Method and apparatus for wavefront treatment of astigmatism, coma and presbyopia in the human eye - Patents.com
Through wavefront technology, multi-focus lenses designed, by introducing spherical distortion and gradient focus design, the problem that the existing technology is difficult to effectively correct multiple visual errors at the same time, achieving efficient visual correction and visual depth expansion.
Patent Information
- Application Number
- JP2021568965
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-02-18
- Filing Date
- 2020-04-09
- Publication Date
- 2025-05-09
- Estimated Expiration
- 2040-04-09
AI Technical Summary
The prior art has limitations in correcting various visual errors in the human eye, such as myopia, hyperopia, strabismus, presbyopia, etc., especially it is difficult to effectively correct a variety of high-order visual aberrations at the same time, resulting in poor visual quality.
Multifocal lenses designed using wavefront technology, including single-focus lenses, dual-focus lenses, multifocus lenses and wavefront corrective lenses, expand the depth of vision by introducing spherical distortion in the central area of the lens, and adapting to the visual needs of different distances through a gradient focal design.
A comprehensive correction of a variety of visual errors has been achieved, especially in expanding the depth of vision and improving visual quality, which can effectively reduce distortion and blur in the field of vision and improve the adaptability of far and myopia.
Smart Images

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Abstract
Description
[Technical field]
[0001] Related Application Data This application is a continuation of U.S. provisional patent applications: 1) US Provisional Patent Application No. 62 / 920,859, filed May 20, 2019 by Junzhong Liang and Ling Yu, entitled “Wavefront monofocal lenses, wavefront bifocals, wavefront trifocals, and methods and devices of using spherical aberration to mitigate eye's astigmatism and focus errors”; 2) US Provisional Patent Application No. 62 / 974,317, filed November 26, 2019 by Junzhong Liang and Ling Yu, entitled “Methods and devices for wavefront correction of Astigmatism, coma, presbyopia in human eyes”; and 3) US Provisional Patent Application No. 62 / 995 / 872, filed February 18, 2020 by Junzhong Liang and Ling Yu, entitled “Wavefront monofocal, EDOF bifocal, EDOF trifocal, continuously-in-focus lenses and wavefront correction for astigmatism, This application claims priority to US Pat. No. 6,399,433, filed on Dec. 13, 2003, entitled "Methods of Treating Inflammatory Bowel Disease in Human Eyes," the disclosures of which are incorporated herein by reference.
[0002] This application relates to refractive correction of the human eye, including myopia, hyperopia, astigmatism, coma, and presbyopia, in the form of devices, methods, and applications. [Background technology]
[0003] Conventional refractive corrections for the human eye have been designed to correct certain refractive errors of the eye: focus error (myopia and hyperopia), astigmatism (cylindrical error), and sometimes spherical aberration. These refractive corrections are compromised for several reasons, including: 1) limitations in the selection of correctors for astigmatism correction, 2) limitations and errors in measuring the refractive error of the eye using subjective refraction, 3) manufacturing errors of ophthalmic lenses, and 4) coma or other higher order aberrations in some eyes.
[0004] Presbyopia is another factor that reduces human vision. Most people begin to notice the effects of presbyopia after age 40, when small print begins to become less clear. Devices for correcting presbyopia include reading glasses, bifocal / trifocal / progressive glasses, multifocal contact lenses, and diffractive bifocal / trifocal intraocular lenses (IOLs).
[0005] Bifocals, invented by Benjamin Franklin in 1824, are glasses with two different refractive powers. Bifocals have a baseline refractive power for distance vision defects, plus an additional refractive power on top of the baseline power for presbyopia correction. The two different refractive powers of bifocals are located in separate physical locations, e.g., at the top for distance and at the bottom for near distance. When people move their eyes up and down, the same optics of the lens are not used for distance vision correction and near vision correction. This split optics design cannot be adopted for contact lenses, IOLs, implantable contact lenses (ICLs), corneal inlays, and surgical procedures, because the eyes must use the same optics to see objects at distance and near when the freedom to move the eyes up and down is lost due to the two different refractive powers.
[0006] Diffractive optics use grooved kinoform shaped steps on top of a monofocal lens to generate 1) a first focus from the non-deviational "0" diffraction order for distance and 2) another focus from the deviational "1" diffraction order, producing simultaneous multiple foci from the same incident light. Diffractive optics have been reported in progressive lenses (see U.S. Pat. No. 5,116,111) and trifocal IOLs (see U.S. Pat. Nos. 8,636,796 and 9,320,594).
[0007] The advantages of diffractive bifocal and trifocal IOLs include: 1) solving the problem of split optics to make bifocal or trifocal lenses; 2) allowing postoperative cataract patients to see at far and near distances without glasses. However, diffractive lenses (bifocal / trifocal IOLs) are not tolerated by most postoperative cataract patients because they significantly reduce the quality of vision. First, diffractive bifocal / trifocal IOLs cause nighttime symptoms such as halos and starbursts due to multiple images of bright objects at a distance. Second, nighttime symptoms of spider veins caused by diffractive rings projected onto the retina are common.
[0008] Diffractive optics cannot be applied to contact lenses because diffractive surfaces that are not continuous and contain sharp edges (see FIG. 1) may cause tissue damage to the corneal surface or disrupt normal tear flow on the cornea. Because both split optics designs in bifocal glasses and diffractive optics in IOLs are not suitable for contact lenses, there are currently no reliable bifocal contact lenses in the prior art, even though many multifocal contact lenses are commercially available. Multifocal contact lenses that rely on pupil division for presbyopia correction have been reported (see U.S. Pat. Nos. 6,808,262, 4,704,016, 4,898,461, 4,704,016, and 6,808,262). When considering physical optical systems, such as the diffraction and interference of light rays crossing the pupil of the eye, both distant and near retinal images are indeterminate.
[0009] The ultimate solution to correct presbyopia for human vision is to restore accommodation of the eye's aging crystalline lens or to replace the eye's optics with an accommodative IOL. After significant efforts in the development of accommodative IOLs in the past two decades, there have been recent advances in achieving accommodation with fluid IOLs (see Figure 2). However, analysis of data on accommodative IOLs shows at least three problems of clinical importance. First, there are large variations in focal power as large as + / - 0.5D in the target accommodation states for both distance near 0D and near near 3D for eyes E13-401 (top right of Figure 2) and E15-301 (bottom right of Figure 2). Second, in the distance accommodation state, accommodative IOLs can result in a mean accommodation error of -1.0D for eye E13-401 (top right of Figure 2) on a time scale of 0 to 5 seconds and for eye E02-411 (bottom left of Figure 2) on a time scale of around 15 and 25 seconds. This large focus error can sometimes make it difficult to see clearly at long distances.Third, the accommodation range of the eye in Figure 2 varies from eye to eye, and for some eyes from moment to moment.
[0010] US Patent No. 8,529,559 B2 and US Patent Application No. 2011 / 0029073 A1 disclose a method and apparatus for inducing spherical aberration in the center of the eye pupil for treating presbyopia. While offering the advantage of extending the depth of focus of an ophthalmic lens, it is believed that inducing spherical aberration with a corrective lens significantly reduces retinal contrast. It has also been proposed to induce spherical aberration of the opposite sign in the center of the eye pupil to extend the depth of focus up to 3.5D. Unfortunately, the original design results in a significant reduction in contrast at long distances. Summary of the Invention [Problem to be solved by the invention]
[0011] As a result, while many configurations and methods for vision correction are known in the art, these conventional methods and systems suffer from one or more of the drawbacks discussed herein above. [Means for solving the problem]
[0012] In a non-limiting embodiment, a wavefront technology monofocal lens for an eye configured as an implantable or wearable lens comprises: a) a baseline diopter power extending across an optical zone with a diameter of 5 mm to 8 mm for sphero-cylindrical correction; and b) at least one aspheric zone having at least one aspheric surface in a center of the monofocal lens with a diameter D0 of 2.5 mm to 4.5 mm, the aspheric zone inducing a spherical aberration in the center of the pupil of the eye, the spherical aberration or wavefront error induced in the center of the lens providing treatment for residual refractive error of the eye that remains uncorrected by the sphero-cylindrical correction, the residual uncorrected refractive error including astigmatism, focus error, coma, and higher order aberrations that are prominent in the center of the pupil of the eye. In a non-limiting embodiment, a bifocal lens for an eye configured as an implantable or wearable lens includes a baseline diopter power extending over an optical zone of diameter 5 mm to 8 mm for sphero-cylindrical correction, a positive focal offset φ1 less than +2.0D and greater than +0.25D in a central zone of diameter less than 2.5 mm and greater than 1.8 mm, and at least two central aspheric zones at the center of the lens, with outer diameters less than 4.5 mm and greater than 2.5 mm, the central aspheric zones comprising at least one aspheric surface for inducing positive spherical aberration in a first zone and negative spherical aberration in a second zone, the first zone and the second zone being coaxial.In a non-limiting embodiment, a trifocal lens for an eye, configured as an implantable or wearable lens, includes a baseline diopter power extending over an optical zone of diameter 5 mm to 8 mm for sphero-cylindrical correction, a positive focal offset φ1 less than +3.0 D and greater than +1.0 D in a central zone having a diameter D0 less than 2.1 mm and greater than 1.65 mm, and two central aspheric zones at least in the center of the lens, with outer diameters less than 4 mm and greater than 2.5 mm, the central aspheric zones being: The lens has at least one aspheric surface for inducing positive spherical aberration in a zone and negative spherical aberration in a second zone, the first zone and the second zone being coaxial, the focus offset φ1 induced in the central aspheric zone and the wavefront error from the induced spherical aberration produces a trifocal lens, i.e., a first "far distance" focus, a second focus with additional refractive power for "middle distance", and a third focus with additional refractive power for "near distance", and the positive focus offset φ1 in the central zone must be less than the total focus range of the trifocal lens.
[0013] In a non-limiting embodiment, a continuous focus (CIF) lens for the eye has an optical zone less than 8 mm in diameter that includes a multifocal structure that provides continuous foci for vision correction over a focal range of greater than 1.0 D, the multifocal structure having multiple foci closely adjacent to one another to provide substantially continuous foci, the multiple foci being achieved by using an aspheric surface to induce spherical aberration in a central portion of the lens less than 4 mm in diameter or by using diffractive optics to produce multiple foci simultaneously.
[0014] In a non-limiting embodiment, a wavefront implantable contact lens (ICL) for an eye comprises a haptic area for fixing the ICL to the iris in the anterior chamber or for holding the ICL in place in the posterior chamber, and an optical lens area, the optical lens area including: i) a baseline diopter power extending across an optical area of diameter 5 mm to 8 mm for sphero-cylindrical correction; ii) a central area of diameter 1.65 mm to 2.5 mm inducing a positive spherical aberration and a positive focus offset φ1 less than +3.0D and greater than +0.5D; and iii) an annular area of outer diameter less than 4.5 mm inducing a negative spherical aberration, wherein wavefront errors from the induced spherical aberration and focus offset in the central and annular areas cause the optical lens to be either: i) a semi-accommodative continuous focus lens; ii) a wavefront bifocal lens; or iii) a wavefront trifocal lens.
[0015] In a non-limiting embodiment, a method for refractive correction of an eye includes determining a refractive error of the eye including at least a spherical power SPH for distance vision correction, and performing refractive correction surgery with an extended focal depth between a first focal power φ1 and a second focal power φ2, and setting a target spherical power SPH between the first focal power φ1 and the second focal power φ2 so as to maintain excellent visual acuity at distance even if future myopic progression occurs in the post-operative eye. [Brief description of the drawings]
[0016] [Figure 1] FIG. 1 is a cross-sectional view of a refractive bifocal IOL (top) and a diffractive trifocal IOL (bottom) in the prior art. [Diagram 2] FIG. 1 illustrates an objective measurement of accommodation of an intraocular accommodative IOL in the prior art. [Diagram 3] FIG. 1 is a diagram showing parameters of a toric contact lens in the prior art. [Figure 4] FIG. 1 is a diagram showing specification parameters of a toric IOL in the prior art. [Figure 5A]FIG. 1 shows the point spread function of a hypothetical eye with 0D to 5 / 8D of astigmatism (CYL) and -0.5D to +0.5D of focus error (SPH) remaining uncorrected by a conventional monofocal contact lens or a conventional monofocal IOL for a pupil diameter of 3.5 mm. [Figure 5B] Calculated retinal images of a hypothetical eye with 0D to 5 / 8D of astigmatism and -0.5D to +0.5D of focus error (SPH) left uncorrected by a conventional monofocal contact lens or a conventional monofocal IOL for a pupil diameter of 3.5 mm. Tumbling E is calibrated for visual acuity of 20 / 16 (smallest letter), 20 / 20, 20 / 25, 20 / 30, and 20 / 40 (largest letter). [Figure 6A] Figure 1 shows the point spread function of a hypothetical eye with 5 / 8D astigmatism (CYL) and focus error (SPH) of -0.5D to +0.5D left uncorrected by a monofocal contact lens or monofocal IOL for a pupil diameter of 3.5mm. Additionally, six scenarios of spherical aberration of the corrected eye are provided, including 1) S1=0, meaning complete correction of the spherical aberration present in the natural eye, 2) S1=-0.26, meaning no change in spherical aberration in the natural eye, and 3) S1=-0.52, -0.78, -1.04, -1.3, meaning more spherical aberration is induced in the eye. [Figure 6B] FIG. 6B shows a retinal image calculated from the point spread function for the case of FIG. 6A. [Figure 6C] Figure 1 shows the point spread function of a hypothetical eye with 5 / 8D astigmatism (CYL) and focus error (SPH) of -0.5D to +0.5D left uncorrected by a monofocal contact lens or monofocal IOL for a pupil diameter of 3.5mm. Additionally, six scenarios of spherical aberration of the eye are provided, including 1) S1=0, 2) S1=0.26, and 3) S1=0.52, 0.78, 1.04, 1.3, which means more spherical aberration is induced in the eye. [Figure 6D] FIG. 6D shows a retinal image calculated from the point spread function for FIG. 6C. [Figure 6E]The point spread function of a hypothetical eye with 3 / 8D of astigmatism (CYL) left uncorrected by a monofocal contact lens or monofocal IOL and focus error (SPH) ranging from -0.5D to +0.5D for a pupil diameter of 3.5mm is shown. Additionally, six scenarios of spherical aberration of the eye are considered, including 1) S1=0, 2) S1=-0.26, and 3) S1=-0.52, -0.78, -1.04, -1.3, which means more spherical aberration is induced in the eye. [Figure 6F] FIG. 6B shows a retinal image calculated from the point spread function for FIG. 6E. [Figure 6G] Figure 1 shows the point spread function of a hypothetical eye with no astigmatism left uncorrected by a monofocal contact lens or monofocal IOL (CYL=0D) and a focus error (SPH) of -0.5D to +0.5D for a pupil diameter of 3.5mm. Additionally, six scenarios of spherical aberration of the eye are considered, including 1) S1=0, 2) S1=-0.26, and 3) S1=-0.52, -0.78, -1.04, -1.3, which means more spherical aberration is induced in the eye. [Figure 6H] FIG. 6C shows a retinal image calculated from the point spread function for FIG. 6G. [Figure 6I] Calculated retinal images of visual acuity charts of a virtual eye with only coma left uncorrected by a conventional monofocal lens (left column) and a monofocal lens with wavefront technology in one exemplary design (right column) for a pupil diameter of 3.5 mm. The coma of the eye is measured by Zernike polynomials with coefficient 1.0 micron for a pupil diameter of 6 mm. Three different orientations of coma are considered. [Figure 6J] Calculated retinal images of visual acuity charts of a virtual eye with only coma left uncorrected by a conventional monofocal lens (left column) and a monofocal lens with wavefront technology in one exemplary design (right column) for a pupil diameter of 3.5 mm. The coma of the eye is measured by the Zernike polynomial with coefficient 1.5 microns for a pupil diameter of 6 mm. Three different orientations of coma are considered. [Figure 7]FIG. 1 is a schematic diagram of a wavefront technology single focal length lens in accordance with an embodiment of the present invention. [Figure 8A] 1 shows point spread functions of a hypothetical eye comparing