Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
  • A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
  • A61F2/164—Aspheric lenses
• • G—PHYSICS
  • G02—OPTICS
  • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
  • G02B5/00—Optical elements other than lenses
  • G02B5/18—Diffraction gratings
  • G02B5/1876—Diffractive Fresnel lenses; Zone plates; Kinoforms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
  • A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
  • A61F2/1618—Multifocal lenses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
  • A61F2/1654—Diffractive lenses
• • G—PHYSICS
  • G02—OPTICS
  • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
  • G02B5/00—Optical elements other than lenses
  • G02B5/18—Diffraction gratings
  • G02B5/1876—Diffractive Fresnel lenses; Zone plates; Kinoforms
  • G02B5/189—Structurally combined with optical elements not having diffractive power
  • G02B5/1895—Structurally combined with optical elements not having diffractive power such optical elements having dioptric power
• • G—PHYSICS
  • G02—OPTICS
  • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
  • G02C7/00—Optical parts
  • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
  • G02C7/04—Contact lenses for the eyes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
  • A61F2/16—Intraocular lenses
  • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
  • A61F2002/1683—Intraocular lenses having supporting structure for lens, e.g. haptics having filiform haptics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2240/001—Designing or manufacturing processes
• • G—PHYSICS
  • G02—OPTICS
  • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
  • G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
  • G02C2202/20—Diffractive and Fresnel lenses or lens portions
• • G—PHYSICS
  • G02—OPTICS
  • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
  • G02C7/00—Optical parts
  • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
  • G02C7/024—Methods of designing ophthalmic lenses
  • G02C7/028—Special mathematical design techniques

Definitions

• the present disclosure relates generally to ophthalmic lenses, and more specifically to a novel double-sided aspheric diffractive multifocal lens, design, manufacture, and uses thereof.
• Ophthalmology is the field of medicine directed to the anatomy, physiology and diseases of the human eye.
• the anatomy of the human eye is rather complex.
• the main structures of the eye include the cornea, a spherical clear tissue at the outer front of the eye; the iris, which is the colored part of the eye; the pupil, an adaptable aperture in the iris that regulates the amount of light received in the eye; the crystalline lens, a small clear disk inside the eye that focuses light rays onto the retina; the retina is a layer that forms the rear or backside of the eye and transforms sensed light into electrical impulses that travel through the optic nerve to the brain.
• the posterior chamber i.e., the space between the retina and the lens
• the anterior chamber i.e., the space between the lens and the cornea
• vitreous humour a clear, jelly-like substance
• the natural crystalline lens has a flexible, transparent, biconvex structure, and together with the cornea, operates to refract light to be focused on the retina.
• the lens is flatter on its anterior side than on its posterior side and its curvature is controlled by the ciliary muscles to which the lens connects by suspensory ligaments, called zonules.
• zonules suspensory ligaments
• the refractive power of the crystalline lens in its natural environment is approximately 18-20 diopters, roughly one-third of the total optical power of the eye.
• the cornea provides the remaining 40 diopters of the total optical power of the eye.
• cataracts With the ageing of the eye, the opaqueness of the lens diminishes, called a cataract. Some diseases like diabetes, trauma, some medications, and excessive UV light exposure may also cause a cataract. A cataract is painless and results in a cloudy, blurry vision. Treatments for cataracts include surgery, by which the cloudy lens is removed and replaced with an artificial one, generally called an intraocular lens (IOL or IOLs).
• IOL intraocular lens
• presbyopia Another age-related effect is called presbyopia, which is manifested by difficulty in reading small print or seeing nearby pictures clearly.
• Presbyopia generally is believed to be caused by a thickening and loss of flexibility of the natural lens inside the eye. Age-related changes also take place in the ciliary muscles surrounding the lens. With less elasticity it becomes harder to focus at objects close to the eye.
• a variety of intraocular lenses are also employed for correcting other visual disorders, such as myopia or nearsightedness, when the eye is unable to see distant objects caused by the cornea having too much curvature, for example.
