Ophthalmic lens with optical non-coaxial zone for myopia control

Abstract

The present disclosure relates to an ophthalmic device such as an ophthalmic lens. The ophthalmic device can include an ophthalmic lens for at least one of slowing, delaying, or preventing myopia progression. The ophthalmic lens can include a central zone having a negative optical power for myopic vision correction and at least one treatment zone surrounding the central zone, the at least one treatment zone having an optical power profile comprising an ADD optical power, the at least one treatment zone having a surface shape comprising a portion of a substantially annular shape, wherein the at least one treatment zone is arranged to form a continuous surface with the central zone.

Description

Background Technology 1. Technical Field

[0002] This disclosure relates to ophthalmic devices such as wearable lenses, including contact lenses, implantable lenses including inlays and onlays, and any other type of device including optical components, and more specifically, to ophthalmic devices designed to slow, delay, or prevent the progression of myopia. The ophthalmic lenses of this disclosure include at least one treatment area having an off-coaxial focal point with ADD power, thereby preventing and / or slowing the progression of myopia.

[0003] 2. Discussion in related fields

[0004] Currently, ophthalmic devices such as contact lenses are used to correct vision defects such as myopia, hyperopia, presbyopia, and astigmatism. However, properly designed lenses can be used to improve vision and correct vision defects.

[0005] Common conditions leading to decreased visual acuity are myopia and hyperopia, which require corrective lenses in the form of glasses or rigid or soft contact lenses. These conditions are generally described as an imbalance between the length of the eye and the focusing ability of the eye's optical components. Myopic eyes focus in front of the retinal plane, while hyperopic eyes focus behind the retinal plane. Myopia typically develops because the axial length of the eye grows longer than the focal length of the eye's optical components—that is, the eye becomes too long. Hyperopia typically develops because the axial length of the eye is too short compared to the focal length of the eye's optical components—that is, the eye does not grow long enough.

[0006] Myopia has a high prevalence in many parts of the world. The most concerning aspect is its potential to develop into high myopia, such as a refractive error greater than five or six (i.e., <-5.00D or -6.00D according to the notation), which significantly impairs a person's abilities without optical aids. As used in this article, the measure D is diopters, 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 diseases, cataracts, and glaucoma.

[0007] Corrective lenses alter the eye's overall focus by shifting the focus from in front of the retinal plane to correct myopia or from behind the retinal plane to correct hyperopia, thereby creating a clearer image at the retinal plane. However, this method of correction does not address the underlying cause; it is merely restorative or only resolves the symptoms.

[0008] Most eyes do not have simple myopia or hyperopia, but rather myopic astigmatism or hyperopic astigmatism. Astigmatic errors in focusing cause the image of a point light source to form two mutually perpendicular lines at different focal lengths. In the preceding discussion, the terms myopia and hyperopia were used to encompass simple myopia or myopic astigmatism and hyperopic astigmatism or mixed astigmatism (combinations thereof), respectively.

[0009] Emmetropia describes a state of clear vision in which objects at infinity are relatively sharply focused when the lens is relaxed. In the eyes of normal or emmetropic adults, light from distant and near objects and passing through the central or paraxial region of the aperture or pupil is focused by the cornea and lens close to the plane of the retina, where an inverted image is sensed. However, the most normal eyes are observed to exhibit positive longitudinal spherical aberration, typically with an amplitude of approximately +0.50D for an aperture of 5.00 mm. This means that when the eye is focused at infinity, light passing through the aperture or pupil at its periphery is focused at +0.50D in front of the plane of the retina.

[0010] The spherical aberration of a normal eye is not constant. For example, accommodation (a change in the eye's optical power caused primarily by altering the internal lens) causes spherical aberration to change from positive to negative.

[0011] As noted, myopia typically occurs due to excessive axial growth or elongation of the eye. It is now generally accepted, primarily from animal studies, that axial eye growth can be influenced by the quality and focus of the retinal image. Experiments using several different paradigms on a range of different animal species have shown that altering the quality of the retinal image can lead to consistent and predictable changes in eye growth.

[0012] Furthermore, it is known that defocusing retinal images in chick and primate models by positive lenses (myopic defocus) or negative lenses (hyperopic defocus) leads to predictable changes in eye growth (in both direction and magnitude) that correspond to eye growth in order to compensate for the imposed defocus. Changes in eye length associated with optical blur have been shown to be modulated by variations in both scleral growth and choroidal thickness. Blurring with positive lenses results in myopic blurring, choroidal thickening, and a reduced rate of scleral growth, leading to hyperopic refractive errors. Blurring with negative lenses results in hyperopic blurring, choroidal thinning, and an increased rate of scleral growth, leading to myopic refractive errors. These changes in eye growth in response to retinal image defocus have been shown to be largely mediated by local retinal structures, as changes in eye length still occur when the optic nerve is damaged, and imposed defocus on local retinal regions has been shown to result in changes in eye growth confined to specific retinal areas.

[0013] In humans, there is both indirect and direct evidence supporting the concept that retinal image quality can influence eye growth. Various eye conditions, all of which lead to visual disturbances such as ptosis, congenital cataracts, corneal opacities, vitreous hemorrhage, and other eye diseases, have been found to be associated with abnormal eye growth in young people, suggesting that relatively large changes in retinal image quality do indeed affect eye growth in human subjects. More subtle variations in retinal image quality have also been hypothesized to influence human eye growth based on optical errors in the human focusing system, which can stimulate eye growth and myopia development.

[0014] One of the risk factors for myopia development is near work. Due to accommodative lag or negative spherical aberration associated with accommodation during such near work, the eye can experience hyperopic blur, which in turn stimulates myopia development as discussed above. Furthermore, the accommodative system is an active adaptive optics system; it constantly responds to the convergence and divergence of the incident optics, which is affected by the optical apparatus and the working distance. For conventional single-vision optics designs used for myopia correction, young eyes may exhibit accommodative lag or negative spherical aberration, and therefore, hyperopic defocus may occur. For traditional multifocal designs employing coaxial ADD power within the treatment zone, such as those used for presbyopia correction and recently modified for myopia control, young eyes may utilize the ADD power for near objects, resulting in hyperopic defocus through the distance portion of the image for such objects. Myopia control is most effective when the user adapts to near vision through the distance correction zone, bringing the image plane onto 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).

[0015] Both the aforementioned monocular and polyvision cases lead to continued myopia progression. One approach to designing optics to slow the rate of myopia progression is to utilize a high ADD (additional dexterity) signal to the retina. ADD is the difference in optical power between the treatment zone of a purpose-specific optics device (such as for presbyopia correction or myopia control) and the myopia correction zone. For myopia control, the ADD in the treatment zone of the optics is more positive (more) or less negative than the optical power in the myopia correction zone.

[0016] U.S. Patent No. 6,045,578 discloses that adding positive spherical aberration to a contact lens can reduce or control the progression of myopia. The method involves changing the spherical aberration of the ocular system by altering the direction and angle associated with changes in eye length growth; in other words, emmetropization can be modulated by spherical aberration. In this process, the cornea of ​​the myopic eye is fitted with a lens having an increased refractive power away from the lens center. Paraxial rays entering the central portion of the lens focus on the retina of the eye, producing a sharp image of the object. Peripheral rays entering the peripheral portion of the pupil focus in the plane between the cornea and retina, and produce positive spherical aberration of the image on the retina. This positive spherical aberration has a physiological effect on the eye that tends to inhibit eye growth, thereby mitigating the tendency for myopia to elongate.

[0017] While the level of positive spherical aberration and / or added power required to achieve optimal deceleration of myopia progression is unclear, researchers in the field have attempted to slow myopia progression using multi-zone devices with zones having positive optical powers ranging from approximately +1.50D to a maximum of +4.00D ADD. To distinguish these multi-zone designs from current publications, the ADD zone in these devices produces a focal point aligned with the axis (primary axis, common axis, optical axis, or geometric axis) of the myopia correction zone and can therefore be considered "coaxial" in design. (e.g., US5929969, US7506983, US7832859, US8240847)

[0018] This method typically results in a treatment efficacy of less than approximately 50%. Treatment efficacy is defined as the relative change in axial length and / or spherical equivalent refraction from baseline in the test group compared to the change in axial length and / or spherical equivalent refraction in the control group over a period of more than one year or a predetermined time. Myopia control treatments with efficacy greater than 50% and closer to 100% are still required. As reported by Wildsoet, Vision Research 1995, since the ocular growth response in animals is proportional to the optical power of the light stimulus, intuitively attaching a high-power treatment zone should provide more effective treatment.

[0019] However, as reported by Ardaya et al. in Optometry in 2004, the conventional wisdom in the field of bifocal or multifocal ophthalmic lenses holds that lenses with high added or high ADD power can have detrimental effects on visual acuity and contrast sensitivity. Furthermore, Smith et al. (US7025460) raised objections to power levels beyond those typically found in bifocal or multifocal lenses used for presbyopia. They stated that "it is important to note that while appropriate types of refractive defocus can drive eye growth (or non-growth) leading to myopia (or its regression) in the lens-compensation phenomenon, when the amount of refractive defocus is large, there can be such a significant deterioration in image quality because the optical state can alter the form deprivation phenomenon and thus induce severe defocus for myopia." Furthermore, they proposed that "before significant visual deterioration occurs, the maximum relative curvature in this region leading to form deprivation myopia is approximately +3.50D to +4.00D spherical equivalent, which represents the upper limit of negative curvature in the region for effective treatment of myopia." This view has prevented researchers from pursuing higher treatment zones for myopia control.

