Color mask for implantable contact lenses

Abstract

An implantable contact lens includes a lens body having an anterior surface and an opposite posterior surface. The lens body is composed of a bulk hydrogel material and a circular insert embedded in the bulk hydrogel material, and includes an annular mask on either the anterior or posterior surface of the lens body. The circular insert includes a peripheral edge. Both the annular mask and the insert are concentric with the central axis of the lens body. The annular mask is an opaque, tinted region that covers or overlaps the peripheral edge of the circular insert to minimize or eliminate optical disturbances induced by the peripheral edge of the circular insert.

Description

[Technical Field]

[0001] The present invention relates generally to the field of contact lenses, and more particularly to color masks for implantable contact lenses each having a diffractive optical insert embedded therein. [Background technology]

[0002] Presbyopia is a well-known disorder in which the eye loses its ability to focus at near distances, affecting over 2 billion people worldwide. Extensive research efforts have been made to develop multifocal ophthalmic lenses (intraocular lenses or contact lenses) to correct presbyopia. One area of ​​extensive research is the development of multifocal diffractive ophthalmic lenses.For example, U.S. Patent Nos. 4,210,391, 4,338,005, 4,340,283, 4,637,697, 4,641,934, 4,642,112, 4,655,565, 4,830,481, 4,881,804, 4,881,805, 4,936,666, 4,995,714, 4,995,715, 5,054,905, 5,056,908, 5,076 684 specification, 5100226 specification, 5104212 specification, 5114220 specification, 5116111 specification, 5117306 specification, 5120120 specification, 5121979 specification, 512 Specification No. 1980, Specification No. 5229797, Specification No. 5748282, Specification No. 5760871, Specification No. 5982543, Specification No. 6120148, Specification No. 6364483, Specification No. 6536899, Specification No. 695 Specification No. 1391, Specification No. 6957891, Specification No. 7025456, Specification No. 7073906, Specification No. 7093938, Specification No. 7156516, Specification No. 7188949, Specification No. 7232218, Specification No. 78 91810 specification, 8038293 specification, 8128222 specification, 8142016 specification, 8382281 specification, 8480228 specification, 8556416 specification, 8573775 specification, 86 See Nos. 78583, 8755117, 9033494, 9310624, 9320594, 9370416, 10197815, 10209533, 10426599, 10463474, 10524899, 10675146, 10725320, 10932901, and 10945834. Multifocal diffractive intraocular lenses are now commercially available for correcting presbyopia.

[0003] However, multifocal diffractive contact lenses are not yet commercially available for correcting presbyopia, likely due to the inherent problems associated with contact lenses (see Perez-Prados, et al., "Soft Multifocal Simultaneous Image Contact Lenses: Review," Clin. Exp. Optom. 2017, 100:107-127). For example, standard lens materials have a refractive index of approximately 1.42 or less, or approximately 0.04 higher than the refractive index of the tear film. Such a small refractive index difference requires a higher diffraction grating height on one of the anterior and posterior surfaces of the contact lens. However, for comfortable wear, the contact lens must have smooth anterior and posterior surfaces. Such a diffraction grating may cause discomfort to the patient.

[0004] U.S. Patent Application Publication Nos. 2021 / 0191153 A1, 2021 / 0191154 A1, and 2023 / 0004023 A1 disclose contact lenses with embedded diffractive optical inserts for correcting presbyopia. The interface between the bulk lens material and the peripheral edge of the diffractive optical insert in such contact lenses can be a potential area of ​​optical disturbance. For example, the angle of the peripheral edge of the embedded diffractive optical insert can affect optical distortion due to significant differences in refractive index between the bulk lens material and the material of the embedded diffractive optical insert. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, improvements are needed to contact lenses having embedded diffractive optical inserts to reduce, control, or eliminate optical disturbances induced by the peripheral edges of the diffractive optical inserts. [Means for solving the problem]

[0006] The present invention provides improvements to implantable contact lenses each having an embedded insert, including reducing, controlling, or eliminating optical disturbances induced by the insert's periphery without changing or modifying the shape or design of the insert's periphery. In certain embodiments, the present invention relates to masking the insert's periphery. Generally, the contact lenses of the present invention include an anterior surface, an opposing posterior surface, a bulk hydrogel material, and an insert embedded in the bulk hydrogel material. The insert is made of a material having a refractive index higher than that of the bulk material. Due to the difference in refractive index between the bulk hydrogel material and the insert material, optical disturbances can occur in the region where the insert's periphery is located within the implantable contact lens. Either the anterior or posterior surface includes an annular mask, which is an opaque region that covers or overlaps the insert's periphery. A mask according to exemplary embodiments of the present invention can help minimize or eliminate optical disturbances induced by the insert's periphery in a user's field of view, for example, by at least partially blocking and / or occluding light transmitted through the mask. Furthermore, masking the periphery of the insert using an annular mask on the front or rear surface can reduce requirements for the specific design of the shape or profile of the periphery of the insert, thereby providing greater freedom for other design considerations.

[0007] In one aspect, the present invention relates to an implantable contact lens comprising a lens body having an anterior surface and an opposite posterior surface, the lens body being composed of a bulk hydrogel material and an insert embedded in the bulk hydrogel material, and the lens body including an annular mask on the anterior or posterior surface. The insert is made of a crosslinkable polymeric material different from the bulk hydrogel material. The insert is circular and has a convex surface, an opposite concave surface, and a peripheral edge. Both the annular mask and the insert are concentric with the central axis of the lens body. The annular mask is an opaque, tinted region that covers or overlaps the peripheral edge of the insert to minimize or eliminate optical disturbances induced by the peripheral edge of the insert.

[0008] In another aspect, the present invention relates to a method for making the implantable contact lenses of the present invention.

[0009] These and other aspects, features, and advantages of the present invention will be understood by reference to the drawings and detailed description herein and realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that the foregoing general description, and both the following brief description of the drawings and detailed description of exemplary embodiments, are descriptions of exemplary embodiments of the invention and are not intended to limit the invention as claimed. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a cross-sectional view of an implantable contact lens according to an exemplary embodiment of the present invention. [Figure 2] FIG. 2 is a plan view of the implantable contact lens of FIG. 1. [Figure 3] 1 is a cross-sectional view of an implantable contact lens according to another exemplary embodiment of the present invention. [Figure 4] 1 is a cross-sectional view of an implantable contact lens according to yet another exemplary embodiment of the present invention. [Figure 5] 1 is a cross-sectional view of an implantable contact lens according to yet another exemplary embodiment of the present invention. [Figure 6] 1 illustrates an annular mask according to an exemplary embodiment of the present invention. [Figure 7] 10 illustrates an annular mask according to yet another exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention may be more readily understood by reference to the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings, which form a part of this disclosure. It is to be understood that the present invention is not limited to the specific devices, methods, conditions, or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only, and is not intended to limit the claimed invention. All patents and other publications identified herein are incorporated by reference as if fully set forth herein.

[0012] Also, as used herein, including the appended claims, the singular forms "a," "an," and "the" include the plural, and references to particular values ​​include at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from one particular value preceded by "about" or "approximately," and / or to another particular value preceded by "about" or "approximately." When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, it will be understood that the particular value forms another embodiment by use of the antecedent "about." Additionally, any use of the terms "about," "approximately," "substantially," and / or "generally" is intended to refer to the exact value or characteristic given, as well as an approximation that will be understood by one of ordinary skill in the art to be sufficiently close to the exact value or characteristic based on the context of the intended use and application. Furthermore, any method described herein is not intended to be limited to the sequence of steps described, and may be practiced in other sequences unless expressly stated otherwise herein.

[0013] "About" as used herein in this application means that the number referred to as "about" includes the recited number, plus or minus 1 to 10% of the recited number.

[0014] "Hydrogel" or "hydrogel material" refers to a crosslinkable polymeric material that has a three-dimensional polymer network (i.e., a polymer matrix) and is insoluble in water but can retain at least 10% by weight of water within its polymeric matrix when fully hydrated (or equilibrated). Hydrogel materials can be non-silicone hydrogel materials or silicone hydrogel materials.

[0015] "Non-silicone hydrogel" or "non-silicone hydrogel material" refers to a hydrogel material that is theoretically free of silicone.