a conventional monofocal lens (left column) and an exemplary wavefront technology monofocal lens of the present invention (right column) for a pupil diameter of 3.5 mm. The eye's astigmatism is considered to be zero or fully corrected (CYL=0). A focus error (SPH) of -0.5D to +0.5D remains uncorrected by the monofocal lens. [Figure 8B] FIG. 8B shows retinal images calculated from the point spread functions of FIG. 8A comparing a conventional monofocal lens (left column) and a wavefront technology monofocal lens (left column) in an exemplary design. [Figure 8C] FIG. 8B shows the modulation transfer function (MTF) calculated from the point spread function of FIG. 8A comparing a conventional prime lens (top) and a wavefront technology prime lens (bottom) in an exemplary design. [Figure 9A] FIG. 2B illustrates the point spread function of a hypothetical eye with the exemplary wavefront technology monofocal lens of Table 2A for a pupil diameter of 3.5 mm. Astigmatism (CYL) from 0D to 5 / 8D and focus error (SPH) from -0.5D to +0.5D remain uncorrected by the wavefront technology monofocal lens. [Figure 9B] FIG. 2B shows the calculated retinal image of the same virtual eye with the exemplary wavefront technology monofocal lens of Table 2A for a pupil diameter of 3.5 mm (indoor vision test). [Figure 9C] FIG. 2 shows the calculated retinal image of the same virtual eye with a single-vision lens with wavefront technology of Table 2A for a pupil diameter of 2.5 mm (daytime vision outdoors). [Figure 9D] FIG. 2 shows the calculated retinal image of a virtual eye with a single-vision lens according to wavefront technology of Table 2A for a pupil diameter of 5 mm (night vision). [Figure 9E] FIG. 2 shows the calculated retinal image of a virtual eye with a conventional single vision lens for a pupil diameter of 5 mm (night vision). [Figure 9F]FIG. 2B shows the point spread function of a virtual eye with a wavefront technology monofocal lens of another exemplary design (Table 2B) for a pupil diameter of 3.5 mm. Astigmatism (CYL) from 0D to 5 / 8D and focus error (SPH) from -0.5D to +0.5D remain uncorrected by the wavefront technology monofocal lens. [Figure 9G] FIG. 9C shows a retinal image calculated from the point spread function for FIG. 9F. [Figure 10A] Calculated point spread functions of a virtual eye with a "PureVision-low" multifocal lens from Bausch & Lomb for pupil diameters of 3.0 mm, 3.5 mm, 4.5 mm, and 5 mm. For simplicity, only CYL=0D is considered. [Figure 10B] FIG. 2 shows calculated retinal images of a virtual eye with a “PureVision low” multifocal lens from Bausch & Lomb. [Figure 10C] 1 shows the point spread function of a virtual eye with an "Air Optix-med" multifocal lens from Alcon for pupil diameters of 3.0 mm, 3.5 mm, 4.5 mm, and 5 mm. For simplicity, only CYL=0D is considered. [Figure 10D] FIG. 1 shows the calculated retinal image of a virtual eye with an "Air Optix-med" multifocal lens from Alcon. [Figure 11] FIG. 1 is a schematic diagram of a Wavefront bifocal, trifocal, continuous focus lens in accordance with one embodiment of the present invention. [Figure 12A] 1 shows the point spread function of a virtual eye with an exemplary design of a wavefront bifocal lens (WF Bifocal 1D) for pupil diameters of 3.0 mm, 3.5 mm, 4.5 mm, and 5 mm. For simplicity, the case CYL=0D is considered. [Figure 12B] FIG. 10B shows the retinal image calculated from the point spread function of FIG. 10A for a wavefront bifocal lens of our design (WF Bifocal 1D). [Figure 12C]FIG. 13 shows plots of calculated retinal contrast “through focus” for WF Bifocal 1D for a pupil diameter of 3.5 mm, and for pupil diameters of 3 mm to 5 mm at 20 / 20 and 20 / 40 lines. [Figure 12D] Figure 1 shows calculated retinal contrast for 20 / 25, 20 / 30, 20 / 40, and 20 / 60 for normal eyes in photopic (A) and mesopic (B) conditions from a study of over 250 eyes of US Navy pilots with 5% low contrast visual acuity in photopic vision and 25% low contrast visual acuity in mesopic vision. [Figure 12E] FIG. 13 shows plots of calculated modulation transfer functions (MTFs) for WF Bifocal 1D at far distances of infinity (−0.25D), 4 meters (0D), and +0.25D focus error, for pupil diameters of 3mm, 3.5mm, and 5mm. [Figure 13A] 1 shows the point spread function of a virtual eye with our design wavefront EDOF Bifocal 3D for pupil diameters of 3.0 mm, 3.5 mm, 4.5 mm, and 5 mm. For simplicity, we consider only the case CYL=0D. [Figure 13B] FIG. 13B shows the retinal image calculated from the point spread function of FIG. 13A with our wavefront EDOF Bifocal 3D lens. [Figure 13C] FIG. 13 shows plots of calculated retinal contrast “through focus” for EDOF Bifocal 3D for a pupil diameter of 3 mm, and for 20 / 20 and 20 / 40 lines with pupil diameters of 3 mm to 5 mm. [Figure 13D] FIG. 13 shows plots of calculated modulation transfer functions (MTF) of EDOF Bifocal 3D at far distances of infinity (−0.25D), 4 meters (0D), and +0.25D focus error, for pupil diameters of 3mm, 3.5mm, and 5mm. [Figure 13E]FIG. 1 shows the calculated retinal contrast at distance (A) and through focus for 20 / 20 vision (B) of our EDOF Bifocal 3D compared to a prior art wavefront design. [Figure 14A] FIG. 1 shows the point spread function of a virtual eye for one design of the wavefront "EDOF Trifocal 2.75D" for pupil diameters of 3.0 mm, 3.5 mm, 4.5 mm, and 5 mm. For simplicity, only the case CYL=0D is considered. [Figure 14B] FIG. 14B shows the retinal image calculated from the point spread function of FIG. 14A with a wavefront "EDOF Trifocal 2.75D" lens. [Figure 14C] FIG. 13 shows plots of calculated retinal contrast “through focus” for EDOF Trifocal 2.75D for a pupil diameter of 3 mm, and for 20 / 20 and 20 / 40 lines with pupil diameters of 3 mm to 5 mm. [Figure 14D] FIG. 13 shows plots of calculated modulation transfer functions (MTF) for EDOF Trifocal 2.75D at far distances of infinity (−0.25D), 4 meters (0D), and +0.25D focus error, for pupil diameters of 3mm, 3.5mm, and 5mm. [Figure 15A] 1 shows the point spread function of a virtual eye for one design of the wavefront quasi-accommodative continuous focus "QACIF2D" for pupil diameters of 3.0 mm, 3.5 mm, 4.5 mm, and 5 mm. For simplicity, only the case CYL=0D is considered. [Figure 15B] FIG. 15B shows the retinal image calculated from the point spread function of FIG. 15A with a wavefront QACIF2D lens. [Figure 15C] FIG. 13 shows plots of calculated retinal contrast “through focus” for QACIF2D for a pupil diameter of 3.5 mm, and for pupil diameters of 3 mm to 5 mm at 20 / 20 and 20 / 40 lines. [Figure 15D]FIG. 13 shows plots of the calculated modulation transfer function (MTF) of QACIF2D at far distances of infinity (−0.25D), 4 meters (0D), and +0.25D focus error, for pupil diameters of 3mm, 3.5mm, and 5mm. [Figure 15E] FIG. 13 shows plots of calculated retinal contrast “through focus” for QACIF2A for a pupil diameter of 3.5 mm, and for pupil diameters of 3 mm to 5 mm at 20 / 20 and 20 / 40 lines. [Figure 15F] FIG. 13 shows the calculated retinal image for a wavefront QACIF2D lens with CYL=1 / 2D. [Figure 15G] FIG. 13 shows the calculated retinal image for a wavefront QACIF2D lens with CYL=3 / 4D. [Figure 16] FIG. 1 provides a comparison of the Wavefront monofocal / multifocal lenses of the present invention with conventional refractive monofocal and diffractive monofocal / multifocal lenses in terms of night vision and quality of vision affected by the incomplete correction of astigmatism and focus errors by these ophthalmic lenses. [Figure 17A] 1 shows calculated retinal images for several exemplary designs of wavefront multifocal lenses of the present invention compared to a conventional refractive monofocal lens at night with a pupil diameter of 5 mm at far distances of infinity (-0.25D), 4 meters (0D), and +0.25D focus error. [Figure 17B] FIG. 1 shows the image principle of a diffractive bifocal lens (A) and the components of the calculated retinal image at distance for a diffractive bifocal lens with additional refractive powers of +1.75D (B) and 3.5D (C), respectively. [Figure 17C] FIG. 1 shows calculated retinal images for a monofocal lens through focus, from -0.75D to +0.75D, and with 3 / 8D of uncorrected astigmatism. [Figure 18] FIG. 1 illustrates a liquid ophthalmic lens in one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] 1. Single vision / toric lenses with Wavefront technology Focus error (SPH) and astigmatism (CYL) are refractive errors of the human eye that cause blurring of images and reduce visual acuity and quality of vision.
[0018] Monofocal lenses, also called single vision lenses, are the most common form of eyeglasses, contact lenses, implantable contact lenses, and IOLs. Types of monofocal lenses include spherical monofocal lenses, aspheric monofocal lenses, and toric monofocal lenses.
[0019] Spherical prime lenses use spherical surfaces on both the front and back surfaces and are used to correct focus errors in the eye, such as myopia and hyperopia.
[0020] Toric monofocal lenses utilize at least one toric surface to provide vision correction for astigmatism as well as focal errors of the eye.
[0021] 1A. Residual Astigmatism Left Uncorrected by Monofocal / Toric Ophthalmic Lenses Correction of astigmatism with toric contact lenses usually starts at 0.75D with step increments of 0.5D. This is shown in Figure 3, which is the online order form for Air Optix toric contact lenses from Ciba Vision and Alcon Laboratories, Inc. Astigmatism correction with IOLs also starts at about 0.75D. Figure 4 shows the specifications for the AcrySof® IQ toric IOL from Alcon Laboratories, Inc. and guidelines for using these toric IOLs. The recommendation indicates that 0.75D to 1.0D of astigmatism may be left uncorrected by toric monofocal IOLs.
[0022] Sources of error in astigmatism correction with contact lenses, implantable contact lenses (ICLs), and IOLs include: 1) uncorrected astigmatism in the prescription when the eye has less than 0.75 D of astigmatism as determined by refraction; 2) limited selection of toric powers in toric lenses with 0.5 D increments; 3) selection of toric axes limited to 10 degree increments; and 4) rotation of the toric contact lens on the cornea or rotation of toric ICLs and IOLs upon post-op settlement.
[0023] Thus, astigmatism in the human eye is not adequately corrected by any of the existing monofocal or toric lenses, including contact lenses, IOLs, and ICLs. The eye's residual uncorrected astigmatism can be as much as 5 / 8D.
[0024] To study the effect of uncorrected astigmatism remaining in the eye by a conventional monofocal lens, we provide in FIG. 5A a simulation of the point spread function of the eye and in FIG. 5B a simulated retinal image of an acuity chart.
[0025] In the simulation, we considered two cases: perfect correction of astigmatism (CYL=0) and uncorrected astigmatism of 3 / 8D and 5 / 8D. Uncorrected focus errors (SPH) of -0.5D, -0.25D, 0D, +0.25D, and +0.5D were also considered because uncorrected focus errors are also common for IOLs, ICLs, and contact lenses. Sources of error include 1) the -0.25D myopic power between distance visual acuity at infinity and distance visual acuity at 4 meters in the refraction test, 2) limited selection of SPH powers for IOLs and ICLs, 3) errors in the SPH power of the ordered lenses, and 4) refractive errors of the eye.
[0026] FIG. 5A shows the retinal image or point spread function of a point source in a virtual eye with a pupil diameter of 3.5 mm. Significant image blurring is evident in FIG. 5A except for the case of perfect correction (SPH=0 and CYL=0). From the calculated point spread functions in FIG. 5A, the corresponding retinal image of the eye's acuity chart in FIG. 5B was calculated by convolving the calculated point spread function in FIG. 5A with a tumbling E acuity chart. The acuity chart consists of letters E of various sizes calibrated for acuity of 20 / 16 (smallest letter in the bottom row of each image in FIG. 5B), 20 / 20, 20 / 25, 20 / 30, and 20 / 40 (largest letter in the top row of each image).
[0027] To illustrate the details of the point spread function, note that the total dimension size of the point spread function in FIG. 5A is 1 / 8 the total dimension size of the retinal image in FIG. 5B.
[0028] All simulated point spread functions in this disclosure have the same dimensional scale, as do all simulated retinal images in this disclosure, with the dimensional scale of the point spread functions being 1 / 8 the size of the dimensional scale of the retinal images. Simulations for all cases throughout this application use the same visual acuity chart, consisting of the letter E in various sizes calibrated for visual acuity of 20 / 16 (smallest letter in the bottom row of each image in FIG. 5B), 20 / 20, 20 / 25, 20 / 30, and 20 / 40 (largest letter in the top row of each image in FIG. 5B).
[0029] From the simulation results in Figures 5A and 5B, we can see that conventional monofocal contact lenses, ICLs, and IOLs are far from adequate. The quality of vision is only good when both SPH and CYL are nearly perfectly corrected. There are several problems.
[0030] First, when astigmatism is not properly corrected, the blurring of the image caused by astigmatism, such as CYL=5 / 8D (third row in Figures 5A and 5B), makes it impossible to recognize the full acuity letter set of 20 / 20 (the second smallest letter on the chart) at any one of the five focal SPH settings. Because of this, people are most likely to have poor vision and their best corrected acuity is in the range of 20 / 40 or 20 / 30 (the largest or second largest letter on the chart) rather than the usual 20 / 20 acuity.
[0031] Second, even when the astigmatism is perfectly corrected (CYL=0, first row in Figures 5A and 5B), a focus error of + / -0.25D will result in the inability to resolve a 20 / 16 letter (the smallest letter on the chart) because the vision will be blurred. A focus error of + / -0.5D will result in complete blurring of vision for all letters from 20 / 40 to 20 / 16. This is significant because visual acuity is tested indoors at 4 meters and a myopic SPH error of -0.25D will occur at infinity outdoors.
[0032] Third, when uncorrected astigmatism is combined with an uncorrected focus error of + / - 0.25D, or when the uncorrected focus error alone reaches a level of 0.5D, image distortion (structural changes between objects and their images) is clearly observed.
[0033] Finally, toric lenses suffer from the same problems due to their limited correction of astigmatism, as shown in FIGS.
[0034] 1B. Spherical aberration in the normal human eye In spherical aberration, parallel rays passing through the central region of a positive lens converge farther than rays passing through the edge of the lens. The optical system of the human eye is a positive lens, and spherical aberration is most pronounced around the pupil. Based on studies of 214 eyes, Zernike spherical aberration (2.236 * (6r 4 -6r 2+1) was found to be +0.138±0.103 microns for a pupil diameter of 5.7 mm, where r is the normalized pupil radius (r=ρ / 2.85) and ρ is the pupil radius of the eye (J.Porter et.al., Monochromatic aberrations of the human eye in a large population, Journal of the Optical Society of America A, Vol.18, issue 8, pp.1793-1803(2001)).
[0035] Porter's mean Zernike spherical aberration W 12 (ρ)=0.138 * 2.236 * 6 * (r 4 -r 2 +1), the corresponding Seidel spherical aberration W(ρ) = 1.85 * r 4 =1.85 * (ρ / 2.85) 4 , or W(ρ) = 0.0280ρ 4 From the Seidel spherical aberration W(ρ), the diopter power profile φ(ρ) is calculated as φ(ρ) = -(dW(ρ) / dρ) / ρ = -0.11 * ρ 2 where ρ is the polar radius in millimeters. 1) It is well known that the refractive power of the eye is higher at the pupil periphery than at the pupil center of the human eye; 2) Diopter power (-0.11±0.08D / mm 2 ) is 0.10±0.06 D / mm with the opposite sign, provided by S. Plainis, DA Atchison and WN Charman, “Power Profiles of Multifocal Contact Lenses and Their Interpretation”, Optometry and Vision Sciences, vol.90, No.10, pp1066-1077. 2Since the diopter profile of the Zernike spherical aberration is close to that of the Zernike spherical aberration of Porter et al., it appears that the Zernike spherical aberration coefficients of Porter et al. are a correction of the Zernike spherical aberration rather than the Zernike spherical aberration itself.
[0036] Therefore, the negative Seidel spherical aberration in a normal eye is W(ρ) = -1.85 * (ρ / 2.85) 4 =-0.0280ρ 4 , the corresponding focus profile across the pupil radius is φ(ρ)=0.11 * ρ 2 It is.
[0037] It should also be mentioned that S. Plainis, DA Atchison, and WN Charman classify the Seidel spherical aberration of the eye as "positive", which contradicts the classical definition of optics (see Warren J. Smith, Modern Optical Engineering, 3rd Edition, p65). Positive spherical aberration is called overcorrected and is generally associated with diverging elements (negative lenses), and negative spherical aberration is called undercorrected and is generally associated with converging elements (positive lenses).
[0038] The human eye has negative spherical aberration, and the wavefront error caused by the negative spherical aberration of the eye can also be expressed as: W(ρ)=S1 * (ρ / r0) 4 Here, r0=0.5 * D0 is the pupil radius, ρ is the polar radius in the pupil plane and has values between 0 and r0, and negative spherical aberration has a negative coefficient S1 (S1<0). Table 1 shows the spherical aberration of the eye in both microns (μm) and wavelength (lambda=0.55 microns) for four different pupil diameters: 5.7 mm, 3.5 mm, 3 mm, and 2 mm. The mean spherical aberration of the human eye is -0.26 microns for a pupil diameter of 3.5 mm. [Table 1]
[0039] It can be seen well in Table 1 that the spherical aberration of the eye is negligible in the center of the pupil, being approximately λ / 20 for a pupil with a diameter of 2 mm and only λ / 4 in a pupil with a diameter of 3 mm, respectively. If the wavefront error is below λ / 4, the optical element is often considered to be diffraction limited or perfect. On the other hand, the mean spherical aberration of the normal human eye reaches 3.4 λ for a large pupil with a diameter of 5.7 in darkness, and is therefore noticeable in the deterioration of night vision.
