The present invention relates generally to intraocular lenses (IOLs), and particularly to IOLs that provide a patient with an image of a field of view without the perception of dark visual artifacts in the peripheral visual field.
The optical power of the eye is determined by the optical power of the cornea and that of the natural crystalline lens, with the lens providing about a third of the eye's total optical power. The process of aging as well as certain diseases, such as diabetes, can cause clouding of the natural lens, a condition commonly known as cataract, which can adversely affect a patient's vision.
Intraocular lenses (IOLs) are routinely employed to replace such a clouded natural lens. Although such IOLs can substantially restore the quality of a patient's vision, some patients in whose eyes conventional IOLs are implanted occasionally report the perception of dark shadows, particularly in their temporal peripheral visual fields. This phenomenon is generally referred to as dysphotopsia.
Accordingly, there is a need for enhanced IOLs, and particularly for IOLs and methods that inhibit the perception of dark shadows in the peripheral visual field.
The present invention is based, in part, on the discovery that the shadows perceived by IOL patients can be caused by a double imaging effect when light enters the eye at very large visual angles. More specifically, it has been discovered that in many conventional IOLs, most of the light entering the eye is focused by both the cornea and the IOL onto the retina, but some of the peripheral light misses the IOL and it is hence focused only by the cornea. This leads to the formation of a second peripheral image. Although this image can be valuable since it extends the peripheral visual field, in some IOL users it can result in the perception of a shadow-like phenomenon that can be distracting.
To reduce the potential complications of cataract surgery, designers of modern IOLs have sought to make the optical component (the “optic”) smaller (and preferably foldable) so that it can be inserted into the capsular bag with greater ease following the removal of the patient's natural crystalline lens. The reduced lens diameter, and foldable lens materials, are important factors in the success of modern IOL surgery, since they reduce the size of the corneal incision that is required. This in turn results in a reduction in corneal aberrations from the surgical incision, since often no suturing is required. The use of self-sealing incisions results in rapid rehabilitation and further reductions in induced aberrations. However, a consequence of the optic diameter choice is that the IOL optic may not always be large enough (or may be too far displaced from the iris) to receive all of the light entering the eye.
Moreover, the use of enhanced polymeric materials and other advances in IOL technology have led to a substantial reduction in capsular opacification, which has historically occurred after the implantation of an IOL in the eye, e.g., due to cell growth. Surgical techniques have also improved along with the lens designs, and biological material that previously affected light near the edge of an IOL, and in the region surrounding the IOL, no longer does so. These improvements have resulted in a better peripheral vision, as well as a better foveal vision, for the IOL users. Though a peripheral image is not seen as sharply as a central (axial) image, peripheral vision can be very valuable. For example, peripheral vision can alert IOL users to the presence of an object in their field of view, in response to which they can turn to obtain a sharper image of the object. It is interesting to note in this regard that the retina is a highly curved optical sensor, and hence can potentially provide better off-axis detection capabilities than comparable flat photosensors. In fact, though not widely appreciated, peripheral retinal sensors for visual angles greater than about 60 degrees are located in the anterior portion of the eye, and are generally oriented toward the rear of the eye. In some IOL users, however, the enhanced peripheral vision can lead to, or exacerbate, the perception of peripheral visual artifacts, e.g., in the form of shadows.
Dysphotopsia (e.g., negative dysphotopsia) is often observed by patients in only a portion of their field of vision because the nose, cheek and brow block most high angle peripheral light rays—except those entering the eye from the temporal direction. Moreover, because the IOL is typically designed to be affixed by haptics to the interior of the capsular bag, errors in fixation or any asymmetry in the bag itself can exacerbate the problem—especially if the misalignment causes more peripheral temporal light to bypass the IOL optic.
The present invention generally provides intraocular lenses (IOLs) and methods of vision correction that utilize them, which can alleviate, and preferably eliminate, the perception of dark shadows that some IOL patients occasionally report. Such IOLs can be implanted posterior or anterior to the iris of the eye. In some aspects of the present invention, the fixation members of an IOL are adapted so as to project the IOL's optic toward the iris in order to alleviate dysphotopsia. For example, an optic can be positioned sufficiently close to the iris of the eye to receive peripheral light rays entering the eye (e.g., at visual angles in a range of about 50 degrees to about 80 degrees) and to direct those rays onto the retina so as to inhibit the formation of a secondary peripheral image or to cause a reduction of the shadow region between such a secondary image and an image formed by the IOL. For example, a fixation member can extend posteriorly from the optic to project the optic toward the iris when the IOL is appropriately implanted. In some cases, the fixation member can have arm-like extensions that extend posteriorly from the optic and form an angle relative to a principal plane of the IOL's optic, e.g., in a range of about 5 degrees to about 45 degrees, or about 15 degrees to about 30 degrees. In many embodiments, the IOLs are preferably deformable such that their delivery to a subject's eye is facilitated. These, as well as other, aspects are disclosed in more detail herein.