[0016] "Silicone hydrogel," "SiHy," "silicone hydrogel material," or "SiHy maleate" refers to a silicone-containing hydrogel obtained by copolymerization of a polymerizable composition comprising at least one silicone-containing monomer, at least one silicone-containing macromer, or at least one crosslinkable silicone-containing prepolymer.

[0017] Siloxane, often also referred to as silicone, refers to a molecule having at least one moiety of -Si-O-Si-, where each Si atom has two organic groups as substituents.

[0018] As used in this application, the terms "non-silicone hydrogel" or "non-silicone hydrogel material" are interchangeable and refer to hydrogels that are theoretically free of silicon.

[0019] "Insert" refers to any three-dimensional article having dimensions of at least 5 microns but small enough to be embedded in the bulk material of an implantable hydrogel contact lens, and made from a material different from the bulk hydrogel material (preferably a non-hydrogel material).

[0020] In accordance with the present invention, a non-hydrogel material can be any material that can absorb less than 5% by weight of water when fully hydrated (preferably about 4% by weight or less, more preferably about 3% by weight or less, and even more preferably about 2% by weight or less).

[0021] In accordance with the present invention, the insert of the present invention has a thickness that is less than any thickness of an implantable hydrogel contact lens in the area where the insert is implanted. The insert can have a body having any geometric shape and can have any desired function.

[0022] As used in this application, the terms "front surface," "front surface," "front curve surface," or "FC surface" in reference to a contact lens or insert are interchangeable and refer to the surface of the contact lens or insert that faces away from the eye during wear. The front surface (FC surface) is convex.

[0023] As used in this application, the terms "posterior surface," "back surface," "base curve surface," or "BC surface" in reference to a contact lens or insert are interchangeable and refer to the surface of the contact lens or insert that faces the eye during wear. The posterior surface (BC surface) is concave.

[0024] As used in this application, "central axis" with respect to a contact lens or lens body means an imaginary reference line passing through the geometric centers of the anterior and posterior surfaces of the contact lens or lens body.

[0025] Referring now to the drawings, wherein like reference numerals represent corresponding parts throughout the several views, FIG. 1 shows a cross-sectional view of a lens body 100 of an implantable contact lens in accordance with an exemplary embodiment of the present invention. The lens body 100 has an anterior (front) surface 101 and an opposite posterior (back) surface 102. The lens body is comprised of a bulk hydrogel material 130 and an insert 120 embedded in the bulk hydrogel material. In the exemplary embodiment, the insert 120 and lens body 100 are generally circular, with the insert 120 located generally in a central portion of the lens body 100 and concentric with the central axis of the lens body 100. The insert 120 is made of a cross-linkable polymeric material having a refractive index higher than that of the bulk hydrogel material 130. The insert 120 has a convex surface 121 and an opposite concave surface 122. In some exemplary embodiments, the convex surface 121 (421) of the insert is integral with the anterior surface 101 (401) of the lens body, and the concave surface 122 (422) of the insert 120 (420) is embedded in the lens body (i.e., in direct contact with the bulk hydrogel material 130 (430)), as shown in Figures 1 and 5. In other exemplary embodiments, the concave surface 222 (322) of the insert 220 (320) may be integral with the posterior surface 202 (302) of the lens body 200 (300), as shown in Figures 3 and 4.

[0026] Depending on the thickness of the insert 120 and the geometry of the insert's periphery, the periphery of the insert 120 may have a tapered surface 140 extending between an outer diameter or periphery (e.g., shown as the outer dashed circle in FIG. 2 ) and an inner diameter or periphery (e.g., shown as the inner dashed circle in FIG. 2 ) spanning widthwise or radial distances at different depths within the lens body. In certain exemplary embodiments, the diameter of the lens body 100 (i.e., measured at the edge of the lens body 100) may be between 12.5 mm and 15.5 mm, e.g., about 14 mm. The diameter of the insert 120 (i.e., measured at the edge of the insert 120) may be between 5 mm and 12.5 mm, e.g., about 7 mm. In exemplary embodiments, the insert 120 is formed of a cross-linkable polymeric material having a first refractive index, and the bulk hydrogel material (a non-silicone hydrogel material or preferably a silicone hydrogel material) has a second refractive index different from the cross-linkable polymeric material of the insert 120 and different from the first refractive index. In exemplary embodiments, the difference between the first and second refractive indices is at least about 0.05. In some exemplary embodiments, the insert 120 may include a diffractive optical element formed of a relatively hard material having a relatively high refractive index, and the bulk hydrogel material 130 may include a relatively soft material having a relatively low refractive index. In alternative embodiments, the material selection for the bulk hydrogel material and the insert material may be reversed. In further exemplary embodiments, one or more additional layers, coatings, or optical elements of the same or different materials may be provided on the lens body 100.

[0027] Any suitable insert material and any suitable bulk hydrogel material can be used in the present invention. Examples of preferred insert materials and bulk hydrogel materials include, but are not limited to, the materials disclosed in U.S. Patent Application Publication Nos. 2022 / 0324187A1, 2022 / 0326412A1, 2022 / 0306810A1, and 2023 / 0004023A1, all of which are incorporated by reference in their entireties.

[0028] In various preferred embodiments, the insert is made of a cross-linkable polymeric material having a first refractive index, and the bulk hydrogel material is a silicone hydrogel material having a second refractive index, the first refractive index being at least 0.05 (preferably at least 0.07, more preferably at least 0.09, and even more preferably at least 0.10) higher than the second refractive index.

[0029] In preferred embodiments thereof, the crosslinkable polymeric material of the insert has a refractive index of at least about 1.47, preferably at least about 1.49, more preferably at least about 1.51, and even more preferably at least about 1.53. Optionally, but preferably, the crosslinkable polymeric material of the insert has an oxygen permeability of at least about 40 barrers, preferably at least about 60 barrers, more preferably at least about 80 barrers, and even more preferably at least about 100 barrers. Such preferred insert materials are described in U.S. Patent Application Publication No. 2023 / 0004023 A1, which is incorporated by reference in its entirety.

[0030] According to the present invention, the bulk hydrogel material is a non-silicone hydrogel material having a water content of about 10% to about 70% by weight when fully hydrated. Non-silicone hydrogel materials can be formed from non-silicone hydrogel lens formulations (i.e., polymerizable compositions), as known to those skilled in the art. Typically, non-silicone hydrogel lens formulations comprise (1) (a) at least one hydrophilic vinyl monomer (e.g., hydroxyethyl methacrylate, glycerol methacrylate, N-vinylpyrrolidone, or a combination thereof) and (b) a crosslinker, a hydrophobic vinyl monomer, a lubricant (or a so-called internal wetting agent incorporated into the lens formulation), a free-radical initiator (photoinitiator or thermal initiator), a UV-absorbing vinyl monomer, a high-energy violet light ("HEVL")-absorbing vinyl monomer, a visibility colorant (e.g., a reactive dye, a polymerizable dye, a pigment, or a mixture thereof), an antimicrobial agent (e.g., preferably silver nanoparticles), a bioactive agent, or a combination thereof. and combinations thereof, or (2) an aqueous solution comprising one or more water-soluble prepolymers and at least one component selected from the group consisting of hydrophilic vinyl monomers, crosslinkers, hydrophobic vinyl monomers, lubricants (or so-called internal wetting agents incorporated into the lens formulation), free-radical initiators (photoinitiators or thermal initiators), UV-absorbing vinyl monomers, HEVL-absorbing vinyl monomers, visibility colorants (e.g., reactive dyes, polymerizable dyes, pigments, or mixtures thereof), antimicrobial agents (e.g., preferably silver nanoparticles), bioactive agents, and combinations thereof. The resulting preformed hydrogel contact lenses can then be subjected to extraction with an extraction solvent to remove unpolymerized components from the resulting lenses and a hydration process, as known to those skilled in the art. It is understood that a lubricant present in a hydrogel lens formulation can improve the lubricity of the preformed hydrogel contact lenses compared to the lubricity of control preformed hydrogel contact lenses obtained from a control hydrogel lens formulation without the lubricant.

[0031] Preferred examples of water-soluble prepolymers include, but are not limited to, the water-soluble crosslinkable poly(vinyl alcohol) prepolymers described in U.S. Pat. No. 5,583,163 and U.S. Pat. No. 6,303,687, both of which are incorporated by reference in their entireties.

