WO2001030273A1

WO2001030273A1 - Sizing a phakic refractive lens

Info

Publication number: WO2001030273A1
Application number: PCT/US2000/041252
Authority: WO
Inventors: Thomas J. Chambers; Robert D. Anello
Original assignee: Staar Surgical Company, Inc.
Priority date: 1999-10-22
Filing date: 2000-10-19
Publication date: 2001-05-03
Also published as: EP1280480A4; CA2401862A1; AU2114201A; EP1280480A1

Abstract

An artificial intraocular phakic refractive lens ('prl') is implanted into an eye that has a natural crystalline lens by steps of providing a phakic refractive lens (50) and inserting the phakic refractive lens into a posterior chamber of the eye to a position anterior to and in a vicinity of the natural crystalline lens. The implanted phakic refractive lens has a size and/or shape that is predetermined with respect to a size and/or shape of the posterior chamber of the eye located between the natural crystalline lens and the pupil of the eye.

Description

SIZING A PHAKIC REFRACTIVE LENS

Field of the Invention

This invention relates to an intraocular lens, in particular an intraocular phakic refractive lens, and a method of implanting a phakic refractive lens to correct the eyesight

of an eye.

The present invention is also directed to sizing a phakic refractive lens.

Specifically, the present invention is directed to a sized phakic refractive lens and a

method of sizing a phakic refractive lens.

Background of the Invention

Major ocular components of an eye include a retina and cornea. The cornea

connects to the sclera at the limbus. An anterior segment of the eye is divided into two

principle chambers by the iris and pupil. An anterior chamber is defined by the space between the cornea and the iris. A posterior chamber is defined by the space between the

iris and vitreous.

A natural crystalline lens is located behind the pupil as defined by the iris. The

natural crystalline lens is attached at its periphery by zonules. The eye is deformable and

the zonule attachments allow the natural crystalline lens to deform to different optical powers. In some cases, the natural crystalline lens does not properly deform to achieve a required focus or the length of the eyeball is such that an image does not fall directly on

the retina. Spectacles or contact lenses are require to compensate for the focus of the natural lens or axial length of the eye. Recent technological developments have provided a deformable and relatively permanent artificial intraocular lens that can be implanted into the eye to provide permanent vision correction. An intraocular lens has an optical zone portion, and generally made of flexible material suitable for optical use such as silicone.

At least two general problems are associated with implantation of an intraocular lens. First, the implantation method requires a relatively large incision, which can lead to complications such as infection, retinal detachment and laceration of the ocular tissue. A second problem relates to the intraocular environment. Intraocular tissue is extremely

delicate and sensitive. Any artificial body that is inserted into the eye must be designed with consideration of the body's interface with intraocular tissue on all surfaces, not just

one surface as with an exterior, surface contact lens. Further, intraocular tissue differs from exterior eye tissue. At least one surface of exterior eye tissue is exposed to the

hardening influence of an exterior environment, which at least to some extent enures the one surface to the effect of foreign bodies such as a surface contact lenses.

U.S. Patent Nos. 4,573,998 and 4,702,244 both to Mazzocco, disclose an improved intraocular lens structure, method and instrumentation for implantation through a relatively small incision in ocular tissue. The disclosures of the 4,573,998 and 4,702,244

patents are incorporated herein by reference. The lens structure disclosed in the 4,573,990 and 4,702,244 patents comprises a deformable optical zone portion having prescribed memory characteristics. The lens can be deformed by compressing, rolling, folding, stretching or by a combination thereof to a small diameter for insertion through a small incision in the eye. The memory characteristics enable the lens to return to an original configuration with full size and fixed focal length after insertion. The optical zone portion of the lens is fabricated from a biologically inert material possessing elasticity and compression characteristics.

Co-pending parent applications, Serial Numbers 08/318,991 and 08/736,433 to

Feingold address a problem of shape of an intraocular lens with regard to the intraocular

environment. The disclosure of this application is incorporated herein by reference.

Feingold teaches a phakic refractive lens ("prl"), for example the IMPLANT ABLE CONTACT LENS (ICL) manufactured by ST AAR Surgical AG of Switzerland, provided

with an outer radius of curvature between a lens body portion (base portion) and a lens portion (optic portion) that smoothly transitions therebetween. Specifically, there exists a transition in the outer radius of curvature of the lens between the lens base portion and

the optic portion. It is important that the transition in the radius of curvature between

these two portions or zones is such that there is a minimization of edge formation so as

to prevent damage or wear to the back of the iris. A transition can be made that has a gradient of radius of curvature within very small dimensions. The transition forms a

transition portion that defines an elliptically transcribed surface transition from the surface of the optic portion to the surface of the base portion. Such an arrangement works well within the eye and does not appear to damage or wear the back of the iris.

Feingold also teaches that at least one groove can be provided in the outer surface of the phakic refractive lens. The groove is preferably in the arrangement of a circular groove located in the base portion and surrounding the optic portion. The circular groove allows for good circulation of eye fluid to facilitate lubrication between the phakic refractive lens and the back of the iris. Other groove configurations can be utilized.

