Ocular prosthesis

Abstract

An ocular prosthesis for replacing a part of an eye of a user, comprising a prosthesis body, characterized in that it comprises a hollow interior space delimited by an anterior element configured so as to simulate the sclera of the eye of the user, and a posterior element, configured so as to copy a portion of an internal ocular edge, and wherein the prosthesis body includes a coating that covers the outer contour of both tne anterior and posterior elements so as to hold them in place, allowing encapsulation of the hollow interior space and simulation of the cornea of the eye of the user.

Description

[0001] DESCRIPTION

[0002] OCULAR PROSTHESIS

[0003] Field and object of the invention

[0004] The invention relates to an ocular prosthesis for replacing part of an eye of a prosthesis user. More specifically, the invention relates to an ocular prosthesis provided with a hollow interior space to reduce the overall weight of said ocular prosthesis and a coating that totally or partially simulates the sclera of the user's eye.

[0005] Background of the invention

[0006] Ocular prostheses are commonly used to replace the partial or complete loss of an eyeball in individuals who have lost it due to an accident, serious injury, illness, or congenital defect. In these situations, to restore a more normal anatomical structure and correct the aesthetic defect caused by the partial or total absence of the eye, an ocular prosthesis is fitted, which imitates or simulates part or all of the eye.

[0007] The residual tissue that forms when the eyeball is totally or partially removed leaves a cavity or sac called the anophthalmic cavity. This is located behind the eyelids and is the space in which the ocular prosthesis is placed to achieve the aesthetic rehabilitation of the eye and the face in general.

[0008] Depending on the amount of orbital volume lost, in addition to the prosthesis, an ocular implant is also inserted that replaces and restores the internal orbital volume of the human eye.

[0009] Current ocular prostheses mimic the cornea, iris, pupil, and sclera. The real cornea of ​​a human eye is a tough, transparent membrane located at the front of the eyeball, and is the part of the eye that is in contact with the outside. It has a convex, domed shape and is approximately one millimeter thick. The cornea covers the iris and the lens and allows for the refraction of light, that is, for light to enter the eye. The iris is a circular membrane that separates the anterior and posterior chambers of the eye. The iris tissue is pigmented due to the presence of different types of melanin at varying depths within the iris, which causes the different eye colors. The pupil is an opening located in the center of the iris that allows light to pass into the posterior chamber of the eye.Finally, the sclera is a thick, tough membrane that covers the eyeball, giving it its characteristic white color and protecting the internal structures. The anterior part of the sclera is attached to the cornea, while the posterior part has an opening that allows the optic nerve to connect to the retina. The cornea, iris, pupil, and sclera together determine the volume of the eyeball.

[0010] The geometry and volume of ocular prostheses depend on the ocular volume to be filled or restored for each user; in other words, it is unique to each individual. Thus, to obtain a prosthesis suitable for each user, an impression of the ocular cavity to be restored is first taken by filling it with a molding fluid, which creates a copy of the anophthalmic cavity. This molding fluid is made of alginate gel, polyvinylsiloxane (VPS), or another material used in the field of ocular impressions. In a short time, a rigid body forms that reproduces the contour of the anophthalmic cavity. Once the negative impression of the anophthalmic cavity is obtained, the ocular prosthesis is manufactured using various procedures, such as molding or 3D printing, among others.

[0011] Ocular prostheses on the market consist of an acrylic resin body, such as polymethyl methacrylate (PMMA), a transparent, scratch-resistant thermoplastic polymer. White color additives are added to this resin to simulate the sclera of the human eye. The white resin body may also incorporate a disc that simulates the iris and pupil of the natural eye. This disc is integrated either by hand-painted or printed sheeting, or by painting directly onto the white resin. Finally, the white acrylic resin body and the disc are partially encased in a transparent resin layer designed to simulate the cornea.

[0012] Ocular prostheses obtained through the procedure described in the previous paragraph have the disadvantage of being very compact and heavy, eventually causing deformation of the lower eyelid and problems of eye irritation in the user of the prosthesis.

[0013] Several attempts have been made to obtain lightweight prostheses, such as the one described in patent EP1855622B1. This document describes an ocular prosthesis manufactured using 3D printing in which a portion of the prosthesis body is hollow. However, the manufacturing method employed limits the final configuration of the resulting prosthesis, such that the one described in this document remains heavy for the user and, furthermore, does not allow for guaranteed sterilization.