[0040] Aspheric prime lenses, which use at least one aspheric surface on the front and back surfaces, are also found in contact lenses and IOLs. The aspheric surfaces are used for two purposes: 1) to provide correction for the spherical aberration of the human eye, which is noticeable around the pupil periphery, and 2) to eliminate spherical aberration in IOLs with large refractive powers. In either case, aspheric prime lenses differ from spherical prime lenses only at the outer lens periphery, about 3 mm in diameter, because the spherical aberration of the human eye and corrective lenses is small in the central optical zone.
[0041] 1C. Reducing astigmatism by inducing spherical aberration in the center of the eye's pupil One aspect of the present invention describes a fundamental discovery regarding the benefits of inducing more spherical aberration in the center of the eye's pupil to improve the quality of ophthalmic lenses.
[0042] 6A shows the point spread function of a hypothetical human eye with uncorrected astigmatism of CYL=5 / 8D and a pupil diameter of 3.5 mm, with six possible cases of spherical aberration in the eye: 1) S1=0 (first row from the left) when the spherical aberration in the eye is completely corrected by a conventional aspheric lens, 2) S1=-0.26 (second row from the left) when the spherical aberration in the eye is left unchanged by a spherical lens, and 3) S1=-0.52, -0.78, -1.04, and -1.34 when additional spherical aberration is induced in the eye by the wavefront technology lens. The wavefront technology monofocal lens of the present invention includes 1) a standard sphero-cylindrical correction over an optical zone of diameter 5 mm to 8 mm, and 2) spherical aberration induced in the center of the lens of diameter 2.5 mm to 4.5 mm. We simulate the visual acuity of the eye with a pupil diameter of 3.5mm, as this is the average pupil diameter of a normal human eye in clinical tests of visual acuity. Different degrees of focus error (SPH) were also considered in the simulation: -0.5D, -0.25D, 0D, 0.25D, and 0.5D.
[0043] If the eye has 5 / 8D astigmatism that is left uncorrected by a single focus contact lens, ICL, or IOL, the point spread function of the eye in Figure 6A is clearly larger in size when the spherical aberration of the eye is fully corrected with S1 = 0 or there is no change with S1 = -0.26. When more spherical aberration is induced in the center of the pupil, for S1 = -0.52 to S1 = -1.3, the point spread function of the eye becomes smaller and decreases in size.
[0044] From the point spread function in Figure 6A, we calculated the retinal image for an eye with an uncorrected astigmatism of CYL=5 / 8D and a pupil diameter of 3.5mm for the visual acuity chart shown in Figure 6B. The best quality images for visual acuities of various spherical aberrations S1=0, -0.26, -0.78, -1.04, -1.30 are identified and boxed.
[0045] From the simulated retinal images in Figure 6B, there are several findings. First, in the case of a conventional aspheric lens (S1=0, first row in Figure 6B) that corrects the spherical aberration of the eye, image blurring makes it impossible to recognize the set of acuity letters of 20 / 20 (the second smallest letter on the chart, fourth row from the top) or even 20 / 25. When an uncorrected CYL=5 / 8D is combined with SPH errors of ±0.25D and ±0.5D, poor visual acuity below 20 / 40 and image distortion are observed. Second, in the case of a spherical lens (S1=-0.26, second row in Figure 6A) where the spherical aberration of the eye remains uncorrected, image distortion is seen at all five focus settings. The best visual acuity quality is seen at focus offset +0.25D, where there is image distortion of all acuity letters from 20 / 16 to 20 / 30. All images at + / -0.25D and + / -0.5D are blurred and difficult to recognize letters below 20 / 40. The best corrected visual acuity can be worse than 20 / 20, and the quality of the corrected visual acuity is poor due to the image distortion caused by the phase shift of the phase transfer function. Thirdly, for a new kind of wavefront aspheric lens that induces more spherical aberration (S1 magnitude is 0.52 microns or more, S1=-0.78, -1.04, and -1.30) in the center of the pupil of the eye, visual acuity is improved in three ways: 1) best corrected visual acuity is improved to 20 / 20 or even 20 / 16, 2) visual acuity quality is improved by eliminating distortion, and 3) tolerance to errors in focus correction is increased.
[0046] Similarly, in Figures 6C and 6D, it can be seen that wavefront aspheric lenses inducing positive spherical aberrations of S1 = 0.78, 1.04, and 1.30 microns for a pupil diameter of 3.5 mm also improve visual acuity, visual quality, and focus tolerance when the eye has 5 / 8D of uncorrected astigmatism.
[0047] Contrary to the common belief that inducing spherical aberration in the eye reduces best corrected visual acuity, it has been shown for the first time that inducing spherical aberration in the center of the pupil of the eye can improve visual acuity and quality of vision in patients with 5 / 8D of astigmatism left uncorrected by ophthalmic lenses (contact lenses / ICLs / IOLs), improving best corrected visual acuity from 20 / 40 and 20 / 30 to 20 / 20 or better.
[0048] Having shown that inducing spherical aberration in the center of the eye's pupil with a wavefront technology monofocal lens can reduce 5 / 8D of uncorrected astigmatism and improve best corrected visual acuity, we would like to examine the effect of induced spherical aberration on eyes with less uncorrected astigmatism, such as CYL=3 / 8D, or even CYL=0D where the astigmatism is completely corrected.
[0049] FIG. 6E shows the point spread function of a virtual human eye with CYL=3 / 8D and a pupil diameter of 3.5 mm, considering the same six cases of spherical aberration of the eye: 1) S1=0 (first row from the left) when the spherical aberration of the eye is corrected by a conventional aspheric lens, 2) S1=-0.26 (second row from the left) when the spherical aberration of the eye remains unchanged by a conventional spherical lens, and 3) S1=-0.52, -0.78, -1.04, and -1.3 when additional spherical aberration is induced in the eye by a wavefront aspheric lens. We also consider eyes with different degrees of focus error: SPH=-0.5D, -0.25D, 0D, 0.25D, 0.5D.
[0050] Similar to the results in Figures 6A and 6C, it is observed that inducing spherical aberration has the same effect as reducing the astigmatism for CYL=3 / 8D in Figure 6E: 1) the point spread function of the eye increases in size when the spherical aberration of the eye is fully corrected (S1=0, first row from the left) or remains unchanged (S1=-0.26, second row from the left). The point spread function of the eye decreases in size when more spherical aberration is induced, for S1=-0.78, -1.04, and -1.3.
[0051] From the point spread function in Figure 6E, we calculated the retinal images of the visual acuity chart for a virtual human eye shown in Figure 6F for a pupil diameter of 3.5 mm. The best quality images for visual acuity S1 = 0, -0.26, -0.78, -1.04, and -1.30 were identified and boxed.
[0052] When 3 / 8D of astigmatism is left uncorrected by the monofocal lens, there are similar findings in FIG. 6F (CYL=3 / 8D) and FIG. 6B (CYL=5 / 8D) and FIG. 6D (CYL=5 / 8D): The new class of wavefront aspheric lenses, which induce more spherical aberration (S1=-0.78, -1.04, and -1.30) in the center of the pupil of the eye, improves vision quality over conventional aspheric lenses (S1=0) and conventional spherical lenses (S1=-0.26) in three ways: 1) improvement of best corrected visual acuity beyond 20 / 16, 2) elimination of distortion due to phase shift in the phase transfer function, and 3) increased tolerance for errors in focus correction.
[0053] For a hypothetical eye with no or perfectly corrected astigmatism, FIG. 6G shows the point spread function of the eye with a pupil diameter of 3.5 mm. The most compact point spread function eye is found for 1) a monofocal setting of SPH=0 when S1=0, 2) a bifocal setting of SPH=0, 0.25 when S1=-0.26, 3) a bifocal setting of SPH=0.25D, 0.50D when S1=-0.52 and S=-1.04, and a trifocal setting of SPH=0, 0.25, 0.50D when S1=-0.78 and S1=-1.3.
[0054] Looking at the simulated visual acuity chart in Figure 6H, we can conclude that in rare cases (about 1 / 20), the new kind of wavefront aspheric lens, which induces more spherical aberration (S1=-0.78, -1.04, and -1.30) in the center of the eye's pupil, improves vision correction beyond that of conventional aspheric lenses (S1=0) and conventional spherical lenses (S1=-0.26) by 1) achieving the same best visual acuity of 20 / 16 or better with little contrast loss while increasing the tolerance for errors in focal power and 2) eliminating distortion due to phase shift in the phase transfer function caused by small errors in focal correction, even when the eye's astigmatism is fully corrected (CYL=0) by monofocal / toric lenses.
[0055] It is also noted that the best quality is achieved when adding a focus offset beyond the spherical aberration induced in the center of the pupil.
[0056] In addition to the traditional baseline diopter power for sphero-cylindrical correction, wavefront technology monofocal lenses intentionally make the lenses imperfect according to the traditional definition. The wavefront error introduced into the central optical zone of a wavefront technology monofocal lens can be expressed as: W(ρ,φ)=S1 * (ρ / r0) 4 -0.5 * φ * ρ 2 Here, r0=0.5 * D0 is the radius of the central aspheric zone, ρ is the polar radius in the pupil plane and has values from 0 to r0, φ is the focal offset in diopters, and S1 is the total spherical aberration induced in the monofocal lens by wavefront technology.
[0057] 1D. Reducing coma by inducing spherical aberration in the center of the eye pupil The coma of the eye reduces the quality of vision. Wavefront correction of coma and higher order aberrations has been demonstrated using adaptive optics by J Liang, DR Williams, DT Miller, “Supernormal vision and high-resolution retinal imaging through adaptive optics”, Journal of the Optical Society of America A, Vol.14, Issue 11, pp.2884-2892(1997). Wavefront correction of higher order aberrations has also been proposed in U.S. Pat. No. 5,777,719.
[0058] Effective correction of ocular coma has not been effectively demonstrated in normal eyes with spectacles, contact lenses, and IOLs for a number of reasons. First, the coma of each eye must be measured individually. Second, the coma correcting lenses (spectacles, contact lenses, IOLs) must be custom made. Third, precise alignment of the lens position and orientation of the coma correcting lenses relative to the eye must be achieved for the spectacles, contact lenses, IOLs to the ocular coma.
[0059] In one aspect of the present invention, FIGS. 6I and 6J show the therapeutic treatment of coma by inducing additional spherical aberration in the center of the pupil of the eye.
[0060] FIG. 6I shows the calculated retinal images of the visual acuity chart of a virtual eye where only coma aberration remains uncorrected by a conventional monofocal lens (left column) and a monofocal lens with wavefront technology (right column) that induces a spherical aberration (S1) of -0.78 microns for a pupil diameter of 3.5 mm. The coma aberration of the simulated eye is measured by the Zernike polynomial with Zernike coefficient 1.0 microns for a pupil diameter of 6 mm. The unpleasant image blur and image distortion caused by the coma aberration of the eye (left column) is effectively eliminated by the wavefront lens (right column).
[0061] Figure 6J shows the simulation results where the Zernike coefficients for coma are increased from 1.0 to 1.5 microns for a pupil diameter of 6 mm. The effectiveness of using a wavefront lens to reduce significant coma is still evident.
[0062] 1E. Monofocal / Toric Contact Lenses, ICLs, and IOLs with Wavefront Technology US Patent No. 8,529,559 B2 and US Patent Application No. 2011 / 0029073 A1 disclose a method and apparatus for inducing spherical aberration in the center of the pupil of the eye for presbyopia correction. Prior to our discovery in the present invention, it was widely believed that inducing more spherical aberration in the eye by a corrective lens would adversely affect the contrast of the image. In the present invention, we have shown that in addition to increasing the depth of focus, inducing spherical aberration in the center of the pupil of the eye is also effective in improving the quality of vision correction: improving best corrected visual acuity (BCVA) and reducing astigmatism, coma, and focus error that remain uncorrected by spherocylindrical correction.
[0063] FIG. 7 discloses a wavefront technology monofocal lens for an eye. The lens 70 is configured as an IOL (75, 76) or contact lens (73, 74) or ICL and comprises 1) a baseline diopter power extending over an optical zone (71+72) with a diameter D1 of the lens between 5 mm and 8 mm for the correction of distance vision errors including at least focus errors and / or cylindrical errors, and 2) at least a central aspheric zone (72) in the center of the lens using at least one aspheric surface (73 or 74, 75 or 76) to induce spherical aberration in the center of the pupil of the eye. The diameter D0 of the central aspheric zone is between 2.5 mm and 4.5 mm. The baseline diopter power is usually specified as a sphero-cylindrical correction. The wavefront errors introduced in the aspheric zone provide a treatment (or reduction) of the residual refractive error that remains uncorrected in the eye by the baseline diopter power for distance vision errors. Refractive errors that remain uncorrected in the eye by the lens include astigmatism, focus errors (myopic or hyperopic powers), coma, and other higher order aberrations that are significant in reducing visual acuity at least in the center of the eye's pupil. Uncorrected (residual) refractive errors further include presbyopic powers less than +1.0D. For presbyopic powers greater than 1.0D, such as 2D in U.S. Pat. No. 8,529,559 B2 and U.S. Patent Application No. 2011 / 0029073 A1, corrected visual acuity is worsened by a significant reduction in image contrast for distance vision at a pupil diameter of about 3.5mm, resulting in worse than 20 / 20 at distance. Wavefront technology monofocal lenses can be fitted as contact lenses, intraocular lenses (IOLs) or accommodative intraocular lenses (AIOLs), implantable contact lenses (ICLs), and phakic IOLs.
[0064] In one embodiment, the central aspheric area is further configured to induce an additional focus offset of between −0.75D and +1.25D in addition to the baseline diopter power.
[0065] In another embodiment, the spherical aberration induced in the central aspheric area is S1 * (ρ / ρ0) 4can be expressed as the wavefront error of ρ0=0.5 * D0 is the radius of the central aspheric area, and ρ is the polar radius in the pupil plane, with values from 0 to ρ0, where ρ0 is from 1.25 mm to 2.25 mm.
[0066] In yet another embodiment, S1 is positive and has a magnitude of 0.78 * (D0 / 3.5) 4 exceeds or is negative and has a magnitude of 0.26 * (D0 / 3.5) 4 D0 is the diameter of the aspheric area. The spherical aberration of the corrected eye in combination with a single vision lens with Wavefront technology is more than twice as large as the statistical average of the spherical aberration of the normal human eye.
[0067] In addition to the traditional baseline diopter power for sphero-cylindrical correction, the wavefront technology monofocal lens of the present invention is intentionally made imperfect according to the traditional definition. The wavefront error introduced in the central optical zone of the wavefront technology monofocal lens can be expressed as: W(ρ,φ)=S1 * (ρ / r0) 4 -0.5 * φ * ρ 2 Here, r0=0.5 * D0 is the radius of the central aspheric zone, ρ is the polar radius in the pupil plane and has values from 0 to r0, φ is the focal offset in diopters, and S1 is the total spherical aberration induced in the monofocal lens by wavefront technology. [Table 2]
[0068] In one exemplary embodiment to further tolerate uncorrected astigmatism and extend depth of focus, Table 2A shows the parameters of an exemplary wavefront design.
[0069] FIG. 8A shows the point spread functions of a virtual eye with a pupil diameter of 3.5 mm comparing a conventional monofocal lens (left column) with an exemplary wavefront technology monofocal lens (right column) with the induced spherical aberration and focus offset of Table 2A. The virtual eye is considered to have no astigmatism (CYL=0), leaving focus errors (SPH) of -0.5D to +0.5D uncorrected by the monofocal lens. It can be seen that the point spread functions of the wavefront technology monofocal lens (right column) are more compact than the point spread functions of the conventional monofocal lens (left column) for all cases of SPH=-0.5D, -0.25D, 0.25D, and 0.5D, except for the full spherical correction when SPH=0.
[0070] Figure 8B shows retinal images calculated from the point spread functions in Figure 8A for a conventional prime lens (left column) and a wavefront technology prime lens (right column). Additionally, Figure 8C shows modulation transfer functions (MTFs) calculated from the point spread functions in Figure 8A for a conventional prime lens (top) and a wavefront technology prime lens of an exemplary design (bottom).
[0071] As expected for perfect correction in the extremely rare (e.g., less than 1 in 20 eyes) SPH (SPH=0) and CYL (CYL=0) cases, inducing spherical aberration with a wavefront lens significantly reduces the contrast of the retinal image at all frequencies as seen in the images (middle row in FIG. 8B) and the MTF in FIG. 8C. Retinal contrast with the wavefront lens decreases from 68% to 16% at 30c / deg for 20 / 20, from 59% to 12% at 37.5c / deg for 20 / 16, and from 47% to 5% at 48c / deg for 20 / 12. It should be noted that this ideal case of SPH=0 and CYL=0 has little or no practical impact since perfect focus correction of both SPH and CYL is extremely rare and the retinal contrast of real eyes is further degraded by third-order Zernike aberrations such as coma (see J Liang and DR Williams, “Aberrations and retinal image quality of the normal human eye”, Journal of the Optical Society of America A, Vol.14, Issue 11, pp.2873-2883(1997)). The formula for the average human optical modulation transfer function as a function of pupil diameter is published by AB Watson in Journal of Vision, 13(6):18, pp.1-11(2013).
