are optically dysfunctional to allow the individual zones to form a continuous surface. Other slices (conic or otherwise) than those outlined herein can also be used.

[0041] One advantage of using a torus as the basis for one or more designs is that the light rays passing through this region of the lens form a ring focus rather than a point focus. The dispersion of this light rays can be arranged to result in a reduced impact on vision achieved from the light rays passing through the correction zone of the lens. The significant advantages of such a design are less impact on vision, minimal interference with normal accommodation, and reduced halo effect. Larger treatment zone areas and higher add powers can be utilized as a result. The reduction in image contrast is proportional to the size of the treatment zone within the pupil of the eye. The focal position of the dispersed light rays is in front of the retina, which still provides a strong myopia control effect. When referring to the "non-coaxial" focus of the present invention, add power means a positive power along the axis of the light rays passing through the treatment zone, as opposed to the traditional definition of power, and is derived from the position where the light rays cross the coaxial axis.

[0042] In accordance with the present invention, an ophthalmic lens has a high addition treatment zone surrounding at least one central zone to treat, prevent, or slow the progression of myopia while also minimizing any halo effect at the black / white edge.

[0043] 5A-5B, a contact lens 500 according to one embodiment of the present disclosure is illustrated. The contact lens 500 includes an optical zone 502 and an outer zone 504. The optical zone 502 includes a first or central zone 506 and at least one peripheral or treatment zone 508. Although two treatment zones 508 are shown, several treatment zones may be used and may be concentrically positioned at various radii from the central axis. In a particular embodiment, the diameter of the optical zone 502 may be selected to be 8.00 mm, the diameter of the generally circular central zone 506 may be selected to be 4.00 mm, and the border diameter of the annular outer treatment zone 508 may be 5 mm and 6.5 mm, as measured from the geometric center 500 of the lens. By way of example, the central zone 506 may be configured with a power profile that corrects myopia and provides adequate visual acuity. Such a power profile may include a negative optical power. As a further example, at least one treatment zone 508 may be configured to treat, prevent, or slow the progression of myopia. At least one treatment zone 508 may be configured to have a surface shape that produces a focal ring, with each location of the infinity focus on the ring being offset from ("non-coaxial with") the geometric axis of the central zone 506. The optics of the treatment zone 508 may include aberrations such that light rays passing through the treatment zone do not have to be focused to a focal shape ring. Alternatively, a blurred focal ring may result. In certain embodiments, the central zone 506 may include an area of ​​add power, as illustrated in FIG. 7 (zone 706).

[0044] It is important to note that Figures 5A-5B only illustrate exemplary embodiments of the present disclosure. For example, in this exemplary embodiment, the outer boundary of the at least one treatment zone 508 does not necessarily coincide with the outer edge of the optical zone 502, but in other exemplary embodiments, it may. The outer zone 504 surrounds the optical zone 502 and provides standard contact lens characteristics, including lens positioning and centering. According to one exemplary embodiment, the outer zone 504 may include one or more stabilization mechanisms to reduce lens rotation when on the eye.

[0045] The various zones in Figures 5A-5B are illustrated as concentric rings. The zones may include any suitable circular or non-circular shape, such as an elliptical shape. It is important to note that as the entrance pupil diameter of the eye varies among subpopulations, in certain exemplary embodiments, the lens design may be customized to achieve both good central vision correction (e.g., myopic correction) and myopia correction based on the average pupil diameter of the patient's eye. Furthermore, since pupil size correlates with the refraction and age of the pediatric patient, in certain exemplary embodiments, the lens may be further optimized for subgroups of the pediatric subpopulation with a particular age and / or refraction based on pupil size. In essence, the lens design may be adjusted or tailored to the pupil diameter to achieve an optimal balance between central vision correction and minimization of the halo effect resulting from the high addition treatment zone.

[0046] 5C-5E, the treatment zones 508 can have a shape that includes a portion of a generally toroidal shape, with at least one treatment zone 508 arranged to form a continuous surface that includes a central zone. As an example, the portion of the toroidal shape can be derived from a torus (e.g., a spherical torus), where a slice through the surface of the spherical torus to generate the portion of the toroidal shape includes an upright cone surface where the major axis of the cone 510 coincides with the axis of rotation about which the torus is generated.

[0047] With reference to Figure 5F, a treatment zone 508 according to the present disclosure can be configured to result in a point focal point 512. With reference to Figure 5G, a treatment zone 508 according to the present disclosure can be configured to result in a ring focal point 514. The portion of the focal ring can depend on the optical power of the treatment zone 508. As will be explained in more detail, the focal point of the annular treatment zone 508 can be the result of various surface properties of the treatment zone 508, including, but not limited to, the slope of the surface of the treatment zone 508, and the optical power of the treatment zone 508.

[0048] Referring now to FIG. 6, a perspective view of a contact lens 600 is illustrated according to an embodiment of the present disclosure. The contact lens 600 includes an optical zone 602 and an outer zone 604. The optical zone 602 includes a first or central zone 606 and at least one treatment zone 608 or peripheral zone. In certain embodiments, the diameter of the optical zone 602 may be selected to be 8.00 mm, the diameter of the generally circular central zone 606 may be selected to be 4.00 mm, and the border diameter of the annular outer treatment zone 608 may be 5 mm and 6.5 mm, relative to the geometric center of the lens 600. By way of example, the central zone 606 may be configured with a power profile that corrects myopia and provides adequate visual acuity. Such a power profile may include a negative optical power. By way of further example, the treatment zone 608 may be configured as a treatment zone for treating, preventing, or slowing the progression of myopia. The treatment zones 608 may be configured to have a surface shape that exhibits a ring focus, with each location of the infinity focus on the ring being offset from ("non-coaxial with") the geometric axis of the central zone 606. Additional treatment zones 608 may also be used.

[0049] As an example, the Ophthalmic Lens 600 may be configured for at least one of slowing, retarding, or preventing the progression of myopia. The Ophthalmic Lens may include a central zone 606 having a negative power for myopia correction, and at least one peripheral zone 608 (e.g., treatment zone) surrounding the central zone 606. The at least one treatment zone 608 may have a power profile including an add power area or zone. The at least one treatment zone 608 may include an absolute optical power of about -10.00D to about +15.00D. The at least one treatment zone 608 may include a relative add power such that the optical power of the treatment zone 608 is more positive than an adjacent zone or a reference zone such as the central zone 606 (e.g., vision correction zone, myopia correction zone, etc.). As an example, the myopia correction zone may have an optical power of -5.00 D and the treatment zone may have an optical power of -3.00 D, thus having an add power of +2.00 D. As a further example, the myopia correction zone may have an optical power of -3.00 D and the treatment zone may have an optical power of +5.00 D, thus having an add power of +8.00 D.

[0050] At least one treatment zone 608 may have an annular configuration that shares a common geometric axis with the central zone 606, and at least one treatment zone 608 exhibits (i.e., results in) a focal ring, with each location of the infinity focus on the ring being offset from ("non-coaxial with") the geometric axis of the central zone 606.

[0051] At least one treatment zone 608 may have a surface shape that includes a portion of a generally toroidal shape, with the at least one treatment zone 608 arranged to form a continuous surface that includes a central zone. As an example, the portion of the toroidal shape to be utilized may be derived from a torus after making a slice of the shape of the surface of a right circular cone through the surface of the torus (e.g., a spherical torus), with the major axis of the cone coinciding with the axis of rotation around which the torus is generated.

