Intraocular lenses and methods of manufacture

Abstract

Intraocular lenses and methods of manufacturing intraocular lenses. Lenses may include optic bodies with an embedded vision correction region. Lenses may include optic bodies with non-uniform refractive indices. Methods of manufacturing may include delivering controlled ionizing energy to a polymerized body to break at least some of the cross-linked bonds and create regions with different swell factors.

Description

INTRAOCULAR LENSES AND METHODS OF MANUFACTUREINCORPORATION BY REFERENCE

[0001] This application claims priority to the following provisional applications, the entire disclosures of which are incorporated by reference herein in their entireties for all purposes: U.S. Provisional Application No. 63 / 662,984, filed June 21, 2024; U.S. Provisional Application No.63 / 715,285, filed November 1, 2024, and U.S. Provisional Application No. 63 / 744,095, filed January 10, 2025.

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] This application incorporates by reference the following publications, the full disclosures of which are incorporated by reference herein in their entireties for all purposes: WO 2020 / 037314, US 2020 / 0071440, and WO 2023 / 060017.BACKGROUND

[0004] Improved deformable intraocular lenses and methods of creating deformable intraocular lenses are needed.SUMMARY OF THE DISCLOSURE

[0005] The disclosure is related to lenses, optionally vision correction lenses such as intraocular lenses, although concepts herein may find broader applicability, such as with polymeric materials in general. One aspect of the disclosure is related to ways of achieving one or more desired optical properties for an optic body of a lens.

[0006] In some examples but not limiting in any way, the lenses may be posterior chamber lenses, such as, without limitation, an Intraocular Collamer Lens (“ICL”); all materials described in WO 2020 / 037314, US 2020 / 0071440, and WO 2023 / 060017 are incorporated by reference herein may optionally be used in one or more portions of the lenses). In some examples, the lenses may be intraocular lenses adapted for placement within a capsular bag after a native lens has been removed.

[0007] Any of the transparent bodies (e.g., optic bodies) herein exposed to ionizing energy (e.g., x-ray energy) to break at least some of the cross-link bonds in an already-cured (polymerized) material may include one or more regions with a non-uniform (variable) cross-link density (e.g. gradient density) within the one or more regions of the body after exposure to the ionizing energy, and which when hydrated creates at least one non-uniform (variable) optical property to the region (e.g., variable refractive index).

[0008] One aspect of the disclosure is a deformable lens sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable cross-link density, the variable cross-link density adaptingthe optic body to swell in a non-uniform manner when hydrated to impart a vision correction region embedded within the optic body. The lens optionally includes a haptic portion disposed about a periphery of the optic body.

[0009] In this aspect, the transparent deformable optic body of polymerized material optionally has a homogeneous chemical formulation throughout.

[0010] In this aspect, the embedded vision correction region optionally comprises one or more of a spherical vision correction surface embedded within the optic body, an aspherical vision correction surface embedded within the optic body, and / or a toric vision correction surface embedded within the optic body.

[0011] In this aspect, the embedded vision correction region optionally comprises a diffractive pattern embedded within the optic body, optionally sawtooth or sinusoidal.

[0012] In this aspect, the embedded vision correction region optionally comprises a transition region between a first region with a first refractive index and a second region with a second refractive index.

[0013] In this aspect, the embedded vision correction region optionally distinguishes a first portion of the optic body with a first refractive index and a second portion of the optic body with a second refractive index different than the first.

[0014] In this aspect, the embedded vision correction region optionally comprises a first region of the optic body at a first radial distance from an optical axis with a first refractive index and a second region of the optic body at a second radial distance from the optical axis with a second refractive index that is different than the first refractive index.

[0015] In this aspect, the embedded vision correction region optionally comprises a plurality of radially spaced annular regions about an optical axis, each having a different refractive index than at least one other of the plurality of radially spaced annular regions.

[0016] In this aspect, the lens is optionally a trifocal lens wherein the embedded vision correction region comprises three annular regions radially spaced to provide distance vision, intermediate vision and near vision.

[0017] In this aspect, the embedded vision correction region optionally comprises a gradient radial change in refractive index within the optic body. A gradient may include an increase or decrease in refractive index from center to periphery.

[0018] In this aspect, an entire optic body optionally has a gradient change in refractive index from a central region of the optic body to a periphery of the optic body.

[0019] In this aspect, each of a plurality of annular regions or zones optionally has a radial span from 5 microns to 3 mm.

[0020] In this aspect, a plurality of annular regions optionally is from 2 to 60 different annular regions.

[0021] In this aspect, the optic body optionally has an anterior surface that is flat or curved.

[0022] In this aspect, the optic body optionally has a vision correction posterior surface, optionally at least one of spherical, aspherical, or toric.

[0023] In this aspect, the optic body is optionally configured to correct myopia or hyperopia, and optionally adapted to correct for presbyopia.

[0024] One aspect of the disclosure is a method of inducing a non-uniform cross-link density in an optic body of an intraocular vision correction lens, comprising: irradiating a polymerized body with controlled ionizing energy to break at least some of a plurality of cross-linked bonds within the polymerized body to create a variable cross-link density within the polymeric body. The variable cross-link density adapts the optic body to swell in a variable manner when hydrated to impart a vision correction region embedded within the polymeric body.

