Staphyloma support device and method for correcting axial length and curvature of the eyeball

Abstract

Surgical implants and methods are provided to help improve, support, or maintain vision by modifying the axial length or curvature of the eye. The staphyloma support device or implant can be monolithically constructed from a single substrate, such as a titanium alloy, and can have a larger macular depressor plate than the implant body and a larger anchor structure than the macular depressor plate. The synthetic concave scleral contact surface can approximate the outer surface of the eye with an anterior radius of curvature and can restore the macular shape and axial length with a second posterior radius of curvature that can be smaller than the anterior radius of curvature.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 200,189, filed February 19, 2021, the entire contents of which are incorporated by reference, including any figures, tables, nucleic acid sequences, amino acid sequences, or drawings. [Background technology]

[0002] In myopia (nearsightedness), the length of the eye increases from front to back (anteroposterior AP). The AP length of the eye is normally 22 to 24 mm (average 23 mm). A 1 mm increase results in a 3 diopter increase in refractive error. In addition to refractive error, if the AP length is longer than normal, the contents of the eye expand to fit the larger space created inside. One structure inside the eye that ultimately expands and fits is the retina. The retina is the inner nerve layer that creates and sends images to the brain. The retina covers the inside of the back of the eye, like wallpaper covering the interior walls of a house. If the eye wall bulges back, the inner retina can widen and form a hole (myopic macular hole) or split in that layer (myopic macular schisis) in the middle or central part of the retina, also called the macula. Macular holes can occur in eyes of normal length. Surgical treatment for macular holes involves the placement of intraocular gas with a procedure called a vitrectomy to close the hole. In high myopia, the retina is so stretched that the hole does not close easily. Extraocular implants have been designed to be pushed in from the outside of the eye, but their bulk and complexity have limited their usefulness. Pushing the eye from the outside using surgical techniques or implants can help correct myopic macular schisis and myopic macular holes.

[0003] A normal eyeball is round and / or spherical in nature. The majority of the human population has a spherical ball size with a diameter ranging from 22 mm to 24 mm. At the front of the eyeball, the cornea and natural lens focus the image onto the retina. If the eyeball is too long (e.g., longer than 24 mm), the anterior structures may focus the image in front of the macula, and the image on the retina may be blurred. Placing eyeglasses in front of the eyeball or cutting and reshaping the cornea with a laser (e.g., laser in situ keratomileusis, LASIK) changes the refractive power of the front of the eyeball, placing the image on the macula. Diagnostic tests can measure the refractive error and diameter of the eyeball (e.g., the anterior-posterior or axial length of the eyeball). Refractive error is measured with eyeglasses or simple refraction with an autorefractometer.

[0004] High myopia has a prevalence of 1.7-2% in the general population in the United States and is particularly common in Asia. In Japan, high myopia is reported to affect 6-18% of the myopic population and 1-2% of the general population.

[0005] Myopia is reported to be the most common eye disorder worldwide and a leading cause of visual impairment in children, with its incidence increasing rapidly. In 2010, an estimated 1.9 billion people (27% of the world's population) were myopic, of which 70 million (2.8%) were highly myopic. These figures are predicted to rise to 52% and 10%, respectively, by 2050.

[0006] Myopia is a major public health concern in many East Asian countries, affecting 80%-90% of high school graduates. Of these individuals, 10%-20% have pathological myopia, which can lead to blindness.

[0007] Myopia-related vision impairment has a significant economic impact and a significant impact on quality of life in terms of patients' physical, emotional, and social functioning. Scientists estimate that the global productivity loss caused by uncorrected myopic refractive error in 2004 was 268.8 billion international dollars, and the cost of addressing this problem was 28 billion US dollars.

[0008] Pathologic myopia (prevalence 0.9%–3.1%) is particularly devastating, resulting in an increased risk of cataract development, retinal detachment, glaucoma, and even blindness. The prevalence of choroidal neovascularization in affected individuals is reported to be 5.2%–11.3%, and macular holes can occur in 6%–8% of patients. The peripapillary region becomes distorted by mechanical stretching of the globe in patients with increased axial length, which can lead to glaucoma and visual field loss. The rapidly increasing incidence of myopia, coupled with its significant societal and economic burden, has prompted research into causative factors, potential treatments, and prevention efforts. Summary of the Invention [Means for solving the problem]

[0009] In one aspect, the present invention provides a single rigid ocular surgical implant or uveal support device for improving a patient's vision by restoring the natural curvature and natural axial length of the eye. The eye, like a ball, has a convex outer scleral surface (its central or lateral region can be referred to as the equator of the eye) and a concave inner surface. The implant can have a plate with a concave scleral mating surface configured to restore the natural curvature of the posterior portion of the eye, an anchor with a concave scleral mating surface configured to approximate the natural curvature of the more anterior portion of the eye, and a body with a continuous, smooth, concave scleral mating surface connecting the plate to the anchor. The implant can have a total implant length that is less than the natural axial length of the eye. The width of the body can be less than the width of the plate and less than the width of the anchor. The width of the anchor can be greater than the width of the plate and the width of the body. In some embodiments, the plate thickness, body thickness, and anchor thickness are each uniform and approximately equal.

[0010] In another aspect, the present invention provides an anchor having a first anchor point at the center of the body, a second anchor point on a side of the body forward of the first anchor point, and a third anchor point on a side of the body forward of the first anchor point, such that a straight line cannot pass between the first anchor point, the second anchor point, and the third anchor point. The anchor can also include a first arm connecting the second anchor point to the body and having a first arm width less than the body width and a first arm length less than the body length, and a second arm connecting the third anchor point to the body and having a second arm width less than the body width and a second arm length less than the body length. The first arm and the second arm can form a symmetrical Y-shape about the body.

[0011] Alternatively, the present invention provides an anchor having a first anchor point at the center of the body, a second anchor point on a side of the body rearward of the first anchor point, and a third anchor point on a side of the body rearward of the first anchor point, such that a straight line cannot pass between the first anchor point, the second anchor point, and the third anchor point. The anchor may also include a first arm connecting the second anchor point to the body and having a first arm width smaller than the body width and a first arm length smaller than the body length, and a second arm connecting the third anchor point to the body and having a second arm width smaller than the body width and a second arm length smaller than the body length. The first arm and the second arm may form a symmetrical Y shape about the body.

[0012] Alternatively, the anchor can include one or more circular, ring-shaped, arcuate, polygonal, triangular, rectangular, square, pentagonal, hexagonal, asymmetric, symmetric, lobed, or irregularly shaped arms, or arms connecting one or more anchor points to the body. In certain embodiments, the width of the anchor arm can be the same as, less than, or greater than the width of the body.

[0013] In certain embodiments, the second anchor point on the side of the body and the third anchor point on the side of the body are on opposite sides of the body. In certain embodiments, the second anchor point on the side of the body and the third anchor point on the side of the body are on the same side of the body. In certain embodiments, a second anchor point at the center of the body and a third anchor point on the side of the body are provided. In certain embodiments, a second anchor point at the center of the body and a third anchor point at the center of the body are provided. Certain embodiments can be provided without a first anchor point or with a first anchor point that is not at the center of the body, and in such embodiments, specific references herein to a first anchor point can instead apply to a lateral, medial, or other specific point on the body (e.g., the intersection of the midlines of two anchor arms, or the point formed by the intersection of the outer surfaces from each of two respective anchor arms, or the point formed by the intersection of an anchor arm with the implant body).

[0014] In any of the above embodiments, the anchor points can be defined, positioned, required, or measured so that a straight line cannot pass between the first anchor point, the second anchor point, and the third anchor point. Alternatively, the anchor points can be defined, positioned, required, or measured so that a straight line can pass between the first anchor point, the second anchor point, and the third anchor point. In certain embodiments, the reference line can be defined, positioned, required, or measured so that it passes through or does not pass through any portion of the diameter, length, or width (as appropriate) of each anchor point. Alternatively, the reference line can be defined, positioned, required, or measured so that it passes through or does not pass through the center, origin, or base (as appropriate) of each anchor point.

[0015] In yet another aspect, the present invention provides a rigid unitary implant of constant or variable thickness having a concave scleral contact surface that progresses from a first radius of curvature along the posterior macular indenter to an advantageously larger second radius of curvature at the anterior scleral anchor with a smooth tangential transition therebetween, wherein the first radius provides a smoother, more aggressive correction to restore the natural length and / or shape of the eye, and the second radius provides improved conformity to the anterior surface of the eye, with the smooth tangential transition providing a more natural alignment of the outer surface of the eye between the two curvatures.

[0016] Alternatively, the second radius of curvature at the anterior scleral anchor can be smaller than the first radius of curvature along the posterior macular indenter, advantageously, the first radius provides a gentler correction to restore the natural length and / or shape of the eyeball, the second radius provides improved mating to the anterior surface of the eyeball, and a smooth tangential transition provides a more natural alignment of an outer surface of the eyeball between the two curvatures.

[0017] The smooth tangential transition can occur at any point along the body of the implant (e.g., proximal to the plate, 1 / 3 of the arcuate distance from the plate to the anchor, 1 / 2 of the arcuate distance from the plate to the anchor, 2 / 3 of the arcuate distance from the plate to the anchor, proximal to the anchor, or any fractional amount in between; e.g., anterior to the scleral fixation point where the body can be pre-attached to the scleral tissue, while posterior to the scleral fixation point or proximal to the scleral fixation point where AP adjustment of the implant allows the eye to recover).

[0018] Alternatively, the second radius of curvature at the anterior scleral anchor can be equal to the first radius of curvature along the posterior macular indenter, with equal radii advantageously providing a more natural fit along the exterior surface of the sclera, simplifying surgical implantation, and improving ease of manufacture.

[0019] In yet another aspect, the present invention provides a method for surgical fixation of a rigid, curved staphyloma support device 3 mm to 10 mm posterior to the limbus in the inferior or superior temporal quadrant of the eye at a desired location, with the implant's concave scleral mating surface in close contact with the scleral surface of the eye beneath the conjunctiva, to restore a more natural curvature and a more natural axial length of the eye.

[0020] The placement of an implant according to the teachings of the present invention for the purpose of increasing the success rate of macular hole closure in highly myopic eyes has many advantages. The present invention shortens the eyeball and corrects refractive error. In the case of myopic macular schisis, certain embodiments can reduce the schisis of existing layers and inhibit the formation of new schisis. While macular holes and schisis are relatively rare conditions (in both myopic and normal eyes), myopia is very common. It is estimated that there are approximately 24 million people in the United States with myopia of -6.00 diopters or greater (referred to as high myopia).

[0021] The implant of the present invention can shorten the AP length of the eye, reducing it from -6.00 diopters or more to near-normal. Even with an AP length of 30 mm or more, some patients are highly myopic. One goal of surgery to place an implant in a highly myopic eye is to correct the axial length. Addressing the need for eyeglasses (e.g., no eyeglasses or thinner eyeglasses after surgery) can make the patient eligible for LASIK surgery for residual refractive error (some patients are not eligible for LASIK surgery if the need for diopter correction is too high, as they may not be able to tolerate the corneal tissue removed using LASIK).

[0022] There are also complications other than macular holes and macular schisis that can occur in patients with high myopia due to excessive retinal expansion within the eye, including retinal neovascular membranes and an increased tendency for retinal detachment. These are serious complications that can result in legal or total blindness. Placement of the implant of the present invention to halt or reduce the elongation of the eye has many beneficial effects. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 shows a three-dimensional view of one embodiment of a single rigid ophthalmic surgical implant according to the present invention. [Figure 2] 1 shows a three-dimensional view of an eye treated with an embodiment of an implant according to the present invention that restores the natural curvature and natural axial length of the eye. [Figure 3A-B] 1A and 1B show top and side views of one embodiment of an implant according to the present invention. [Figure 4] 1 shows an eyeball with normal shape and normal refraction, and an elongated eyeball exhibiting myopia due to axial elongation of the eyeball that can be treated by the implants and methods of the present invention. [Figure 5] 1 shows a top perspective view of one embodiment of an implant according to the present invention. [Figures 6A-E] 1A-1C show a top view, an end view, and four cross-sectional views of one embodiment of an implant according to the present invention. [Figure 7] 1 shows a perspective view of one embodiment of an implant according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0024] Embodiments of the present invention provide an implant (e.g., a single rigid ophthalmic staphyloma support device surgical implant) for improving a patient's vision (e.g., by restoring the natural curvature and / or natural axial length of the eye). The implant can include a plate having a concave scleral-matching surface (e.g., a surface configured to restore the natural curvature of the posterior portion of the eye), an anchor having a concave scleral-matching surface (e.g., a surface configured to approximate the natural curvature of the anterior portion of the eye), and a body having a surface (e.g., a continuous, smooth concave scleral-matching surface) connecting the plate to the anchor.

