Modular IOL design

Abstract

A modular intraocular lens (IOL) is disclosed having a ring configured to prevent glare artifacts. The ring includes a flange on a posterior edge, wherein an anterior surface of the flange has a first profile, and a posterior surface of the flange has a second profile that is non-parallel to the first profile. The non-parallel surface of the flange can be configured to defocus light transmitted through the optic and the flange at off-axis angles.

Description

[0001] Priority declaration

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 000,553, filed on March 27, 2020, entitled “MODULAR IOL DESIGN,” with inventors Stephen John Collins, PhilipMatthew McCulloch, and Rudolph F. Zacher, which is hereby incorporated by reference in its entirety as if fully and completely set forth herein. Technical Field

[0003] The present disclosure relates generally to the field of modular intraocular lenses (IOLs), and more particularly to an IOL including an optic supported by a ring having features that reduce or even prevent glare artifacts. Background Art

[0004] For many purposes, the eye is described as an organ that responds to light. As a conscious sensory organ, the eye produces vision. The rods and cones in the retina produce conscious light perception and vision, including color discrimination and depth perception. In addition, the non-image-forming photosensitive ganglion cells in the retina of the human eye receive light signals that affect the adjustment of pupil size, the regulation and suppression of the hormone melatonin, and the periodic changes of the biological clock.

[0005] The lens is a transparent, biconvex structure in the eye that, along with the cornea, helps refract light so that it is focused on the retina. The lens acts to change the focal length of the eye by changing its shape so that the eye can focus on objects at various distances, allowing a sharp, true image of the object of interest to be formed on the retina. This adjustment of the lens is called accommodation and is similar to how a camera focuses by moving its lens.

[0006] When age or disease causes the lens to become less transparent (e.g., cloudy), vision deteriorates due to the reduced amount of light that is able to transmit to the retina. This defect in the lens of the eye is medically known as a cataract. The treatment accepted for this condition is to surgically remove the lens from the capsular bag and place an artificial intraocular lens (IOL) in the capsular bag. In the United States, most cataractous lenses are removed through a surgical technique called phacoemulsification. In this procedure, an opening is made on the front side of the capsular bag (capsulotomy), and a thin phacoemulsification cutting tip is inserted into the diseased lens and ultrasonically vibrated. The vibrating cutting tip liquefies or emulsifies the lens so that it can be sucked out of the capsular bag. Once the diseased lens is removed, it is replaced with an IOL.

[0007] Some conventional IOLs are single focal length IOLs. Single focal length IOLs have a single focal length or power. Objects at the focal length of the eye / IOL are sharp, while objects closer or farther away may be blurry. Although objects are only completely in focus when they are at the focal length, objects within the depth of focus (within a certain distance of the focal length) are still acceptably in focus so that the patient considers the objects in focus. Summary of the invention

[0008] Embodiments of the modular intraocular lenses (IOLs) disclosed herein are unique in that the ring supporting the optic has a flange to defocus light that might otherwise cause glare.

[0009] The modular IOL includes an optic and a base for supporting the optic. The optic has a front surface, a rear surface, and a thickness configured to focus light at a focal length. The base includes a ring formed with: a front edge sized to have an inner diameter that allows a surgeon to insert the optic; a recess for seating the optic in the base; and a rear edge having a flange defining an inner diameter suitable for preventing the optic from passing through the ring. The flange has a unique geometry to defocus light that enters the IOL off-axis and is transmitted through the optic and the flange.

[0010] Embodiments overcome the challenges of creating a modular optical unit that can be assembled and disassembled by the surgeon in the capsular bag and yet minimize the potential for glare caused by off-axis light passing through the optic and the posterior edge of the ring.

[0011] A modular IOL including an optic and a base minimizes the cross-sectional area, thereby achieving a smaller incision than that required for a complete IOL. A base formed with a ring including a front edge, a rear edge, and an inwardly facing recess allows a surgeon to seat the optic in the base. A ring having a flange having a first profile on the front surface and a second profile on the rear surface that is not parallel to the first profile can avoid or mitigate a plate effect that may cause glare. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] For a more thorough understanding of the present disclosure and advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings, in which like reference numerals indicate like features, and in which:

[0013] Figure 1 A stereogram of a modular IOL is depicted;

[0014] Figure 2 depicts a partial close-up side view of a modular IOL with an optic seated in a ring, and further depicts a flange, wherein the anterior and posterior surfaces of the flange are parallel;

[0015] Figure 3 depicts a partial close-up side view of a modular IOL with an optic seated in a ring, and further depicts a flange, wherein anterior and posterior surfaces of the flange are non-parallel;

[0016] Figure 4A A simplified diagram depicting light transmitted through the optic and lamella to the focal point (FL1) illustrates how light is expected to be transmitted through the IOL in the eye;

[0017] Figure 4B Simplified diagram depicting light transmitted through an optic and a thick plate focusing the light at a second focal point (FL2) farther from the optic, showing how mechanical features in an IOL may result in a plate effect that may otherwise cause off-axis light to be perceived as glare;

[0018] Figure 5A Depicted is a simulated irradiation image showing the radiation transmitted through Figure 2 Light distribution and glare artifacts caused by off-axis light from the optics and flanges; and

[0019] Figure 5B Depicted is a simulated irradiation image showing the transmission through Figure 3 The optical device and flange distribute the off-axis light. DETAILED DESCRIPTION

[0020] Reference will now be made in detail to examples of the present disclosure illustrated in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. In the following discussion, relative terms such as "about," "substantially," "approximately," etc. are used to indicate a possible variation of ±10% of the value, number, or other, unless otherwise indicated.