[0025] In this aspect, the lens may include any features of any of the lenses in the preceding aspect.

[0026] One aspect of the disclosure is a deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable cross-link density, the variable cross-link density adapting the optic body to swell in a non-uniform manner when hydrated to impart a plurality of radially spaced annular zones of different refractive index, and optionally including a haptic portion disposed about a periphery of the optic body.

[0027] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.

[0028] One aspect of the disclosure is a deformable lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable swell factor such that at least first and second optic body regions are adapted to swell to a different extent when the optic body is hydrated and impart a vision correction region embedded within the optic body.

[0029] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.

[0030] One aspect of this disclosure is a deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent optic body with a diffractive pattern embedded within the optic body, wherein anterior and posterior surfaces of the optic body do not have a diffractive pattern formed thereon.

[0031] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.

[0032] One aspect of this disclosure is a deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: an optic body with a variable cross-link density, the optic body further comprising a plurality of radially-spaced annular zones, a first of the plurality of annular zones zone having a refractive index that is different than a refractive index of a second zone, the differences in refractive indices due to a difference in swell factors in the first andsecond zones. The zones may be discrete zones, or they may not have specific inner and outer boundaries.

[0033] One aspect of the disclosure is a posterior chamber phakic vision correction lens, comprising: an optic body with a central port that has a diameter from 40 microns to 200 microns.

[0034] In this aspect, one or both sides of the central port are optionally chamfered.

[0035] In this aspect, the central port optionally has an axis that is disposed at an angle relative to an optical axis of the optic body.

[0036] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.

[0037] One aspect of this disclosure is a trifocal posterior chamber lens configured to provide near vision, far vision, and intermediate vision, wherein the lens comprises: an optic body that has an anterior surface with a diffractive pattern formed therein.

[0038] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.

[0039] One aspect of the disclosure is a posterior chamber lens configured to interface with a sulcus of an eye when implanted into the eye, the lens comprising: an optic body and a haptic region, the haptic region including a plurality of deformable footplates protruding outward from adjacent haptic regions. Each of the plurality of footplates optionally has a footplate length (FL) from 1.0 mm to 1.6 mm.

[0040] In this aspect, each of the plurality of footplates optionally has a footplate width (FW) from 1.5 mm to 2.25 mm.

[0041] In this aspect, the plurality of footplates are optionally sized and configured to deform so as to absorb all or substantially all forces on the footplates from eye tissue.

[0042] In this aspect, the lens is optionally packaged as a one-size-fits-all lens.

[0043] In this aspect, the lens is optionally packaged with instructions that do not limit the lens for implantation based on patient eye size(s).

[0044] In this aspect, each of the plurality of footplates optionally includes first and second outer surface regions (in a top view of the lens) that are parallel or substantially parallel.

[0045] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.

[0046] One aspect of the disclosure is a deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable cross-link density, the variable cross-link density adapting the optic body to swell in a non-uniform manner when hydrated to impart an embedded vision correction region within the optic body, and optionally including a haptic portion disposed about a periphery of the optic body.

[0047] In this aspect, the lens may include any one or more features of any of the lenses in the preceding aspects.BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIG. 1 is a side view of an example of a lens with an optic body including an embedded vision correction region.

[0049] FIG. 2 illustrates an exemplary diffractive lens pattern.

[0050] FIG. 3A illustrates delivery of ionizing energy to a polymerized body to break at least some cross-link bonds.

[0051] FIG. 3B is a side view of an example of a lens with an optic body including an embedded vision correction region including a diffractive pattern.

[0052] FIG. 4 illustrates features of an exemplary embedded sinusoidal diffraction pattern, relative to a representative iris.

[0053] FIG. 5A illustrates delivery of ionizing energy to a polymerized body to break at least some cross-link bonds.

[0054] FIG. 5B is a side view of an example of a lens with an optic body including an embedded vision correction region that includes a diffractive pattern.

[0055] FIG. 6A represents a perspective view of a lens with an embedded diffractive optic design.

[0056] FIG. 6B illustrates merely exemplary and non-limiting design parameters for sinusoidal patterns formed and embedded within any of the optic bodies herein.

[0057] FIG. 7 illustrates a merely exemplary energy source delivering ionizing energy to a cured polymeric body that will be an optic of a vision correction lens.

[0058] FIG. 8 illustrates an exemplary lens with a diffractive pattern formed in an anterior surface of an optic body.

[0059] FIGS. 9A and 9B represent varying refractive indices in a plurality of annular zones.

[0060] FIG. 10 is a side view of lens with a central port.

[0061] FIGS. 11A, 11B, 11C and 11D illustrate exemplary features of exemplary central ports.

[0062] FIGS. 12, 13, 14 and 15 are top view of intraocular lenses with different haptic / footplate configurations.DETAILED DESCRIPTION

[0063] The disclosure is related to lenses, optionally vision correction lenses such as intraocular lenses. The disclosure herein may, however, find broader applicability, such as in creating variable (not uniform) refractive indices in one or more regions of polymeric materials in general.

