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 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 IOL users 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. 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. 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. 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 methods and devices (e.g., intraocular lenses (IOLs)), which can alleviate, and preferably eliminate, the perception of dark shadows that some IOL users report. Various embodiments of the present invention alleviate, and preferably prevent, dysphotopsia by adapting one or more optic fixation members of an IOL to direct at least some of the incident light onto a reduced intensity (shadow) region of the retina between an image formed by the IOL and a secondary peripheral image formed by light rays entering the eye that miss the IOL. Many such embodiments can help alleviate the perceived peripheral visual artifacts (e.g., shadows) without a substantial increase, if any, of the IOL's size. Accordingly, such IOLs can be deformed into a configuration suitable for delivery by minimally invasive methods.
In one aspect, an intraocular lens (IOL) is disclosed that includes an optic suitable for implantation in the eye of a subject, where the optic is adapted to form an image of a field of view upon the retina of the eye when the IOL is implanted in the subject's eye. The IOL can further have one or more fixation members coupled to the optic, which can be used to facilitate placement of the optic in the subject's eye. The fixation member(s) can include one or more portions that are adapted to receive some of the light rays entering the eye (e.g., entering the eye's pupil), and to direct those rays to the retina so as to inhibit (ameliorate and preferably prevent) the perception of peripheral visual artifacts (e.g., to inhibit dysphotopsia). Many such IOLs are deformable such that their delivery to a subject's eye is facilitated.
In a related aspect, in the above IOL, the portions of the fixation members that direct light to the retina to inhibit dysphotopsia comprise one or more light-directing elements. By way of example, such light-directing elements can inhibit dysphotopsia by directing at least some of the light incident thereon to a retinal location offset from a region of the retina in which the optic forms an image. Though the light-directing element(s) can potentially be located anywhere on a fixation member, in some embodiments the element is located in a region (e.g., a connection) between the optic and the fixation member body. For example, the light-directing elements can be disposed in a junction region connecting the fixation member to the optic. In many embodiments, such a junction region is positioned on the nasal side of the IOL in order to receive light rays (e.g., peripheral light rays) entering the eye from the temporal side. The light-directing elements can comprise any number of components, such as one or more Fresnel lenses and/or refractive surfaces and/or diffractive structures. By way of example, the light-directing elements can include one or more lenslets, and/or zonal regions, or any other suitable optical structures. Other examples include structures and/or coatings that diffuse light and/or scatter light in a manner to alleviate or prevent dysphotopsia. In some cases, the light-directing element(s) can have a designated focusing power, e.g., a focusing power less than that of the optic.
In another aspect, a deformable IOL includes an optic, one or more haptics coupled to the optic, and a junction region between the optic and at least one of the haptics, wherein the junction region can be adapted to direct light rays to one or more retinal locations offset from a retinal region in which the optic forms an image, so as to inhibit dysphotopsia. In some cases, the junction region can direct some of the light rays entering eye from the temporal side to the retina. In some cases, the junction region can provide a designated focusing power via, for example, a diffractive structure, a refractive structure, one or more lenslets, and/or a zonal region—such structures, however, can still be used to alleviate dysphotopsia without the designated focusing power. For instance, the focusing power can be less than that of the optic, or can be less than the optical power of the eye's cornea alone, or can be less than the combined optical power of the cornea and the optic, e.g., by a factor in a range of about 25% to about 75%). The junction region can also include a diffusive structure and/or a scattering structure, which can be adapted to direct light rays to a retinal location such as to prevent or alleviate dysphotopsia.
In another aspect, an IOL is disclosed, which includes an optic and one or more fixation members. At least one of the fixation members can include at least a portion (e.g., a diffractive structure) adapted to receive some light rays entering the eye and directing them to the retina so as to inhibit dysphotopsia. By way of example, the fixation member can be positioned on a nasal side of the eye, and can include a junction region for connecting it to the optic. The junction region can form the light-directing portion of the fixation member. Such an IOL can be deformable to facilitate its delivery to a subject's eye.
In another aspect, the invention provides an IOL, which includes an optic and one or more fixation members coupled to the optic. The IOL further includes a diffractive structure disposed on a surface of at least one of the fixation members. The diffractive structure can provide a focusing power that is less than the focusing power of the optic. For instance, the focusing power can be less than the optical power of the eye's cornea alone, or can be less than the combined optical power of the cornea and the optic, e.g., by a factor in a range of about 25% to about 75%). Alternatively, or in addition, one or more Fresnel lenses can be disposed on one or more fixation members to direct incident light. The focusing power of the Fresnel lens can be commensurate with that discussed with respect to diffractive structures.
