WO2004066870A2

WO2004066870A2 - Combined iol and scleral implants and method of use

Info

Publication number: WO2004066870A2
Application number: PCT/US2004/002189
Authority: WO
Inventors: Howard N. Straub
Original assignee: Restorvision Ltd
Priority date: 2003-01-27
Filing date: 2004-01-27
Publication date: 2004-08-12
Also published as: WO2004066870A3

Abstract

This invention relates to presbyopia and in particular, it relates to the combined use of intraocular lenses and scleral implants (2) and method of use in subjects without a crystalline lens or with a crystalline lens and also an implanted artificial lens.

Description

COMBINED IOL AND SCLERAL IMPLANTS AND METHOD OF USE

Cross References To Related Applications

This application claims benefit of U.S. Provisional Patent Application Serial No.

60/442,698, filed January 27, 2003, which is incorporated herein by reference in its entirety.

Field of the Invention

This invention relates to presbyopia and in particular, it relates to the combined use of intraocular lenses and scleral implants and method of use in subjects without a crystalline lens or with a crystalline lens and also an implanted artificial lens.

Background of the Invention

The human eye has an anterior chamber between the cornea and the iris, a posterior chamber behind the iris containing a crystalline lens, a vitreous chamber behind the lens containing vitreous humor, and a retina at the rear of the vitreous chamber. The crystalline lens of a normal human eye has a lens capsule attached about its periphery to the ciliary muscle of the eye by zonules and containing a crystalline lens matrix. This lens capsule has elastic optically clear anterior and posterior membrane-like walls commonly referred by ophthalmologists as anterior and posterior capsules, respectively. Between the iris and ciliary muscle is an annular crevice-like space called the ciliary sulcus.

Commonly, the human eye possesses a natural accommodation capability. Natural accommodation involves relaxation and constriction of the ciliary muscle by the brain to provide the eye with near and distant vision. Without being bound by any particular theory it is believed that ciliary muscle action is automatic and shapes the natural crystalline lens to the appropriate optical configuration for focusing on the retina the light rays entering the eye from the scene being viewed, h subject with crystalline lenses presbyopia that arises almost universally among people in their 40s. Presbyopia is a reduction in the ability to focus on near objects. This is a loss of reading vision.

The human eye is subject to a variety of disorders which degrade or totally destroy the ability of the eye to function properly. One of the more common of these disorders involves progressive clouding of the natural crystalline lens matrix resulting in the formation of what is referred to as a cataract. It is now common practice to treat a cataract by surgically removing the cataractous human crystalline lens and implanting an intraocular lens ("IOL") in the eye to replace the natural lens. Implantation of artificial lenses into the human eye has been a standard technique for many years, both to replace the natural or crystalline lens (aphakic eye) and to supplement and correct refractive errors of the natural lens (phakic eye). In the past 40 years over 200 million IOLs have been implanted. Many types of IOLs are known. Intraocular lenses are described in the following U.S. Pat. Nos. 4,254,509, 4,298,996, 4,842,601, 4,963,148, 4,994,082, 5,047,051. h some embodiments design elements are directed to , accommodation. Reference is made to Lang et al, US Pat. No. 6,503,276, Levy U.S. Pat. No. 4,409,691 and several patents to Gumming, including U.S. Pat. Nos. 6,494,111, 5,674,282 and 5,496,366. The disclosure of each of these patents is incorporated herein by reference

In some subjects, scleral implants improve reading vision in eyes with crystalline lenses, with particularly reference to subjects with presbyopia . Presbyopia arises almost universally among people in their 40s. This has been discussed in OPHTHALMIC DEVICE AND METHOD OF MANUFACTURE AND USE (Straub) WO0117460, the teachings of which are incorporated herein by reference. Another scleral device is disclosed in Scleral Prosthesis for Treatment of Presbyopia and Other Eye Disorders (Schachar) US 6,007,578, the teachings of which are incorporated herein by reference.