[0072] SPH is usually not completely corrected due to 1) the myopic power of -0.25D between the distance visual acuity at infinity and the distance visual acuity at 4 meters in the visual acuity test, and 2) the error of the manufactured lens or the refractive error of the eye. When SPH=-0.25D and SPH=0.25, the retinal contrast is only about 1.2% at a spatial frequency of 37.5 cycles / degree, 2.1% at a visual acuity of 20 / 16, and 48 cycles / degree at a visual acuity of 20 / 12.5, as shown in FIG. 8C, so that the virtual eye cannot recognize letters with visual acuity of 20 / 16 or less with the conventional single-focus lens with both SPH and CYL perfectly corrected as shown in FIG. 8B. The MTF of the conventional single-focus lens is less than 2.5% in the entire spatial frequency range from 36 cycles / degree to 48 cycles / degree, which limits the best-corrected visual acuity to less than 20 / 16.
[0073] This is quite different from our wavefront technology monofocal lens. The wavefront design improves the retinal contrast from less than 1.2% to 14% at SPH=-0.25D, 5% at SPH=0.25 at 37.5 cycles / degrees with 20 / 16 vision, and improves the retinal contrast from 2.1% to 11% at SPH=-0.25D at 48 cycles / degrees with 20 / 12.5 vision. Thus, the wavefront technology monofocal lens allows the virtual eye to achieve best corrected vision of 20 / 16, or even 20 / 12.5 at SPH=-0.25D, as shown in FIG. 8B. It is also observed that when compared to conventional monofocal lenses, our wavefront technology monofocal lenses provide better visual acuity and improved image contrast and sharpness at spatial frequencies higher than 24 cycles / degree (20 / 25 vision) at the small cost of slightly reduced retinal contrast at low spatial frequencies, such as 15 cycles / degree at 20 / 40 vision and 20 cycles / degree at 20 / 30 vision.
[0074] For SPH=-0.5D and SPH=0.5D, the virtual eye cannot see the 20 / 40 and 20 / 20 letters with the conventional monofocal lens as shown in FIG. 8B, because the retinal contrast is nearly zero at 15 cycles / degree and 30 cycles / degree as shown in FIG. 8C. It is also noted that the 20 / 30 and 20 / 25 letters are distorted as shown in FIG. 8B due to the phase inversion of the phase transfer function (PTF) between 15 cycles / degree and 31 cycles / degree. The phase inversion of the PTF causes the position of the corresponding spatial frequency to shift by half a cycle. In contrast, the monofocal lens with wavefront technology allows the virtual eye to see all acuity letters from 20 / 40 to 20 / 16 without distortion as shown in FIG. 8B. For SPH=-0.5D, the monofocal lens with wavefront technology can also see the 20 / 12 letters with 11% retinal contrast at 48 cycles / degree. The elimination of the poor retinal image blur of conventional single vision lenses with Wavefront Technology single vision lenses is achieved by 1) preventing nearly 100% loss of retinal contrast in the eye's MTF between 15 cycles / degree and 40 cycles / degree, and 2) eliminating the phase reversal of the eye's PTF with conventional lenses.
[0075] To study the correction of residual astigmatism, focus error, and its pupil diameter dependency of a monofocal lens with the exemplary wavefront technology shown in Table 2A, optical simulations are provided in FIGS. 9A-9D.
[0076] Figure 9A shows the calculated point spread function of a virtual human eye for a pupil diameter of 3.5 mm for the exemplary wavefront technology monofocal lens of Table 2 A. Also, the retinal images of the human eye for a tumbling E-chart with different pupil diameters were calculated in Figure 9B for a pupil diameter of 3.5 mm (indoor vision test).
[0077] When comparing the retinal images obtained with the conventional single focus lens of FIG. 5B and the wavefront lens of FIG. 9B under the same conditions with a pupil diameter of 3.5 mm, significant differences are observed in three aspects.
[0078] First, unlike the conventional monofocal lens in Figure 5B, the wavefront technology monofocal lens in Figure 9B shows the elimination of astigmatism. There is little or no difference in the retinal images calculated under different values of astigmatism (CYL) with the same focus error (SPH) in Figure 9B.
[0079] Second, single vision lenses with Wavefront technology offer exceptional visual acuity: 1) 20 / 16 visual acuity can be obtained with a tolerance of at least ±0.25D of focus error regardless of the eye's residual astigmatism, and 2) 20 / 20 visual acuity is achieved with up to 5 / 8D of residual astigmatism and ±0.5D of focus error.
[0080] Third, the quality of vision is improved with wavefront technology single vision lenses because the image distortion of conventional lenses caused by residual focus error and / or residual cylinder error as shown in FIG. 5B is eliminated. In Fourier optics, the image blur of an optical system is characterized by 1) the loss of image contrast at various spatial frequencies of an object, as measured by the modulation transfer function (MTF), and 2) the phase shift or phase inversion between various spatial frequencies of an object, as measured by the phase transfer function (PTF). The phase inversion at a given spatial frequency results in a half-cycle position shift at a particular frequency of the retinal image. When the half-cycle displaced spatial frequency is combined with the non-displaced spatial frequency of an object, the final retinal image is not only blurred but also distorted, making letters distorted and difficult to read.
[0081] It can be concluded that monofocal lenses with wavefront technology improve vision correction in most normal eyes, but may reduce visual acuity or contrast in a small group (e.g., 1 in 20 people) whose best corrected visual acuity with monofocal is 20 / 10.
[0082] Modern cameras use autofocus to dynamically correct focus errors and aspheric lenses and multiple lens elements to correct spherical aberration, astigmatism, and coma. Spherical aberration, by definition, reduces the image quality of an optical system, and this is true not only for camera lenses but of course for the human eye with its large pupil diameter at night. Using spherical aberration to improve vision and vision quality seems counterintuitive, but makes perfect sense when considering the imperfect nature of ophthalmic correction in state-of-the-art IOLs and contact lenses, as shown in Figures 5A and 5B.
[0083] The quality of an ophthalmic lens for an eye must take into account the visual acuity for different pupil diameters, e.g., 2.5 mm for outdoor and daylight, and 5 mm for night vision. Figures 9C and 9D show the calculated retinal images of the same hypothetical eye when the pupil diameter is reduced to 2.5 mm or increased to 5 mm, respectively.
[0084] Compared to the calculated retinal image in Figure 9B for a pupil diameter of 3.5 mm, the retinal image in Figure 9C for a pupil diameter of 2.5 mm provides much better contrast and legibility of the acuity letters for each combination of astigmatism and focus error.
[0085] Simulating the retinal point spread function and retinal image in night vision is difficult because it is necessary to consider the high-order aberrations of the eye at night, which differ from eye to eye. For simplicity, we assume that the astigmatism and focus error that remain uncorrected by the monofocal lens are more significant than the high-order aberrations of the eye that are relevant for 3 / 8D and 5 / 8D astigmatism and / or + / -0.25D and + / -0.5D focus errors.
[0086] 9D and 9E show the calculated retinal images of a virtual eye with an exemplary wavefront technology monofocal lens (FIG. 9D) and a conventional monofocal lens (FIG. 9E), respectively, for a pupil diameter of 5 mm. The wavefront error of the wavefront technology monofocal lens does not exceed a pupil diameter of 4 mm, while the uncorrected astigmatism and focus error spread across the entire pupil diameter of 5 mm. It is clear that the night vision performance of the exemplary wavefront technology monofocal lens for a pupil diameter of 5 mm is significantly better than that of the conventional monofocal lens in terms of visual acuity and quality of vision, except for the rare case of SPH=0 and CYL=0. The nighttime effect of FIG. 9D (wavefront monofocal) compared to FIG. 9E (conventional monofocal) appears more dramatic than the comparison of FIG. 9B (wavefront monofocal) compared to FIG. 5B (conventional monofocal) for a pupil diameter of 3.5 mm.
[0087] Therefore, when it is considered that astigmatism, coma, and focus errors remain uncorrected in the human eye by traditional single vision lenses, it can be concluded that spherical aberration at the center of the pupil is no longer a negative factor in designing ophthalmic lenses and eyepieces for vision devices.
[0088] In another exemplary embodiment of the wavefront technology monofocal lens, the wavefront errors introduced in the aspheric area are negative spherical aberration (S1<0) and negative focus offset. Table 2B shows the parameters of the second exemplary wavefront technology monofocal lens.
[0089] Figure 9F shows the calculated retinal image of a point source, the point spread function, of a virtual human eye with a pupil diameter of 3.5 mm for a second exemplary wavefront technology monofocal lens. From the calculated point spread function of Figure 9F, we also calculated the retinal image of a tumbling E chart, shown in Figure 9G. [Table 3]
[0090] The second exemplary wavefront technology monofocal lens in Table 2B with negative spherical aberration (S1<0) and negative focus offset shares similar advantages with the first wavefront technology monofocal lens in Table 2A with positive spherical aberration (S1>0) and positive focus offset, and there is one obvious difference between them: the second exemplary wavefront technology monofocal lens (Table 2B) has better vision quality for positive focus error SPH=0.25D and 0.50D, while the first exemplary wavefront technology monofocal lens (Table 2A) has better vision quality for positive focus error SPH=0.25D and 0.50D.
[0091] In one embodiment of the wavefront technology monofocal lens, the induced total spherical aberration is negative (S1<0) and the induced focal offset φ is negative and has a magnitude less than 0.75D (φ>-0.75D). The induced negative spherical aberration (S1) is -0.71 microns to -7.51 microns in the central aspheric zone, which is scaled to pupil diameters 2.5mm to 4.5mm according to Table 2C, which shows the spherical aberration (S1) induced in the pupil for different radii r0 of the aspheric zone from 1.25mm to 2.25mm.
[0092] In another embodiment, the induced total spherical aberration is positive (S1>0) and the induced focus offset φ is positive and has a magnitude less than 0.75 D (φ<0.75 D). The induced positive spherical aberration (S1) is 0.71 microns to 7.51 microns at the central aspheric zone, which is scaled to pupil diameters 2.5 mm to 4.5 mm according to Table 2C, which shows the spherical aberration (S1) induced in the pupil for different radii r0 of the aspheric zone from 1.25 mm to 2.25 mm. [Table 4]
[0093] In yet another embodiment, the induced spherical aberration is further defined as ρ nwhere n is an integer equal to or greater than 3. The wavefront error due to generalized spherical aberration can be characterized as a generalized polynomial φ(ρ)=c3ρ 3 +c4ρ 4 +c5ρ 5 +c6ρ 6 In some cases, the induced spherical aberration can be further expressed as ρ n where n is an even integer greater than 4. [Table 5]
[0094] Further embodiments of wavefront technology monofocal lenses are provided in Table 2D. WFM-CL1 and WFM-CL2 are optimized for wavefront contact lenses in patients without presbyopia. WF-EDOF M1 and WF-EDOF M2 are optimized for wavefront EDOF monofocal lenses in patients with presbyopia correction and can be fitted to contact lenses, IOLs, and accommodative IOLs. Table 2E shows the spherical aberration induced in the aspheric central area. [Table 6]
[0095] All these designs (WFM-CL1, WFM-CL2, WF-EDOF M1, WF-EDOF M1) and the designs in Tables 2A and 2B can be used for implantable contact lenses (ICL). ICL shares similar problems of limited lens selection (SPH or CYL), cylinder axis error, lens manufacturing error, refractive prescription error, and presbyopia of the eye. ICL is less forgiving than contact lenses because it involves a surgical procedure.
[0096] In some embodiments, the wavefront technology monofocal lens is configured as a wavefront contact lens with a diameter of 9 mm to 16 mm and has a front and a back surface, at least one of which is aspheric to induce spherical aberration in a central aspheric zone.
[0097] In one embodiment, the wavefront contact lens is configured to have a focal offset of +0.12D to +1.2D and a central pupil induced spherical aberration of 0.31 microns to 7.51 microns in a central aspheric area with a diameter of 2.5 mm to 4.5 mm.
[0098] In another embodiment, the wavefront contact lens is configured such that the spherical aberration induced at the center of the pupil is between -0.31 microns and -7.51 microns in a central aspheric area having a diameter of 2.5 mm to 4.5 mm, and the magnitude of the focus offset is less than 0.5D.
[0099] In yet another embodiment, the wavefront contact lens is further configured such that the spherical aberration (S1) induced in the central aspheric zone is determined individually based on the spherical aberration and other higher order aberrations measured in each individual eye.
[0100] In yet another embodiment, the wavefront contact lens further comprises correction of high order aberrations of the eye for therapeutic treatment, the high order aberrations of the eye being aberrations other than astigmatism and focus errors of the eye.
[0101] In another embodiment, the wavefront monofocal contact lens is further configured as a toric contact lens.
[0102] In yet another embodiment, the back surface of the contact lens is further configured to have an aspheric shape at the lens periphery to prevent rotation of the lens on the eye if the lens is also a toric lens.
[0103] In some embodiments, the wavefront monofocal lens is configured as a wavefront monofocal intraocular lens (IOL) having a diameter of approximately 6 mm, e.g., 5 mm to 7 mm, and includes a front surface and a back surface, at least one of which is aspheric to induce spherical aberration in the aspheric area. The wavefront monofocal IOL further includes a haptic area.
[0104] In one embodiment, the wavefront monofocal IOL is configured to have a negative focal offset magnitude less than 0.75D and an induced spherical aberration between -0.31 microns and -7.5 microns in a central aspheric area with a diameter of 2.5 mm to 4.5 mm.
[0105] In another embodiment, the wavefront monofocal IOL is configured with a focal offset of +0.25D to +1.20D and an induced spherical aberration of 0.31 microns to 7.5 microns with a central aspheric area of 2.5 mm to 4.5 mm in diameter.
[0106] In yet another embodiment, the wavefront monofocal IOL is further configured as a toric IOL.
[0107] In yet another embodiment, the wavefront monofocal IOL is configured as an accommodative IOL.
[0108] In some embodiments, wavefront technology monofocal lenses (contact lenses, IOLs, and accommodating IOLs, ICLs) are further configured to include aspheric areas outside the central aspheric area to a) correct for normal eye spherical aberration at the pupil periphery, and b) correct for spherical aberration at the pupil periphery of the human eye.
[0109] S. Plainis, DA Atchison, and WN Charman studied the four major brands of multifocal contact lenses and published their findings in “Power Profiles of Multifocal Contact Lenses and Their Interpretation”, Optometry and Vision Sciences, vol.90, No.10, pp1066-1077 in 2013. They found that five contact lenses use aspheric surfaces to change spherical aberration when placed on the eye: Air Optix -low, -med, -high from Alcon, and PureVision -Low, -High from Bausch & Lomb.
[0110] The diopter profiles of PureVision from Bausch & Lomb and Air Optix from Alcon, marked with "low", are φ(ρ)=0.67-0.18ρ at a diameter of about 6 mm, respectively. 2 and φ(ρ) = 0.54-0.15ρ 2 They are essentially the mean spherical aberration (0.112ρ 2) correction and aspheric lenses for positive focal offsets of +0.67D and 0.54D over the baseline correction for low presbyopia correction. Consumers could actually purchase less expensive single vision lenses with offset SPH powers of +0.50D or +0.75D in the prescription, paying a premium to obtain these so-called multifocal contact lenses. Figures 10A and 10B show the calculated point spread function of the PureVision -low lens from Bausch & Lomb and the calculated retinal image of the visual acuity chart. There are two conclusions. First, as expected, the best focus of the eye shifts from the baseline correction (SPH=0) to an add SPH=+0.67D throughout the lens such that low presbyopia of +0.5D to +1.0D is alleviated. At the same time, vision at distances of -0.08D and +0.17D becomes severely blurred. Secondly, while providing correction of the spherical aberration of the eye, these so-called multifocal contact lenses cannot be adapted as monofocal lenses with wavefront technology as described in the present invention since they 1) result in poor vision at long distances as seen in Figures 10A and 10B, and 2) cannot provide relief of the uncorrected astigmatism of the eye for S1=0 as shown in Figures 6A-6H.
[0111] The diopter profile of the Air Optix multifocal contact lenses marked "med" is φ(ρ)=1.14-0.44ρ at the center of a 2.8 mm diameter pupil. 2 The mean spherical aberration (0.112ρ 2 ) and after correction for the baseline focus error of each eye, this lens has a φ'(ρ)=1.14-0.33ρ 210C and 10D show the calculated point spread function and retinal image of the visual acuity chart of the "Air Optix-med" lens, respectively. The acceptable visual acuity indoors for pupil diameters of 3mm and 3.5mm is +0.5D to +1.25D, with the best visual acuity set at around +0.5D. However, the presbyopic correction of the "Air Optix-med" lens also comes at a high price for visual acuity at distance -0.25D to +0.25D. In addition, the distance visual acuity at 0D and -0.25D is terrible as seen in Figs. 10C / 10D, and most people wearing the Air Optix med lens would not be able to pass the driver's license test seeing 20 / 40 at around 6 meters based on the simulated results, so the "Air Optix med" lens cannot be used for the wavefront technology monofocal lens described in this invention. Even when these lenses are prescribed for off-label use, the Air Optix med has an incorrect combination of focus offset and induced negative spherical aberration.
