The present invention relates to apparatus and laser means to alter the shape of the human cornea in order to improve the vision in a person with macular disease.
The retina is the light sensitive portion at the back of the human eye which receives light rays focused by the cornea and lens at the front of the eye. In a normal eye (
The advent of a device called a micro perimeter which combines eye tracking with visual field testing in the macula region demonstrates the PRLs present in these diseases.
Prior to the present invention, patients with macular degeneration could sometimes improve their vision by moving an image onto PRL areas of the macula outside of the fovea using prisms in their spectacles or with telescopes mounted on their spectacles or hand held magnifiers for close work. A prism shifts the image location but causes double vision when both eyes are open. For this reason forming a prism out of the corneal tissue with ablation techniques or implanting a prism inside the cornea, methods taught by Macoul et al. in U.S. Pat. No. 5,984,961 and Azar in U.S. Pat. No. 5,634,919 have failed to live up to their theoretical ability to move the image to a retinal location outside the fovea. In practice, their techniques create double vision and move the image on a permanent basis to an area of the macula that will soon becomes non-functioning due to the progression of disease. In a group of diseases that are progressive, it is essential to the success of any treatment that it be temporary so that as available PRLs change, it can be repeated. Furthermore, patients often have multiple PRLs in different axes as shown in
Telescopes enlarge the image size so that its footprint upon the retina is enlarged to include all PRLs close to the fovea. Unfortunately, the concomitant loss of peripheral vision with telescopes make such methods problematic. Recently, telescopic intraocular implants such as those taught by Azar et al. in U.S. Pat. No. 8,506,626, have been placed into corneas or used to replace cataracts in patients with macular disease according to Peyman in U.S. Pat. No. 7,186,266 and Portnoy in U.S. Pat. No. 4,759,761. Again, severe loss of peripheral vision and extreme cost and complexity make them impractical. The present invention temporarily enlarges and moves an observed image to multiple PRLs without reducing peripheral vision and without the use of prisms or telescopes.
The eye, like any other optical system, suffers from a number of optical aberrations which reduce vision. Correction of spherocylindrical refractive errors, namely myopia, hyperopia and astigmatism has been possible for nearly two centuries following Airy's development of methods to measure ocular astigmatism. These so-called lower order aberrations have been corrected with spectacles, contact lenses, intraocular lenses and refractive corneal surgery such as radial keratotomy and laser corneal reshaping surgery such as LASIK. None of these techniques effectively correct the higher order aberrations of spherical aberration, coma and trefoil which fortunately do not often occur naturally.
At the risk of putting the reader into a coma a brief discussion of higher order aberrations including coma is necessary. Light coming off of a perceived object can be described either as discrete rays or as a wave of light perpendicular to those rays.
For light to converge and focus to a perfect point such as the fovea of the eye, the wavefront emerging from the optical system comprising the cornea and lens of the eye must be a perfect sphere centered on the fovea. This is seen in
Ophthalmologists, optometrists and opticians exist because no eye is ideal. In the normal population the most prevalent optical aberrations are second-order spherocylindrical focusing errors, which are called refractive errors such as myopia (nearsighted), hyperopia (farsighted) and astigmatism. In myopia, distant objects are defocused while near objects are in focus at the fovea. In hyperopia both distance and near objects are out of focus as their wavefronts strike the retina. Both myopia and hyperopia result in defocus, seen in
Higher order aberrations are a relatively small component of typical visual disturbances, comprising about 10% of the normal eye's total aberrations and include spherical aberration, coma and trefoil. Spherical aberration results in observed halos around point images and is treated with pupil constricting drops. In optics (especially telescopes), the coma, or comatic aberration, refers to an aberration due to imperfection in a lens that results in point sources such as stars appearing enlarged, having a comet-like tail, hence the term coma. In fact, coma is often defined as an image enlargement. Coma is portrayed in
While there is copious prior art covering the use of lasers and intracorneal inlays to change the shape of the human cornea, it mainly concerns itself with improving the refracting ability of the normal eye so that light from a perceived object can be best focused upon the fovea of the eye. Such prior art teaches methods to reduce pre-existing optical aberrations of the eye such as myopia, hyperopia and astigmatism while limiting any aberrations that might be caused by the treatment. Most LASIK procedures remove collagen from the central cornea to reduce the corneal sphericity, reducing its refractive power and improving myopia. Customized LASIK wavefront-guided refractive corneal laser treatments are designed to reduce existing aberrations and to help prevent the creation of new aberrations. Alignment of the treatment and the pupil is usually achieved through iris feature detection and eye tracking so that the treatment is perfectly centered around the patient's pupil. In another technique called thermal keratoplasty, a laser is used to heat-shrink collagen in peripheral areas of the cornea in a symmetric pattern centered on the pupil in order to cause the center of the cornea to bulge outward, making the cornea more convex and prolate to decrease hyperopia or presbyopia. If one skilled in the art were to follow each of the exemplary techniques and methods of the prior art in this field, they would not be able to improve the vision in a person with a macular disease which has destroyed foveal function. In fact, all operative guidelines as well as the labeling guidelines of the FDA forbid the use of such lasers and techniques in patients with retinal disease as being contraindicated (if not pointless).