[0032] Numerous non-silicone hydrogel lens formulations have been described in numerous patents and patent applications published as of the filing date of this application and have been used to produce commercially available non-silicone hydrogel contact lenses. Examples of commercially available non-silicone hydrogel contact lenses include, without limitation, alphafilcon A, acofilcon A, deltafilcon A, etafilcon A, focofilcon A, herfilcon A, herfilcon B, hylafilcon B, hyoxifilcon A, hyoxifilcon B, hyoxifilcon D, metafilcon A, metafilcon B, nelfilcon A, nesofilcon A, ocfilcon A, ocfilcon B, ocfilcon C, ocfilcon D, omafilcon A, femfilcon A, polymacon, sanfilcon A, terfilcon A, tetrafilcon A, and bifilcon A.

[0033] In a preferred embodiment, the bulk hydrogel material is a non-silicone hydrogel material comprising at least 50 mole percent repeat units of at least one hydroxyl-containing vinyl monomer, preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, N-2-hydroxyethyl (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, vinyl alcohol, allyl alcohol, and combinations thereof, more preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, and vinyl alcohol. The mole percentage of repeat units can be calculated based on the non-silicone hydrogel lens formulation for producing the non-silicone hydrogel contact lenses.

[0034] In another preferred embodiment, the bulk hydrogel material is a silicone hydrogel material having an equilibrium water content (i.e., in a fully hydrated state or when fully hydrated) of about 20% to about 70% by weight (preferably about 20% to about 65% by weight, more preferably about 25% to about 65% by weight, and even more preferably about 30% to about 60% by weight), an oxygen permeability coefficient of at least about 40 barrers (preferably at least about 60 barrers, more preferably at least about 80 barrers, and even more preferably at least about 100 barrers), and an elastic modulus (i.e., Young's modulus) of about 1.5 MPa or less (preferably about 0.2 MPa to about 1.2 MPa, more preferably about 0.3 MPa to about 1.1 MPa, and even more preferably about 0.4 MPa to about 1.0 MPa). Such preferred bulk hydrogel materials (i.e., silicone hydrogel materials) are described in U.S. Patent Application Publication No. 2023 / 0004023 A1, the entire contents of which are incorporated by reference.

[0035] Numerous SiHy lens formulations have been described in numerous patents and patent applications published as of the filing date of this application and have been used in producing commercially available SiHy contact lenses. Examples of commercially available SiHy contact lenses include, without limitation, asmofilcon A, balafilcon A, confilcon A, derefilcon A, eflofilcon A, enfilcon A, funfilcon A, galyfilcon A, lotrafilcon A, lotrafilcon B, narafilcon A, narafilcon B, senofilcon A, senofilcon B, senofilcon C, sumafilcon A, somofilcon A, and stenfilcon A.

[0036] In an exemplary embodiment, the lens body 100 further includes a mask 150 on the anterior surface 101. The mask 150 is generally an opaque tinted and / or colored region configured to mask or cover the tapered surface 140 at the periphery of the insert 120 and the area surrounding the tapered surface 140. Generally, the mask region has an annular or ring-like shape or contour and is concentrically disposed with the insert 120. In an exemplary embodiment, the mask 150 is configured to help block or shield (at least partially) the transmission of light through the mask 150 to the eye. Blocking light transmitted through the mask 150 minimizes optical disturbances induced by the tapered surface 140 and / or optical distortions caused by the tapered surface 140. As shown in FIG. 2 , the mask 150 generally has an annular shape or contour and follows the contour of the tapered surface 140. In other words, for example, the mask 150 may include buffer zones on either side of the tapered surface 140, thereby overlapping or covering at least a portion of both the insert 120 and the area extending radially from the insert 120. In some exemplary embodiments, for example, the radius of the radially outer edge of the mask 150 may be approximately 0.1 mm to 1.0 mm larger than the radius of the tapered surface 140 (see reference character L2 in FIG. 2 ), or preferably approximately 0.5 mm larger than the radius of the tapered surface 140, and the radius of the radially inner edge of the mask 150 may be approximately 0.1 mm to 1.0 mm smaller than the radius of the tapered surface 140 (see reference character L1 in FIG. 2 ), or preferably approximately 0.5 mm smaller than the radius of the tapered surface. In other exemplary embodiments, L1 may be larger than L2. In alternative embodiments, L2 may be larger than L1. In yet another exemplary embodiment, the mask 150 may be configured to cover only the area where the tapered surface 140 of the insert's periphery is located (i.e., the area between the two dashed circles). In a preferred embodiment, the difference between the outer and inner radii of the mask 150 is about 0.2 mm to 2.0 mm, or more preferably about 1 mm. Furthermore, in an exemplary embodiment, the width of the mask depends on the size of the periphery; for example, a wider periphery requires a wider mask.

[0037] The annular mask 150 may have a substantially uniform radially outer edge and a substantially uniform radially inner edge or an uneven or jagged radially inner edge. In some exemplary embodiments, the annular mask 150 may have a non-uniform or jagged radially outer edge and a substantially uniform radially inner edge or an uneven or jagged radially inner edge.

[0038] As used herein, "substantially uniform radial edges" refers to radial edges whose positions are at a substantially constant radial distance (i.e., from the central axis of the lens body), i.e., differing from each other by less than 20%. As used herein, "uneven or jagged radial edges" refers to radial edges whose positions are at a radial distance (i.e., from the central axis of the lens body) that differ from each other by at least about 20%.

[0039] FIG. 6 shows a schematic representation of a preferred shape of an annular mask 500, which is an annular ring, concentric with the central axis 501 of the lens body, and has a substantially uniform radial outer edge 514 and a substantially uniform radial inner edge 516.

[0040] FIG. 7 schematically illustrates another preferred shape of annular mask 600, which is an annular ring, concentric with the central axis 601 of the lens body, and has a substantially uniform radially outer edge 614 and a non-uniform or jagged radially inner edge 616.

[0041] The annular mask may be a monochromatic or multichromatic opaque color image having the shape of an annular ring. The opaque color image may include one or more rings arranged on top of each other to provide masking and cosmetic effects (e.g., matching the wearer's eye color, correcting the wearer's eye color, enlarging the wearer's eyes, etc.). Examples of such color images are disclosed in U.S. Pat. No. 9,039,173, which is incorporated by reference in its entirety.

[0042] FIG. 1 illustrates an implantable contact lens in which an insert is embedded such that the convex surface of the insert is integrated with the anterior surface of the lens body. However, the insert may also be embedded such that the concave surface of the insert is integrated with the posterior surface of the lens body, as shown in FIGS. 3 and 4. According to exemplary embodiments of the present invention, a mask may be provided or incorporated on any surface of the lens body of the implantable contact lens, regardless of the configuration of the insert of the implantable contact lens. For example, FIG. 1 illustrates an implantable contact lens 100 in which an insert 120 is embedded on the anterior side of the lens body. In the illustrated embodiment, a mask 150 is provided or incorporated on the anterior surface of the lens body 100 (however, the mask 150 may also be provided on the posterior surface of the lens body). FIG. 3 illustrates an implantable contact lens 200 in accordance with another exemplary embodiment, in which an insert 220 is embedded on the posterior side of the lens body and a mask 250 is provided on the anterior surface of the lens body. FIG. 4 illustrates an implantable contact lens 300 in accordance with yet another exemplary embodiment, in which an insert 320 is embedded on the posterior side of the lens body and a mask 350 is provided on the posterior surface of the lens body.

[0043] The implantable contact lenses of the present invention can be obtained by applying ink directly onto a preformed implantable contact lens with an embedded insert according to any known method. A preferred method for applying ink onto a preformed implantable contact lens with an embedded insert according to the present invention is by printing, for example by pad transfer printing and / or inkjet printing using an ink, preferably a water-based ink.

[0044] Inks typically include pigment particles, binder polymers, and solvents known to those skilled in the art. The inks may optionally include crosslinkers, humectants, surfactants, monomers, polymerization initiators, antimicrobial agents, antioxidants, anti-kogating agents, and other additives known in the art.

[0045] The solvent can be water (water-based ink) or any suitable organic solvent (organic solvent-based ink). Any known suitable solvent can be used as long as it can dissolve the binder in the ink of the present invention and promote the stability of the colorant. Examples of preferred solvents include water or water mixed with one or more co-solvents. Alternatively, organic solvents such as alcohols, glycols, ketones, esters, methyl ethyl ketone, cyclopentanone, and cyclohexanone can be used.