[0025] The restored eye can have a natural linear axial length (e.g., the natural axial length of the eye between 22 mm and 24 mm), and the implant can have a total implant linear length (e.g., measured in a straight line from the posterior end of the implant to the anterior end of the implant) that is less than the natural axial length of the eye (e.g., less than 26 mm, or less than 25.5 mm, or less than 25 mm, or less than 24.5 mm, or less than 24 mm, or less than 23.5 mm, or less than 23 mm, or less than 22.5 mm, or less than 22 mm, or less than 21.5 mm, or less than 21 mm, or less than 20.5 mm, or less than 20 mm, or less than 19.5 mm, or less than 19 mm, or less than 18.5 mm, or less than 18 mm, or any increment of the foregoing).

[0026] Pre-operatively, the restored eye may be deformed, measured, and have a pre-operative axial length (and the implant may have an overall implant linear length that is less than the deformed axial length of the eye). Post-operatively, the restored eye may have a restored axial length (and the implant may have an overall implant linear length that is less than the restored axial length of the eye, or is less than the pre-operative or post-operative measured axial length of the eye).

[0027] In certain embodiments, the deformed axial length of the eye can be measured pre-operatively and / or intra-operatively, and the implant can be selected to have a total implant linear length that is less than 99% of the deformed axial length of the eye, or less than 95% of the deformed axial length of the eye, or less than 90% of the deformed axial length of the eye, or less than 85% of the deformed axial length of the eye, or less than 80% of the deformed axial length of the eye, or less than 75% of the deformed axial length of the eye, or less than 70% of the deformed axial length of the eye, or any increment of the foregoing.

[0028] In certain embodiments, the deformed axial length of the eye can be measured pre-operatively and / or intra-operatively to determine a desired corrected axial length of the eye, and the implant can be selected to have a total implant linear length that is less than 99% of the desired axial length of the eye, or less than 95% of the desired axial length of the eye, or less than 90% of the desired axial length of the eye, or less than 85% of the desired axial length of the eye, or less than 80% of the desired axial length of the eye, or less than 75% of the desired axial length of the eye, or less than 70% of the desired axial length of the eye, or any increment of the foregoing.

[0029] Any suitable biocompatible implant material can be used to form certain embodiments of the present invention. Polymers, including but not limited to, ultra-high molecular weight polyethylene (UHMWP), high-density polyethylene (HDP), polymethyl methacrylate (PMMA) or other methacrylates, silicone (polysiloxane), or VICRYL® (Polyglactin 910), can be used as the primary material, coating, cover, cushion, mesh, bag, or liner in accordance with certain embodiments of the present invention. When the implant comprises a metallic material, suitable metals can include surgical-grade stainless steel (e.g., 316L), cobalt-chromium (Co-Cr) alloy, pure commercial or surgical-grade titanium (Ti), nickel-titanium alloy (nitinol), or other titanium alloys. Other metals, such as gold, platinum, silver, iridium, tantalum, and tungsten, can be used. Metals can be used as the primary material, coating, cover, or liner in accordance with certain embodiments of the present invention. Implants can be completely or partially metallic, bimetallic (e.g., composed of two different metals), or non-metallic. Surface coatings such as titanium dioxide or anodized finishes can be advantageously used. Ceramics including aluminum oxide, calcium hydrogen phosphate, zirconium oxide (zirconia), and silicon oxide (silica) can be used. Ceramics can be used as primary materials, coatings, covers, or liners in accordance with certain embodiments of the present invention. Natural or synthetic biological materials, including autografts, allografts, xenografts, synthetic tissue substitutes, and cultured or engineered tissues or tissue substitutes, can be advantageously used as primary materials, coatings, covers, cushions, meshes, bags, or liners in accordance with certain embodiments of the present invention.Biological materials may also be used in conjunction with certain embodiments of the present invention; for example, biological tissue or tissue replacement implants (e.g., Tutoplast Sclera, Pericardium, or Fascia Lata; AMBIO2® Amniotic Membrane; or TARSYS™ Bioengineered Eyelid Spacer Implant, all available from Katena, Parsippany, New Jersey) may be placed between the implant and the sclera of the eye to augment or protect natural tissue, or to provide a barrier between adjacent tissues and / or a pathway for guided regeneration over, across, or adjacent to the implant.

[0030] In some embodiments, a combination of materials can be advantageously used (e.g., a strong inner member with a soft outer protective coating or a biocompatible coating). A single material or design can offer advantages in cost, reduced risk of side effects, manufacturability, robustness, ease of manufacture, and ease of use. Biocompatibility, strength-to-size ratio, strength-to-weight ratio, longevity, fracture resistance, cost, availability, and manufacturability can all affect the usefulness of a given material in a particular embodiment.

[0031] It is important to the simplified design and function of certain embodiments of the present invention that the implant have sufficient structural rigidity to correct and restore the natural curvature and / or axial length of the eye without resorting to complex insertion or fixation procedures, complicated mechanisms, or excessive tension or deformation within the implant itself. One example of a material suitable for application in certain embodiments of the present invention is titanium, which has a long history of biocompatibility, is used in surgical implants, and has a high strength-to-weight ratio, a high size-to-weight ratio, and structural rigidity.

[0032] Stiff or high strength materials (e.g., titanium or titanium alloys, stainless steel, or other metallic or ceramic materials) have a high modulus of elasticity (e.g., 105 gigapascals (GPa) to 120 GPa for certain titanium alloys, Ti-6Al-4V The elastic modulus may have a modulus of elasticity of 113.8 GPa for ELI (Grade 23), annealed titanium alloy, or 193 GPa for 316 stainless steel, annealed bar, and certain other rigid or high-strength materials having a modulus above or below these exemplary values), compared to semi-rigid or medium-strength materials (e.g., polymers such as polymethyl methacrylate (PMMA) or other suitable methacrylates or biocompatible polymers may have a modulus of elasticity in the range of 2.4 GPa to 3.4 GPa, and certain other semi-rigid or medium-strength materials having a modulus above, between, or below these exemplary values), or compared to flexible, soft, or lower-strength materials (e.g., silicone rubber may have a modulus of elasticity in the range of 0.00000500 GPa to 1.90 GPa, and certain other flexible, soft, or lower-strength materials having a modulus above, between, or below these exemplary values), which may offer the advantage of being thin, lightweight, and meeting the strength and stiffness requirements for restoring the natural curvature and axial length of the eye.

[0033] In certain embodiments, the entire implant can be advantageously made of one or more materials (e.g., titanium, titanium alloys, stainless steel, other suitable metals, PMMA, or other biocompatible polymers) having an elastic modulus of greater than 105 GPa, or greater than 1.9 GPa, greater than 2 GPa, greater than 2.4 GPa, greater than 3.4 GPa, greater than 4 GPa, greater than 5 GPa, greater than 10 GPa, greater than 20 GPa, greater than 30 GPa, greater than 40 GPa, greater than 50 GPa, greater than 60 GPa, greater than 70 GPa, greater than 80 GPa, greater than 90 GPa, greater than 100 GPa, greater than 110 GPa, greater than 120 GPa, greater than 130 GPa, greater than 140 GPa, greater than 150 GPa, greater than 200 GPa, greater than 250 GPa, greater than 300 GPa, greater than 400 GPa, or greater than 500 GPa.

[0034] In certain embodiments, the pressure is 105 GPa or less, or less than 1.9 GPa, less than 2 GPa, less than 2.4 GPa, less than 3.4 GPa, less than 4 GPa, less than 5 GPa, less than 10 GPa, less than 20 GPa, less than 30 GPa, less than 40 GPa, less than 50 GPa, less than 60 GPa, less than 70 GPa, less than 80 GPa, less than 90 GPa, less than 100 GPa, or less than 110 GPa. In this case, the entire implant can be advantageously made of one or more materials (e.g., titanium, titanium alloys, stainless steel, other suitable metals, PMMA, siloxane, silicone, or other biocompatible polymers) having an elastic modulus of less than 120 GPa, less than 130 GPa, less than 140 GPa, less than 150 GPa, less than 200 GPa, less than 250 GPa, less than 300 GPa, less than 400 GPa, or less than 500 GPa.

[0035] In certain embodiments, implants can be advantageously fabricated from two or more materials (e.g., including a primary material and a coating) (e.g., a titanium alloy as the primary material and silicone as the secondary material), where the difference in modulus of elasticity between the two materials is greater than 1 GPa, greater than 2 GPa, greater than 3 GPa, greater than 4 GPa, greater than 5 GPa, greater than 6 GPa, greater than 7 GPa, greater than 8 GPa, greater than 9 GPa, greater than 10 GPa, greater than 20 GPa, greater than 30 GPa, greater than 40 GPa, greater than 50 GPa, greater than 60 GPa, greater than 70 GPa, greater than 80 GPa, greater than 90 GPa, greater than 100 GPa, greater than 200 GPa, greater than 300 GPa, greater than 400 GPa, or greater than 500 GPa (e.g., a titanium alloy as the primary material and silicone as the secondary material). When used, the titanium can be pure titanium or a titanium alloy, and can be used in its natural state, coated with titanium oxide, anodized, plated, or otherwise coated. In certain embodiments, the substrate may be covered, coated, plated, sheathed, or encased with a secondary material. Suitable secondary materials and treatments for use in certain embodiments may include silicone resins, ceramic coatings, and polymer coatings. Secondary materials and surface finishes may range in thickness from less than 1 micrometer to providing the majority of the thickness of the finished or coated implant and may include bags, meshes, or other coverings placed over or around all or a portion of the implant. Natural, bare, anodized, oxide, or thinly coated implants may offer advantages in certain embodiments, including ease and simplicity of manufacture, reduced risk of toxicity, and reduced risk of failure. Coated implants may offer advantages in certain embodiments, including improved biocompatibility, cushioning, reduced potential for tissue damage, and improved surface texture on the substrate.

[0036] In certain embodiments, the body can have a body width and the plate can have a plate width, where the body width is greater than half the plate width, where the body width is less than the plate width, or where the body width is greater than one-third the plate width, or greater than two-thirds the plate width, or greater than three-quarters the plate width, or greater than 40% the plate width, or greater than 50% the plate width, or greater than 60% the plate width, or greater than 70% the plate width, or greater than 80% the plate width, or greater than 90% the plate width, or greater than 95% the plate width, or greater than the plate width, or any of the foregoing increments. In certain embodiments, the body width can be less than the plate width, or less than 150% of the plate width, or less than 150% of the plate width, or less than 120% of the plate width, or less than 110% of the plate width, or less than 99% of the plate width, or less than 95% of the plate width, or less than 90% of the plate width, or less than 80% of the plate width, or less than 70% of the plate width, or any of the foregoing increments.

[0037] In certain embodiments, the anchor can have an anchor width that can be greater than the plate width, alternatively greater than 90% of the plate width, alternatively greater than 110% of the plate width, alternatively greater than 120% of the plate width, alternatively greater than 150% of the plate width, alternatively greater than 200% of the plate width, alternatively greater than 250% of the plate width, alternatively greater than 300% of the plate width, alternatively greater than 400% of the plate width, or any of the foregoing increments. In certain embodiments, the anchor width can be less than 5 times the plate width, alternatively less than 4 times the plate width, alternatively less than 3 times the plate width, alternatively less than 2 times the plate width, alternatively less than 450% of the plate width, alternatively less than 350% of the plate width, alternatively less than 250% of the plate width, alternatively less than 150% of the plate width, alternatively less than 120% of the plate width, alternatively less than 110% of the plate width, or any of the foregoing increments.

[0038] In certain embodiments, the plate can have a plate thickness, the body can have a body thickness, the anchor can have an anchor thickness, the plate thickness can be greater than 50% of the body thickness, the plate thickness can be less than 200% of the body thickness, the anchor thickness can be greater than 50% of the body thickness, the anchor thickness can be less than 200% of the body thickness, or any of the aforementioned increments.

[0039] Alternatively, the plate thickness can be greater than 60% of the body thickness, the plate thickness can be greater than 70% of the body thickness, the plate thickness can be greater than 80% of the body thickness, the plate thickness can be greater than 90% of the body thickness, the plate thickness can be greater than 100% of the body thickness, the plate thickness can be greater than 110% of the body thickness, the plate thickness can be greater than 120% of the body thickness, the plate thickness can be greater than 150% of the body thickness, the plate thickness can be greater than 175% of the body thickness, the plate thickness can be greater than 200% of the body thickness, or any of the aforementioned increments.