U.S. Pat. No. 8,852,176 issued to Riedel et al. and U.S. Pat. No. 8,764,737 to Kurtz et al. describe image-guided methods to insure that a refractive laser will deliver a treatment that is well-centered upon the pupil.
U.S. Pat. No. 8,663,208 awarded to Bor teaches intrastromal laser refractive correction comprising a plurality of intrastromal incisions radially oriented about an optical axis of the eye.
U.S. Pat. Nos. 8,617,146 and 8,409,179 issued to Naranjo-Tackman et al. and to Bille et al. respectively describe a system, apparatus and methods for laser cataract surgery as well as making cuts in the corneal periphery centered on the pupil for the purpose of reducing astigmatism.
U.S. Pat. Nos. 8,556,886 and 5,891,132 to Hohla teaches an iris recognition system and an earlier topography system that measures abnormalities in the patient's corneal surface topography and translates that into a laser treatment pattern to counteract and correct the refractive error caused by those abnormalities. He describes the possibility of non-standard treatment, using manually or semi-manually placed shots but only in order to counteract and correct for pre-existing irregular corneal abnormalities such as hot spots, curved and irregular astigmatism in order to bring light to focus on the fovea.
There have been a few other non-standard or eccentric patterns of excimer laser corneal ablations proposed in the prior art. U.S. Pat. No. 8,529,558 to Stevens describes a laser ablation method to correct pre-existing or post-refractive surgery higher order optical aberrations and to better focus light on the fovea of the eye. Clapham in U.S. Pat. Nos. 6,245,059, 6,572,607 and 7,004,935 also teaches the purposeful off-center ablation of an irregularly shaped cornea with an excimer laser for the purpose of making the cornea more spherical and reducing higher order optical aberrations. The goal in each of the foregoing patents is to improve the cornea's curvature to better focus light onto the fovea, even if that requires non-standard patterns of corneal ablation. Another non-standard pattern is proposed by Kuo in U.S. Pat. No. 8,298,214 in which an excimer laser unit is used to form multiple convex arcs on a cornea of an eyeball of a person so that the healthy person or the person with refractive errors can also prevent oncoming presbyopia by virtue of having multiple defocused images on the fovea that one day might be useful as presbyopia progresses. The only prior art that contemplates a non-standard eccentric pattern of excimer corneal ablation in order to shift at least part of the image onto still functioning areas of the macula that are not affected by macular degeneration is in U.S. Pat. Nos. 8,192,023, 7,871,163 and 7,874,672 awarded to Grierson and Lieberman. In their teaching, an excimer laser is used to permanently create multiple arcs as in the Kuo patent above but altering their position relative to the pupil such that the cornea is reshaped to refract the light from a perceived object into a plurality of points of focus so as to form a predetermined pattern, one of a circle, a spiral, a rose pattern and a dual rose pattern upon the retina. By decentering the multiple ablation arcs, Grierson and Lieberman create a focused image at a distance of only up to 0.01 mm from the fovea. The present invention overcomes two problems with the Grierson and Lieberman art. First, the prior art alters the corneal shape permanently by removing corneal tissue with excimer laser ablation, when in fact macular diseases are progressive, wherein available locations are likely to change over time. The apparatus and methods described by the present invention create temporary, alterable changes to the corneal shape. Secondly, the prior art taught in the Grierson and Lieberman patents can only decenter a focused image up to 0.01 mm from the fovea whereas the present invention moves the image by several hundred fold up to 3 mm from the fovea where many PRLs still exist in patients with advanced macular disease.