Historically, in subjects with cataracts, lensectomy was surgically performed by either intracapsular extraction involving removal of the entire human lens including both its outer lens capsule and its inner crystalline lens matrix, or by extracapsular extraction involving removal of the anterior capsule of the lens and the inner crystalline lens matrix but leaving intact the posterior capsule of the lens. Another surgical procedure is anterior capsulotomy Anterior capsulotomy involves forming an opening in the anterior capsule of the natural lens, leaving intact within the eye a capsular bag having an elastic posterior capsule, and anterior capsular remnant or rim about the anterior capsule opening, and an annular sulcus, referred to herein as a capsular bag sulcus, between the anterior capsule remnant and the outer circumference of the posterior capsule. This capsular bag remains attached about its periphery to the surrounding ciliary muscle of the eye by the zonules of the eye. The cataractous natural lens matrix is extracted from the capsular bag through the anterior capsule opening by phacoemulsification and aspiration or in some other way after which an intraocular lens is implanted within the bag through the opening.

In some instances a form of anterior capsulotomy known as capsulorhexis is performed. This is essentially a continuous tear circular or round capsulotomy. A capsulorhexis is performed by tearing the anterior capsule of the natural lens capsule along a generally circular tear line substantially coaxial with the lens axis and removing the generally circular portion of the anterior capsule surrounded by the tear line. A continuous tear circular capsulotomy or capsulorhexis, provides a generally circular opening through the anterior capsule of the natural lens capsule substantially coaxial with the axis of the eye and surrounded circumferentially by a continuous annular remnant or rim of the anterior capsule having a relatively smooth and continuous inner edge bounding the opening.

Another anterior capsulotomy procedure, referred to as an envelope capsulotomy. Another capsulotomy procedure is referred to as a beer can or can opener capsulotomy.

There are four possible placements of an intraocular lens within the eye. These are (a) in the anterior chamber, (b) in the posterior chamber, (c) in the capsular bag, and (d) in the vitreous chamber. All placements are contemplated in the practice of this invention.

Summary of the Invention

This invention includes a method of presbyopia palliation the eye of a subject with an intraocular lens comprising the steps of placing at least one scleral-implant in the pars plana of the sclera. In some embodiments the method further includes a scleral implant is placed in the pars plan in a position selected from about 2:00, 4:00, 8:00 and 10:00, and optionally wherein at least about 2 scleral implants are placed in the pars plana.

This invention further includes a method of treating an eye having a cataractous lens in an eye comprising both removal of the cataractous lens followed by replacement of said cataractous lens with an intraocular lens, and insertion of at least one scleral implant in the pars plana of said eye. hi yet another embodiment the invention includes amethod of treating an eye having a mammalian crystalline lens in an eye comprising both removal of the lens followed by replacement of said lens with an intraocular lens, and insertion of at least one scleral implant within the sclera in the region of the pars plana of said eye.

In a further embodiment the invention includes a method of presbyopia palliation for a subject with presbyopia and two eyes and further with an intraocular lens in one eye and a crystalline lens in the other eye comprising the step of placing at least one scleral-implant in the eye with the crystalline lens such placement being in the pars plana.

Brief Description of the Drawings

Fig. 1(a) is a top plan view of a scleral stent, one embodiment, of the present invention.

Fig. 1(b) is a side elevational view thereof; Fig. 1(c) is a section view according to section line A-A of Fig. lb.

Fig. 1(d) is a rear elevational view of the scleral stent of Fig. 1(a); Fig. 1(e) is a semi-perspective view showing a stent protruding from a scleral tunnel; Fig. 1(f) is a side elevation in cutaway showing a stent protruding from a scleral tunnel; Fig. 2(a) is a cut away view of an eye with an IOL but no scleral implant.

Fig. 2(b) is a cut away view of an eye with an scleral implant and an IOL. Fig. 3 is a particular embodiment of a scleral implant.

Fig. 4(a) and (b) is two views of a particular embodiment of a scleral implant with insert cross-bars at each end. Fig. 5 is a front elevational view of the ocular globe showing location of the stents at

10:00, 2:00, 4:00 and 8:00.

Fig. 6(a) is a top plan view illustrating the stent of the "pull-through" assembly; and Fig. 6(a)(b) illustrates the stent of 16(a) with a stent pulling device. Detailed Description of the Invention This invention will be better understood with reference to the following definitions. A. Scleral implants (or stents) of this invention include a variety of implants used in ophthalmic surgery. One source of scleral implants is Restorvision, Ltd. Christ Church Barbados.