[0014] Description of the invention

[0015] The objective of the present invention is to provide an ocular prosthesis that solves the aforementioned drawbacks and presents the advantages that will be described below.

[0016] According to this objective, according to a first aspect, the present invention provides an ocular prosthesis to replace all or part of a user's eye, comprising a prosthesis body, and is characterized in that said prosthesis body comprises a hollow interior space delimited by;

[0017] - a front element with a concave profile configured to totally or partially simulate the sclera of the user's eye, and

[0018] - a rear element configured so that it copies a rear portion of a user's inner eye rim and acts as a lid for the front element,

[0019] - where the prosthesis body also includes a wrapper that covers the outer contour of both the front and back elements so that it keeps both elements together, allowing the hollow interior space of the prosthesis body to be encapsulated and simulating part of the cornea of ​​the user's eye.

[0020] In the present invention, the prosthesis body has a hollow interior space delimited by the anterior and posterior elements and encapsulated by the sheath that covers the contour of both the anterior and posterior elements, and which simultaneously holds both elements together. The posterior element replicates a portion of the user's inner ocular rim formed wholly or partially by residual tissue that posteriorly delimits the anophthalmic cavity, or by an ocular implant that occupies part of said anophthalmic cavity.

[0021] Thanks to the aforementioned enclosure, the hollow interior space is completely isolated from the outside, providing the necessary sanitary guarantees for this type of prosthesis. Furthermore, the claimed configuration allows for a considerable reduction in the prosthesis's weight compared to prior art prostheses. This significantly reduces the effects of gravity on the user's lower eyelid, preventing its deterioration.

[0022] Another advantage of the claimed prosthesis is that it is safer to use in aquatic environments where the user is in less stable physical positions to maintain the prosthesis in its proper position, making it quite common for the prosthesis to fall. In these environments, the claimed prosthesis is easy to locate if it falls, since its low weight provides it with high buoyancy.

[0023] According to one embodiment, the above element is obtained by molding using a first portion of a mold and subsequently emptying a molded piece to form a concave cavity.

[0024] In the present invention, the concave profile of the anterior element of the prosthesis body is obtained by casting a molded piece obtained by means of a first mold portion that reproduces or copies a part of the user's anophthalmic cavity.

[0025] The molded piece is preferably emptied manually, with a suitable tool for emptying, for example, a mini drill, hand scrapers or molding tools, thus obtaining a front element with a concave internal profile and a convex external profile that reproduces the convexity of the cornea of ​​the human eye.

[0026] According to one embodiment, the posterior element is also obtained by molding using a second mold portion that replicates a posterior portion of the user's inner ocular rim. The concave cavity of the anterior element is filled with a filler material, and a non-stick element is provided to prevent the material of the anterior element from directly contacting the molding material of the posterior element when the mold is closed. This filler material is discarded when the mold is opened. According to this embodiment, the posterior element of the prosthesis body is also obtained by molding, acting as a lid for the cavity of the anterior element. Both the anterior and posterior elements are positioned with their ends adjacent, thus defining the final geometry of the prosthesis body with its hollow interior space.

[0027] Preferably, the filler material used to fill the concave cavity of the anterior element is an inorganic polymer, such as silicone, with high inert properties and stability at high temperatures. This ensures it does not react with the anterior element material, so that during molding and polymerization, the filler material does not bond or adhere to the anterior element material. Once the pieces are demolded, the posterior and anterior elements, along with the filler material, are obtained separately. The filler material can then be discarded, resulting in a prosthesis body that is hollow inside.

[0028] According to one embodiment, the aforementioned element comprises a component that simulates the iris and pupil of the user's eye. However, according to other embodiments, the aforementioned element of the prosthesis may lack elements that simulate the iris or pupil of the user's eye. For example, it may comprise elements that simulate other types of representations.

[0029] Preferably, the iris-simulating component consists of a transparent PMMA silicone disc with an integrated support depicting the user's actual iris and pupil. This support can preferably be made of paper, cardboard, or plastic, on which the iris and pupil of the user's eye are printed, drawn, or otherwise represented. Other representations are possible, such as the use of colors or aesthetic representations that do not depict a typical human eye. This iris-simulating component is integrated into the molding material of the anterior element, positioned on its convex outer surface. It is fully embedded and integrated, preventing the formation of internal pores and / or defects at the joint between the iris component and the anterior element, thus avoiding a connection that could weaken the ocular prosthesis.