[0040] Alternatively, the plate thickness can be less than 30% of the body thickness, the plate thickness can be less than 40% of the body thickness, the plate thickness can be less than 50% of the body thickness, the plate thickness can be less than 60% of the body thickness, the plate thickness can be less than 70% of the body thickness, the plate thickness can be less than 80% of the body thickness, the plate thickness can be less than 90% of the body thickness, the plate thickness can be less than 100% of the body thickness, the plate thickness can be less than 110% of the body thickness, the plate thickness can be less than 120% of the body thickness, the plate thickness can be less than 150% of the body thickness, the plate thickness can be less than 175% of the body thickness, the plate thickness can be less than 200% of the body thickness, or any of the aforementioned increments.

[0041] Alternatively, the anchor thickness can be greater than 60% of the body thickness, the anchor thickness can be greater than 70% of the body thickness, the anchor thickness can be greater than 80% of the body thickness, the anchor thickness can be greater than 90% of the body thickness, the anchor thickness can be greater than 100% of the body thickness, the anchor thickness can be greater than 110% of the body thickness, the anchor thickness can be greater than 120% of the body thickness, the anchor thickness can be greater than 150% of the body thickness, the anchor thickness can be greater than 175% of the body thickness, the anchor thickness can be greater than 200% of the body thickness, or any of the aforementioned increments.

[0042] Alternatively, the anchor thickness can be less than 30% of the body thickness, the anchor thickness can be less than 40% of the body thickness, the anchor thickness can be less than 50% of the body thickness, the anchor thickness can be less than 60% of the body thickness, the anchor thickness can be less than 70% of the body thickness, the anchor thickness can be less than 80% of the body thickness, the anchor thickness can be less than 90% of the body thickness, the anchor thickness can be less than 100% of the body thickness, the anchor thickness can be less than 110% of the body thickness, the anchor thickness can be less than 120% of the body thickness, the anchor thickness can be less than 150% of the body thickness, the anchor thickness can be less than 175% of the body thickness, the anchor thickness can be less than 200% of the body thickness, or any of the foregoing increments.

[0043] In certain embodiments, the plate thickness, body thickness, and anchor thickness can each be uniform and approximately equal. Alternatively, the thickness of the implant can vary from the plate, through the body, to the anchor. The thickness can be smaller at the plate, increasing through the body, and larger at the anchor. The thickness can be larger at the plate, decreasing through the body, and smaller at the anchor.

[0044] Alternatively, the plate and anchors can be of uniform thickness while the body is thicker than either the plate or the anchor. Alternatively, the plate and anchors can be of uniform thickness while the body is thinner than either the plate or the anchor.

[0045] Alternatively, the plate and body can be of uniform thickness while the anchor is thicker than either the plate or the body. Alternatively, the plate and body can be of uniform thickness while the anchor is thinner than either the plate or the body.

[0046] Alternatively, the body and anchors can be of uniform thickness while the plate is thicker than either the body or the anchors. Alternatively, the body and anchors can be of uniform thickness while the plate is thinner than either the body or the anchors.

[0047] In certain embodiments, the plate width can be greater than the body width, and the anchor width can be greater than the plate width. Alternatively, the plate width, body width, and anchor width can each be uniform and approximately equal. Alternatively, the implant width can vary from the plate, through the body, to the anchor. The width can be smaller at the plate, increasing through the body, and larger at the anchor. The width can be larger at the plate, decreasing through the body, and smaller at the anchor.

[0048] Alternatively, the plate and anchors can be of uniform width while the body is of a larger width than either the plate or the anchor. Alternatively, the plate and anchors can be of uniform width while the body is of a smaller width than either the plate or the anchor.

[0049] Alternatively, the plate and body can be of uniform width while the anchor is of a larger width than either the plate or the body. Alternatively, the plate and body can be of uniform width while the anchor is of a smaller width than either the plate or the body.

[0050] Alternatively, the body and anchors can be of uniform width while the plate is of a larger width than either the body or the anchors. Alternatively, the body and anchors can be of uniform width while the plate is of a smaller width than either the body or the anchors.

[0051] In certain embodiments, the anchor can include a first anchor point in the center of the body, a second anchor point on the interior side of the body either anterior or posterior to the first anchor point, and a third anchor point on the exterior side of the body either anterior or posterior to the first anchor point.

[0052] In certain embodiments, the body can include a first anchor point at the center of the body, and the anchor can include a second anchor point on the interior side of the body, either anterior or posterior to the first anchor point, and a third anchor point on the exterior side of the body, either anterior or posterior to the first anchor point.

[0053] In certain embodiments, a line drawn from the first anchor point to the second anchor point forms an angle with a line drawn from the first anchor point to the third anchor point that is less than 170 degrees and greater than 10 degrees.

[0054] Alternatively, a line drawn from the first anchor point to the second anchor point can form an angle with a line drawn from the first anchor point to the third anchor point that is less than 160 degrees, or less than 150 degrees, or less than 140 degrees, or less than 130 degrees, or less than 120 degrees, or less than 110 degrees, or less than 150 degrees, or less than 150 degrees, or less than 100 degrees, or less than 90 degrees, or less than 80 degrees, or less than 70 degrees, or less than 60 degrees, or less than 50 degrees, or less than 40 degrees, or less than 30 degrees, or less than 20 degrees, or any of the foregoing increments.

[0055] Alternatively, a line drawn from the first anchor point to the second anchor point can form an angle with a line drawn from the first anchor point to the third anchor point that is greater than 160 degrees, or greater than 150 degrees, or greater than 140 degrees, or greater than 130 degrees, or greater than 120 degrees, or greater than 110 degrees, or greater than 150 degrees, or greater than 150 degrees, or greater than 100 degrees, or greater than 90 degrees, or greater than 80 degrees, or greater than 70 degrees, or greater than 60 degrees, or greater than 50 degrees, or greater than 40 degrees, or greater than 30 degrees, or greater than 20 degrees, or any of the foregoing increments.

[0056] Alternatively, any of the aforementioned lines can be drawn between a central feature or point of the body or anchor (e.g., a point or midpoint of the centerline of the body or anchor portion of the implant, proximal to an edge or boundary along or between the body and anchor, or a geometric feature such as a point where a first arm joins either the body or the second arm) in place of the first anchor point described above.

[0057] In certain embodiments, the anchor can have a first arm connecting a second anchor point to the body, the first arm can have an arm width smaller than the body width, and the anchor can also have a second arm connecting a third anchor point to the body, the second arm can have an arm width smaller than the body width. Additionally, alternatively, or otherwise, the first arm can have a first arm length smaller than the body length, and the second arm can have a second arm length smaller than the body length.

[0058] In certain embodiments, the first arm and the second arm form a Y shape with respect to the body. Alternatively, the first arm and the second arm can form a T shape with respect to the body. Alternatively, the first arm and the second arm can form a U shape with respect to the body. Alternatively, the first arm and the second arm can form an inverted Y, inverted U, "arch" shape, or "arrow" shape with respect to the body. Alternatively, the first arm and the second arm can form a symmetric Y shape or arrow shape with respect to the body. Alternatively, the first arm and the second arm can form an asymmetric Y shape or arrow shape with respect to the body. Alternatively, the first arm and the second arm can form an irregular Y shape or arrow shape with respect to the body.

[0059] In certain embodiments, the plate can have a first radius of curvature (RP), the anchor can have a second radius of curvature (RA), and the first radius of curvature is smaller than the second radius of curvature (RP < RA). Alternatively, the first radius of curvature can be made larger than the second radius of curvature (RP > RA).

[0060] In certain embodiments, the body can have a first radius of curvature (RB1) that is close to the plate, and the body can have a second radius of curvature (RB2) that is close to the anchor, where the first radius of curvature is smaller than the second radius of curvature (RB1 < RB2). Alternatively, the first radius of curvature can be larger than the second radius of curvature (RB1 > RB2). The surface connecting RB1 to RB2 can be tangential, continuous, but mismatched, or discontinuous. RB1 can be equal to RP, or RB1 can be larger than RP, or RB1 can be smaller than RP. The surface connecting RB1 to RP can be tangential, continuous, but mismatched, or discontinuous. RB2 can be equal to RA, or RB2 can be larger than RA, or RB2 can be smaller than RA. The surface connecting RB2 to RA can be tangential, continuous, but mismatched, or discontinuous.

[0061] Each of the above relationships can be selected to provide benefits in terms of cost, manufacturability, or clinical effectiveness (e.g., a mismatched surface connecting RB1 to RB2 can cost less to manufacture, or a tangential surface connecting RB1 to RP can result in improved clinical outcomes in the restoration of natural curvature).

[0062] In certain embodiments, the connection between the plate and the body can be continuous and smooth at the concave scleral shell surface. Additionally, or alternatively, the connection between the body and the anchor can be continuous and smooth at the concave scleral shell surface. Additionally, or alternatively, the body can have a gradual curvature transition that maintains the surface tangent between the first radius of curvature (RB1) and the second radius of curvature (RB2). Additionally, or alternatively, the body can have a third radius of curvature (RB3) that is different from RB1 and RB2 (e.g., RB3 can be larger than twice RB2). Additionally, or alternatively, the body can have a neutral (neither concave nor convex) curvature region, a flat region, a segmented linear region, or a concave region.

[0063] One embodiment of the present invention provides a single, rigid ophthalmic surgical implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eye, the implant having a plate with a concave scleral mating surface configured to restore the natural curvature of the posterior portion of the eye, an anchor with a concave scleral mating surface configured to approximate the natural curvature of the anterior portion of the eye, and a body with a continuous, smooth, concave scleral mating surface connecting the plate to the anchor. The eye and implant having a natural axial length can have an overall implant length that is less than the natural axial length of the eye. The body can have a body width, and the plate can have a plate width that is less than the plate width. The anchor can have an anchor width that is greater than the plate width. The plate has a plate thickness, the body has a body thickness, and the anchor has an anchor thickness, and the plate thickness, body thickness, and anchor thickness are each approximately equal.

[0064] Certain embodiments may further provide a first anchor point at the center of the body, a second anchor point on the inside or outside of the body, either forward or backward from the first anchor point, and a third anchor point on the outside of the body, either forward or backward from the first anchor point, wherein a line drawn from the first anchor point to the second anchor point forms an angle with a line drawn from the first anchor point to the third anchor point that is less than 170 degrees and greater than 10 degrees.

[0065] Certain embodiments may further provide a first arm connecting the second anchor point to the body, the first arm having an arm width smaller than the body width, and a second arm connecting the third anchor point to the body, the second arm having an arm width smaller than the body width. The first arm may have a first arm length smaller than the body length, and the second arm may have a second arm length smaller than the body length. The first arm and the second arm may form a Y shape that is symmetrical about the body.

[0066] In certain embodiments, the plate can have a constant radius of curvature (R) (e.g., a single value for the radius of curvature from the plate, through the body, to the anchor). The value of R in millimeters (mm) can be equal to the value of the anchor width (AW) in mm (e.g., R = AW), or R can be less than 99% of AW, less than 95% of AW, less than 90% of AW, less than 85% of AW, less than 80% of AW, less than 75% of AW, less than 70% of AW, less than 65% of AW, less than 60% of AW, less than 55% of AW, less than 50% of AW, less than 45% of AW, less than 40% of AW, or any percentage of the foregoing. Alternatively, R can be greater than AW, greater than 105% of AW, greater than 110% of AW, greater than 115% of AW, greater than 120% of AW, greater than 125% of AW, greater than 130% of AW, greater than 135% of AW, greater than 140% of AW, greater than 145% of AW, greater than 150% of AW, greater than 175% of AW, greater than 200% of AW, or any percentage of the foregoing.

[0067] In certain embodiments, the value of R in millimeters (mm) can be equal to the value of body width (BW) in mm (e.g., R=BW), or R can be less than 99% of BW, less than 95% of BW, less than 90% of BW, less than 85% of BW, less than 80% of BW, less than 75% of BW, less than 70% of BW, less than 65% of BW, less than 60% of BW, less than 55% of BW, less than 50% of BW, less than 45% of BW, less than 40% of BW, or any percentage of the foregoing. Alternatively, R can be greater than BW, greater than 105% of BW, greater than 110% of BW, greater than 115% of BW, greater than 120% of BW, greater than 125% of BW, greater than 130% of BW, greater than 135% of BW, greater than 140% of BW, greater than 145% of BW, greater than 150% of BW, greater than 175% of BW, greater than 200% of BW, or any percentage of the foregoing.

[0068] In certain embodiments, the value of R in millimeters (mm) can be equal to the value of the plate width (PW) in mm (e.g., R=PW), or R can be less than 99% of PW, less than 95% of PW, less than 90% of PW, less than 85% of PW, less than 80% of PW, less than 75% of PW, less than 70% of PW, less than 65% of PW, less than 60% of PW, less than 55% of PW, less than 50% of PW, less than 45% of PW, less than 40% of PW, or any percentage of the foregoing. Alternatively, R can be greater than PW, greater than 105% of PW, greater than 110% of PW, greater than 115% of PW, greater than 120% of PW, greater than 125% of PW, greater than 130% of PW, greater than 135% of PW, greater than 140% of PW, greater than 145% of PW, greater than 150% of PW, greater than 175% of PW, greater than 200% of PW, or any percentage of the foregoing.