In one aspect, an intraocular lens (herein “IOL”) is disclosed that includes an optic suitable for implantation in the eye of a subject, as well as one or more fixation members coupled to the optic and adapted to position the optic sufficiently close to the iris to inhibit the perception of peripheral visual artifacts, e.g., dysphotopsia.
In a related aspect, in the above IOL, the fixation members can project the optic toward the iris to ensure sufficient proximity of the optic to the pupil. By way of example, one or more fixation members can be adapted to position an anterior-most portion of the IOL's optic at an axial distance less than about 0.8 mm, or less than about 0.7 mm, or less than about 0.6 mm relative to a tip of the eye's iris.
The fixation members can have a variety of shapes and configurations. For instance, a fixation member can include one or more extension members that are coupled to a peripheral portion of the IOL's optic. In a particular example, an extension member can be configured as an annular structure that is coupled to the peripheral portion of the optic. Such an annular structure can be adapted to position the optic in a capsular bag of the eye, and can optionally include one or more protuberances that extend from a surface thereof to contact the capsular bag. For example, one or more protuberances can contact either the anterior surface, the posterior surface, or both surfaces of the capsular bag. In another example, a fixation member can be in the form an arm-like extension that extends posteriorly from the optic.
Another aspect is directed to an IOL that includes an optic for implantation in the eye of a subject. The IOL can also include one or more haptics, which can be coupled to the optic. Any of the haptics can have a free-end that is positioned posterior to a posterior-surface of the optic. For example, the free-end of the haptic can be separated from the optic's posterior-surface by an axial distance of at least about 0.4 mm, or at least about 0.5 mm, or at least about 0.6 mm. The IOL can be implanted in a subject's eye such that the optic intercepts peripheral light rays entering the pupil at particular angles (e.g., from about 50 degrees to about 80 degrees relative to the eye's visual axis). For example, the fixation members can be employed to position an anterior-most portion of the optic an axial distance of less than about 0.8 mm from a tip of the iris. One of more of the haptics can also be adapted to contact a portion of the eye posterior to an anterior-most portion of the optic.
An IOL includes an optic and one or more fixation members coupled to the optic in another aspect of the invention. Any of the fixation members can be adapted to position the optic such that the anterior-most portion of the optic and a tip of iris are an axial distance of less than about 0.8 mm, or less than about 0.7 mm, or less than about 0.6 mm apart when the IOL is implanted. Any one of the fixation members can also be adapted to intercept peripheral light rays (e.g., rays entering the pupil at angles from about 50 degrees to about 80 degrees relative to the eye's visual axis), and/or to contact a portion of the eye posterior to an anterior-most portion of the IOL's optic. Any fixation member can be configured consistent with any of the earlier described fixation members. For example, a fixation member can be an extension member (e.g., an annular structure) or as a haptic.
Another aspect is directed to a method of inhibiting dysphotopsia in a patient having an implanted IOL by positioning an anterior surface of the IOL's optic close enough to the iris to inhibit dysphotopsia. For instance, the anterior surface can be positioned such that the anterior surface would intercept peripheral light rays and would direct those rays to the retina so as to inhibit the formation of a secondary image on the retina or to reduce the extent of a retinal dark (shadow) region between such a secondary image and an image formed by the optic. In many cases, such peripheral light rays can enter the eye at an angle in the range from about 50 degrees to about 80 degrees relative to the eye's visual axis. By way of example, in some cases, the optic's anterior surface can be positioned an axial distance of less than about 0.8 mm from a tip of an iris of the subject's eye.
Other aspects are directed to methods of inhibiting dysphotopsia in a patient's eye by implanting an IOL therein. The IOL can be consistent with any of the embodiments discussed herein.
Various features of embodiments of the present invention will be more readily understood from the following detailed description when read in conjunction with the appended drawings (not necessarily drawn to scale), in which:
The present invention generally provides intraocular lenses (IOLs) and methods for correcting vision that employ such lenses, which can ameliorate, and preferably prevent, the perception of dark shadows that some IOL patients report.