[0020] Conversely, the applicant's research shows that designs using a high ADD treatment zone with a central distance zone and an ADD power greater than approximately 3.00D reduce visual acuity loss compared to low ADD design designs, which do not have a significant additional effect on contrast sensitivity. This is also supported by the work of De Gracia et al. in OVS in 2013, although they only investigated ADD powers up to 4.00D and did not make the work involve potential benefits in myopia progression control. This breakthrough enables ophthalmic designs to achieve a meaningful slowing of myopia progression greater than 50% without further negatively impacting visual acuity.

[0021] Furthermore, the significantly higher added power relative to the power used to provide clear distance vision is not expected to result in the reduced accommodation that can occur with a lower ADD power design, where subjects may rely to some extent on the ADD power for clear vision during near work activities, as observed during our study. This reduced adaptation can lead to hyperopic defocus because light passes through the optical zone of the device used to provide clear distance vision (the distance portion of the device or the myopia correction zone). In the current disclosure, because objects imaged through the treatment zone with high ADD power are sufficiently unfocused and cannot be cleared by the accommodative convergence system, subjects must adjust the distance portion of the lens for near vision correction.

[0022] Other attempts to slow the progression of myopia may involve showing a gradient distribution of optical power in certain zones of the lens. Various methods have been applied. Some treatment zones are progressive zones, where a systematic alteration of the coaxial focal point is configured, e.g., see US8240847, US8662664. However, other designs are configured to produce more peripheral retinal myopic defocus (e.g., see US7665842, US8684520). Furthermore, some designs may be referred to as blending zones or transition zones because they are essentially non-functional optically intended zones designed to join treatment zones with corrective zones (e.g., see US8240847, US 8684520). None of these designs have a treatment zone that includes a portion of a generally annular surface to produce annular focal points as per this disclosure.

[0023] US20170184875 envisions "an optical feature of the lens body that, when worn on the eye, directs peripheral light away from the central region of the retina into the eye, wherein the optical feature also causes peripheral light away from the central region of the retina to have a focal point not on the retina." It specifies that "the optical feature may have the following characteristics: directing light into the peripheral region of the retina, precisely focusing light onto the peripheral region of the retina, focusing light in front of the peripheral region of the retina, focusing light behind the peripheral region of the retina, or a combination thereof." This patent does not envision a treatment area including a portion of a general annular surface to produce an annular focal point as described in this disclosure.

[0024] As another example in this field, R. Griffin (WO2012 / 173891) claims to reduce accommodative lag and accommodative stress that contribute to myopia development by creating artificial pinholes that increase depth of focus and field. According to Griffin, "the eye adapts more easily."

[0025] Now for reference Figure 1 The graph illustrates a device with a design that combines a central distance zone for corrected visual acuity with a peripheral zone of variable added power. Visual acuity was measured using a four-alternative forced selection method with progressively decreasing Snellen targets. Increasing the peripheral added power to approximately +2.00D to +3.00D resulted in a greater loss of high-contrast visual acuity, typical of multifocal designs for presbyopia. As the peripheral power continued to increase, however, the relative effect on visual acuity improved dramatically and stabilized, making the loss of visual acuity relatively constant with peripheral additions exceeding approximately +4.00D to +5.00D. As reported in Wildsoet, Vision Research 1995, this has significant implications for the design of myopia control lenses, as higher added power has been found (in animal models) to have a significant impact on eye growth.

[0026] However, further optimization of the ADD optical power design is needed to improve image quality. (See reference now.) Figure 2 The diagram shows optical power distributions of +5.00D or +10.00D with a radial position 2.25mm from the center of the lens. Light rays passing through these high ADD optical power regions form a sharp focus in front of the retina. However, as they continue to propagate to the retina, these rays create a ring-shaped defocus blur on the retina.

[0027] As in Figure 3 As shown in the point spread function (PSF) cross-section, light from the +5.00D and +10.00D regions forms independent peaks on the retina. Therefore, if a person views a point light source through one of these +5.00D or +10.00D high-power lenses, their retina should receive a peak signal surrounded by a ring of light. Normally, this is not a problem when a person is reading text or resolving details of objects because the presence of peaks in the PSF allows energy from a white background to leak into black, which is problematic if a person is viewing a black / white edge.

[0028] Now for reference Figure 4 By convolving the PSF with black / white edges in object space, the effect at an incident pupil size of 6.00 mm is shown. Figure 2 Image cross-sections of the +5.00D and +10.00D power distributions. A lens with 0.00D power forms a sharp edge between black and white (at the 0.00mm position) and therefore does not have a ring-like structure. On the other hand, lenses with +5.00D and +10.00D regions do not have sharp edges between black and white, resulting in a black background that is not completely black and a white background that is not completely white in the image.

[0029] Therefore, improvements are needed. Summary of the Invention

[0030] This disclosure relates to an ophthalmic device for slowing, delaying or preventing at least one of the shortcomings of the prior art in slowing down, delaying or preventing the development of myopia.

[0031] According to one aspect, the present invention relates to ophthalmic lenses for slowing down, delaying, or preventing at least one of the progressions of myopia. The ophthalmic lens includes a central region with negative optical power for myopia correction and at least one treatment region surrounding the central region. The at least one treatment region has an optical power distribution including positive optical power relative to the central region. The at least one treatment region has a surface shape including a portion of a generally annular shape, wherein the at least one treatment region is arranged to form a continuous surface with the central region.

[0032] According to another aspect, the present invention relates to ophthalmic lenses for slowing, delaying, or preventing at least one of the progressions of myopia. The ophthalmic lens includes a central region having a negative optical power for myopia correction; and at least one treatment region surrounding the central region, the at least one treatment region having an optical power distribution including a positive optical power relative to the central region, wherein the at least one treatment region has a ring configuration having a radial center point shared with the central region, and wherein the at least one treatment region generates a focal ring, the trajectory of each of the infinite focal points on the ring being displaced from the geometric axis of the central region (“non-coaxial”), and wherein the at least one treatment region is arranged to form a continuous surface with the central region.

[0033] According to another aspect, the present invention relates to ophthalmic lenses for slowing, delaying, or preventing at least one of the progressions of myopia. The ophthalmic lens includes a central treatment zone, a myopia correction zone surrounding the central zone, wherein the myopia correction zone exhibits negative optical power for myopia correction, and wherein the central zone exhibits ADD optical power relative to the myopia correction zone, and at least one treatment zone surrounding the central zone and arranged radially outward from the myopia correction zone, the at least one treatment zone having an optical power distribution including positive optical power relative to the myopia correction zone, wherein the at least one treatment zone has a ring configuration having a radial axis shared with the central zone, and wherein the at least one treatment zone generates a focal ring, the trajectory of each of the infinite focal points on the ring being displaced from the geometric axis of the central zone (“non-coaxial”), and wherein the at least one treatment zone is arranged to form a continuous surface with the central zone.

[0034] According to another aspect, the present invention relates to ophthalmic lenses for slowing down, delaying, or preventing at least one of the progressions of myopia. The ophthalmic lens includes a central treatment area, a myopia correction area surrounding the central area, wherein the myopia correction area exhibits negative optical power for myopia correction, and wherein the central area exhibits ADD optical power relative to the myopia correction area, and at least one treatment area surrounding the central area and disposed radially outward from the myopia correction area, the at least one treatment area having an optical power distribution including positive optical power, the at least one treatment area having a surface shape including a portion of a generally annular shape, and wherein the at least one treatment area is arranged to form a continuous surface with the central area.

[0035] According to another aspect, the present invention relates to ophthalmic lenses for slowing, delaying, or preventing at least one of the progressions of myopia. The ophthalmic lens includes a central region having a negative optical power for myopia correction, the central region having a principal axis orthogonal to its surface and passing through the center of the ophthalmic lens, and at least one treatment area surrounding the central region, the at least one treatment area having an optical power distribution including a positive optical power relative to the central region, the at least one treatment area having a surface shape including a portion of a generally annular shape, wherein the at least one treatment area is arranged to form a continuous surface with the central region, and wherein the at least one treatment area has a tilt angle configured to guide the innermost light rays relative to the cross-section of the treatment area to intersect the principal axis at a point at or before the retinal plane of the wearer of the ophthalmic lens.

[0036] According to another aspect, the present invention relates to ophthalmic lenses for slowing down, delaying, or preventing at least one of the progressions of myopia. The ophthalmic lens includes a central region having negative optical power and exhibiting an on-axis focal point, and at least one treatment zone surrounding the central region, the at least one treatment zone having an optical power distribution including an ADD optical power relative to the central region, the at least one treatment zone exhibiting an annular focal point, wherein the optical power distribution of the treatment zone includes a curved ramp configuration. Attached Figure Description

[0037] The above and other features and advantages of this disclosure will become apparent from the more detailed description of the preferred embodiments shown in the accompanying drawings.

