INTRAOCULAR LENS IMPLANT

20200206388 · 2020-07-02

Assignee

Inventors

Cpc classification

International classification

Abstract

The invention concerns an intraocular lens implant for placement into an intracapsular space of a lens capsule of an eye and a composition, kit and methods related to the lens implant. The lens implant is designed for a placement into a posterior portion of the intracapsular space after removal of a native lens body and has a convex posterior surface. The lens implant is formed of one part and is manufactured from a suitable transparent non-structural cellular material. This keeps an anterior portion of the intracapsular space free of the implant which is dimensioned to comprise at most 40% of a volume of the native lens body.

Claims

1. Lens implant (12) for a placement into a posterior portion (3b) of an intracapsular space (3) after removal of a native lens body (2) from a lens capsule 13 of an eye, wherein the lens implant (12) is formed of one part and manufactured from suitable non-cellular structural transparent material, wherein the lens implant (12) is dimensioned to keep an anterior portion (3a) of the intracapsular space (3) free of non-cellular structural material, wherein the lens implant (12) is devoid of any further part formed by non-cellular structural material or components thereof, wherein the lens implant (12) comprises at most 40% of a volume of the native lens body (2), which was removed or of the volume of a native lens body (2) with an average size, and wherein the lens implant (12) has a convex posterior surface with a curvature which is shaped to fit a posterior inner surface (13b) of the capsule (13).

2. The lens implant (12) according to claim 1, wherein the lens implant (12) is dimensioned to comprise at most 35%, 30%, 25%, 20%, 15%, 10%, 5% or 2% of a volume of the native lens body (2), in particular a volume of at most 120 l, 110 l, 100 l, 90 l, 80 l, 70 l, 60 l, 50 l, 40 l 30 l, 20 l or 10 l.

3. The lens implant (12) according one of claim 1, wherein the radius of curvature of the posterior surface of lens implant (12) is in a range of 4 to 8 mm, or 4.6 to 7.5 mm or 5 to 7 mm or around 6 mm.

4. The lens implant (12) according to claim 1, wherein a maximal diameter (14) of the implant (12) at most equals the length of an equatorial diameter (5) of the native lens (1) or wherein the maximal diameter (14) of the implant (12) measures at most 98%, 95%, 90%, 80%, 70%, 60% or 50% of the equatorial diameter (5) of the native lens (1) or wherein the maximal diameter (14) of the implant (12) measures in a range with an upper boundary of 5 to 12 mm, in particular 11, 10, 9, 8, or 7, or 6 mm.

5. The lens implant (12) according to claim 1, wherein the maximal diameter (14) of the implant (12) measures at least 50%, 60%, 70%, 80% or 90% of the equatorial diameter (5) of the native lens (1) or wherein the maximal diameter (14) of the implant (12) measures in a range with a lower boundary in a range of 3 to 7 mm, in particular 3, 4, 5 or 6 mm.

6. The lens implant (12) according to claim 1, wherein the transparent material is selected to be deformable, allowing the implant (12) to be introduced into the intracapsular space (3) in a folded or rolled-up state through an opening in the lens capsule (13), wherein the largest diameter of the opening measures in the range of 0.5 to 4 mm, in particular between 0.5 and 3 mm, more particularly less than 3, 2, 1.5 or 1 mm.

7. The lens implant (12) according to claim 1, wherein an anterior surface of the implant (12) is also convex or wherein the anterior surface is plan or concave.

8. The lens implant (12) according to claim 1, wherein it is dimensioned and shaped to provide a refractive power suitable for vision adapted to infinity, in particular with a refractive power adaptable to the dimensions of the eye in a range from .sup.20 dioptre to .sup.+60 dioptre including no refractive power corresponding to 0 dioptre.

9. Capsule filling composition (15) for use in intraocular surgery for filling an intracapsular space (3) after removal of a native lens body (2) from a lens capsule 13 of an eye, wherein the filling of the intracapsular space (3) accompanies the introduction of a lens implant (12) manufactured from suitable non-cellular structural transparent material into a posterior portion 3 (b) of the intracapsular space (3) replacing a posterior portion (2b) of the lens body (2) and wherein the volume of the lens implant (12) amounts to at most 40% of the volume of the lens body (2), wherein the introduced volume of the filling composition (15) together with the volume of the implant (12) provides for reconstitution of a volume essentially corresponding to the volume of the native lens body (2), which was removed or of the volume of a native lens body (2) with an average size and wherein the capsular filling composition (15) is of an aqueous composition and is devoid of non-cellular structural material or components thereof for replacement of lens fibers.