The term “intraocular lens” and its abbreviation “IOL” are used herein interchangeably to describe devices that include one or more optics (e.g., lenses) that are implanted into the interior of the eye to either replace the eye's natural lens or to otherwise augment vision regardless of whether or not the natural lens is removed. Intracorneal lenses and phakic lenses are examples of lenses that may be implanted into the eye without removal of the natural lens.
Though the presence of the secondary image can potentially aid in the peripheral visual perception of a subject, the separation of the two illuminated portions of the retina can result in the perception of a shadow-like phenomenon in a region between those images. It is hypothesized that this shadow-like perception is due to the presence of a reduced intensity region 170 on the retina between a primary image 145 and a secondary image 155. This phenomenon is known as dysphotopsia, and is typically perceived on the temporal side of the subject's field of view. Dysphotopsia can also occur as a result of light reflection effects within an IOL's optic.
In this exemplary embodiment, the fixation members are adapted to position the optic sufficiently close to an eye's iris to inhibit the occurrence of dysphotopsia. For example, as shown in the side view of the IOL 20 depicted in
An example of how an IOL, according to an embodiment of the present invention, can alleviate dysphotopsia is provided herein with reference to
As shown in
In some cases, even with the reduction of the axial distance between the IOL's optic and the iris, some peripheral light rays 158 entering the eye might still miss the optic 311, and hence form a secondary peripheral image 148 on the retina 240 as depicted in
Optics, as utilized by a variety of the embodiments disclosed herein, are preferably formed of a biocompatible material, such as soft acrylic, silicone, hydrogel, or other biocompatible polymeric materials having a requisite index of refraction for a particular application. For example, in some embodiments, the optic can be formed of a cross-linked copolymer of 2-phenylethyl acrylate and 2-phenylethyl methacrylate, which is commonly known as Acrysof®.
The term “fixation member” as utilized herein can refer to any structure that is coupled to the optic for positioning the IOL in a desired orientation upon implantation in a subject's eye, typically in a manner such that the optic acts as an effective optical aid to the subject.
Referring back to the exemplary IOL depicted in
In some embodiments, an IOL can include one or more haptics, or other fixation members, such that a free-end of the haptic or fixation member is positioned posterior to a posterior-surface of the IOL's optic. For instance, as depicted in
In another embodiment, an IOL can include one or more fixation members, which are adapted to contact a portion of the eye posterior to the optic. For example, as shown in
The fixation members can have a variety of structures and shapes. In some embodiments, a fixation member can be formed as one or more extension members that are coupled to a peripheral portion of the IOL's optic, and protrude there from. Such extension members can be adapted to position the optic in the capsular bag of the subject's eye, e.g., in a manner to help alleviate or prevent dysphotopsia. Decentration of an implanted IOL can be a cause of dysphotopsia, allowing peripheral light rays to miss the optic and strike the retina. Accordingly, the extension members of an IOL can be adapted to maintain centering, or positioning, of an IOL in a manner such that peripheral light rays strike the IOL to help inhibit dysphotopsia.
Extension members can be constructed of any appropriate material, such as those utilized in optic and/or haptic formation. In many embodiments, they are formed from polymethylmethacrylate (PMMA). It is also understood that such extensions can be formed integrally with the optic, or separately and subsequently coupled with the optic. As well, the relative sizes of the optic and the extension members can be any that make the IOL suitable for alleviating or preventing dysphotopsia and which can make the IOL suitable for implantation in a subject's eye. In some embodiments, such as that depicted in
The fixation members, such as those schematically depicted in
Other exemplary features of an IOL, which embody aspects of the present application, are illustrated in
Further exemplary features of IOLs include the use of optics that provides multiple optical focusing powers. By way of one embodiment, a diffractive structure can be disposed on an anterior surface (or a posterior surface or both surfaces) of the optic such that the optic would provide not only a far-focus optical power (e.g., in a range of about −15 D to about 34 D) but also a near-focus optical power, e.g., in a range of about 1 D to about 4 D. The optic's diffractive structure can be configured to include a plurality of diffractive zones that are separated from one another by a plurality of steps that exhibit a decreasing height as a function of increasing distance from the optical axis OA—though in other embodiments the step heights can be uniform. In other words, in this embodiment, the step heights at the boundaries of the diffractive zones are “apodized” so as to modify the fraction of optical energy diffracted into the near and far foci as a function of aperture size (e.g., as the aperture size increases, more of the light energy is diffracted into the far focus). By way of example, the step height at each zone boundary can be defined in accordance with the following relation:
wherein
λ denotes a design wavelength (e.g., 550 nm),
a denotes a parameter that can be adjusted to control diffraction efficiency associated with various orders, e.g., a can be selected to be 1.9;
n2 denotes the index of refraction of the lens material,
n1 denotes the refractive index of a medium in which the lens is placed, and
ƒapodize represents a scaling function whose value decreases as a function of increasing radial distance from the intersection of the optical axis with the anterior surface of the lens. By way of example, the scaling function ƒapodize can be defined by the following relation:
wherein
ri denotes the radial distance of the ith zone,
rout denotes the outer radius of the last bifocal diffractive zone. Other apodization scaling functions can also be employed, such as those disclosed in a co-pending patent application entitled “Apodized Aspheric Diffractive Lenses,” filed Dec. 1, 2004 and having a Ser. No. 11/000770, which is herein incorporated by reference.