[0038] Figure 1 The graph shows the change in visual acuity as the ADD power in the peripheral zone increases.

[0039] Figure 2 The power distribution of the two lenses is shown, one with a +5.00D treatment area and the other with a +10.00D treatment area.

[0040] Figure 3 This shows the effect of an incident pupil size of 6.00 mm on... Figure 2 The cross-section of the point spread function of the optical power distribution.

[0041] Figure 4 It shows the result of Figure 2 The optical power distribution produces a cross-section of image intensity for black and white edges.

[0042] Figure 5A A schematic diagram of an example of an ophthalmic device having at least one treatment area according to the present disclosure is shown.

[0043] Figure 5B It shows Figure 5AA perspective view of an ophthalmic device.

[0044] Figure 5C This shows a portion of the annular shape after it has been cut through a tapered surface.

[0045] Figure 5D The diagram shows a ring-shaped portion set on an elliptical shape.

[0046] Figure 5E A portion of a ring shape set on a hat is shown, which may be, for example... Figure 5D It is part of an oval shape.

[0047] Figure 5F The concentric treatment area that causes the point focus is shown.

[0048] Figure 5G The treatment area of ​​this disclosure that causes the ring focus is shown.

[0049] Figure 6 An example of an ophthalmic device having a central myopia correction zone and at least one treatment zone according to the present disclosure is shown.

[0050] Figure 7 An example of an ophthalmic device according to the present disclosure is shown, having a central myopia correction zone, a myopia correction area, and at least one treatment zone.

[0051] Figure 8A The optical power distribution of the ophthalmic device is shown.

[0052] Figure 8B It shows Figure 8A Annotated version of the optical power distribution.

[0053] Figure 8C A ray diagram showing coaxial and non-coaxial focal points associated with the ophthalmic device of this disclosure is shown.

[0054] Figure 9A It is a schematic diagram of light rays associated with a plane wavefront passing through an orthogonal (or fully corrected) eye toward the retina.

[0055] Figure 9B This is a schematic diagram of the light rays associated with a wavefront, which has a spherical wavefront error of +10.00D (relative to the retina) traveling through the eye towards the retina. Figure 9A (errors in the process).

[0056] Figure 9C It is a schematic diagram of light passing through an optical system (normal vision plus optical device), in which the optical device has a plane (i.e., 0.00D) optical power at the center and a coaxial optical power of +10.00D at the periphery.

[0057] Figure 9D It is a schematic diagram of light passing through an optical system (normal vision plus optical device), wherein the optical device has a plane (i.e., 0.00D) optical power at the center and a non-coaxial optical power of +10.00D at the periphery.

[0058] Figure 9E It is a schematic diagram of light passing through an optical system (normal vision plus optical device), wherein the optical device has a planar power (i.e., 0.00D) at the center and a non-coaxial power of +10.00D at the periphery, wherein the center of the light beam from the peripheral region is tilted inward and points away from the central fovea.

[0059] Figure 10A A ray diagram showing the focal ring of the ophthalmic device according to the present disclosure is shown.

[0060] Figure 10B A ray diagram illustrating the focal ring and central region with ADD optical power of an ophthalmic device according to the present disclosure is shown.

[0061] Figure 11A It is a schematic diagram of light rays passing through an optical system (normal vision plus optical device), wherein the optical device has a planar power (i.e., 0.00D) at the center and a non-coaxial power of +10.00D at the periphery, wherein the center of the light ray beam in the peripheral region is tilted inward and points asymmetrically away from the central fovea.

[0062] Figure 11B It is a schematic diagram of light rays passing through an optical system (normal vision plus optical device), wherein the optical device has a planar power (i.e., 0.00D) at the center and a non-coaxial power of +10.00D at the periphery, wherein the center of the light ray beam in the peripheral region is tilted outward and points symmetrically away from the central fovea.

[0063] Figure 11C It is a schematic diagram of light rays passing through an optical system (normal vision plus optical device), wherein the optical device has a planar power (i.e., 0.00D) at the center and a non-coaxial power of +10.00D at the periphery, wherein the center of the light ray beam in the peripheral region is tilted outward and points asymmetrically away from the central fovea.

[0064] Figure 12A A ray diagram showing the focal ring of the ophthalmic device according to the present disclosure is shown, which demonstrates that light rays passing through the peripheral region converge to a point behind the retinal plane.

[0065] Figure 12B A ray diagram illustrating the focal ring of the ophthalmic device according to the present disclosure is shown, which demonstrates that light passing through the peripheral region does not converge to any point behind the retinal plane.

[0066] Figure 13 A comparison of two power distributions of various ophthalmic devices according to this disclosure is shown.

[0067] Figure 14A A graph showing the variation in axial length of the human eye exposed to various sample optical configurations is presented.

[0068] Figure 14B A graph showing the variation in axial length of the human eye exposed to various sample optical configurations is presented.

[0069] Figure 14C A graph showing the variation in axial length of the human eye exposed to various sample optical configurations is presented.

[0070] Figure 14D A graph showing the variation in axial length of the human eye exposed to various sample optical configurations is presented.

[0071] Figure 15A The power distribution of an ophthalmic device with two peripheral treatment zones according to this disclosure is shown.

[0072] Figure 15B The optical power distribution of an ophthalmic device having two peripheral treatment zones and a central treatment zone with ADD optical power according to the present disclosure is shown.

[0073] Figures 16A-16B Subjective responses regarding comfort, vision, and handling were shown 1–3 days after lens placement with three multi-zone test lenses and one control lens (a commercially available single-vision soft contact lens). These responses were measured in the contact lens user experience, CLUE. TM A comparison chart of scores, where Figure 16A The LSM and CLUE lens types are shown. TM The score has a 95% CI, and Figure 16B The LSM difference and CLUE are shown between each of the three test lenses and the control lens. TM The 95% CI of the Vision score.

[0074] Figures 17A-17B The graph shows a comparison of monocular (A) and binocular (B) logMAR visual acuity between three multi-zone test lenses and one control lens (commercially available monocular soft contact lens) under three different contrast / illumination conditions (LSM and 95% CI).

[0075] Figures 18A-18B The graph shows a comparison of monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and control lenses under high-contrast bright conditions (LSM difference and 95% CI).

[0076] Figures 19A-19B The graph shows a comparison of monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and control lenses under high-contrast dim conditions (LSM difference and 95% CI).

[0077] Figures 20A-20B The graph shows a comparison of monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and control lenses under low-contrast bright conditions (LSM difference and 95% CI). Detailed Implementation

[0078] Ophthalmic devices can include implantable devices and / or wearable devices such as contact lenses. Conventional contact lenses consist of polymer structures with specific shapes to correct various vision problems.

[0079] As part of a typical ophthalmological examination, eye care professionals can determine the contact lens scheme needed to correct a patient's refractive errors. This scheme can specify the refractive power, cylindrical power, and / or cylindrical axis of the contact lens, which can be used to determine the design or selection of the contact lens.

[0080] The optical function of radially concentric multi-zone ophthalmic lenses, at least for spherical correction purposes, typically derives from the anterior and posterior surfaces. One of these surfaces may be essentially spherical or ellipsoidal. The other surface typically has a spherical or elliptical cap, followed by one or more curved sections, each of which is a spherical or elliptical truncated cone (“zone”) surface, arranged symmetrically to form a continuous surface. These zones may be radially concentric and optically coaxial around a common axis.

[0081] In one aspect, each truncated cone can be produced by cutting a sphere or ellipsoid of appropriate size and shape to achieve the desired optical power perpendicular to the principal axis of such a sphere or ellipsoid. In some cases, transitional regions (e.g., optical dysfunction) may be required to allow the individual zones to form a continuous surface. For myopia treatment, some zones will typically produce a more corrected wavefront number than one or more zones used to correct distance vision, where the wavefront number is obtained relative to the radial distance from the principal axis (dW / dr). Light rays parallel to the common axis and passing through the zones will become the principal focal points of each zone, and these focal points will lie on the common axis used for rotationally symmetric zones. When ophthalmic lenses are used to correct vision and one or more zones have principal focal points with different focal lengths, the image formed at the retina of the eye may be blurred, or have double images or halos, leading to visual impairment.

[0082] In some implementations, satisfactory visual effects can be achieved by preparing regions (or design regions for replacing lenses) with surface shapes derived from a toroidal shape (e.g., a spherical torus), or, in the case of replacing multiple regions, from one or more toroidals. As an example, after slicing the surface of a spherical torus in the shape of a straight conical surface, a generally toroidal portion can be derived from the torus (e.g., a spherical torus) where the principal axis of the cone coincides with the axis of rotation, creating the torus around said axis of rotation. The toroidal portion forming part of the lens surface is arranged to form a continuous surface with other regions of the lens or connected by transitional regions of optical dysfunction, allowing the individual regions to form continuous surfaces. Other slices (conical or other slices) besides those outlined herein can also be used.