[0052] It is important to note that Figure 6 illustrates only an exemplary embodiment of the present invention. For example, in this exemplary embodiment, the outer boundary of the at least one treatment zone 608 does not necessarily coincide with the outer edge of the optical zone 602, but in other exemplary embodiments, it may. The outer zone 604 surrounds the optical zone 602 and provides standard contact lens characteristics, including lens positioning and centering. According to one exemplary embodiment, the outer zone 604 may include one or more stabilization mechanisms to reduce lens rotation when on the eye.

[0053] 7, a perspective view of a contact lens 700 is shown, according to an embodiment of the present disclosure. The contact lens 700 includes an optical zone 702 and an outer zone 704. The optical zone 702 includes a first or central zone 706 and at least one peripheral treatment zone 708, as well as a myopia correction zone 707 disposed between the central zone 706 and the at least one peripheral treatment zone 708. In a particular embodiment, the diameter of the optical zone 702 may be selected to be 8.0 mm, the diameter of the generally circular central zone 706 may be selected to be 4.0 mm, and the border diameter of the annular outer treatment zone 708 may be 5 mm and 6.5 mm, relative to the geometric center of the lens 700. By way of example, the central zone 706 may be configured with a power profile having an add power. This central zone 706 may be configured to present a focal point between the lens 700 and the wearer's retinal surface to treat myopia and provide sufficient visual acuity. The myopia correction zone 707 may surround the central zone 706 and may be configured with a power profile that corrects distance vision for myopia. Such a power profile may include a negative optical power. As a further example, the treatment zone 708 may be configured as a treatment zone for treating, preventing, or slowing the progression of myopia. The treatment zone 708 may be configured to have a surface shape exhibit (i.e., resulting in) a focus ring, where each location of the infinity focus on the ring is offset from ("non-coaxial with") the geometric axis of the central zone 706. Additional treatment zones 708 may be used. At least one treatment zone 708 may have a power profile that includes an add power area or zone, such as the central zone 706. At least one treatment zone 708 may include an absolute optical power of about -10.00D to about +15.00D. At least one treatment zone 708 may include a relative add power such that the optical power of the treatment zone 708 is more positive than an adjacent zone or a reference zone (e.g., vision correction zone, myopia correction zone, etc.), such as the central zone 707. As an example, the myopia correction zone may have an optical power of -5.00D and the treatment zone may have an optical power of -3.00D, thus having an add power of +2.00D.As a further example, the myopia correction zone may have an optical power of -3.00D and the treatment zone may have an optical power of +5.00D, thus having an add power of +8.00D.

[0054] At least one treatment zone 708 may have an annular configuration sharing a common geometric axis with the central zone 706, and at least one treatment zone 708 exhibits a focal ring, with each location of an infinity focus on the ring being offset from ("non-coaxial with") the geometric axis of the central zone 706.

[0055] At least one treatment zone 708 may have a surface shape that includes a portion of a generally toroidal shape, with the at least one treatment zone 708 arranged to form a continuous surface that includes a central zone. As an example, the portion of the toroidal shape that will be utilized may be derived from a torus after making a slice of the shape of the surface of a right circular cone through the surface of the torus (e.g., a spherical torus), with the major axis of the cone coinciding with the axis of rotation about which the torus is generated.

[0056] It is important to note that Figure 7 illustrates only an exemplary embodiment of the present invention. For example, in this exemplary embodiment, the outer boundary of the at least one treatment zone 708 does not necessarily coincide with the outer edge of the optical zone 702, but in other exemplary embodiments, it may. The outer zone 704 surrounds the optical zone 702 and provides standard contact lens characteristics, including lens positioning and centering. According to one exemplary embodiment, the outer zone 704 may include one or more stabilization mechanisms to reduce lens rotation when on the eye.

[0057] FIG. 8A illustrates a power profile of an example ophthalmic device, where the power profile illustrates optical characteristics versus radial distance from the center of the ophthalmic device. As shown, a central zone 802 or region disposed at and / or adjacent to the center of the ophthalmic lens has a positive optical power. The surface of the ophthalmic lens then exhibits a negative optical power radially outward of the central zone 802. However, a treatment zone 804 is illustrated at approximately 1.50 mm to 2.00 mm, where the optical power rises from the surrounding region and exhibits a lower negative optical power. As a further example, the treatment zone 804 may be configured as a treatment zone for treating, preventing, or slowing the progression of myopia. The treatment zone 804 may be configured to have a surface shape that exhibits a focal ring, where each location of the infinity focus on the ring is offset from the geometric axis of the central zone 802 (is "non-coaxial"). Additional treatment zones 804 may be used. At least one treatment zone 804 may have an annular configuration sharing a common geometric axis with the central zone 802. At least one treatment zone 804 may have a surface shape that includes a portion of a generally toroidal shape, with the at least one treatment zone 804 arranged to form a continuous surface that includes the central zone. As an example, the portion of a toroidal shape to be utilized may be derived from a torus after making a slice of the shape of the surface of a right circular cone through the surface of the torus (e.g., a spherical torus), with the major axis of the cone coinciding with the axis of rotation about which the torus is generated.

[0058] 8B illustrates an annotated description of the power profile of FIG. 8A. As shown, the radial width and optical power of the central zone 802 can be configured to provide slowing, retardation, or prevention of myopia progression while providing sufficient visual acuity. As a further example, the location of the treatment zone 804 relative to the central zone 802 can be customized.

[0059] FIG. 8C illustrates an annotated power profile 810 with reference to respective ray diagrams 812. The ray diagrams 812 relate to a lens design according to the present disclosure. As shown, the lens design exhibits a particular ray pattern (e.g., refraction) based on the incident light on the lens. As an example, a central coaxial treatment zone 814 may be created by configuring a central add power area that exhibits the convergence of the incident light rays with respect to an on-axis focal point disposed between the lens and the wearer's retinal surface. One or more vision correction zones 816 may be created by configuring the lens to exhibit the convergence of the incident light rays with respect to an on-axis focal point at or near the retinal surface. A non-coaxial treatment zone may be created by configuring an add power area that exhibits the convergence of the incident light rays with respect to a ring of off-axis foci disposed between the lens and the wearer's retinal surface. It is understood that the add power may refer to a positive optical power with respect to adjacent areas and / or vision correction zones 816.

[0060] Referring to FIG. 9A, there is shown a wavefront and associated rays passing through an emmetropic (or perfectly corrected) eye 910. The rays originate from a plane wavefront outside the eye (i.e., 0.00D spherical power) and travel through the optics of the eye and any corrective devices towards the retina 912. As shown, assuming the system has zero wavefront aberrations, the rays 911 of this wavefront focus at a single focal point 914 along the optical axis 916. Considering this is a representation of the wavefront error for a perfectly corrected eye, the focal point 914 is on the fovea, which is located at the center of the macula of the retina 912. The fovea is the area of ​​the retina responsible for sharp central vision.