Further, Feingold teaches that a passageway can be provided in the phakic refractive lens between posterior and anterior surfaces to equalize intraocular pressure

against the lens surfaces to allow equalization of pressure between anterior and posterior

eye chambers. The passageway is provided in a variety of different forms. The

passageway can be in the form of a groove in the anterior surface and a groove in the posterior surface that connect to form a continuous channel or the passageway can be provided in the form of a hole through the thickness dimension of the phakic refractive

lens at one or more locations.

Feingold also provides one or more through holes in the iris to place the anterior chamber and posterior chamber in fluid communication to allow equalization of pressure therebetween. This prevents the phakic refractive lens from being sucked into tight

contact with the back of the iris to cause damage and wear to the back of the iris. The tight contact effect is due to a differential pressure between the posterior and anterior eye chambers The through holes eliminate the differential pressure between the chambers

Figure 25 is a partial side sectional view of a human eye showing a location of an implanted phakic refractive lens The lens is located in the posterior chamber and can be fixed in the chamber by a peripheral body member (haptic), which extends beyond the optic portion of the lens The body member accomplishes fixation by contacting the

peripheral tissues of the eye posterior to the iris in the area of the ciliary sulcus The

posterior surface of the lens intimately contacts the convex anterior surface of the lens

One problem with this arrangement is that the intimate contact between surfaces of the implanted lens and the natural crystalline lens can cause cataracts It is desirable to place the phakic refractive lens in a position with respect to the natural lens that minimizes contact between surfaces of the implanted lens and the natural crystalline lens

to reduce the risk of cataracts Heretofore however, it has been believed necessary to

intimately contact the two surfaces in order to achieve proper refractive correction The

present invention is based in part on a finding that proper refractive correction can be

achieved and at the same time, development of cataracts can be avoided by implanting a phakic refractive lens so as to form a spacing between the posterior surface of the phakic

refractive lens and the anterior surface of the natural crystalline lens

The concept of a deformable phakic refractive lens was invented by Dr Thomas R Mazzocco In U S Patent No 4,702,244 to Thomas R Mazzocco, Fig 60 shows a deformable phakic refractive lens positioned in the posterior chamber between the natural

crystalline lens and the iris.

STAAR Surgical AG of Switzerland has been developing a refractive phakic lens and refers to their phakic refractive lens under the trademark IMPLANTABLE CONTACT LENS or ICL. STAAR Surgical AG has been conducting significant clinical studies on the IMPLANTABLE CONTACT LENS, which studies indicate that the IMPLANTABLE CONTACT LENS is effective for refractive correction of the human

eye. The IMPLANTABLE CONTACT LENS has also been utilized as a phakic/pseudo- phakic lens in which the natural crystalline lens has been replaced with an intraocular lens

and then further corrected with a phakic refractive lens such as the IMPLANTABLE

CONTACT LENS.

Summary of the Invention

A first object of the invention is to provide an improved intraocular lens in the

form of an phakic refractive lens and improved method of implanting the phakic refractive

lens.

A second object is to provide a phakic refractive lens that forms a spacing with the natural crystalline lens of the eye when the phakic refractive lens is implanted into the eye. A third object is to provide a phakic refractive lens that cooperates with the natural crystalline lens to correct eyesight.

A fourth object of the present invention is to provide a phakic refractive lens that

remains comfortably fitted into the eye over extended periods of time.

A fifth object of the present invention is to provide an improved method of implantation of a phakic refractive lens.

These and other objects of the present invention are described in detail in the description of the invention taken in conjunction with the drawings.

The invention relates to a method of implanting an intraocular phakic refractive

lens into an eye having a natural crystalline lens and pupil. The method comprises steps of providing a phakic refractive lens and inserting the phakic refractive lens into a

posterior chamber of the eye into a position anterior to and in a vicinity of the natural crystalline lens in the location of the pupil to provide a spacing between the phakic

refractive lens and the natural crystalline lens.

The invention also relates to a phakic refractive lens implanted in a posterior chamber of an eye in a vicinity of the natural crystalline lens. The phakic refractive lens

comprises a shape predetermined with respect to a shape of the natural crystalline lens to form a spacing between a posterior surface of the phakic refractive lens and an anterior

surface of the natural crystalline lens.

The invention also relates to a phakic refractive lens for implanting in the vicinity

of a natural crystalline lens of an eye. The phakic refractive lens comprises a shape that

is predetermined with respect to a shape of the natural crystalline lens to form a spacing between a posterior surface of the phakic refractive lens and an anterior surface of the natural crystalline lens when the phakic refractive lens is implanted into the eye.

Sizing A Phakic Refractive Lens

A first object of the present invention is to provide an improved phakic refractive

lens.

A second object of the present invention is to provide a sized phakic refractive

lens.

A third object of the present invention is to provide a sized phakic refractive lens

to custom fit the actual dimensions of an eye.