[0030] According to another embodiment, the aforementioned element includes a representation that simulates the natural vascularization of the eye, so that the prosthesis acquires greater detail, more realistically simulating the user's natural eye. Preferably, the vascularization is represented with elements that simulate the blood vessels of the eyes. These elements are preferably red silk threads or filaments, although other types of simulation are possible, such as painting the blood vessels directly onto the convex outer surface of the aforementioned element, specifically around the iris, preferably with red paint.

[0031] According to another embodiment, the anterior element, the posterior element of the prosthesis body, and the outer shell are made of acrylic resin. This type of resin has heat-curing properties that allow for a prosthesis with greater strength, adhesion, and dimensional stability. Advantageously, the resin of the anterior and posterior elements of the prosthesis body is acrylic resin with a color additive. This color additive gives the anterior element the natural color of the user's sclera. The color used is usually white, although other colors are possible.

[0032] According to another configuration, the acrylic resin of the anterior and posterior elements of the prosthesis body is transparent resin so that the anterior and posterior elements are made of more natural / pure material reducing the risk of allergies and irritations.

[0033] According to a second aspect, the present invention provides a method for manufacturing the claimed ocular prosthesis. The method comprises the steps of: a) obtaining a mold that copies the anophthalmic cavity of a user's eye, wherein said mold includes a first mold portion that reproduces or copies a part of the user's anophthalmic cavity, and a second mold portion that copies a posterior portion of an inner ocular rim of the anophthalmic cavity, b) obtaining a molded part from the first mold portion, c) hollowing out the molded part from step b) to form the anterior element comprising the concave profile, d) filling the concave cavity of the anterior element with a filler material, e) forming the posterior element using the second mold portion,placing the second mold portion over the filler body and preventing the molding material of the posterior element from directly contacting the material of the anterior element by using a non-stick element when closing the mold, and f) opening the mold to remove the filler body, g) polishing the outer contour of both the anterior and posterior elements to reduce their thickness, h) after step g), placing both the anterior and posterior elements back into the mold so that they define the hollow interior space of the prosthesis body, i) forming the envelope in the mold that covers the outer contour of both elements to hold them together, encapsulate the hollow interior space, and simulate part of the user's cornea.

[0034] In more detail, according to one realization, the manufacturing process includes the following steps;

[0035] - From an impression of the user's anophthalmic cavity to be filled / replaced, a plaster mold is constructed consisting of a first and a second mold portion.

[0036] - Starting from the first portion of the plaster mold, reproduce a piece molded with PMMA material, obtaining a copy / reproduction of the profile and volume of a first part of the anophthalmic cavity.

[0037] - Empty the molded piece, obtaining a front element with a concave internal profile and an external profile with a geometry that reproduces the natural convexity of the user's eye.

[0038] - Insert the previous element with a concave profile into the first portion of the plaster mold.

[0039] - Fill the concave cavity of the previous element with a semi-solid material filler.

[0040] - Add a non-stick element over the edge of the previous element.

[0041] - Add a semi-solid molding material inside the second portion of the plaster mold. This material will not contact the previous element because the non-stick element will have been added in the previous step.

[0042] - Close the plaster mold to form the back element so that the molding material will take on the geometry / profile of the second mold portion.

[0043] - Polymesh the mixture with an increase in pressure and temperature. This stabilizes the semi-solid materials and allows them to take their final shape.

[0044] - Open the mold, and the front element, the back element, and the filler body are removed independently. The filler body can then be discarded.

[0045] - Reduce the thickness of the front and back elements.

[0046] - Replace the lowered front element and the lowered rear element as a lid, inside the mold.

[0047] - Add a molding material for the wrap, covering both the front and back elements, preferably made of transparent material.

[0048] - Apply a second polymerization, so that the shell permanently acquires the geometry of the mold. The front and back elements are permanently joined, encapsulating the hollow interior space.

[0049] - Polish the prosthesis body's outer layer to avoid irritation to the tissue surrounding the eye socket and to achieve a shine that simulates the natural shine of an eye.

[0050] According to one embodiment, a piece simulating the iris and pupil is inserted into the first mold portion during the casting process. Thus, when the cast piece is removed from the mold, the piece simulating the iris and pupil will be adhered to the outer convex surface of the previous element.

[0051] According to another embodiment, after reducing the thickness of the previous element, advantageously, some threads or filaments of red silk or red paint are added on the convex outer face of the previous element, adjacent to the piece that simulates the iris and pupil, so as to simulate the vascularization of the real eye.