[0064] In some examples but not limiting in any way, the lenses may be sized and configured as posterior chamber lenses, such as, without limitation, an Intraocular Collamer Lens. In some examples, the lenses may be intraocular lenses adapted for placement within a capsular bag after a native lens has been removed.

[0065] An aspect of the disclosure is related to using ionizing energy to control one or more optical properties of an optic portion of a lens, which may be a vision correction lens. The disclosureof W02020 / 037314 is fully incorporated by reference herein in its entirety in this regard for all purposes. Controlled ionizing energy is delivered in a controlled manner to an already polymerized and deformable polymeric optic body of a vision correction lens, as part of a process that ultimately creates a controlled variable (non-uniform) refractive index “RI” (optionally a gradient RI) within one or more regions of the optic body. The energy is applied to the polymer body in a controlled manner prior to implantation and based on the subject’s vision correction needs, additional details of which are described in W02020 / 037314.

[0066] As is described in more detail in W02020 / 037314, methods of manufacturing lenses herein may include delivering controlled ionizing energy to a polymerized flexible body to break at least some of the cross-links in one or more regions or portions of the polymerized body in a controlled manner. At a subsequent time, the polymeric body is exposed to hydration (e.g., in aqueous in an eye following implantation). Due to the difference in cross-link densities, one or more regions of the body will swell to a different extent than at least one other region of the body with a different cross-link density. The difference in swelling creates regions with different refractive indices, as is described in more detail in W02020 / 037314. The extent to which a region swells is generally referred to herein as a swell factor. A region with a relatively greater swell factor is adapted to swell more than one or more other regions with relatively lower swell factors.

[0067] Transparent optic bodies herein may include a non-uniform RI that imparts or creates an embedded vision correction region (e.g., an optical surface), which is based on the subject’s vision correction needs. “Embedded” in this context refers to an internal vision correction region disposed within the transparent optic between anterior and posterior surfaces (i.e., within the optic body), and again is based on the subject’s vision correction needs. An embedded vision correction region may comprise, for example only, a diffractive pattern, such as, for example, a sawtooth design or a wave design (e.g., a sinusoidal wave design); a spherical surface; an aspherical surface; a surface configured to treat astigmatism; a gradient region (optionally the entire optic has a gradient RI (grin) lens) or any other desired vision correction region configuration based on the subject’s vision correction needs.

[0068] An embedded vision correction region may comprise a gradient change in RI, with either a plurality of discrete regions of varying RI, or a gradual or continuous variation in RI, or combinations thereof. An embedded vision correction region herein with a gradient change in RI may be similar to a native crystalline lens.

[0069] Embedded vision correction regions herein may comprise an embedded vision correction surface, examples of which are provided above (e.g., a diffractive pattern; a spherical surface; an aspherical surface; a surface configured to treat astigmatism; or any other desired vision correction surface configuration based on the subject’s vision correction needs). The phrase “vision correction surface” may not necessarily create a clear distinction between adjacent regions of different RI (like an interface between air and water), but rather the vision correction surface may comprise a transitional region of relatively minimal size where there is some gradual change between two regions of the transparent optic body having different refractive indices.

[0070] An embedded vision correction surface herein may separate a first portion of the transparent optic body (e.g., an anterior portion) with a first RI and a second portion of the optic body (e.g., a posterior portion) with a second RI different than the first RI, although as described above there may be some relatively small progressive transitional volume between the first and second portions of different RI.

[0071] Lenses herein with embedded vision correction regions may include an optic with one or more of an anterior surface or a posterior that are not machined to a particular configuration (curvature) to correct the vision. In some examples, the embedded vision correction region provides the desired vision correction based on the subject’s needs. In some examples, the embedded vision correction region in combination with the curvatures of one or both of the anterior surface and posterior surface provides the vision correction based on the subject’s needs.

[0072] In some examples, one or both of anterior and posterior surfaces of optic body may be flat or substantially flat surfaces. For example only, optics may be formed from buttons, and if one or both of the anterior and posterior surfaces of a button are not machined or otherwise formed into a particular vision correction surface, the final shape of the anterior and / or posterior surface of the optic may be flat or substantially flat. Vision correction surfaces may, however, be formed into one or both of an anterior surface or a posterior surface of a button, such as for example only, a spherical surface, an aspherical surface, atoric surface, or any surface configuration.

[0073] Any of the optics herein with non-uniform refractive indices may have a homogenous chemical composition or formulation through the optic body (i.e., the chemical formulation is the same throughout the optic), which includes homogenous chemical compositions having a non- uniform crosslink density. Any of the lenses herein may have any of the exemplary chemical formulation described in W02020 / 037314.