10. Capsule filling composition (15) for use in intraocular surgery according to claim 9, comprising cells which are capable of developing lens fibers which in particular are obtained from a probe of an eye, more particularly from a probe comprising lens epithelial cells (4).

11. Capsule filling composition (15) for use in intraocular surgery according to claim 9, wherein the cells are derived from an autologous or a heterologous human eye or from a non-human eye in particular from a non-human mammalian eye.

12. Capsule filling composition (15) for use in intraocular surgery according to claim 9, wherein the filling composition (15) comprises ingredients selected from the group consisting of: hyaluronic acid, an anti-TGF blocking agent, a growth factor, in particular one or several of: a fibroblast growth factor, including FGF-1 and FGF-2, epidermal growth factor (EGF), platelet-derived growth factor (PDGF), insulin growth factor I or II (IGF-I or IGF-II) and a retinoid.

13. A kit comprising a lens implant (12) according to claim 1 and a capsule filling composition (15) for use in intraocular surgery, wherein the capsule filling composition (15) is adapted for filling an intracapsular space (3) after removal of a native lens body (2) from a lens capsule 13 of an eye, wherein the filling of the intracapsular space (3) accompanies the introduction of a lens implant (12) manufactured from suitable non-cellular structural transparent material into a posterior portion 3 (b) of the intracapsular space (3) replacing a posterior portion (2b) of the lens body (2) and wherein the volume of the lens implant (12) amounts to at most 40% of the volume of the lens body (2), wherein the introduced volume of the filling composition (15) together with the volume of the implant (12) provides for reconstitution of a volume essentially corresponding to the volume of the native lens body (2), which was removed or of the volume of a native lens body (2) with an average size and wherein the capsular filling composition (15) is of an aqueous composition and is devoid of non-cellular structural material or components thereof for replacement of lens fibers.

14. A method for providing the kit according to claim 13 comprising the steps of a. providing results of measurements of an eye or taking measurements for providing such results selected in particular of measurements of dimensions of the eye, in particular of a lens 1 or a cornea 10, or of the length of the eye along a visual axis 11, of an optical power of the eye, of a curvature of a posterior surface of the lens 1 or of a radius of curvature of a posterior surface of the lens 1, and b. selecting an implant based on the results of step a.

15. The method according to claim 14 wherein in an additional step the ingredients of the filling composition are adapted by addition of autologous or heterologous living cells and/or by addition of an ingredient selected from the group consisting of: hyaluronic acid, an anti-TGF blocking agent, a growth factor, in particular one or several of: a fibroblast growth factor, including FGF-1 and FGF-2, epidermal growth factor (EGF), platelet-derived growth factor (PDGF), insulin growth factor I or II (IGF-I or IGF-II), and a retinoid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. This description makes reference to the annexed drawings, wherein:

[0028] FIG. 1 shows a sectional view of a healthy human eye depicting schematically parts relevant in the context of this invention.

[0029] FIG. 2 shows a schematic sectional view of a human eye after use of an exemplary embodiment of a kit comprising an exemplary embodiment of an intraocular lens implant and of an exemplary embodiment of a capsule filling composition for introduction into an intracapsular space after removal of a native lens body from a lens capsule.

MODES FOR CARRYING OUT THE INVENTION

[0030] The parts of the eye which are most relevant in the context of this invention are depicted schematically in a section of the eye in FIG. 1 with a lens 1, and an equatorial diameter 5 between two equatorial poles 6 of the lens 1, which equatorial diameter 5 divides the lens 1 into an anterior and a posterior portion. The term anterior refers to the side towards the cornea; the term posterior refers to the side towards the retina of the eye. The lens 1 comprises a lens body 2 divided accordingly along the equatorial diameter 5 into an anterior portion 2a and a posterior portion 2b.

[0031] The lens body 2 is essentially made up by transparent lens fibers. The lens body 2 is surrounded by a capsule 13 with anterior and posterior inner surfaces 13a and 13b. After removal of the lens body 2 an essentially empty capsule (or empty capsular bag) forms an intracapsular space 3. The intracapsular space 3 is divided along the equatorial diameter 5 into an anterior portion 3a and a posterior portion 3b. The equatorial diameter 5 is the largest diameter of the lens 2 or the capsule 13 or the intracapsular space 3, respectively and is oriented essentially perpendicular to the visual axis.