[0083] One advantage of using one or more toroidal surfaces as the basis for designing one or more zones is that the light rays passing through that zone of the lens should form a ring focal point rather than a point focal point. This scattering of light can be arranged such that it results in a reduction in the visual impact of the light rays passing through one or more correction zones of the lens. Significant advantages of this design are less impact on visual acuity, minimal interference with normal accommodation, and reduced halo effect. As a result, a larger treatment zone and higher ADD power can be used. The reduction in image contrast is proportional to the size of the treatment zone within the pupil of the eye. The focal point of the scattered light rays is in front of the retina, but this still provides a strong myopia control effect. The ADD power referred to as "non-coaxial" focal point in this invention refers to a positive power along the axis of the light rays passing through the treatment zone, contrary to the conventional definition of power, derived from the location where the light rays intersect the coaxial axis.

[0084] According to the disclosure, ophthalmic lenses have at least one high ADD treatment zone around the central area for treating, preventing or slowing myopia progression, while also minimizing any halo effect.

[0085] Now for reference Figures 5A-5BThe image illustrates a contact lens 500 according to one embodiment of the present disclosure. The contact lens 500 includes an optical zone 502 and an outer zone 504. The optical zone 502 includes a first zone or central zone 506 and at least one peripheral zone or treatment zone 508. Although two treatment zones 508 are shown, multiple treatment zones can be used, and the multiple treatment zones can be concentrically positioned from a central axis at various radii. In a specific embodiment, as measured from the geometric center of the lens 500, the diameter of the optical zone 502 can be selected as 8.00 mm, the diameter of the substantially circular central zone 506 can be selected as 4.00 mm, and the boundary diameter of the annular outer treatment zone 508 can be 5 mm and 6.5 mm. As an example, the central zone 506 can be configured to have a power distribution to correct myopia and provide satisfactory visual acuity. Such a power distribution can include negative power. As another example, at least one treatment zone 508 can be configured to treat, prevent, or slow the progression of myopia. At least one treatment area 508 can be configured to have a surface shape that produces a focal ring, the trajectory of each of the infinite focal points on the ring being displaced from the geometric axis of the central area 506 (“non-coaxial”). The optics of the treatment area 508 may include aberrations, thereby causing light rays passing through the treatment area not to be focused onto a sharp focal ring. Instead, a blurred focal ring may be produced. In some aspects, the central area 506 may include an area of ​​ADD optical power, such as… Figure 7 As described in (section 706).

[0086] It is important to note that Figures 5A-5B Only exemplary embodiments of this disclosure are shown. For example, in this exemplary embodiment, the outer boundary of at least one treatment area 508 may not coincide with the outer edge of the optical area 502; however, in other exemplary embodiments, they may coincide. The outer area 504 surrounds the optical area 502 and provides standard contact lens features, including lens positioning and centering. According to one exemplary embodiment, the outer area 504 may include one or more stabilizing mechanisms to reduce rotation when the lens is on the eye.

[0087] Figures 5A-5BThe various zones within are shown as concentric rings. Zones may include any suitable circular or non-circular shape, such as an ellipse. It is important to note that, due to differences in the incident pupil size among subgroups, in some exemplary embodiments, lens design can be tailored based on the patient's average pupil size to achieve good foveal visual acuity correction (e.g., vision correction) and myopia treatment efficacy. Furthermore, since pupil size is related to the refractive index and age of pediatric patients, in some exemplary embodiments, lenses can be further optimized for subgroups of pediatric subgroups with specific age and / or refractive indices based on their pupil size. Essentially, lens design can be adjusted or tailored to pupil size to achieve an optimal balance between foveal visual acuity correction and minimizing the halo effect originating from the high ADD treatment zone.

[0088] refer to Figure 5C-5E Treatment area 508 may have a shape including a portion of a generally annular shape, wherein at least one treatment area 508 is arranged to form a continuous surface with respect to the central area. As an example, the annular portion may be derived from a torus (e.g., a spherical torus), wherein a slice passing through the surface of the spherical torus to produce the annular portion includes a right circular conical surface, the main axis of the cone 510 coinciding with the axis of rotation, about which the torus is produced.

[0089] refer to Figure 5F According to this disclosure, the treatment area 508 can be configured to generate a point focus 512. (See reference...) Figure 5G According to this disclosure, the treatment area 508 can be configured to generate an annular focal point 514. The position of the focal ring can depend on the optical power of the treatment area 508. As will be described in further detail, the focal point of the annular treatment area 508 can be a result of various surface features of the treatment area 508, including but not limited to the tilt of the surface of the treatment area 508 and the optical power of the treatment area 508.

[0090] Now for reference Figure 6The image shows a perspective view of a contact lens 600 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 zone or central zone 606 and at least one treatment zone 608 or peripheral zone. In a specific embodiment, the diameter of the optical zone 602, as measured from the geometric center of the lens 600, can be selected as 8.00 mm, the diameter of the substantially circular central zone 606 can be selected as 4.00 mm, and the boundary diameter of the annular outer treatment zone 608 relative to the geometric center of the lens 600 can be 5 mm and 6.5 mm. As an example, the central zone 606 can be configured to have a power distribution to correct myopia and provide satisfactory visual acuity. Such a power distribution can include negative power. As another example, the treatment zone 608 can be configured as a treatment zone for treating, preventing, or slowing the progression of myopia. Treatment area 608 can be configured to have a surface shape exhibiting the foci of the ring, the trajectory of each of the infinite foci on the ring being displaced from the geometric axis of central area 606 (“non-coaxial”). Additional treatment areas 608 may be used.

[0091] As an example, ophthalmic lens 600 can be configured to slow, delay, or prevent at least one of the following: the progression of myopia. The ophthalmic lens may include a central area 606 and at least one peripheral area 608 (e.g., a treatment area) surrounding the central area 606, the central area 606 having a negative optical power for myopia correction. At least one treatment area 608 may have an area or zone including an ADD optical power region. At least one treatment area 608 may include an absolute optical power from about -10.00D to about +15.00D. At least one treatment area 608 may include a relative ADD optical power, thereby causing the optical power of the treatment area 608 to be corrected compared to adjacent or reference areas such as the central area 606 (e.g., a vision correction area, a myopia correction area, etc.). As an example, the myopia correction area may have a -5.00D optical power and the treatment area may have a -3.00D optical power, thus having a +2.00D ADD optical power. As another example, the myopia correction zone can have a power of -3.00D and the treatment zone can have a power of +5.00D, thus having a power of +8.00D ADD.

[0092] At least one treatment area 608 may have a ring configuration sharing a common geometric axis with the central area 606, and wherein at least one treatment area 608 exhibits (i.e., causes) a focal ring, wherein the trajectory of each of the infinite focal points on the ring is displaced from the geometric axis of the central area 606 (“non-coaxial”).

[0093] At least one treatment area 608 may have a surface shape including a portion of a generally annular shape, wherein at least one treatment area 608 is arranged to form a continuous surface with respect to the central area. As an example, after slicing the surface of a spherical torus in the shape of a straight circular cone, a portion of a generally annular shape may be derived from the torus (e.g., a spherical torus), wherein the principal axis of the cone coincides with the axis of rotation, and the torus is generated around the axis of rotation.

[0094] It is important to note that Figure 6 Only exemplary embodiments of this disclosure are shown. For example, in this exemplary embodiment, the outer boundary of at least one treatment area 608 may not coincide with the outer edge of the optical area 602; however, in other exemplary embodiments, they may coincide. The outer area 604 surrounds the optical area 602 and provides standard contact lens features, including lens positioning and centering. According to one exemplary embodiment, the outer area 604 may include one or more stabilizing mechanisms to reduce rotation when the lens is on the eye.

[0095] Now for reference Figure 7The diagram shows a perspective view of a contact lens 700 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 zone or central zone 706 and at least one peripheral treatment zone 708, and a myopia correction zone 707 disposed between the central zone 706 and at least one peripheral treatment zone 708. In a specific embodiment, the diameter of the optical zone 702, as measured from the geometric center of the lens 700, can be selected as 8.0 mm, the diameter of the substantially circular central zone 706 can be selected as 4.0 mm, and the boundary diameter of the annular outer treatment zone 708 relative to the geometric center of the lens 700 can be 5 mm and 6.5 mm. As an example, the central zone 706 can be configured with an optical power distribution having an ADD optical power. The central zone 706 can be configured to exhibit (i.e., cause) a focal point between the lens 700 and the wearer's retinal plane to treat myopia and provide satisfactory visual acuity. A myopia correction zone 707 can be configured to surround a central zone 706 and can be configured to have a power distribution to correct distance vision for myopia. Such a power distribution may include negative power. As another example, a treatment zone 708 can be configured as a treatment zone for treating, preventing, or slowing the progression of myopia. The treatment zone 708 can be configured to have a surface shape exhibiting (i.e., causing) annular focal rings, the trajectory of each of the infinite focal points on the rings being displaced from the geometric axis of the central zone 706 (“non-coaxial”). Additional treatment zones 708 may be used. At least one treatment zone 708 may have a power distribution including an ADD power region or area such as the central zone 706. At least one treatment zone 708 may include an absolute power from about -10.00D to about +15.00D. At least one treatment zone 708 may include a relative ADD power, thereby making the power of the treatment zone 708 more corrected than that of a neighboring zone or reference zone, such as the central zone 707 (e.g., a vision correction zone, a myopia correction zone, etc.). As an example, the myopia correction zone may have a power of -5.00D and the treatment zone may have a power of -3.00D, thus having a +2.00D ADD power. As another example, the myopia correction zone may have a power of -3.00D and the treatment zone may have a power of +5.00D, thus having a +8.00D ADD power.

