Lenticular refractive surgery of presbyopia, other refractive errors, and cataract retardation

Abstract

Methods for the creation of microspheres treat the clear, intact crystalline lens of the eye with energy pulses, such as from lasers, for the purpose of correcting presbyopia, other refractive errors, and for the retardation and prevention of cataracts. Microsphere formation in non-contiguous patterns or in contiguous volumes works to change the flexure, mass, or shape of the crystalline lens in order to maintain or reestablish the focus of light passing through the ocular lens onto the macular area, and to maintain or reestablish fluid transport within the ocular lens.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]The application claims benefit to and is a Continuation-in-Part of U.S. patent application Ser. No. 09 / 897,585 filed Jun. 29, 2001, now abandoned, which is a Continuation of U.S. patent application Ser. No. 09 / 312,518, filed May 14, 1999, now abandoned, which in turn is a Continuation of U.S. patent application Ser. No. 08 / 821,903, filed Mar. 21, 1997, now abandoned, which claims priority to U.S. Provisional Application No. 60 / 036,904, filed Feb. 5, 1997, and U.S. Provisional Application No. 60 / 013,791, filed Mar. 21, 1996.[0002]BACKGROUND[0003]1. Field of Invention[0004]The invention comprises the use of electromagnetic energy to make physical and biochemical alterations to the ocular lens of a mammalian eye for the correction of visual impairments, particularly presbyopia and including other ametropias such as myopia, hyperopia and regular and irregular astigmatism, and the retardation of cataract development.[0005]2. Description of Rel...

AI Technical Summary

Benefits of technology

[0035]In a preferred embodiment, the creation of microspheres occurs through a mechanism that may be referred to as photodisruption. The photodisruption mechanism used to create microspheres, which is described in detail in the following section, produces the beneficial visual effects mentioned above (correction of presbyopia and other refractive errors, retardation and prevention of cataracts, and treatment of other ocular anomalies) via two primary modes of action that are termed (1) photophacomodulation and (2) photophacoreduction. Photophacomodulation refers to any mechanism of light-induced change in crystalline lens tissue that affects its chemical and physical properties and thereby alters the dynamic properties of the crystalline lens including its ability to change shape. Photophacoreduction refers to any mechanism of light-induced change in the crystalline lens whereby the change primarily effects a reduction in the mass or volume of crystalline lens tissue. While these two terms are intended to be used consistently throughout this patent, they may be referred to elsewhere respectively using the terms crystalline lens modulation and volumetric reduction, or in combination using the umbrella term photorefractive lensectomy. By either mode of action, the beneficial effects of the invention are principally achieved through generation of microspheres (as noted above).

[0036]Embodiments of the invention that utilize the photophacomodulation mode (effecting a change in the dynamic properties of the crystalline lens) generally generate individual microspheres essentially independent from one another, or may generate individual microspheres that interact, for example by coalescence after generation. Generally, the methods of the invention use the photophacomodulation mode to change lens tissue within the older areas of the ocular lens such as the nucleus, and particularly within specific regions of the juvenile and adult nucleus, since older, more compact tissues are thought to be most responsible for loss in accommodation. In this respect, the present invention can be contrasted with disclosures of the Schachar patents previously cited, in which Schachar proposes treatment of the epithelium, an outer cortex layer, to impair the growth of the epithelium.

[0037]Embodiments of the invention that utilize the photophacoreduction mode (effecting volume reduction in the crystalline lens) generally generate microspheres that overlap on formation because their respective sites of photodisruption are contiguous as described below. Generally, the methods of the invention use the photophacoreduction mode to reduce lens tissue volume within the younger cortical areas of the ocular lens, often for the purpose of changing the topography of the exterior surface of the lens. The photophacoreduction mode, however, may be used within the nuclear regions as well.

[0038]In a preferred embodiment the methods of the invention such as photophacomodulation or photophacoreduction can be performed as outpatient ophthalmic procedure without the use of general anesthesia and without outside exposure of incised tissue with possible consequent infection.