[0112] The diopter profiles of the PureVision multifocal contact lens (Bausch & Lomb) and the Air Optix multifocal contact lens (Alcon) marked "high" are φ(ρ) = 1.93-0.50ρ at the center of pupils with diameters of 2.4 mm and 2.8 mm, respectively. 2 and φ(ρ) = 1.58-0.69ρ 2 The mean spherical aberration (0.112ρ 2 After correction for the baseline focus error of each eye, these lenses have φ'(ρ) = 1.93-0.39ρ, respectively. 2 and φ'(ρ) = 1.58-0.58ρ 2The diopter profile remains at 1.000. The PureVision and Air Optix multifocal lens structures marked with "high" cannot be adapted to the Wavefront monofocal lenses described in this invention, since the visual acuity at distance is reduced even more severely than in the Air Optix med lenses. Even when these lenses are prescribed for off-label use, the combination of focal offset and induced negative spherical aberration is wrong.
[0113] 2. Wavefront Extended Depth of Focus (EDOF) Progressive Lenses Progressive lenses have two different refractive powers, usually providing a first focus for distance vision and a second focus for presbyopia correction.
[0114] Diffractive bifocal lenses are available in IOLs with diopter separation between the two foci ranging from +1.75D to +4.0D. As mentioned earlier, problems associated with diffractive multifocal IOLs include: 1) halo and starburst nighttime symptoms due to simultaneous bifocal images, 2) spider web nighttime symptoms associated with the diffractive structure, 3) ghost images of large distant objects caused by a lack of near focus, and 4) poor visual acuity and image distortion between foci due to focus errors or astigmatism in the eye.
[0115] Because contact lenses cannot use the split power designs of spectacles or the diffractive designs of IOLs due to their sharp diffractive surfaces, there are currently no bifocal contact lenses that can provide presbyopic correction without significantly reducing visual acuity at distance. So-called multifocal contact lenses (Air Optix from Alcon and PureVision from Bausch & Lomb) are single-focus lenses, and Figures 10A-10D show that the patient's distance visual acuity is significantly impaired and therefore cannot be qualified as bifocal lenses.
[0116] Inducing spherical aberration of the opposite sign in the pupil center has been proposed in US Patent No. 8,529,559 B2 and US Patent Application No. 2011 / 0029073 A1. To obtain the desired depth of focus (DoF) of 3D for a presbyopia-correcting IOL, a focal offset of +4.0D (+1D more than the desired DOF of +3.0D) is introduced in the central aspheric area. This design results in a significant reduction in retinal contrast at distance for a pupil diameter of 3mm or 3.5mm (indoor vision test), which is the standard diameter for IOL testing.
[0117] The Mini Well Ready IOL (S1fi SpA), designed based on inducing spherical aberration of opposite sign in the center of the pupil, uses a special configuration to solve the low contrast problem at distance, providing an EDOF progressive lens with a high contrast distance first focus and a second extended depth of focus of +1.0D to +2.5D. However, the Mini Well Ready IOL also has at least one drawback in that its depth of focus is 2.5D, much less than the 3D required for reading at a near distance of 33mm.
[0118] In one embodiment of the present invention, two EDOF bifocal lenses are described in Table 3A, one labeled EDOF Bifocal 3D for high presbyopia correction of about 3D, and the other labeled EDOF Bifocal 1D for low presbyopia of about +1.0D. Unlike the Mini Well Ready IOL (see "A New Extended Depth of Focus Intraocular Lens Based on Spherical Aberration", R Bellucci and MC Curatolo, J Refract Surg. 2017;33(6):389-394), which has an extended depth of focus for near distance, our EDOF bifocal lens has an extended depth of focus for distance, which increases the chances of achieving best corrected visual acuity of 20 / 20 at distance vision with IOL / ICL surgery. [Table 7]
[0119] In a non-limiting embodiment, the EDOF bifocal lens (110) of FIG. 11 for an eye is configured as an implantable or wearable lens and has 1) a baseline diopter power extending across the optical zones (111, 112, 113) of the lens having a total diameter D2 of 5 mm to 8 mm, including a central zone (111), an intermediate annular zone (112), and an outer annular zone (113), for the correction of distance vision defects; and 2) a diopter power of 100% or more for the correction of distance vision defects, the diopter power extending across the optical zones (111, 112, 113) of the lens having a total diameter D2 of 5 mm to 8 mm, the diopter power including a central zone (111), an intermediate annular zone (112), and an outer annular zone (113). 2) a positive focal offset φ1 of less than 2.0D and greater than +0.25D at the central zone (111) of greater than 1.8mm; and 3) two aspheric zones (111 and 112) with outer diameters of less than 4.5mm and greater than 2.5mm covering at least the center of the pupil of the eye, characterized in that at least one surface of the lens is aspheric to induce positive spherical aberration in the first zone (111) and negative spherical aberration in the second zone (112). The first zone and the second zone are coaxial. The second zone can further be configured to have a positive focal offset of less than 1.5D in some embodiments. The Wavefront EDOF bifocal lens can be configured as a contact lens, an intraocular lens (IOL), an accommodating intraocular lens (AIOL), an ICL (implantable contact lens or posterior chamber phakic intraocular lens), or a phakic IOL that works with the cornea and lens of the eye.
[0120] A first exemplary design provides an EDOF bifocal lens with an additional refractive power of 1.0D + / - 0.25D between the two foci. Parameters of an exemplary Wavefront bifocal lens (labeled "EDOF Bifocal 1D") are shown in Table 3A.
[0121] Assume that an EDOF progressive lens has an optical zone diameter of 5mm to 8mm. The lens has a baseline diopter power that extends across the optical zone of the lens to correct distance vision defects in the same way as a single vision lens.
[0122] The bifocal lens also has two aspheric zones covering the center of the pupil of the eye, with an outer diameter D0 of 3.5 mm (radius 1.875). The aspheric zones are characterized in that at least one surface of the lens is aspheric to induce a positive spherical aberration in a first zone and a negative spherical aberration in a second zone. The spherical aberration induced in the aspheric zones is expressed as a wavefront error (OPD) across the pupil of the eye, i.e. If ρ≦1.15, OPD(ρ)=0.7 * (ρ / r0) 4 If 1.15<ρ≦1.75, OPD(ρ)=-1.11 * (ρ / r1) 4 where ρ is the polar radius in the pupil plane. The positive spherical aberration of the first zone has a peak value of 0.70 microns at the boundary ρ=r0=1.15. The negative spherical aberration of the second zone has a peak value of -1.11 microns at the boundary ρ=r1=1.75 mm. The aspheric zone covering the center of the eye's pupil has a diameter of 3.5 mm.
[0123] In addition to the baseline diopter power and the spherical aberration induced in the aspheric zone, there is a positive focus offset of 1.0 D in the central (first) zone and a positive focus offset of 0.37 D in the annular (second) zone.
[0124] The performance of the wavefront bifocal lens was simulated, and the calculated point spread functions (PSFs) from SPH=-0.25D to SPH=+1.5D are shown in Figure 12A, and the calculated retinal image of the visual acuity chart is shown in Figure 12B. The parameter SPH is used to specify the focus error of the eye through focus. SPH=0D specifies the best corrected visual acuity at 4 meters, a common distance for visual acuity testing in the United States. SPH=-0.25D specifies the corrected visual acuity at infinity, which is myopic by -0.25D when the target distance is 4 meters for traditional visual acuity testing. SPH=+1.0D specifies a presbyopic correction of +1.0D. Four pupil diameters were considered: 3.0mm and 3.5mm for visual acuity testing, and 4.5mm and 5.0mm for night vision.
[0125] Unlike the PSFs of Figures 10A and 10C, the calculated PSF of the WF Bifocal 1D lens in Figure 12A is observed to have a first focus covering a focus range of at least -0.25D to +0.25D and a second focus covering a focus range of +0.75D to +1.5D.
[0126] FIG. 12C shows the calculated "through focus" retinal contrast plots for WF Bifocal 1D for 3.5mm pupil diameter and for 20 / 20 and 20 / 40 lines from 3mm to 5mm pupil diameter. Our EDOF bifocal 1D works slightly differently than conventional bifocal lenses in two ways. First, the first focus for distance is an extended depth of focus from -3 / 8D to +3 / 8D at visual acuity tests with 3.0mm and 3.5mm pupil diameters. Second, the second focus for presbyopic correction from +0.75D to +1.5D has a gap for 20 / 20 vision at +1.25D. The calculated retinal images in FIG. 12B confirm the wavefront bifocal characteristics as well as the slightly reduced visual acuity and visibility at +1.25D.
[0127] To estimate best corrected visual acuity from the through-focus MTF in Figure 12C, one needs to know the threshold contrast for each visual acuity line. Figure 12D shows the calculated retinal contrasts for normal eyes at 20 / 25, 20 / 30, 20 / 40, and 20 / 60 in photopic (A) and mesopic (B) conditions, respectively. These are unpublished data from J Liang, D Tanzer, and T Brunstetter studying over 250 eyes of US Navy pilots with normal uncorrected visual acuity of 20 / 20 to 20 / 10. The photopic curves (A) above were derived from 1) each subject's best subjective visual acuity reading a 5% low-contrast visual acuity chart in photopic conditions, and 2) the calculated MTFs of each eye during subjective testing of 5% low-contrast visual acuity. From (A) of FIG. 12D, the average threshold contrast for photopic vision is estimated to be less than 2% for 20 / 25 (24 cycles / deg), 20 / 30 (20 cycles / deg), and 20 / 40 (15 cycles / deg). Mesopic vision curves (B) were obtained from 1) the best subjective visual acuity of each eye reading a chart with 25% low contrast in mesopic conditions, and 2) the calculated MTF of each eye for the pupil diameter during the subjective test of 25% low contrast visual acuity. From (B) of FIG. 12D, the average threshold contrast for mesopic vision is estimated to be about 5%-6% for 20 / 25 (24 cycles / deg), 20 / 30 (20 cycles / deg), and 20 / 40 (15 cycles / deg).
[0128] FIG. 12E shows plots of the calculated modulation transfer function (MTF) of WF Bifocal 1D at infinity (-0.25D), 4 meters (0D), and far distances with focus error of +0.25D for pupil diameters of 3mm, 3.5mm, and 5mm. Also shown in FIG. 12E is the average MTF of a normal eye, labeled as "Normal Eye", calculated based on the formula provided by AB Watson in Journal of Vision, 13(6):18, pp.1-11 (2013), and the estimated MTF of a diffractive bifocal lens, labeled as "Diffractive Bifocal 40%", calculated from the average MTF of a normal eye using a 50% bifocal lens as well. Diffractive bifocal lenses typically have about 20% energy loss that does not contribute to either the "0" or "1" order diffraction images. Our WF Bifocal 1D provides better contrast than 50% diffractive multifocal lenses at distances, with no contrast loss at spatial frequencies above 20c / deg (characteristics below 20 / 30) and slight contrast loss at spatial frequencies below 20c / deg when compared to normal human eyes. This is especially true for real eyes, since our WF Bifocal 1D lenses can reduce the uncorrected astigmatism and coma of the eye that degrades the quality of vision with conventional single vision and diffractive multifocal lenses.
[0129] From the data in Figures 12C and 12E, there are several findings for the EDOF bifocal 1D. First, this EDOF bifocal is expected to provide patients with 20 / 16 or better visual acuity with relatively high contrast. Second, night vision at 4.5mm and 5mm pupil diameters is exceptional at distance. Therefore, a 1D presbyopic correction bifocal is invented with little or no loss of retinal contrast at distance. Another advantage of the Wavefront bifocal is its tolerance to uncorrected astigmatism (approximately 0.5D).
[0130] In the exemplary design of "EDOF bifocal 3D" in Table 3A, this bifocal lens also has an aspherical region that covers the center of the eye's pupil. The spherical aberration induced in the aspherical region is represented as the wavefront error (OPD) across the eye's pupil, that is, When ρ < r0 = 1.1, OPD(ρ) = 1.0 * (ρ / r0) 4 When 1.1 < ρ ≤ r1 = 1.75, OPD(ρ) = -2.22 * (ρ / r1) 4 Here, ρ is the polar radius in the pupil plane. The positive spherical aberration in the first region has a peak value of 1.0 micron at the boundary ρ = r0 = 1.1. The negative spherical aberration in the second region has a peak value of -2.22 microns at the boundary ρ = r1 = 1.75.
[0131] In addition to the baseline diopter power and the spherical aberration induced in the aspherical region, there is a positive focus offset of 1.65D in the central (first) region and a positive focus offset of 1.15D in the annular (second) region.
[0132] The performance of the wavefront EDOF bifocal 3D was simulated, and the calculated point spread function (PSF) for SPH = -0.25D to SPH = +3.25D is shown in Fig. 13A, and the calculated retinal image of the visual acuity chart is shown in Fig. 13B. SPH = 0D designates the best corrected visual acuity at 4 meters, which is a common distance for vision tests in the United States. SPH = -0.25D designates the corrected visual acuity at infinity, and SPH = +3.0D designates a presbyopia correction of +3.0D. Four pupil diameters of 3.0mm and 3.5mm for vision tests and 4.5mm and 5.0mm for night vision were considered.
[0133] It is observed that the calculated PSF of the WF Bifocal 3D lens in Fig. 13A has a first focus that covers an extended focus range of 0D to +1.25D and a second focus that covers a focus range of +2.75D to 3.25D. The focus at +2.25D is too narrow and too weak to be considered a focal region.
[0134] FIG. 13C shows the calculated "through-focus" retinal contrast plots for EDOF Bifocal 3D for a pupil diameter of 3.5 mm, and for 20 / 20 and 20 / 40 lines with pupil diameters of 3 mm to 5 mm. Our EDOF bifocal 3D works slightly differently than a conventional bifocal lens in two ways. First, the first focus for distance is an extended depth of focus from 0D to +1.25D for visual acuity tests with pupil diameters of 3.0 mm and 3.5 mm. Second, the second focus for presbyopia correction is from +2.75D to +3.25D. The calculated retinal images in FIG. 13B confirm the EDOF bifocal properties.
[0135] FIG. 13D shows plots of the calculated modulation transfer function (MTF) of WF Bifocal 3D at infinity (-0.25D), 4 meters (0D), and far distances with focus error of +0.25D for pupil diameters of 3mm, 3.5mm, and 5mm. Also shown in FIG. 13D is the average MTF of a normal eye, labeled as "Normal Eye," and the estimated MTF of a diffractive bifocal lens, labeled as "Diffractive Bifocal 40%." Our WF Bifocal 3D provides comparable or better contrast than diffractive multifocal lenses at far distances, with no contrast loss at spatial frequencies above 30c / deg (characteristics below 20 / 20) and slight contrast loss at spatial frequencies below 30c / deg when compared to the normal human eye. This is especially true for the real eye, since our WF Bifocal 3D Lens can reduce the eye's uncorrected astigmatism and coma aberrations that degrade vision quality with conventional single vision and diffractive multifocal lenses.
[0136] From Figures 13C and 13D, there are several findings for the EDOF bifocal 3D lens. First, this EDOF bifocal is expected to provide patients with 20 / 16 or better visual acuity with high contrast and extended depth of focus. Second, night vision with 4.5mm and 5mm pupil diameters is excellent at distance and near. Another advantage of this Wavefront progressive lens is its tolerance to uncorrected astigmatism up to 0.5D.
[0137] Solving the problem of low contrast at distance with the prior art wavefront design (U.S. Pat. No. 8,529,559 B2 and U.S. Patent Application No. 2011 / 0029073 A1) is possible by finding an optimum solution using EDOF bifocal 3D to reduce the focus offset at the central aspheric zone to +1.65D, which is 1.35D less than the 3D total depth of focus of the wavefront progressive lens. In contrast, the central aspheric zone of the prior art wavefront design sees a focus offset of +4.0D, which is 1.0D more than the 3D total depth of focus. The dramatic improvement in contrast with our inventive EDOF bifocal 3D is plotted in Figure 13E, which shows retinal contrast at distance (A) and through-focus contrast at 20 / 20 vision (B) comparing the prior art wavefront design (U.S. Pat. No. 8,529,559 B2 and U.S. Pat. Appl. No. 2011 / 0029073 A1) with our new EDOF Bifocal 3D. Figure 13E is obtained with a lens diameter of 3 mm, the industry standard dimension for testing multifocal lenses.
[0138] In one embodiment, the spherical aberration induced in the aspheric area is expressed as a wavefront error across the pupil, or OPD, i.e. If ρ≦r0, then OPD(ρ)=S1 * (ρ / r0) 4 If r0<ρ≦r1, OPD(ρ)=(-S2) * (ρ / r1) 4 where ρ is the polar radius in the pupil plane, S1 is positive and represents the positive spherical aberration of the first area (111), and r0=0.5 * D0 is the radius of the first zone greater than 0.87 mm and less than 1.25 mm. (-S2) is negative and represents the negative spherical aberration of the second zone, and r1 is the outer diameter of the second zone (112) less than 2.25 mm and greater than 1.20 mm. The second zone of the aspheric zone can be further configured to add a focal offset φ2, which is between -1.0D and +1.0D. In one embodiment, the positive spherical aberration S1 is greater than 0.20 microns and less than 1.50 microns. Table 3B shows the calculated positive spherical aberration of a wavefront bifocal lens with a central aspheric zone diameter between 1.75 mm and 2.4 mm. In one embodiment, the magnitude of the negative spherical aberration (-S2) is greater than 0.25 microns and less than 6 microns. Table 3C shows the calculated negative spherical aberration of wavefront progressive lenses with annular aspheric zone outer diameters between 2.5 mm and 4.4 mm.
