Modified intraocular lens and method of correcting optical...

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens

Reexamination Certificate

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C623S006110

Reexamination Certificate

active

06413276

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates to a method for correcting optical aberrations in the optical system of an eye having an intraocular lens. More particularly, this invention relates to a method of correcting optical aberrations and other focusing abnormalities measured by wave front or other such technology to quantify optical aberrations in the optical system of the eye, using a laser, or other apparatus and/or methods of fabricating or modifying a lens, for the optical system of an eye having an intraocular lens.
2. Description of Related Art
The field of refractive surgery has been evolving rapidly during the past few decades. Unfortunately, the current procedures or methods used by most refractive surgeons may not ultimately satisfy the total refractive needs of the patient. Particularly, the most commonly performed refractive surgical procedures, such as, for example, cataract extraction with intraocular lens implantation, in addition to the most recently popularized corneal refractive surgical procedures, such as eximer laser photoblation, have a number of drawbacks and limitations A reason for some of these drawbacks and limitations is the fact that the lack of post-operative refractive accuracy renders these surgical procedures uncompetitive with the already available non-surgical alternatives available to patients, which are commonly known as glasses and contact lenses.
Current refractive cataract surgeons who perform the most common refractive surgical procedure, i.e., routine cataract surgery, demonstrate refractive accuracies in the ±0.75 to ±1.00 diopter (D) range. However, such a refractive accuracy is generally not satisfactory, given an industry established accepted accuracy goal of ±0.25 D. Furthermore, several recent reports analyzing current corneal refractive technologies indicate the presence of a significant amount of preexisting or naturally occurring post-operative, as well as preoperative, image distortion (optical aberration) or degradation, particularly under low light conditions, such as when driving at night.
Because of surgery, as well as the biological and physical behavior of the human eye during and after the various types of intraocular surgery, the predictability at the ±0.25 D level with just a single surgical procedure is virtually impossible 100% of the time. Furthermore, factors like biometry errors, variable wound healing and capsular contraction around the intraocular lenses all contribute to decreasing the ability of the refractive surgeon to be able to achieve the desired refractive accuracy. Accordingly, practitioners in the industry have found that an adjustable intraocular lens (IOL), hereinafter referred to as the MC-IOL (multi-component) or C-IOL (compound), following lens extraction surgery, provides a number of desirable options for the refractive surgeons as well as their patients.
First and foremost, an adjustable IOL allows fine tuning of the initial refractive result by exchange of several optical elements of the lens implant. Accuracies in the ±0.25 D range should be virtually guaranteed for those patients which demand perfect vision. It is very likely IOL technology will continue to evolve in the future. Therefore, it is desirable to provide the patient with the opportunity to undergo an exchange of “old” technology lens components for the new and improved technology. This can only happen if the surgeon has an effective, efficient, and sale method of performing lens element exchanges. Additionally and more importantly, within the months and/or years after any refractive surgical procedure, if the optical properties of the inserted IOL, such as multifocality for example, becomes problematic, the surgeon has the ability to safely exchange the undesirable optical elements of the IOL to reverse or eliminate any optical problems that are not tolerated by the patient.
In 1990, the inventor of this application began to investigate the feasibility of such an adjustable intraocular lens, commonly known as the multi-component intraocular lens, hereinafter referred to as the MC-IOL (FIG.
1
), for use following clear lens or refractive cataract surgery, wherein the optical properties of the MC-IOL can be modified at any post-operative time. The base intraocular lens component of the MC-IOL is shown in FIG.
1
. The cap (mid) lens attaches to the top of the base lens and holds the third component of the MC-IOL, the sandwich (top) lens, in place as well.
The base intraocular lens
10
and cap
20
each have securing flanges
16
,
18
and
20
,
24
, respectively, extending therefrom. The MC-IOL also comprises at least one sandwich lens
30
), as illustrated in FIG.
1
. The sandwich lens
30
is positioned on top of the cap
20
. See
FIGS. 1-2
.
The MC-IOL also includes projections
11
and
13
which serve to hold the MC-IOL in place in the human eye, wherein eye tissue (lens capsule) takes hold on the projections. This arrangement permits the base intraocular lens
10
to form a platform upon which the cap
20
can be placed to provide a vehicle to hold the sandwich lens
30
. Therefore, during routine cataract surgery, the MC-IOL replaces the crystalline lens of the human eye. Once a patient's eyes have healed after such a surgery, the surgeon can reenter the eye and replace, if necessary, and more than once, the sandwich lens
30
and the cap
20
to modify the optical characteristics until they reach desired levels.
FIGS. 3A-3B
illustrate the assembled compound intraocular lens, hereinafter C-IOL, that can be used with a preexisting lens within the human eye. The C-IOL has two components similar to the cap (mid)
FIGS. 4A-4B
and sandwich (top)
FIGS. 5A-5B
lens components of the MC-IOL. The preexisting lens can be the crystalline lens of the eye with the C-IOL placed in the sulcus (
FIG. 6
) or in the anterior chamber angle (FIG.
7
). However, the C-IOL can also be used with a conventional IOL and be mounted in the sulcus (FIG.
8
), in the anterior chamber angle (FIG.
9
), in the anterior chamber with posterior chamber fixation (
FIG. 10
) or in the anterior chamber with iris fixation (FIG.
11
). Thus, a surgeon modifies the optical characteristics of the optical system of the eye by using the cap and sandwich lenses in tandem with the preexisting conventional IOL implant or the crystalline lens of the eye.
A single component, exchangeable (adjustable) anterior chamber lens can be used in combination with a single component posterior chamber lens. (FIG.
12
). This enables the adjustment capability for one of the two components and allows more latitude with respect to the space available in the anterior chamber. Both single component conventional nonadjustable anterior chamber and single component conventional nonadjustable posterior chamber refractive intraocular lenses are currently being used with success. In this lens design however, the exchangeable element of the anterior chamber lens component is unique. Finally, the separation of the two lens components might allow an additional refractive capability such as telescopic vision. This might also necessitate the use of either an additional corneal contact lens or spectacle lens or both.
The C-IOL and MC-IOL provide numerous enhanced features. For example, the C-IOL and MC-IOL can each be structured as a monofocal or multifocal optical system, correct astigmatism, as well as comprise ultraviolet light-absorbing, tinted, or other such chemically treated materials.
It should be understood that there are various reasons why an adjustable, MC-IOL or C-IOL is more desirable than a single component implant. In order to achieve all of the permutations and combinations of the astigmatism, multifocality, and spherical correction needed to achieve emmetropia would take an inventory of over ten thousand lenses, whereas with the MC-IOL (multiple components) concept, an inventory of about one hundred components would be necessary. With anterior chamber lenses, progressive encapsulation or engulfment o

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