U.S. Pat. No. 8,454,167 given to Seiler, et al. outlines a thermal laser that corrects presbyopia by shrinking corneal collagen symmetrically around the visual axis, increasing the convexity of the central cornea.
U.S. Pat. No. 8,444,632 to Reinstein et al. emphasizes the importance of centering refractive laser eye surgery along the visual axis of a human eye.
U.S. Pat. No. 8,409,177 to Lai and incorporated herein by reference teaches a method to inducing a corneal shape change for treating a keratoconus condition, or correcting a refractive error or a high order aberration, or combinations thereof, and particularly to generating an intrastromal pocket within a patient's eye with a laser and filling the pocket with a polymeric insert. Other similar patents incorporated herein by reference include Zickler et al. in U.S. Pat. No. 8,246,609 in which a corneal pocket is filled with human donor cornea and U.S. Pat. No. 6,551,307 by Peyman, who teaches the use of a biocompatible gel to fill a corneal pocket to modify the cornea to correct refractive error.
U.S. Pat. No. 8,052,674 to Steinert et al. describes one of many methods to track eye movement in order to avoid decentering the treatment. U.S. Pat. No. 6,626,896 to Frey et al. is another example of eye tracking to keep the laser treatment centered on the visual axis so that after surgery, light from an image will focus on the fovea.
U.S. Pat. No. 6,530,917 granted to Seiler et al. describes a device and method to measure the wavefront optical aberrations of the entire optical system of the eye and creates an ablation profile, calculating the layer thickness of the corneal collagen to be permanently removed at various sites in order to reduce or eliminate higher order aberrations and to better focus light on the fovea.
U.S. Pat. No. 6,344,039 to Targ et al. describes a microscope viewing system to reduce parallax errors which can inadvertently cause a decentered laser ablation.
It was only through a surgical error in a Phase I FDA blind eye study of a thermal laser that the present invention was discovered. An inadvertent and totally decentered treatment with a thermal laser in a patient with late stage AMD surprisingly improved the patient's vision to a remarkable degree. Understanding how that happened is the basis for the present invention.
After careful screening for suitable candidates with macular disease, in one method, a femtosecond laser is used to create an off center pocket within the cornea for the placement of a spacing material such as hydrogel contact lens or human donor cornea material and in another method a thermal laser is used to produce a pattern of corneal collagen shrinkage that is one or more of asymmetric, decentered or eccentric with with respect to the visual axis and in a third method, a thermal conducting wire is used in place of a thermal laser to create collagen shrinkage in a similar pattern with respect to the visual axis. These methods temporarily create a more convex altered corneal topography to purposely increase one or more of the optical aberrations of myopic defocus, astigmatism, coma, trefoil, tilt and tetrafoil which moves light rays from an observed object to preferred retinal locations away from a diseased fovea. This stimulates the photoreceptors in PRLs comprising functional non-foveal areas of retina located 0.01 to 3.0 mm from the diseased fovea to improve the vision in persons with macular disease. All of these techniques are meant to be temporary, lasting from several months to several years so that as the retinal disease progresses, additional treatments can be performed to place the observed image onto remaining PRLs more distant from the fovea. In the case of corneal pockets, the material can be easily removed after which the pocket naturally heals and another pocket in a more eccentric location can be made. In the case of the thermal laser, a wavelength and technique are chosen that produce a temporary change to the cornea and can be repeated in the same or different locations after the cornea returns to its original shape.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention.
Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following. FIGURES, wherein like reference numerals refer to like parts throughout the various views unless otherwise specified.
The present invention first requires selection of patients who have a cornea without pre-existing irregular astigmatism, scars or corneal dystrophies and who have lost all or most of their foveal function but still have islands of functioning parafoveal photoreceptors, termed PRLs. In addition, the patient should not have a dense cataract. This selection process requires a standard slit lamp examination of the cornea and lens of the eye as well as photographic and indirect ophthalmoscopic examination of the retina. A phoropter refraction using an American Optical phoropter for example as well as auto refraction and topography with for example a NIDEK OPD II machine from NIDEK Corporation, Japan and a ray tracing using the iTrace machine made by Tracey Corporation of Houston, Tex. will rule out patients with irregular astigmatism, corneal scars or dystrophies and cataracts who are not good candidates for this procedure. A microperimeter made by Centervue Inc of San Jose, Calif. is then used to confirm loss of central foveal function and to locate PRLs of still functioning macular regions.