A fourth object of the present invention is to provide a phakic refractive lens

custom designed and sized to fit an eye. A fifth object of the present invention is to provide a phakic refractive lens custom designed to fit to the inner dimensions of the inner structure of an eye.

A sixth object of the present invention is directed to a method of sizing a phakic refractive lens for an eye.

A seventh object of the present invention is directed to a method of sizing a phakic refractive lens for an eye previously measured.

The present invention is directed to a sized phakic refractive lens and a method of

sizing a phakic refractive lens.

The phakic refractive lens according to the present invention is a sized phakic refractive lens. Specifically, the structure of the eye is carefully measured to determine its shape, conformation and size dimensions of the inner structure of the eye, and

subsequently a custom phakic refractive lens is designed based on this information and

then implanted in the eye.

The eye is measured by any suitable technique for providing details of the shape, confirmation and/or size dimensions of the inner structure of the eye. Specifically, the

phakic refractive lens known as the IMPLANTABLE CONTACT LENS ("ICL") is

designed to fit in the posterior chamber between the natural crystalline lens and the iris, and vaults over at least a center portion of the natural crystalline lens. The edges of the IMPLANTABLE CONTACT LENS along its major axis are located on the zonules and/or located in the ciliary sulcus. Thus, accurate measurement of the location of the

shape, conformation, and size dimensions of the zonules and/or sulcus is important with respect to sizing the length and width dimensions of the IMPLANTABLE CONTACT LENS along its major and minor axes. Further, the actual detailed shape of the zonules and/or sulcus must be determined along one or more axis in the eye along which the major axis of the intraocular contact lens will be aligned, since the zonule-to-zonule and/or sulcus-to-sulcus dimensions can change at different angles of orientation within each eye

of a patient. Further, it is not uncommon that the dimensions from eye-to-eye of a particular patient vary (i.e. different in dimensions at the same angle of orientation in each eye). Thus, the sl ape, confirmation and/or size dimensions of each eye of a patient

typically are different, and must be precisely and accurately measured to properly design and size an IMPLANTABLE CONTACT LENS for the particular patient's eye.

In the application of an IMPLANTABLE CONTACT LENS, the length of the

major axis, length of the minor axis, degree of vaulting defined by the angle between the center plane of the lens portion and a average plane of a haptic portion, dimensions of the

lens portion, dimensions of the haptic portion, shape of the haptics, shape of the edges, shape and size o^ the footpads, and other important design parameters of the IMPLANTABLE CONTACT LENS are all specified based on the shape, confirmation and size prescription of a patient's particular eyes after precisely and accurately measuring

the particular eye. Further, the distance and location of each footpad designed to contact with the zonules and/or sulcus must be precisely and accurately be specified for proper and comfortable fit of the implantable contact lens in the eye

One preferred method of measuring the eye for designing and sizing an implantable contact lens is by measuring the exterior white-to-white measurements of the eye particularly along an axis of the eye along which the major axis of the implantable contact

lens will be aligned once implanted The white-to-white measurement can also be made

at other angles of orientation of the eye (e g along diagonal axis of the footpads of the implantable contact lens) to properly design and shape the implantable contact lens for the particular eye Based on the white-to-white measurements of the eye, this information is fed into a formula or algorithm to provide the exact design parameters of the implantable

contact lens to provide proper design and sizing of the implantable contact lens

Another preferred method of measuring an eye involves use of ultrasonic radiation for measuring the exact shape, confirmation and size dimensions of the inner structures

of the eyes For example, the exact shape and location of the zonules and/or sulcus can

be determined using ultrasonic radiation to detect these structures within the eye The

ultrasonic radiation, emission and detection is based on emitting ultrasonic waves into the eye with some of the ultrasonic waves reflecting at the interface between the inner structure of the eye and the fluid medium within the eye, which provides a reflected image

detectable to create a precise and accurate visual depiction of the shape, confirmation and size dimensions of the inner structure of the eye The ultrasonic apparatus can scan the

entire eye or portions thereof to carefully map the shape, confirmation and size dimensions of the inner structure of the eye (e g natural crystalline lens, capsular bag, zonules, sulcus, iris, pupil, sclera and other structure involved with the surgical placement of an IMPLANTABLE CONTACT LENS)

The preferred method of mapping the eye including determining the shape, confirmation and size dimensions of the inner structure of the eye can be accomplished by using one or more beams of ultrasonic radiation generated by an ultrasonic transducer

positioned outside the eye The one or more beams can scan an sweep the entire inner structure of the eye to provide a reflected image that is captured on a detector The detected image can be displayed on a cathode ray tube (CRT), which can be scaled to

precisely and accurately measure the shape, confirmation and size dimensions of the inner

structure of the eye

Brief Description of the Figures

Figure 1 is a cross-sectional view of a positive intraocular phakic refractive lens,

as indicated in Figure 3

Figure 2 is a cross-sectional view of the phakic refractive lens in Figure 1, as indicated in Figure 3

Figure 3 is a top planar view of the positive phakic refractive lens as shown in

Figures 1 and 2 Figure 4 is a cross-sectional view of another embodiment of a positive phakic refractive lens as indicated in Figure 6.