[0046] "Binder polymer," as the term is known in the art, refers to a crosslinkable polymer that contains crosslinkable groups and can be crosslinked by a crosslinking agent or by initiating chemical or physical means (e.g., moisture, heat, UV radiation, etc.) to entrap or fuse a colorant onto or within a contact lens.

[0047] The term "crosslinkable group" is used broadly herein and is intended to encompass, for example, functional groups and photocrosslinkable or thermally crosslinkable groups, which are well known to those skilled in the art. It is well known in the art that a pair of compatible crosslinkable groups can form a covalent bond or covalent linkage under known reaction conditions, such as oxidation-reduction conditions, dehydration condensation conditions, addition conditions, substitution (or displacement) conditions, free radical polymerization conditions, 2+2 cycloaddition conditions, Diels-Alder reaction conditions, ROMP (ring-opening metathesis polymerization) conditions, vulcanization conditions, cationic crosslinking conditions, and epoxy curing conditions. For example, an amino group can be covalently fused with an aldehyde (the Schiff base formed from the aldehyde and amino groups can be further reduced), a hydroxyl group and an amino group can be covalently fused with a carboxyl group, a carboxyl group and a sulfo group can be covalently fused with a hydroxyl group, a mercapto group can be covalently fused with an amino group, or a carbon-carbon double fusion can be covalently fused with another carbon-carbon double fusion.

[0048] Exemplary covalent bonds or linkages formed between pairs of crosslinkable groups include, but are not limited to, alkanes (single carbon-carbon fusions), alkenes (double carbon-carbon fusions), esters, ethers, acetals, ketals, vinyl ethers, carbamates, ureas, amines, amides, enamines, imines, oximes, amidines, iminoesters, carbonates, orthoesters, phosphonates, phosphinates, sulfonates, sulfinates, sulfide, sulfate, disulfides, sulfinamides, sulfonamides, thioesters, aryls, silanes, siloxanes, heterocycles, thiocarbonates, thiocarbamates, and phosphonamides.

[0049] Exemplary crosslinkable groups include, but are not limited to, hydroxyl groups, amine groups, amide groups, sulfhydryl groups, -COOR (where R and R' are hydrogen or C1-C8 alkyl groups), halides (chloride, bromide, iodide), acyl chlorides, isothiocyanates, isocyanates, monochlorotriazines, dichlorotriazines, mono- or dihalogen-substituted pyridines, mono- or dihalogen-substituted diazines, phosphoramidites, maleimides, aziridines, sulfonyl halides, hydroxysuccinimide esters, hydroxysulfosuccinimide esters, imidoesters, hydrazines, oxidonitrophenyl groups, azides, 3-(2-pyridyldithio)propionamide, glyoxal, aldehydes, epoxies, and olefinically unsaturated groups.

[0050] The binder polymer in the ink can be any polymer compatible with the lens material. The binder polymer can be prepared by polymerization of monomers containing vinyl alcohol, vinyl butyral, vinyl acetate, acrylic acid, methacrylic acid, hydroxy C1-C6 alkyl esters of acrylic and methacrylic acid, amino C1-C8 alkyl esters of acrylic and methacrylic acid, glycerol esters of acrylic and methacrylic acid, vinyl pyrrolidone, vinyl chloride, hydroxyethyl methacrylate, dimethylacrylamide, and the like. Mixtures of these various monomers can be made to form various copolymers. Other polymers may include various cellulose resins, polyesters, polyurethanes, polyureas, or polyamides having at least one crosslinkable group. Preferably, the monomers used in preparing the fusion polymer are the same as those used in fabricating the lens.

[0051] Pad transfer printing is well known in the art (see, e.g., U.S. Pat. Nos. 3,536,386, 4,582,402, 4,704,017, and 5,034,166, which are incorporated herein by reference in their entireties). A typical example of this printing process is as follows: An image is etched into metal to form a cliche. The cliche is placed in a printer. Once placed in the printer, the cliche is inked by either an open inkwell doctor blade system or a closed ink cup that slides across the image. A silicone pad then picks up the ink image from the cliche and transfers the image to the contact lens. The silicone pad is made of a material that includes silicone, which has variable elasticity. The properties of the silicone material allow the ink to temporarily and completely release from the pad when it contacts the contact lens or mold. Suitable pad transfer printing structures include, but are not limited to, tampo type printing structures (Tampo vario 90 / 130), rubber stamps, thimbles, doctor blades, direct printing, or transfer printing, as known in the art.

[0052] Any known suitable silicone pad can be used in the present invention. Silicone pads are commercially available. However, different pads may provide different print qualities. A person skilled in the art would know how to select a pad for a given ink.

[0053] Cliches can be made from ceramic or metal (e.g., steel). If the cliche is made from steel, it is desirable to neutralize the pH of the aqueous ink (e.g., adjust the pH to 6.8-7.8) by adding a buffer (e.g., phosphate). Images can be etched into the cliche by any method known to those skilled in the art, such as chemical etching or laser ablation. After use, the cliche is desirably cleaned by standard cleaning techniques known to those skilled in the art, such as immersion in a solvent, ultrasonic treatment, or mechanical abrasion.

[0054] Printing may be done on either the front (convex) or back (concave) surface of the lens, although it is currently understood that printing on the front surface is preferred to obtain an annular mask.

[0055] Printing lenses using an inkjet printing process is described in U.S. Patent Application Publication Nos. 2001 / 0050753, 2001 / 0085934, 2003 / 0119943, and 2003 / 0184710, which are incorporated herein by reference in their entireties.

[0056] Preformed implantable contact lenses can be obtained according to the methods disclosed in US Patent Application Publication No. 2022 / 0324187A1, which is incorporated herein by reference in its entirety.

[0057] As a first illustrative example, an implantable contact lens of the present invention can be manufactured by the following steps: (1) obtaining a female mold half, a first male mold half, and a second male mold half, wherein the female mold half has a first molding surface that defines a front surface of the contact lens to be molded, the first male mold half has a second molding surface that defines a back surface of the insert to be molded, and the second male mold half has a third molding surface that defines a posterior surface of the contact lens to be molded, and wherein the first male mold half and the female mold half are arranged such that when the female mold half is closed with the first male mold half, the second molding surface and the first male mold half are closed. (1) a second male mold half and a female mold half configured to receive one another such that an insert molding cavity is formed between the first molding surface and a central portion of the third molding surface, and the second male mold half and the female mold half configured to receive one another such that an insert molding cavity is formed between the first molding surface and a central portion of the third molding surface when the female mold half is closed with the second male mold half; (2) dispensing an amount of insert-molding composition onto the central portion of the first molding surface of the female mold half; and (3) placing the first male mold half on top of the insert-molding composition in the female mold half and closing the first male mold half and the female mold halves to form an insert molding cavity. (4) forming a first mold assembly containing an insert-molding composition in the insert-molding cavity of the first mold assembly to form a mold insert; (5) separating the first mold assembly obtained in step (4) into first male and female mold halves and adhering the mold insert onto a central region of the first mold surface; and (6) dispensing a lens-forming composition into the female mold half to which the mold insert is adhered in an amount sufficient to fill the lens-molding cavity. (7) placing a second male mold half over the lens-forming composition in the female mold half and closing the second male mold half and female mold half to form a second mold assembly containing the lens-forming composition in the lens-forming cavity and a mold insert immersed therein; and (8) curing the lens-forming composition in the lens-forming cavity of the second mold assembly to form an implantable contact lens precursor containing a bulk hydrogel material formed from the lens-forming composition and the insert embedded in the bulk hydrogel material.(9) separating the second mold assembly obtained in step (8) into a second male mold half and a female mold half, and adhering the implantable contact lens precursor to one of the female mold half and the second male mold half, which is a lens bonding mold half; (10) applying ink to form an annular mask on the exposed surface of the implantable contact lens precursor adhered to the lens bonding mold half; (11) removing the implantable contact lens precursor obtained in step (10) from the lens bonding mold half; and (11) subjecting the implantable contact lens precursor to a post-molding process, including a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof, to obtain the implantable contact lens of the present invention.

