Scleral prosthesis for treatment of presbyopia and other eye disorders

Abstract

Presbyopia is treated by implanting within a plurality of elongated pockets formed in the tissue of the sclera of the eye transverse to a meridian of the eye, a prosthesis having an elongated base member having an inward surface adapted to be placed against the inward wall of the pocket and having a ridge on the inward surface of the base extending along at least a major portion of the major dimension of the base. The combined effect of the implanted prostheses is to exert a radially outward traction on the sclera in the region overlying the ciliary body which expands the sclera in the affected region together with the underlying ciliary body. The expansion of the ciliary body restores the effective working distance of the ciliary muscle in the presbyopic eye and thereby increases the amplitude of accommodation. Hyperopia, primary open angle glaucoma and/or ocular hypertension can be treated by increasing the effective working distance of the ciliary muscle according to the invention.

1 . An ocular scleral prosthesis comprising 
 a base member having an elongated planform with a major dimension, a minor dimension, an inner major surface and an outer major surface, said outer major surface being generally smooth and adapted to contact ocular tissue within a pocket surgically formed within scleral tissue of an eye, and    a ridge member on said inner major surface of said base member, extending along at least a substantial fraction of said major dimension of said base.    
     
     
         2 . The prosthesis of  claim 1  wherein said anterior rim is anteriorly concave and said posterior rim is posteriorly convex.  
     
     
         3 . The prosthesis of  claim 1  wherein said outer major surface of said base is planar.  
     
     
         4 . The prosthesis of  claim 1  wherein said outer major surface of said base is outwardly convex along said major dimension.  
     
     
         5 . The prosthesis of  claim 1  wherein said planform is generally rectangular.  
     
     
         6 . The prosthesis of  claim 1  wherein said planform has semicircular ends.  
     
     
         7 . The prosthesis of  claim 1  wherein said planform is elliptical.  
     
     
         8 . The prosthesis of  claim 1  wherein said ridge extends along substantially the entire major dimension of said base.  
     
     
         9 . The prosthesis of  claim 1  wherein said ridge extends along a portion of said major dimension of said base member.  
     
     
         10 . The prosthesis of  claim 1  wherein said ridge has a maximum height above said base located intermediate between said anterior edge and said posterior edge.  
     
     
         11 . The prosthesis of  claim 10  wherein said maximum height of said ridge is located less than halfway from said anterior edge to said posterior edge.  
     
     
         12 . The prosthesis of  claim 1  wherein said maximum height of said ridge is located about 12% of the distance from said anterior edge to said posterior edge.  
     
     
         13 . The prosthesis of  claim 1  wherein said maximum height of said ridge is located at said anterior edge.  
     
     
         14 . The prosthesis of  claim 1  wherein said major dimension is about 5 millimeters.  
     
     
         15 . The prosthesis of  claim 1  wherein said minor dimension is about 2 millimeters.  
     
     
         16 . The prosthesis of  claim 1  wherein said prosthesis is made of a physiologically acceptable metal.  
     
     
         17 . The prosthesis of  claim 1  wherein said prosthesis is made of metal selected from the group consisting of titanium, platinum, gold, tantalum, stainless steel, and physiologically acceptable alloys.  
     
     
         18 . The prosthesis of  claim 1  wherein said prosthesis is made of a ceramic material.  
     
     
         19 . The prosthesis of  claim 18  wherein said ceramic is selected from the group consisting of porcelain, alumina, silica, silicon carbide, and high-strength glasses.  
     
     
         20 . The prosthesis of  claim 1  wherein said prosthesis is made of a synthetic resin.  
     
     
         21 . The prosthesis of  claim 20  wherein said synthetic resin is selected from the group consisting of poly(methyl methacrylate), polyethylene, polypropylene, poly(tetrafluoroethylene), polycarbonate, and silicone resins.  
     
     
         22 . The prosthesis of  claim 1  wherein said prosthesis is made of a reinforced composite material.  
     
     
         23 . The prosthesis of  claim 22  wherein said reinforced composite material is a glass-fiber-reinforced synthetic resin.  
     
     
         24 . The prosthesis of  claim 22  wherein said reinforced composite material is a carbon-fiber-reinforced material.  
     
     
         25 . The prosthesis of  claim 22  wherein said reinforced composite material is carbon-fiber-reinforced carbon.  
     
     
         26 . The prosthesis of  claim 1  wherein said prosthesis is made of flexible material and is provided with an internal cavity filled with a fluid or a gel.  
     