[0069] In certain embodiments, the plate can have a first radius of curvature (RP), the anchor can have a second radius of curvature (RA), and the first radius of curvature is less than the second radius of curvature (RP < RA). The body can have a first radius of curvature (RB1) proximate to the plate and the body can have a second radius of curvature (RB2) proximate to the anchor, the first radius of curvature is less than the second radius of curvature (RB1 < RB2), the connection between the plate and the body is continuous and smooth at the concave forced-fitting surface, the connection between the body and the anchor is continuous and smooth at the concave forced-fitting surface, and the body can have a gradual curvature transition that maintains the surface tangent between the first radius of curvature (RB1) and the second radius of curvature (RB2).

[0070] In certain embodiments, the plate can provide one or more attachment points (e.g., if a larger indentation of the eye is desired, the surgeon can suture a local sponge (such as those readily available for general retinal detachment recovery) or have other additional options to the plate). The attachment points can take the form of one or more holes, slots, protrusions, or other features known in the art to facilitate or enhance the retention of sutures. According to one embodiment, two holes are provided that are symmetrically positioned proximal to the center of the plate, and the holes are spaced and sized to facilitate the passage of suture threads.

[0071] One embodiment of the present invention is a surgical method for improving a patient's vision by helping to restore, support, or preserve the natural curvature and natural axial length of the eyeball with the conjunctiva and sclera, the surgical method comprising the steps of: providing a single rigid ophthalmic surgical implant according to the present invention; selecting a quadrant of the eyeball; incising the conjunctiva to expose the sclera in the selected quadrant; first inserting the implant plate such that the concave scleral mating surface is in close contact with the scleral surface below the conjunctiva in the selected quadrant; advancing the implant until the anchors are 3 mm to 10 mm behind the limbus; anchoring the body of the implant to the sclera; determining a desired location for the implant to restore the natural curvature and natural axial length of the eyeball; and anchoring the anchors to the sclera at at least two desired anchor points to restore the natural curvature and natural axial length of the eyeball.

[0072] In one embodiment, the selected quadrant can be either the inferior temporal quadrant or the superior temporal quadrant. The method can additionally or alternatively include attaching an autograft, allograft, xenograft, or synthetic scleral implant to the sclera beneath the implant, either before or after placing the implant.

[0073] Determining the desired position of the implant can include measuring the corrected AP length and adjusting the position of the implant during surgery. Additionally or alternatively, determining the desired position of the implant can include referencing a nomogram or pre-operative measurements and adjusting the position of the implant during surgery.

[0074] Ultrasound can measure how long the eye is and how much it deviates from the normal 22 to 24 mm length. Ultrasound can also indicate deformation and shape of the back of the eye. There are other means of more accurately measuring the length of the eye to calculate the intraocular lens power for the lens to be placed (e.g., using laser light with an IOL Master 500 (Carl Zeiss Meditec AG, Jena, Germany) or a Lenstar LS900 (Haag Steit AG, Koeniz, Switzerland), which are commonly used to measure ocular length before cataract surgery). In certain embodiments of the invention, an intraocular device such as an intraoperative aberrometry (ORA) or a simple autorefractometer can be used to determine the refractive error of the eye immediately after the implant is placed in the eye during surgery to ensure that the implant is properly positioned to provide the desired length and / or curvature of the eye. The desired length is one that minimizes or eliminates the refractive error after placement, if the implant is being placed to correct the refractive error. In some cases, when the implant is positioned to inhibit the posterior widening of the eye to prevent, inhibit, reduce, or correct macular pathologies, i.e., macular schisis, myopic macular hole, macular scarring, and related conditions, the desired length is approximately 22-24 mm.

[0075] Certain embodiments can additionally or alternatively include closing the conjunctiva over the implant and attaching an autograft, allograft, xenograft, or synthetic scleral graft under, around, and / or over the implant. Dissecting the conjunctiva can include blunt posterior dissection to open a nested pocket for the implant between the conjunctiva and the sclera.

[0076] One embodiment of the present invention provides a surgical implant for changing the axial length of an eye, the surgical implant comprising: a body having an inferior surface facing the scleral surface of the eye and an superior surface; a macular depressor extending from a posterior end of the body; one or more anchoring arms extending from an anterior end of the body opposite the posterior end of the body; and one or more anchoring portals passing through the body at points on or adjacent to the anchoring arms, the inferior surface having a compound concave surface defined by a first radius of curvature at the posterior end of the body and a second radius of curvature at the anterior end of the body, the first radius of curvature being smaller than the second radius of curvature. In certain embodiments, the first radius of curvature extends along the inferior surface through the macular depressor, and the second radius of curvature extends along the inferior surface through the one or more anchoring arms, the first radius of curvature meeting the second radius of curvature at a point between the posterior end of the body and the anterior end of the body, at a tangent along the bottom surface. In certain embodiments, the macular indenter extends from the lower surface of the body to the upper surface of the body and is generally cylindrical in shape, defining a cylindrical central axis perpendicular to the lower surface at the center of gravity of the macular indenter. In certain embodiments, the body can have a longitudinal central axis extending along the midplane of the body from the posterior end to the anchor end, and two anchor arms of equal length and equal width form a symmetric anchor structure having symmetry in a plane passing through the longitudinal central axis of the body and the cylindrical central axis of the macular indenter. The body can have a substantially constant body width and body thickness between the macular ends, and at least one of the anchor arms can have an arm width less than the body width and an arm thickness substantially equal to the body thickness.

[0077] One embodiment of the present invention provides a surgical implant for changing the axial length of an eye, the implant comprising: a plate; an anchor; an elongated body having a body length extending between the anchor and the plate; a concave scleral surface connecting the plate, the body, and the anchor; a convex orbital surface opposite the scleral surface; and a pair of opposing side surfaces connecting the orbital surface and the scleral surface along at least a portion of the body length. The plate can have a shape defining a plate width at the scleral surface, the elongated body can have a shape defining a body width between the opposing side surfaces at the scleral surface, and the anchor can have two suture portals extending from the scleral surface to the orbital surface and defining an anchor width therebetween, the body width being at least about two-thirds the plate width, and the anchor width being greater than the body width.

[0078] In certain embodiments, the plate has a center of mass, the body has a center of mass, a length vector is defined as extending from the plate center of mass through the center of mass, the anchor comprises two anchor arms, a first anchor arm extends from the body to the suture portal along a path at a first angle relative to the length vector, and a second anchor arm extends from the body to the suture portal along a path at a second angle relative to the length vector, the two arms defining a space therebetween, the first angle and the second angle being on opposite sides of the length vector, and the first angle and the second angle being equal in magnitude.

[0079] In certain embodiments, the first arm has a first length and the second arm has a second length, the second length being equal to the first length.

[0080] One embodiment of the present invention provides a surgical implant for changing the axial length of an eye, the implant having a concave scleral-facing surface extending from a posterior end of the implant to an anterior end of the implant and defining an anterior-posterior (AP) direction along the implant, the scleral surface having a posterior radius of curvature in a region adjacent the posterior end and an anterior radius of curvature in a region adjacent the anterior end, the posterior radius being smaller than the anterior radius. This embodiment further provides a concave macular indenter plate at the posterior end of the implant, the concave macular indenter plate having a radius of curvature substantially the same as the posterior radius and a plate width measured across the scleral surface perpendicular to the AP direction, and a concave anchor at the anterior end of the implant, the concave anchor having a radius of curvature substantially the same as the anterior radius and an anchor width measured across the scleral surface perpendicular to the AP direction. This embodiment further provides a concave body portion connecting the plate and anchor, the concave body portion having a variable radius of curvature that varies from substantially the same as the posterior radius in the region adjacent to the plate to substantially the same as the anterior radius in the region adjacent to the anchor, the variable radius of curvature of the body maintaining a continuity of curvature from the region adjacent to the plate to the region adjacent to the anchor, the body comprising two regions of constant radius of curvature that meet at their intersection, or the body including a region of constant rate of change of radius of curvature between the anterior and posterior radii.

[0081] One embodiment of the present invention provides a surgical implant for changing the axial length of an eye, the implant comprising: a plate located at a posterior end of the implant; an anchor located at an anterior end of the implant; an elongated body having a body length extending between the anchor and the plate; a concave scleral surface extending from the posterior end of the implant to the anterior end of the implant, connecting the plate, the body, and the anchor and defining an anterior-posterior (AP) direction along the implant; a convex orbital surface opposite the scleral surface; and a pair of opposing side surfaces connecting the orbital surface and the scleral surface along at least a portion of the body length, wherein the plate has a shape defining a plate width at the scleral surface, the elongated body has a shape defining a body width between the opposing side surfaces at the scleral surface, and the anchor includes two suture portals extending from the scleral surface to the orbital surface and defining an anchor width therebetween, the body width being at least about two-thirds the plate width, and the anchor width being greater than the body width. Additionally, the implant can include a concave scleral-facing surface having a posterior radius of curvature in a region proximal to the posterior end and an anterior radius of curvature in a region proximal to the anterior end, the posterior radius being smaller than the anterior radius; a concave macular depressor plate at the posterior end of the implant having a plate width measured across the scleral plane perpendicular to the AP direction and having substantially the same radius of curvature as the posterior radius; a concave anchor at the anterior end of the implant having an anchor width measured across the scleral plane perpendicular to the AP direction and having substantially the same radius of curvature as the anterior radius; and a concave body portion connecting the plate and the anchor and having a variable radius of curvature that varies from substantially the same as the posterior radius in a region proximal to the plate to substantially the same as the anterior radius in a region proximal to the anchor.

[0082] One embodiment of the present invention provides a surgical implant (100) for altering the axial length of an eye, the implant having a plate (110) located at a posterior end of the implant, an anchor (130) located at an anterior end of the implant, and an elongated body (120), the body having a body length extending between the anchor and the plate, a concave scleral surface (140) extending from the posterior end of the implant to the anterior end of the implant and connecting the plate, the body, and the anchor, a convex orbital surface (150) opposing the scleral surface, and a pair of opposing side surfaces (160) connecting the orbital surface and the scleral surface along at least a portion of the body length, The surface can have a posterior radius of curvature (R1) in a region adjacent to the posterior end and an anterior radius of curvature (R2) in a region adjacent to the anterior end, the posterior radius being smaller than the anterior radius; the plate can have a shape that defines a plate width (PW) at the scleral surface; the elongated body can have a shape that defines a body width (BW) between opposing sides at the scleral surface; the anchor can have two suture portals (131A, 131B) extending from the scleral surface to the orbital surface and defining an anchor width (AW), the body width being at least about 2 / 3 of the plate width PW, and the anchor width being greater than the body width.

[0083] Additionally, certain embodiments can provide a concave macular indenter plate at the posterior end of the implant having a radius of curvature substantially the same as the posterior radius and a plate width measured across the scleral plane perpendicular to the AP direction; a concave anchor at the anterior end of the implant having a radius of curvature substantially the same as the anterior radius and an anchor width measured across the scleral plane perpendicular to the AP direction; and a concave body portion connecting the plate and the anchor having a variable radius of curvature that varies from a radius of curvature substantially the same as the posterior radius in a region adjacent the plate to a radius of curvature substantially the same as the anterior radius in a region adjacent the anchor.

[0084] FIG. 1 is a three-dimensional representation of one embodiment of a single, rigid ophthalmic surgical implant for improving a patient's vision by restoring the natural curvature and axial length of the eyeball in accordance with the present invention. The implant 100 includes a plate 110 located at the posterior end of the implant, an anchor 130 located at the anterior end of the implant, and an elongated body 120, the body having a body length extending between the anchor and the plate. The implant has two distinct curvatures, i.e., a large anterior radius of curvature transition, at 121, with a smooth tangent surface junction. A concave scleral surface 140 extends from the posterior end of the implant to the anterior end of the implant, connecting the plate, body, and anchor. A convex orbital surface 150 is found opposite the scleral surface, and a pair of opposing side surfaces 160 connect the orbital surface and scleral surface along at least a portion of the body length. The anchor has two anchor points in the form of suture portals 131A, 131B extending from the scleral surface to the orbital surface at the end of each of two anchor arms 132A and 132B. A third anchor point in the form of suture portal 131C extends proximally and centrally on the body from the scleral surface to the orbital surface within the anchor.