• myopia is that distant light rays focus at a point in front of the retina, rather than directly on its surface.
• Hyperopia or farsightedness caused by an abnormally flat cornea, such that light rays entering the eye focus behind the retina, not allowing to focus on objects that are close, and astigmatism, which is another common cause of visual difficulty in which images are blurred due to an irregularly shaped cornea.
• an IOL can include diffractive structures to have not only a far-focus power but also a near- focus power, thereby providing a degree of pseudo-accommodation.
• spherical and astigmatic aberrations can adversely affect the optical performance of such lenses.
• spherical aberrations can degrade vision contrast, especially for large pupil sizes.
• intraocular lenses that can simultaneously provide a near focus, an intermediate focus, and a distance focus, which can also address adverse effects such as spherical and astigmatic aberrations, thereby providing enhanced contrast and improved visual acuity.
• the present disclosure is related to a double-sided aspheric diffractive multifocal lens, which can eliminate spherical and astigmatic aberrations and provide enhanced contrast and improved visual acuity.
• the diffractive multifocal lens can include a lens body, the lens body can include: a first aspheric surface; and a second aspheric surface including a central zone and a plurality of diffractive elements comprising concentric annular zones extending in a radial direction, each concentric annular zone having a periodically structured curve comprising two smooth turning points between two sharp turning points, thereby producing a near focus (/ 2 ), an intermediate focus (/- j ) . and a distance focus (/ 0 ).
• the first aspheric surface is anterior surface, and the second aspheric surface is posterior surface.
• the first aspheric surface can include a toric component.
• a height profile of the first aspheric surface and/or the second aspheric surface is represented by: wherein Z asp is the height profile of the aspheric structure, r is the radial distance in millimeters, c is the curvature, k is the conic constant, and A ⁇ is high order aspheric coefficients.
• a height profile of the diffractive elements is represented by: wherein l is the design wavelength, F (h) (t) is phase profile, m is refractive index of lens material, and no is refractive index of a medium covering the lens.
• phase profile F ( barn ) (G ) can be represented as: wherein r is the radial distance of the lens in millimeter, r n is radius of n th zone, r n+i is radius of (n+l)* zone, and A, B, C and D, are light distribution parameters.
• A is amplitude; B is the
• phase profile (n) (r) can be in the range of — 4p ⁇ ( ⁇ 4p.
• the distance focus (/ 0 ), the intermediate focus (fi) and the near focus (/ 2 ) are in the range of:
• the diffractive multifocal lens can be an intraocular lens (IOL).
• the diffractive multifocal lens can further include a pair of haptics extended outwardly from the lens body.
• the IOL is a posterior chamber IOL, and the posterior chamber IOL is configured to be implanted into capsular bag of a human eye.
• the present disclosure is directed to a method of treating an ophthalmic disease or disorder in a subject, the method can include implanting into an eye of the subject a diffractive multifocal lens comprising a lens body, the lens body can include a first aspheric surface; and a second aspheric surface comprising a central zone and a plurality of diffractive elements comprising concentric annular zones extending in a radial direction, each concentric annular zone having a periodically structured curve comprising two smooth turning points between two sharp turning points.
• the present disclosure is directed to a method of manufacturing a diffractive multifocal lens, the method can include (a) manufacturing a first aspheric surface optionally comprising a toric component; (b) manufacturing a second aspheric surface; and(c) generating a central zone and diffractive elements comprising a plurality of concentric annular zones on the second aspheric surface, each concentric annular zone having a periodically structured curve comprising two smooth turning points between two sharp turning points, thereby producing a near focus (/ 2 ), an intermediate focus (/j), and a distance focus (/ 0 ).
• the method can further include performing an in situ image quality analysis to ensure the performance meets the pre-established quality criteria.