Figure 5 is a cross-sectional view of the positive phakic refractive lens shown in

Figure 4, as indicated in Figure 6.

Figure 6 is a top planar view of the positive phakic refractive lens as shown in

Figures 4 and 5.

Figure 7 is a table of examples of positive phakic refractive lenses directed to the

two embodiments shown in Figures 5-10.

Figure 8 is a cross-sectional view of a negative phakic refractive lens according

to the present invention, as indicated in Figure 10.

Figure 9 is a cross-sectional view of the negative phakic refractive lens shown in Figure 8, as indicated in Figure 10.

Figure 10 is a top planar view of the negative phakic refractive lens shown in

Figures 8 and 9.

Figure 11 is another embodiment of a negative phakic refractive lens according to

the present invention, as indicated in Figure 12. Figure 12 is a cross-sectional view of the phakic refractive lens shown in Figure

11, as indicated in Figure 13.

Figure 13 is a top planar view of the negative phakic refractive lens shown in

Figures 11 and 12.

Figure 14 is a table of examples of negative phakic refractive lenses directed to the

two embodiments shown in Figure 8-13.

Figure 15 is a top planar view of another embodiment of a positive phakic refractive lens according to the present invention.

Figure 16 is a cross-sectional view of the positive phakic refractive lens, as

indicated in Figure 15.

Figure 17 is a partial detailed cross-sectional view of a portion of the positive

phakic refractive lens shown in Figures 15 and 16, illustrating the detailed curvature

thereof.

Figure 18 is a table indicating the detailed curvature as an example of the

embodiment of the positive phakic refractive lens shown in Figures 15-17. Figure 19 is another embodiment of a negative phakic refractive lens according to the present invention.

Figure 20 is a top planar view of another negative phakic refractive lens according to the present invention with a circular groove in the lens body portion thereof.

Figure 21 is a cross-sectional view of the negative phakic refractive lens, as

indicated in Figure 20.

Figure 22 is a cross-sectional view of an eye having an phakic refractive lens according to the present invention implanted therein.

Figure 23 is a cross-sectional view the eye with a prior art phakic refractive lens implanted therein.

Figure 24 is a cross-sectional view of another embodiment of a phakic refractive

lens.

Figure 25 is a partial side sectional view of a human eye with a phakic refractive

lens illustrating a lens implant of the prior art.

Figures 26-28 are partial side sectional views of a human eye with phakic refractive lenses illustrating lens implants according to the present invention. Figure 29 is a detailed perspective view of an eye.

Figure 30 is a detailed cross-sectional view of an eye containing an IMPLANTABLE CONTACT LENS type of phakic refractive lens.

Detailed Description of the Preferred Embodiments

The intraocular phakic refractive lens ("prl") according to the present invention can be provided with a concave posterior face that is shaped substantially complementary to the convex shape of the anterior surface of the natural crystalline lens. The phakic

refractive lens is adapted to provide a face to face relationship with the anterior surface

of the natural crystalline lens. However, as hereinafter described, at least a part of the posterior surface of the phakic refractive lens is separated from the anterior surface of the

natural crystalline lens to form a spacing between the phakic refractive lens and the natural crystalline lens. The spacing is formed at a location between the phakic refractive lens and the pupil of the eye.

An embodiment of a positive phakic refractive lens according to the present invention is shown in Figures 1-3.

The phakic refractive lens 10 is defined by an oval-shaped lens body portion 12

defined by major axis diameter DM and minor axis diameter Dm, and radius R2, and a

circular shaped lens portion 14 having a diameter Do. The lens portion 14 has a thickness Tc and the lens body portion 12 has an edge

thickness Te, as shown in Figure 1 Further, the lens portion 14 has a curvature SRfr, and

the lens body portion 12 has an outer curvature SRo and an inner curvature SRi

Another embodiment of a positive phakic refractive lens according to the present invention as shown in Figures 4-6

The phakic refractive lens 20 is defined by an oval-shaped lens body portion 22

defined by major axis diameter DM and minor axis diameter Dm, and a radius R2, and a

circular shaped lens portion 24 having a diameter Do

The lens portion 24 has a thickness Tc and the lens body portion 22 has an edge

thickness Te, as shown in Figure 4 Further, the lens portion 24 has a curvature SRfr and

the lens body portion 22 has an outer curvature SRfr2 (SRo) and an inner curvature SRi

Specific examples of the positive phakic refractive lens are given in the table in Figure 7. In these examples, T = 0 05 ± 0 02mm, Sro = 9 4 ± 0 1, SRi = 9 8, DM = 10 5 ± 0.1mm, Dm = 6 ± 0 3mm and R2 ± 0 1

An embodiment of a negative phakic refractive lens according to the present

invention as shown in Figures 8-10 The phakic refractive lens 30 is defined by an oval-shaped lens body portion 32

defined by major axis diameter DM and minor axis diameter Dm, and having a radius R2, and a circular shaped lens portion 34 having a diameter Do.