[0085] 2 shows a three-dimensional representation of an eye 200 treated with an embodiment of an implant that restores the natural curvature and natural axial length AL of the eye by a surgical technique, according to an embodiment of the present invention. The axial length AL of the eye is measured from the anterior surface 211 of the cornea 210 to the restored axial position 221 of a point on the retina 220 immediately above the plate 110, which supports the retina 220 and the sclera 230. The conjunctiva immediately outside the sclera 230 is not shown in this view. Sutures 170A, 170B, 170C, and 170D hold the body 120 of the implant and secure anchor points 131A, 131B, and 131C to the sclera, respectively. Suture 170D forms an initial fixation by wrapping loosely around body 120 while still allowing axial adjustment of the implant to restore the patient's vision before securing sutures 170A, 170B, and 170C to secure anchor points 131A, 131B, and 131C, respectively, to the sclera. The implant has two distinct curvatures, a large anterior radius transition, at 121 with smooth tangential surface junctions.

[0086] 3A and 3B respectively show top and side views of one embodiment of a single, rigid ophthalmic implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eyeball in accordance with the present invention. The implant 100 includes a plate 110 located at the posterior end of the implant, an anchor 130 located at the anterior end of the implant, and an elongated body 120, the body having a body length extending between the anchor and the plate. A concave scleral surface 140 extends from the posterior end of the implant to the anterior end of the implant, connecting the plate, the body, and the anchor. A convex orbital surface 150 is found on the opposite side of the scleral surface, and a pair of opposing side surfaces 160 connect the orbital surface and the scleral surface along at least a portion of the body length. The scleral surface has a posterior radius of curvature R1 in a region adjacent the posterior end and an anterior radius of curvature R2 in a region adjacent the anterior end, the posterior radius being smaller than the anterior radius. The plate has a shape at the scleral surface that defines a plate width PW. The elongate body has a shape that defines a body width BW between opposing sides at the scleral surface. The anchor extends from the scleral surface to the orbital surface and has two anchor points 131A and 131B, respectively, that define an anchor width AW spanned by two anchor arms 132A and 132B, respectively. A third anchor point 131C extends from the scleral surface to the orbital surface within the anchor, but is proximal and central to the body. In this embodiment, the body width BW is at least about two-thirds the plate width PW, and the anchor width AW is greater than the body width BW.

[0087] 4 illustrates an eye 200 with a normal ocular shape 231N and normal refraction that focuses an image 202 of an object 201 onto the retina 220, and an eye 200 with an elongated ocular shape 231E that represents myopia and an inability to focus the image 202 onto the retina 220. In some embodiments, the normal axial length ALN of the eye and the elongated axial length ALE of the eye are each measured from the anterior surface 211 of the cornea 210 to the focal point on the macula 221. The optic nerve is 240. The retina 220 is the inner layer of nervous tissue. When an image is formed on the retina with an eye of normal length, it can be properly focused on the retina. When the eye is myopic, the image may fall in front of the retina.

[0088] FIG. 5 includes an engineering sketch defining the top surface (in a slight perspective view) of one exemplary embodiment of a manufacturing intermediate (e.g., a sheet metal flat stamped blank prior to bending) useful for producing a single, rigid ophthalmic surgical implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eyeball in accordance with the present invention. Blank 500 includes a "spoon" or plate 510 located at the posterior end of the implant, an anchor 530 located at the anterior end of the implant, and an elongated body 520, the body having a body length extending between the anchor and the plate. The plate, body, and anchor have a linear implant length L (30.5 mm), measured from the posterior end of the plate to the anterior end of the anchor. A flat surface, which can later be bent to form a concave scleral surface (not visible behind the implant in this view), extends from the posterior end of the implant to the anterior end of the implant and connects the plate, body, and anchor. A flat surface 550 is visible that can be bent to form a convex orbital surface, and a pair of opposing side surfaces 560 connect the orbital surface and the scleral surface along at least a portion of the body length. The flat surface is shown to be bent to form a scleral surface having a posterior radius of curvature R1 (or diameter = 25 mm) in a region adjacent the posterior end and an anterior radius of curvature R2 (or diameter = 29 mm) in a region adjacent the anterior end (the posterior radius is smaller than the anterior radius). The bending axis 521 indicates the intended transition from the anterior radius to the posterior radius in the finished implant, located 16.50 mm from the posterior end and 14.00 mm from the anterior end. The plates have a shape that defines a plate width PW at the scleral and / or orbital surfaces, respectively. The elongated body has a shape that defines a body width BW between the opposing side surfaces at the scleral surface. The anchor has two anchor points 531A and 531B, respectively, that extend from the scleral surface to the orbital surface and define an anchor width AW spanned by two anchor arms 532A and 532B, respectively. A third anchor point 531C extends from the scleral surface to the orbital surface within the anchor, but is proximal and central to the body. In this embodiment, the body width BW is at least about two-thirds the plate width PW, and the anchor width AW is greater than the body width BW.Note that the anchor arms are smaller than the diameter of their respective anchor points and less than half the width (BW) of the body (e.g., 1 mm), the plate is 0.5 mm thick, and the body, arms, and anchor points have curved, rounded ends and can be flat, sharp, or squared. The cross-sectional sketch shows example geometric shapes, rounding, and end treatment details of the anchor's body, spoon or plate, and short arms.

[0089] In certain embodiments, the transition from the body to the anchor is defined at the transition point from the body width or thickness to the anchor width or thickness. This transition point can be defined by a change in the implant width or thickness, or by the beginning of a gradual increase in the implant width or thickness, or a specified distance (e.g., 1 mm or 0.5 mm) from such a point. Alternatively, the anchor can be defined as the origin of one or more anchor arms protruding from the body. Alternatively, the anchor can be defined by the location of one or more anchor points (e.g., 531C), or a specified distance, radius, or diameter (e.g., 1 mm or 0.5 mm) away from the center, end, or quadrant of one or more anchor points in a specified direction.

[0090] Figures 6A-6E show top, end, and cross-sectional views of one embodiment of an implant according to the present invention. Figure 6A shows top and end views of an embodiment of an implant with rounded top edges, three anchor points, and two additional suture holes within the plate (e.g., useful for attaching sponges or other items). Figure 6B shows a cross-section through one of the anchor points. The anchor hole (e.g., a 1 mm diameter through-hole) is supported around the hole diameter by a wall (e.g., 0.5 mm thick) with rounded outer and upper ends (e.g., full or partial rounded corners on the edges around all or part of the hole). Figure 6C shows a cross-section of an anchor arm with a rounded or partially rounded top plate profile and a flat bottom surface. Figure 6D shows a cross-sectional profile of a flat body with rounded upper corner ends. Figure 6E shows a cross-section through a plate with two additional suture holes.

[0091] 7 shows a perspective view of one embodiment of an implant according to the present invention. The curvature and three-dimensional shape of this embodiment can be seen curving from the anchor portion with three attachment points, through the body, to the plate portion with two additional optional holes or attachment points.

[0092] Certain embodiments of the present invention provide improved stability of the implant after surgical placement. The quantity, location, orientation, design, placement, and configuration of attachment points can affect implant stability, which can affect patient outcomes. Sutures are one form of fixation. Non-absorbable sutures can be used for secure and durable fixation of the implant. Absorbable sutures can be used to secure the implant in place until sufficient healing and formation of scar tissue has occurred to hold the implant in place before the sutures are absorbed. Multiple attachment points can be provided. In some embodiments, two attachment points are provided at the anterior end of the implant, separated by an anchor distance measured in the mediolateral direction across the body of the implant. Attachment points at the anterior end of the implant can provide advantages in access and ease of attachment. Attachment points can be spread further apart from each other and from the body of the implant, and / or located along the edges or periphery of the implant, providing improved force distribution, stability, and retention. Attachment points in the central or posterior regions of the implant can provide advantageous force points or fixation due to their proximity to the plate. Attachment points located closer to each other, closer to the body, or closer to the plate can provide the advantage of avoiding ocular muscle, nerve, and vascular attachment and providing better access and more options for attachment (e.g., by suturing two or more anchor points with the same suture and / or passing multiple sutures through one or more attachment points).

[0093] Some embodiments of the present invention provide a means for achieving a desired AP length, shortening, or reshaping of an elongated eye. Surgeon experience (e.g., by tracking results across multiple patients and / or multiple surgeries), improved nomograms, or intraocular AP length measurement can all contribute to improved outcomes. The present invention provides a means for avoiding unintended injury (e.g., blood vessel breakage despite blunt dissection). The surgical approach is optimized to minimize risk, and the implant is specifically sized to fit between the anatomical landmarks of the eye. In certain embodiments, implant encroachment is minimized by placing a bioaugmentation implant (e.g., TUTOPLAST®) adjacent to the implant. The concave scleral mating surface of the implant can be designed to remain in intimate contact with the scleral surface beneath the conjunctiva, regardless of the application of a bioaugmentation or other implant.

[0094] In certain embodiments, the procedure normalizes only the approximately 5 mm diameter portion of the posterior portion of the eye where the plate is placed. An advantage is that this can be the most critical 5 mm portion of the eye. If the eye is too long, serious complications can occur here. By subtracting 5 mm from the center, refractive correction of the eye is achieved. Under extremely rare circumstances, the implantation site may become infected, necessitating implant removal. The present invention offers the possibility of easy removal in the event of infection or postoperative complications. Having a body width close to the size of the plate allows for easy retrieval if the implant needs to be removed by minimizing the adhesion of scar tissue that later forms around the body and increases the difficulty of removal. Therefore, selecting a body width and / or height close to the width and / or height of the plate provides advantages to the surgeon and the patient.

[0095] Pre-existing scarring in the sclera through which the implant placement is intended to be placed or attached may be present due to previous scleral implant surgery or previous severe trauma to the eye. The implants and methods of the present invention, in certain embodiments, minimize the impact of scar tissue on the surgical procedure by providing implants with uniform or tapered thickness, small variations in width, and an implant length that is less than the axial length of the eye. The present invention facilitates a wide range of surgical approaches that can be performed under an operating microscope, a magnifying loop, or the naked eye, depending on the surgeon's preference.

[0096] According to certain embodiments of the method of the present invention, the axial length of the globe of the eye can be measured (e.g., in the office, days or weeks before surgery). Based on the axial length, the desired size implant can be selected. Certain embodiments of the present invention offer the advantage of a standard procedure with iteration of implant parameters and design features to account for each patient's unique situation. Implants according to certain embodiments of the present invention can advantageously be provided in a kit that gives the surgeon numerous options in various implant length, width, thickness, curvature, anchor configuration, material, coating, and accessory combinations. For example, a kit can include three implants, each with a common 5 mm diameter circular plate, 10 mm anchor width, 4 mm body width, and 14.5 mm anterior radius, with each of the three implants having a unique posterior radius of 12.0 mm, 12.5 mm, and 13.0 mm, respectively. As can be appreciated, other variables can be varied or kept constant within a kit or across different kits, resulting in multiple kit configurations of different sizes, each offering advantages to the surgeon in terms of cost, availability, or ease of use.

[0097] The surgical instruments required to practice the present invention are, in certain embodiments, very simple. The instruments include, but are not limited to, sharp scissors for cutting the conjunctiva, forceps for holding the implant and the conjunctiva and sclera, calipers for measuring surgical distance, two needle holders, and sutures. In certain embodiments, the present invention provides accurate intraoperative AP length measurements or intraoperative refractive power (e.g., using an OCULAR RESPONSE ANALYZER® (ORA) device, Reichert, Inc., Depew, NY) to achieve the desired restoration of ocular length and natural curvature.

[0098] Restoration can be complete or partial, lengthening or shortening, or reshaping, as needed to restore the patient's vision. Axial length is a linear length measurement, and can be measured in a straight line or along a vector or measurement axis (e.g., using ultrasound or optical measuring equipment) from the anterior surface of the cornea or other suitable anatomical landmark to the restoration point on the concave inner retinal surface (e.g., measurements can be taken of the uncorrected actual pre-operative length and / or curvature; the natural, adequately functional, or desired length and / or curvature; and / or the corrected actual, improved functional, or post-operative condition).

[0099] In some embodiments, the total linear implant length can be measured along a line or vector from the posterior extent of the implant to the anterior extent of the implant; in certain embodiments, this would measure the total implant length from the posterior end or posterior extent of the plate to the anterior end or anterior extent of the anchor. Linear width, thickness, or length can be a maximum, minimum, or local measurement (e.g., the largest or smallest length, width, or height measurable at any point along the implant or within a specified region, portion, feature, or area of ​​the implant; e.g., the total length of the implant, the width of an anchor arm, the body thickness, or the plate diameter) and can be classified as either constant or variable, continuous or discontinuous, piecewise, straight, curvilinear, rectilinear, actual, or approximate across, around, through, or on sections, regions, features, or areas of the implant. Linear measurements can include linear measurements of the smallest distance between two points in space. Unless otherwise specified, measurements described herein refer to linear measurements.

