The human eye often suffers from aberrations such as defocus and astigmatism that must be corrected to provide acceptable vision to maintain a high quality of life. Correction of these defocus and astigmatism aberrations can be accomplished using a lens. The lens can be located, for example, at a spectacle plane, at the corneal plane (a contact lens or corneal implant), or within the eye as a phakic (crystalline lens intact) or aphakic (crystalline lens removed) intraocular lens (IOL).
In addition to the basic aberrations of defocus and astigmatism, the eye often has higher-order aberrations such as spherical aberration and other aberrations. Chromatic aberrations, which are generally aberrations due to varying focus with wavelength across the visible spectrum, are also present in the eye. These higher-order aberrations and chromatic aberrations negatively affect the quality of a person's vision. The negative effects of the higher-order and chromatic aberrations increase as the pupil size increases. Vision with these aberrations removed is often referred to as high definition (HD) vision.
Presbyopia is the condition where the eye loses its ability to focus on objects at different distances. Aphakic eyes have presbyopia. A standard monofocal IOL implanted in an aphakic eye restores vision at a single focal distance. A variety of devices and procedures are used to provide improved vision over a range of distances, among them, using a monofocal IOL combined with bi-focal or progressive addition spectacles. A monovision IOL system is another option to restore near and distance visio—one eye is set at a different focal length than the fellow eye, thus providing binocular summation of the two focal points and providing blended visions. Monovision is currently the most common method of correcting presbyopia by using IOLs to correct the dominant eye for distance vision and the non-dominant eye for near vision in an attempt to achieve spectacle-free binocular vision from far to near.
Additionally, IOLs can be multifocal, for example, bifocal (having two focal regions—usually far and near) or trifocal (having three focal regions—far, intermediate, and near). Most multifocal IOLs are designed to have one or more focal regions distributed within an addition range. However, using elements with a set of discrete foci is not the only possible strategy of design: the use of elements with extended depth of field (EDOF), that is, elements producing a continuous focal segment spanning the required addition, can also be considered. These methods are not entirely acceptable as stray light from the various focal regions degrade a person's vision.
Disclosed are systems, devices, and methods that overcome limitations of IOLs at least by providing by providing a phakic or aphakic IOL that simultaneously provides correction of defocus and astigmatism, decreases higher-order and chromatic aberrations, and provides an extended depth of field to improve vision quality. In addition, a central optic of the IOL provides a small “add” sector to increase the quality of vision corresponding to objects in a “near vision” region.
In one aspect, there is disclosed an intraocular lens configured to provide an extended depth-of-field, said intraocular lens comprising: an optical zone comprising at least one anterior optical surface and at least one posterior optical surface; a first periphery region peripherally positioned relative to the optical zone, the first periphery region comprising a virtual aperture, the virtual aperture comprising an anterior virtual aperture surface and a posterior virtual aperture surface, wherein at least one of the anterior virtual aperture surface and the posterior virtual aperture surface, wherein the virtual aperture comprises a plurality of hexagonal micro-structures; and a second periphery region peripherally positioned relative to the first periphery region, the second periphery region comprising a haptic for positioning the intraocular lens within an eye, wherein the haptic comprises an outermost region of the intraocular lens; wherein a first plurality of light rays incident on the anterior optical surface pass through the optical zone to form an image on a retina when the intraocular lens is implanted in an eye; and wherein a second plurality of light rays incident on the anterior virtual aperture surface are dispersed widely downstream from the intraocular lens towards and across the retina, such that the image comprises the extended depth-of-field and further wherein said virtual aperture reduces monochromatic and chromatic aberrations in the image.
In a related method, an IOL, such as any embodiment of an IOL described herein, is implanted or otherwise coupled to an eye, such as a human eye. The IOL is used to modify or adjust a transmission of lights rays onto a retina of an eye pursuant to the features described herein.
The disclosed IOL has an optical configuration that allows central focused light to reach the central focal area of the retina and spread defocused and aberrated light to a periphery of the retina. In one or more IOL regions where defocused and aberrated light is widely spread across the retina, high power refractive and/or total internal reflection is employed. The result is an optical configuration that increases depth of focus and decrease monochromatic and chromatic aberrations providing high definition vision over a wide range of object distances from far to near vision.
The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.
Before the present subject matter is further described, it is to be understood that this subject matter described herein is not limited to particular embodiments described, as such may of course vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical terms used herein have the same meaning as commonly understood by one skilled in the art to which this subject matter belongs.
Disclosed are systems, devices, and methods that overcome limitations of IOLs at least by providing a phakic or aphakic IOL that provides correction of defocus and astigmatism, decreases higher-order monochromatic and chromatic aberrations, and provides an extended depth of field to improve vision quality. The disclosed IOL is sometimes referred to herein as the Z+ optic or Z+ IOL. U.S. Pat. No. 10,285,807 and U.S. patent application Ser. No. 16/380,622 describe related systems and methods and are both incorporated herein by reference in their entirety.