[0061] In contrast, in FIG. 9B, light rays 921 from a wavefront with a spherical wavefront error of +10.00D (for an emmetropic or perfectly corrected eye) are illustrated as they would travel through the eye and any optical device towards the retina 922 of the eye 920. As illustrated, the wavefront focuses along the optical axis 926 at a single point 924 in front of the retina 922, as would be expected for a defocus of +10.00D. Consistent with conventional spherical optics, the optics of the lens are designed with a principal optical axis. The light rays converge towards a single point, i.e., a focal point that lies on this axis. The amount of spherical wavefront error determines the location of the focal point on or in front of the fovea of ​​the retina, as in the examples illustrated in FIG. 9A and FIG. 9B, respectively. These two figures can be used to set the basic parameters / principles on which the details of the present invention are based. However, while for ease of explanation only spherical refractive error is shown and described, it should be understood that the present invention is equally applicable to toric lenses that include cylindrical refractive power at a particular axis, and as described in more detail thereafter, the treatment zone may include cylinder power and axis, as well as more complex optical designs such as higher order aberrations.

[0062] FIG. 9C illustrates light rays originating from a plane wavefront external to an emmetropic eye passing through an optical system (eye plus optical device) with an optical device having a planar (i.e., 0.00D) power at the center 931 and a coaxial power of +10.00D at the periphery (i.e., "coaxial" treatment zone) 933 as the light rays travel through the eye 930 toward the retina 932. Those skilled in the art will appreciate that what is shown and what follows can also be adapted to apply to an ametropic eye, where the central power of the device is corrected for refractive error and the peripheral power remains at +10.00D (+10.00D addition) to the central power. As shown, light rays passing through the central portion of the device focus at a single point 934 along the main optical axis 936. Considering this to be a representation of an emmetropic eye, the focal point 934 is on the fovea of ​​the retina 932. Light rays 933 passing through the treatment zone may focus at a single point 938 between the retina 932, as would be expected for a defocus of +10.00D. Concentric or aspheric multifocal lens designs typically have both primary distance and add powers with a common axis. Also, in these applications, the add power is typically limited to a range of about +1.00 to +3.00D to maintain optimal image quality. Thus, high add powers may not work with this arrangement of coaxial treatment zones, although non-coaxial arrangements may be used, as will be elucidated in more detail subsequently.

[0063] FIG. 9D illustrates light rays originating from a plane wavefront external to the eye passing through an optical system (eye plus optical device) with a planar (i.e., 0.00D) power at the center 941 and a non-coaxial power of +10.00D at the periphery (i.e., "non-coaxial" treatment zone) 943 as the light rays travel through the eye 940 toward the retina 942. As shown, light rays passing through the central portion of the device focus at a single point 944 along the main optical axis 946. Considering this to be a representation of an emmetropic eye, the focal point 944 is on the fovea of ​​the retina 942. Light rays 943 passing through the treatment zone focus at single points 948 and 949 in front of the retina 942 in this cross-sectional view, as would be expected for a +10.00D lens. However, these cones of light rays are now directed toward the fovea, unlike those illustrated in FIG. 9C, where the light rays strike the retina the same distance from the fovea. The treatment zones now have focal points 948 and 949 that are not coincident with the original common optical axis 946 (i.e., the principal axis of the optical system) and are therefore non-coaxial. It is important to note that the light rays passing through the non-coaxial treatment zones enter the focal point +10.00D in front of the retina 942 along their own axes. However, the central ray of each of the non-coaxial treatment zones intersects the principal axis at the fovea and therefore does not have a power error individually.

[0064] FIG. 9E illustrates light rays originating from a plane wavefront external to the eye passing through an optical system (eye plus optical device) with a planar (i.e., 0.00D) power at the center 951 and a non-coaxial power of +10.00D at the periphery (i.e., "non-coaxial" treatment zone) 953 as the light rays travel through the eye 950 toward the retina 952. As shown, light rays passing through the central portion of the device focus at a single point 954 along the principal optical axis 956. Considering this to be a representation of an emmetropic eye, the focal point 954 is on the fovea of ​​the retina 952. Light rays 953 passing through the treatment zone focus at single points 958 and 959 in front of the retina 952 in this cross-sectional view, as would be expected for a +10.00D lens. However, these cones of light rays are now directed symmetrically away from the fovea. Again, the treatment zones have focal points 958 and 959 that are not coincident with the original common optical axis 956 (i.e., the principal axis of the optical system) and are therefore non-coaxial. It is important to note that the light rays passing through the non-coaxial treatment zones enter the focal point +10.00D in front of the retina 952 along their own axis, but with a different direction or gradient (i.e., "tilt") than the treatment zone of FIG. 9D in order to direct the central light rays symmetrically away from the fovea. In addition, the treatment zone axes converge symmetrically toward the principal axis 956. In other words, the treatment zones direct the light rays to intersect with the original common optical axis 956 toward the peripheral sections of the retina 952 at equal distances from the fovea in a symmetrical arrangement of this two-dimensional representation, which forms a blur ring on the retina in three-dimensional space.

[0065] It is important to note that combinations of each of the above configurations are also contemplated, for example an optical design including a base sphere as a myopia correction zone, a treatment zone that directs the central ray of the zone to intersect with an optical axis in front of the retina, and a treatment zone that directs the central ray of the zone to intersect with an optical axis behind the retina. The principles embodied in these descriptions may also be applied to devices that include multiple treatment zones.

[0066] Also incorporated herein is a design with negative add power for the reduction of hyperopia in children, where the distance correction zone may have a positive power of, for example, +0.25 to +20.00D. The same principles that apply to myopia control apply here in that the wearer of the device should not use the add section of the device for near or distance vision, but should use the hyperopic distance correction for the entire field of vision. The non-coaxial nature of the ring focus prevents the user from adjusting for vision to look through the treatment area. The negative add power (e.g., -0.25 to -20.00D) then acts to stimulate eye growth to reduce the degree of hyperopia.

[0067] FIG. 10A illustrates a ray diagram of an ophthalmic lens according to the present disclosure. As shown, a peripheral zone or treatment zone 1004 is shown surrounding a central myopia correction zone 1002. The annular treatment zone 1004 includes a generally toroidal shape (e.g., a portion of a torus), a cross-section of which is illustrated in FIG. 10A. The treatment zone 1004 is configured to result in a focal ring that is generated in front of the retinal surface of a wearer of the ophthalmic device, such as between the ophthalmic lens and the retinal surface. As shown, the innermost ray 1006 of the treatment zone 1004 along with a corresponding (opposite position around the annulus) innermost ray 1008 are configured to converge to a point 1009 that is behind the retinal surface.

[0068] FIG. 10B illustrates a ray diagram of an ophthalmic lens according to the present disclosure. The lens incorporates a correction 1016 for myopia. The lens also incorporates a central treatment zone 1012 and a peripheral treatment zone 1014 radially offset from the central treatment zone 1012. The treatment zone 1014 comprises a portion of a generally toroidal shape, a cross-section of which is illustrated in FIG. 10B. The central zone 1012 is shown including a surface structure configured to generate a coaxial point focus at a location consistent with the add power of that zone. The treatment zone 1014 is configured to exhibit (i.e., result in) a focal ring, which is generated in front of the retinal plane of the wearer of the ophthalmic device, such as between the ophthalmic lens and the retinal plane. One or more myopia correction zones 1016 may be configured with a negative optical power and may exhibit a focal point that is coaxial with the principal axis of the lens including the focal point generated by the central zone 1012. As shown, the treatment zone 1014 has an annular configuration, with the innermost ray 1017 along with the corresponding (opposite position around the annulus) innermost ray 1018 configured to converge to a point 1019, which is the intersection of the retinal plane and the principal axis.