• Figure 1A illustrates the top view of a double-sided aspheric multifocal diffractive IOL, according to some embodiments of the present disclosure
• Figure IB shows the cross-sectional view of a double-sided aspheric multifocal diffractive IOF, according to some embodiments of the present disclosure
• Figure 2A illustrates a blow-up view of the lens body of the IOF, according to some embodiments of the present disclosure
• Figure 2B illustrates the height profile of the diffractive elements, according to some embodiments of the present disclosure
• Figure 2C illustrates the height profile of the diffractive elements, according to another embodiment of the present disclosure.
• Figure 3A illustrates the optical performance (modulation transfer function, MTF) at a 3mm aperture and at a resolution measurement of 50 FP/mm by varying parameters according to a first embodiment of the present disclosure
• Figure 3B illustrates the height profile of the aspheric and diffractive combination structure according to a first embodiment of the present disclosure
• Figure 4A illustrates the optical performance (MTF) at a 3mm aperture and at a resolution measurement of 50 FP/mm by varying parameters according to a second embodiment of the present disclosure
• Figure 4B illustrates the height profile of the aspheric and diffractive combination structure according to a second embodiment of the present disclosure
• Figure 5A illustrates the optical performance (MTF) at a 3mm aperture and at a resolution measurement of 50 FP/mm by varying parameters according to a third embodiment of the present disclosure
• Figure 5B illustrates the height profile of the aspheric and diffractive combination structure according to a third embodiment of the present disclosure
• Figure 6 is a flowchart illustrating the design and manufacture of the double-sided aspheric multifocal diffractive IOF, according to some embodiments of the present disclosure.
• the present disclosure is related to a double-sided aspheric diffractive multifocal lens and methods of designing and manufacturing of such lenses in the field of ophthalmology.
• the lens can include an aspheric anterior surface and an aspheric posterior surface.
• One of the two surfaces can include a plurality of concentric diffractive multifocal zones.
• the other surface can optionally include a toric component.
• the double-sided aspheric surface design results in an improvement of the modulation transfer function (MTF) of the lens-eye combination by aberration reduction and vision contrast enhancement as compared to one sided aspheric lens.
• the surface having a plurality of concentric diffractive multifocal zones can produce a near focus, an intermediate focus, and a distance focus.
• Multifocal IOLs are commonly used to treat presbyopia, a condition in which the eye exhibits a progressively diminished ability to focus on near objects.
• Human beings become presbyopic due to aging, and the effect typically becomes noticeable starting at about the age of 40-45 years old, when they discover they need reading glasses.
• Presbyopic individuals who wear corrective lenses may then find that they need two separate prescriptions, preferably within the same bifocal lens, one for reading (near) and another for driving (distance).
• a trifocal lens can further improve vision at intermediate distances, for example, when working at a computer.
• Diffractive IOLs can have a repeating structure that may be formed in the surface of an optical element by a fabrication method such as, for example, cutting the surface using a lathe that may be equipped with a cutting head made of a hard mineral such as diamond or sapphire; direct write patterning using a high energy beam such as a laser beam or electron beam or a similar method of ablating the surface; etching the surface using a photolithographic patterning process; or molding the surface.
• the diffractive structure is typically a series of concentric annular zones, which requires each zone to become progressively narrower from the center to the edge of the lens. There may be, for example, about 5 to 30 zones between the center and the edge of the lens.
• the surface profile within each zone is typically a smoothly varying function such as an arc, a parabola, or a line. At the outer periphery of each zone there is a discrete step in the vertical surface profile.
• the resulting surface structure can act as a circularly symmetric diffraction grating that disperses light into multiple diffraction orders, each diffraction order having a consecutive number, zero, one, two, three and so forth.
• Diffractive IOLs lenses may be used for correcting presbyopia.
• the lens can include one refractive surface and one diffractive surface.
• the light energy passing through a diffractive lens is typically concentrated into one, two, or three diffractive orders, while contributing an insignificant amount of light energy to other diffractive orders.
• the present disclosure is directed to an intraocular lens (IOL), which provides an extended vision range.
• IOL intraocular lens
• Ligure 1A shows a top view of a double-sided aspheric multifocal diffractive IOL 100, according to some embodiments of the present disclosure.