[0139] In yet another embodiment, the aspheric zone further comprises ρ n where n is an integer greater than or equal to 3.
[0140] In some embodiments, the wavefront bifocal lens is configured as a bifocal contact lens having a diameter between 9 mm and 16 mm. The wavefront bifocal contact lens has a front surface and a back surface, at least one of which is aspheric at the center of the lens.
[0141] In one embodiment, the back surface of the Wavefront EDOF bifocal contact lens is further configured to have an aspheric shape at the lens periphery to prevent lens rotation on the eye when the lens is a toric bifocal contact lens. [Table 8] [Table 9]
[0142] In some embodiments, the wavefront bifocal lens is configured as a wavefront bifocal IOL having a diameter of 5 mm to 7 mm, and the aspheric surface is the anterior or posterior surface of the IOL. In one embodiment, the wavefront bifocal IOL is further configured as an accommodating IOL.
[0143] In another embodiment, the wavefront bifocal lens is configured as a wavefront corneal inlay having a diameter of about 6 mm or 5-7 mm, and the aspheric surface is the anterior or posterior surface of the corneal inlay.
[0144] 3. Wavefront EDOF Trifocal Lens Diffractive trifocal IOLs not only provide a high rate of spectacle-free IOL surgery, but also allow the postoperative eye to see non-existent artifacts produced by diffractive optics, such as 1) halos and starburst nighttime symptoms caused by simultaneous multiple images, 2) spider web nighttime symptoms associated with diffractive structures, and 3) ghost images of large distant objects caused by a lack of intermediate and near focus.
[0145] Inducing spherical aberration of the opposite sign in the pupil center for a +3D presbyopia-correcting IOL has been proposed in U.S. Pat. No. 8,529,559 B2 and U.S. Patent Application No. 2011 / 0029073 A1. To obtain a desired 3D depth of focus (DoF), a focal offset of +4.0D greater than the desired DoF is introduced in the central aspheric area. [Table 10]
[0146] There are at least three problems with the design of U.S. Patent No. 8,529,559 B2 and U.S. Patent Application No. 2011 / 0029073 A1. First, the design suffers from low contrast at distances, which has been noted and addressed in the improved design of the Mini Well Ready IOL. Second, the original design and the Mini Well Ready IOL are not trifocal lenses that satisfy the active lifestyle of patients who require good vision at distances for driving and watching TV, at intermediate distances (approximately 0.6 m) for working on a computer, and at close distances (approximately 0.3 m) for reading books or small print. Third, trifocal ophthalmic lenses with a full focal range of 2.0D to 2.5D for contact lenses, implantable contact lenses, and corneal inlays are also lacking, as these lenses work in conjunction with the crystalline lens of the eye.
[0147] To address these issues, in one aspect of the present invention, we provide a new class of wavefront EDOF trifocal lenses in Table 4A. First, we could create wavefront trifocal lenses with three foci: a first "distance" focus, a second "intermediate" focus with small additional power, and a third "near" focus with large additional power. These trifocal lenses provide functional vision at "far", "intermediate" and "near" distances. Second, these trifocal lenses cover a wide presbyopic range of 2.25D to 3.25D for IOLs as well as contact lenses, ICLs and corneal inlays. Third, we solve the problem of low contrast at far distances for 3D presbyopic correction by finding an optimal solution with a focus offset φ1 smaller than the total presbyopic range from baseline diopter power to "near" additional power. Fourth, the trifocal lenses have an extended depth of focus at far distances.
[0148] In one exemplary design of "EDOF Trifocal 2.75D" in Table 4A, this lens has two aspherical regions that cover the center of the eye's pupil, and its outer diameter is 3.0 mm. The aspherical regions are characterized in that at least one surface of the lens is aspherical to induce positive spherical aberration in the first region and negative spherical aberration in the second region, and the first region and the second region are coaxial. The spherical aberration induced in the aspherical regions is represented as the wavefront error (OPD) across the eye's pupil, that is, When ρ < r0 = 0.92, OPD(ρ) = 0.80 * (ρ / r0) 4 When 0.92 < ρ ≤ r1 = 1.5, OPD(ρ) = -2.2 * (ρ / r1) 4 where ρ is the polar radius in the pupil plane. The positive spherical aberration of the first region has a peak value of 0.80 microns at the boundary ρ = r0 = 0.92. The negative spherical aberration of the second region has a peak value of -2.2 microns at the boundary ρ = r1 = 1.5.
[0149] In addition to the baseline diopter power and the spherical aberration induced in the aspherical regions, there is a positive focus offset of +2.0D in the central (first) region with a diameter of 1.75 mm (radius 0.875 mm).
[0150] The performance of EDOF Trifocal 2.75D was simulated, and the calculated point spread function (PSF) from -0.25D to +3.0D is shown in FIG. 14A, and the calculated retinal image of the visual acuity chart is shown in FIG. 14B. The parameter SPH is used to specify the focus error of the eye's through-focus. SPH = 0D specifies the best corrected visual acuity at 4 meters. SPH = -0.25D specifies the corrected visual acuity at infinity, which means that when the target far distance is 4 meters in the conventional visual acuity test, it is only -0.25D myopic. SPH = +3.0D specifies a presbyopia correction of +3.0D. Four different pupil diameters of 3.0 mm and 3.5 mm for the visual acuity test and 4.5 mm and 5.0 mm for night vision were considered.
[0151] FIG. 14C shows plots of calculated "through-focus" retinal contrast for the EDOF Trifocal 2.75D with a pupil diameter of 3.5 mm, 20 / 20 line, and 20 / 40 line.
[0152] From the calculated PSF in FIG. 14A and the “Through Focus” plot in FIG. 14C, it is observed that the EDOF Trifocal 2.75D has three distinct foci: a first focus covering an extended focal range of −0.25D to +0.75D for viewing at long distances, a second focus covering a focal range of +1.25D to +2.0D for mid-range, and a third focus of 2.25D to 3.0D for close distances.
[0153] FIG. 14D shows plots of the calculated modulation transfer function (MTF) of the EDOF Trifocal 2.75D at infinity (-0.25D), 4 meters (0D), and far distances with focus error of +0.25D for pupil diameters of 3mm, 3.5mm, and 5mm. Also shown in FIG. 14D is the average MTF of a normal eye labeled as "normal eye" and the estimated MTF of a diffractive bifocal lens labeled as "diffractive bifocal 40%". Our EDOF Trifocal 2.75D provides comparable or better contrast than a diffractive multifocal lens at far distances, with no contrast loss at spatial frequencies above 30c / deg (characteristics below 20 / 20) and some contrast loss at spatial frequencies below 30c / deg when compared to a normal eye. This is especially true for the real eye, since our EDOF Trifocal 2.75D lens can reduce the eye's uncorrected astigmatism and coma aberrations that degrade vision quality with conventional single vision and diffractive multifocal lenses.
[0154] From Figures 14C and 14D, there are several findings for the EDOF Trifocal 2.75D lens. First, the EDOF bifocal is expected to provide visual acuity of 20 / 16 or better with relatively high contrast and extended depth of focus. Second, night vision with 4.5mm and 5mm pupil diameters is excellent at distance and near. Another advantage of this Wavefront progressive lens is its tolerance to uncorrected astigmatism up to 0.5D.
[0155] Table 4A shows three other embodiments of EDOF trifocal lenses that solve the low contrast problem at long distances of the designs of U.S. Patent No. 8,529,559 B2 and U.S. Patent Application No. 2011 / 0029073 A1, and provide the following features: 1) extended depth of focus for long distances, 2) a second focus with presbyopia correction of +1.25D to +1.75D, and 3) a third focus that extends the total focus range from 2.25D to 3.25D. [Table 11] [Table 12]
[0156] The invention of wavefront trifocal lenses with high retinal contrast at distance is made possible by finding the optimum solution with low focal offsets of +1.62D and +2.7D in the central aspheric zone. These EDOF trifocal designs can be fitted to contact lenses, IOLs, accommodative IOLs, phakic IOLs, ICLs, and corneal inlays.
[0157] In some embodiments, the wavefront EDOF trifocal lens of FIG. 11 is configured as an implantable or wearable lens. It comprises 1) a baseline diopter power extending over the optical zones (111, 112, 113) of the lens with a diameter D2 between 5 mm and 8 mm for the correction of distance vision defects including focus errors and / or cylinder errors; 2) a positive focus offset φ1 less than +3.0D and more than +1.0D in a central zone (111) with a diameter D0 less than 2.1 mm and more than 1.65 mm; and 3) two central aspheric zones (111, 112) at least in the center of the lens, covering the center of the pupil of the eye, with an outer diameter less than 4 mm and more than 2.5 mm, characterized in that at least one surface of the lens is aspheric to induce a positive spherical aberration in the first zone (111) and a negative spherical aberration in the second zone (112), and the first and second zones are coaxial. Wavefront errors beyond the baseline diopter power will transform the monofocal lens into a trifocal lens, i.e., a first "distance" focus, a second focus with additional refractive power for "middle distance", and a third focus with additional refractive power for "near distance", and the positive focus offset φ1 in the central zone must be smaller than the full focal range of the trifocal lens.
[0158] In one embodiment of a wavefront EDOF trifocal lens, the spherical aberration induced in the aspheric zone is expressed in terms of the optical path difference (OPD), or wavefront error across the pupil of the eye, i.e. If ρ≦r0, then OPD(ρ)=S1 * (ρ / r0) 4 If r0<ρ≦r1, OPD(ρ)=(-S2) * (ρ / r1) 4 where ρ is the polar radius in the pupil plane; S1 is positive and represents the positive spherical aberration of the first zone with a peak value of S1 at the boundary ρ=r0, r0 being the radius of the first zone and greater than 0.82 mm and less than 1.1 mm; (-S2) is negative and represents the negative spherical aberration of the second zone with a peak value of (-S2) at the boundary ρ=r1, r1 being the outer radius of the second zone and greater than 1.2 mm and less than 2 mm.
[0159] In another embodiment, the positive spherical aberration S1 of the first zone is greater than 0.30 microns and less than 2 microns.
[0160] In yet another embodiment, the magnitude of the negative spherical aberration (-S2) is greater than 0.50 microns and less than 8.5 microns.
[0161] In yet another embodiment, the aspheric zone further comprises ρ n where n is an integer greater than or equal to 3.
[0162] In yet another embodiment, the wavefront trifocal lens is further configured to add a focus error φ2 to a second area of the aspheric area, the focus error being between −1.0D and +1.0D.
[0163] In some embodiments, the wavefront trifocal lens is configured as a wavefront trifocal contact lens with a diameter between 9 mm and 16 mm, and the aspheric surface is the front or back surface of the contact lens. The back surface of the trifocal contact lens is further configured to have an aspheric shape at the lens periphery to prevent rotation of the lens on the eye if the contact lens is also a toric lens.
[0164] In another embodiment, the wavefront trifocal lens is configured as a wavefront trifocal IOL and has a diameter of about 6 mm and an optical zone of 5 mm to 7 mm. The wavefront trifocal IOL has an anterior surface and a posterior surface, at least one of the anterior surface or posterior surface is aspheric in the center of the lens.
[0165] 4. Quasi-Accommodating Lens Accommodating IOLs are currently plagued by one or more of the following drawbacks: 1) a narrow accommodation range that is insufficient for effective presbyopia correction, 2) insufficient control of artificial accommodation to freely achieve the desired accommodation state, 3) visual acuity becomes unstable due to large fluctuations in artificial accommodation, 4) low visual acuity due to uncorrected astigmatism of the eye.
[0166] In one aspect of the present invention, a new class of wavefront lens for the eye, a Quasi-Accommodating Continuous Focus (QACIF) lens, is disclosed. The QACIF lens has an optical zone with a diameter of less than 8 mm and provides a substantially continuous focus over a focal range of more than 1.0 D up to 2 D. The 2 D focal range is smaller than the 3 D of the IOLs used in cataract surgery, but the QACIF lens with a 2 D focal depth is sufficiently good for the treatment of all presbyopic eyes without cataracts that use ICLs, phakic IOLs, or contact lenses. The QACIF lens can be realized by a special multi-focus structure having a plurality of foci that are close enough to produce a substantially continuous focus. The multi-focus lens can be realized by 1) using an aspheric surface to induce spherical aberration in the central part of the lens with a diameter of less than 4 mm, or 2) using diffractive optics to produce simultaneous multiple foci.
[0167] In one exemplary design of the QACIF lens “QACIF2D” in Table 5A, the lens has two aspheric zones that cover the center of the pupil of the eye, and its outer diameter is 3.5 mm. The aspheric zones are characterized in that at least one surface of the lens is aspheric to induce positive spherical aberration in the first zone and negative spherical aberration in the second zone, and the first zone and the second zone are coaxial. The spherical aberration induced in the aspheric zones is represented as the wavefront error (OPD) across the pupil of the eye, that is, When ρ < r0 = 1.25, OPD(ρ) = 1.0 * (ρ / r0) 4 When 1.25 < ρ ≤ r1 = 1.75, OPD(ρ) = -1.11 * (ρ / r1) 4 where ρ is the polar radius in the pupil plane. The positive spherical aberration of the first zone has a peak value of 1.0 microns at the boundary ρ=r0=1.25 mm. The negative spherical aberration of the second zone has a peak value of -1.11 microns at the boundary ρ=r1=1.75 mm.
[0168] In addition to the baseline diopter power and the spherical aberration induced by the two aspheric zones, there is a positive focal offset of +1.25D in the central (first) zone with a diameter of 2.5mm (radius of 1.25mm) and a positive focal offset of +0.75D in the annular (second) zone with an outer diameter of 3.5mm (radius of 1.75mm).
[0169] The performance of the wavefront QACIF2D was simulated and the calculated point spread function (PSF) is shown in FIG. 15A and the calculated retinal image of the visual acuity chart is shown in FIG. 15B. The parameter SPH is used to specify the focus error of the eye through focus. SPH=0D specifies the best corrected visual acuity at 4 meters. SPH=-0.25D specifies the corrected visual acuity at infinity. SPH=+2.0D specifies a presbyopic correction of +2.0D. Four pupil diameters were considered: 3.0mm and 3.5mm for visual acuity testing and 4.5mm and 5.0mm for night vision.
[0170] From the calculated point spread functions from SPH=-0.25D to SPH=+2.0D in Figure 15A, this lens yields three focal zones, one centered near 0D, one near +0.75D, and one near +1.75D with two peaks at +1.5D and +2.0D. For vision test pupil diameters of 3mm and 3.5mm, these foci are close enough to form an extended depth of focus that nearly focuses the lens over the entire focal range SPH=-0.25D to SPH=2.0D, except for a relatively weak focus at SPH=+1.25D.
[0171] FIG. 15C shows plots of the calculated "through focus" retinal contrast for QACIF2D for a pupil diameter of 3.5 mm and for 20 / 20 and 20 / 40 lines from 3 mm to 5 mm. The QACIF lens can provide visual acuity of 20 / 20 or better at the first focus at extended depth of focus of -0.25D to 1.0D, and 20 / 20 or 20 / 25 at +1.50D to +1.75D. Visual acuity of 20 / 30 or better is expected at through focus of -0.25D to +2.0D. These findings may be contradicted in the calculated retinal image of FIG. 15B. Thus, we see a nearly continuous focus lens with slightly reduced visual acuity at +1.25D for all pupil diameters and at +2.0D for a pupil diameter of 3 mm.
[0172] FIG. 15D shows plots of the calculated modulation transfer function (MTF) of the QACIF2D at infinity (-0.25D), 4 meters (0D), and far distances with focus error of +0.25D for pupil diameters of 3 mm, 3.5 mm, and 5 mm. Also shown in FIG. 15D is the average MTF of a normal eye labeled as "normal eye" and the estimated MTF of a diffractive bifocal lens labeled as "diffractive bifocal 40%". Our QACIF2D provides better contrast than diffractive multifocal lenses at far distances, with no contrast loss at spatial frequencies above 30c / deg (characteristics below 20 / 20) and slight contrast loss at spatial frequencies below 30c / deg when compared to normal human eyes. This is especially true for real eyes, since our QACIF2D lens can reduce the uncorrected astigmatism and coma of the eye that degrades the quality of vision with conventional monofocal and diffractive multifocal lenses.
[0173] The QACIF2D lens is expected to provide patients with visual acuity of 20 / 16 or better with relatively high contrast and exceptional night vision at 4.5mm and 5mm pupil diameters.
[0174] Figures 15E and 15F show the calculated retinal images with the QACIF2D lens when the eye has 1 / 2D and 3 / 4D of uncorrected astigmatism, respectively. It can be seen that the image in Figure 15E with 0.5D of uncorrected CYL is almost identical to the image in Figure 15B with CYL=0. Even in the case of 0.75D of uncorrected astigmatism shown in Figure 15F, the visual acuity is still good at +0.25D to +1.25D.
[0175] In addition to eliminating astigmatism, the QACIF2D is also independent of pupil diameters from 3mm to 5mm, which can be verified in the retinal images in Figures 15A / 15E / 15F and through-focus plots (B) and (C) in Figure 15c. This is quite different from the conventional lenses shown in Figures 5B and 10B, where the optical system for larger pupil diameters is more sensitive to focus errors and astigmatism.