[0069] 11A illustrates light rays originating from a plane wavefront external to the eye passing through an optical system (eye plus optical device) with a planar (i.e., 0.00D) power at the center 1101 and a non-coaxial power of +10.00D at the periphery (i.e., "non-coaxial" treatment zone) 1103 as the light rays travel through the eye 1100 toward the retina 1102. As shown, light rays passing through the central portion of the device focus at a single point 1104 along the principal optical axis 1106. Considering this to be a representation of an emmetropic eye, the focal point 1104 is on the fovea of ​​the retina 1102. Light rays 1103 passing through the treatment zone enter local point foci at single points 1108 and 1109 in front of the retina 1102 but symmetrically away from the fovea, as would be expected for a +10.00D lens, in this cross-sectional view. The treatment zone may create a coaxial focus, which is a focal ring (or ellipse) that includes a focal point 1108 that is not coincident with the original common axis (e.g., main optical axis 1106) and is therefore non-coaxial, and another focal point 1109 that is coincident with the original common axis. It is important to note that the light rays from any bundle passing through the treatment zone will focus along their own axis and these may have different gradients (tilts) within the treatment zone.

[0070] 11B illustrates light rays originating from a plane wavefront external to the eye passing through an optical system (eye plus optical device) with an optical device having a planar (i.e., 0.00D) power at the center 1111 and a non-coaxial power of +10.00D at the periphery (i.e., "non-coaxial" treatment zone) 1113 as the light rays travel through the eye 1110 toward the retina 1112. As shown, light rays passing through the central portion of the device focus at a single point 1114 along the principal optical axis 1116. Considering this to be a representation of an emmetropic eye, the focal point 1114 is on the fovea of ​​the retina 1112. Light rays 1113 passing through the treatment zone enter local point foci at single points 1118 and 1119 in front of the retina 1112, as would be expected for a +10.00D lens, in this cross-sectional view. The treatment zone may create a focal ring including focal points 1118 and 1119 that are not aligned with the original common axis (e.g., the main optical axis 1116) and therefore are non-coaxial. It is important to note that the light rays passing through the treatment zone focus along their own axis and have a different gradient (slope) than the treatment zone of FIG. 9D to direct the central light rays of the treatment zone symmetrically away from the fovea, but still have a local point focus of +10.00D in front of the retina 1112. In addition, the central light rays from the treatment zone converge symmetrically behind the focus of the myopia correction zone 1114. In other words, the treatment zone directs the light rays so that they intersect the original main optical axis 1116 outside the eye in a symmetric manner.

[0071] 11C illustrates light rays originating from a plane wavefront external to the eye passing through an optical system (eye plus optical device) with a planar (i.e., 0.00D) power at the center 1121 and a non-coaxial power of +10.00D at the periphery (i.e., "non-coaxial" treatment zone) 1123 as the light rays travel through the eye 1120 toward the retina 1122. As shown, light rays passing through the central portion of the device focus at a single point 1124 along the principal optical axis 1126. Considering this to be a representation of an emmetropic eye, the focal point 1124 is on the fovea of ​​the retina 1122. Light rays 1123 passing through the treatment zone enter local point foci at single points 1128 and 1129 in front of the retina 1122 but symmetrically away from the fovea, as would be expected for a +10.00D lens, in this cross-sectional view. The treatment zone may create a focal ring (or ellipse) including focal points 1128 and 1129 that are not coincident with the original common axis (e.g., main optical axis 1126) and therefore non-coaxial. It is important to note that the light rays from any bundle passing through the treatment zone will focus along their own axis and these may have different gradients (tilts) within the treatment zone. In other words, the treatment zone directs the light rays so that they intersect the original common optical axis, e.g., main optical axis 1126, outside the eye in an asymmetric manner.

[0072] Combinations of the above configurations are also contemplated, for example optical designs including a base sphere as a myopia correction zone, a treatment zone that directs light rays intersecting the main optical axis, and a treatment zone that directs light rays to the same side of the main optical axis.

[0073] FIG. 12A illustrates a ray diagram of an ophthalmic lens according to the present disclosure. As shown, a peripheral or treatment zone 1204 is shown surrounding a central zone 1202. An annular treatment zone 1204 includes a portion of a generally toroidal shape, a cross-section of which is illustrated in FIG. 12A. The treatment zone 1204 is configured to exhibit (result in) a focal ring, which is generated in front of the retinal surface of a wearer of the ophthalmic device, such as between the ophthalmic lens and the retinal surface. As shown, an innermost ray 1206 of the treatment zone 1204 with a corresponding (opposite position around the annulus) innermost ray 1208 is configured to intersect at a point 1209 that is behind the retinal surface. Thus, a portion of the biconic shape representing the amount of intersection of rays passing through the treatment zone falls behind the retina.

[0074] However, the surface of the treatment zone 1204 may be configured to minimize convergence of the light rays behind the wearer's retinal surface (e.g., tilted so that the light rays are directed by the lens toward or away from the central or principal axis), as illustrated in FIG. 12B. As shown in FIG. 12B, the innermost light rays 1207 passing through the annular treatment zone 1204 along with the corresponding (opposite location around the annulus) innermost light rays 1208 are configured to converge at a point 1209 of intersection of the retinal surface with the principal axis of the lens. Such tilt control may be used to configure the innermost light rays to intersect the principal axis between the retinal surface and in front of the retinal surface. Thus, the portion of the biconic shape that represents the amount of intersection of the light rays passing through the treatment zone will not fall behind the retina. The location of convergence of these rays should be configured to minimize vision impairment, such as that which would occur if the treatment zone 1204 were configured to generate a coaxial point focus.

[0075] To further illustrate the "tilted" configuration of the treatment zone 1204, Figure 13 shows a comparison between two power profiles for respective ophthalmic devices, where the "tilted" treatment zone minimizes the negative power dip in the power profile. Additionally, the power profile of the treatment zone may have a curvilinear (e.g., convex) shape that results in a ring focus.

[0076] As an illustrative example, favorable results have been achieved using tilt angles of +0.035 to +0.3215 degrees relative to the zero angle comparator. The tilt angle is designated as zero where the central (intermediate annular) ray of the treatment zone passes through the intersection of the retinal plane with the central or principal axis (as in FIG. 12A). A positive direction for tilt results in the central (intermediate annular) ray of the treatment zone intersecting the principal axis in front of the retina, whereas a negative direction for tilt results in the central (intermediate annular) ray of the treatment zone intersecting the principal axis behind the retina. It is understood that other positive and / or negative angles of tilt may be used.

[0077] As a further example, certain lens designs have been tested using a choroidal thickness model to predict their potential myopia control effect. In this model, a human eye is exposed to an optical configuration for a period of time and the axial length of the eye is monitored. The choroidal thickness will remain relatively constant without any change in the optical stimulus over the short period of time examined. An optical configuration that is likely to have a myopia control effect will be accompanied by an increase in choroidal thickness and a corresponding decrease in the apparent axial length of the eye as measured by partial coherence interferometry. Conversely, an optical configuration that is likely to worsen the progression of myopia will be accompanied by a decrease in choroidal thickness and a corresponding increase in the apparent axial length of the eye. For example, Read et al. have shown that exposure to a +3D single vision lens results in an apparent reduction in axial length, whereas a -3D lens results in an apparent axial elongation (Read SA, Collins MJ, Sander BP. Human optical axial length and defocus. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6262-9.). In animal models, manipulation of the visual environment with a positive lens results in less eye growth, whereas manipulation of the visual environment with a negative lens results in more eye growth and myopia.