• Ligure IB shows a cross-sectional view of the double-sided aspheric multifocal diffractive IOL 100, according to some embodiments of the present disclosure.
• IOL 100 can include a light transmissive circular disk-shaped lens body 101 with an optic diameter of 106 and a center thickness 110, as well as a pair of haptics 102 as flexible support for the IOL when implanted into patient’s eye, with a total outer diameter 107.
• Lens body 101 can include an anterior surface 108, a posterior surface 109, a central zone 103 and a plurality of diffraction elements 104 on the posterior surface 109.
• Lens body 101 can include an optical axis 105 extending transverse to the anterior surface 108 and posterior surface 109.
• the optical axis 105 is a virtual axis for purposes of referring to the optical properties of IOL 100.
• the pair of haptics 102 can be extended outwardly from the lens body 101 for supporting the IOL 100 after being implanted in the human eye.
• the haptics 102 of IOL 100 can hold the IOL in place in the capsular bag.
• lens body 101 can take the shape of biconvex shape.
• Other shapes of lens body 101 can include, but are not limited to, plano-convex, biconcave, plano concave shape, or combinations of convex and concave shapes.
• both anterior surface 108 and posterior surface 109 can feature an aspheric structure, providing a double-sided asphericity for IOL 100.
• Diffractive element 104 can include diffractive rings or steps or also known as diffractive zones having a characteristic radial separation to produce constructive interference at characteristic foci on the optic area of the IOL.
• diffractive elements 104 can include about 3 to about 30 diffractive rings/zones. In some embodiments, diffractive elements 104 can include about 5, 10, 15, 20, or 25 diffractive rings/zones.
• the IOL can contain diffractive elements on one of the surfaces or both surfaces of the lens. In some embodiments, the diffractive elements 104 can be placed on the posterior surface of the IOL. In some embodiments, the diffractive elements can be placed at the posterior surface, because there is less light scattering effect at the posterior surface than at the anterior surface.
• the plurality of diffractive elements 104 can include rings or zones extending concentrically with respect to the optical axis 105 through the central zone 103 over at least part of the posterior surface 109 of the lens body 101.
• the diffraction elements 104 can provide a focal point of far, intermediate, and/or near distance.
• diffraction elements 104 are not limited to concentric circular or annular ring-shaped zones, but can include concentric elliptic or oval shaped zones.
• the optic diameter 106 of lens body 101 can be about 4 to about 8 mm, while the total outer diameter 107 of IOL 100 including the haptics 102 can be about 9 to about 18 mm.
• Lens body 101 can have a center thickness 110 of about 0.8 to about 1.2 mm.
• the amount of correction that an ophthalmic lens provides is called optical power, and is expressed in Diopter (D).
• the optical power is calculated as the inverse of a focal distance f measured in meters, which can be a respective focal distance from the lens to a respective focal point for far, intermediate, or near vision.
• Lens body 101 in the double-sided aspheric shape of the present disclosure can provide a base optical power of about 10 to about 25 D. In some embodiments, lens body 101 can provide a base optical power of about 12, 14, 16, 18, 20, 22, or 24 D.
• IOLs can be made of flexible material which permits a reduction of their overall apparent girth by temporary deformation, facilitating their insertion through the cornea, thereby advantageously enabling the use of a corneal incision of concomitantly reduced size.