In some embodiments scleral implants are dimensioned from about 2 mm to about 6 mm, in length with particular reference to about 4.75 to about 5 mm. In particular embodiments the implants are tapered from the sides with a narrow end of about 550 microns to about 650 microns and a wide end of about 600 to about 850 microns adjoining a flange of about 1000 to about 15 hundred microns with particular reference to about 1200 microns. Implants with the long axis generally describing an arc are noted with a radii at the upper surface of from about 3 to about 10 mm with particular reference to about 4.0 to about 4.7 mm and particularly about 4.4 mm. Implants with the long axis generally describing and arc are noted with a radii at the lower surface of from about 3 to about 15 mm with particular reference to about 7 to about 10 mm.

For convenience, scleral implant shall be broadly construed to include sleral plugs such as silicone scleral plugs described in "Anterior ciliary sclerotomy with silicone expansion plug implantation: effect on presbyopia and intraocular pressure," Hideharu Fukasaku et al, frit Ophthalmol Gin. 2001 Spring;41(2): 133-41. Further, particular attention is drawn to surgical and laser surgical procedures to enlarge the globe at the pars plana as included in the meaning of scleral implant as have been described by Surgilight, Inc. (Orlando Florida).

In addition, noted are scleral implants which press inward on the sclera cause an inward displacement of the ciliary muscle. This inward displacement causes an axipetal movement of the ocular contents, effecting the vitreous body to push the intraocular lens to forward, allowing the eye to focus for near. h particular embodiments, a pressing scleral implant is fashioned of any suitable material with attention to bio-compatibility. For example poly-methyl methacrylate ("PMMA"), both thermosetting and thermoplastic, are suitable. PMMA is supplied by a number of sources. Thermosetting PMMA is available as Perspex CQ (ICI Derby,

England). Thermosetting PMMA is preferred over thermoplastic PMMA because it is out- gassing free. That is, it does not release monomers in situ. Teflon® and tantalum are also noted. It is also possible to coat implants with bio-compatible materials if elements of the implant are not bio-compatible. In some embodiments the implant materials contain pigments or dyes. In particular embodiments implants are coated or impregnated with bioactive substances including anti-inflammatory agents/immunomodulating agents and antiinfective agents. Particular implants will contain radio-opaque, radioactive, fluorescent, NMR contrast or other "reporter" materials. Smooth implants with no more than 100 μ peak to valley are noted. A particular advantage of such a smooth surface is the reduction of implant erosion into or out of the sclera. In particular embodiments textured implants are useful permitting adhesion with associated tissues.

Preferably, placement of the implants is adjusted to avoid compression of the ciliary arteries. Placement is preferred at about the 2:00, 4:00, 8:00 and 10:00 positions around the globe. Such placement comprises non-circulatory-compression arcs. Placement compressing the ciliary arteries, in some instances, leads to anterior segment ischemia, h some embodiments it is useful to place implants anywhere from about 3 to about 8 mm and preferably about 4 to 6 mm posterior to the limbus in the oblique quadrants of the eye at a depth of about 250 to about 350 microns within scleral tunnels that are about 3 to 5 mm long and preferably about 3.8 to 4.0 mm long.

Without being bound by any particular theory, it is believed that scleral implants cause compression or indentation on the sclera into the eye.

B. Crystalline lens shall mean the lens of the human or mammalian eye. In non- cataractous state the lens is a transparent bi-convex body or crystalline in appearance and situated between the iris and the vitreous. The diameter of the lens in humans is about 9-10 mm. Its axial diameter varies markedly with accommodation. By direct measurement it is about 3.5 or 4.0 mm at birth. About 4 mm at age 50 years, increasing slowly to 4.75 to 5.0 mm in extreme old age. Like all lenses, the human lens has two surfaces, anterior and posterior, and a border where these surfaces meet, known as the equator (equator lentis).

The anterior surface, less convex than the posterior, is the segment of a sphere whose radius averages 10 mm (8.0 to 14.0 mm).