[0074] FIG. 1 illustrates an exemplary vision correction lens 800, including optic 802, and haptic region 804. Lens 800 is an example of a lens with optic 802 with anterior surface 809, posterior surface 805, and an embedded vision correction region 807, which in this example is shown as a vision correction surface 807 embedded within the optic body between the anterior and posterior surfaces. A hashed line is shown in FIG. 8 to illustrate location of vision correction surface 807, but it is understood that a hashed line would not be visible in a transparent optic 802. In this example, posterior surface 805 may be an optical surface formed by, for example, machining, and anterior surface 809 is an example of a flat (or substantially flat) surface.

[0075] Vision correction region 807 may be formed using techniques herein, such as by applying controlled ionizing energy to optic 802 in a first region while applying a different amount of ionizing energy (or no energy) to optic 802 in a second region, followed by hydration, which creates different RI in different regions of the optic based on the different swell factors due to the variation in crosslink densities in the different regions. For example only, ionizing energy may be delivered to region 822 to break at least some of the cross-link bonds of the polymerized material in region 822, and energy is not delivered to region 824. In this example, regions 822 and 824 are examples of anteriorand posterior optic regions, respectively. Alternatively, ionizing energy may be applied to both regions 822 and 824, but different energy delivery parameters may be used in regions 822 and 824 to cause different amounts or degrees of cross-link breakage in regions 822 and 824, ultimately creating different RI in regions 822 and 824 upon swelling. The difference in RI creates or imparts vision correction region 807. Embedded vision correction surface 807 may be formed to provide an embedded spherical surface, an embedded aspherical surface, an embedded toric surface, or any other vision correction surface as needed to correct the subject’s vision.

[0076] In this example, optic anterior surface 809 is shown as flat or substantially flat, and is uncut, or un-machined relative to a button created during the manufacturing process. Anterior surface 809 may, however, undergo typical finishing steps such as polishing or smoothing to smooth the surface and remove any irregularities that may have formed during the polymerization process. There are a variety of possible benefits from creating an embedded vision correction region rather than forming a vision correction surface into an anterior and / or posterior surfaces of the optic, such as, for example only, it may eliminate the need for a machining step to one or both sides of a button during manufacturing; it may allow for more efficient creation of a desired optical interface; it may provide more options for creating optical surfaces for the optic; and / or it may allow the anterior surface of the optic to remain flat and smooth, which may, depending on the application, prevent or minimize damage to tissue adjacent to the optic when the lens is implanted.

[0077] Some posterior chamber phakic vision correction lenses, including those incorporated by reference herein, may be implanted such that the haptic region is placed in the sulcus, with the optic in front of the capsular bag and proximate the iris. These types of IOLS have optic bodies positioned closer to the iris than, for example, a pseudophakic lens in the capsular bag, and thus may be relatively more susceptible to effects from anatomical differences in pupil size and changes in pupil size due to light conditions. Multifocal optics (optionally with fixed, discrete zones of correction based on radial distance from the optical axis) positioned in close proximity to the iris in the posterior chamber may in particular be more susceptible to anatomical differences in pupil size and changes in pupil size due to light conditions. It may thus be beneficial for some posterior chamber phakic lenses to be configured as diffractive lenses rather than multi-focal lenses, which provide power zones represented equally throughout the optic rather than having fixed zones based on radial distance from the optical axis for which pupil size can negatively influence vision correction. FIG. 2 is meant to illustrate a representative sawtooth diffractive optic design that may be used with vision correction lenses herein. For posterior chamber phakic lenses, however, due to their proximity to the iris, any irregular edges on the anterior surface of the optic (e.g., the sharp anterior surface edges as shown) may damage the sensitive pigment epithelium of the iris and may thus be undesirable.

[0078] An exemplary implementation of concepts herein is for lenses (optionally posterior chamber phakic lenses) to have an embedded diffractive pattern. An embedded diffractive pattern can avoid an anterior optic surface with a diffractive surface pattern, thus reducing the likelihood of damage to iris tissue.

[0079] FIG. 3A illustrates an exemplary step of applying ionizing energy (e.g., X-ray energy) to at least a portion of a polymerized, flexible polymeric body to break at least some cross-link bonds in a controlled manner, wherein the polymeric body is an optic of an implantable vision correction lens. In this example, energy is applied in a controlled manner to break bonds such that upon hydration and swelling, an optic with an embedded vision correction region 1007 is created as shown in FIG. 3B due to differences in refractive index between adjacent regions. In this example, anterior surface 1009 of the optic need not have a diffractive pattern formed therein, which can minimize iris damage while providing the benefits of a refractive and diffractive posterior chamber optic. Anterior surface 1009 may be substantially the same shape as a button created during the manufacturing process (e.g., but may be finished, such as with polishing or other surface treatments). In this example, posterior surface 1005 has been formed as a vision correction surface (e.g., machining), but in alternative lenses it may not be formed as a vision correction surface. Similar to FIG. 1, manufacturing lens 1000 can include delivering controlled energy to an anterior region of the polymeric body and a different amount of energy to a posterior region of the polymeric body to create different cross-link density regions, which upon hydration creates regions with different refractive indexes, thus creating the embedded vision correction region within the optic.