[0052] Thanks to this manufacturing process, a prosthesis body can be obtained that has a hollow interior space delimited by the anterior and posterior elements. Since both anterior and posterior elements are encapsulated by a transparent envelope, both elements remain joined, so that the hollow interior space is completely isolated from the outside, offering the necessary health guarantees for this type of prosthesis.

[0053] Another advantage of the manufacturing process is that it allows for an ocular prosthesis with a considerably lower weight compared to state-of-the-art prostheses, thus significantly reducing the effects of gravity on the user's lower eyelid and preventing its deterioration.

[0054] Brief description of the figures

[0055] For a better understanding of what has been explained, some drawings are included which, schematically and only as a non-limiting example, represent a practical case of implementation.

[0056] Figure 1 shows a plan view of an embodiment of the ocular prosthesis that is the subject of the present invention.

[0057] Figure 2 shows an elevation view of the realization of Figure 1.

[0058] Figure 3 shows the ocular prosthesis of the realization of Figure 1 positioned within the eye cavity of a user.

[0059] Figure 4 shows a plan view of an eye that includes the ocular prosthesis of Figure 1, in which the internal position of the prosthesis body in relation to the user's eye has been indicated with dashed lines.

[0060] Figure 5 shows a cross-section of the front element, the back element, and the piece that simulates the iris and pupil of the user's eye separately. The wrapping that covers the outer contour of both the front and back elements is not shown.

[0061] Figure 6 shows a cross-section of the elements shown in Figure 5, but together, defining the hollow interior space. This figure also does not show the outer shell that covers the exterior contour of both the front and rear elements.

[0062] Figure 7 shows a cross-section of the ocular prosthesis in Figure 1, showing the anterior element, the posterior element, and the envelope, encapsulating the hollow interior space.

[0063] Figure 8 shows the manufacturing steps for the previous element of the ocular prosthesis shown in Figure 1.

[0064] Figure 9 shows a cross-section of a mold in which the rear element of the embodiment of Figure 1 has been molded, using as support the front element, the filler body and the non-stick element.

[0065] Figure 10 shows the demolding of the front and rear elements of the mold in Figure 9.

[0066] Figure 11 shows a cross-section of the mold in Figure 9, which shows the molding of the envelope that covers the entire outer contour of the prosthesis, so that the anterior and posterior elements are joined and encapsulate the hollow interior space.

[0067] Description of a preferred embodiment

[0068] A preferred embodiment of the ocular prosthesis of the present invention is described below, with reference to Figures 1 to 11.

[0069] The implementation of the ocular prosthesis 1 described comprises a prosthesis body, comprising a hollow interior space “e” delimited by;

[0070] - a front element 2 with a concave profile configured to totally or partially simulate the sclera of the user's eye, and

[0071] - a rear element 3 configured so that it copies a rear portion of a user's inner eye rim and acts as a lid for the front element 2, and

[0072] - where the prosthesis body also includes a wrapper 6 that covers the outer contour of both anterior 2 and posterior 3 elements so that it keeps both elements together, allowing the hollow interior space “e” of the prosthesis body to be encapsulated and simulating part of the cornea of ​​the user's eye.

[0073] In the described embodiment, the envelope 6 is made of transparent resin, so the previous element 2 remains visible.

[0074] To more realistically simulate the user's eye, the ocular prosthesis 1 is equipped with a component 5 that simulates the iris and pupil of a user, and filaments 7 that simulate the natural vascularization of the eye. In this embodiment, the filaments 7 are made of red silk, which are positioned on the anterior component 2 during the manufacturing process, adjacent to component 5. Other types of representation are possible, such as a painted representation on the anterior component 2.

[0075] Figure 2 shows a side elevation view of the claimed prosthesis, illustrating the profile that defines the anterior and posterior elements. Specifically, the profile of the posterior element corresponds to a copy of a posterior portion of the user's inner ocular rim, which posteriorly delimits the user's anophthalmic socket.

[0076] As shown in figures 3 and 4, piece 5, which simulates the iris and pupil, is positioned on the convex face of the anterior element 2. Once the prosthesis is in its position of use, this piece 5, the filaments 7, and part of the anterior element 2 are the visible part of the prosthesis.

[0077] In some cases, as shown in Figure 3, when the loss of the eyeball is total or considerable, the internal volume is reconstructed with the aid of an ocular implant “I”. In this case, the profile of the posterior element is adapted to an inner ocular rim formed by at least part of the ocular implant “I”. In the same Figure 3, it can be seen how the ocular prosthesis 1 is positioned and occupies, totally or partially, the anophthalmic cavity existing between the anterior area of ​​the ocular implant “I” and the eyelids of the user “P”.