The center of the anterior surface is known as the anterior pole and is about 3 mm from the back of the cornea.

The posterior surface, more curved than the anterior, presents a radius of about 6mm (4.5 to 7.5 mm). It is usually described as lying in a fossa lined by the hyaloid membrane on the front of the vitreous, but it is separated from the vitreous by a slight space filled the primary vitreous.

C. Intraocular lens are replacements for crystalline lenses. Intraocular lenses can be of varying shapes and designs. The lens optic itself, can be made of poly-methyl methacrylate ("PMMA"), vulcanized silicone, acrylic, or other materials. The optic diameter is about 5 to 6 mm, and the surfaces can be bi-convex, or piano convex. The lenses usually have haptics to hold the lens in position in the human capsular bag. These lenses can be "modified C" style, with angulations of 0 to 15 degrees. The haptics can be made of polyimide, in lenses of three-piece construction, or of the same material as the optic in one piece constructed lenses.

D. Phakic and aphakic & pseudphakic are terms reference the presen or absence of a crystalline lens. Phakic shall mean a mammalian (human) eye with the original crystalline lens in place. Aphakic shall mean a mammalian (human eye) whose crystalline lens has been removed and not replaced with an artificial lens. Customarily in humans, the refractive correction removed by surgical or traumatic removal of the human lens is replaced through spectacles or contact lenses of high power. Pseudophakic shall mean a mammalian (human) eye in which an artificial lens has been replaced after the human lens has been removed.

E. Cataract is a condition wherein the crystalline lens loses transparency, h particular conditions the protein in a human lens denatures and the lens becomes opaque. Opacities in the human lens are referred to as cataracts. Cataracts can be of different sizes and shapes, and have different positions within the lens, and are identified by these characteristics. Some types of cataracts are (i) Nuclear Sclerotic - Sclerosis of the central portion of the human lens, (ii) Cortical - Opacity of the cortical cells surrounding the nucleus of the lens, and (iii) Posterior Subcapsular - Cataract forming in the posterior portion of the lens.

F. pars plana of the sclera shall mean the region of the sclera of the eye, within the first 6 mm posterior to the corneal limbus or corneo-scleral junction.

Referring now to Figs. 1(a) - 1 (d), which illustrate one embodiment of a scleral implant or stent of the invention. A scleral stent 2 of the invention is adapted for positioning in a tunnel formed in a sclera of an eye. The stent (2) comprises a generally T- shaped body having a torsion-resistant element, a flange or a cross portion (6) formed with a substantially flat rear bottom surface (10) and a leg portion (4) extending outwardly from a side surface of the portion and having a substantially flat front bottom surface (8). The leg portion (4) is formed with a bottom area having an arcuate region (7) which extends rearwardly from the front bottom surface (8) so that its rear end is situated in the close vicinity to the cross-portion (6). A curvature of the arcuate region (7) is greater than the curvature of the globe in an area of the tunnel. Thus, at least a portion of the arcuate region (7) is adapted to increase the diameter of the scleral size adjacent the tunnel when the stent is positioned within the tunnel. Upon proper positioning of the stent of the invention, the rear bottom surface (10) of the cross portion (6) is adapted to be disposed externally to the tunnel.

As best illustrated in Figures 1 (a) and 1 (b), the stent (2) in general and a top area thereof in particular are formed with a front tapered region (12) and a rear tapered region (14). The front tapered region 12 extends rearwardly from a rounded front tip (16) of the leg portion (6) and is provided to facilitate insertion of the stent into the tunnel during the surgery. The rear tapered region (14) slopes downwardly from an area in the vicinity of the junction between the cross portion (6) and the leg portion (4) toward the rear end of the stent.

Fig. 1(b) represents a side elevational view of the scleral stent (2) of Fig. l(a).The total height M-N of the arched stent (2) is about 900 microns based on an 8.8 mm base curve. To facilitate insertion of the stent into the tunnel during surgery, the front tapered region (12) is provided. Taper is noted as angle θ which is from about 25° to about 45°. The length of the front torsion-resistant element or substantially flat bottom surface (8) is about 500 microns. The length of the substantially flat rear bottom surface (10) performing torsion-resistant function is about 500 microns. Referring now to Fig. 1(c) which represent a sectional view of the stent according to section line A-A of Fig. 1(b). The height of the segment G-H is about 500 microns, whereas the total height of the segment G-I is from about 700 to about 1000 microns with particular reference to about 900 microns.