[0096] At least one treatment area 708 may have a ring configuration sharing a common geometric axis with the central area 706, and at least one treatment area 708 exhibits a focal ring, wherein the trajectory of each of the infinite focal points on the ring is displaced from the geometric axis of the central area 706 (“non-coaxial”).

[0097] At least one treatment area 708 may have a surface shape including a portion of a generally annular shape, wherein at least one treatment area 708 is arranged to form a continuous surface with respect to the central area. As an example, after slicing the surface of a spherical torus in the shape of a straight circular cone, a portion of a generally annular shape may be derived from the torus (e.g., a spherical torus), wherein the principal axis of the cone coincides with the axis of rotation, and the torus is generated around the axis of rotation.

[0098] It is important to note that Figure 7 Only exemplary embodiments of this disclosure are shown. For example, in this exemplary embodiment, the outer boundary of at least one treatment area 708 may not coincide with the outer edge of the optical area 702; however, in other exemplary embodiments, they may coincide. The outer area 704 surrounds the optical area 702 and provides standard contact lens features, including lens positioning and centering. According to one exemplary embodiment, the outer area 704 may include one or more stabilizing mechanisms to reduce rotation when the lens is on the eye.

[0099] Figure 8A An example ophthalmic device is illustrated with a power distribution showing the power relative to radial distances from the center of the device. As shown, a central region 802 or area located at and / or near the center of the ophthalmic lens has positive power. The surface of the ophthalmic lens then exhibits negative power at a radius outside the central region 802. However, a treatment zone 804 is shown as approximately 1.50 mm to 2.00 mm, where the power increases from the surrounding area and exhibits a less negative power. As another example, the treatment zone 804 can be configured for treating, preventing, or slowing the progression of myopia. The treatment zone 804 can be configured with a surface shape exhibiting a focal ring, the trajectory of each of the infinite focal points on the ring being displaced from the geometric axis of the central region 802 (“non-coaxial”). Additional treatment zones 804 may be used. At least one treatment zone 804 may have a ring configuration sharing a common geometric axis with the central region 802. At least one treatment area 804 may have a surface shape including a portion of a generally annular shape, wherein at least one treatment area 804 is arranged to form a continuous surface with respect to the central area. As an example, after slicing the surface of a spherical torus in the shape of a straight circular cone, a portion of a generally annular shape may be derived from the torus (e.g., a spherical torus), wherein the principal axis of the cone coincides with the axis of rotation, and the torus is generated around the axis of rotation.

[0100] Figure 8B It shows Figure 8A Annotated version of the power distribution. As shown in the figure, the radial width and power of the central zone 802 can be configured to provide a slowing, delaying, or preventing of myopia progression while providing satisfactory visual acuity. As another example, the position of the treatment zone 804 relative to the central zone 802 can be customized.

[0101] Figure 8C Annotated power distribution 810 with reference to a corresponding ray diagram 812 is shown. Ray diagram 812 relates to a lens design according to one aspect of this disclosure. As shown, the lens design is based on the specific ray pattern (e.g., refraction) exhibited by incident light on the lens. As an example, a central coaxial treatment zone 814 can be generated by configuring a central ADD power zone that exhibits incident light converging to an on-axis focal point located between the lens and the wearer's retinal plane. One or more vision correction zones 816 can be generated by configuring the lens to exhibit incident light converging to an on-axis focal point at or near the retinal plane. A non-coaxial treatment zone can be generated by configuring an ADD power zone that exhibits incident light converging to an off-axis focal ring located between the lens and the wearer's retinal plane. It should be understood that the ADD power can be referenced to the positive power relative to adjacent areas and / or vision correction zones 816.

[0102] refer to Figure 9A This diagram illustrates the light rays associated with the wavefront passing through an emmetropic (or fully corrected) eye 910. The light rays originate from a planar wavefront outside the eye (i.e., with 0.00D spherical power) and travel towards the retina 912 through the eye's optics and any corrective devices. As shown, assuming the system has zero wavefront aberration, the light rays 911 from this wavefront are focused along the optical axis 916 at a single focal point 914. Given that this is a representation of the wavefront error for a fully corrected eye, the focal point 914 is located on the fovea, which is situated at the center of the corpus luteum in the retina 912. The fovea is the region of the retina responsible for sharp central vision.

[0103] In contrast, Figure 9B The diagram illustrates light rays 921 from a wavefront with a spherical wavefront error of +10.00D (relative to emmetropic or fully corrected eyes), as they are to travel toward the retina 922 of the eye 920 through the eye and any optical device. As shown, the optical axis 926 in front of the wavefront retina 922 focuses at a single point 924, as should be expected with a +10.00D defocus. Consistent with conventional spherical optics, the lens optics are designed with a principal optical axis. Light rays converge to a single point, i.e., the focal point located on this axis. The amount of spherical wavefront error determines the location of the focal point above or in front of the fovea of ​​the retina, as... Figure 9A and Figure 9BAs shown in the figures below. These two figures can be used to set the basic parameters / principles on which the description of the invention is based; however, it should be understood that although only spherical refractive errors are shown and described for ease of explanation, the invention is equally applicable to toric lenses that include cylindrical optical power on a particular axis. Furthermore, as will be explained in more detail later, the treatment area may include cylindrical optical power and axis, and they may also include more complex optical designs such as higher-order aberrations.

[0104] Figure 9C The diagram illustrates light rays originating from a plane wavefront passing through an optical system (eye plus optical device) outside a morphological eye, wherein the optical device has a plane (i.e., 0.00D) optical power at its center 931 and a coaxial optical power (i.e., a “coaxial” treatment zone) 933 at its periphery, as they are to travel toward the retina 932 through the eye 930. Those skilled in the art will understand that the illustrations and subsequent diagrams can also be applied to eyes with refractive errors, where the central optical power of the device corrects for refractive errors, and the peripheral optical power is maintained at +10.00D relative to the central optical power (+10.00D ADD). As shown, light rays passing through the central portion of the device are focused at a single point 934 along the principal optical axis 936. Given that this is a representation of a morphological eye, the focal point 934 is located on the fovea of ​​the retina 932. Light rays 933 passing through the treatment zone can be focused at a single point 938 in front of the retina 932, as should be expected with a +10.00D defocus. Concentric or aspherical multifocal lens designs typically have a principal distance power and an ADD power with a common axis. Furthermore, in these applications, to maintain optimal image quality, the ADD power is usually limited to the range of approximately +1.00D to +3.00D. Therefore, high ADD power may not be suitable for this arrangement in the coaxial treatment area, and instead, as explained in detail later, a non-coaxial arrangement may be used.

[0105] Figure 9D The diagram illustrates light rays originating from a planar wavefront passing through the exterior of the eye via an optical system (eye plus optical device), where the optical device has a planar (i.e., 0.00D) power at its center 941 and a +10.00D non-coaxial power (i.e., a “non-coaxial” treatment zone) 943 at its periphery, as they are to travel toward the retina 942 through the eye 940. As shown, the light rays passing through the central portion of the device are focused along the principal optical axis 946 at a single point 944. Given that this is a representation of an emmetropic eye, the focal point 944 is located on the fovea of ​​the retina 942. The light rays 943 passing through the treatment zone are focused at single points 948 and 949, in this cross-sectional view, in front of the retina 942, as should be expected with a +10.00D lens. However, these light rays conical in shape appear to point toward the fovea, unlike... Figure 9CAs shown, light rays strike the retina at a certain distance from the fovea. The treatment area now has focal points 948 and 949, which do not coincide 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 light rays passing through the non-coaxial treatment area reach a focal point +10.00D in front of the retina 942 along their own axes; however, the central rays of each of the non-coaxial treatment areas intersect the principal axis at the fovea and therefore each has no optical power error.

[0106] Figure 9E The diagram illustrates light rays originating from a plane wavefront passing through the exterior of the eye in an optical system (eye plus optical device), where the optical device has a plane (i.e., 0.00D) optical power at its center 951 and a +10.00D non-coaxial optical power (i.e., a "non-coaxial" treatment zone) 953 at its periphery, as they are to travel toward the retina 952 through the eye 950. As shown, the light rays passing through the central portion of the device are focused at a single point 954 along the principal optical axis 956. Given that this is a representation of an emmetropic eye, the focal point 954 is located on the fovea of ​​the retina 952. The light rays 953 passing through the treatment zone are focused at single points 958 and 959, in this cross-sectional view, in front of the retina 952, as should be expected with a +10.00D lens. However, these light cones are now symmetrically positioned away from the fovea. Again, the treatment zone has focal points 958 and 959 that do not coincide 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 light rays passing through the non-coaxial treatment area reach the focal point +10.00D in front of the retina along their own axes, but with the same... Figure 9D The treatment area is oriented in different directions or slopes (i.e., "tilted") so that the central light rays are symmetrically directed away from the fovea. Additionally, the treatment area axes converge symmetrically toward the principal axis 956. In other words, the treatment area guides the light rays toward the peripheral portion of the retina 952, which is equidistant from the fovea, intersecting with the original common optical axis 956. This symmetrical arrangement in two-dimensional representation forms a blurred ring on the retina in three-dimensional space.