• the lens body can include polypropylene, polycarbonate, polyethylene, acryl- butadiene styrene, polyamide, polychlorotrifluoroethylene, polytetrafluoroethylene, polyvinyl chloride, polyvinylidene fluoride, polyvinylchloride, polydimethylsiloxane, polyethylene terephthalate, ethylene tetrafluoroethylene, ethylene chlorotrifluoroethylene, perfluoroalkoxy, polymethylpentene, polymethylmethacrylate, polystyrene, polyetheretherketone, tetrafluoroethylene, polyurethane, poly(methyl methacrylate), poly (2-hydroxyethyl methacrylate), nylon
• the lens body can include a hydrophilic polymer made of monomers selected from the group consisting of: 2-acrylamido-2-methylpropane sulfonic acid, 2-hydroxyethyl methacrylate, N-vinylpyrrolidone, vinylbenzyltrimethyl ammonium salt, diethylaminoethyl methacrylate, dimethylaminoethyl acrylate, dimethylaminoethyl methacrylate, diethylaminoethyl acrylate, diethylaminomethyl methacrylate, tertiary butylaminoethyl acrylate, tertiary-butylaminoethyl methacrylate and dimethylaminopropylacrylamide, acrylic acid, methacrylic acid, styrenesulfonic acid and salts thereof, hydroxypropyl acrylate, vinylpyrrolidone, dimethylacrylamide, ethylene glycol monomethacrylate
• these hydrophilic monomers are surface grafted onto the polymeric matrix in the previous paragraph to make the lens body.
• the IOL of the present disclosure can be made of polymeric compositions according to U.S. Patent No. 10,494,458, which is incorporated herein by reference in its entirety.
• the haptics of the IOL according to the present disclosure can be made of polymeric materials including, but not limited to polymethacrylate, polypropylene, polyethylene, polystyrene, and polyacrylate.
• the surface of the IOL can include a spheric, aspheric, or toric element.
• Spheric surfaces can cause spherical aberration, which is a type of optical imperfection that can cause increased glare, and reduced overall quality of vision especially in low light and darkness.
• Aspheric lenses can correct spherical aberration.
• Aspherical IOL can provide improved contrast sensitivity, enhanced functional vision and superior night driving ability.
• a toric element is typically used for astigmatic eye correction.
• astigmatism is an optical defect in which vision is blurred due to the ocular inability to focus a point object into a sharply focused image on the retina. This may be due to an irregular curvature of the cornea and/or lens.
• the refractive error of the astigmatic eye stems from a difference in degree of curvature, and therefore in degree of refraction, of the different meridians of the cornea and/or the crystalline lens, which causes the eye to have two focal points, one correspondent to each meridian.
• a meridian includes one of two axes that subtend a curved surface, such as the prime meridian on the earth, for example.
• Meridians may be orthogonal.
• the meridians of the earth may be any orthogonal line of longitude and any line of latitude that curve about the surface of the earth.
• an image may be clearly focused on the retina in the horizontal (sagittal) plane, but may be focused behind the retina in the vertical (tangential) plane.
• the two astigmatism meridians may be the two axes of the cornea. If the astigmatism results from the crystalline lens, the two astigmatism meridians may be the two axes of the crystalline lens. If the astigmatism results from a combination of the cornea and the crystalline lens, the two astigmatism meridians may be the respective axes of the combined lenses of the cornea and the crystalline lens.
• An astigmatism arising from the cornea or crystalline lens, or the combination of the two lenses, may be corrected by a lens including a toric component.
• a toric surface resembles a section of the surface of a football, for which there are two regular radii of curvature, one smaller than another. These radii may be used to correct the defocus in the two meridians of the astigmatic eye.
• blurred vision caused by astigmatism may be corrected by corrective lenses or laser vision correction, such as glasses, hard contact lenses, contact lenses, and/or an IOL, providing a compensating optic specifically rotated around the optical axis.
• the IOL according to the present disclosure can provide far vision for viewing objects at distances ranging from about infinity to about 4 meters (m). In some embodiments, the IOL of the present disclosure can provide near vision for viewing objects at distances less than about 0.4 m. In some embodiments, the IOL of the present disclosure can provide intermediate vision for viewing objects at distances in a range of about 0.4 to about 1 m, about 2 m, about 3 m, or about 4 m. As a result, the IOL of the present disclosure can advantageously provide a degree of accommodation for different distance ranges, typically referred to as pseudo-accommodation.
• the combined power of the eye’s cornea and the near, intermediate, and far power of the IOL of the present disclosure can allow focusing light emanating from objects within a near, an intermediate, and a far distance range of the patient onto the retina.