[0078] It is important to note that by varying the power, size, location and inclination of the treatment zones, various design configurations are contemplated, as will become apparent below and as shown in Figures 14 and 16-20.

[0079] Non-coaxial + 5D design (two rings) Ring 1 = +5D non-coaxial power, 1.87-3.43mm diameter zone, +0.109 degree tilt Ring 2 = +5D non-coaxial power, 4.45-9.00mm diameter zone, +0.321 degree tilt

[0080] Non-coaxial +5D design (one ring with 1.00mm center +10D area) Ring = +5D non-coaxial power, 3.00-4.00mm diameter zone, +0.066 degree tilt Non-coaxial +2.5D design (one ring with 1.00mm center +5D area) Ring = +2.5D non-coaxial power, 3.00-4.00mm diameter zone, +0.035 degree tilt

[0081] Non-coaxial +5D~+10D design (4 rings with center +10D area of ​​1.00mm) Ring 1 = +5D non-coaxial power, 3.00-4.00mm diameter zone, +0.066 degree tilt Ring 2 = +10D non-coaxial power, 6.00-7.00mm diameter zone, +0.131 degree tilt Ring 3 = +10D non-coaxial power, 7.00-8.00mm diameter zone, +0.129 degree tilt Ring 4 = +10D non-coaxial power, 8.00-9.00mm diameter zone, +0.129 degree tilt

[0082] Non-coaxial + 5D design (one ring) Ring = +5D non-coaxial power, 3.00-4.00mm diameter zone, +0.066 degree tilt

[0083] Non-coaxial + 7D design (two rings) Ring 1 = +7D non-coaxial power, 3.40-4.80mm diameter zone, +0.132 degree tilt Ring 2 = +7D non-coaxial power, 6.80-8.30mm diameter zone, +0.140 degree tilt

[0084] Non-coaxial +7D design (2 rings with 1.20mm centers +10D area) Ring 1 = +7D non-coaxial power, 2.80-4.00mm diameter zone, +0.111 degree tilt Ring 2 = +7D non-coaxial power, 6.50-8.00mm diameter zone, +0.142 degree tilt

[0085] The results of a series of lens designs are illustrated in Figures 14A-14D. In each of these experiments, +3D defocus was used as a comparison. As can be seen, the optical configurations described in this disclosure can show similar or greater myopia control effects as estimated for +3D defocus. The results of these experiments show that a positive powered treatment zone can result in an apparent reduction in the axial length of the eye, the effect increases with increasing add power, a non-coaxial design is effective in myopia control, and a tilt definition can enhance myopia control.

[0086] In addition, as shown below, a tilt angle can be applied to the central ray of the treatment zone to have all rays passing through the treatment area intersect the axis at or in front of the fovea (zero or positive power). This means that the angle will vary with the zone power, the deviation of the zone from the primary axis, and also with the zone width (e.g., more tilt is required if the zone width and / or local individual axis power is increased). As explained, the degree of tilt is measured relative to a zero angle comparator where the central (intermediate annular) ray of the treatment zone passes through the intersection of the retinal plane with the central or primary axis:

[0087] FIG. 15A illustrates a conventional power profile of an example of an ophthalmic device, where the power profile illustrates optical characteristics versus radial distance from the center of the ophthalmic device. As shown, a central zone 1502 or region disposed at and / or adjacent to the center of the ophthalmic lens has a generally flat optical power profile 1502. In this example, this zone has zero power and thus represents an example for an emmetropic eye, however, it is readily apparent that the entire power profile of this zone may be adjusted to correct myopic refractive error. A first treatment zone 1504 is illustrated at approximately 1.80 mm to 2.40 mm, where the optical power rises from the surrounding area and exhibits a more positive optical power. A second treatment zone 1506 is illustrated at approximately 3.40 mm to 4.20 mm, where the optical power rises from the surrounding area and exhibits a more positive optical power. A conventional power profile derives the power for a given radial distance from the center of the lens from the inverse of the distance at which a ray passing through that location on the lens will intersect the principal axis. This value will differ from the power derived from the local curve of the treatment zone, which is also a function of the distance of vergence of the rays passing through the zone along its own individual axis.

[0088] As a further example, the treatment zones 1504, 1506 may be configured as treatment zones for treating, preventing, or slowing the progression of myopia. The treatment zones 1504, 1506 may be configured to have a surface shape that produces a focal ring, where the location of each of the infinity foci on the ring is offset from the geometric axis of the central zone 1502 ("non-coaxial"). Additional treatment zones 1504 may be used. At least one of the treatment zones 1504, 1506 may have an annular configuration that shares a common geometric axis with the central zone 1502, where at least one of the treatment zones 1504, 1506 exhibits (i.e., results in) a focal ring, where the location of each of the infinity foci on the ring is offset from the geometric axis of the central zone 1502 ("non-coaxial"). At least one of the treatment zones 1504 may have a surface shape that includes a portion of a toroidal shape, where at least one of the treatment zones 1504, 1506 is arranged to form a continuous surface that includes the central zone. As an example, a portion of a toroidal shape may be derived from a torus (e.g., a spherical torus), where a slice through the surface of the spherical torus to generate the portion of the toroidal shape includes a right cone surface whose principal axis coincides with the axis of rotation about which the torus is generated.

[0089] FIG. 15B illustrates a conventional power profile of an example of an ophthalmic device, where the power profile illustrates optical characteristics versus radial distance from the center of the ophthalmic device. As shown, a central zone 1512, or a region disposed at the center of the ophthalmic lens and / or adjacent thereto, has an add power with a focus along the major axis of the lens (coaxial) and is the first treatment zone of this example of an ophthalmic device. The surface of the ophthalmic lens then exhibits a generally flat optical power profile radially outward of the central zone 1512, again representing an example for an emmetropic eye, although it is readily apparent that the entire power profile herein may be adjusted to correct myopic refractive error. A second treatment zone 1514 is illustrated at approximately 1.40 mm to 2.00 mm, where the optical power rises from the surrounding region and exhibits a more positive optical power. A third treatment zone 1516 is illustrated at approximately 3.30 mm to 4.00 mm, with the optical power rising from the surrounding area to provide a more positive optical power. Conventional power profiles derive the power for a given radial distance from the center of the lens from the inverse of the distance at which a ray passing through that location on the lens will intersect the primary axis. This value will differ from the power derived from the local curve of the treatment zone, which is also a function of the distance of vergence of the rays passing through the zone along its own individual axis.