The lens portion 34 has a thickness Tc and the lens body portion 32 has an edge

thickness Te, as shown in Figure 8. Further, the lens portion 34 has a curvature SRfr and

the lens body portion 32 has an outer curvature SRo and an inner curvature SRi.

Another embodiment of a negative phakic refractive lens according to the present

invention as shown in Figures 1 1-13.

The phakic refractive lens 40 is defined by an oval-shaped lens body portion 42 defined by major axis diameter DM and minor axis diameter Dm, and having a radius R2,

and a circular shaped lens portion 44 having a diameter Do.

The lens portion 44 has a thickness Tc and the lens body portion 42 has an edge

thickness Te, as shown in Figure 11. Further, the lens portion 44 has a curvature SRfr and

the lens body portion 42 has an outer curvature SRfr2 (SRo) and an inner curvature SRi.

Specific examples of the positive intraocular refractive lens are given in the table

in Figure 14. In these examples, T = 0.05 ± 0.02mm, Sro = 9.4 ± 0.1, SRi = 9.8, DM = 10.5 ± 0.1mm, Dm = 6 ± 0.3mm and R2 ± 0.1. When the value of Rfr reaches 100,000mm, as shown in Figure 14, the anterior surface of the optic portion of the lens is essentially planar, as it appears in Figure 1 1.

A further embodiment of a positive intraocular refractive lens 50 is shown in Figures 15-17.

The phakic refractive lens 50 is defined by an oval-shaped lens body portion 52

circular shaped lens portion 54 having a diameter Do. The lens portion 54 has a thickness

Tc and the lens body portion 52 has an edge thickness Te, as shown in Figure 16.

The detailed curvature of the phakic refractive lens is shown in Figure 17. An

example of this particular lens is given in the table in Figure 18 with the designations Rl-

R8 corresponding to Figure 17.

A further embodiment of a negative phakic refractive lens 60 is shown in Figure

19. The advantage of this embodiment is that a small gap exists between the phakic

refractive lens center and the natural lens allowing for flow of body fluids, and to minimize

friction which could potentially cause mechanical damage and cataracts in the eye.

An even further embodiment of a negative phakic refractive lens 70 is shown in

Figure 20. The phakic refractive lens 70 is defined by an oval-shaped lens body portion 72

defined by major axis diameter DM and minor axis diameter Dm, and a circular shaped

lens portion 74 having a diameter Do. The lens portion 74 has a thickness Tc and the lens

body portion 72 has an edge thickness Te, as shown in Figure 21.

The important feature of this embodiment is the circular groove G provided in the

lens body portion 72 surrounding the lens portion 74. The circular groove G allows for

circulation of fluid inside the eye. Further, the groove G can be used for lens manipulation during surgery, and facilitates the equalization of intraocular pressure.

An embodiment of an phakic refractive lens 80 having a lens body portion 82 and

lens portion 84, is shown in Figs. 22 and 23. In this embodiment, an air passageway 86

(e.g. hole) is provided in the center optical axis of the lens portion 84 for equalizing the

pressure between the anterior surface 88 and posterior surface 90 of the phakic refractive

lens 80. This air passageway 86 allows for equalization of pressure between the anterior

chamber and posterior chamber of the eye. Otherwise, a significant suction or negative

pressure can occur on the anterior surface of the phakic refractive lens sucking the back

of the iris into contact therewith and causing damage or wear to the iris.

The phakic refractive lens 80 is provided with a pair of indents 92, as shown in

Figs. 22 to 24, for allowing the phakic refractive lens 80 to be manipulated under the iris

during the implantation operation. The indents 92 are significantly better than through

holes for purposes of manipulation, since the bottoms of the indents prevent penetration of a manipulating tool through the lens and inadvertently into contact with the natural lens that would cause an immediate cataract of the natural lens.

Figure 25 illustrates a lens implantation according to the prior art Figure 25

shows a natural eye 100 with posterior chamber 102 and natural crystalline lens 104 with

anterior surface 106. A phakic refractive lens 108 is shown implanted into the posterior

chamber 102 into a position at the pupil 98 wherein the posterior surface 110 of lens 108

is in intimate contact with the anterior surface 106 of natural crystalline lens 104.

In one embodiment, a dimension of the eye is determined and the phakic refractive

lens is provided according to the eye dimension so that the phakic refractive lens forms a spacing when inserted into the posterior chamber. For example, the arc of radius of

curvature of the natural crystalline lens can be determined by methodology known in the art. The arc of radius of curvature of the phakic refractive lens is then determined according to the arc of radius of curvature of the natural crystalline lens If a phakic refractive lens is provided that has an arc of radius of curvature less than the arc of

curvature of the natural crystalline lens, the implanted phakic refractive lens will form a

spacing with the anterior surface of the natural crystalline lens In another embodiment, the arc from a location on the ciliary body of the natural crystalline lens over an arc of radius of curvature of the natural crystalline lens to another location on the ciliary body

of the natural crystalline lens is determined If the phakic refractive lens is provided with a posterior surface having an arc greater than the determined arc, the implanted phakic refractive lens will form a spacing with the anterior surface of the natural crystalline lens.