As to Fig. 1 (d), the width of the flange (6) is about 1200 microns. Fig. 1(e) is a side view of the stent (2) positioned within a tunnel in the sclera (1).

The stent in general and the leg portion (4) in particular are situated within the tunnel in such a manner that the front substantially flat surface (8) and the rear substantially flat surface (10) extend outwardly therefrom. Fig. 1(f) is a side elevation in cutaway showing a stent protruding from a scleral tunnel wherein the stent (2) is positioned within a tunnel in the sclera (1). The stent in general and the leg portion (4) in particular are situated within the tunnel in such a manner that the front substantially flat surface (8) and the rear substantially flat surface (10) extend outwardly therefrom and showing a space (9) between the floor of the scleral tunnel and leg portion (4).

Fig. 2(b) is a cut away view of an eye with an scleral implant and an IOL. Fig. 2(a) is a cut away view of an eye with an IOL but no scleral implant. Without being bound by any particular theory it is believed that the reading implant as inserted into the sclera in the pas plana presses inward . This pressure moves or displaces the IOL forward. Fig. 3 is a particular embodiment of a scleral implant. This embodiment has en enlarged flange portion in the shape of a ring.

Fig. 4(a) and (b) are two views of a particular embodiment of a scleral implant with insert cross-bars at each end. The cross-bar is insertable into a horizontal hole in the tip of a scleral implant configured to tightly and fixably engage the cross-bar. In Fig. 4(a) one cross-bar is already inserted and one is in position to insert. In Fig. 4(b) both cross-bars are inserted.

Fig. 5 is a view of the ocular globe (200)with intrasclerally implanted devices. Position of the IOL is not shown in this figure. The outer layer of the eye is the sclera (202) and the external muscles (218). The cornea (214) is the most anterior structure with the pupil (224) seen behind and central thereto. The limbus (216) is the junction of sclera (202) and cornea (214). Tunnels (220) in the sclera are seen with anterior margins (222) about 4 to 5 millimeters posterior to the limbus (216). Each tunnel (220) contains the stent (204) having the front end (207) protruding from one end thereof and a flange (206) protruding from the other end. The body (205) of the stent positioned within the tunnel is shown in phantom. The stent is oriented with its protruding front end (207) and flange (206) resting on the sclera and its arcuate peak (205) within the tunnel.

As best illustrated in Fig. 6(a) the rounded front end (312) of the stent (310) is formed with an attachment opening (314) The attachment hole is of 0.34 mm in diameter. Dimensionally, the stent is 600 microns wide at the tip bearing attachment hole (314). The stent is 750 microns wide at A-A as it joins the flange element (306). The total length is 4.75 mm. The top is curved from 200 microns in height at the ends to 900 microns at the center of the long axis (apical height). Fig. 6(b) illustrates the pulling arrangement (320) in the form of a semi-rigid member having a handle (324) and a stent engagement means (322) adapted for engagement with the opening (314). Upon securing of a connection between these elements, an operator can draw the stent into the tunnel. Fig. 1(f) is a side elevation in cutaway showing a implant protruding from a scleral tunnel wherein the implant (2) is positioned within a tunnel in the sclera (1). The implant in general and the leg portion (4) in particular are situated within the tunnel in such a manner that the front substantially flat surface (8) and the rear substantially flat surface (10) extend outwardly therefrom and showing a space (9) between the floor of the scleral tunnel and leg portion (4).