[0090] As a further example, the treatment zones 1514, 1516 may be configured as treatment zones for treating, preventing, or slowing the progression of myopia. The treatment zones 1514, 1516 may be configured to have a surface shape that produces a focal ring, where the location of each of the infinity foci on the ring is offset from the geometric axis of the central zone 1512 ("non-coaxial"). Additional treatment zones 1514 may be used. At least one of the treatment zones 1514, 1516 may have an annular configuration that shares a common geometric axis with the central zone 1512, where at least one of the treatment zones 1514, 1516 exhibits a focal ring, where the location of each of the infinity foci on the ring is offset from the geometric axis of the central zone 1512 ("non-coaxial"). At least one of the treatment zones 1514 may have a surface shape that includes a portion of a toroidal shape, where at least one of the treatment zones 1514, 1516 is arranged to form a continuous surface that includes the central zone. As an example, a portion of a toroidal shape may be derived from a torus (e.g., a spherical torus), where a slice through the surface of the spherical torus to generate the portion of the toroidal shape includes a right cone surface whose principal axis coincides with the axis of rotation about which the torus is generated.

[0091] 16A-16B illustrate a comparison of subject responses after 1-3 days of lens administration between three multi-zone test lenses and one commercially available single vision soft control lens. The test lenses included two novel designs described in this disclosure and a competitive design with conventional optics incorporating concentric treatment rings, concentric focus, and optical add powers of +2.00 to +2.50D. CLUE™ scores were obtained for comfort, vision, and handling. CLUE™ is a validated patient reported outcomes (PRO) questionnaire that evaluates patient experience attributes of soft contact lenses in a US contact lens wearer population aged 18-65 years (Wirth RJ et al. Development of the Contact Lens User Experience: CLUE Scales. Optom Vis Sci. 2016;93(8):801-808). As illustrated, higher CLUE scores are desirable. Figure 16A shows the least squares means (LSM) and 95% confidence intervals (CI) of CLUE scores by lens type, and Figure 16B shows the LSM difference and 95% CI of CLUE visual acuity scores between each of the three test lenses and the control lens. CLUE visual scores were significantly lower for all three multifocal test lenses than for the single vision control lens. However, the competitive lens with a coaxial design had the least visual acuity deterioration (CLUE score reduced by 45.5) compared to the two coaxial lens designs (CLUE scores reduced by 24.1 and 13.2, respectively).

[0092] 17A-B illustrate comparative plots of monocular (A) and binocular (B) logMAR visual acuity between the three multizone test lenses and one control lens (a commercially available single vision soft contact lens) under three different contrast / illumination conditions (LSM and 95% CI). It is important to note that the competitive coaxial designs had optical add powers of +2.00 to +2.50 D.

[0093] 18A-B illustrate comparative plots of monocular (A) and binocular (B) logMAR visual acuity differences between each of the three test lenses and one control lens under high contrast bright conditions (LSM difference and 95% CI). All three test lenses were better than 20 / 20 (0.00 logMAR) visual acuity (both monocular and binocular). Monocular logMAR visual acuity was, on average, 0.07, 0.04, and 0.05 logMAR worse than the control lens for the non-coaxial +5D, non-coaxial +7D, and competitive coaxial designs, respectively, which are about half to one line worse. Binocular logMAR visual acuity was, on average, 0.08, 0.05, and 0.07 logMAR worse than the control lens for the non-coaxial +5D, non-coaxial +7D, and competitive coaxial designs, respectively, which are about half to one line worse than the control lens.

[0094] 19A-19B illustrate comparative plots of monocular (A) and binocular (B) logMAR visual acuity differences between each of the three test lenses and one control lens under high contrast dark conditions (LSM difference and 95% CI). Monocular logMAR visual acuity was, on average, 0.10, 0.05, and 0.12 logMAR worse than the control lens for the non-coaxial +5D, non-coaxial +7D, and competitive coaxial designs, respectively, which are about half a line worse than the control lens. Binocular logMAR visual acuity was, on average, 0.05, 0.03, and 0.06 logMAR worse than the control lens for the non-coaxial +5D, non-coaxial +7D, and competitive coaxial designs, respectively, which are about half a line worse than the control lens.

[0095] 20A-B illustrate comparative plots of monocular (A) and binocular (B) logMAR visual acuity differences between each of the three test lenses and one control lens under low contrast bright conditions (LSM difference and 95% CI). It is important to note that the competitive coaxial designs had optical add powers of +2.00 to +2.50 D. Monocular logMAR visual acuity was, on average, 0.13, 0.08, and 0.13 logMAR worse than the control lens for the non-coaxial +5D, non-coaxial +7D, and competitive coaxial designs, respectively, which are about one line to one and a half lines worse than the control lens. Binocular logMAR visual acuity was, on average, 0.08, 0.06, and 0.08 logMAR worse than the control lens for the non-coaxial +5D, non-coaxial +7D, and competitive coaxial designs, respectively, which are about one and a half lines worse than the control lens.

[0096] The non-coaxial +7D design showed the least deterioration in CLUE™ scores and logMAR visual acuity (both monocular and binocular under all three contrast / lighting conditions) among the three lenses compared to the control lens. Visual acuity was similar between the non-coaxial +5D and the competitive coaxial design, but the CLUE™ scores for the competitive lens were worse. Note that the competitive designs with traditional coaxial optics had optical add powers of only +2.00 to +2.50 D.

[0097] These results demonstrate the advantages of the present invention. Previous myopia control designs with conventional optics are limited in their effectiveness in controlling myopia in that they worsen visual acuity. Exemplary embodiments of the present invention may be more effective at slowing the progression of myopia, while also impacting visual acuity less.

[0098] Currently available contact lenses remain a cost-effective means of vision correction. Thin plastic lenses are worn over the cornea of ​​the eye to correct vision defects, including myopia or nearsightedness, hyperopia or farsightedness, astigmatism, and presbyopia, i.e., the loss of the lens' ability to accommodate. Contact lenses are available in a variety of forms and are manufactured from a variety of materials to provide different functionality.

[0099] Daily wear soft contact lenses are usually made from soft polymeric materials combined with water to provide oxygen permeability. Daily wear soft contact lenses may be daily disposable or continuous wear disposable. Daily disposable contact lenses are usually worn for one day and then discarded, while continuous wear or frequent replacement disposable contact lenses are usually worn for periods of up to 30 days. Tinted soft contact lenses use different materials to provide different functionality. For example, identification tinted contact lenses utilize a light tint to assist the wearer in finding a lost contact lens, highlight tinted contact lenses have a translucent tint intended to accentuate the wearer's natural eye color, tinted color contact lenses feature a darker, opaque tint intended to alter the wearer's eye color, and light filtering tinted contact lenses function to accentuate certain colors while attenuating others. Rigid gas-permeable hard contact lenses are made from siloxane-containing polymers, but are harder than soft contact lenses and therefore retain their shape better and are more durable. Bifocal contact lenses are designed specifically for patients with presbyopia and are available in both soft and hard varieties. Toric contact lenses are designed specifically for patients with astigmatism and are also available in both soft and hard varieties. Combination lenses, such as hybrid contact lenses, that combine the various aspects described above are also available.

[0100] It is important to note that the lens design of the present disclosure may be incorporated into any number of different contact lenses formed from any number of materials. Specifically, the lens design of the present disclosure may be utilized in any of the contact lenses described herein, including daily disposable contact lenses, rigid gas permeable contact lenses, bifocal contact lenses, toric contact lenses, and hybrid contact lenses. Furthermore, although the present disclosure is described with respect to contact lenses, it is important to note that the concepts of the present disclosure may be utilized in spectacle lenses, intraocular lenses, corneal inlays, and onlays.