In this exemplary embodiment, the diffractive zones are in the form of annular regions, where the radial location of a zone boundary (ri) is defined in accordance with the following relation:
r
i
2=(2i+1)λƒ Equation (3)
wherein
i denotes the zone number (i=0 denotes the central zone),
ri denotes the radial location of the ith zone,
λ denotes the design wavelength, and
ƒ denotes an add power.
It is understood that various embodiments of IOLs can utilize or contain features described in other embodiments, and that the scope of the present invention is not necessarily limited to the explicitly described embodiments herein. For instance, features of IOLs using haptics as fixation members can also be used in embodiments that utilize extension members as fixation members. For example, embodiments which describe the axial distance between an anterior-most portion of an optic and the tip of the iris; or the distance between an end point of a fixation member and a posterior surface of the optic of an IOL, or the distance of position of an anterior-most portion of an optic relative to where a portion of a fixation member contacts an eye can be applied to IOL with extensions as fixation members, as opposed to haptics. In one particular example, the distance 74 between the edge of an annular structure 71 and an anterior-most surface of an optic 72, as depicted in
IOLs according to the teachings of the invention, such as the above embodiments, can be employed in methods of correcting vision, e.g., to replace a clouded natural lens. For example, in cataract surgery, a clouded natural lens can be removed and replaced with an IOL. By way of example, an incision can be made in the cornea, e.g., via a diamond blade, to allow other instruments to enter the eye. Subsequently, the anterior lens capsule can be accessed via that incision to be cut in a circular fashion and removed from the eye. A probe can then be inserted through the corneal incision to break up the natural lens via ultrasound or other techniques. The lens fragments can be subsequently aspirated. An IOL according to the teachings of an aspect of the invention, which can include an optic and at least one fixation member projecting the optic toward the pupil, can be implanted into the eye to correct vision while inhibiting dysphotopsia. For example, forceps can be employed to place the IOL in a folded state in the original lens capsule. Upon insertion, the IOL can unfold and its haptics can anchor it within the capsular bag.
In some cases, the IOL is implanted into the eye by utilizing an injector system rather than employing forceps insertion. For example, an injection handpiece having a nozzle adapted for insertion through a small incision into the eye can be used. The IOL can be pushed through the nozzle bore to be delivered to the capsular bag in a folded, twisted, or otherwise compressed state. The use of such an injector system can be advantageous as it allows implanting the IOL through a small incision into the eye, and further minimizes the handling of the IOL by the medical professional. By way of example, U.S. Pat. No. 7,156,854 entitled “Lens Delivery System,” which is herein incorporated by reference, discloses an IOL injector system. The IOLs according to the embodiments of the invention, are preferably designed to inhibit dysphotopsia while ensuring that their shapes and sizes allow them to be inserted into the eye via injector systems through small incisions.
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments in any suitable combination. Such modifications and variations are intended to be included within the scope of the present invention. As well, one skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
This application is related to the following patent applications that are concurrently filed herewith: “Intraocular Lens with Asymmetric Haptics” (Attorney Docket No. 3227); “Intraocular Lens with Asymmetric Optics” (Attorney Docket No. 3360); “Intraocular Lens with Peripheral Region Designed to Reduce Negative Dysphotopsia” (Attorney Docket No. 2817); “IOL Peripheral Surface Designs To Reduce Negative Dysphotopsia” (Attorney Docket No. 3345); “Product Solutions to Reduce Negative Dysphotopsia” (Attorney Docket No. 3225); “Graduated Blue Filtering Intraocular Lens” (Attorney Docket No. 2962); and “Haptic Junction Designs to Reduce Negative Dysphotopsia” (Attorney Docket No. 3344), each of which is incorporated herein by reference.