It is specifically contemplated within the instant invention that a scleral implant procedure may be performed, before, after , or at the same time as an IOL procedure. It is further noted that in particular instances, a scleral implant will be placed in one eye or both eyes of a subject. Similarly an intraocular lens may be placed in one eye or both eyes of a subject. Surprisingly, scleral implants placed in one eye have been found to improve vision in both eyes of a subject. In some instances in the practice of the present invention, scleral implantation will be performed in only a single eye of a subject. In some embodiments, that subject will have an intraocular lens implanted in both eyes, the eye ultimately having scleral implantation, or an IOL in one eye and a scleral implant in the other eye. Further, in some subjects, the cataractous lens will not be removed and/or replaced by an IOL. Scleral implants in such subjects improve vision to the point at which cataract removal is not necessary. In some embodiments a clear crystalline lens is removed and replaced with an IOL.

COMBINATION IOL IMPLANT AND SCLERAL IMPLANT PLACEMENT In the practice of this invention at least one sclearal implant and one IOL are placed in a first eye of a subject. In some instances more than one scleral implant is placed in a single eye of a subject , with particular reference to two and four scleral implants. Typically an IOL will be placed in both eyes, but single eye IOLS are also contemplated. In particular situations based on the subjects condition and the judgment of an attending medical professional, at least one scleral implants is placed in the second eye of the subject.. Scleral implants are implanted either before or after an IOL, or at the same time. Given the large number of implanted IOLs at this date, a significant number of procedures entail inserting scleral implants long after the IOLs have been placed within an eye. In some embodiments a subject with reading implants will later receive at least one IOL. h one embodiment of the surgical procedure IOLs are placed in both eyes of a subject in need of such treatment.

About 3 months thereafter, the eye is "quiet" and at least one scleral implant are then placed in at least one of the eyes. Particular not is made of placing two scleral implants in a single IOL bearing eye of a subject. For Scleral implant placement the first step is to place a drop of 0.5% proparacaine in the eye of a subject being surgically treated. Next, mark the eye at the 12:00 and 6:00 positions with the subject seated at a slit lamp, using an 18-gauge sterile needle.

After that, the subject is placed supine upon the operating table and the eye is prepped with full strength Povidone-Iodine (Betadine™ Solution). Sterilization preparations which contain soap are not recommended (e.g., Betadine™ Prep). The procedure is perfoπned under monitored local anesthesia. Systemic medications, such as Valium, are optionally used for relaxation.

A microscope is centered and the eye is draped using a 3M™ 1020 plastic eye drape. Another drop of 0.5% proparacaine is placed in the eye and a lid speculum is inserted in the conjunctival gutters. The 10:00, 2:00, 4:00 and 8:00 positions are marked, using Gentian Violet or Brilliant Green, using the previously marked 12:00 position as a reference.

In an embodiment employing two implants, two horizontal incisions of 6mm are made in the conjunctiva tangential to, and approximately 5-7 mm posterior to, the corneal limbus. If required, bi-polar cautery is used for hemostasis. Dissection is performed down through Tenon's Capsule to the sclera and anteriorly over the sclera to the corneal limbus (clearing the area of sclera to be operated).

Marks are made 2 mm to either side of the previously marked 45-degree meridians (10:00, and 2:00, positions), to map the entrance and exit of each scleral tunnel. Two partial thickness scleral incisions are made with the Diamond Punch Blade™ in the areas of these marks. The incisions should be about 250-350 microns deep and parallel to each other at a distance of approximately 4-mm, and 2-3.5 mm posterior to the corneal limbus. The Spatula Blade™ is used to tunnel between these two partial thickness incisions. The scleral implants are inserted in the tunnels and positioned, making sure that at least about 350 to 500 microns of the implant protrude out each end of the two tunnels. A forceps that conforms to the shape of the long axis of the implant just ahead of the flange is useful to hold, manipulate and push the implants into the tunnels, and avoid implant twisting or misplacement. In some surgeries, the tunneling blade will be drawn backwards from the point of entry and reinserted into the tunnel being cut. This permits "pocketing" which leads to difficulty in implant insertion. To avoid pockets, if present, the implant should be inserted into the tunnel from a direction opposite to that from which the tunnel was cut. The tapered first portion of the implant (4) A-B is pushed through the tunnel to protrude beyond the slit. Alternatively, the implant is pulled through by the implant pulling device of Fig. 6(b). In practice, a combination of pulling and pushing is used to insert the implant properly. The flanged rear portion (6) of the implant remains outside the tunnel resting on the sclera. The conjunctiva is re-approximated with 8-0 Chromic or 8-0 Vicryl suture. One drop of 1 % pilocarpine eye drops, and one drop of Tobradex™ eye drops are administered into the conjunctival gutter.