[0176] Based on two basic characteristics of the exemplary lens: 1) excellent visual acuity of 20 / 20 or 20 / 25 from SPH=-0.25D to SPH=+2.0D, and 2) near independence from pupil diameter of 3mm to 5mm, this type of lens is classified as a 2.0D quasi-accommodative continuous focus (QACIF) lens without artificial accommodation of the AIOL.
[0177] ICLs or phakic IOLs with QACIF2D optics can treat all people over 45 years of age without cataracts with myopia / hyperopia, astigmatism, and presbyopia, making them spectacle independent and free from reading glasses.
[0178] FIG. 15G shows another design of a semi-accommodative continuous focus lens, "QACIF2A". It results in a pupil diameter independent EDOF trifocal lens with an extended depth of focus, a first focus at -0.25D to +0.5D, a second focus centered at +1.25D, and a third focus at +1.75D. QACIF2A can be used to supplement QACIF2D. When QACIF2A and QACIF2D are applied separately to the two eyes, patients can expect visual acuity of 20 / 20 or better in the full focus range of -0.25D to +2.0D and all pupil diameters of 3mm to 5mm.
[0179] Two additional designs of QACIF lenses are also shown in Table 5A. They share similar features of nearly continuous focus over a 2.0D focus range and a high tolerance for uncorrected astigmatism.
[0180] In some embodiments, a wavefront quasi-accommodative continuous focus (QACIF) lens is configured as an implantable or wearable lens, the wavefront QACIF lens comprising: 1) a baseline diopter power extending across an optical zone of the lens with a diameter of 5 mm to 8 mm for the correction of distance vision errors including focus error and / or cylinder error; 2) a central aspheric zone having a positive focus offset φ1 and a positive spherical aberration S1, the positive focus offset φ1 being less than 2.0 D and greater than 0.75 D, the positive spherical aberration S1 being greater than 0.25 microns and less than 2.75 microns for a central aspheric zone with a diameter of less than 2.75 mm and greater than 1.9 mm; and 3) an annular aspheric zone outside the central aspheric zone with an outer diameter of less than 4.5 mm and greater than 2.5 mm that induces a negative spherical aberration. The positive spherical aberration of the QACIF lens at the central aspheric area for diameters of 1.9 mm, 2.2 mm, and 2.75 mm was calculated and is shown in Table 5B.
[0181] The Wavefront QACIF lens may be configured as a contact lens, an intraocular lens (IOL), an accommodating intraocular lens (AIOL), a phakic IOL, an ICL (implantable contact lens or posterior chamber phakic intraocular lens), or a corneal inlay.
[0182] In one embodiment, the annular aspheric zone outer than the central aspheric zone is further configured to have a positive focus offset greater than 0 and less than 1.5D. [Table 13] [Table 14]
[0183] In another embodiment, the spherical aberration induced in the aspheric area is expressed in terms of the optical path difference (OPD), or wavefront error across the pupil of the eye, i.e. If ρ≦r0, then OPD(ρ)=S1 * (ρ / r0) 4 If r0<ρ≦r1, OPD(ρ)=(-S2) * (ρ / r1) 4 where ρ is the polar radius in the pupil plane, S1 is positive and represents the positive spherical aberration of the first zone having a peak value of S1 at the boundary ρ=r0, r0 is the radius of the first zone and is greater than 0.9 mm and less than 1.4 mm, (-S2) is negative and represents the negative spherical aberration of the second zone having a peak value of (-S2) at the boundary ρ=r1, r1 is the outer radius of the second zone and is greater than 1.25 mm and less than 2.25 mm.
[0184] In yet another embodiment, the magnitude of the negative spherical aberration (-S2) is greater than 0.15 microns and less than 4.75 microns when the outer diameter of the annular aspheric zone is less than 4.5 mm and greater than 2.5 mm. The negative spherical aberration of the annular aspheric zone for diameters of 2.5 mm, 3.0 mm, and 3.75 mm is calculated and shown in Table 5C.
[0185] In yet another embodiment, the aspheric zone further comprises ρ n where n is an integer greater than or equal to 3.
[0186] In one embodiment, the wavefront QACIF lens is configured as a wavefront contact lens with a diameter between 9 mm and 16 mm, and the aspheric surface is the front or back surface of the contact lens, the back surface of the contact lens being further configured to have an aspheric shape at the lens periphery to prevent rotation of the lens on the eye if the contact lens is also a toric lens. [Table 15]
[0187] In another embodiment, the wavefront QACIF lens is configured as a wavefront IOL and has a diameter of about 6 mm and an optic zone of 5 mm to 7 mm. The wavefront IOL has an anterior surface and a posterior surface, at least one of which is aspheric in the center of the lens.
[0188] In yet another embodiment, the QACIF IOL is further configured as an accommodative IOL.
[0189] In yet another embodiment, the wavefront QACIF lens is configured as a wavefront ICL that is implanted between the iris and the lens of the eye, and the aspheric surface is the anterior or posterior surface of the wavefront ICL lens.
[0190] In another embodiment, the QACIF ICL is achieved through optic thickness variation when the baseline power magnitude is less than 1.0D.
[0191] In yet another embodiment, the wavefront QACIF lens is configured as a wavefront corneal inlay that can be implanted in the cornea of the eye for vision correction, and the aspheric surface is the anterior or posterior surface of the wavefront corneal inlay.
[0192] In another aspect, a wavefront implantable contact lens (ICL) for an eye is disclosed, comprising: a) a haptic area for fixing the ICL to the iris in the anterior chamber in the example of WO1999062434A1 or for holding the ICL in place in the posterior chamber in the example of U.S. Pat. No. 6,106,553; and b) a wavefront lens including: b1) a baseline diopter power extending over an optical area of 5 mm to 8 mm diameter for sphero-cylindrical correction; b2) a central area of 1.65 mm to 2.5 mm diameter inducing positive spherical aberration and a positive focal offset φ1 less than +3.0D and greater than +0.5D; and b3) an annular area of less than 4.5 mm outer diameter inducing negative spherical aberration. Due to the wavefront errors from induced spherical aberration and focus offsets in the central and annular zones, the optical lens can be one of the following: 1) a semi-accommodative continuous focus lens, 2) a wavefront bifocal lens, or 3) a wavefront trifocal lens.
[0193] In one embodiment, the wavefront ICL has a central aspheric area and an annular aspheric area for inducing the required spherical aberration.
[0194] In yet another aspect, a method of refractive correction of an eye is disclosed, comprising: a) determining the refractive error of the eye, including at least a spherical power SPH for distance vision correction; and b) performing a refractive correction surgery to provide an extended depth of focus in the post-operative eye from a first focal power φ1 to a second focal power φ2, and to provide the spherical power SPH of the eye between φ1 and φ2, such that the post-operative eye retains good vision at distance even if the eye has a post-operative myopic progression of -0.5D to -1.25D. In one embodiment, the refractive correction surgery to provide the extended depth of focus includes implanting a wavefront ICL having an extended depth of focus. For example, if an ICL with an optic of QACIF2D is implanted in the eye with a target distance of SPH=+0.75D instead of SPH=0D, the eye not only has post-operative 20 / 20 vision, but also has good vision in the focal range of -0.25D to +1.0D as shown in FIG. 15B / 15C. This is advantageous because 1) up to 1D of postoperative myopia progression can be reduced in young adults, and 2) less than 1D of postoperative myopia progression can beneficially begin after age 40, when the postoperative eye would develop presbyopia.
[0195] 5. Advantages of Wavefront Monofocal, Progressive, Trifocal and QACIF Lenses Although traditional monofocal and diffractive multifocal lenses may be superior based on their optical design and laboratory test results, there are many issues with their performance when they are actually placed in or on the human eye.
[0196] The disclosed Wavefront lenses (monofocal and multifocal) solve several fundamental problems of prior art monofocal / multifocal lenses: 1) eliminate the halos and starbursts associated with diffractive multifocal lenses, 2) eliminate the blurred zones between the foci of multifocal lenses, 3) improve the quality of vision for patients by eliminating the image distortions of traditional monofocal and diffractive multifocal lenses, and 4) increase the likelihood of achieving best corrected vision of 20 / 20 by extending the 20 / 20 depth of focus and increasing the tolerance to uncorrected astigmatism. This is shown in Figures 9B / 9G, 12C, 13C, 14C, and 15C.
[0197] FIG. 16A provides a comparison of the wavefront monofocal / multifocal lenses of the present invention with conventional refractive monofocal and diffractive monofocal / multifocal lenses.
[0198] Figure 17A shows the calculated retinal images at night with a pupil diameter of 5 mm for a wavefront multifocal lens of an exemplary design of the present invention compared to a conventional refractive monofocal lens. Three focus settings are considered: -0.25D for distance vision at infinity, 0D for the target visual acuity chart at 4 meters, and +0.25D for presbyopia at +0.25D. The angular dimension of each square in Figure 16B is 0.25 degrees of arc. Compared to the angular dimension of the sun in the sky (about 0.5 degrees of arc), the point spread function patterns at the three far distances are very small: 1) about 1 / 12 for the conventional monofocal lens, and 2) 1 / 14 to 1 / 6 for our wavefront EDOF bifocal, EDOF trifocal, and QACIF lenses.
[0199] A diffractive multifocal lens is constructed as a single-focus lens + kinoform diffractive surface (see FIG. 17B (A)). The retinal image of a diffractive multifocal lens consists of a diffraction order "0" image without deviation for the designed distance vision correction, a diffraction order "1" image with deviation with additional refractive power, and other deviation "higher" order diffraction images. Therefore, in addition to the in-focus image of diffraction order "0" affected by the wavefront error of the eye, there is a defocused image of diffraction order "1" with focus error of "additional refractive power" shown in FIG. 17B (C) for the additional refractive power of +1.75D and +3.5D, respectively. Therefore, it is inevitable that halos and starbursts are associated with diffractive multifocal lenses due to the defocused images of the near focus. In addition, nighttime symptoms associated with diffractive lenses may be caused by 1) light scattering and light shadows caused by the sharp edge pattern, and 2) diffraction patterns due to discontinuous phase at each step of the kinoform.
[0200] Therefore, it can be concluded that our wavefront multifocal lens has similar night vision performance as a monofocal lens with perfect correction of focus errors. The nighttime halos and starbursts of diffractive multifocal lenses are effectively eliminated. Furthermore, our wavefront multifocal lens outperforms conventional monofocal IOLs when the target distance visual acuity of the monofocal IOL is near 1 meter for alleviating presbyopia, instead of 4 meters for best distance visual acuity.
[0201] Two other fundamental problems of conventional multifocal lenses are 1) blurred vision between foci and 2) poor vision quality associated with image distortion. From the calculated retinal image through focus of a monofocal lens in Figure 10B, it can be seen that acceptable vision has a short depth of focus of about + / - 0.25D for full correction of astigmatism (CYL=0). However, if the eye has uncorrected astigmatism, the depth of focus is further reduced. Figure 17C shows the calculated retinal image through focus of a monofocal lens from -0.75D to +0.75D with uncorrected astigmatism 3 / 8D. It can be concluded that 1) retinal image distortion occurs as soon as the focus error reaches 0.25D, and 2) the depth of focus for 20 / 20 is much smaller than + / - 0.25D. For a diffractive bifocal IOL with a diffraction efficiency of 40% at distance, the retinal images are similar to those in Figure 10B for CYL=0 and Figure 17C for CYL=3 / 8D, but with a reduction in contrast (1-40%) across all spatial frequencies. Thus, for a multifocal lens with additional refractive power greater than 1.5D, one would expect the interfocal images to appear blurred or distorted for any focal length with a focus error of about 0.25D from either of the foci.
[0202] Complete blurring or distortion between foci is effectively solved with our Wavefront Bifocal, Trifocal and QACIF lenses shown in Figures 9B / 9D / 9G, 15B / 15E, 12B, 13B and 14B. Our Wavefront lenses for presbyopia provide continuous visual acuity of 20 / 40 or better across the entire focal range of each design.
[0203] 6. Liquid Ophthalmic Lenses In one embodiment of the present invention, Fig. 18 discloses a liquid ophthalmic lens (180) comprising: 1) a liquid lens portion having a flexible bag formed by a front optical element (181) and a rear optical element (182) and a liquid (183) filling the flexible bag formed by the front optical element and the rear optical element, 2) a solid optical element (184) immersed in the liquid in the liquid lens region and configured to change the refractive properties of the liquid lens, and 3) an attachment mechanism (185) for securing the solid optical element (184) to the flexible bag.
[0204] In one embodiment, the liquid lens portion is configured to be deformable between a disaccommodated state for a nominal optical power and an accommodated state for a different optical power. The solid optical element (184) has a front and back surface and a refractive index n1 that is different from the refractive index of the liquid (n2).
[0205] Many mechanisms for surgically attaching a liquid lens to an eye exist in the prior art for controlling accommodation of the liquid lens. In one embodiment, the liquid ophthalmic lens further comprises a haptic portion configured to deform in response to forces exerted by movement of the ciliary muscles of the eye, the haptic portion having an internal liquid volume in fluid communication with the liquid lens portion.
[0206] In yet another embodiment, the solid optical element immersed in the liquid lens portion is an optically spherical lens configured to change the spherical power of the combined liquid lens. This design allows the same structure to be used for the front and back elements of the liquid lens to accommodate a large number of people with different IOL power requirements. The liquid lens has an IOL power of 29D with one structure design of the front (101), back (102) and liquid without the immersed solid optical element. Its shape can be deformed to achieve a fixed accommodation range of up to 4.0D. If the immersed solid optical element can be selected for one refractive power of +11.0D to -11.0D, the combination of the same structure of the liquid lens and the immersed lens achieves a focal range of +18D to +40D. One advantage of using one structure for the deformable liquid lens is that it reduces the potential variation in accommodation control caused by different structures of the deformable liquid lens.
[0207] In yet another embodiment, the solid optic immersed in the liquid lens portion is an optically toric lens configured to add cylinder power to the liquid lens, allowing the front and back elements of the liquid lens to be fitted with an accommodating toric IOL using the same structures of the accommodating IOL.
[0208] In yet another embodiment, a solid optical element immersed in the liquid lens portion induces spherical aberration and focus offset in a central section of the liquid lens having a diameter of approximately 3.5 mm, e.g., 2.2 mm to 4.5 mm, the induced spherical aberration and focus offset resulting in reduction of astigmatism, coma, focus error, and presbyopia that remain uncorrected by the liquid IOL when implanted in a human eye.
[0209] 7. Wavefront Corneal Implants for Presbyopia Correction In one aspect, a wavefront corneal implant configured for presbyopia correction of an eye is disclosed. The wavefront corneal implant comprises an optic having a diameter D1 between 2.0 mm and 4.5 mm. The optic has a base section of uniform thickness and an add-on section for refractive correction. The total thickness is between 10 microns and 50 microns. The add-on section induces wavefront errors in the eye including: 1) a positive focal power φ1 of 1.0D to 2.5D in a central section having a diameter D0 between 1.5 mm and 2.5 mm, 2) a positive spherical aberration in the central section, and 3) a negative spherical aberration in an annular section outside the central section.
[0210] In one embodiment, the annular area can further induce a focus error of between -1.0D and +1.0D.
[0211] Unlike conventional corneal inlays in the form of positive lenses in U.S. Patent Nos. 8,057,541 B2 and 8,900,296B, the Wavefront inlays using one of the Wavefront Bifocal, Wavefront Trifocal, and QACIF designs provide excellent visual acuity of 20 / 20 or better at distance and 20 / 20 or better at near with an additional optical power of +1.0D to +2.5D.
[0212] The uniform thickness base section can be configured as parallel plates or with a radius of curvature of approximately 7.8 mm, like that of a normal cornea, hi one embodiment, the add-on section is configured to vary in thickness only across the corneal implant.
[0213] In another embodiment, the corneal implant is made of a biocompatible material and is created by a molding or lathing process.
[0214] In another embodiment, the corneal implant is made with human corneal tissue from a donor and is created through a process using laser ablation with UV light and / or laser cutting with a short pulse laser.
[0215] In yet another embodiment, the add-on optical zone of the corneal implant includes a thickness change and a refractive index change. The refractive index change can be achieved using a short pulsed laser. The use of a refractive index change in the corneal implant has the advantage that the refractive index change is very small, in the range of 0.001 to 0.03, allowing fine tuning of the wavefront map.
[0216] In yet another embodiment, the wavefront corneal implant is made with human corneal tissue from a donor through a process of laser ablation / ablation and changing the refractive index of the corneal tissue using a short pulsed laser.
[0217] In one embodiment, the add-on area further includes a baseline diopter power that extends across the corneal implant for 1) traditional spherical correction, or 2) sphero-cylindrical correction of distance vision errors.
[0218] In another embodiment, the add-on area of the corneal implant further comprises ρ n where n is an integer greater than or equal to 3.