[0058] As a second illustrative example, an implantable contact lens of the present invention can be manufactured by the following steps: (1) obtaining a first female mold half, a male mold half, and a second female mold half, wherein the first female mold half has a first molding surface that defines a front surface of an insert to be molded, the male mold half has a second molding surface that defines a posterior surface of a contact lens to be molded, and the second female mold half has a third molding surface that defines a front surface of a contact lens to be molded, and wherein the first female mold half and the male mold half are arranged such that when the first female mold half is closed with the male mold half, the first molding surface and the second molding surface form a contact lens to be molded. (1) a second female mold half and a male mold half configured to receive one another such that an insert molding cavity is formed between the second molding surface and a central portion of the third molding surface, and the second female mold half and the male mold half configured to receive one another such that a lens molding cavity is formed between the second molding surface and a central portion of the third molding surface when the second female mold half is closed with the male mold half; (2) dispensing an amount of insert molding composition onto the first molding surface of the first female mold half; and (3) placing a male mold half on top of the insert molding composition in the first female mold half and closing the first female mold half and the male mold halves to form an insert molding cavity. (4) forming a first mold assembly containing an insert-forming composition within the cavity; (5) curing the insert-forming composition within the insert-molding cavity of the first mold assembly to form a mold insert; (6) separating the first mold assembly from step (4) into a first female mold half and a first male mold half and adhering the mold insert onto a central portion of a second mold surface; (7) dispensing a lens-forming composition into the second female mold half in an amount sufficient to fill the lens-molding cavity; and (8) adhering the mold insert onto the first female mold half. (7) placing the male mold half onto the lens-forming composition in the second female mold half and closing the second female mold half and male mold half to form a second mold assembly containing the lens-forming composition and the mold insert immersed therein within the lens-forming cavity; and (8) curing the lens-forming composition within the lens-forming cavity of the second mold assembly to form an implantable contact lens precursor containing a bulk hydrogel material formed from the lens-forming composition and the insert fully or partially embedded in the bulk hydrogel material.(9) separating the second mold assembly obtained in step (8) into a second female mold half and a male mold half, and adhering the implantable contact lens precursor to one of the male mold and the second female mold half, which is a lens bonding mold half; (10) applying ink to form an annular mask on the exposed surface of the implantable contact lens precursor adhered to the lens bonding mold half; (11) removing the implantable contact lens precursor obtained in step (10) from the lens bonding mold half; and (11) subjecting the implantable contact lens precursor to a post-molding process, including a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof, to obtain the implantable contact lens of the present invention.

[0059] Mold halves for producing contact lenses (or inserts) are well known to those skilled in the art and are employed, for example, in cast molding. Generally, a molding assembly includes at least two mold halves, one male and one female. The male mold half has a first molding (or optical) surface that directly contacts the polymerizable composition for cast molding of the contact lens (or insert) and defines the posterior (back) surface of the molded contact lens (or mold insert), and the female mold half has a second molding (e.g., optical) surface that directly contacts the polymerizable composition and defines the anterior (front) surface of the molded contact lens (or mold insert). The male and female mold halves are configured to receive each other such that a lens or insert-forming cavity is formed between the first and second molding surfaces.

[0060] In a preferred embodiment, the mold half having the molding surface defining one of the front and back surfaces of the insert includes an overflow groove that surrounds the molding surface and receives excess insert-forming material when the mold assembly is closed. By including such an overflow groove, flash formed from excess insert-forming material during molding of the insert can be reliably deposited on the mold half having the molding surface defining the front or back surface of the insert during the step of separating the mold assembly halves, thereby enabling the flash to be removed.

[0061] Methods for manufacturing mold halves for cast molding contact lenses or inserts are generally well known to those skilled in the art. The process of the present invention is not limited to a particular method for forming the mold halves. In fact, any method for forming mold halves can be used in the present invention. Mold halves can be formed by a variety of techniques, such as injection molding or lathing. Examples of suitable processes for forming mold halves are disclosed in U.S. Pat. Nos. 4,444,711, 4,460,534, 5,843,346, and 5,894,002, which are incorporated herein by reference in their entireties.

[0062] To manufacture mold halves for producing contact lenses or inserts, virtually any material known in the art for manufacturing mold halves can be used, such as polymeric materials such as polyethylene, polypropylene, polystyrene, PMMA, Topas® COC Grade 8007-S10 (a transparent amorphous copolymer of ethylene and norbornene, manufactured by Ticona GmbH of Frankfurt, Germany and Summit, New Jersey).

[0063] In accordance with the present invention, the insert-forming composition and the lens-forming composition are different polymerizable compositions that may differ from one another in the presence or absence of one or more polymerizable components, in the amount of one or more polymerizable components, and / or in the presence or absence of one or more non-leaching additives to provide different optical properties (e.g., photochromic dyes or pigments, UV absorbing materials, HEVL absorbing materials, fluorescent dyes or pigments, color filtering materials to correct color vision deficiencies, diffractive materials, high refractive index materials, etc.).

[0064] Any polymerizable composition can be used as the insert-forming composition in the present application. Examples of preferred insert-forming compositions include, but are not limited to, those described in U.S. Patent Application Publication No. 2022 / 0324187 A1, which is incorporated herein by reference in its entirety.

[0065] Any polymerizable composition for forming a hydrogel material can be used as the lens-forming composition.

[0066] In preferred embodiments, the lens-forming composition is a non-silicone hydrogel lens-forming composition (or non-silicone hydrogel lens formulation) that is either (1) a monomer mixture comprising: (a) at least one hydrophilic vinyl monomer (e.g., a hydroxyl-containing vinyl monomer, N-vinylpyrrolidone, or a combination thereof); and (b) at least one component selected from the group consisting of a crosslinker, a hydrophobic vinyl monomer, a free-radical initiator (photoinitiator or thermal initiator), a UV-absorbing vinyl monomer, a high-energy violet light ("HEVL")-absorbing vinyl monomer, a visibility colorant, and combinations thereof; or (2) an aqueous solution comprising one or more water-soluble prepolymers and at least one component selected from the group consisting of a hydrophilic vinyl monomer, a crosslinker, a hydrophobic vinyl monomer, a lubricant (or a so-called internal wetting agent incorporated into the lens formulation), a free-radical initiator (photoinitiator or thermal initiator), a UV-absorbing vinyl monomer, a HEVL-absorbing vinyl monomer, a visibility colorant, and combinations thereof.

[0067] Numerous non-silicone hydrogel lens formulations have been described in numerous patents and patent applications published as of the filing date of this application and have been used to produce commercially available non-silicone hydrogel contact lenses. Examples of commercially available non-silicone hydrogel contact lenses include, but are not limited to, alphafilcon A, acofilcon A, deltafilcon A, etafilcon A, focofilcon A, herfilcon A, herfilcon B, hylafilcon B, hyoxifilcon A, hyoxifilcon B, hyoxifilcon D, metafilcon A, metafilcon B, nelfilcon A, nesofilcon A, ocfilcon A, ocfilcon B, ocfilcon C, ocfilcon D, omafilcon A, femfilcon A, polymacon, sanfilcon A, terfilcon A, tetrafilcon A, and bifilcon A. These can be used as lens-forming compositions of the present invention.

[0068] Preferably, the non-silicone hydrogel lens-forming composition comprises at least 50 mol % of at least one hydroxyl-containing vinyl monomer, preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, N-2-hydroxyethyl (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, vinyl alcohol, allyl alcohol, and combinations thereof, more preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, and vinyl alcohol.

[0069] In another preferred embodiment, the lens-forming composition is a silicone hydrogel lens-forming composition (i.e., a silicone hydrogel lens formulation). Numerous silicone hydrogel lens formulations have been described in numerous patents and patent applications published as of the filing date of this application and have been used in the manufacture of commercially available SiHy contact lenses. Examples of commercially available SiHy contact lenses include, but are not limited to, asmofilcon A, balafilcon A, confilcon A, derefilcon A, eflofilcon A, enfilcon A, funfilcon A, galyfilcon A, lotrafilcon A, lotrafilcon B, narafilcon A, narafilcon B, senofilcon A, senofilcon B, senofilcon C, sumafilcon A, somofilcon A, and stenfilcon A. These can be used as lens-forming compositions of the present invention. Examples of preferred silicone hydrogel lens-forming compositions include, but are not limited to, those disclosed in U.S. Patent Application Publication No. 2022 / 0324187A1, which is incorporated herein by reference in its entirety.

[0070] The insert-forming composition and lens-forming composition can be introduced into the insert-molding cavity and lens-molding cavity, respectively, according to any technique known to those skilled in the art.