A phakic refractive lens according to any of Figures 1-24 can be implanted in a natural eye by the method of the present invention. The artificial intraocular phakic refractive lens is inserted into a posterior chamber of the eye to a position anterior to and in a vicinity of the natural crystalline lens to provide a spacing between the phakic

refractive lens and the natural crystalline lens as shown in Figures 26-28. Preferably the

spacing is a separation between the posterior surface of the phakic refractive lens and the anterior surface of the natural crystalline lens of between 50μm and 150μm.

Figure 26 illustrates one embodiment wherein the phakic refractive lens 102 rests

at its periphery edge 104 at zonule attachment 106. In this embodiment, the radius of

curvature of the arc of the posterior surface 108 of the phakic refractive lens 102 is less

than the radius of curvature of the arc of the anterior surface 110 of the crystalline lens

112 and the arch of the arc of the phakic refractive lens 102 forms a vaulted relationship

over the crystalline lens surface 110 at the location of the pupil 98 to form the spacing 114

of the invention. The spacing 114 is located between phakic refractive lens 102 and the

pupil 98. As shown in Figure 26, the phakic refractive lens 102 does not contact either

the natural crystalline lens 112 or the iris, at any point on the lens 112 or the iris.

In another embodiment shown in Figure 27, the phakic refractive lens 122 includes

a body portion 124 that positions the optic portion 126 of the lens in its vaulted relationship anterior to the natural crystalline lens 128 at the location of pupil 98. A vaulted phakic refractive lens describes a phakic refractive lens having a concave posterior

surface 132 that is arched to form a spacing 134 between the posterior surface 132 of the

phakic refractive lens 122 and the anterior surface 136 of natural crystalline lens 128

when the phakic refractive lens 122 is implanted and seated in an eye. The vaulted arch

is formed as a result of an elongated body portion 124 that is seated to extend from zonule

attachment 138 at lens periphery 140 so as to form the arched structure separated by a

spacing 134 from tne natural lens anterior surface 136.

In still another embodiment shown in Figure 28, the phakic refractive lens 152

comprises an optic portion 154 and a body portion 156. The radius of the arc of posterior

surface 158 of the optic portion is smaller than the radius of the arc of the posterior

surface 160 of the body portion 156 so that the respective arcs meet at an angle. The

smaller radius of the arc of the optic portion 154 forms the vaulted relationship with the

anterior surface 162 of the crystalline lens 164 in the location of the pupil 98 to form

spacing 166. In this embodiment, the radius of the arc of the lens body 156 can be the

same as the radius of the arc of the anterior surface 162 of the crystalline lens 164 so that

the posterior surface 160 of the lens body portion 156 resides on the surface of the

anterior surface 162 of the crystalline lens 164 in a face to face relationship. The alternate

relationship is shown in Figure 27 where the radius of the arc of the body portion 124 can

be less than the radius of the arc of the anterior lens surface 136 so that the spacing 134

of the invention is formed by a combination of the vaulted optic portion and a cavity

between the body portion and the crystalline lens 128. The phakic refractive lens of the present invention can be deformable in accordance with the lenses of the Mazzocco patents so that the lens can be implanted through a small incision made in the ocular tissue. These phakic refractive lenses have prescribed memoiy characteristics. The phakic refractive lenses can be deformed by compressing, rolling, folding, stretching or the like or by a combination thereof, to a diameter of 80% or less of the cross-sectional diameter of the optic. The prescribed memory characteristics permit the lenses to restore to their original configuration, full size and fixed focal length after insertion into the eye.

Preferably, the phakic refractive lens body of the present invention can be a silicon

material or more preferably a collagenous acrylic reaction copolymer that is biologically compatible with tissue of the natural eye. These materials are known in the art as represented by U.S. Patent 5, 104,957 to Kelman et al. The collagenous acrylic reaction

copolymers are particularly advantageous. The acrylic collagen polymer lens is permeable to both gases and nutrients. The lens has significant water content and permits free

perfusion of nutrients that are required by the eye. Further while applicants do not intend to be bound by the following explanation, it is believed that an acrylic collagen polymer

phakic refractive lens permits a permeation of ocular fluid through the lens body and into the spacing formed between the implanted phakic refractive lens body posterior surface

and the natural crystalline lens anterior surface. A reaction may take place within the spacing. At any rate, it is known that an interphase zone is formed in the spacing. The interphase zone enhances wearing comfort of the implanted phakic refractive lens.

Additionally the interphase provides a transition between the natural crystalline lens and implanted phakic refractive lens that permits adjustment of light transmission properties of the phakic refractive lens to light transmission properties of the natural crystalline lens

so as to provide accurate vision .