In some embodiments this procedure provides about 2-8 diopters increase in amplitude of accommodation and further up to about 10 diopters increase or more. In practice, curing or ameliorating the vision deficit such as presbyopia in a single eye is sufficient to satisfy a subject. If both eyes are to be treated, operating on one eye and then awaiting recovery before operating on the second eye is useful.

Example 1

IOL and Scleral Implant

A 60 year old white male, had bilateral cataract extraction with intraocular lens insertion several years ago. This was followed by LASIK eye surgery to correct his refractive error to remove the need for distance glasses. The patient still needed a reading correction of +2.50 diopters. Approximately 1 year after the LAS IK surgery, four Reading™ scleral implants (Restor Vison Ltd., Christ Church Barbados) were inserted, in the right eye only. Insertion was in the pars plana with placement at 10:00, 2:00, 4:00, and 8:00 positions. At the conclusion of scleral implant surgery the patient saw clearly with both eyes looking at subject matter from normal reading distance, about 18 to 12 inches, and continuing with clarity almost up to his nose. No reading spectacles were required postoperatively, as the patient's reading add decreased to zero diopters.

Example 2 IOL and Scleral Implant

A 55 year old black female undergoes cataract removal and intraocular lens insertion in the right eye. The patient still needed a readmg correction of +2.50 diopters.

Approximately 6 months later, two Reading™ scleral implants are inserted into the right eye in the pars plana with placement at 10:00 and 2:00 positions. The result is that immediately after surgery both eyes see clearly from normal reading distance, about 18 to 12 inches, and continuing with clarity almost up to the nose. No reading spectacles were required postoperatively, as the patient's reading add decreased to zero diopters.

Example 3

IOL and Scleral Implant

A 25 year old Hispanic female undergoes bilateral clear lensectomy followed by intraocular lens insertion for improvement of high myopia. The patient still needed a reading correction of +2.50 diopters. During the procedure, four scleral implants are placed in the right eye at the 4:00 and 8:00 positions. The result is that immediately after surgery both eyes see clearly from normal reading distance, about 18 to 12 inches, and continuing with clarity almost up to the nose. No reading spectacles were required postoperatively, as the patient's reading add decreased to about zero diopters.

Example 4 IOL and Pressing Implant

A 60 year old Oriental male undergoes insertion of two scleral implants in the right eye. These are placed in the right eye at the 10:00 and 8:00 positions. Prior to the operation the patient read using a +2.50 diopter reading correction. Postoperatively, the patient read at 0 diopters. Postoperatively, both eyes were able to see clearly at near. Two years later, the patient developed a cataract in the opposite (left) eye. The cataract was removed, and an intraocular lens inserted, and the patient continued to read, postoperatively, with each eye, still at 0 dipoters.

Claims

What is claimed is:

1. A method of presbyopia palliation the eye of a subject with an intraocular lens comprising the steps of placing at least one scleral-implant in the pars plana of the sclera.

2. The method of claim 1 wherein said scleral implant is placed in the pars plan in a position selected from about 2:00, 4:00, 8:00 and 10:00.

3. The method of Claim 1 wherein at least about 2 scleral implants are placed in the pars plana.

4. A method of treating an eye having a cataractous lens in an eye comprising both (a) removal of the cataractous lens followed by replacement of said cataractous lens with an intraocular lens, and (b) and insertion of at least one scleral implant in the pars plana of said eye

5. A method of treating an eye having a mammalian crystalline lens in an eye comprising both

(a) removal of the lens followed by replacement of said lens with an intraocular lens, and

(b) and insertion of at least one scleral implant within the sclera in the region of the pars plana of said eye.

6. A method of presbyopia palliation for a subject with presbyopia and two eyes and further with an intraocular lens in one eye and a crystalline lens in the other eye comprising the step of placing at least one scleral-implant in the eye with the crystalline lens in the pars plana.