[0107] It is important to note that combinations of the above configurations are also possible, for example, including an optical design that serves as the base sphere for myopia correction, a treatment area where the central ray of the guide zone intersects the optical axis in front of the retina, and a treatment area where the central ray of the guide zone intersects the optical axis behind the retina. The principles embodied in these descriptions can also be applied to devices with multiple treatment areas.

[0108] This article also includes designs with negative ADD power for reducing hyperopia in young children. The distance correction zone can now have positive power, for example, from +0.25D to +20.00D. The same principle applied to myopia control applies here, because the wearer should not use the device's ADD segment for near or far vision, but rather use hyperopic distance correction for all viewing. The non-coaxial nature of the ring focal point prevents the user from adapting to see through the treatment zone. The negative ADD power (e.g., from -0.25D to -20.00D) then stimulates eye growth to reduce the degree of hyperopia.

[0109] Figure 10A A light diagram of an ophthalmic lens according to this disclosure is shown. 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 annular shape (e.g., a portion of a torus) with a cross-section in... Figure 10A As shown in the figure, the treatment area 1004 is configured to generate a focal ring that 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. As shown, the innermost ray 1006 of the treatment area 1004 and the corresponding (relative position around the ring) innermost ray 1008 are configured to converge to a point 1009 located behind the retinal plane.

[0110] Figure 10B A ray diagram of an ophthalmic lens according to this disclosure is shown. The lens includes correction for myopia 1016. The lens also includes a central treatment area 1012 and a peripheral treatment area 1014 radially displaced from the central treatment area 1012. The treatment area 1014 includes a portion of a generally annular shape, the cross-section of which is... Figure 10B As shown in the figure, the central region 1012 is shown to include a surface structure configured to produce a coaxial point focal point at a location consistent with the ADD power of the region. The treatment region 1014 is configured to exhibit (i.e., produce) a focal ring that is generated in front of the wearer's retinal plane, such as between the ophthalmic lens and the retinal plane. One or more myopia correction regions 1016 may be configured to have a negative power and may exhibit a focal point coaxial with the principal axis of the lens, including the focal point generated by the central region 1012. As shown, the treatment region 1014 has a ring configuration and the innermost ray 1017 and the corresponding (relative position around the ring) innermost ray 1018 are configured to converge to a point 1019 located at the intersection of the retinal plane and the principal axis.

[0111] Figure 11AThe diagram illustrates light rays originating from a planar wavefront passing through the exterior of the eye via an optical system (eye plus optical device), wherein the optical device has a planar (i.e., 0.00D) power at center 1101 and a +10.00D non-coaxial power (i.e., a "non-coaxial" treatment zone) 1103 at the periphery, as they are to travel toward the retina 1102 through the eye 1100. As shown, light rays passing through the central portion of the device are focused along the principal optical axis 1106 at a single point 1104. Given that this is a representation of an emmetropic eye, the focal point 1104 is located on the fovea of ​​the retina 1102. Light rays 1103 passing through the treatment zone reach a local point focal point at 1108 and 1109 in this cross-sectional view, in front of the retina 1102, as should be expected with a +10.00D lens, but asymmetrically away from the fovea. The treatment zone can produce a focal ring (or ellipse) including focal point 1108 and another focal point 1109. Focal point 1108 does not coincide with the original common axis (e.g., principal optical axis 1106), and is therefore non-coaxial. Focal point 1109, on the other hand, coincides with the original common axis, and is therefore a coaxial focal point. It is important to note that any small beams of light passing through the treatment zone will be focused along their own axes, and these beams can have different slopes (tilts) within the treatment zone.

[0112] Figure 11B The diagram illustrates light rays originating from a planar wavefront passing through the exterior of the eye via an optical system (eye plus optical device), wherein the optical device has a planar (i.e., 0.00D) power at its center 1111 and a +10.00D non-coaxial power (i.e., a “non-coaxial” treatment zone) 1113 at its periphery, as they are to travel toward the retina 1112 through the eye 1110. As shown, light rays passing through the central portion of the device are focused along the principal optical axis 1116 at a single point 1114. Given that this is a representation of an emmetropic eye, the focal point 1114 is located on the fovea of ​​the retina 1112. Light rays 1113 passing through the treatment zone reach a local point focal point at 1118 and 1119 in this cross-sectional view, in front of the retina 1112, as should be expected with a +10.00D lens. The treatment zone can produce focal rings including focal points 1118 and 1119, which do not coincide with the original common axis (e.g., the principal optical axis 1116) and are therefore non-coaxial. It is important to note that light rays passing through the treatment zone are focused along their own axes and have a coaxial relationship with the original common axis (e.g., the principal optical axis 1116). Figure 9D The treatment zones have different slopes (inclinations) to guide the central rays from the treatment zones symmetrically away from the fovea, but still maintain a local point focal point of +10.00D in front of the retina 1112. Furthermore, the central rays from the treatment zones converge symmetrically behind the focal point of the myopia correction zone 1114. In other words, the treatment zones guide the rays so that they intersect the original principal optical axis 1116 of the eye's exterior in a symmetrical manner.

[0113] Figure 11C The diagram illustrates light rays originating from a plane wavefront passing through the exterior of the eye via an optical system (eye plus optical device), wherein the optical device has a plane (i.e., 0.00D) power at center 1121 and a +10.00D non-coaxial power (i.e., a “non-coaxial” treatment zone) 1123 at the periphery, as they are to travel toward the retina 1122 through the eye 1120. As shown, light rays passing through the central portion of the device are focused along the principal optical axis 1126 at a single point 1124. Given that this is a representation of an emmetropic eye, the focal point 1124 is located at the fovea of ​​the retina 1122. Light rays 1123 passing through the treatment zone reach a local point focal point at 1128 and 1129 in this cross-sectional view, in front of the retina 1122, as should be expected with a +10.00D lens, but asymmetrically away from the fovea. The treatment zone can produce focal rings (or ellipses) including focal points 1128 and 1129, which do not coincide with the original common axis (e.g., the principal optical axis 1126) and are therefore non-coaxial. It is important to note that any small beams of light passing through the treatment zone will focus along their own axes, and these beams can have different slopes (tilts) within the treatment zone. In other words, the treatment zone guides the light rays, thereby causing them to intersect the original common optical axis, such as the principal optical axis 1126 outside the eye, in an asymmetrical manner.

[0114] Combinations of the above configurations are also possible, such as including an optical design that serves as the base sphere for myopia correction, a treatment area that guides light rays to intersect with the principal optical axis, and a treatment area that guides light rays to the same side of the principal optical axis.

[0115] Figure 12A A light diagram of an ophthalmic lens according to this disclosure is shown. As shown, a peripheral area or treatment area 1204 is shown surrounding a central area 1202. The annular treatment area 1204 includes a portion of a generally annular shape, the cross-section of which is... Figure 12A As shown in the figure, the treatment area 1204 is configured to exhibit (generate) a focal ring that 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. As shown, the innermost ray 1206 of the treatment area 1204 and the corresponding (relatively positioned around the ring) innermost ray 1208 are configured to intersect at a point 1209 located behind the retinal plane. Therefore, a portion of the biconical shape representing the volume of the light rays crossing the treatment area falls behind the retina.

[0116] However, the surface of the treatment area 1204 can be configured (e.g., tilted, thereby directing light by the lens toward or away from the central or principal axis) to minimize the convergence of light behind the wearer's retinal plane, such as Figure 12B As shown. Figure 12BAs shown, the innermost ray 1207 passing through the annular treatment area 1204, along with the corresponding (relatively positioned around the annulus) innermost ray 1208, is configured to converge at point 1209, the intersection of the retinal plane and the principal axis of the lens. This tilt control can be used to configure the innermost ray to intersect the principal axis between or in front of the retinal plane. Now, a portion of the biconical shape representing the volume of the light rays crossing the treatment area does not fall behind the retina. The convergence point of these rays should be configured to minimize visual disturbances, such as if the treatment area 1204 is configured to produce a coaxial point focus.

[0117] To further illustrate the "tilted" configuration of treatment area 1204, Figure 13 A comparison between two power distributions of a corresponding ophthalmic device is shown, where a “tilted” treatment zone minimizes the negative power drop in the power distribution. Furthermore, the power distribution of the treatment zone can have a curved (e.g., convex) shape to induce annular focal points.

[0118] As an illustrative example, favorable results were achieved using tilt angles between +0.035 degrees and +0.3215 degrees relative to a zero-angle comparator. The tilt angle is specified as zero, where the central (intermediate ring) light rays of the treatment area pass through the intersection of the retinal plane and the central axis or principal axis (e.g., ...). Figure 12A (As shown in the diagram). A positive tilt causes the central (middle ring) rays of the treatment area to intersect the principal axis in front of the retina, while a negative tilt causes the central (middle ring) rays of the treatment area to intersect the principal axis behind the retina. It should be understood that other positive and / or negative tilt angles can be used.