[0071] When the first molding assembly is closed, excess insert molding composition is forced into an overflow groove provided in the insert mold half (i.e., the first male mold half having a second molding surface that defines the rear face of the molded insert, or the first female mold half having a first molding surface that defines the front face of the molded insert).

[0072] When the second molding assembly is closed, excess lens-forming composition is forced into an overflow groove in one of the two mold halves, each of which has a molding surface that defines one of the anterior and posterior surfaces of the contact lens to be molded. The overflow groove surrounds the molding surface that defines one of the anterior and posterior surfaces of the contact lens to be molded.

[0073] Curing of the insert-forming composition in the insert-molding cavity of the closed first mold assembly and the lens-forming composition in the lens-molding cavity of the closed second mold assembly can be carried out thermally (i.e., by heating) or actinically (i.e., by actinic radiation, e.g., UV radiation and / or visible light radiation) to activate a polymerization initiator.

[0074] Actinic polymerization of the insert or lens-forming composition of the molding assembly can be carried out by irradiating the closed molding assembly with the insert or lens-forming composition with UV or visible light according to any technique known to those skilled in the art.

[0075] Thermal polymerization of the mold assembly insert or lens-forming composition can be conveniently carried out in an oven at temperatures of 25-120°C, preferably 40-100°C, as is well known to those skilled in the art. The reaction time can vary within wide limits, but is conveniently, for example, 1-24 hours, or preferably 2-12 hours. It is advantageous to previously degas the silicone hydrogel lens-forming composition and to carry out the copolymerization reaction under an inert atmosphere, for example, under a N2 or Ar atmosphere.

[0076] The step of separating the first molding assembly can be carried out according to any technique known to those skilled in the art. It is understood that the molding insert is bonded onto a female mold having a molding that defines the anterior surface of the contact lens to be molded (in one embodiment) or onto a male mold having a molding surface that defines the posterior surface of the contact lens to be molded (in another embodiment). Many techniques are known in the art. For example, the molding surface of a mold half designed to bond the molding insert can be surface treated to cause the molding insert to preferentially adhere to the molding surface of the mold half. Alternatively, a mold opening device can be used to apply a compressive force to the non-optical surface (opposite the molding surface) of the mold half of the first molding assembly (the one to which the molding insert is not bonded) at an angle of less than about 30 degrees, preferably less than about 10 degrees, and most preferably less than about 5 degrees relative to the axis of the mold (i.e., in a direction substantially perpendicular to the central region of the non-optical molding surface) at a location near the central region of the non-optical molding surface to deform the mold half, thereby breaking the fusion between the molding surface of the mold half and the molding insert. Various methods of breaking the fusion between the optical molding surface of a mold half and a mold insert by applying a force to the non-optical molding surface of the mold half at a location near the central region of the non-optical molding surface along the axis of the mold to deform the mold half. It is understood that the mold opening device may have any configuration known to those skilled in the art for performing the function of separating the two mold halves from each other.

[0077] Similarly, the step of separating the second molding assembly can be performed according to any technique known to those skilled in the art, and it is understood that the molded implantable contact lens precursor can be adhered to either one of the two mold halves of the second molding assembly.

[0078] Ink is applied onto the unprocessed implantable contact lens bonded to one of the two mold halves of the second molding assembly to form an annular mask on the exposed surface, after which the implantable contact lens precursor with the annular mask can be removed (i.e., detached) from the lens-bonding mold half according to any technique known to those skilled in the art.

[0079] After removal, the implantable contact lens precursor is typically extracted with an extraction medium, as is well known to those skilled in the art. The extraction liquid medium is any solvent capable of dissolving the diluent, unpolymerized polymerizable material, and oligomers in the implantable contact lens precursor. Water, any organic solvent known to those skilled in the art, or mixtures thereof, can be used in the present invention. Preferably, the organic solvent used in the extraction liquid medium is water, buffered saline, C1-C3 alkyl alcohol, 1,2-propylene glycol, polyethylene glycol having a number average molecular weight of about 400 Daltons or less, C1-C6 alkyl alcohol, or a combination thereof.

[0080] The extracted implantable contact lens precursor can then be hydrated to form the bilayer contact lens of the present invention according to any method known to those skilled in the art.

[0081] The extracted implantable contact lens precursor may also be subjected to further processes such as, for example, surface treatment, packaging into a lens package using a packaging solution familiar to those skilled in the art, sterilization such as autoclaving at 118-124°C for at least about 30 minutes, and the like.

[0082] Lens packages (or containers) are well known to those skilled in the art for autoclaving and storing soft contact lenses. Any lens package can be used in the present invention. Preferably, the lens package is a blister package comprising a base and a cover, wherein the cover is removably sealed to the base, and wherein the base comprises a cavity for receiving a sterile packaging solution and a contact lens.

[0083] The lenses are packaged in individual packages, sealed, and sterilized (e.g., by autoclaving at about 120°C or higher under pressure for at least 30 minutes) before being distributed to users. Those skilled in the art will be familiar with methods for sealing and sterilizing lens packages.

[0084] Alternatively, the implantable contact lenses of the present invention can be obtained according to a different process similar to the mold printing process described in US Pat. No. 5,034,166, which is incorporated herein by reference.

[0085] For example, the first process described above can be modified by eliminating step (10) and adding a step after step (6) and before step (7) of applying an ink to the molding surface of the second male mold half to form a colored coat (having a color image) in the shape of an annular ring. Optionally, but preferably, after printing the ink of the present invention onto the molding surface of the mold half, the printed ink can be cured by UV or other actinic radiation to form a colored film according to the present invention. The printed ink is desirably cured by actinic radiation to an extent that minimizes loss of pattern definition in the colored coat due to subsequent filling with the lens-forming composition of step (6). The colored coat or film is peeled from the molding surface and becomes an integral part of the lens body of the molded implantable contact lens.

[0086] Similarly, the second process described above can be modified by eliminating step (10) and adding a step after step (5) and before step (6) of applying ink to the molding surface of the second female mold half to form a colored coat (having a color image) in the shape of an annular ring. Optionally, but preferably, after printing the ink of the present invention onto the molding surface of the mold half, the printed ink can be cured by UV or other actinic radiation to form a colored film according to the present invention. It is desirable to cure the printed ink by actinic radiation to an extent that minimizes loss of pattern definition in the colored coat due to subsequent steps (6) and (7). The colored coat or film is peeled from the molding surface and becomes an integral part of the lens body of the molded implantable contact lens. In addition, it should be understood that aspects of the various embodiments of the present invention can be interchanged, either in whole or in part, or combined in any manner and / or used together (e.g., the following embodiments as described below).

[0087] 1. An implantable contact lens comprising a lens body having an anterior surface and an opposite posterior surface, comprised of a bulk hydrogel material and an insert embedded in the bulk hydrogel material, and including an annular mask on the anterior or posterior surface, wherein the insert is made from a crosslinkable polymeric material different from the bulk hydrogel material, the insert is circular and has a convex surface, an opposite concave surface, and a periphery, both the annular mask and the insert are concentric with the central axis of the lens body, and the annular mask is an opaque, tinted region that covers or overlaps the periphery of the insert to minimize or eliminate optical disturbances induced by the periphery of the insert.

[0088] 2. The implantable contact lens of embodiment 1, wherein the bulk hydrogel material is a non-silicone hydrogel material having a water content of about 10% to about 70% by weight when fully hydrated.

[0089] 3. The implantable contact lens of embodiment 1, wherein the bulk hydrogel material is a non-silicone hydrogel material having a water content of about 10% to about 70% by weight when fully hydrated, and comprising at least 50 mol % repeat units of at least one hydroxyl-containing vinyl monomer preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, N-2-hydroxyethyl (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, vinyl alcohol, allyl alcohol, and combinations thereof, more preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, and vinyl alcohol.

[0090] 4. The implantable contact lens of embodiment 1, wherein the bulk hydrogel material is a silicone hydrogel material having a water content of about 10% to about 70% by weight when fully hydrated and an oxygen permeability of at least about 50 barrers.