In other aspects, methods of inhibiting the perception of visual artifacts (e.g., dysphotopsia) in a peripheral visual field of an IOL user are disclosed. Any of the IOLs described herein, which are effective for inhibiting dysphotopsia, can be implanted into the subject eye to help alleviate the perception of such visual artifacts.
In other aspects, methods are disclosed for inhibiting dysphotopsia in patients that have an IOL, wherein the IOL includes an optic and one or more fixation members coupled to the optic. The IOL can also include a junction region between the optic and a fixation member. Dysphotopsia can then be inhibited by altering the paths of at least some of the light rays that enter the eye's pupil and strike a portion of a fixation member (e.g., a junction region). For example, light rays that strike the fixation member can be redirected in a manner suitable to alleviate dysphotopsia, e.g., to one or more retinal locations in the eye offset from an image of a field of view formed on a retina by the IOL's optic. By way of example, such redirection can be accomplished by diffracting the light rays, refracting the light rays, or some combination of both.
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 ophthalmic methods and lenses (e.g., intraocular lenses (IOLs)), which can ameliorate, and preferably prevent, the perception of dark shadows that some IOL users report. Such an effect is known generally as negative dysphotopsia. Many embodiments are based on the discovery that such shadows can be caused by a double imaging effect when light enters the eye at very large visual angles, as described below.
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 illumination region 170 on the retina between a primary image 145 and a secondary image 155. This phenomenon is known as negative dysphotopsia, and is typically perceived on the temporal side of the subject's field of view. The nose can block peripheral light rays from the nasal side, reducing the effect of the phenomenon in this direction. Dysphotopsia can also occur as a result of light reflection effects within an IOL's optic. Termed “positive dysphotopsia,” this effect can occur when the angular orientation of light entering the optic, combined with the index of refraction of the optic, results in total internal reflection of light rays within the optic, which subsequently exit the optic to form a secondary illuminated region on the retina.
An example of how an IOL according to an embodiment of the present invention can alleviate dysphotopsia is provided herein with reference to
In some instances, light rays 160 that are incident on a portion 325 of a fixation member enter from a temporal side 120 of the eye as shown in
Optics utilized in 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 an IOL's 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. Similar to the optic 21, a fixation member 25 can also be formed of a suitable biocompatible material, such as polymethylmethacrylate (PMMA). While in some embodiments, a fixation member can be formed integrally with the optic, in other embodiments, the fixation member is formed separately and attached to the optic in a manner known in the art.
In some embodiments, a fixation member can include one or more light-directing elements, which can be used to direct light rays that are incident thereon in a desired direction, e.g., so as to inhibit dysphotopsia once the IOL is implanted in the eye. Light-directing elements can include any number of components assembled to guide light in a particular direction. Such elements include structures and/or coatings that can be formed either integrally with a fixation member, or manufactured separately and subsequently coupled to the fixation member. Some examples include zonal regions and/or lenslets that can be incorporated with a fixation member. Other examples include refractive and/or diffractive coatings or structures. Refractive coatings/structures can utilize any combination of material properties (e.g., interfaces between materials with different indices of refraction) and structural features which have a tendency to refract light in a particular manner. By way of example, diffractive coatings/structures can be embodied as a grating with a periodicity suitable for diffracting light in a given direction. Such diffractive elements can be tailored to diffract with one or more orders with particular efficiency. Another example of a light-directing element is the use of one or more Fresnel lenses to direct light rays. Further examples of light-directing elements include structures and/or coatings capable of diffusing light or scattering light in a manner to inhibit dysphotopsia, such as by directing the light into a reduced intensity region of the retina.