[0032] The capsule 13 is composed of an extracellular basement membrane comprising type IV collagen fibers and sulfated glycosaminoglycans. The capsule is elastic due to lamellar arrangement of collagen fibers. The capsule 13 is secreted anteriorly by lens epithelial cells 4 and posteriorly by elongating lens fiber cells. The lens epithelial cells (LECs) 4 line the anterior inner surface 13a of the lens capsule 13 as displayed enlarged in inset A. LECs 4 have been observed to additionally line an area of the inner capsular surface centering around the equator and reaching also into the posterior portion of the capsule. The LECs 4 not only secret the anterior portion of the lens capsule 13, they also differentiate into elongating lens fiber cells in an equatorial area along the equatorial circumference of the lens 1. Furthermore, the LECs are able to multiply and differentiate into lens fiber cells not only in vivo but also in vitro and they are able reconstitute a clear lens body 2 or a portion thereof.

[0033] In cataract surgery minimally invasive surgical techniques for removal of a defective lens have been developed. In a frequently applied method called capsulorhexis an incision in the capsule 13, in particular in the anterior part of the capsule 13, creates a circular opening which allows the lens body 2 to be extracted. In a commonly used procedure called phacoemulsification, the defective lens body 2 is emulsified by sonication and aspirated. Such surgical procedures as described e.g. by Zhou et al (Invest Ophthalmol Vis Sci. 2016; 57, p. 6615, see in particular also Supplementary 2) result in an essentially empty capsular bag surrounding the intracapsular space 3 with the anterior portion 3a and the posterior portion 3b from which the native lens body 2 has been removed. Advantageously, with such minimal invasive surgery most of the lens capsule 13 and the lining of LECs 4 on the anterior inner capsular surface 13a are left intact. It has been shown that this is permitting spontaneous regeneration of clear lens tissue (see e.g. Lin et al, 2016 cited above, extended data FIG. 1 or Zhou et al. Invest Ophthalmol Vis Sci. 2016, 57, p. 6615, Supplementary 2). In the method of medical treatment according to the invention including surgical removal of a native lens body, particular care is taken to place the incision into the capsular bag in a peripheral area of the lens capsule away from the visual axis 11. Furthermore, care is taken to keep the size of the incision small, in particular to keep a largest diameter of the incised hole below 3 mm, in particular below 2.5 mm, 2 mm, 1.5 mm or 1 mm. After introduction of the implant the incision is closed e.g. by a fibrin sealant or another a biological glue. Alternative options for closing the incision include e.g. laser tissue welding, introduction of a plug formed by a turnable lamella closure or introduction of a plug formed by a small amount of a curable artificial material (wherein no more artificial material is used than what is necessary for formation of a plug that closes the incision). Optionally, in some embodiments of the kit components for the closing of the incision into the capsular bag may be included.

[0034] FIG. 1 further shows the visual axis 11 perpendicular to the equatorial diameter 5 passing horizontally through cornea 10, iris 9 and lens 1. In FIG. 1 the eye is represented in a state adapted to distant vision as schematically shown by zonulas 7 attaching at the lens 1 circumferentially along the equator, as shown in FIG. 1 at both equatorial poles 6. The zonulas 7 are shown in a stretched state thereby flattening the lens 1. A circular ciliary muscle 8 upon contraction causes the zonulas 7 to relax which in turn permits the lens 1 to assume a rounder shape resulting in a higher refractive power and thereby accommodating the eye to near vision.

[0035] The radius of curvature of the posterior surface of the lens of an adult human eye ranges between approximately 4.5 and 7.5 mm with the radius of posterior curvature averaging around 5.5 to 6 mm in a human adult eye. The equatorial diameter of the lens of an adult human eye ranges between approximately 9 to 11 mm. The volume of the lens of an adult human eye as measured in vitro ranges from approx. 180 l to 280 l (Rosen et al, Vision Research 2006, 46: 1002). The volume of the lens 1 of an adult human eye essentially corresponds to the volume of the lens body 2 and to the volume of the intracapsular space.

[0036] FIG. 2 shows an exemplary embodiment of an intraocular lens implant 12 placed into the posterior portion 3b of the intracapsular space 3. As evident from this exemplary embodiment, the lens implant 12, made of a suitable transparent material does not reach into the anterior portion 3a of the intracapsular space 3. The volume of the lens implant 12 is less than 40% of the volume of the native lens body 2; in exemplary embodiments it may be below 20% or 10% of the volume of the native lens.