[0119] As another example, a choroid thickness model was used to test specific lens designs to predict their potential myopia control effects. In this model, the human eye was exposed to an optical configuration for a period of time, and the axial length of the eye was monitored. Over the short time period studied, the choroid thickness remained relatively constant in the absence of changes in optical stimulation. Optical configurations that may have a myopia control effect were accompanied by an increase in choroid thickness and a corresponding decrease in the apparent axial length of the eye as measured by partial coherence interferometry. Conversely, optical configurations that may exacerbate myopia development were accompanied by a decrease in choroid thickness and a corresponding increase in the apparent axial length of the eye. For example, Read et al. have shown that exposure to +3D single-vision lenses resulted in a significant decrease in axial length, while -3D lenses resulted in a significant increase in axial length (Read SA, Collins MJ, Sander BP. Human optical axial length and defocus Invest Ophthalmol Vis Sci. Dec 2010; 51(12): 6262-9.). In animal models, manipulation of the visual environment with positive lenses resulted in reduced eye growth, while negative lenses resulted in increased eye growth and myopia.

[0120] It is important to consider various design configurations by changing the optical power, size, position, and tilt of the treatment area, as described below, and as shown in Figures 14 and 16 through 20:

[0121] Non-coaxial + 5D design (2 rings)

[0122] Ring 1 = +5D non-coaxial power; 1.87mm to 3.43mm diameter region: +0.109 degrees tilt.

[0123] Ring 2 = +5D non-coaxial power; 4.45mm to 9.00mm diameter zone: +0.321 degrees tilt.

[0124] Non-coaxial + 5D design (1 ring with 1.00mm center + 10D area)

[0125] Ring = +5D non-coaxial power; 3.00mm to 4.00mm diameter region: +0.066 degrees tilt

[0126] Non-coaxial + 2.5D design (1 ring with 1.00mm center + 5D area)

[0127] Ring = +2.5D non-coaxial power; 3.00mm to 4.00mm diameter region: +0.035 degrees tilt.

[0128] Non-coaxial +5D to +10D design (4 rings with a 1.00mm center +10D area)

[0129] Ring 1 = +5D non-coaxial power; 3.00mm to 4.00mm diameter region: +0.066 degrees tilt.

[0130] Ring 2 = +10D non-coaxial power; 6.00mm to 7.00mm diameter region: +0.131 degrees tilt.

[0131] Ring 3 = +10D non-coaxial power; 7.00mm to 8.00mm diameter region: +0.129 degrees tilt.

[0132] Ring 4 = +10D non-coaxial power; 8.00mm to 9.00mm diameter region: +0.129 degrees tilt.

[0133] Non-coaxial + 5D design (1 ring)

[0134] Ring = +5D non-coaxial power; 3.00mm to 4.00mm diameter region: +0.066 degrees tilt

[0135] Non-coaxial + 7D design (2 rings)

[0136] Ring 1 = +7D non-coaxial power; 3.40mm to 4.80mm diameter region: +0.132 degrees tilt.

[0137] Ring 2 = +7D non-coaxial power; 6.80mm to 8.30mm diameter region: +0.140 degrees tilt.

[0138] Non-coaxial + 7D design (2 rings, with a 1.20mm center + 10D area)

[0139] Ring 1 = +7D non-coaxial power; 2.80mm to 4.00mm diameter region: +0.111 degrees tilt.

[0140] Ring 2 = +7D non-coaxial power; 6.50mm to 8.00mm diameter region: +0.142 degrees tilt.

[0141] The result of a series of lens designs Figures 14A-14D As shown in the diagram. In each of these experiments, +3D defocus was used as a comparator. It can be observed that the optical configurations described in this disclosure can exhibit similar to or greater projective myopia control effects in response to +3D defocus. The results of these experiments indicate that the positive optical power treatment zone can lead to a significant reduction in the axial length of the eye, with the effect increasing with increasing ADD optical power, that the non-coaxial design is effective in myopia control, and that refined tilt can enhance myopia control.

[0142] Additionally, as shown below, a tilt angle can be applied to the central rays of the treatment area so that all rays passing through the area intersect the axis (zero or positive optical power) at or in front of the fovea. This means the angle will vary with the area's optical power, the area's displacement from the principal axis, and the area's width (e.g., a larger tilt is required if the area width and / or local uniaxial optical power increases). As described above, the tilt is measured relative to a zero-angle comparator, where the central (intermediate ring) rays of the treatment area pass through the intersection of the retinal plane and the central or principal axis:

[0143] Figure 15A A typical power distribution for an example ophthalmic device is shown, illustrating power relative to radial distances from the center of the device. As shown, a central region 1502 or area located at and / or adjacent to the center of the ophthalmic lens has a generally flat power distribution 1502. In this example, this region has zero power and should therefore represent an example of emmetropia; however, it is readily understood that the entire power distribution in this region can be adjusted to correct myopic refractive errors. A first treatment zone 1504 is shown as approximately 1.80 mm to 2.40 mm, where the power increases from the surrounding area and exhibits a more righteous power. A second treatment zone 1506 is shown as approximately 3.40 mm to 4.20 mm, where the power increases from the surrounding area and exhibits a more righteous power. A typical power distribution yields the power at a given radial distance from the lens center, obtained from the reciprocal of the distance, at which light rays passing through that location on the lens will intersect the principal axis. This value will differ from the optical power derived from the local curvature of the treatment area, where such optical power is also a function of the converging distance of light rays passing through the area along its own axis.

[0144] As another example, treatment areas 1504, 1506 can be configured as treatment areas for treating, preventing, or slowing the progression of myopia. Treatment areas 1504, 1506 can be configured to have a surface shape that produces a focal ring, the trajectory of each of the infinite focal points on the ring being displaced from the geometric axis of the central area 1502 (“non-coaxial”). Additional treatment areas 1504 can be used. At least one of treatment areas 1504, 1506 can have an annular configuration sharing a common geometric axis with the central area 1502, and wherein at least one of treatment areas 1504, 1506 exhibits (i.e., results in) a focal ring, wherein the trajectory of each of the infinite focal points on the ring is displaced from the geometric axis of the central area 1502 (“non-coaxial”). At least one treatment area 1504 can have a surface shape that includes a portion of the annular shape, wherein at least one of treatment areas 1504, 1506 is arranged to form a continuous surface with the central area. As an example, the annular portion can be derived from a torus (e.g., a spherical torus), wherein a slice passing through the surface of the spherical torus to produce the annular portion includes a right circular conical surface, the main axis of the cone coinciding with the axis of rotation, around which the torus is produced.

[0145] Figure 15B The conventional power distribution of the example ophthalmic device is shown, illustrating the power distribution relative to the radial distance from the center of the device. As shown, a central region 1512 or area located at and / or adjacent to the center of the ophthalmic lens has an ADD power with focal point along the principal axis (coaxial) of the lens, and is the first treatment area in this example ophthalmic device. The surface of the ophthalmic lens then exhibits a generally flat power distribution at a radius lateral to the central region 1512. This should again represent an example of emmetropia, but it is readily understood that the entire power distribution here can be adjusted to correct myopic refractive errors. A second treatment area 1514 is shown as approximately 1.40 mm to 2.00 mm, where the power increases from the surrounding area and exhibits a more rectified power. A third treatment area 1516 is shown as approximately 3.30 mm to 4.00 mm, where the power increases from the surrounding area and exhibits an even more rectified power. A typical optical power distribution yields the optical power at a given radial distance from the center of the lens, calculated from the reciprocal of the distance, at which light rays passing through that location on the lens will intersect the principal axis. This value will differ from the optical power derived from the local curvature of the treatment area, where such optical power is also a function of the converging distance of light rays passing through that area along its own axis.

[0146] As another example, treatment areas 1514, 1516 can be configured as treatment areas for treating, preventing, or slowing the progression of myopia. Treatment areas 1514, 1516 can be configured to have a surface shape that produces a focal ring, the trajectory of each of the infinite focal points on the ring being displaced from the geometric axis of the central area 1512 (“non-coaxial”). Additional treatment areas 1514 can be used. At least one of treatment areas 1514, 1516 can have an annular configuration sharing a common geometric axis with the central area 1512, and wherein at least one of treatment areas 1514, 1516 exhibits a focal ring, wherein the trajectory of each of the infinite focal points on the ring is displaced from the geometric axis of the central area 1512 (“non-coaxial”). At least one treatment area 1514 can have a surface shape that includes a portion of the annular shape, wherein at least one of treatment areas 1514, 1516 is arranged to form a continuous surface with the central area. As an example, the annular portion can be derived from a torus (e.g., a spherical torus), wherein a slice passing through the surface of the spherical torus to produce the annular portion includes a right circular conical surface, the main axis of the cone coinciding with the axis of rotation, around which the torus is produced.