[0078] Figure 4 shows a front view of a user's eye. The user's eyelids “P” partially enclose the ocular prosthesis 1, helping to hold it in its wearing position. Figure 4 shows part of the prosthesis body visible, specifically a portion of the anterior element that simulates the sclera of the user's eye, part of the envelope that simulates part of the cornea, the filaments 7, and piece 5 that simulates the iris and pupil. The dashed lines show the profile of the portion of the prosthesis that remains inside the user's eye socket and is not visible.

[0079] Figure 5 shows an elevation section of the front element 2 and the rear element 3, where the two elements are separated. The profile of the front element 2 consists of a concave inner face and a convex outer face that simulates the convexity of the user's eye, while the profile of the rear element 3 is configured to reproduce a posterior portion of the user's inner ocular rim. Figure 5 also shows a section of part 5 that simulates the iris and pupil of the eye.

[0080] Figure 6 shows a section of the anterior element 2 in contact with the posterior element 3, thus defining the hollow interior space “e” of the prosthesis body. Also shown is part 5, embedded in the anterior element 2, specifically on its convex outer surface, so that part 5 will also be a visible part of the ocular prosthesis 1.

[0081] Figure 7 shows a section of the prosthetic body of the described embodiment, in which the anterior element 2 and the posterior element 3 are in contact, defining the hollow interior space “e”, and the envelope 6 covers the entire outer contour of both the anterior and posterior elements, thus holding them together and encapsulating the hollow interior space “e”. In this way, a prosthetic body is constructed that is hollow on the inside and closed, isolating the hollow interior space “e” from the outside to prevent any leakage. The envelope 6 is preferably made of transparent material, allowing the iris-like piece 5, part of the anterior element 2, and the filaments 7 to be visible, even though they are covered by the envelope 6. Alternatively, in some cases, the envelope 6 may be colored and not transparent.

[0082] The manufacturing method for making the ocular prosthesis 1 described below is shown in Figures 8 to 11.

[0083] As discussed in the description of the invention, the rear element 3, the front element 2 and the envelope 6 are obtained by molding using a first mold portion M1 and a second mold portion M2, which are obtained from a previous impression of the anophthalmic cavity to be recovered from the user.

[0084] Figure 8 shows the steps for manufacturing the previous element 2 of conical profile. This is obtained by molding using the first mold portion “M1”, and subsequently pouring a molded piece “PM” to form a concave cavity “C”.

[0085] Subsequently, as shown in Figure 9, the posterior element 3 is also obtained by molding using a second mold portion “M2” that copies a posterior portion of the inner ocular rim that posteriorly delimits the user's anophthalmic cavity. For this purpose, the concave cavity “C” of the anterior element 2 is filled with a filler material 8, and then a non-stick element 9 is placed to prevent the material of the anterior element 2 from coming into direct contact with the molding material of the posterior element 3 when the mold is closed.

[0086] Figure 10 shows the separate demolding of the rear element 3, the filler body 8, and the front element 2, with the filler body 8 being discarded. During molding and subsequent polymerization, the front element 2 and the rear element 3 permanently acquire their final geometry, taking on the geometry of the adjacent elements. The filler body 8 is preferably made of silicone, which, due to its inert and stable properties, does not adhere to the inner surface of the front element 2 and can be demolded independently.

[0087] Figure 11 shows a section of the ocular prosthesis body being described, at the moment when the shell 6 is being molded. Before molding the shell 6, the thickness of the anterior element 2 is reduced to allow for the application of the shell 6, which, after further polymerization, adopts the external geometry of the mold. The shell 6 holds the anterior element 2 and posterior element 3 together, encapsulating the hollow interior space “e” and isolating it from the exterior, thus ensuring the necessary hygienic conditions.

[0088] In summary, the present invention provides a prosthesis body comprising a hollow interior space “e”, delimited by the anterior element 2, which has a concave profile and simulates, totally or partially, the sclera of the user's eye, and the posterior element 3, which acts as a cover for the anterior element 2. The prosthesis body includes a shell 6 that covers the outer contour of both the anterior and posterior elements, holding them together and encapsulating the hollow interior space of the prosthesis body. Furthermore, the shell 6 simulates part of the cornea of ​​the user's eye.

[0089] It has been observed that, advantageously, an ocular prosthesis body with a hollow interior space allows for ocular prostheses with reduced weight and high buoyancy, so that in aquatic environments it is easy to recover it in case of a fall.