All these exemplary components of light-directing elements, among others (including those within the knowledge of one skilled in the art), can be used individually or in combination to provide light-directing capabilities in a fixation member. For instance, a light directing element can be formed from any combination of elements disposed on an anterior surface (i.e., the surface facing toward the cornea of the eye), a posterior surface, or both surfaces of a fixation member and/or a region of the IOL intermediate between the fixation member and the optic. In one example, it can be beneficial to place the light-directing element on an anterior surface, rather than a posterior surface, of the fixation member or a junction region to alleviate the potential risk of posterior capsule opacification (PCO)—though in other cases the light-directing element can be placed on the posterior surface or both surfaces. As well, the body of a fixation member and/or junction region, having anterior and posterior surfaces, can be adapted to also direct light in a particular manner. For example, the body can be a translucent body to cause diffusion of light passing therethrough. Such a body can be formed, in one example, by incorporating scattering centers in a biocompatible transparent polymeric material. Some examples of potential combinations are described herein with respect to
In some embodiments, a light-directing element of the fixation member comprises a diffractive structure adapted to direct light incident thereon to a reduced intensity region between an image formed by the IOL and one formed by rays entering the eye that miss the IOL. Such a diffractive structure is schematically depicted in
In use, a diffractive structure can direct at least some of the light rays incident thereon to a shadow region between a secondary peripheral image and an image formed by the IOL. In some implementations, the diffractive structure provides an optical power that is less than an optical power of the optic (e.g., by a factor in a range of about 25% to about 75%). As in many embodiments the diffractive structure receives off-axis peripheral light rays, it can be characterized as having an effective optical power for bending such peripheral rays (e.g., rays entering the eye at visual angles in a range of about 50 degrees to about 80 degrees) so that they would reach the reduced intensity region of the retina between an image formed by the optic and one formed by rays entering the eye that miss the IOL. For example, with respect to
In other embodiments, the light-directing element of the fixation member comprises one or more Fresnel lenses which can be adapted to direct light incident thereon to a region of a retina for potentially alleviating dysphotopsia. For example, the structures 211 on the portion of the fixation member shown in
Returning to the specific IOL embodiment shown in
In some embodiments, a light-directing structure of the IOL that is adapted to receive and direct light rays to the retina so as to alleviate dysphotopsia can be located between the IOL's optic and its fixation member. For example, the structure can include a light-directing element that forms a part of, or an entirety of; a connecting junction between the fixation member and the optic. An exemplary embodiment is depicted in
Further, light-directing structures associated with a fixation member can be made advantageously small in some embodiments, which can be beneficial for limiting the size of the IOL. Further, it is advantageous in many embodiments to adapt a junction region between the haptic and the optic to redirect light to the reduced intensity region as such a junction can more readily receive peripheral light rays entering the eye.
In some embodiments, an IOL can include a junction having a portion (e.g., a light-directing element) that is oriented proximate to the nasal direction when the IOL is implanted in the eye. This can be advantageous since typically dysphotopsia is not associated with the other direction. As shown in
As dysphotopsia is generally perceived in the nasal retina, in many embodiments only the fixation member positioned on the nasal side is configured to direct some light into the shadow region, e.g., via one or more light-directing elements such as those discussed above. For example, as shown in
The IOL depicted in
In some embodiments, the IOL provides multiple focal powers. By way example, a diffractive structure can be disposed on an anterior surface (or a posterior surface or both surfaces) of the optic to provide the IOL with not only a far-focus (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). In some cases, 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),
α 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 optic,
n1 denotes the refractive index of a medium in which the lens is placed, and
fapodize 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 fapodize 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. 11/000,770, which is herein incorporated by reference. In addition, further teachings regarding apodized diffractive lenses can be found in U.S. Pat. No. 5,699,142 entitled “Diffractive Multifocal Ophthalmic Lens,” 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)λf 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
f denotes an add power.
IOLs according to various embodiments of the invention can be employed in methods of correcting vision. As discussed above, such IOLs advantageously inhibit the perception of visual artifacts in a peripheral visual field of the IOL user. For example, the IOLs can be employed to replace a clouded natural lens via cataract surgery. 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, which can include an optic and at least one fixation member, can be implanted into a patient's eye (e.g., to replace the natural crystalline lens) to correct vision while inhibiting the perception of peripheral visual artifacts (e.g., 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.
In some instances, dysphotopsia can be inhibited by altering a path of light that enters the pupil of the eye and strikes at least a portion of the fixation member. For example, the dysphotopsia can be inhibited by redirecting light rays that strike the fixation member. Such light rays can be redirected toward a retinal location offset from where an image of a field of view is provided by the IOL's optic. As discussed above, redirection of the light rays can be achieved by any one, or a combination of, refraction and diffraction of light rays that are incident on a fixation member.
IOLs that can be utilized with the exemplary method include any IOL suitable for practicing the method. Such IOLs include, but are not limited to, the IOLs that are taught or suggested in the present application. For example, the IOL can include a junction region between the optic and the fixation member, in which the junction region can include a portion adapted to alter the path of light rays that strike the portion. The portions of an IOL that can be used to direct light can include any of the light-directing elements disclosed herein.
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. Accordingly, particular features with respect to described fixation members and light directing portions of such members (e.g., light-directing elements) can be chosen to construct alternative embodiments of the present invention. For example, the anterior and posterior surfaces shown in