Other modifications of the present invention will occur to those skilled in the art subsequent to a review of the present application. For example, the arch that forms the spacing can be a result of an elongated haptic lens portion that is seated so as to extend from a zonule attachment at the lens periphery so as to form an ached structure separated

from the natural crystalline lens anterior surface. In this application, a haptic portion is

a portion of an intraocular lens that extends from the zonule attachment at the lens periphery. The haptic portion may coincide with the base portion or the haptic may be considered only a part of a larger base portion that extends with the transition portion and

optic portion to form the vault over the natural crystalline lens.

These modifications and equivalents thereof are intended to be included within the

scope of this invention.

Siring Phakic Refractive Lens

Figure 29 shows a detailed perspective view of an eye. The white-to-white

measurement Dww is shown in Figure 29 being measured along the y-axis. The same

measurement can be made at continuous or incremental angles A around the entire 180

degrees to fully map the white-to-white dimension. This information can then be utilized in a formula or algorithm to compute the size of the phakic refractive lens for proper sizing within the eye. Specifically, the white-to-white measurement is somewhat mathematically related to the dimensions of the inner structure of the eye including the dimensions of the zonules-to-zonules and/or sulcus-to-sulcus measurements. Specifically, there is a correlation between the white-to-white measurement and the zonule-to-zonule dimensions and/or sulcus-to-sulcus measurements. This is a fast and easy method for sizing a phakic refractive lens. However, it is preferable to be able to actually map with high precision and accuracy the inner structure of the eye involved with the placement of

a phakic refractive lens into the eye.

A detail cross-sectional view of the eye is shown in Figure 30. The natural

crystalline lens 200 is enclosed within the capsular bag 202. The capsular bag 202 is

supported within the eye by zonules 204. The zonules 204 sunound the entire periphery

of the capsular bag 202 and operate like a sphincter. The zonules 204 are connected to

the congentiva 206, which is a muscular portion of the eye. The iris 208 is located in front

of the natural crystalline lens 200 and the pupil 210 is defined by an opening through the

iris 208. The base of the iris 208 connects with the congentiva 206 and defines an annular

recess referred to as the sulcus 212.

In the embodiments shown in Figure 30, a IMPLANTABLE CONTACT LENS

214 type of phakic refractive lens is positioned between the natural crystalline lens 200

and the iris 208. It is to be noted that the IMPLANTABLE CONTACT LENS 214

substantially vaults over the entire natural crystalline lens 200 and rests on the zonules 204. Specifically, a space 216 is provided between the anterior surface of the capsular

202 covering the anterior portion of the natural crystalline lens 200 and the posterior

surface of the IMPLANTABLE CONTACT LENS 214.

Typically, this space 216 is filled with nourishing eye fluid which continues to

circulate and be replenished to maintain the health of the capsular bag 202 and natural

crystalline lens 200. The IMPLANTABLE CONTACT LENS 214 is defined by a lens

portion 214a, and a haptic portion 214b. The haptic portion 214b is provided with four

(4) spaced apart footpads 214c resting or in contact with the zonules 204. The footpads

214c support the remaining portions of the IMPLANTABLE CONTACT LENS 214 up

and away from the surface of the natural crystalline lens 202, or otherwise allows the lens

to vault over the natural crystalline lens 202 so as to prevent any substantial contact with

the natural crystalline lens 202.

Various important dimensions of the eye to be measured for proper sizing of the

IMPLANTABLE CONTACT LENS 214 is shown in Figure 30. The length of the natural

crystalline lens 200 is defined by the dimension D,. The dimension D^ defines the inner

dimension of the location where the zonules connect to the natural crystalline lens 200.

The dimension Dzi is less than the dimension D_b since the zonules 204 connect somewhat

inwardly from an outer edge of the natural crystalline lens 200. The dimension D_zo defines

the outer dimension of the zonules at or near where the zonules connect to the congentiva 206. The dimension D_s defines the outer dimension of the sulcus 212. The dimensions

Z,_j and Z₁₂ define the length of the zonules on the left side and right side, respectively, of the natural crystalline lens 200. The dimension Z„ and the dimension Z₁₂ can vary with

respect to each other and also vary around the entire circumference of the natural

crystalline lens 200. The dimensions S_u and S₁₂ define the depth of the sulcus 212. These are the macroscopic dimensions of the eye of interest in sizing the implantable contact lens

214. However, the dimensions of substructure including the width of the point of

connections of the outer portion of the zonules to the congentiva 206 may be of interest

for accurate and precise positioning of the IMPLANTABLE CONTACT LENS 214 within the eye.

In the event that the IMPLANTABLE CONTACT LENS 214 is oversized for the

particular eye in which it has been implanted, the IMPLANTABLE CONTACT LENS

214 may vault too much and force the anterior surface of the implantable contact lens 214

into the posterior chamber of the iris 208 potentially causing rubbing and/or damage to

a back portion of the iris (e.g. rubbing off pigment located on posterior side of iris 208).

Further, overvaulting of the implantable contact lens 214 may cutoff natural fluid flow

from the sulcus 212 where eye fluid is generated and then circulated towards the pupil 210

into the anterior chamber causing a surgically induced glaucoma in the patient's eye. In the event that the implantable contact lens is undersized, it may cause undesirable contact

with the natural crystalline 220 inducing a cataract due to rubbing therebetween. Thus,

proper sizing of the IMPLANTABLE CONTACT LENS 214 is important.