[0090] Although reference has been made to a specific embodiment of the invention, it is evident to a person skilled in the art that the described ocular prosthesis is susceptible to numerous variations and modifications, and that all the details mentioned can be substituted by technically equivalent ones, without departing from the scope of protection defined by the attached claims.

Claims

CLAIMS 1. Ocular prosthesis (1) for replacing a part of a user's eye, comprising a prosthesis body, characterized in that said prosthesis body comprises a hollow inner space (e) delimited by; - a front element (2) with a concave profile configured to totally or partially simulate the sclera of the user's eye, and - a rear element (3) configured so that it copies a rear portion of a user's inner eye rim and acts as a lid for the front element (2), and - where the prosthesis body also includes a wrap (6) that covers the outer contour of both the front (2) and back (3) elements so as to keep both elements together, allowing the hollow interior space (e) of the prosthesis body to be encapsulated and to simulate part of the cornea of ​​the user's eye.

2. Ocular prosthesis (1) according to claim 1, wherein the previous element (2) is obtained by molding using a first mold portion (M1), and subsequently emptying a molded piece (PM) to form a concave cavity (C).

3. Ocular prosthesis (1) according to claim 2, wherein the posterior element (3) is also obtained by molding using a second mold portion (M2) that copies a posterior portion of the inner ocular rim of the user's anophthalmic cavity, filling the concave cavity (C) of the anterior element (2) by means of a filler body (8), and providing a non-stick element (9) to prevent the material of the anterior element (2) from coming into direct contact with the molding material of the posterior element (3) when closing the mold, said filler body (8) being susceptible to being discarded when opening the mold.

4. Ocular prosthesis (1) according to any of claims 1 to 3, wherein the above element (2) comprises a piece (5) that simulates the iris and pupil of the user's eye.

5. Ocular prosthesis (1) according to claim 4, wherein the piece (5) simulating the iris and pupil is integrated into the molding material of the previous element (2), positioned on the convex outer part of the previous element (2).

6. Ocular prosthesis (1) according to any of claims 1 to 5, wherein the foreelement (2) comprises filaments (7) that simulate the natural vascularization of the eye.

7. Ocular prosthesis (1) according to claim 6, wherein the filaments (7) that simulate the natural vascularization of the eye are silk threads.

8. Ocular prosthesis (1) according to any of the preceding claims 1 to 5, wherein the preceding element (2) is provided with a paint-based representation that simulates the natural vascularization of the eye.

9. Ocular prosthesis (1) according to any of the preceding claims, wherein the anterior (2) and posterior (3) elements of the prosthesis body and the casing are made of acrylic resin.

10. Ocular prosthesis (1) according to claim 9, wherein the acrylic resin of the anterior (2) and posterior (3) elements of the prosthesis body is transparent.

11. Ocular prosthesis (1) according to any of claims 9 or 10, wherein the acrylic resin is provided with a color additive.

12. A method for manufacturing an ocular prosthesis (1) according to any of claims 1 to 11, comprising the steps of: a) obtaining a mold that copies the anophthalmic cavity of a user's eye, wherein said mold includes a first mold portion that reproduces or copies a part of the user's anophthalmic cavity, and a second mold portion that copies a posterior portion of an inner ocular rim of the anophthalmic cavity, b) obtaining a molded part from the first mold portion, c) hollowing out the molded part from step b) to form the anterior element comprising the concave profile, d) filling the concave cavity of the anterior element with a filler body, e) forming the posterior element using the second mold portion,placing the second portion of the mold over the filler body and preventing the molding material of the posterior element from directly contacting the material of the anterior element by using a non-stick element when closing the mold, and f) opening the mold to remove the filler body, g) polishing the outer contour of both the anterior and posterior elements to reduce their thickness. h) after step g), placing both the anterior and posterior elements back into the mold so that they define the hollow interior space of the prosthesis body, i) forming in the mold the envelope that covers the outer contour of both elements to hold both elements together, encapsulate the hollow interior space, and simulate part of the cornea of ​​the user's eye.

13. Method for manufacturing an ocular prosthesis (1) according to claim 12, comprising, prior to step b, introducing into the first portion of the mold, a piece that simulates the iris and the pupil.

14. Method for manufacturing an ocular prosthesis (1) according to claim 12, comprising, prior to step b, adding red silk threads or filaments or paint to the convex outer face of the anterior element, so as to simulate the vascularization of the real eye.

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