[0037] In some embodiments, the lens implant 12 is dimensioned to comprise at most 35%, 30%, 25%, 20%, 15%, 10%, 5% or 2% of a volume of the native lens body 2. In in particular, the lens implant 12 is dimensioned to comprise a volume of at most 120 l, 110 l, 100 l, 90 l, 80 l, 70 l, 60 l, 50 l, 40 l 30 l, 20 l or 10 l.

[0038] The lens implant 12 is manufactured from a suitable transparent material, in particular selected from flexible materials, e.g. materials known in the art for the manufacture of intraocular lenses such as silicone or hydrophobic and hydrophilic acrylic materials, hydrogels or collagen polymers.

[0039] The lens implant 12 has a convex posterior surface with a curvatureor a posterior curvature for shortwhich is shaped to fit a curvature of a posterior surface of the capsule 13. In some embodiments of the lens implant 12, the radius of curvature of the posterior surface varies in a range of 4 to 8 mm, in particular in a range of 5.5 mm to 6 mm plus or minus up to 25 or 20 or 15 or 10 or 5 percent or e.g. in ranges of 4.6 to 7.5 mm or 5 to 7 mm or around 6 mm.

[0040] The above-indicated radii of curvature refer in particular to the radius of curvature measured on the visual axis 11 or in a vicinity of the visual axis 11. The vicinity of the visual axis is defined as a range adjacent to the visual axis within a solid angle of up to 10, up to 20 or up to 30 of the visual axis 11.

[0041] In some of these and other embodiments, the lens implant 12 has a maximal diameter 14, in particular a maximal outer diameter 14 as measured from an outside surface to an outside surface of the lens implant 12, which at most equals the length of an equatorial diameter 5 of the native lens 1. The maximal diameter 14 in particular, as shown in FIG. 2, is perpendicular to the visual axis 11 of the eye and parallel to the equatorial diameter 5. In particular, the maximal diameter 14 of the implant 12 measures at most 98%, 95%, 90%, 80%, 70%, 60% or 50% of the equatorial diameter 5 of the native lens 1. In some of these and other embodiments the maximal diameter 14 of the implant 12 measures at least 50%, 60%, 70%, 80% or 90% of the equatorial diameter 5 of the native lens 1. In some embodiments, the maximal diameter 14 of the implant 12 measures in a range with an upper boundary of 5 to 12 mm, in particular 11, 10, 9, 8, 7, or 6 mm. In some of these and other embodiment of the implant the lower boundary of the maximal diameter 14 of the implant is in a range of 3 to 7 mm, in particular 3, 4, 5 or 6 mm. Embodiments of the lens implant with a maximal diameter 14 that is smaller than the equatorial diameter 5 of the native lens do not reach into an equatorial portion of the intracapsular space. Thereby epithelial cells lining an equatorial area of the inner surface also in a posterior portion of the capsular bag remain untouched by non-cellular structural material. The size of this untouched posterior equatorial portion increases with a decreasing maximal diameter 14 of the implant.

[0042] In some of these and other embodiments, the lens implant 12 is manufactured from a transparent material which is selected to be deformable, thereby allowing the implant 12 to be introduced into the intracapsular space 3 in a folded or rolled-up state through an opening in the lens capsule 13. In some embodiments, the lens implant is manufactured from flexible materials which allow the implant to be introduced through openings of the capsule 13 wherein the largest diameter of the opening measures in the range of 0.5 to 4 mm, in particular between 0.5 and 3 mm, more particularly less than 3, 2, 1.75, 1.5 or 1.25 or 1 mm.

[0043] In some of these and other embodiments, the lens implant 12 is manufactured from a transparent material which is expandable by absorption of liquid. In these embodiments the implant 12 when after introduction into an aqueous environment within the lens capsule it has reached its expanded volume, its properties including shape and size correspond to properties described here for embodiments of the implant which are not manufactured from an expandable material. Expandable lens materials are known in the art. E.g. the commercially available implants (Acqua) made from hydrophilic acrylic polymers comprising hydroxyethyl methacrylate, vinyl pyrilidone and methylmethacrylate or a hydrophilic polymer or hydrophilic/hydrophobic copolymer such as described by Mehta in http://www.boamumbai.com/journalpdfs/an-mar2001/torpedo.pdf or such as described in U.S. Pat. No. 4,834,753 or expandable hydrogels as described in WO2004/026928.