In one exemplary method shown schematically in
In another exemplary method, a thermal laser such as the thulium laser (Optimal Acuity Corporation, Austin, Tx) is used to remodel the cornea, making topographic and contour changes to produce a pattern of increased corneal convexity which is one or more of asymmetric, decentered, or eccentric in relationship to the visual axis of the cornea in order to purposely increase optical aberrations which moves the reflected light from an observed object to still functioning PRL areas up to 3 mm from a diseased fovea. The more asymmetric, decentered and/or eccentric that the treatment pattern is, the farther away from the fovea the light from the object will be projected. However, since the potential resolution of the retina decreases rapidly with distance from the fovea, it is important to keep the image as close to the fovea as possible provided that there are PRLs available. While this is likely early in a macular disease, as the macular disease progresses, PRLs close to the fovea may be lost, leaving only more distant PRLs with lower potential visual resolution available. Since the treatment of the present invention is designed to be temporary, the cornea will gradually return to its original shape and allow the physician to repeat the procedure with a more eccentric pattern in order to reach the remaining PRLs later in the disease.
Possible strategies for patterns of thermal treatment on the cornea of a patient with macular disease and their resulting light ray patterns on the retina are shown in
The thulium laser thermal treatment pattern on the cornea surface is shown in
The following examples are given to illustrate the scope of the present invention. Because these examples are for illustrative purposes only, the invention should not be inferred to be limited to these examples. Other methods besides those in the examples and those already described herein and known to those skilled in the art for altering the topography of the cornea including the use of wires conducting heat or radio frequency waves, ultrasonic waves, and the use of other lasers such as holmium or even excimer in extreme cases could be used according to the present invention to remodel and alter the topography of the human cornea and thereby purposely create optical aberrations such as tilt, coma, astigmatism and trefoil in order to move the light from an observed object to still functioning PRL areas away from a diseased fovea. Other optical aberrations could be created in addition to astigmatism and coma for this purpose such as myopic defocus, trefoil, prism, and tetra foil. The treatment of the present invention could be beneficial in a large number of retinal disorders including but not limited to macular degeneration, geographic atrophy, Best's disease, Stargardt's disease, chronic macular edema, macular hole, macular pucker, chloroquine maculopathy, solar maculopathy, angloid streaks, cone degenerations, choroidal folds, chronic epiretinal membrane, chronic central serous maculopathy, and foveal loss due to histoplasmosis, toxoplasmosis, or amoebiasis. The laser and method used in the following examples produces a temporary alteration in the shape of the cornea, which will gradually return to its original shape so that the cornea can be retreated at a later time using a more eccentric pattern if the macular disease progresses and the distance of remaining PRLs from the fovea increase; however, in extreme cases where the disease is at its full extent and PRLs are at a maximal distance from the fovea to allow for any useful visual resolution, a final and permanent treatment eccentrically removing corneal tissue with an excimer or femtosecond laser might be necessary. In such patients, the temporary effect of a thermal laser or method could also be made permanent through the use of a technique known in the art as riboflavin cross linking.
A patient with macular degeneration and best corrected vision of 20/400 in the right eye with no reading vision (less than Jaeger 10 meaning he could not read even the largest print) underwent a four spot treatment with a thulium laser at a power of 46 millijoules per spot. The four spots were equidistant from each other at the corners of a square 6 mm×6 mm in size. Rather than centering the square with the pupil in the center, it was decentered laterally on the cornea by 4 mm as shown in
A female patient with early AMD had best corrected vision of 20/200 but could read only Jaeger 10 size print. She underwent the exact same procedure as in Example 1. Her ray tracings are shown in
In this woman with geographic atrophy of the macula which had destroyed her fovea and much of the macula, only a PRL more than 0.5 mm above the fovea could be detected by preoperative microperimetry (Centerview Inc, San Jose, Calif.). In order to spread the image that far above the fovea, a 4 spot pattern with the thulium laser using 48 mJ of power was decentered such that one spot was directly on the visual axis, upon the pupil center as shown in
The present application claims priority to co-pending U.S. provisional patent application No. 62/083,656 filed Nov. 24, 2014, and entitled “APPARATUS AND CORNEAL REMODELING METHOD TO IMPROVE VISION IN MACULAR DISEASE”, the entire contents of which is incorporated by reference herein.
Number | Date | Country | |
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62083656 | Nov 2014 | US |