[0101] While the embodiments shown and described herein are considered to be the most practical and preferred embodiments, it will be apparent to one skilled in the art that variations from the specific designs and methods shown and disclosed herein will be obvious to those skilled in the art and may be used without departing from the spirit and scope of the invention. The present invention is not limited to the specific constructions described and illustrated, but should be constructed consistent with all modifications that may fall within the scope of the appended claims. Furthermore, the repeated use of the term "comprising" may include "consisting essentially of" and / or "consisting of," as support is found herein for such terms by use of the term "comprising."

[0102] [Embodiment] (1) An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: a central zone having a negative power for the correction of myopia; and 1. An ophthalmic lens comprising at least one treatment zone surrounding said central zone, said at least one treatment zone having a power profile including a positive power relative to said central zone, said at least one treatment zone having a surface shape including a portion of a generally toroidal shape, said at least one treatment zone being disposed to form a continuous surface with said central zone. (2) An ophthalmic lens as described in embodiment 1, wherein the portion of the approximately toroidal shape may be derived from a torus (e.g., a spherical torus) after creating a slice in the shape of the surface of a right circular cone through the surface of the torus, the principal axis of the cone coinciding with the axis of rotation around which the torus is generated. (3) An ophthalmic lens as described in embodiment 1, wherein the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (4) An ophthalmic lens as described in embodiment 3, wherein the entrance surface of the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (5) The ophthalmic lens of embodiment 1, further comprising a transition zone disposed between the central zone and the at least one treatment zone, whereby the at least one treatment zone, the transition zone, and the central zone form a continuous surface.

[0103] (6) The ophthalmic lens of embodiment 1, wherein the at least one treatment zone comprises an add power to the myopia correction of greater than +0.50D. (7) The ophthalmic lens of embodiment 1, wherein the at least one treatment zone comprises an optical power of about -10.00D to about +15.00D. (8) The ophthalmic lens according to embodiment 1, wherein the diameter of the central zone is from about 2 mm to about 7 mm. (9) An ophthalmic lens as described in embodiment 1, wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the central zone, the at least one treatment zone generating a focal ring, and the location of each of the infinity foci on the ring is offset ("non-coaxial") from the geometric axis of the central zone. (10) The ophthalmic lens of embodiment 1, wherein the at least one treatment zone has an outer edge that is approximately 4.5 mm from the center of the lens.

[0104] (11) An ophthalmic lens as described in embodiment 1, in which the halo effect is minimized. (12) The ophthalmic lens of embodiment 1, wherein the ophthalmic lens comprises a contact lens. (13) The ophthalmic lens of embodiment 1, wherein the ophthalmic lens comprises a spectacle lens. (14) The ophthalmic lens of embodiment 1, wherein the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay. (15) The ophthalmic article of embodiment 1, further comprising one or more stabilizing mechanisms.

[0105] (16) An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: 1. An ophthalmic lens comprising: a central zone having negative power for the correction of myopia; and at least one treatment zone surrounding the central zone, wherein the at least one treatment zone has a power profile including positive power relative to the central zone; the at least one treatment zone has an annular configuration having a shared radial center point with the central zone; the at least one treatment zone produces a focal ring, each location of an infinity focus on the ring being offset from the geometric axis of the central zone ("non-coaxial"), and the at least one treatment zone is arranged to form a continuous surface with the central zone. (17) The ophthalmic lens of embodiment 16, wherein the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (18) An ophthalmic lens as described in embodiment 17, wherein the entrance surface of the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (19) The ophthalmic lens of embodiment 16, further comprising a transition zone disposed between the central zone and the at least one treatment zone, whereby the at least one treatment zone, the transition zone, and the central zone form a continuous surface. (20) The ophthalmic lens of embodiment 16, wherein the at least one treatment zone comprises an add power of greater than +5.00D.

[0106] (21) The ophthalmic lens of embodiment 16, wherein the at least one treatment zone comprises an optical power of about -10.00D to about +15.00D. (22) The ophthalmic lens according to embodiment 16, wherein the diameter of the central zone is from about 3 mm to about 7 mm. (23) The ophthalmic lens of embodiment 16, wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the central zone, the at least one treatment zone exhibiting a focal ring, and the location of each of the infinity foci on the ring is offset from ("non-coaxial with") the geometric axis of the central zone. (24) The ophthalmic lens of embodiment 16, wherein the at least one treatment zone has an outer edge that is about 4.5 mm from the center of the lens. (25) An ophthalmic lens as described in embodiment 16, wherein the halo effect is minimized.

[0107] (26) The ophthalmic lens of embodiment 16, wherein the ophthalmic lens comprises a contact lens. 27. The ophthalmic lens of claim 16, wherein the ophthalmic lens comprises a spectacle lens. (28) The ophthalmic lens of embodiment 16, wherein the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay. (29) The ophthalmic article of embodiment 16, further comprising one or more stabilizing mechanisms. (30) An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: A central treatment zone; a myopia correction zone surrounding said central zone, said myopia correction zone exhibiting a negative optical power for the correction of myopia, said central zone exhibiting an add power relative to said myopia correction zone; an ophthalmic lens comprising: at least one treatment zone surrounding the central zone and disposed radially outward from the myopia correction zone; wherein the at least one treatment zone has a power profile including a positive power relative to the myopia correction zone; the at least one treatment zone has an annular configuration having a shared radial axis with the central zone; the at least one treatment zone produces a focal ring, each location of an infinity focus on the ring being offset from the geometric axis of the central zone ("non-coaxial"), and the at least one treatment zone is positioned to form a continuous surface with the central zone.

[0108] (31) The ophthalmic lens of embodiment 30, wherein the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (32) An ophthalmic lens as described in embodiment 31, wherein the entrance surface of the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (33) The ophthalmic lens of embodiment 30, further comprising a transition zone disposed between the central zone and the at least one treatment zone, whereby the at least one treatment zone, the transition zone, and the central zone form a continuous surface. (34) The ophthalmic lens of embodiment 30, wherein the at least one treatment zone comprises an add power of greater than +5.00D. (35) The ophthalmic lens of embodiment 30, wherein the at least one treatment zone comprises an optical power of about -10.00D to about +15.00D.

[0109] (36) The ophthalmic lens according to embodiment 30, wherein the diameter of the central zone is from about 3 mm to about 7 mm. (37) The ophthalmic lens of embodiment 30, wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the central zone, the at least one treatment zone exhibiting a focal ring, and the location of each of the infinity foci on the ring is offset from ("non-coaxial with") the geometric axis of the central zone. (38) The ophthalmic lens of embodiment 30, wherein the at least one treatment zone has an outer edge that is about 4.5 mm from the center of the lens. (39) An ophthalmic lens according to embodiment 30, wherein the halo effect is minimized. (40) The ophthalmic lens of embodiment 30, wherein the ophthalmic lens comprises a contact lens.

[0110] 41. The ophthalmic lens of claim 30, wherein the ophthalmic lens comprises a spectacle lens. (42) The ophthalmic lens of embodiment 30, wherein the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay. (43) The ophthalmic article of embodiment 30, further comprising one or more stabilizing mechanisms. (44) An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: A central treatment zone; a myopia correction zone surrounding said central zone, said myopia correction zone exhibiting a negative power for the correction of myopia, said central zone exhibiting an add power relative to said myopia correction zone; at least one treatment zone surrounding the central zone and disposed radially outward from the myopia correction zone, wherein the at least one treatment zone has a power profile including a positive power, the at least one treatment zone has a surface shape including a portion of a generally toroidal shape, and the at least one treatment zone is disposed to form a continuous surface with the central zone. (45) The ophthalmic lens of embodiment 44, wherein the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye.