[0044] In some of these and other embodiments, the lens implant 12 has an anterior surface of the implant 12 which is also convex or it has an anterior surface which is plan or it has an anterior surface which is concave. In some embodiments, the lens implant has a posterior convex and an anterior concave side with a positive meniscus or a negative meniscus appropriately dimensioned for achieving a desired refractive (i.e. optical) power. In some embodiments the lens implant can be toric to correct for astigmatism.

[0045] In some embodiments, the lens implant 12 is dimensioned and shaped to provide a refractive power suitable for vision adapted to infinity, in particular with a refractive power in a range between of 20 dioptre to +60 dioptre, as desired for the treatment of a particular patient. Lens implants 12 with a refractive power of 0 are included, because the lens implant independently of an optical power correction due to its adaptation in shape to the posterior inner surface of the capsule 13b allows for particularly effective treatment of secondary cataract by laser surgery, whereby areas of the posterior lens capsule may be even fully removed and still keep the intracapsular space 3 enclosed by a shell without holes as described above.

[0046] Besides showing an exemplary embodiment of an intraocular lens implant 12 placed into the posterior portion 3b of the intracapsular space 3, FIG. 2 also schematically shows an exemplary embodiment of a capsule filling composition 15 for use in intraocular surgery and how this filling composition 15 may be filling the intracapsular space 3 within the lens capsule 13. Evidently, the filling composition 15 fills not only the anterior portion 3a of the intracapsular space 3 but also parts of the posterior portion 3b of the intracapsular space 3. It thereby essentially replaces the remaining volume of the removed native lens body 2 to the extent that it is not replaced by the lens implant 12. The volume of the filling composition 15 accordingly may be defined as a complementary volume to the volume of the implant 12, wherein the sum of the two corresponds to the volume of the native lens body 2, or intracapsular space 3 within the empty capsular bag.

[0047] The capsule filling composition 15 is of an aqueous composition and is devoid of non-cellular structural components for permanent replacement of lens fibers comprised by the native lens body. The capsule filling composition 15 by filling up the intracapsular space 3 provides for an intracapsular pressure, which corresponds to a physiological intracapsular pressure prior to the removal of the native lens body. An intact intracapsular pressure is relevant for the accommodative function of the eye.

[0048] The shape, geometry and size of the lens implant 12 is not restricted to the exemplary shape and size as depicted in FIG. 2, but may be quite freely adapted to fit the size and optical characteristics of a particular eye and to yield a desired refractive power, provided that the lens implant 12 does not reach into the anterior portion 3a of the intracapsular space 3 and in particular that the lining of epithelial cells 4 on the anterior inner surface 13a of the capsule 13 are not in contact with the implant 12, but instead with the capsular filling composition 15.

[0049] In some of these and other embodiments the capsule filling composition 15 comprises living cells. Such cells may be obtained e.g. from an in vitro culture or from a tissue probe. In particular, the cells may be obtained from a probe of an eye, more particularly from a probe comprising lens epithelial cells 4. In particular, the cells which are added to the aqueous filling composition 15 are capable of developing lens fibers and/or are secreting factors promoting the formation of lens fibers from remaining or added lens epithelial cells.

[0050] In some of these and other embodiments, the cells comprised by the capsule filling composition 15 are derived from autologous or heterologous human eyes or from non-human eyes, in particular from non-human mammalian eyes with or without in vitro culturing prior to the mixing of the cells into to the capsule filling composition or prior to administering the cells along with the capsule filling composition 15 into the intracapsular space 3. The transplantation of heterologous or non-human cells, benefits from the fact that the contents inside the capsule 13 are immune-privileged, i.e. not accessible to the immune system and therefore not prone to immune rejection. In some embodiments the capsular filling composition is administered as one fraction, in other embodiments it is administered in several fractions, wherein the fractions may be administered at the same time or at separate times and they may be of the same or of a variable composition.