[0080] As illustrated generally in FIG. 4, vision correction lenses herein may include an embedded sinusoidal diffraction pattern rather than a sawtooth design, which can provide the benefit of having each wave provided near, distance and intermediate, as shown (trifocal). As shown, the radially outer part of the wave contributes to near focus, the radially inner part contributes to far focus, and the whole surface contributes to intermediate vision. The relative strength of Near and Far can be tuned by minor manipulation to the two wave sides, which can be tuned by controlling the ionizing energy (e.g., strength and / or location) delivered to the polymeric body. The diffraction pattern can alternatively be formed on the anterior optic surface, as shown in exemplary FIG. 8.

[0081] FIG. 5A illustrates an exemplary step of applying ionizing energy (e.g., X-ray energy) to a cured (polymerized) polymeric body to break cross-linked bonds, wherein the polymeric body will be the optic of an implantable vision correction lens. FIG. 5B illustrates lens 1200 with optic 1202 and haptic region 1204. Optic 1202 includes an embedded vision correction region 1207, which in this example includes embedded gradient refractive index defining a sinusoidal diffractive pattern.

[0082] FIG. 6A represents a perspective view of lens 1200 with the embedded diffractive optic design. FIG. 6B illustrates merely exemplary and non-limiting design parameters for sinusoidal patterns formed and embedded within any of the optics herein.

[0083] FIG. 7 illustrates a merely exemplary energy source 2 delivering ionizing energy 220 to a cured polymeric body 4 that will be an optic of a vision correction lens, additional exemplary details of which can be found in W02020 / 037314, which is incorporated by reference.

[0084] FIG. 8 illustrates a side view of an exemplary intraocular phakic vision correction lens 1500, which may include any combination of features of any of the lenses herein and may incorporate the entire disclosure of FIG. 4 by reference. FIG. 8 shows a diffractive pattern formed (e.g.,machined) into anterior surface 1509 of the optic to provide a multifocal optic, in this case trifocal (providing near vision, intermediate vision, and distance vision), which is described in more detail with respect to FIG. 4. This is an alternative lens to some lenses herein that include an embedded vision correction region.

[0085] FIG. 9A illustrates an exemplary optic portion of a corrective intraocular lens (haptics not shown for clarity) configured as a positive correction lens thicker in the center than at the periphery (e.g., to correct for hyperopia), and FIG. 9B illustrates an exemplary optic portion of a corrective intraocular lens configured as a negative correction lens thinner at the center than at the periphery (e.g., to correct for myopia). The optic bodies in FIGS. 9A and 9B are examples of optic bodies with embedded vision correction regions. As shown in FIGS. 9A and 9B, in another implementation of the concepts herein, the index of refraction (“IR” in the figures) can be controlled and varied radially within the optic body. FIGS. 9 A and 9B illustrate that any number of annular zones or regions (optionally concentric) may be created (after swelling) as desired (up to any number “n”).

[0086] In one particular example, the optics in FIGS. 9A and 9B have a gradient refractive index (a grin lens) that varies radially from the optic axis to the periphery. A gradient lens may have several small annular regions with discrete boundaries that together essentially create a smooth gradient in RI, or it may have a continuously changing RI radially outward. The RI may be greatest at the center and decrease outward, or it may be smallest at the center and increase radially outward.

[0087] In another example, the optics in FIGS. 9A and 9B may have three different RI zones (a trifocal lens): a central zone that includes the optic axis, and intermediate zone, and a radially outer zone, each with different indices of refraction, providing for distance, intermediate and near vision. The refractive index can be controlled such that the different zones can provide any correction that is needed. For example, a central zone may be for adapted for distance vision, near vision, or intermediate vision.

[0088] In another example, the lens may have two different RI zones (a bifocal lens).

[0089] Optic bodies with a plurality of annular zones or regions may have from two to one hundred and twenty annular zones. For example, a grin lens may be created with many zones to create a smooth refractive index gradient.

[0090] Annular zones herein may have radial thicknesses (radial span) from 5 microns to 3 mm. The radial thickness is controlled by controlling the energy delivery to the polymerized body to create the desired refractive indices.

[0091] The different zones may or may not have the same radial thickness (radial span), which refers to the distance between the zone outer radius and the zone inner radius.

[0092] Another aspect of this disclosure is related to optic portions of vision correction lenses with a central aperture or port that extends through the optical axis of the optic, providing for the flow of aqueous humor through the optic and a healthy flow of fluid within the eye (e.g., for reducing cataract formation and glaucoma and / or hydration). Any of the lenses herein may have additionalapertures as well, such as through one or more haptic regions. Figures herein show exemplary central optic apertures.

[0093] Any of the optic central apertures herein may optionally be from 50 microns to 400 microns, such as from 50 microns to 200 microns. Any exemplary benefit of having smaller central apertures from 50 microns to 200 microns includes a decrease in light scattering and reflections, while still allowing the flow of aqueous fluid through the optic body.