[0091] 5. An implantable contact lens of embodiment 4, wherein the bulk hydrogel material in a fully hydrated state has a water content of about 20% to about 70% by weight (preferably about 25% to about 65% by weight, more preferably about 30% to about 60% by weight), a modulus of about 0.2 MPa to about 2.0 MPa (preferably about 0.25 MPa to about 1.5 MPa, more preferably about 0.3 MPa to about 1.2 MPa, even more preferably about 0.35 MPa to about 1.0 MPa), an oxygen permeability of at least 60 barrer / mm (preferably at least 70 barrer / mm, more preferably at least 80 barrer / mm, even more preferably at least 100 barrer / mm), and an average water contact angle of less than 90 degrees (preferably less than 80 degrees, more preferably less than 70 degrees, even more preferably less than 60 degrees).

[0092] 6. The implantable contact lens of any one of embodiments 1 to 5, wherein the crosslinkable polymeric material has a first refractive index and the bulk hydrogel material has a second refractive index different from the first refractive index, and wherein there is a difference between the first and second refractive indices of at least 0.05 (preferably at least 0.07, more preferably at least 0.09, and even more preferably at least 0.10).

[0093] 7. The implantable contact lens of any one of embodiments 1 to 5, wherein the crosslinkable polymeric material has a first refractive index and the bulk hydrogel material has a second refractive index different from the first refractive index, and the first refractive index is at least 0.05 (preferably at least 0.07, more preferably at least 0.09, and even more preferably at least 0.10) higher than the second refractive index.

[0094] 8. The implantable contact lens of embodiment 7, wherein the crosslinkable polymeric material of the insert has a first refractive index of at least about 1.47 (preferably at least about 1.49, more preferably at least about 1.51, and even more preferably at least about 1.53).

[0095] 9. The implantable contact lens of embodiment 1, wherein the first material comprises a first material hardness and a first diffraction index, and the second material comprises a second material hardness greater than the first material hardness and a second diffraction index greater than the first diffraction index.

[0096] 10. The implantable contact lens of any one of embodiments 1-9, wherein the insert comprises a diffractive optical element.

[0097] 11. The implantable contact lens of any one of embodiments 1 to 10, wherein the lens body has a diameter of from about 12.5 mm to about 15.5 mm.

[0098] 12. The implantable contact lens of any one of embodiments 1-11, wherein the insert has a diameter of from about 5 mm to about 12.5 mm.

[0099] 13. The implantable contact lens of any one of embodiments 1-12, wherein the anterior surface of the lens body comprises an annular mask.

[0100] 14. The implantable contact lens of any one of embodiments 1-12, wherein the posterior surface of the lens body comprises an annular mask.

[0101] 15. The implantable contact lens of any one of embodiments 1-14, wherein the annular mask has an outer radius that is about 0.1 mm to 1.0 mm larger than the radius of the periphery of the insert.

[0102] 16. The implantable contact lens of any one of embodiments 1-14, wherein the annular mask has an inner radius that is about 0.1 mm to 1.0 mm smaller than the radius of the periphery of the insert.

[0103] 17. The implantable contact lens of any one of embodiments 1-16, wherein the difference between the outer and inner radii of the annular mask is from about 0.2 mm to about 2.0 mm.

[0104] 18. The implantable contact lens of any one of embodiments 1-17, wherein the annular mask has a substantially uniform radially outer edge and a substantially uniform or non-uniform radially inner edge.

[0105] 19. The implantable contact lens of any one of embodiments 1-18, wherein the insert is implanted such that the convex surface of the insert is integrated with the anterior surface of the lens body.

[0106] 20. The implantable contact lens of any one of embodiments 1-18, wherein the insert is implanted such that the concave surface of the insert is integral with the posterior surface of the lens body.

[0107] 21. A method for manufacturing an implantable contact lens having an annular mask, comprising: obtaining a female mold half, a first male mold half, and a second male mold half, wherein the female mold half has a first molding surface that defines a front surface of an implantable contact lens, the first male mold half has a second molding surface that defines a back surface of an insert to be molded, and the second male mold half has a third molding surface that defines a posterior surface of the contact lens to be molded, the first male mold half and the female mold half being configured to receive each other such that when the female mold half is closed on the first male mold half, an insert molding cavity is formed between the second molding surface and a central portion of the first molding surface, and the second male mold half and the female mold half being configured to receive each other such that when the female mold half is closed on the second male mold half, a lens molding cavity is formed between the first molding surface and the third molding surface; dispensing a quantity of insert-molding composition onto a central portion of a first molding surface of a female mold half; placing a first male mold half over the insert-molding composition in the female mold half and closing the first male mold half and the female mold half to form a first mold assembly containing the insert-molding composition within the insert mold cavity; curing the insert-molding composition in the insert-molding cavity of the first mold assembly to form a molded insert; separating the first mold assembly into first male and female mold halves and adhering a mold insert onto a central region of the first mold surface; dispensing a lens-forming composition into the female mold half having the mold insert adhered thereto in an amount sufficient to fill the lens-molding cavity; placing a second male mold half over the lens-forming composition in the female mold half and closing the second male mold half and the female mold half to form a second mold assembly containing the lens-forming composition in the lens-molding cavity and a mold insert immersed therein; curing the lens-forming composition in the lens-forming cavity of the second molding assembly to form an implantable contact lens precursor comprising a bulk hydrogel material formed from the lens-forming composition and an insert embedded in the bulk hydrogel material; separating the second mold assembly into a second male half and a second female half and bonding an implantable contact lens precursor to one of the female half and the second male half, the lens bonding mold half; applying an ink to form an annular mask on the exposed surface of the implantable contact lens precursor bonded to the lens bonding mold half, the annular mask being an opaque colored area that covers or overlaps the periphery of the insert to minimize or eliminate optical disturbances induced by the periphery of the insert; removing the implantable contact lens precursor from the lens bonding mold half; A method comprising:

[0108] 22. The method for manufacturing an implantable contact lens of embodiment 21, further comprising subjecting the implantable contact lens precursor to a post-molding process, including a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof.

[0109] 23. The method of manufacturing an implantable contact lens of embodiment 21 or 22, wherein the bulk hydrogel material is a non-silicone hydrogel material.

[0110] 24. The method for producing an implantable contact lens of embodiment 21 or 22, wherein the bulk hydrogel material is a silicone hydrogel material.

[0111] 25. A method for manufacturing an implantable contact lens having an annular mask, comprising: obtaining a first female mold half, a male mold half, and a second female mold half, wherein the first female mold half has a first molding surface defining a front surface of an insert to be molded, the male mold half has a second molding surface defining a posterior surface of a contact lens to be molded, and the second female mold half has a third molding surface defining a front surface of a contact lens to be molded, the first female mold half and the male mold half being configured to receive each other such that when the first female mold half is closed with the male mold half, an insert molding cavity is formed between a central portion of the first molding surface and the second molding surface, and the second female mold half and the male mold half being configured to receive each other such that when the second female mold half is closed with the male mold half, a lens molding cavity is formed between the second molding surface and the third molding surface; dispensing a quantity of an insert-molding composition onto a first molding surface of a first female mold half; placing a male mold half over the insert-molding composition in the first female mold half and closing the first female mold half and the male mold half to form a first mold assembly containing the insert-molding composition within the insert mold cavity; curing the insert-molding composition in the insert-molding cavity of the first mold assembly to form a molded insert; separating the first mold assembly into first female and male mold halves and adhering a mold insert onto a central portion of the second mold surface; dispensing a lens-forming composition into the second female mold half in an amount sufficient to fill the lens-forming cavity; placing the male mold half with the mold insert adhered thereto over the lens-forming composition in the second female mold half and closing the second female mold half and the male mold half to form a second mold assembly containing the lens-forming composition in the lens-molding cavity and the mold insert immersed therein; curing the lens-forming composition in the lens-forming cavity of the second molding assembly to form an implantable contact lens precursor comprising a bulk hydrogel material formed from the lens-forming composition and an insert completely or partially embedded in the bulk hydrogel material; separating the second mold assembly into a second female mold half and a second male mold half and bonding an implantable contact lens precursor to one of the male and second female mold halves, the lens bonding mold half; applying an ink to form a mask on the exposed surface of an implantable contact lens precursor bonded to a lens bonding mold half, the annular mask being an opaque colored area that covers or overlaps the periphery of the insert to minimize or eliminate optical disturbances induced by the periphery of the insert; removing the implantable contact lens precursor from the lens bonding mold half; A method comprising:

[0112] 26. The method for producing the implantable contact lens of embodiment 25, further comprising the step of subjecting the implantable contact lens precursor to a post-molding process, including a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof, to obtain the implantable contact lens of the present invention.