[0147] Figures 16A-16B A comparison of subjective responses 1–3 days after lens allocation is shown between three multi-zone test lenses and a commercially available single-vision soft control lens. The test lenses include two novel designs described in this disclosure and a control group design with conventional optics, including concentric treatment rings, coaxial focal lengths, and optical ADD power between +2.00D and +2.50D. CLUE was obtained. TM Scores are used to assess comfort, vision, and processing. CLUE TM It is a validated Patient Reported Outcomes (PRO) questionnaire used to assess patient-experience attributes of soft contact lenses in the U.S. population aged 18–65 (Wirth RJ et al. developed Contact Lens User Experience: CLUE Scales. Optom Vis Sci. 2016; 93(8): 801–808). As shown in the figure, a higher CLUE score is expected. Figure 16A The least squares mean (LSM) and 95% confidence interval (CI) of the CLUE score for each lens type are shown. Figure 16B The 95% CI of the LSM difference and CLUE Vision score for each of the three test lenses and the control lens is shown. All three multifocal test lenses had significantly lower CLUE Vision scores compared to the monocular control lens. However, the control group with the coaxial design had the worst visual acuity reduction (CLUE score reduction of 45.5) compared to the two non-coaxial lens designs (24.1 and 13.2, respectively).

[0148] Figures 17A-17B A comparison graph showing monocular (A) and binocular (B) logMAR visual acuity is presented between three multi-zone test lenses and one control lens (commercially available monovision soft contact lens) under three different contrast / illumination conditions (LSM and 95% CI). It is important to note that the coaxial design of the control group has an optical ADD power between +2.00D and +2.50D.

[0149] Figures 18A-18B A comparison graph shows the monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and the control lens under high-contrast bright conditions (LSM difference and 95% CI). The visual acuity of all three test lenses was better than 20 / 20 (0.00 logMAR) (monocular and binocular). For the coaxial designs of non-coaxial +5D, non-coaxial +7D, and the control group, the monocular logMAR visual acuity was on average 0.07, 0.04, and 0.05 logMAR worse than the control lens, respectively, by about half to a line. For the coaxial designs of non-coaxial +5D, non-coaxial +7D, and the control group, the binocular logMAR visual acuity was on average 0.08, 0.05, and 0.07 logMAR worse than the control lens, respectively, by about half to a line.

[0150] Figures 19A-19B The graphs show a comparison of monocular (A) and binocular (B) logMAR visual acuity between each of the three test lenses and the control lens under high-contrast dim conditions (LSM difference and 95% CI). For the coaxial designs of non-coaxial +5D, non-coaxial +7D, and the control group, the monocular logMAR visual acuity was on average 0.10, 0.05, and 0.12 logMAR worse than the control lens, respectively, representing a difference of approximately half to a line. For the coaxial designs of non-coaxial +5D, non-coaxial +7D, and the control group, the binocular logMAR visual acuity was on average 0.05, 0.03, and 0.06 logMAR worse than the control lens, respectively, representing a difference of approximately half to a line.

[0151] Figures 20A-20BA comparative graph showing monocular (A) and binocular (B) logMAR visual acuity is presented between each of the three test lenses and the control lens under low-contrast bright conditions (LSM difference and 95% CI). It is important to note that the optical ADD power of the coaxial design in the control group is between +2.00D and +2.50D. For the non-coaxial +5D, non-coaxial +7D, and coaxial designs in the control group, the monocular logMAR visual acuity was on average 0.13, 0.08, and 0.13 logMAR worse than the control lens, respectively, representing a difference of approximately half to a line. For the non-coaxial +5D, non-coaxial +7D, and coaxial designs in the control group, the binocular logMAR visual acuity was on average 0.08, 0.06, and 0.08 logMAR worse than the control lens, respectively, representing a difference of approximately half to a line.

[0152] Compared to the control lens, the non-coaxial +7D design exhibited the least degradation in CLUE™ score and logMAR visual acuity (monocular and binocular in all three contrast / illumination conditions) among the three tested lenses. Visual acuity was similar between the non-coaxial +5D and the control coaxial design, but the control lens showed a higher CLUE™ score. TM The scores are even worse. It should be noted that the optical ADD designed using conventional coaxial optics has a power of only +2.00D and +2.50D.

[0153] These results demonstrate the advantages of the present invention. Previous myopia control designs using conventional optics are limited in their effectiveness in controlling myopia by the degree to which they reduce visual acuity. Exemplary embodiments of the present invention can more effectively slow the progression of myopia while having less impact on vision.

[0154] Currently available contact lenses have been a cost-effective device for vision correction. Thin plastic lenses are attached to the cornea of ​​the eye to correct vision defects, including myopia or nearsightedness, hyperopia or farsightedness, astigmatism, and presbyopia (i.e., the lens loses its ability to adapt). Contact lenses are available in various forms and made from a variety of materials to provide different functionalities.

[0155] Daily wear soft contact lenses are typically made of soft polymer materials mixed with water for oxygen permeability. They are available in daily disposable or extended wear versions. Daily disposable lenses are usually worn for one day and then discarded, while extended wear or frequently replaced disposable lenses are typically worn for up to thirty days. Tinted soft contact lenses use different materials to provide different functionalities. For example, tinted contact lenses use light tint to help the wearer locate a dropped lens; enhanced tinted contact lenses have a semi-transparent tint, meaning they enhance the wearer's natural eye color; colored tinted contact lenses include dark transparent tints, meaning they alter the wearer's eye color; and light-filtering tinted contact lenses are used to enhance certain colors while weakening others. Rigid, gas-permeable rigid contact lenses are made of silicone-containing polymers but are more rigid than soft contact lenses, thus maintaining their shape and being more durable. Bifocal contact lenses are specifically designed for presbyopia patients and are available in both soft and rigid types. Toposcopic contact lenses are specifically designed for astigmatism patients and are also available in both soft and rigid types. Combinations of different aspects are also possible, such as hybrid contact lenses.

[0156] It is particularly noteworthy that the lens designs of this disclosure can be incorporated into a variety of different contact lenses made of many materials. Specifically, the lens designs of this disclosure can be used in any of the contact lenses described herein, including daily wear soft contact lenses, rigid gas-permeable contact lenses, bifocal contact lenses, toric contact lenses, and hybrid contact lenses. Furthermore, although this disclosure is described in relation to contact lenses, it is particularly important to note that the concepts of this disclosure can be applied to spectacle lenses, intraocular lenses, corneal inlays, and inlays.

[0157] While the contents shown and described are believed to be the most practical and preferred embodiments, it will be apparent that variations to the specific designs and methods shown and described will be helpful to those skilled in the art, and such variations can be used without departing from the spirit and scope of this disclosure. This disclosure is not limited to the specific constructions shown and described, but should be constructed to conform to all modifications that may fall within the scope of the appended claims. Furthermore, the description of the term "comprising" may include substantially consisting of and / or consisting of, thereby providing support for such a term herein through the use of the term "comprising".

Claims

1. An ophthalmic lens for at least one of slowing, delaying, or preventing myopia progression in a wearer, the ophthalmic lens comprising: a central zone centered on an optical axis, the central zone having a negative optical power for myopia vision correction of the wearer; and at least one treatment zone disposed radially outward from and surrounding the central zone and centered on the optical axis, the at least one treatment zone having an ADD optical power relative to the central zone, wherein the at least one treatment zone has a surface shape derived from a portion of a torus, wherein the surface shape is configured to direct light therethrough to form a continuous focal ring located in front of a retina of the wearer and surrounding the optical axis, and wherein the surface shape of the at least one treatment zone forms a continuous surface with the central zone.

2. The ophthalmic lens of claim 1, wherein, The portion of substantially toroidal shape can be derived from a torus after slicing the surface of the torus with the surface shape of a right circular cone, wherein the major axis of the cone coincides with an axis of rotation about which the torus is generated.

3. The ophthalmic lens of claim 1, wherein, The portion of substantially toroidal shape can be derived from a torus after slicing the surface of the torus with the surface shape of a right circular cone, wherein the major axis of the cone coincides with an axis of rotation about which the torus is generated.

4. The ophthalmic lens of claim 1, wherein, The at least one treatment zone is configured to minimize the creation of a retinal plane back focus of a wearer’s eye.

5. The ophthalmic lens of claim 1, further comprising a transition zone disposed between the central zone and the at least one treatment zone, such that the at least one treatment zone, the transition zone, and the central zone form a continuous surface.

6. The ophthalmic lens of claim 1, wherein, The at least one treatment zone comprises an ADD optical power relative to myopia correction optical power that is greater than +5.00 D.

7. The ophthalmic lens of claim 1, wherein, The at least one treatment zone has an outer edge at about 4.5 mm from the center of the lens.

8. The ophthalmic lens of claim 1, wherein, A light ring effect is minimized.

9. The ophthalmic lens of claim 1, wherein, The ophthalmic lens comprises a contact lens.

10. The ophthalmic lens of claim 1, wherein, The ophthalmic lens comprises an eyeglass lens.

11. The ophthalmic lens of claim 1, wherein, The ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay.

12. The ophthalmic lens of claim 1, further comprising one or more stabilization mechanisms.

13. The ophthalmic lens of claim 1, comprising: wherein the at least one treatment zone further comprises a tilt angle configured to direct an innermost ray relative to a cross-section of the treatment zone to intersect the optical axis at a point at or in front of a retinal plane of a wearer of the ophthalmic lens.

14. The ophthalmic lens of claim 13, wherein, The tilt angle is configured to direct the innermost ray to intersect the optical axis at a point between the retinal plane and a point on the optical axis representing a coincident focal point of the treatment zone.

15. The ophthalmic lens of claim 13, wherein, The tilt angle is dependent on the optical power of the treatment zone.

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