[0094] Any of the optics with a central aperture herein may include a region around the central aperture adapted to be an antireflective region to reduce scattering of light about the aperture. For example, the disclosure in W02020 / 037314 is completely incorporated by reference herein. For example, FIGS. 13A and 13B in W02020 / 037314 illustrate region 108 of an optic that defines the aperture, wherein region 108 may be irradiated using methods herein to create an anti -reflection region about the aperture (with a different swell factor and thus a different RI when hydrated). This may help reduce the scattering of light at the location of the aperture, wherein anti -reflection region 108 may optionally be formed with a gradient RI change. In some examples, the anti-reflection region 108 may be 5 microns to 100 microns wide. Any of the optics herein may include a gradient RI about a central aperture, as is described in W02020 / 037314.

[0095] For lenses that have relatively thicker central regions (e.g., ICL correcting for hyperopia and / or presbyopia), creating a central port creates relatively more surface area in the port for light to scatter and create glare and halos. That is, for ICLs that are relatively thick in the center (compared to negative lenses for myopia, for example, which are relatively thinner in the center) a central port will inherently create greater surface area for light to scatter and cause visual disturbances such as glare and halos. Relatively thinner centers of negative ICLs for myopia may cause minimal and acceptable amount of glare and halos.

[0096] One aspect of this disclosure is lenses with one or more ports configured to reduce the amount of light scattered from the central port that reaches the retina, thereby minimizing visual disturbances such as glare and halos. Any of the central ports herein may be mechanically drilled, for example.

[0097] FIG. 10 illustrates an existing negative ICL for correcting myopia (thinner in center of optic than at periphery), illustrating a current central port through the center, which is shown highlighted in FIG. 11 A.

[0098] FIG. 1 IB illustrates an example of a central port with a chamfer formed on the anterior side that may be incorporated into any lens herein to reduce the amount of scatter light that reaches the retina.

[0099] FIG. 11C illustrates an example of a central port with a chamfer on both the anterior side and the posterior side that may be incorporated into any lens herein to reduce the amount of scatter light that reaches the retina.

[0100] FIG. 1 ID illustrates an alternative approach, in that the central port is created to define an axis at an angle alpha relative to the optical axis, as shown. The angle can be selected to reduce theamount of scattered light that reaches the retina, compared with a straight central port (not at an angle) without a chamfer on either side.

[0101] An additional aspect of this application is a one-size-fits-all lens (or as few lens sizes as possible), with footplates that will sufficiently deform when implanted in patients with smaller posterior chambers without losing centration of the lens. Additionally, footplates that have greater flexibility may cause less tissue damage. While FIGS. 12 and 13 illustrate posterior chamber phakic lenses that may be considered more traditional, FIGS. 14 and 15 illustrate lenses with haptic profiles (including the footplate profile) that cause the footplates to absorb more forces compared to traditional footplate profiles, which can allow the lens to be used in a greater variety of patient sizes.

[0102] FIG. 12 shows the length dimension “L” and the width dimension (“W”) that are described with reference to FIGS. 12-15. In FIGS. 12-15, all of the lenses are shown with the same maximum length. The four lenses each include four footplates 1806, 1906, 2006 and 2106, respectively (only one of the four footplates is labeled for each lens). The lenses in FIGS. 14 and 15 have footplates that in general have a greater footplate length “FL” than the lenses shown in FIGS. 12 and 13. This may alternatively be described as footplates that protrude further outward in the length dimension than other footplate profdes (e.g., FIGS. 12 and 13). The footplates in FIG. 14 have greater footplate widths “FW” than the footplates in FIGS. 12, 13 and 15. The footplates 2106 in FIG. 15 define an outer surface with surface regions 2198 and 2199 that are parallel or substantially parallel or are closer to parallel than corresponding side surface regions of the footplates in FIGS. 12-14. Alternatively, surface regions 2198 and 2199 may not be parallel or substantially parallel, but surface regions 2199 (on each of the footplates) may still extend aligned or generally aligned with the dimension in which the length is measured.

[0103] The lenses in FIGS. 14 and 15 each have less material in the haptic region of the lens, compared to the lenses in FIGS. 12 and 13. The outer profile of the lens can be formed using common manufacturing techniques such as milling. By removing more haptic material (such as during milling), the radially outer footplate regions in the lenses in FIGS. 14 and 15 are more flexible than the lenses in FIGS. 12 and 13 and absorbing more forces.

[0104] FIGS. 13, 14, and 15 illustrate a merely exemplary dimensional difference from the lens in FIG. 12, which in these examples is .200 mm, 1.055 mm, and 0.935 mm. The differences result in footplates with greater footplate lengths FL than the FL of the lens in FIG. 12.

[0105] In exemplary embodiments of FIGS. 14 and 15, FL may optionally be from 1 mm to 1.6 mm. In exemplary embodiments of FIGS. 14 and 15, FW may be from 1.5 mm to 2.25 mm.

[0106] The lenses in FIGS. 14 and 15 may include any other one or more lens features described herein, and vice versa.