[0100] Alternatively, in some embodiments, the arcuate implant length can be measured along a curve, path, or arc from the posterior extent of the implant to the anterior extent of the implant, which in certain embodiments results in an overall arcuate implant length measured from the posterior edge or extent of the plate to the anterior edge or extent of the anchor along a surface (e.g., the scleral-facing surface of the implant). The arcuate width, thickness, or length can be a maximum, minimum, or local measurement (e.g., the maximum or minimum arcuate length, width, or height measurable at any point along the implant, or the maximum or minimum arcuate length, width, or height measurable within a specified region, portion, feature, or area of ​​the implant; e.g., the overall arcuate implant length, anchor arm arcuate width, arcuate body thickness, or arcuate plate diameter measured along the path of one or more surfaces, curves, midplanes, or lines of the implant, anchor, body, or plate) and can be classified as either constant or variable, continuous or discontinuous, piecewise linear, curvilinear, rectilinear, actual, or approximate across, around, through, or over sections, regions, features, or areas of the implant. Arcuate measurements differ from linear measurements in that arcuate measurements follow a specific path and do not represent the absolute shortest distance between two points on a curved body.

[0101] In certain embodiments, the plate width can be measured across the plate in a scleral mounting plane perpendicular to the implant length. The body width can be measured across the body in a scleral mounting plane perpendicular to the implant length. The anchor width can be measured across the anchor in a scleral mounting plane perpendicular to the implant length. Each of the implant, body, plate, or anchor thicknesses can be measured from a scleral mounting plane perpendicular to the implant length and / or perpendicular to the width.

[0102] Certain embodiments of the present invention provide a rigid, robust, long-lasting, inert, monolithic, fracture-resistant, resilient, tough, or breakage-resistant surgical implantable grade material (e.g., titanium or titanium alloy) having a thickness of 0.6 mm to 0.7 mm, alternatively 0.65 mm to 0.75 mm, alternatively 0.5 mm to 0.8 mm, alternatively 0.4 mm to 0.9 mm, alternatively 0.3 mm to 1.0 mm, or any of the foregoing increments, providing sufficient thickness for rigidity and robustness while minimizing bulk, weight, and discomfort in an implant that can remain permanently in the eye without complications. Alternatively, the thickness of the implant (e.g., having titanium, other metals, biocompatible polymers, or ceramic materials) can be 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.45 mm, 0.55 mm, 0.65 mm, 0.75 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.7 mm, or 2 mm, or any increments thereof. Materials can be used in different thicknesses according to the teachings of the present invention, depending on the material properties of each individual material.

[0103] For example, compared to more complex designs, including those that wrap around the eye or have adjustable structures, the implants and methods of the present invention offer the advantage of a less complex design and surgical technique. Thus, embodiments of the present invention reduce complication rates, increase surgeon confidence, and improve patient outcomes while reducing the risk of damage to the tissues, nerves, and blood vessels surrounding the eye.

[0104] In some embodiments, the present invention provides an implant with an inner surface that is concave in all sections, providing a more natural fit to the eye. The eye is circular, and the present invention provides an implant that fits closely to the eye's concave surface, so that the surface of the retina inside the eye (where images are formed) remains concave. Because the brain has learned to process information coming from a concave retinal surface, certain embodiments of the present invention offer an advantage over implants with flat or convex plates that face and contact the eye's posterior surface, reversing or flattening the concavity of the retina inside the eye, resulting in images projecting onto the retina in a pattern that is unnatural and confusing to the patient. The concave surface of the plate provides the advantage that, after the eye is shortened and the retraction corrected, images still project onto the natural concave retina.

[0105] In certain embodiments, a wider implant body facilitates easier removal, if desired, provides better implant stability, improves surgeon handling and confidence, and reduces the risk of dislodgement after initial placement.

[0106] In certain embodiments, the present invention provides a flared, forked anterior (front) section with three-point fixation (e.g., with sutures threaded through holes) that ensures that the implant does not move from side to side or back and forth once in place. The surgical technique of the present invention is much simpler than other techniques involving larger, more complex, or more unstable implants.

[0107] Advantages provided by certain embodiments of the present invention include fixation without the need to wrap around the eyeball or pass through sensitive structures behind the eyeball (e.g., the optic nerve); robustness with three-point fixation to the implant body or additional attachment points and optional additional fixation; ease of removal when desired; easy intraoperative adjustment to the desired AP length; and a simple structure with minimal irregularities on the implant that helps avoid erosion and exposure after initial implantation.

[0108] In certain embodiments, the length of the body determines how much the implant can shorten the eye. The length of the body and the radius of curvature of the body determine where the plate fits and where the anchor structure (e.g., fork) lands in front of the eye. In some embodiments, a kit with two or three different standard sizes (or four, five, or six sizes) for body length and / or implant linear length and / or implant arcuate length may be sufficient to serve most patients, allowing the surgeon to advantageously utilize intraoperative adjustments in conjunction with anterior anchor fixation to determine the final corrected AP length of the eye. In certain embodiments, the size of the plate determines how much of the posterior area of ​​the eye the implant normalizes. Advantageously, the implant is small enough to avoid touching or affecting the optic nerve or other structures before, during, and / or after implantation, yet large enough to normalize the effective area of ​​the eye. In some embodiments, the plates are generally circular or cylindrical in shape and have a diameter of 5 mm, alternatively 4.5 mm to 5.5 mm, alternatively 4 mm to 6 mm, alternatively 3.5 mm to 6.5 mm, alternatively 3 mm to 7 mm, alternatively 2.5 mm to 7.5 mm, alternatively 2 mm to 8 mm, alternatively 1.5 mm to 8.5 mm, alternatively 1 mm to 9 mm, or any of these increments. Alternatively, the plates can have a diameter (or length or width, depending on the shape of the plate) of approximately 2 mm, or 3 mm, or 4 mm, or 5 mm, or 6 mm, or 7 mm, or 8 mm, or 9 mm, or 10 mm, or any of these increments. Alternatively, the plates can be generally circular, oblong, elliptical, oval, conical, irregular, or any combination of the above shapes. Alternatively, the plate can have a primary shape and a secondary shape in addition to and subtracted from the primary shape (e.g., a primary circle with a secondary elliptical cutout, or a primary cylinder with the addition of a cone).The sizes described above in terms of diameter of a primary circle or cylinder can be applied to secondary shapes as well as primary, and can be applied to other measurements such as effective or local diameter, chord length, width, or length used to describe the size of the plate relative to the area of ​​the eye to be corrected.

[0109] In certain embodiments of the invention, the implant can have a radius of curvature (or radius of curvature) along the scleral-facing surface of 14.5 mm in the anterior (e.g., anterior or anchor) section and a radius of curvature (or radius of curvature) along the scleral-facing surface of 12.5 mm in the posterior (e.g., posterior or plate) section. Alternatively, the radius of curvature in the anterior, posterior, medial, lateral, central, plate, body, anchor, or transition section of the implant can be 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, or 17.5 mm, or any increment of the foregoing. Radii can also be greater than 17.5 mm at either end of the implant or on flat or straight sections connecting the other two sections of the implant. The radii along any two sections of the implant can be the same or different from one another. The radii along any section of the implant can be constant or variable (e.g., varying continuously or discontinuously along the section), and the transition between any two sections can be smooth, sharp, tangential, continuous, or discontinuous. Two different radius of curvature values ​​can be bridged by a third section that transitions between the two.

[0110] With respect to radii of curvature, a section can be defined by multiple features along the length, width, or thickness of the implant, including defining a section by a single radius (or multiple radii) present therein. Radii of curvature can exist in three-dimensional space within the implants of the present invention and can be measured along any appropriate plane or path (e.g., anterior-posterior, medial-lateral, inferior-superior, anterior-posterior, left-right, superior-inferior, or the intersection of an appropriately defined plane or path relative to or projecting from the implant shape). At any given point or section of the implant, radii of curvature can exist in more than one direction (e.g., a longitudinal radius of curvature of 14.5 mm can correspond to a lateral radius of curvature of 8 mm). Radii of curvature can vary in different directions and across different sections of the implant. Smaller or larger radius values ​​can occur in either small, narrow, short sections of the implant, or large, wide, long sections.

[0111] In addition to transitioning across a section of the implant, the radius of curvature can have different values ​​or termination conditions at the ends or boundaries of a section, feature, or functional portion of the implant. For example, the radius can have one value across a macular indenter plate and a different value (e.g., smaller, larger, opposite, or convex) around the edge of the plate material.

[0112] In some embodiments, a concave plate with rounded edges and / or a very small convex rim can reduce trauma or interference with surrounding tissue and / or can provide a corrected curvature of the retina, ease of use for the surgeon, and / or improved patient comfort. Certain endpoints, edges, or boundary conditions (e.g., rounded edges, convex lips, rounded peripheries, or smooth and / or tangential transitions from the plate to the body and / or anchors) can beneficially reduce the severity or likelihood of cutting and / or damage and / or distortion of the eye by the implant.

[0113] In certain embodiments, implants according to the present invention can be made entirely from surgical-grade titanium or titanium alloys, including smooth, finished, polished, and oxidized titanium. Titanium finishes can include oxidation, which changes the metal color to the well-known titanium blue. Alternatively, implants can include a secondary material (e.g., silicone or other bioinert or bioactive polymer) applied as a coating, protective layer, or integrated design element (e.g., overmolded, dipped, or sprayed). The secondary material can be used alone or as an additional component of a kit or assembled implant, in a kit (e.g., a silicone bag, mesh, or sleeve, etc.) that can be fitted at the time of manufacture or at the time of implantation by the surgeon, or can be permanently fixed, removable, or temporarily removable (e.g., a removable cover that attaches to the implant until secured in place by heat staking, adhesive application, riveting, or similar connection methods known in the art). Implants can optionally be machined or hand-processed to prepare surfaces or edges prior to implantation (e.g., machine tumbling and / or hand-polishing during manufacture). For example, the ends may be chamfered or rounded to a minimum chamfer or radius of 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1 mm, or any of the foregoing increments.

[0114] Certain embodiments of the present invention advantageously promote the growth of fibrous scar tissue on, around, or near the implant by providing smooth or textured surfaces, surface coatings, surface features, minimal thickness, rounded or chamfered edges, or low, moderate, or high width-to-thickness ratios, in some cases, the width-to-thickness ratio is 7:1, or a thickness ratio of 20:1, 15:1, 12:1, 10:1, 8:1, 6:1, 4:1, or 2:1, or increments of any of the foregoing.

[0115] In addition to simplified handling and placement at the surgical site, certain embodiments of the present invention advantageously provide a simple design, easy removal of the implant if desired, and a smooth profile with a single design (e.g., no mechanical connection sections that can break or malfunction). These and other features provide a simplified surgical technique, including simplified intraoperative adjustment and confirmation of the corrected AP length of the eye (e.g., initial fixation of the body of the implant to the sclera still allows axial adjustment of the implant to determine the desired ocular length and curvature prior to final fixation and / or anchoring of the implant to the eye).

[0116] The overall implant length can be 20 mm in certain embodiments. The length in certain embodiments can be measured or defined along a linear axis (e.g., the linear axial length from the anterior tip of the anchor to the posterior tip of the plate) or along a curved path of the implant (e.g., the arcuate length along the curve of the scleral-mating surface, or the orbital surface, the edge or feature of the implant, or the plane or mid-plane of the implant from the anterior tip of the anchor to the posterior tip of the plate). Alternatively, the implant length can be 45 mm, 44 mm, 43 mm, 42 mm, 41 mm, 40 mm, 39 mm, 38 mm, 37 mm, 36 mm, 35 mm, 34 mm, 33 mm, 32 mm, 31 mm, 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, or any increment of the foregoing.

[0117] In certain embodiments, the anchor can include a fork structure supporting two or more (e.g., two, three, four, five, or six or more) surgical attachment points. In some embodiments, attachment point and anchor point can be used interchangeably. Alternatively, attachment can refer to either initial, primary, temporary, and / or adjustable fixation (e.g., loosely suturing the body to the sclera before determining final placement of the implant), or final, secondary, permanent, and / or fixed attachment of the implant (e.g., firmly and / or securely suturing and / or otherwise anchoring the anchor point to the sclera after determining final placement of the implant).

[0118] The fork length (e.g., measured arcuately or linearly along the direction of the forks) or anchor length (measured arcuately or linearly along the length of the implant and / or anchor structure) can be between 4 mm and 6 mm, or the fork length or anchor length can be less than 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 25 mm, 30 mm, 40 mm, or 45 mm, or any increment of the foregoing. The fork width (of a single fork) or anchor structure width (of a carrier and / or branched and / or split anchor structure member) can be between 1 mm and 2 mm, or 0.25 mm, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, or increments of any of the foregoing.