[0111] (46) An ophthalmic lens as described in embodiment 45, wherein the entrance surface of the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (47) The ophthalmic lens of embodiment 44, further comprising a transition zone disposed between the central zone and the at least one treatment zone, whereby the at least one treatment zone, the transition zone, and the central zone form a continuous surface. (48) The ophthalmic lens of embodiment 44, wherein the at least one treatment zone comprises an add power of greater than +5.00D. (49) The ophthalmic lens of embodiment 44, wherein the at least one treatment zone comprises an optical power of about -10.00D to about +15.00D. (50) The ophthalmic lens according to embodiment 44, wherein the diameter of the central zone is from about 3 mm to about 7 mm.

[0112] (51) The ophthalmic lens of embodiment 44, wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the central zone, the at least one treatment zone exhibiting a focal ring, and the location of each of the infinity foci on the ring is offset from ("non-coaxial with") the geometric axis of the central zone. (52) The ophthalmic lens of embodiment 44, wherein the at least one treatment zone has an outer edge that is about 4.5 mm from the center of the lens. (53) An ophthalmic lens as described in embodiment 44, wherein the halo effect is minimized. (54) The ophthalmic lens of embodiment 44, wherein the ophthalmic lens comprises a contact lens. (55) The ophthalmic lens of embodiment 44, wherein the ophthalmic lens comprises a spectacle lens.

[0113] (56) The ophthalmic lens of embodiment 44, wherein the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay. (57) The ophthalmic article of embodiment 44, further comprising one or more stabilizing mechanisms. (58) An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: a central zone having a negative power for the correction of myopia, said central zone having a principal axis perpendicular to its surface and passing through the center of said ophthalmic lens; at least one treatment zone surrounding the central zone, the at least one treatment zone having a power profile including a positive power relative to the central zone, the at least one treatment zone having a surface shape including a portion of a generally toroidal shape, the at least one treatment zone being disposed to form a continuous surface with the central zone, and the at least one treatment zone having an inclination angle configured to direct an innermost light ray relative to a cross section of the treatment zone to intersect the principal axis at a point at or in front of a retinal plane of a wearer of the ophthalmic lens. (59) An ophthalmic lens as described in embodiment 58, wherein the tilt angle is configured to direct the innermost ray to intersect the principal axis at a point between the retinal surface and a point on the principal axis representing the coincidence point focus of the treatment zone. (60) An ophthalmic lens as described in embodiment 58, wherein the portion of the approximately toroidal shape may be derived from a torus (e.g., a spherical torus) after creating a slice in the shape of the surface of a right circular cone through the surface of the torus, the principal axis of the cone coinciding with the axis of rotation around which the torus is generated.

[0114] (61) The ophthalmic lens of embodiment 58, further comprising a transition zone disposed between the central zone and the at least one treatment zone, whereby the at least one treatment zone, the transition zone, and the central zone form a continuous surface. (62) The ophthalmic lens of embodiment 58, wherein the at least one treatment zone comprises an add power for myopia correction of greater than +5.00D. (63) The ophthalmic lens of embodiment 58, wherein the at least one treatment zone comprises an optical power of about -10.00D to about +15.00D. (64) The ophthalmic lens of embodiment 63, wherein the inclination angle depends on the optical power of the treatment zone. (65) The ophthalmic lens according to embodiment 58, wherein the diameter of the central zone is from about 3 mm to about 7 mm.

[0115] (66) The ophthalmic lens of embodiment 58, wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the central zone, the at least one treatment zone exhibiting a focal ring, and the location of each of the infinity foci on the ring is offset from ("non-coaxial with") the geometric axis of the central zone. (67) The ophthalmic lens of embodiment 58, wherein the at least one treatment zone has an outer edge that is about 4.5 mm from the center of the lens. (68) The ophthalmic lens of embodiment 58, wherein the halo effect is minimized. (69) The ophthalmic lens of embodiment 58, wherein the ophthalmic lens comprises a contact lens. (70) The ophthalmic lens of embodiment 58, wherein the ophthalmic lens comprises a spectacle lens.

[0116] (71) The ophthalmic lens of embodiment 58, wherein the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay. (72) The ophthalmic article of embodiment 58, further comprising one or more stabilizing mechanisms. (73) An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising: a central zone having negative power and exhibiting an on-axis focus; at least one treatment zone surrounding the central zone, the at least one treatment zone having a power profile including an add power relative to the central zone, the at least one treatment zone exhibiting a ring focus, and the power profile of the treatment zone including a curved ramp configuration. (74) An ophthalmic lens as described in embodiment 73, wherein a portion of the approximately toroidal shape may result from a torus (e.g., a spherical torus) after creating a slice in the shape of the surface of a right circular cone through the surface of the torus, the principal axis of the cone coinciding with the axis of rotation around which the torus is generated. (75) The ophthalmic lens of embodiment 73, wherein the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye.

[0117] (76) An ophthalmic lens as described in embodiment 75, wherein the entrance surface of the at least one treatment zone is configured to minimize the creation of a focal spot behind the retinal surface of the wearer's eye. (77) The ophthalmic lens of embodiment 73, further comprising a transition zone disposed between the central zone and the at least one treatment zone, whereby the at least one treatment zone, the transition zone, and the central zone form a continuous surface. (78) The ophthalmic lens of embodiment 73, wherein the at least one treatment zone comprises an add power for myopia correction of greater than +5.00D. (79) The ophthalmic lens of embodiment 73, wherein the at least one treatment zone comprises an optical power of about -10.00D to about +15.00D. (80) The ophthalmic lens of embodiment 73, wherein the diameter of the central zone is from about 3 mm to about 7 mm.

[0118] (81) The ophthalmic lens of embodiment 73, wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the central zone, the at least one treatment zone exhibiting a focal ring, and the location of each of the infinity foci on the ring is offset from ("non-coaxial with") the geometric axis of the central zone. (82) The ophthalmic lens of embodiment 73, wherein the at least one treatment zone has an outer edge that is about 4.5 mm from the center of the lens. (83) The ophthalmic lens of embodiment 73, wherein the halo effect is minimized. (84) The ophthalmic lens of embodiment 73, wherein the ophthalmic lens comprises a contact lens. (85) The ophthalmic lens of embodiment 73, wherein the ophthalmic lens comprises a spectacle lens.

[0119] (86) The ophthalmic lens of embodiment 73, wherein the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay. (87) The ophthalmic article of embodiment 73, further comprising one or more stabilizing mechanisms.

Claims

1. 1. An ophthalmic lens for at least one of slowing, retarding, or preventing the progression of myopia, comprising:

1. An ophthalmic lens comprising: a central zone having negative power for the correction of myopia; and at least one treatment zone surrounding the central zone, wherein the at least one treatment zone has a power profile including positive power relative to the central zone, the at least one treatment zone having an annular configuration having a shared radial center point with the central zone, the at least one treatment zone producing a focal ring, each location of an infinity focus on the ring being offset from the geometric axis of the central zone ("non-coaxial"), and the at least one treatment zone being arranged to form a continuous surface with the central zone.

Images