[0107] Any of the lenses herein may be made of any of the polymeric materials described inW02020 / 037314. Any of the lenses herein may include any one or more lens features described in W02020 / 037314. Any of the ionizing energy delivery parameters described in W02020 / 037314 may be used herein in a controlled manner to break cross-links bonds as described herein. Methods hereinmay optionally include delivering ionizing energy with one or more of the following parameters: 5- 1000 micron beam; x-ray photon energy in the range of 1-100 keV; absorbed dose of ionizing radiation of 1 kGy to 100 kGy (1 Gray = 1 Joule ionization energy per kilogram = 100 rad), additional exemplary details of which are described in W02020 / 037314.

[0108] Any feature of any embodiment, example, claim, figure, or other part of this disclosure may be integrated with any other suitable combinable feature of any embodiment, example, claim, figure, or other part of this disclosure, unless indicated to the contrary herein.

Claims

CLAIMS1. A deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable cross-link density in which a first region of the optic body has fewer crosslinks than in a second region of the optic body, the variable cross-link density adapting the optic body to swell in a non-uniform manner when hydrated to impart a vision correction region embedded within the optic body; and a haptic portion disposed about a periphery of the optic body.

2. The lens of claim 1, wherein the transparent deformable optic body of polymerized material has a homogeneous chemical formulation throughout.

3. The lens of claim 1, wherein the embedded vision correction region comprises a spherical vision correction surface embedded within the optic body.

4. The lens of claim 1, wherein the embedded vision correction region comprises an aspherical vision correction surface embedded within the optic body.

5. The lens of claim 1, wherein the embedded vision correction region comprises a toric vision correction surface embedded within the optic body.

6. The lens of claim 1, wherein the embedded vision correction region comprises a diffractive pattern embedded within the optic body.

7. The lens of claim 6, wherein the diffractive pattern is sinusoidal.

8. The lens of claim 6, wherein the diffractive pattern is sawtooth.

9. The lens of claim 1, wherein the embedded vision correction region comprises a transition region between a first region with a first refractive index and a second region with a second refractive index.

10. The lens of claim 1, wherein the embedded vision correction region distinguishes a first portion of the optic body with a first refractive index and a second portion of the optic body with a second refractive index different than the first.

11. The lens of claim 1, wherein the embedded vision correction region comprises a first region of the optic body at a first radial distance from an optical axis with a first refractive index and a second region of the optic body at a second radial distance from the optical axis with a second refractive index that is different than the first refractive index.

12. The lens of claim 11, wherein the embedded vision correction region comprises a plurality of radially spaced annular regions about an optical axis, each having a different refractive index than at least one other of the plurality of radially spaced annular regions.

13. The lens of claim 12, wherein the lens is trifocal lens, wherein the embedded vision correction region comprises three annular regions radially spaced to provide distance vision, intermediate vision and near vision.

14. The lens of claim 12, wherein the embedded vision correction region comprises a gradient radial change in refractive index within the optic body.

15. The lens of claim 14, wherein the gradient includes an increase in refractive index in a radially outward direction.

16. The lens of claim 14, wherein the gradient includes a decrease in refractive index in a radially outward direction.

17. The lens of claim 14, wherein the entire optic body has a gradient change in refractive index from a central region of the optic body to a periphery of the optic body.

18. The lens of claim 12, wherein each of the plurality of annular regions has a radial span from 5 microns to 3 mm.

19. The lens of claim 12, wherein the plurality of annular regions includes from 2 to 60 different annular regions.

20. The lens of claim 12, wherein a central optic region is adapted for distance vision.

21. The lens of claim 12, wherein a central optic region is adapted for near vision.

22. The lens of claim 12, wherein a central optic region is adapted for intermediate vision.

23. The lens of claim 12, wherein an anterior optic body surface is spherical, aspherical, or a combination thereof.

24. The lens of claim 12, wherein a posterior optic body surface is spherical, aspherical, or a combination thereof.

25. The lens of claim 1, wherein the optic body has an anterior surface that is flat.

26. The lens of claim 1, wherein the optic body has a vision correction posterior surface, optionally at least one of spherical, aspherical, or toric.

27. The lens of claim 1, wherein the optic body is configured to correct myopia or hyperopia.

28. The lens of claim 1, wherein the lens is adapted to correct for presbyopia.

29. A method of inducing a non-uniform cross-link density in an optic body of an intraocular vision correction lens, comprising: with a cross-linked polymeric body comprising a plurality of cross-linked bonds and outside of an eye, irradiating the polymeric body with controlled ionizing energy to break at least some of the plurality of cross-linked bonds within the polymeric body to create a variable cross-link density within the polymeric body, the variable cross-link density adapting the optic body to swell in a variable manner when hydrated to impart a vision correction region embedded within the polymeric body.

30. The method of claim 29, wherein the embedded vision correction region comprises a spherical vision correction surface embedded within the optic body.

31. The method of claim 29, wherein the embedded vision correction region comprises an aspherical vision correction surface embedded within the optic body.

32. The method of claim 29, wherein the embedded vision correction region comprises a toric vision correction surface embedded within the optic body.

33. The method of claim 29, wherein the embedded vision correction region comprises a diffractive pattern embedded within the optic body.

34. The method of claim 33, wherein the diffractive pattern is sinusoidal.

35. The method of claim 33, wherein the diffractive pattern is sawtooth.

36. The method of claim 29, wherein the embedded vision correction region comprises a transition between a first region with a first refractive index and a second region with a second refractive index.