[0119] The body length can be between 15mm and 20mm, or 45mm, 40mm, 35mm, 30mm, 29mm, 28mm, 27mm, 26mm, 25mm, 24mm, 23mm, 22mm, 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm, 12mm, 11mm, 10mm, 9mm, 8mm, 7mm, 6mm, 5mm, 4mm, 3mm, 2mm, 1mm, or less than 1mm, or in increments of any of the foregoing. The body width can be between 4mm and 5mm, or 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, or 20mm, or increments of any of the foregoing.

[0120] The plate diameter (or length or width, depending on the shape of the plate) can be between 4 mm and 6 mm, or 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, or in increments of any of the foregoing.

[0121] The anchor points can have hole or opening sizes between 0.5 mm and 1 mm, or 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 4.5 mm, or 5 mm, or any of the foregoing increments. The anchor points (e.g., two or more holes, each hole at one end of each of two or more arms) can be spaced apart by an anchor distance of about 8 mm to about 10 mm, or 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, or any increment of the foregoing. The anchor distance or anchor width can be defined across any two or more anchor or fastener points.

[0122] All implant dimensions referred to herein can also range around and between the individual values ​​specifically recited (e.g., fork length can be greater than about 3.5 mm and less than about 7.25 mm).

[0123] Certain embodiments can advantageously use values ​​obtained from available ranges for different parameters of the implant, measured linearly or along the curvature of the implant. For example, a 5.5 mm long plate can be mated with a 2 mm body and a 30 mm anchor to form a 37.5 mm long implant. In some cases, as the anchors and / or anchor arms extend from or proximal to the plate itself, the body length (while still existing) can approach zero or less than 1 mm. In some embodiments, the body can be bifurcated or otherwise divided into sections that follow the corresponding sections of the anchors and / or anchor arms. Alternatively, a 5 mm long plate can be mated with a 30 mm body and a 2 mm anchor to form a 37 mm long implant. In some cases, as the anchors and / or anchor arms extend from or proximal to the body itself, the anchor length (while still existing) can approach zero or less than 1 mm. In some embodiments, the anchor can be monolithic or of a single shape. Alternatively, the anchors can be bifurcated or otherwise divided into sections that lead to corresponding sections of the body and / or a single body section. Alternatively, in certain embodiments, the anchors extend directly from the plate (i.e., there can be no body). In certain embodiments, the implant does not have anchors, the anchors are the same width as or smaller than the body, and / or the implant is anchored directly from, through, or around the body.

[0124] In certain embodiments, a lightweight, compact, and simple implant design is advantageously applied to provide a smooth, uncomplicated, and gentle procedure that provides stable fixation while reducing the risk of potential rupture of any thin tissue, such as in the wall of the patient's eye. The design, including a stable base and anchoring of the implant plate and body, along with innovative placement, advances from the body to the anchor point, allowing for planned and controlled intraoperative adjustments during the innovative placement and anchoring process. Accurate measurement of the exact location to place the implant (e.g., preoperative and intraoperative measurements) further aids in reducing risk and improving patient outcomes.

[0125] In myopia, the anterior-posterior (AP) length of the eye increases. The AP length of the eye is normally 22mm to 24mm (average 23mm). A 1mm increase results in a 3 diopter increase in the eye's refractive error. If the AP length is 26mm (approximately 2mm larger than normal), the patient has a myopia of (2x3D) -6.00. When the AP length is larger than normal, the contents of the eye expand to fit the larger space created inside. One structure inside the eye that eventually expands and fits is the retina. The interior retina contains the nerve layer that creates and sends images to the brain. The retina covers the interior of the back of the eye like wallpaper covering a wall. If the eye wall bulges at the back of the eye, the interior wallpaper may expand and tear in the center. In the actual eye, this tear can take the form of a central, round hole, or macular hole. Surgeons refer to this condition as a macular hole in highly myopic eyes. Macular holes can also occur in eyes of normal length. One procedure for treating a macular hole involves placing an air bubble inside the eye and having the patient hold their head down to push the hole closed, allowing the floating air bubble to push the hole closed. In cases of high myopia, the retina is so stretched that the hole does not easily close. When the wall of the eye is pushed from the outside in accordance with the present invention, the patient has a greater chance of success. Placing an implant to move the wall of the eye forward in accordance with the present invention increases the chances of closing the macular hole after intraocular surgery to treat the macular hole.

[0126] Advantages of the present invention include ease of manufacturing and implantation; simply put, the eye can better handle a simpler design. With fewer mechanical components, connections, and electronics, the present invention reduces the complications and risks of placing and maintaining an implant within the eye for decades. An easier and simpler design promotes better outcomes. The surgical technique is simpler and less challenging with a simpler, integrated design. The implants and methods of the present invention provide greater accessibility to retinal specialists or any other certified specialist in the field of ophthalmology who can thread sutures on the sclera (i.e., the white part, outer covering of the eye). Retinal surgeons and strabismus surgeons are familiar with techniques for threading sutures through the sclera in a manner that is adaptable to the surgical technique of the present invention.

[0127] One application of certain embodiments of the present invention is to shorten the axial length of the eye to correct myopia (nearsightedness). Certain embodiments can be used to correct hyperopia (farsightedness) and / or astigmatism (where the eye is football or egg shaped rather than the usual round sphere). One embodiment shown in FIG. 1 can be described as a "J" shaped stent with a plate on one end and a "Y" shaped fork on the other end. In certain embodiments, the designed length of the stent can vary based on the size of the intended patient's eye.

[0128] Figure 2 shows one representative, non-limiting embodiment attached to the eye after surgery. In the case of myopia, when the eye is longer than normal, the device can be pulled forward behind the eye to shorten it, and the device can be sutured to the side of the eye with three holes on the two ends of the "Y" and where the Y-fork meets the body. Additional holes can be formed in the device to further suture the device to the eye. In some embodiments, holes can be located on the anchor, body, or plate of the implant. In addition to holes, certain embodiments can advantageously use protrusions, notches, ridges, slots, bumps, arms, depressions, grooves, or other attachments known in the art and depending on the fasteners (e.g., sutures or staples) used.

[0129] Certain embodiments of the present invention provide a surgical implant (100) for changing the axial length of an eye, comprising a plate (110) disposed at the posterior end of the implant, an anchor (130) disposed at the anterior end of the implant, an elongated body (120) having a body length extending between the anchor and the plate, and a concave scleral surface (140) extending from the posterior end of the implant to the anterior end of the implant, connecting the plate, the body, and the anchor. The implant may also have a convex orbital surface (150) facing the scleral surface and a pair of opposing side surfaces (160) connecting the orbital surface and the scleral surface along at least a portion of the body length, the scleral surface having a posterior radius of curvature (R1) in a region adjacent the posterior end and an anterior radius of curvature (R2) in a region adjacent the anterior end, the posterior radius being smaller than the anterior radius. The plate may have a shape defining a plate width (PW) at the scleral surface. The elongated body may have a shape defining a body width (BW) between the opposing side surfaces at the scleral surface. The anchor can have two suture portals (131A, 131B) extending from the scleral surface to the orbital surface and defining an anchor width (AW) therebetween, the body width being at least about 2 / 3 of the plate width, and the anchor width being greater than the body width.

[0130] In certain embodiments, the surgical application site can be on the exterior of the eye, as shown in FIG. 2. When viewing the eye from the front, there are four major straight muscles that move the eye up, down, right, and left. These muscles are anchored at approximately 12 o'clock (superior rectus), 3 o'clock (lateral rectus for the right eye, medial rectus for the left eye), 6 o'clock (inferior rectus), and 9 o'clock (medial rectus for the right eye, lateral rectus for the left eye). The muscles are not visible from the outside of the eye. These muscles typically begin 6-7 mm posterior to the limbus (i.e., where the cornea meets the sclera, i.e., the circular edge where the white sclera begins when looking at the eye). The section of the eye between these four muscles can be referred to as a quadrant. Although implants can be placed in any quadrant (subnasal, supranasal, infratemporal, supranasal), the infratemporal quadrant (outer bottom) and supranasal (outer upper) offer easier access and less potential risk of contacting the optic nerve during implant placement. Certain embodiments of the present invention provide implants configured and adapted to avoid the optic nerve, which may partially obstruct implants placed in the supranasal (medial upper) and subnasal (medial lower) quadrants if the temporal quadrant is too scarred (e.g., from previous surgery or trauma). Surgical placement of implants in the temporal quadrant, according to certain embodiments of the present invention, reduces risk to critical structures (e.g., optic nerve and / or veins). Retinal surgeons are very familiar with accessing these quadrants below the conjunctiva (i.e., the skin of the globe of the eye). Retinal surgeons typically place silicone implants for retinal detachment repair in these quadrants on the sclera by passing half-thickness sutures through the sclera. Blunt dissection of these quadrants provides access to the wall of the eye without damaging nerves and blood vessels. In certain embodiments, implants of the present invention with blunt edges are easily placed without damaging vital structures, following surgical approaches and techniques familiar to ophthalmic surgeons.In certain embodiments, the implants of the present invention provide simple, compact, and stable attachment to the delicate structures of the eye within the confines of the surrounding tissue.

[0131] In certain embodiments, the implant is positioned perpendicular (and posterior) to the limbus of the patient's eye (e.g., extending above the limbus toward the back of the eye). The plate is inserted posteriorly (e.g., by passing first the plate, then the body, and finally the anchor through the incision) to support the back of the eye and pull it forward. In certain embodiments, a Y-shaped fork with holes is secured approximately 3-10 mm posterior to the limbus. After securing and anchoring the implant at the desired depth, it is covered with the patient's own conjunctiva. If the patient's own sclera is too thin, a scleral patch (e.g., processed donor sclera such as TUTOPLAST®) can be placed over the implant under the conjunctiva. The body of the implant can be initially positioned on the eye using a non-absorbable stitch (e.g., MERSILENE® polyester fiber suture, available from J&J Ethicon, Cincinnati, OH).

[0132] In certain embodiments, the final implant position can be determined after the desired shortening has been determined by the surgeon by anchoring the anchoring arms onto the globe of the eye and initially positioning and securing the body onto the globe (e.g., with sutures), followed by pulling the implant forward and pushing it back in. The desired shortening and shape change of the globe of the eye can be determined by measuring the AP length intraoperatively and adjusting it during placement (e.g., with an OCULAR RESPONSE ANALYZER® (ORA) device, Reichert, Inc., Depew, NY), or by referencing a nomogram (e.g., by referencing a chart of previously collected data).

[0133] The present invention provides an easily created surgical pathway for retinal specialists or surgeons familiar with placing sutures on the sclera to place scleral implants, simplifying the procedure for surgeons familiar with retinal detachment repair (e.g., retinal specialists) and surgeons performing strabismus surgery (e.g., surgeons experienced in cutting eye muscles and suturing them back onto the sclera). In some embodiments, the procedure requires cutting the conjunctiva to access the sclera in the desired quadrant. Blunt posterior dissection, such as a tunnel scrape, on the sclera creates a nest or implant location for the implant. The implant is placed in this location, and the body is initially secured onto the globe of the eye (e.g., using sutures). Pulling or pushing the implant still allows the body to slide within the initial attachment, allowing the surgeon to adjust the anterior-posterior positioning to determine where to secure the anterior anchor section (e.g., with additional sutures through the holes). The conjunctiva can be sutured over the implant with or without a biological covering (e.g., TUTOPLAST®) over the implant.

[0134] definition In order that the present disclosure may be more readily understood, certain terms are defined below to provide guidance as to their meanings as used herein throughout the detailed description.

[0135] As used herein, "a," "an," "the," and similar terms used in the context of the present invention shall be construed to encompass both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Thus, for example, "one arm" or "one hole" shall be construed to cover or encompass both a single arm or single hole and multiple arms and multiple holes, unless otherwise indicated herein or clearly contradicted by context.

[0136] As used herein, the terms "about" and "approximately" are generally intended to mean an acceptable degree of error for the quantity measured given the nature or precision of the measurement. Exemplary degrees of error are within 20 percent (%), typically within 10%, and more typically within 5% of a given value or range of values. As used herein, the term "and / or" should be understood to mean "either or both" of the features so conjoined, i.e., the elements present jointly in some cases and separately in other cases.

[0137] As used herein, the terms "comprising," "consisting of," and "consisting essentially of" are defined with their standard meaning. These terms may be substituted for one another herein to add the specific meaning associated with each term.

[0138] As used herein, the term "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating a list of items, "and / or" or "or" shall be interpreted as being inclusive, i.e., including not only at least one, but two or more items, any number of items, and optionally, additional, unlisted items. Conversely, only expressly indicated terms such as "only one of" or "exactly one of," or "consisting of" as used in the claims, shall refer to the inclusion of any number or exactly one element of the listed elements. Generally, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e., "one or the other, but not both") when preceded by exclusive terms such as "any of," "one of," "only one of," or "exactly one of."