[0039]A further benefit of the present invention for presbyopic correction is that it may actually restore natural accommodation (i.e., the ability of the lens to change its focusing dynamics), instead of attempting to correct for presbyopia through the use of aspherical optics on external lenses, implanted lenses, or the cornea, or requiring the gaze of the eyes to be translated to two or more locations as when using bifocal, trifocal, or progressive lenses.

[0040]In another embodiment, treatment according to this invention makes possible the retardation of cataract development. As mentioned above, Koretz observed in 1994 that an inverse relationship exists between lens accommodation and light scatter development, and that the processes leading to light scatter accelerate with decreasing accommodation. In view of the corrollary that maintaining or increasing accommodation limits the increase of or reduces light scatter, by surgically increasing accommodation, as mentioned above, embodiments of the present invention may reduce current and anticipated future increases in light scatter. It is hypothesized that such a reduced rate for the processes leading to light scatter is achieved, at least in part, through increased aqueous circulation within the crystalline lens, which results from increased accommodation. As well, the present invention encompasses the creation of microchannels through the photodisruption process that would enhance aqueous circulation within the lens and thereby lead to reduced light scatter. This cataract retardation effect is differentiated from cataract removal (partial or full) and cataract prevention. Cataract retardation has been suggested elsewhere through the use of pharmaceuticals such as antioxidants used over long periods of time that allow for maintaining the transparency of the lens. In this invention, we disclose the use of antioxidants, but only for treatment of the acute or immediate effects of the laser therapy during and after lens irradiation. It is the longer term effects of laser therapy that may lead to a reduction in cataract development through use of certain embodiments of this invention. Whereas cataract removal traditionally has meant the total removal of the lens except for the posterior capsule, and Gwon (U.S. Pat. No. 6,322,556) has proposed removing partial cataracts, both complete and partial removal are different from cataract retardation, which is a benefit of embodiments of this invention.

Problems solved by technology

Vision impairment is an exceedingly common problem in humans.

In a vast majority of people needing vision correction the problem is associated with the crystalline lens of the eye.

Two primary problems that occur in the crystalline lens are (a) insufficient flexibility resulting in the inability to correctly focus incoming light and (b) light scattering also resulting in blurred vision.

Astigmatism is a refractive error that results in the eye's inability to focus along a first axis in a plane perpendicular to the line of sight being different from the eye's ability to focus along a second axis in the same plane perpendicular to the first axis, thus producing an image incapable of focusing at any distance.

Of the ametropias, presbyopia stands out as a significant problem because of its prevalence and because it is not corrected as successfully as are myopia and hyperopia with the current treatment methods.

Presbyopia is the focusing error caused by a loss of flexibility of the ocular lens.

Cataracts, however, can occur much earlier as a result of risk factors including disease, trauma, and family history.

However, disulfide bonds are weak chemical bonds, and are subject to modification and breakage with relatively little energy.

Bifocal contact lenses are uncommonly used because, for fitting or for technical reasons, they are optically inferior to bifocal spectacles.

All of these techniques have one or more of the following disadvantages: a) they do not have the continuous range of focusing that natural accommodation provides; b) they are external devices placed on the face or eye; or c) they cut down the amount of light that normally focuses in the eye for any one particular distance, a particular problem because middle-aged individuals actually need more light because of light loss due to the development of light scattering, as described above.

None of these treatments has been widely accepted.

Alternative treatment methods to glasses have been more successful in correcting such refractive errors as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism compared with their limited success in treating presbyopia.

These procedures are of limited utility specifically because they treat the static cornea and do not account for the dynamics of the crystalline lens, which change over time as evidenced by the occurrence of presbyopia.

Another disadvantage of the present photorefractive procedures is that they generally involve fairly invasive surgery.

Above the threshold, ultraviolet or infrared light can cause damage to the eye, including the establishment of cataracts or even tissue destruction.

The size of the initial tissue destruction using these lasers is relatively large, however.

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