[0051] In some of these and other embodiments of the capsule filling composition 15, it comprises ingredients in particular selected from: [0052] hyaluronic acid, [0053] a growth factor, in particular one or several of: a fibroblast growth factor, including FGF-1 and FGF-2, epidermal growth factor (EGF), platelet-derived growth factor (PDGF), insulin growth factor I or II (IGF-I or IGF-II), [0054] an anti-TGF blocking agent [0055] a retinoid

[0056] The term ingredient refers to a liquid or soluble compound which is suitable for establishing a physiological aqueous environment in the lens capsule, and may be based e.g. on a physiological saline solution. The term ingredient includes in particular active ingredients with an active biochemical function such as e.g. ingredients which actively promote regeneration of clear lens fiber tissue. For example, Lovicu et al. (Exp Eye Res, 142: 92, 2016) have shown that anti-TGF blocking agents promote the initiation of lens fiber formation from lens epithelial cells. In addition, there are growth factors known which stimulate lens regeneration as reviewed e.g. by Henry (Int. Rev. Cytology, 228: 195, 2001). Further ingredients include nutrients, antibiotic agents or other agents with a biochemical effect, such as e.g. osmotically active ingredients modulating the intracapsular pressure.

[0057] In a further aspect, a kit comprising both a lens implant 12 and a capsule filling composition 15 as they are described above is provided. In some embodiments of the kit, a collection of implants of different sizes and/or shapes and/or refractive power may be included in the kit for selection of the appropriate implant according to a patients need. The kit is suitable for fully replacing the volume of a removed native lens body 2. In some embodiments of the kit, lens implants and samples with complementary volumes of a capsule filling composition resulting in essentially the same volume as the volume of the native lens body may be provided. The filling composition 15 may facilitate regeneration of lens fibers based on residual cells or based on added cells, in particular lens epithelial cells. In some embodiments, the filling composition may actively promote regeneration by comprising active ingredients, in particular selected ingredients according to the needs of a particular patient. In some embodiments the kit may comprise further suitable components to be used or to be administered to the eye a during, before or after surgery.

[0058] A further aspect concerns a method for providing a personalized intraocular lens implant 12 or for providing a personalized kit comprising an intraocular lens implant 12 as described above and optionally further comprising a capsule filling composition 15 as described above. In some embodiments of the method of providing the kit comprises steps (a) of measuring an eye and a step (b) of selecting at least one implant 12. In step (a) in particular the dimensions of the cornea and/or of the lens and/or the axial length eye are determined. The axial length of an eye or eyeball is defined by the distance between the anterior and the posterior poles of the eyeball. Step (a) and step (b) may be performed at different times and in particular prior to the operation such as e.g. several weeks before the operation, in particular up to 1 or 2 months before the operation. Such methods of measurements are possible without invasive or surgical procedure performed on a human or animal body. Further embodiments of the method of providing a personalized lens implant or kit in step (a) rely on the provision of measurement results obtained from an external source.

[0059] Methods of measuring an eye and the size of the lens capsule are known in the art (see e.g. WO 2011/02068). Biometric methods include ultrasound biometry such as for cataract and refractive treatment in recent years routinely used laser interference biometry (also called optical biometry) of the eye. An alternative method known in the art is partial coherence interferometry. Commonly used and commercially available exemplary ocular biometers include the IOL Master of Zeiss and the Lenstar system of Haag Streit.

[0060] In some embodiments of the method of providing the personalized kit in an additional step the ingredients of the filling composition 15 are adapted to the needs of a particular patient. In some embodiments the a filling composition 15 is adapted e.g. by addition of autologous cells or by a selection of heterologous living cells and/or of a particular ingredient or active ingredient. In some embodiments of the method of providing a personalized kit with the filling composition comprising cells, the cells may be cultured in vitro e.g. for amplification according to procedures known in the art. The filling composition may be provided in the kit with all ingredients pre-mixed. Alternatively, the filling composition may be provided in a number of fractions some of which may comprise ingredients or cells to be added and mixed into the filling composition at a prescribed time before administration of the filling composition to the patient or to be administered into the intracapsular space along with the filling composition as a separate fraction of the filling composition at the same or at a different time.

[0061] In some embodiments of the method a preferable volume or a range of volumes of the filling composition complementary to the volume of the implant is determined for introduction into the intracapsular space.

[0062] By way of this method of providing a personalized kit comprising one or more implants 12 or in some embodiments by additionally comprising a filling composition 15, the implant or kit are advantageously adapted to the particular needs of a patient e.g. in a suitable time ahead of the surgical procedure.

[0063] While there are shown and described presently preferred embodiments of the invention, it is to be distinctly understood that the invention is not limited thereto but may be otherwise variously embodied and practiced within the scope of the following claims.