[0219] 8. Wavefront Surgical Procedure for Presbyopia Correction in Human Eyes In one aspect of the invention, a wavefront method of surgical procedure for the correction of presbyopia in a human eye is disclosed, which includes 1) using a first laser beam to create a central island at the center of the pupil with a diameter D1 between 2.0 mm and 4.5 mm, whose optical effect is represented by a wavefront error W1(r), and 2) using a second laser beam to change the refractive index of the corneal tissue by δn and a tissue depth distribution d(r) due to the change in refractive index at the center of the pupil. The combination of the effect of the central island W1(r) due to the first laser and a gradient index (GRIN) optic created through laser writing with the second laser beam on the cornea results in a combined wavefront error that includes: a) a positive focal power φ0 of 1.0D to +2.50D in the central zone with diameter D0 of 1.5mm to 2.5mm, b) a positive spherical aberration in the central zone, c) a negative spherical aberration in the annular zone outside the central zone, and d) a focus error of -1.0D to +1.0D in the annular zone.
[0220] In one embodiment, the wavefront procedure further includes using a first laser to generate a baseline refractive correction, or a conventional spherical or sphero-cylindrical correction, as needed for distance vision defects, where the baseline refractive correction is performed either by tissue ablation using a UV beam or by tissue removal using a short pulsed laser.
[0221] 9. Wavefront Lenses for Contact Lens Fitting In one aspect of the present invention, a wavefront contact lens for testing human eyes is disclosed, the test contact lens having 1) a theoretical, not eye specific, hypothetical baseline diopter power extending over an optical zone of diameter 5 mm to 9 mm, and b) at least a central aspheric zone of diameter 2.2 mm to 4.5 mm at the center of the lens, which uses at least one aspheric surface to induce additional spherical aberration at the center of the eye's pupil.
[0222] In some embodiments, the virtual baseline diopter power comprises at least one of: a) an optically plano-concave with no refractive power; b) a correction for astigmatism of the eye; c) a virtual sphero-cylindrical correction.
[0223] In one embodiment, the test contact lens further includes a focus offset at the central aspheric area.
[0224] In another embodiment, the central aspheric zone is configured to have at least one aspheric surface for inducing positive spherical aberration in a first zone and negative spherical aberration in a second zone, the first zone and the second zone being coaxial.
[0225] In another aspect, a method for prescribing a contact lens is disclosed, comprising the steps of: 1) determining a spherocylinder correction of the contact lens, including astigmatism as specified by the spherical power SPH and / or CYL and AXIS, 2) placing a test contact lens, a wavefront contact lens, on a test eye, the test contact lens comprising: 2a) a virtual baseline diopter power extending over an optical zone of diameter 5-9 mm, and 2b) at least a central aspheric zone with diameter D0 of 2.2 mm-4.5 mm at the center of the lens, using at least one aspheric surface to induce additional spherical aberration at the center of the pupil of the eye, 3) subjectively updating the determined spherocylinder correction of the contact lens using a phoropter, and 4) prescribing a contact lens based on the updated spherocylinder correction and the optical properties of the wavefront contact lens placed on the test eye.
[0226] In yet another aspect, a system for prescribing a contact lens is described, comprising: 1) a wavefront module for measuring the aberrations of the eye; 2) a processor module for determining a spheric cylindrical correction of the contact lens, consisting of 2a) a focus error SPH and / or astigmatism specified by CYL and AXIS, and 2b) determining at least an aspheric component with a diameter between 2.2 mm and 4.5 mm at the center of the lens that induces a spherical aberration in the eye to correct for reducing an estimated residual refractive error of the eye under conventional spheric cylindrical correction; 3) a phoropter module for subjectively updating the determined spheric cylindrical correction of the contact lens by maintaining or changing at least a spherical power SPH; and 4) an output module for prescribing a contact lens based on the updated spheric cylindrical correction and the aspheric component at the center of the lens.
[0227] In one embodiment, the estimated residual refractive errors of the eye under conventional sphero-cylindrical correction include astigmatism, coma, focus error, and presbyopia.
[0228] In another embodiment, subjectively updating the determined sphero-cylindrical correction of the contact lens further comprises placing a wavefront contact lens on the test eye, the wavefront contact lens including at least an aspheric component having a diameter of 2.2 mm to 4.5 mm at a central portion of the lens, the aspheric component of the lens inducing spherical aberration in the corrected eye. The system may further provide a choice between a conventional contact lens and a wavefront contact lens.
[0229] In yet another embodiment, at least an aspheric component in the center of the lens is determined for vision optimization with the objectives of: 1) increasing the contrast of the modulation transfer function at high spatial frequencies above 30 cycles / degree and improving best corrected visual acuity to 20 / 20 or better; and 2) eliminating image distortion, especially phase reversal of the phase transfer function (PTF) at low spatial frequencies below 30 cycles / degree.
[0230] 10. Therapeutic Treatments for Higher Order Aberrations of the Eye Inducing spherical aberration in the center of the eye's pupil for vision correction is effective, resulting in the reduction of uncorrected astigmatism, focus error, coma, and presbyopia. Our wavefront technology lenses are also effective in improving the therapeutic correction of the eye's higher order aberrations.
[0231] In one aspect, a contact lens for therapeutic treatment of an eye is disclosed that comprises: a) a baseline wavefront refractive correction including focus error, astigmatism, and higher order Zernike aberrations such as coma and spherical aberration extending over an optical zone of the lens with a diameter of 5 mm to 8 mm for the correction of distance vision defects; and b) at least one aspheric zone in the center of the lens that induces spherical aberration in the center of the pupil of the eye to mitigate imperfections in the correction of distance vision defects.
[0232] In one embodiment, the imperfections in correcting distance vision aberrations include one or more of the following imperfections: 1) registration errors between the baseline wavefront correction and the wavefront error of the eye, 2) limitations in correcting some aberrations in the baseline wavefront refractive correction, and 3) imperfections in measuring the baseline wavefront correction for distance vision aberrations.
[0233] In one embodiment, the therapeutic contact lens further comprises an optically clear outer zone having a diameter of between 6.0 and 13 mm.
[0234] In another embodiment, the therapeutic contact lenses are configured as EDOF monofocal lenses, EDOF bifocal lenses, EDOF trifocal lenses, and QACIF lenses.
[0235] 11. Methods and Apparatus for Improving the Vision Apparatus, Including the Eye Inducing spherical aberration in the center of the eye's pupil for vision correction has been found to be effective in correcting astigmatism, coma, focus errors, and presbyopia that remain uncorrected by conventional corrective lenses, and can also be applied to improve vision devices that include the eye as an image sensor.
[0236] In one aspect of the invention, an improved vision device is disclosed that uses the human eye as an image sensor. The vision device includes 1) an optical imaging module and 2) an eyepiece module, which is a lens or group of lenses closest to the eye. Either the eyepiece or the optical imaging module induces spherical aberration at least in the center of the pupil of the human eye, which has a diameter D0 between 2.2 mm and 4.5 mm.
[0237] In one embodiment, the vision device is one of a virtual reality (VR) device, a microscope, including a stereo microscope and a surgical microscope, a telescope, including a monocular or binocular, vision goggles, including night vision goggles and gaming goggles.
[0238] In another embodiment, the optical image module provides one of: a) a microscopic view of a nearby object; b) a telescopic view of a distant object; c) an electronic display view.
[0239] In yet another embodiment, the eyepiece has a central aspheric area that induces spherical aberration in a small numerical aperture near the optical axis, covering eye pupil diameters up to 4.5 mm.
[0240] In yet another embodiment, the central aspheric area of the eyepiece further comprises a focus offset that is greater than the induced spherical aberration.
[0241] In one embodiment, the eyepiece has a central aspheric area to induce a wavefront error including: a) a positive focal power of +1.0D to +2.5D in a central area with a diameter D of 1.5 mm to 2.5 mm; b) additional positive spherical aberration in the central area; and c) negative spherical aberration in an annular area with an outer diameter of 2.5 mm to 4.5 mm outside the central area.
[0242] In yet another embodiment, the eyepiece further corrects for spherical aberration of the human eye at the pupil periphery when the vision device is used with an eye pupil with a diameter greater than 4.5 mm.
[0243] In one embodiment, the eyepiece induces spherical aberrations of opposite signs in the observer's eye at least at the pupil center with a diameter D0 between 3.0 mm and 4.5 mm.
[0244] In another embodiment, inducing spherical aberration at least at the center of the observer's eye pupil is accomplished by adding a phase plate to a conventional eyepiece. The eyepiece may further provide a pupil tracker to assist in focusing for eyes with various degrees of myopia or hyperopia and in aligning the optical axis of the eyepiece with the center of the eye pupil.
[0245] In yet another embodiment, the vision device is further integrated with a surgical instrument or a head mounted device.
[0246] Another aspect of the invention discloses an eyepiece for inducing spherical aberration in at least a central area of an optical system having a diameter D between 2.2 mm and 4.5 mm, the lens or group of lenses closest to the eye and having one aspheric surface. In one embodiment, the eyepiece further corrects spherical aberration of the human eye at the pupil periphery when the vision device is used with eye pupils having a diameter greater than 4.5 mm.
[0247] Since its discovery in the 19th century, spherical aberration has been considered as an optical defect that causes image blurring, such as astigmatism and coma.However, the present invention shows that spherical aberration can be intentionally delivered to the center of the pupil of the eye in a controlled manner by lens to treat common refractive errors that remain uncorrected by ophthalmic lenses, including astigmatism, coma, focus error, and presbyopia, just as some harmful substances and drugs used in medicines to treat diseases are delivered to the human body in a controlled manner in small enough quantities to be effective.These uncorrected refractive errors reduce the quality of vision correction in almost all eyes, causing low visual acuity, distorted vision, and nighttime symptoms.
[0248] When these lenses with induced spherical aberration are placed in or on the eye, decentering of the lens from the visual axis of the eye is possible. The optical quality of the lens in the presence of decentering was simulated and it was concluded that decentering of the lens within 0.5 mm has no or negligible effect on the lens performance.
[0249] It should also be noted that excess spherical aberration in the pupil periphery of the eye can reduce night vision. Spherical aberration in the pupil periphery can be treated in the same way as with conventional aspheric lenses. Wavefront lenses (single vision, bifocal, trifocal, QACIF lenses) have several options for optical properties in the pupil periphery beyond the central aspheric zone. These wavefront lenses can be constructed to include 1) a spherical zone outside the central aspheric zone, 2) a toric shape in the entire toric lens, and 3) an aspheric zone outside the central aspheric zone to modify the spherical aberration of the corrective lens with high refractive power and / or to correct the mean spherical aberration of the normal eye in the pupil periphery.
[0250] Reference will now be made in detail to embodiments of the disclosed invention, one or more examples of which are illustrated in the accompanying drawings. Each example is provided to illustrate the present technology, not to limit it. Indeed, while the present specification has been described in detail with respect to certain embodiments of the present invention, it will be understood that those skilled in the art, upon gaining an understanding of the above, can readily envision modifications, variations, and equivalents of these embodiments. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield yet a further embodiment. It is therefore intended that the present subject matter cover all such modifications and variations within the scope of the appended claims and their equivalents. These and other modifications and variations to the present invention may be implemented by those skilled in the art without departing from the scope of the present invention, which is more particularly set forth in the appended claims. Moreover, those skilled in the art will appreciate that the above description is merely illustrative and is not intended to limit the present invention.
Claims
1. 1. A non-diffractive multifocal lens for an eye, comprising: an optical system having a front surface and a back surface, the optical system having a diameter D of 5 mm to 8 mm; 2 the optical zone comprising a plurality of optical subzones; the plurality of optical sub-areas include an outer annular optical sub-area and a central optical sub-area; (I) an inner diameter of 2.5 mm to 4.5 mm and an outer diameter D of 5 mm to 8 mm 2 In the outer annular optical sub-zone having The optical system has a baseline diopter power (essentially a single vision lens) or refractive sphere power φ for baseline correction of the hyperopic or myopic distance vision defect of the eye. 0 and configured to have (II) Diameter D of 2.5 mm to 4.5 mm 1 In the central optical sub-area having the central optical sub-zone is configured as a non-diffractive multifocal lens; The central optical sub-zone has a first refractive sphere for the correction of hyperopia or myopia. Φ 1 (Hereinafter, "First focus Φ 1 ") and two additional foci Φ 2 and Φ 3 (Hereinafter, "Second Focus Φ 2 " and "The third focus Φ 3 "), Here, the first focus for a long distance field of view, the second focus for a medium distance field of view, and the third focus for a short distance field of view are related by the following formula: Φ 2 = Φ 1 + |δΦ 1 | (Equation 1) Φ 3 = Φ 1 + |δΦ 1 | + |δΦ 2 | (Equation 2) and the difference in power between adjacent foci is |δΦ 1 | and | δΦ 2 | is greater than 0.5D to create three distinct foci that are sufficiently separated for presbyopia correction; The non-diffractive multifocal lens is achieved by the following (a) and (b): (a) inducing a positive spherical aberration in a first area and a negative spherical aberration in a second area, the first and second areas being coaxial, and the first and second areas having a diameter D 1 forming the central optical sub-area having (b) Diameter D within 2.5 mm 0 and the central optical zone has a refractive spherical power φ different from the refractive spherical power of the single vision lens of the outer annular optical subzone. 0 have A non-diffractive multifocal lens.
2. The first focal point Φ for the far field of view 1 is in the range of −0.25D to +0.75D, and the second focus Φ 2 The non-diffractive multifocal lens of claim 1, wherein is in the range of +1.25D to +2.00D.
3. The first focal point Φ for the far field of view 1 is in the range of −0.25D to +0.75D, and the third focus Φ 3 The non-diffractive multifocal lens of claim 1, wherein is in the range of +2.25D to +3.0D.
4. The diameter D 0 2. The non-diffractive multifocal lens of claim 1, wherein the difference between the refractive spherical power of the central optical zone and the refractive spherical power of the single vision lens of the outer annular optical sub-zone is less than 3.0 D.
5. The refractive spherical power φ of the non-diffractive multifocal lens in the central optical sub-zone 1 is the refractive spherical power φ of the single vision lens in the outer annular optical sub-zone within 0.4 diopters; 0 The non-diffractive multifocal lens of claim 1 , configured to be equal to:
6. The diameter D of the central optical sub-zone 1 The non-diffractive multifocal lens of claim 1, wherein is 3 mm.
7. The first focus φ for the distance vision defect 1 2. The non-diffractive multifocal lens of claim 1, wherein the contrast metric is greater than or equal to a threshold of 10% at a spatial frequency of 30 cycles / degree associated with a 20 / 20 visual acuity metric.
8. The first focus of the central optical sub-zone for distance vision (φ 1 The maximum contrast metric of the additional two foci (φ) for presbyopic correction at a spatial frequency of 30 cycles / degree is 2 and φ 3 2. The non-diffractive multifocal lens of claim 1, configured to have a maximum contrast metric equal to or greater than the maximum contrast metric of 1.
9. 2. The non-diffractive multifocal lens of claim 1, wherein the first focus, the second focus, and the third focus of the non-diffractive multifocal lens in the central optical sub-zone are separate and have a contrast that is greater than or equal to a threshold of 10% at a spatial frequency of 30 cycles / degree associated with a 20 / 20 vision metric.
10. The non-diffractive multifocal lens of claim 1 , wherein the first focus, the second focus, and the third focus of the non-diffractive multifocal lens in the central optical sub-zone are characterized by their through-focus point spread functions.
11. The non-diffractive multifocal lens of claim 1 , wherein the first focus, the second focus, and the third focus of the non-diffractive multifocal lens in the central optical sub-zone are characterized by their through-focus images on a vision chart.
12. The non-diffractive multifocal lens of claim 1 , wherein the central optical sub-zone has at least one aspheric surface.
13. The non-diffractive multifocal lens of claim 1 , wherein inducing positive spherical aberration in the first zone and negative spherical aberration in the second zone comprises a gradient index (GRIN) optic.
14. The non-diffractive multifocal lens of claim 1 , further comprising a haptic area outside the optical system and configured as one of an intraocular lens (IOL), a phakic IOL, an implantable contact lens (ICL), or an accommodating intraocular lens (AIOL).
15. The non-diffractive multifocal lens of claim 1 further comprising a non-refractive zone outside the optical system and configured as a contact lens.
16. The induced positive spherical aberration in the first zone and the negative spherical aberration in the second zone are expressed in terms of optical path difference (OPD), or wavefront error, i.e. ρ≦r 0 If OPD(ρ)=S 1 * (ρ / r 0 ) 4 r 0 <ρ≦r 1 In the case of , OPD(ρ)=(-S 2 ) * (ρ / r 1 ) 4 where ρ is the polar radius and S 1 is positive and represents the positive spherical aberration of the first area, r 0 is the radius of the first region less than 1.2 mm and greater than 0.9 mm, (-S 2 ) is negative and represents the negative spherical aberration of the second zone, r 1 The non-diffractive multifocal lens of claim 1 , wherein is an outer diameter less than 2.25 mm and greater than 1.25 mm.
17. The lens of the central optical sub-zone further comprises ρ n 17. The non-diffractive multifocal lens of claim 16, which induces a spherical aberration of a generalized form characterized as the sum of several terms of:
18. The non-diffractive multifocal lens of claim 1 configured as a toric lens.
19. 2. The non-diffractive multifocal lens of claim 1, wherein the outer annular optical sub-zone is configured to include an aspheric surface to modify spherical aberration around the pupil of the human eye and to include a correction for mean spherical aberration in the normal group.
20. 20. The non-diffractive multifocal lens of claim 19, further configured to correct spherical aberration in the outer annular optical sub-zone when the spherical aberration of the human eye including the optical zone is significant.
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