37. The method of claim 29, wherein the embedded vision correction region distinguishes a first portion of the optic body with a first refractive index and a second portion of the optic body with a second refractive index different than the first.

38. The method of claim 29, wherein the embedded vision correction region comprises a first region of the optic body at a first radial distance from an optical axis with a first refractive index and a second region of the optic body at a second radial distance from the optical axis with a second refractive index that is different than the first refractive index.

39. The method of claim 38, wherein the embedded vision correction region comprises a plurality of radially spaced annular regions about an optical axis, each having a different refractive index than at least one other of the plurality of radially spaced annular regions.

40. The method of claim 39, wherein the lens is a trifocal lens, and wherein the embedded vision correction region comprises three annular regions radially spaced to provide distance vision, intermediate vision and near vision.

41. The method of claim 39, wherein the embedded vision correction region comprises a gradient radial change in refractive index within the optic body.

42. The method of claim 41, wherein the gradient includes an increase in refractive index in a radially outward direction.

43. The method of claim 41, wherein the gradient includes a decrease in refractive index in a radially outward direction.

44. The method of claim 41, wherein the entire optic body has a gradient change in refractive index from a central region of the optic body to a periphery of the optic body.

45. The method of claim 39, wherein each of the plurality of annular regions has a radial span from 5 microns to 3 mm.

46. The method of claim 39, wherein the plurality of annular regions is from 2 to 60 different annular regions.

47. The method of claim 39, wherein a central optic region is adapted for distance vision.

48. The method of claim 39, wherein a central optic region is adapted for near vision.

49. The method of claim 39, wherein a central optic region is adapted for intermediate vision.

50. The method of claim 38, further comprising forming an anterior optic body surface to be spherical, aspherical, or a combination thereof.

51. The method of claim 38, further comprising forming a posterior optic body surface to be spherical, aspherical, or a combination thereof.

52. The method of claim 29, wherein the optic body has an anterior surface that is flat.

53. The method of claim 29, wherein the optic body is configured to correct myopia or hyperopia.

54. The method of claim 29, wherein the lens is adapted to correct for presbyopia.

55. A deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable cross-link density, the variable cross-link density adapting the optic body to swell in a non-uniform manner when hydrated to impart a plurality of radially spaced annular zones of different refractive index; and a haptic portion disposed about a periphery of the optic body.

56. A deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable swell factor such that at least first and second optic body regions are adapted to swell to a different extent when the optic body is hydrated and impart a vision correction region embedded within the optic body.

57. The lens of claim 56, further comprising any one or more lens features described or claimed herein.

58. A deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent optic body with a diffractive pattern embedded within the optic body, wherein anterior and posterior surfaces of the optic body do not have a diffractive pattern formed thereon.

59. A deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: an optic body with a variable cross-link density, the optic body further comprising a plurality of radially-spaced annular zones disposed about an optical axis, a first of the plurality of radially-spaced annular zones zone having a refractive index that is different than a refractive index of a second zone of the plurality of radially-spaced zones, wherein the differences in the refractive index is due to a difference in swell factors in the first and second radially-spaced zones.

60. A posterior chamber phakic vision correction lens, comprising: an optic body with a central port that has a diameter from 40 microns to 200 microns.

61. The lens of claim 60, wherein one or both sides of the central port is chamfered.

62. The lens of claim 60, wherein the central port has an axis that is disposed at an angle relative to an optical axis of the optic body.

63. A trifocal posterior chamber lens configured to provide near vision, far vision, and intermediate vision, wherein the lens comprises: an optic body that either has an anterior surface with a diffractive pattern formed therein or an embedded diffractive pattern.

64. A posterior chamber lens configured to interface with a sulcus of an eye when implanted into the eye, the lens comprising: an optic body and a haptic region, the haptic region including a plurality of deformable footplates protruding outward from adjacent haptic regions, wherein each of the plurality of footplates has a footplate length (FL) from 1.0 mm to 1.6 mm.

65. The lens of claim 64, wherein each of the plurality of footplates has a footplate width (FW) from 1.5 mm to 2.25 mm.

66. The lens of claim 64, wherein the plurality of footplates are sized and configured to deform so as to absorb all or substantially all forces on the footplates from eye tissue.

67. The lens of claim 64, wherein the lens is packaged as a one-size-fits-all lens.

68. The lens of claim 64, wherein the lens is packaged with instructions that do not limit the lens for implantation based on patient eye size(s).

69. The lens of claim 64, wherein each of the plurality of footplates includes first and second outer surface regions (in a top view of the lens) that are parallel or substantially parallel.

70. A deformable vision correction lens (“lens”) sized and configured for intraocular placement, the lens comprising: a transparent deformable optic body of polymerized material that prior to placement in an eye has a variable cross-link density, the variable cross-link density adapting the optic body to swell in a non-uniform manner when hydrated to impart an embedded vision correction region within the optic body; and a haptic portion disposed about a periphery of the optic body.

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