• the distance focus (/ 0 ), intermediate focus (/j). and near focus (/ 2 ) provided by the IOL of the present disclosure can have the following ranges: 5 D, £ 2.5 D , and 2 D ⁇ - - - ⁇ 5 D . h fo
• Figure 2A shows a blow-up view of lens body 101, including anterior surface 108, posterior surface 109, optical axis 105, central zone 103 and the plurality of diffraction elements 104 generated on the posterior surface.
• the central zone 103 and diffraction elements 104 are further illustrated in Figure 2B.
• the central zone begins from the 0 th Fresnel zone (from d Q to d 1 ) .
• the diffraction elements are configured as periodically structured smooth curve (from d 2 to d 3 ), each periodic structure of the diffraction elements contains two smooth turning points (e 1 , e 2 ) in between two sharp turning points (d 2 , d 3 ).
• Figure 2C illustrates another embodiment of the present disclosure, by smoothing out two smooth turning points (e 1 , e 2 ), and their periodically corresponding turning points.
• This diffractive structure embodied on the IOLs of the present disclosure can be designed using Equations (I) to (IV) as discussed below.
• a pupil function is a lens characteristic function that describes the physical effect of a lens by which it is possible to change the state of light made incident on the lens, and in specific terms, is represented by the product of the amplitude function A(r) and the exponential function of the phase function F( P )(G) as noted in Equation (I) below.
• T (r) pupil function
• A(r) amplitude function
• F( h ) (G) phase function
• n natural number
• phase function is defined as the function that mathematically expresses the physical effect provided in a lens such as giving changes in the phase of incident light on a lens (position of wave peaks and valleys) using any method.
• the variable of the phase function is mainly expressed by position r in the radial direction from the center of the lens, and the phase of light made incident on the lens at the point of the position r undergoes a change by the phase function F( P )(G) and is emitted from the lens. In specific terms, this is represented by an r-F coordinate system.
• phase is noted as F, and the unit is radians.
• One wavelength of light is represented as 2p radians, and a half wavelength as p radians, for example.
• phase profile A distribution of phase in the overall area in which the phase function is provided expressed in the same coordinate system is called a phase profile, or is simply called a profile or zone profile.
• a phase profile A distribution of phase in the overall area in which the phase function is provided expressed in the same coordinate system is called a phase profile, or is simply called a profile or zone profile.
• this means that the light made incident at the point of F 0 is emitted without changing the phase.
• this reference line when a positive value is used for F, this means that progress of the light is delayed by that phase amount, and when a negative value is used for F, this means that progress of the light is advanced by that phase amount.
• a refracting surface for which a diffractive structure is not given corresponds to this reference line (surface). Light undergoes a phase change based on this phase function and is emitted from the lens.
• An amplitude function is the function expressed by A(r) in Equation (I) noted above. In the present disclosure, this is defined as a function that represents the change in the light transmission amount when passing through a lens.
• the variable of the amplitude function is represented as position r in the radial direction from the center of the lens, and represents the transmission rate of the lens at the point of position r.
• Zone In the present disclosure, a zone is used as the minimum unit in a diffractive structure, element, or diffraction grating provided in a lens.
• Equation (II) Equation (II)
• the radius of a particular diffractive zone (r n ) can be calculated based on Equation (III) below.
• r n 2 X l X n X f Equation (III)
• r n radius of the n th zone l: design wavelength f: reciprocal of add power
• Phase function (F (h) ( )) can he calculated via Equation (IV) below. Equation (IV)
• phase function r is the radial distance from a center of lens r n : radius of the n th zone r n+i : radius of the (n+l) th zone
• A, B, C and D are the light distribution parameters.
• A is the amplitude;
• B is the period as — ;
• C is the phase shift, if it is +C, it shifts left, if the phase shift is -C, it shifts right;
• D is the vertical shift, if it is +D, the function moves up, if it is -D, then the function moves down.