Claims

What is Claimed:

X . A method of sizing and implanting an artificial phakic refractive lens into an eye having a pupil and a natural crystalline lens, said method comprising steps of:

providing an artificial phakic refractive lens for the eye;

sizing said refractive lens; and

inserting said phakic refractive lens into a posterior chamber of the eye to a position anterior to and in a vicinity of the natural crystalline lens at a location between

the natural crystalline lens and the pupil.

2. The method of claim 2, wherein said providing step comprises providing a deformable phakic refractive lens.

3. The method of claim 1, comprising providing an artificial phakic refractive lens

with prescribed memory characteristics comprising a deformable optic portion and

deformable base portion.

4. The method of claim 3, comprising steps of deforming said phakic refractive lens by compressing said optical portion and base portion to a diameter of less than a length

of an incision in the eye, inserting the phakic refractive lens through the incision and allowing the phakic refractive lens to return to an original configuration within the eye.

5. The method of claim 4, comprising allowing the phakic refractive lens to return to an original configuration of full size and fixed focal length in a position in the vicinity

of the natural crystalline lens.

6. The method of claim 5, comprising providing said phakic refractive lens with said deformable optic portion having a convex anterior surface and concave posterior surface.

7. The method of claim 6, wherein said position in the vicinity of said crystalline lens

is anterior to the natural crystalline lens and said concave surface of said phakic refractive lens is complementary to a convex surface and in said vicinity of the natural crystalline

lens.

8. The method of claim 1 , wherein said artificial phakic refractive lens is seated in said posterior chamber of the eye in a position to form said spacing.

9. The method of claim 1, wherein said artificial phakic refractive lens is elongated and seated at its peripheral edge in said posterior chamber to provide said spacing.

10. The method of claim 1, wherein said sizing step includes measuring at least one white-to-white measurement of the eye.

11. The method of claim 1 , wherein said sizing step includes measuring an inner structure of the eye using ultrasonic radiation.

12. The method of claim 1, comprising steps of:

measuring at least one eye dimension; and

providing said phakic refractive lens according to the eye dimension so that said

phakic refractive lens properly fits when inserted into the posterior chamber.

13. The method of claim 12, comprising steps of:

measuring white-to- white dimensions at different angles relative to a fixed

reference coordinate of the eye.

14. The method of claim 12, comprising steps of:

measuring an inner structure of the eye with ultrasonic radiation at different angles

relative to a fixed reference coordinate of the eye.

15. A sized phakic refractive lens implanted in a posterior chamber of an eye in a vicinity of a natural crystalline lens and pupil of the eye, comprising a size and shape predetermined with respect to a size and shape of an inner structure of the eye located in the posterior chamber between the natural crystalline lens and pupil of the eye.

16. The phakic refractive lens of claim 15, comprising a sized major axis.

17. The phakic refractive lens of claim 15, comprising a sized minor axis.

18. The phakic refractive lens of claim 15, comprising an optic portion and base

portion.

19. The phakic refractive lens of claim 18, comprising an optic portion having an

essentially planar anterior surface.

20. The phakic refractive lens of claim 18, comprising an optic portion with convex

anterior surface.

21. The phakic refractive lens of claim 15, comprising a posterior surface in a concave shape in a arc having a radius of curvature less than a radius of curvature of an arc of an anterior surface of the natural crystalline lens.

22. The phakic refractive lens of claim 18, comprising a transition portion that defines an elliptically transcribed surface transition from a surface of said optic portion to a surface of said base portion.

23. The phakic refractive lens of claim 15, comprising an acrylic collagen polymer.

24. The phakic refractive lens of claim 15, comprising a silicone material.

25. A sized phakic refractive lens for implanting in the vicinity of a natural crystalline lens and pupil of an eye, comprising a size and shape predetermined with respect to a size

and shape of the posterior chamber of the eye between the natural crystalline lens and pupil when said phakic refractive lens is implanted in the eye.

26. The phakic refractive lens of claim 25, comprising an optic portion and base

portion.

27. The phakic refractive lens of claim 26, comprising an optic portion having an

essentially planar anterior surface.

28. The intraocular refractive correction lens of claim 26, comprising an optic portion

with convex anterior surface and concave posterior surface.

29. The phakic refractive lens of claim 25, comprising a posterior surface in a concave shape in a arc having a radius of curvature less than a radius of curvature of an arc of an

anterior surface of the natural crystalline lens of an eye.

30. The phakic refractive lens of claim 27, comprising a transition portion that defines an elliptically transcribed surface transition from a surface of said optic portion to a surface of said base portion.

31. The phakic refractive lens of claim 25, comprising an acrylic collagen polymer.

32. The phakic refractive lens of claim 25, comprising a silicone material.

33. The phakic refractive lens of claim 25, compressed into a diameter of less than a

length of an incision in the eye for insertion through the incision into the eye.