A description of the basic principle used to reduce monochromatic and chromatic aberrations and provide an increased depth of field is now provided.
In
Note that the same relationship regarding incident ray height and blur circle size also holds for hyperopic or far-sighted eyes. This is schematically illustrated in
Similarly,
In general, an eye has aberrations, which means that as an incident ray location changes, the focal point in the eye also changes. But regardless of where the focal points are located (in front of-, on-, or behind the retina), as incident ray heights are reduced so are the blur circle diameters on the retina. Stated another way, for a given amount of defocus (dioptric error) in the eye, vision is improved as the height of incident rays is reduced. This principle is used when someone squints causing the eyelids to block the incident rays further from the optic axis of the eye in an attempt to see an out-of-focus distant or near object more clearly.
The ray tracing illustrated in
In
In
Taken together,
Exemplary Optical Layout of the IOL
The IOL includes a virtual aperture 48 that is positioned further peripherally outward relative to the center location of the central optical zone 46. Moving peripherally outward from the virtual aperture 48, at least one IOL haptic 50 (with back side 50b) is located on the IOL. The haptic 50 can be formed of one or more arms that extend peripherally outward to define a peripheral most edge of the IOL. In an example, the optical zone has a diameter of 1.5 mm. The haptic 50 may define an outermost peripheral region of the IOL. A first plurality of light rays incident on an anterior optical surface of the optical zone can pass through the optical zone to form an image on a retina when the IOL is positioned in an eye, while a second plurality of light rays incident on an anterior virtual aperture surface are dispersed widely downstream from the IOL towards and across the retina, such that the image comprises an extended depth-of-field and further wherein the virtual aperture reduces monochromatic and chromatic aberrations in the image. The optical zone can comprise at least one of bifocal optics, trifocal optics and multifocal optics.
The virtual aperture is connected to the optical zone 46 by a first transition region 47, which is located at a peripheral edge of the optical zone 46 such that the virtual aperture is a first periphery region that surrounds or partially surrounds the optical zone. The haptic can comprise a second periphery region for positioning the intraocular lens within an eye. The first transition region is located peripherally outward of the optical zone 46. A second transition region 49 connects the haptic 50 to the virtual aperture 48. The first transition region 47 and the second transition region 49 are configured to ensure zero- and first-order continuity of an outer surface of the IOL on either side of the respective transition region. A common way to implement these transition regions is a polynomial function such as a cubic Bezier function. Transition methods such as these are known to those skilled in the art. On the back side of the IOL is a central optic zone 46b, a haptic 50b, and a transition 47b between them.
The IOL has an anterior surface and a posterior surface and the components of the IOL including the optical zone 46, the first transition region 47, the second transition region 49, the virtual aperture 48, the haptic 50 can each have a respective anterior surface and posterior surface. The optical zone 46 has an anterior optical surface that can include at least one multifocal zone and/or a toric region. At least a portion or region of the anterior surface and/or the posterior surface, such as in the region of the virtual aperture or other portion of the IOL, can have a surface contour or shape that achieves a desired or predetermined effect for light passing therethrough. In nonlimiting examples, the surface contour of the anterior surface and/or the posterior surface includes a region with a ripple-type contour such as a wave shape or an undulating shape that forms a series of raised and lowered surfaces. The surface contours can achieve various effects with respect to light passing through the IOL. For example, the surface contour can achieve a wide or wider spread of stray light depending upon the type of surface contour used. The surface contour can be used to achieve a spread of stray light which is guided away from a focal point of the retina.
The IOL includes one or more orientation structures 610 such as one or more protrusions or nubs. In the illustrated embodiment, the orientation structures 610 are positioned on a peripheral edge of a portion of the IOL with at least one orientation structure 610 on the first side of a vertical meridian of the IOL and a second orientation structure 610 on a second side of the vertical meridian. Meridian. The vertical meridian is shown as a dashed line in
A discussed, the haptic(s) 605 provide a mechanical interface with the eye and holds the various zones of the IOL at its proper position relative to the eye.
Example Optic Zone Details—Hexagonal Micro-Lens Virtual Aperture
The virtual aperture employs a two-dimensional hexagonal sampled array of micro-lenses which mimics the photo sensor sampling of the retina. This arrangement is a beneficial layout for widely spreading light across the retina when the IOL is implanted in an eye.