• the double-sided aspheric structure (anterior and posterior of the optic area of the IOL) is for the correction of the spherical aberration of the lens.
• the height profile of the aspheric base structure ( Z asp ) of the lens can be calculated according to the following Equation (V):
• Z asp is the height profile of the aspheric structure r: is the radial distance from a center of lens k: is the conic constant c: is the curvature
• the height profile of the combination structure ( Z totai ) will be the summation of the height profile of the aspheric structure ( Z asp ) and the height profile of the diffractive structure ⁇ Z di ff), as calculated according to the below Equation (VI).
• the above-described lens can be contact lens or IOL.
• the IOL can be intracorneal IOL, anterior chamber IOL or posterior chamber IOL.
• the IOL can be posterior chamber IOL. While the haptic arms are illustrated in the embodiment, any suitable haptics fixation structure for the capsular bag or the ciliary sulcus compatible with posterior chamber implantation can also be used in a posterior chamber IOL.
• a way of estimating the optical priority of an intraocular lens comprises determining experimentally its modulation transfer function (MTF).
• MTF modulation transfer function
• the MTF of an optical system can be measured according to Annex C of ISO 11979-2, which reflects the proportion of the contrast which is transmitted through the optical system for a determined spatial frequency of a test pattern, which frequency is defined as “cycles/mm” or “LP/mm”, in which “LP” indicates “line pairs.”
• the contrast decreases with an increase in spatial frequency.
• Equation (IV) From Equation (IV), by varying parameters A, B, C and D, and controlling the distance focus (/ 0 ), the intermediate focus (/)). and the near focus (/ 2 ), the optical performance (modulation transfer function, MTF) at a 3 mm aperture and at a resolution measurement of 50 line pairs per millimeter (LP/mm) is shown in Figure 3 A.
• the parameters of A, B, C and D are varied according to Table 1 below.
• the curve in Figure 3A shows three peaks corresponding to a distance focus at about 14.0 D, an intermediate focus at about 16.2 D, and a near focus at about 17.3 D, respectively.
• the Z total (r ) height profile of the aspheric and diffractive combination structure is shown in Figure 3B. The height is depicted at pm scale along the vertical axis.
• Equation (IV) From Equation (IV), by varying parameters A, B, C and D, and controlling the f Q , /i and f 2 , the optical performance (MTF) at a 3 mm aperture and at a resolution measurement of 50 line pairs per millimeter (LP/mm) is shown in Figure 4A.
• the parameters of A, B, C and D are varied according to Table 2 below.
• the Z toi:ai (r) height profile of the aspheric and diffractive combination structure is shown in Figure 4B. Table 2. Variation of parameters A-D in a second embodiment of the present disclosure.
• the curve in Figure 4A shows three peaks corresponding to a distance focus at about 24.0 D, an intermediate focus at about 26.2 D, and a near focus at about 27.3 D, respectively.
• Equation (IV) From Equation (IV), by varying parameters A, B, C and D, and controlling the /o, fi and f 2 , the optical performance (MTF) at a 3 mm aperture and at a resolution measurement of 50 line pairs per millimeter (LP/mm) is shown in Figure 5A.
• the parameters of A, B, C and D are varied according to the Table 3 below.
• the Z total (r ) height profile of the aspheric and diffractive combination structure is shown in Figure 5B.
• Figure 6 is a flowchart 600 illustrating the design and manufacture of the double sided aspheric multifocal diffractive IOL, according to some embodiments of the present disclosure.
• Step 601 manufactures a first aspheric surface optionally including a toric component.
• Step 602 manufactures a second aspheric surface.
• Step 603 generates a plurality of concentric diffractive multifocal zones on the second aspheric surface to produce a near focus, an intermediate focus, and a distance focus.
• Step 604 performs an in situ image quality analysis of the double-sided aspheric diffractive multifocal lens on an ISO Model Eye 2 to measure the through focus MTF using the TRIOPTICS OptiSpheric® IOL PRO 2 up to the pre-established performance criteria.

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