     
         27 . The prosthesis of  claim 26  wherein said fluid is water or a physiological saline solution.  
     
     
         28 . The prosthesis of  claim 26  wherein said gel is a silicone material, or collagen, or gelatin.  
     
     
         29 . The prosthesis of  claim 26  wherein said fluid is a physiologically acceptable oil.  
     
     
         30 . The prosthesis of  claim 29  wherein said fluid is a silicone oil.  
     
     
         31 . The prosthesis of  claim 1  wherein said prosthesis is provided with at least one hole for the passage of a suture.  
     
     
         32 . A method for treating presbyopia comprising 
 forming a plurality of elongated pockets, each having a lengthwise dimension, in a sclera of said eye, said lengthwise dimension being oriented generally transversely to a meridian of said eye, 
 said eye having a sclera forming a generally globular outer layer of said eye, a transparent cornea forming an anterior surface of said eye, a limbus formed by the junction of said cornea with said sclera, a generally circular ciliary body located inwardly of said sclera posterior to said limbus, and a crystalline lens located centrally within said ciliary body and having an equator, said equator of said lens defining a plane intersecting said sclera in a generally circular intersection posterior to said limbus,  
 said pockets having an anterior margin and a posterior margin, said anterior margin being located a distance of from about 0.5 millimeters to about 4.5 millimeters posterior to said limbus; and  
   positioning in each of said pockets a prosthesis according to  claim 1 , with said anterior edge of said prosthesis oriented toward the anterior portion of said eye and said inner major surface with said ridge oriented inwardly.    
     
     
         33 . A method for treating hyperopia comprising 
 forming a plurality of elongated pockets, each having a lengthwise dimension, in a sclera of said eye, said lengthwise dimension being oriented generally transversely to a meridian of said eye, 
 said eye having a sclera forming a generally globular outer layer of said eye, a transparent cornea forming an anterior surface of said eye, a limbus formed by the junction of said cornea with said sclera, a generally circular ciliary body located inwardly of said sclera posterior to said limbus, and a crystalline lens located centrally within said ciliary body and having an equator, said equator of said lens defining a plane intersecting said sclera in a generally circular intersection posterior to said limbus,  
 said pockets having an anterior margin and a posterior margin, said anterior margin being located a distance of from about 0.5 millimeters to about 4.5 millimeters posterior to said limbus; and  
   positioning in each of said pockets a prosthesis according to  claim 1 , with said anterior edge of said prosthesis oriented toward the anterior portion of said eye and said inner major surface with said ridge oriented inwardly.    
     
     
         34 . A method for treating primary open angle glaucoma comprising 
 forming a plurality of elongated pockets, each having a lengthwise dimension, in a sclera of said eye, said lengthwise dimension being oriented generally transversely to a meridian of said eye, 
 said eye having a sclera forming a generally globular outer layer of said eye, a transparent cornea forming an anterior surface of said eye, a limbus formed by the junction of said cornea with said sclera, a generally circular ciliary body located inwardly of said sclera posterior to said limbus, and a crystalline lens located centrally within said ciliary body and having an equator, said equator of said lens defining a plane intersecting said sclera in a generally circular intersection posterior to said limbus,  
 said pockets having an anterior margin and a posterior margin, said anterior margin being located a distance of from about 0.5 millimeters to about 4.5 millimeters posterior to said limbus; and  
   positioning in each of said pockets a prosthesis according to  claim 1 , with said anterior edge of said prosthesis oriented toward the anterior portion of said eye and said inner major surface with said ridge oriented inwardly.    
     
     
         35 . A method for treating ocular hypertension comprising 
 forming a plurality of elongated pockets, each having a lengthwise dimension, in a sclera of said eye, said lengthwise dimension being oriented generally transversely to a meridian of said eye, 
 said eye having a sclera forming a generally globular outer layer of said eye, a transparent cornea forming an anterior surface of said eye, a limbus formed by the junction of said cornea with said sclera, a generally circular ciliary body located inwardly of said sclera posterior to said limbus, and a crystalline lens located centrally within said ciliary body and having an equator, said equator of said lens defining a plane intersecting said sclera in a generally circular intersection posterior to said limbus,  
 said pockets having an anterior margin and a posterior margin, said anterior margin being located a distance of from about 0.5 millimeters to about 4.5 millimeters posterior to said limbus; and  
   positioning in each of said pockets a prosthesis according to  claim 1 , with said anterior edge of said prosthesis oriented toward the anterior portion of said eye and said inner major surface with said ridge oriented inwardly.