The hexagonal micro-lens virtual aperture 711 include a plurality of hexagonal shaped microstructures positioned on a front side and/or a backside of the IOL. The hexagonal shape is with respect to an outer boundary of each hexagonal micro-structure has an outer boundary defined by a hexagon microstructure when viewed from a front or rear of the IOL. That is, a hexagonal micro-structure can have an outer boundary defined by a hexagon. A small lens is placed inside the bounds of each of the hexagonal micro-structures. The lens can be a structure that is positioned on or in the micro-structure. The lens may also be monolithically formed as part of the microstructure during manufacture. To help prevent unwanted patterning of light on the retina, the centers of micro-lenses inside each hexagon are randomly moved or positioned on the IOL, and the radii of the micro-lenses are also adjusted. To facilitate manufacturing of the hexagonal micro-lens virtual aperture, between the hexagon boundaries of the micro-lenses, a blending region or fillet is placed with a radius of curvature greater than the radius of a lathe cutter that forms the micro-lens. This radius is on the order of 0.05 mm in a non-limiting example.
The hexagon can have a variety of dimensions. In an embodiment, the hexagon of a micro-structure is more tall than wide. In another embodiment, the hexagon of a micro-structure is more wide than tall. In another embodiment, the outer boundary of a micro-structure is an arbitrarily-shaped polygon.
With reference still to
The micro-lenses are implemented as one or more outer surfaces defined at least partially by a sphere, conicoid, or other similar outer surface that can achieve high optical power to widely spread incoming light rays across the retina. For example, the micro-lenses are implemented as one or more outer surfaces defined at least partially by a prismatic or pyramid shape. As an example, in the following discussion there are illustrated embodiments with spherical micro-lenses.
Nominal Hexagonal Sampling
One example hexagon is illustrated in
width=√{square root over (3)}×r (1)
height=2×r (2)
where r=radius of bounding circle
Also, (a) each interior angle of the hexagon is 120 degrees, (b) each side and the center point form an equilateral triangle with interior angle of 60 degrees, and (c) the hexagon side length is equal to the radius of the bounding circle.
The center portion of a two-dimensional array of hexagons is illustrated in
In this equation, Nis a positive, even integer, for example, 50. The (x, y) location of the center of each hexagon is given by equations (4a) and (4b).
The index of the two-dimensional hexagonal array elements as well as the (x, y) coordinates of the hexagon centers are illustrated in the pairs of values above and below each hexagon center in
Smooth Profiles Across the Micro-Lenses
Pursuant to a manufacturing process of an IOL, the radius of a spherical fillet is selected to be larger than the radius of a lathe cutting tool so that the surface can be generated with the given cutting tool. To find the surface points of the smooth profile AA′, the center 1025 of the spherical fillet 1024 is defined as a known radius. For simplicity the centers of the micro-lenses are constrained to have z value on a plane perpendicular to the optical axis. The point P shown in
In these equations,
R12=the radius of the first sphere (item 1020) plus the radius of the fillet sphere
R22=the radius of the second sphere (item 1021) plus the radius of the fillet sphere
x1, y1, z1=the center of the first sphere (item 1022)
x2, y2, z2=the center of the first sphere (item 1023)
The set of center points for the center of the fillet sphere for the entire micro-lens spheres can then be found from equation (6a).
The angle θ is in the plane containing P and perpendicular to the line intersecting the two micro lens sphere centers. Using this geometry, there can be traced out the surface points along the curve segments AB, BB′, and B′A′. Together, these points form a continuous blending between each of the micro-lenses in the virtual aperture such that they can be cut on a lathe using a tool of radius less than the fillet sphere radius.
To use the concepts described above to define a surface of the IOL, the following is done. First, the central optic of the IOL is specified such as described in PCT Patent Application Serial No. PCT/US20/37014 and U.S. patent application Ser. No. 16/380,622, which are incorporated by reference in their entirety. The diameter of the optic zone can be around 1.5 mm and preferably between (1.4 and 1.6 mm) in non-limiting examples. Optical powers for this optic zone vary from −10 to 40 D in steps or 0.25 or 0.5 D. Cylinder powers for toric IOLs vary from 0.5 to 6.0 D in steps of 0.25 to 0.5 D.
The micro-lens array virtual aperture is then generated using the concepts above where the radius of the circles bounding the hexagons is about 0.125 mm. The centers of the individual micro-lens spheres are randomly varied about 0.05 mm in x and y. The radii of the micro-lens spheres are randomly varied 0.05 mm from a mean radius of about 0.2 mm. The width of the virtual aperture region is about 2.0 mm.
The micro-lens array fillet sphere radius is set to be about 25% larger than the lathe tool radius. This can be around 0.05 mm.
The width of the front surface transition regions is each set to around 0.15 mm. The width of the back-surface transition region is set to around 2.3 mm.
The configuration of the haptic is configured according to routine procedures for those skilled in the art.
Once the front and back surfaces have been specified, individual profile samples are taken from the center of the IOL to the periphery to specify the points for the lathe cutting file.