[0113] 27. The method of manufacturing an implantable contact lens of embodiment 25 or 26, wherein the bulk hydrogel material is a non-silicone hydrogel material.

[0114] 28. The method of manufacturing an implantable contact lens of embodiment 25 or 26, wherein the bulk hydrogel material is a non-silicone hydrogel material.

[0115] Although the present invention has been described with reference to exemplary embodiments, those skilled in the art will appreciate that various modifications, additions, and deletions are within the scope of the invention as defined by the claims that follow.

Claims

1. 1. An implantable contact lens comprising: a lens body having an anterior surface and an opposite posterior surface, the lens body being comprised of a bulk hydrogel material and an insert embedded in the bulk hydrogel material, the lens body including an annular mask on the anterior surface or the posterior surface, the insert being made from a crosslinkable polymeric material different from the bulk hydrogel material, the insert being circular and having a convex surface, an opposite concave surface, and a peripheral edge, both the annular mask and the insert being concentric with a central axis of the lens body, the annular mask being an opaque, tinted region that covers or overlaps the peripheral edge of the insert to minimize or eliminate optical disturbances induced by the peripheral edge of the insert, the bulk hydrogel material having a water content of about 10% to about 70% by weight when fully hydrated, and the lens body having a diameter of about 12.5 mm to about 15.5 mm.

2. The implantable contact lens of claim 1 , wherein the bulk hydrogel material is a non-silicone hydrogel material comprising at least 50 mole % repeat units of at least one hydroxyl-containing vinyl monomer.

3. 10. The implantable contact lens of claim 1, wherein the bulk hydrogel material is a silicone hydrogel material and when fully hydrated has an oxygen permeability of at least about 50 barrers, an elastic modulus of about 0.2 MPa to about 2.0 MPa, an oxygen transmission rate of at least 60 barrers / mm, and an average water contact angle of less than 90 degrees.

4. 4. The implantable contact lens of claim 1, wherein the crosslinkable polymeric material has a first refractive index and the bulk hydrogel material has a second refractive index different from the first refractive index, the first refractive index being at least 0.05 (preferably at least 0.07, more preferably at least 0.09, even more preferably at least 0.10) higher than the second refractive index.

5. 5. The implantable contact lens of claim 4, wherein the crosslinkable polymeric material of the insert has a first refractive index of at least about 1.47 (preferably at least about 1.49, more preferably at least about 1.51, and even more preferably at least about 1.53).

6. The implantable contact lens of any one of claims 1 to 5, wherein the insert comprises a diffractive optical element.

7. The implantable contact lens of any one of claims 1 to 6, wherein the insert has a diameter of from about 5 mm to about 12.5 mm.

8. An implantable contact lens according to any one of claims 1 to 7, wherein the anterior surface of the lens body comprises the annular mask.

9. An implantable contact lens according to any one of claims 1 to 7, wherein the posterior surface of the lens body comprises the annular mask.

10. 10. The implantable contact lens of any one of claims 1 to 9, wherein the annular mask has an outer radius that is about 0.1 mm to 1.0 mm greater than the radius of the periphery of the insert, and wherein the annular mask has an inner radius that is about 0.1 mm to 1.0 mm smaller than the radius of the periphery of the insert.

11. 11. An implantable contact lens according to any one of claims 1 to 10, wherein the difference between the outer and inner radii of the annular mask is from about 0.2 mm to about 2.0 mm, and the annular mask has a substantially uniform radially outer edge and a substantially uniform or non-uniform radially inner edge.

12. An implantable contact lens according to any one of claims 1 to 11, wherein the insert is embedded such that the convex surface of the insert is integral with the anterior surface of the lens body.

13. An implantable contact lens according to any one of claims 1 to 11, wherein the insert is embedded such that the concave surface of the insert merges with the posterior surface of the lens body.

14. 1. A method of manufacturing an implantable contact lens having an annular mask, comprising: obtaining a female mold half, a first male mold half, and a second male mold half, wherein the female mold half has a first molding surface that defines a front surface of the implantable contact lens, the first male mold half has a second molding surface that defines a back surface of an insert to be molded, and the second male mold half has a third molding surface that defines a posterior surface of the contact lens to be molded, the first male mold half and the female mold half configured to receive each other such that when the female mold half is closed with the first male mold half, an insert molding cavity is formed between the second molding surface and a central portion of the first molding surface, and the second male mold half and the female mold half configured to receive each other such that when the female mold half is closed with the second male mold half, a lens molding cavity is formed between the first molding surface and the third molding surface; dispensing a quantity of insert molding composition onto the central portion of the first molding surface of the female mold half; placing the first male mold half on top of the insert-molding composition in the female mold half and closing the first male mold half and the female mold half to form a first mold assembly containing the insert-molding composition within the insert-molding cavity; curing the insert-molding composition in the insert-molding cavity of the first mold assembly to form a molded insert; separating the first mold assembly into the first male half and the first female half and adhering the mold insert onto the central region of the first mold surface; dispensing a lens-forming composition into the female mold half having the mold insert adhered thereto in an amount sufficient to fill the lens molding cavity; placing the second male mold half over the lens-forming composition in the female mold half and closing the second male mold half and the female mold half to form a second mold assembly including the lens-forming composition in the lens molding cavity and the mold insert immersed therein; curing the lens-forming composition in the lens-forming cavity of the second molding assembly to form an implantable contact lens precursor comprising a bulk hydrogel material formed from the lens-forming composition and the insert embedded in the bulk hydrogel material; separating the second mold assembly into the second male mold half and the second female mold half, and bonding the implantable contact lens precursor to one of the female mold half and the second male mold half; applying ink to form the annular mask on the exposed surface of the implantable contact lens precursor bonded to the lens bonding mold half, the annular mask being an opaque colored area that covers or overlaps the periphery of the insert to minimize or eliminate optical disturbances induced by the periphery of the insert; removing the implantable contact lens precursor from the lens bonding mold half; subjecting the implantable contact lens precursor to post-molding processes, including a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof; A method comprising:

15. 1. A method of manufacturing an implantable contact lens having an annular mask, comprising: obtaining a first female mold half, a male mold half, and a second female mold half, wherein the first female mold half has a first molding surface defining a front surface of an insert to be molded, the male mold half has a second molding surface defining a posterior surface of a contact lens to be molded, and the second female mold half has a third molding surface defining a front surface of the contact lens to be molded, the first female mold half and the male mold half configured to receive each other such that, when the first female mold half is closed with the male mold half, an insert molding cavity is formed between a central portion of the first molding surface and the second molding surface, and the second female mold half and the male mold half configured to receive each other such that, when the second female mold half is closed with the male mold half, a lens molding cavity is formed between the second molding surface and the third molding surface; dispensing a quantity of insert molding composition onto the first molding surface of the first female mold half; placing the male mold half over the insert molding composition in the first female mold half and closing the first female mold half and the male mold half to form a first mold assembly containing the insert molding composition within the insert molding cavity; curing the insert-molding composition in the insert-molding cavity of the first mold assembly to form a molded insert; separating the first mold assembly into the first female mold half and the first male mold half and adhering the mold insert onto the central portion of the second mold surface; dispensing a lens-forming composition into the second female mold half in an amount sufficient to fill the lens-molding cavity; placing the male mold half with the mold insert adhered thereto over the lens-forming composition in the second female mold half and closing the second female mold half and the male mold half to form a second mold assembly containing the lens-forming composition within the lens molding cavity and the mold insert immersed therein; curing the lens-forming composition in the lens-forming cavity of the second molding assembly to form an implantable contact lens precursor comprising a bulk hydrogel material formed from the lens-forming composition and the insert fully or partially embedded in the bulk hydrogel material; separating the second mold assembly into the second female mold half and the second male mold half, and bonding the implantable contact lens precursor to one of the male and second female mold halves; applying ink to form the mask on the exposed surface of the implantable contact lens precursor bonded to the lens bonding mold half, the annular mask being an opaque colored area that covers or overlaps the periphery of the insert to minimize or eliminate optical disturbances induced by the periphery of the insert; removing the implantable contact lens precursor from the lens bonding mold half; subjecting said implantable contact lens precursor to a post-molding process, including a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof, to obtain an implantable contact lens of the present invention; A method comprising:

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