[0139] As used herein, the terms "patient" and "subject" are used interchangeably herein to refer to a human or non-human animal.

[0140] As used herein, the terms "device" and "implant" are used interchangeably herein (e.g., with respect to an ophthalmic surgical implant or a staphylococcal support device) unless a clear distinction is made.

[0141] All patents, patent applications, provisional applications, and publications mentioned or cited herein are hereby incorporated by reference in their entirety, including any figures and tables, to the extent they do not contradict the express disclosure of this specification.

[0142] The following are illustrative procedures for carrying out the present invention. These examples are not to be considered limiting. Unless otherwise specified, all percentages are by weight and all mixture ratios are by volume.

[0143] Example 1 - Prospective Surgical Case Study This prospective surgical case study included a patient with extreme myopia (nearsightedness) who had previously undergone unsuccessful macular hole surgery. This patient had a break in the retina in the form of a macular hole, a round hole in the middle, in a highly myopic eye. Prospective macular hole surgery involves placing an air bubble inside the eye and having the patient hold their head down to push the hole closed, allowing the floating air bubble to close the hole. In cases of high myopia, the retina can become so stretched that the hole does not easily close. The patient's previous surgery had not closed the hole. If the wall of the eye could be pushed from the outside, the patient's chances of success would be much better. Placing the implant in a way that brings the wall of the eye forward increases the chances of the macular hole closing.

[0144] The total AP length measured for this patient was approximately 30 mm. Based on preoperative measurements, an implant according to the present invention was designed and manufactured by the inventor (Total Titanium Inc., Red Bud, IL). A 6 mm diameter circular plate was joined to a 5 mm wide body, and a 12 mm wide anchor was configured in the form of a symmetrical Y, with two arms supporting two anterior fixation points and a third central fixation point at the neck of the Y proximal to the body. All fixation points were 1 mm diameter through-holes for suture attachment. The implant was manufactured from 6AL-4EV-ELI titanium flat sheet stock with a uniform thickness of 0.7 mm. Before bending the radius of curvature to the scleral contact surface, the flat pattern length of the implant was 30.5 mm, and the flat pattern length of the anchor section was 5 mm. After bending the radius of curvature to the scleral contact surface, the arcuate length of the implant was approximately 30.5 mm, and the arcuate length of the anchor section was 5 mm. The posterior radius of curvature was 12.5 mm, the anterior radius of curvature was 14.5 mm, and the two curvatures coincided with the condition of the tangent surface along a line 14 mm from the anterior edge of the flat pattern blank and 16.5 mm from the posterior edge of the flat pattern blank. The resulting implant AP length, measured in a straight line from the posterior edge of the scleral contact surface at the plate to the anterior edge of the scleral contact surface at the anchor, was approximately 24 mm.

[0145] Example 2 - Actual surgical case study In this real-life surgical case study, the objective was to introduce a new design for an easily placed titanium staphyloma support device (also called a macular implant or staphyloma support implant) and the surgical technique for its placement in a myopic macular hole.

[0146] A 60-year-old patient with degenerative myopia was diagnosed with macular holes in both eyes. The right eye had a recurrent long hole that had been present for 5 years since the initial consultation. The patient refused surgery because the left eye had good vision. The visual acuity in the right eye was 20 / 400.

[0147] Because there are no commercially available staphyloma support devices, a custom titanium implant was designed and fabricated for this patient (shown in Figure 7). In addition to standard pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade, a titanium staphyloma support device was placed externally to provide a depression over the macula.

[0148] The titanium staphyloma support device provided a 1 mm recess and reduced the axial length from 28.88 mm to 27.94 mm. Postoperatively, the macular hole was closed. Postoperative best-corrected visual acuity was 20 / 400 at 1 month, and there were no complications from the titanium staphyloma support device or surgical procedure.

[0149] Preoperative optical coherence tomography (OCT) and postoperative OCT were recorded. The tip of the implant was visible on postoperative OCT just below the macular cup.

[0150] This surgical case study demonstrates that a titanium staphyloma support device according to the present invention can be advantageously applied for the surgical correction of degenerative myopic macular pathologies, including myopic macular holes.

[0151] It should be understood that the examples and embodiments described herein are for illustrative purposes only, and that various modifications or changes in light thereof will be suggested to those skilled in the art and are within the spirit and scope of this application and the scope of the appended claims. Furthermore, any element or limitation of any invention or embodiment thereof disclosed herein may be combined with any other element or limitation (individually or in any combination) or with any other invention or embodiment thereof disclosed herein, and all such combinations are considered within the scope of the present invention without limitation thereto.

Claims

1. 1. A surgical implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eyeball, comprising: a plate having a concave scleral mating surface configured to restore the natural curvature of the posterior portion of the eye; an anchor having a concave scleral mating surface configured to approximate the natural curvature of the anterior portion of the eye; a body having a continuous, smooth, concave scleral mating surface connecting the plate to the anchor; Including, the eye has the natural axial length and the implant has a total implant length that is less than the natural axial length of the eye; the body has a body width; the plate has a plate width; the body width is greater than half the plate width; the body width is smaller than the plate width; the anchor has an anchor width; the anchor width is greater than the plate width; the anchor width is less than three times the plate width; The anchor is a first anchor point at the center of the body; a second anchor point inside the body, either forward or rearward of the first anchor point; a third anchor point on the exterior of the body, either forward or rearward of the first anchor point; Surgical implants, including:

2. 2. The surgical implant of claim 1, wherein a line drawn from the first anchor point to the second anchor point forms an angle with a line drawn from the first anchor point to the third anchor point that is less than 170 degrees and greater than 10 degrees.

3. The anchor is a first arm connecting the second anchor point to the body and having an arm width smaller than the body width; a second arm connecting the third anchor point to the body, the second arm having an arm width less than the body width.

4. the first arm has a first arm length that is less than a length of the body; The surgical implant of claim 3 , wherein the second arm has a second arm length that is less than a length of the body.

5. The surgical implant of claim 4 , wherein the first arm and the second arm form a Y-shape with respect to the body.

6. The surgical implant of claim 5 , wherein the first arm and the second arm form a Y-shape that is symmetrical about the body.

7. the plate has a first radius of curvature (RP); the anchor has a second radius of curvature (RA); The surgical implant of claim 1 , wherein the first radius of curvature is less than the second radius of curvature (RP<RA).

8. the body has a first radius of curvature (RB1) adjacent the plate; the body has a second radius of curvature (RB2) proximate the anchor; The surgical implant of claim 7 , wherein the first radius of curvature is less than the second radius of curvature (RB1<RB2).

9. the connection between the plate and the body is continuous and smooth at the concave sclera-matching surface; The surgical implant of claim 8 , wherein the connection between the body and the anchor is continuous and smooth at the concave scleral-mating surface.

10. 9. The surgical implant of claim 8, wherein the body has a gradual curvature transition that maintains a surface tangent between the first radius of curvature (RB1) and the second radius of curvature (RB2).

11. The surgical implant of claim 8 , wherein the body has a third radius of curvature (RB3) different from RB1 and RB2.

12. 9. The surgical implant of claim 8, wherein RB3 is greater than twice RB2.

13. The surgical implant of claim 8 , wherein the body has a neutral curvature region.

14. 1. A surgical implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eyeball, comprising: a plate having a concave scleral mating surface configured to restore the natural curvature of the posterior portion of the eye; an anchor having a concave scleral-matching surface configured to approximate the natural curvature of the anterior portion of the eye; a body having a continuous, smooth, concave scleral mating surface connecting the plate to the anchor; the eye has a natural axial length and the implant has a total implant length that is less than the natural axial length of the eye; the body has a body width; the plate has a plate width; the body width is greater than half the plate width; the body width is smaller than the plate width; the anchor has an anchor width; the anchor width is greater than the plate width; the anchor width is less than three times the plate width; the plate has a plate thickness; the body having a body thickness; the anchor has an anchor thickness; the plate thickness, the body thickness, and the anchor thickness are each approximately equal; The anchor further comprises: a first anchor point at the center of the body; a second anchor point inside the body, either forward or rearward of the first anchor point; a third anchor point on the exterior of the body, either forward or rearward of the first anchor point, wherein a line drawn from the first anchor point to the second anchor point forms an angle with a line drawn from the first anchor point to the third anchor point that is less than 170 degrees and greater than 10 degrees; a first arm connecting the second anchor point to the body and having an arm width less than the body width; a second arm connecting the third anchor point to the body and having an arm width smaller than the body width; the first arm has a first arm length that is less than a length of the body; the second arm has a second arm length that is less than the length of the body; The surgical implant, wherein the first arm and the second arm form a symmetric Y-shape about the body.

15. 1. A surgical implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eyeball, comprising: a plate having a concave scleral mating surface configured to restore the natural curvature of the posterior portion of the eye; an anchor having a concave scleral-matching surface configured to approximate the natural curvature of the anterior portion of the eye; a body having a continuous, smooth, concave scleral mating surface connecting the plate to the anchor; the eye has a natural axial length and the implant has a total implant length that is less than the natural axial length of the eye; the body has a body width; the plate has a plate width; the body width is greater than half the plate width; the body width is smaller than the plate width; the anchor has an anchor width; the anchor width is greater than the plate width; the anchor width is less than three times the plate width; the plate has a plate thickness; the body having a body thickness; the anchor has an anchor thickness; the plate thickness, the body thickness, and the anchor thickness are each approximately equal; the plate has a first radius of curvature (RP); the anchor has a second radius of curvature (RA); the first radius of curvature is smaller than the second radius of curvature (RP<RA); the body has a first radius of curvature (RB1) adjacent the plate; the body has a second radius of curvature (RB2) proximate the anchor; the first radius of curvature is smaller than the second radius of curvature (RB1<RB2); the connection between the plate and the body is continuous and smooth at the concave sclera-matching surface; the connection between the body and the anchor is continuous and smooth at the concave scleral-matching surface; A surgical implant, wherein the body has a gradual curvature transition that maintains a surface tangent between the first radius of curvature (RB1) and the second radius of curvature (RB2).

16. 1. A surgical implant for improving a patient's vision by restoring the natural curvature and natural axial length of the eyeball, comprising: a plate having a concave scleral mating surface configured to restore the natural curvature of the posterior portion of the eye; an anchor having a concave scleral mating surface configured to approximate the natural curvature of the anterior portion of the eye; Including, the eye has a natural axial length and the implant has a total implant length that is less than the natural axial length of the eye; the anchor has a minimum anchor width; the anchor has a maximum anchor width; the plate has a plate width; the minimum anchor width is greater than half the plate width; the maximum anchor width is less than three times the plate width; the anchor has an average anchor width; the average anchor width is greater than the plate width; the average anchor width is less than three times the plate width; The anchor is a first anchor point at the center of the implant; a second anchor point medial to the implant and either anterior or posterior to the first anchor point; a third anchor point external to said implant and either anterior or posterior to said first anchor point.

17. 17. The surgical implant of claim 16, wherein a line drawn from the first anchor point to the second anchor point forms an angle with a line drawn from the first anchor point to the third anchor point that is less than 170 degrees and greater than 10 degrees.

18. The anchor is a first arm connecting the second anchor point to the plate and having an arm width smaller than the plate width; a second arm connecting the third anchor point to the plate, the second arm having an arm width less than the plate width.

19. the first arm has a first arm length that is less than three-quarters of the implant length; 20. The surgical implant of claim 18, wherein the second arm has a second arm length that is less than 3 / 4 of the implant length.

20. 20. The surgical implant of claim 19, wherein the first arm and the second arm form a Y-shape with respect to the plate.

21. 21. The surgical implant of claim 20, wherein the first arm and the second arm form a Y-shape that is symmetrical about the plate.

22. the plate has a first radius of curvature (RP); the anchor has a second radius of curvature (RA); 17. The surgical implant of claim 16, wherein the first radius of curvature is less than the second radius of curvature (RP<RA).

23. the implant has a first radius of curvature (RB1) proximal to the plate; the implant has a second radius of curvature (RB2) proximal to the anchor; 23. The surgical implant of claim 22, wherein the first radius of curvature is less than the second radius of curvature (RB1<RB2).

24. 24. The surgical implant of claim 23, wherein the connection between the plate and the anchor is continuous and smooth at the concave scleral-mating surface.

25. 24. The surgical implant of claim 23, wherein the implant has a gradual curvature transition that maintains a surface tangent between the first radius of curvature (RB1) and the second radius of curvature (RB2).

26. 24. The surgical implant of claim 23, wherein the implant has a third radius of curvature (RB3) different from RB1 and RB2.

27. 24. The surgical implant of claim 23, wherein RB3 is greater than twice RB2.

28. 24. The surgical implant of claim 23, wherein the implant has a neutral curvature region.

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