Multi-Region Optical Zone
Due to the special nature of IOL's optical mechanism of action, providing a bifocal optical zone is not as problematic as normal size optical zones of 5.0 mm and larger. This is because the extra aberrations caused by incident rays which are outside the central optical zone diameter of, typically, 1.5 mm, are widely distributed across the retina so as not to negatively affect the central vision of the eye.
Distribution of Optic Zone Regions
In an example configuration, the distance power region of the central optic takes up 75% of the optic zone area and the near power region of the central optic takes up 25% of the optic zone area. Since the diameter of the central optic zone is typically 1.5 mm, the central region 1109 of the optical zone has diameter 1.3 mm and the remainder of the optic zone provides 25% for the near vision region 1110.
For some eyes it can be preferred to have the distribution of distance region area and near region area portioned to 50% each or 25% for distance and 75% for near vision. Providing one eye with a majority of the optic zone area for distance vision, such as 75 to 100%, and the other eye with more area optical zone area for near vision may would be used for extended depth of focus/monovision patients. In this case, both eyes have extended depth of focus, but one eye (usually the dominant eye) has slightly better performance for distance vision and the other eye has slightly better visual performance for near vision.
Optic Surfaces for the Optic Zone Regions
To provide the desired optical powers for the optic zone regions, either conic refractive profiles can be used, or diffractive profiles can be used.
In the case of simple conic refractive profiles, each optic zone provides its optical power via a conic curve such that the apical radius of curvature provides the desired optical power and the conicity (K) value is set to reduce spherical aberrations for the region. Optimization to find the apical radius and the conicity can be done numerically using commercially available optical design programs such as Zemax or using closed form analytical equations. Both of these methods are known to those skilled in the art.
When simple conic refractive profiles are used and the central region 9 of the optical zone provides distance vision and the peripheral region 10 provides near vision, the transition between the regions is negligibly small. This is the preferred arrangement as transition regions generally cause stray light that would otherwise be properly focused by one of the two optical power regions.
When simple conic refractive profiles are used and the central region 9 of the optical zone provides near vision and the peripheral region 10 provides distance vision, the transition between the regions is required to smoothly join the regions. This transition profile is generally implemented by either a Bezier curve or a circular fillet, both of which are known to those skilled in the art.
Peripheral Add Zone
In another embodiment the add zone can be placed inside the virtual aperture region. In still another embodiment the add zone can be placed on the posterior side inside the large transition region. The peripheral add zone could be present along with the add zone in the central optic.
Cylinder Power to Correct Astigmatism
To correct for astigmatism, a cylinder component can be added to one or both surfaces of the IOL optic zone. The cylinder power for this purpose is in the range of 0.5 to 6.0 diopters in steps of either 0.25 or 0.5 D.
To use the concepts described above to define a surface of the IOL, the following is done. First, the central optic of the IOL is specified as explained above. The diameter of the optic zone is around 1.5 mm and preferably between (1.4 and 1.6 mm). Optical powers for this optic zone vary from −10 to 40 D in steps or 0.25 or 0.5 D. Cylinder powers for toric IOLs vary from 0.5 to 6.0 D in steps of 0.25 to 0.5 D.
The virtual aperture is then generated using the concepts described in previous disclosures. The width of the virtual aperture region is about 2.0 mm.
The width of the front surface transition regions is each set to around 0.15 mm. The width of the back-surface transition region is set to around 2.3 mm.
The design of the haptic is considered a separate issue and is routine for those skilled in the art.
Once the front and back surfaces have been specified, individual profile samples are taken from the center of the IOL to the periphery to specify the points for the lathe cutting file.
While this specification contains many specifics, these should not be construed as limitations on the scope of an invention that is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.
This application claims priority to U.S. Patent Application No. 62/951,832, filed Dec. 20, 2019, entitled “HIGH DEFINITION AND EXTENDED DEPTH OF FIELD INTRAOCULAR LENS WITH HEXAGONAL SAMPLED MICRO-LENSES”, U.S. Patent Application No. 62/951,839, filed Dec. 20, 2019, entitled “HIGH DEFINITION AND EXTENDED DEPTH OF FIELD INTRAOCULAR LENS WITH MULTI-FOCAL OPTICAL ZONE”, and U.S. Patent Application No. 63/056,110, filed Jul. 24, 2020, entitled “HIGH DEFINITION AND EXTENDED DEPTH OF FIELD INTRAOCULAR LENS”, the contents of which are hereby incorporated by reference herein in their entirety.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US20/65557 | 12/17/2020 | WO |
Number | Date | Country | |
---|---|---|---|
63056110 | Jul 2020 | US | |
62951839 | Dec 2019 | US | |
62951832 | Dec 2019 | US |