[0021] Exemplary embodiments relate to ophthalmic devices such as IOLs and contact lenses. The following description is presented to enable a person of ordinary skill in the art to make and use the invention, and is provided in the context of a patent application and its requirements. Various modifications to the exemplary embodiments and general principles and features described herein will be apparent. These exemplary embodiments are described primarily in terms of specific methods and systems provided in the specific embodiments. However, these methods and systems will operate effectively in other embodiments. Phrases such as "exemplary embodiments," "one embodiment," and "another embodiment" may refer to the same or different embodiments, as well as to multiple embodiments. These embodiments will be described with respect to systems and / or devices having certain components. However, these systems and / or devices may include more or fewer components than those shown, and the arrangement and type of these components may be changed without departing from the scope of the present invention. The exemplary embodiments will also be described in the context of specific methods having certain steps. However, for other methods having different and / or additional steps and steps in different orders inconsistent with the exemplary embodiments, the methods and systems still operate effectively. Therefore, the present invention is not intended to be limited to the embodiments shown, but is given the broadest scope consistent with the principles and features described herein.

[0022] Modular IOLs – An Overview

[0023] Figure 1 A perspective view of a modular intraocular lens (IOL) 10 is depicted in which embodiments disclosed herein may be implemented. The IOL 10 generally includes a base 12 and an optic 14. The base 12 is formed with an annular ring 16 and haptics 18. The optic 14 is seated in the ring 16. The haptics 18 may position and retain the ring 16 in the capsular bag to ensure that the optical axis (OA) of the optic 14 is properly aligned for the patient.

[0024] Figure 2 and Figure 3 A partial close-up cross-sectional view of modular IOL 10 with optic 14 positioned within ring 16 is depicted.

[0025] Optic 14 includes an anterior surface 14a and a posterior surface 14b separated by an optic thickness 14c. The radius of curvature of anterior surface 14a, the radius of curvature of posterior surface 14b, and optic thickness 14c are selected to focus light passing through IOL 10 at a focal distance described in more detail below.

[0026] like Figure 2 and Figure 3As depicted, the ring 16 includes an anterior edge 20 and a posterior edge 22, wherein the anterior edge 20 and the posterior edge 22 form an inwardly facing recess 24 for seating the optic 14. The anterior edge 20 is formed with an anterior edge opening 26 sized to allow a surgeon to insert the optic 14 into the ring 16. The diameter of the anterior edge opening 26 may be smaller than the diameter of the optic 14 to prevent the optic 14 from exiting the ring 16 through the anterior edge opening 26 after implantation.

[0027] The inwardly facing recess 24 may be defined by a front edge inner surface 28, a rear edge front surface 30, and an outer surface 32. When the optic 14 is fully seated in the recess 24, the front edge inner surface 28, the rear edge front surface 30, and the outer surface 32 form a geometry that may limit movement of the optic 14 relative to the ring 16 in the forward, rearward, and radial directions.

[0028] The posterior edge 22 includes a posterior edge front surface 30 and further includes a flange 34, wherein the inner diameter of the flange 34 defines a posterior edge opening 36. The flange 34 is formed such that the diameter of the posterior edge opening 36 is smaller than the diameter of the optic 14 to prevent the optic 14 from passing through the ring 16 during implantation and to prevent the optic 14 from exiting the ring 16 after implantation.

[0029] Figure 2 and Figure 3 The changes of ring 16 are further depicted, wherein Figure 3 A ring 16 is depicted, which is connected to Figure 2 Compared to the flange 34 of the ring 16 of FIG. 1 , there is an embodiment of the flange 34 formed to reduce or even prevent glare. Figure 2 and Figure 3 As depicted, the flange 34 includes a flange front surface 38 and a flange rear surface 40 defined between an inner diameter of the flange 34 and an outer diameter of the flange 34 (generally referring to the diameter at which the flange front surface 38 transitions to the rear edge front surface 30). Figure 2 and Figure 3 In both, the flange front surface 38 and the flange rear surfaces 40a and 40b are formed with at least a portion having a curved profile, wherein the flange front surface 38 is formed as a concave surface, and the flange rear surfaces 40a and 40b are at least partially formed as convex surfaces. However, Figure 2 An IOL 10 is depicted in which the contour of the flange posterior surface 40a is parallel to the contour of the flange anterior surface 38, and Figure 3 An IOL 10 is depicted in which the profile of the flange posterior surface 40b is non-parallel to the profile of the flange anterior surface 38. The profiles of the flange anterior surface 38 and the flange posterior surface 40b may be shaped to reduce or potentially prevent glare, as discussed below.

[0030] Glare caused by off-axis light transmitted through optics and flanges

[0031] As described above, the optic 14 is formed with an anterior optic surface 14a and a posterior optic surface 14b, and has an optical axis (OA). Light 42 aligned with the optical axis or at an angle less than a threshold incident angle (Φ) relative to the optical axis enters the IOL 10 via the anterior edge opening 26, is transmitted through the optic 14, and exits the IOL 10 via the posterior edge opening 36 to be focused at a desired focal length. Ideally, in an eye having the IOL 10, both the light 42 aligned with the optical axis and the off-axis light 44 are focused at a desired focal length. However, the off-axis light 44 that enters the IOL 10 at an incident angle equal to or greater than the threshold incident angle (Φ) relative to the optical axis is transmitted through the optic 14, and is also transmitted through the flange 34 or some other mechanical feature. The transmission of the off-axis light 44 through the flange 34 can delay the focusing of the off-axis light 44 on the retina, which can be perceived as glare. The threshold angle of incidence (Φ) at which off-axis light 44 is transmitted through the optic 14 and the flange 34 may depend on one or more of the material or dimensions of the optic 14 and the flange 34. For example, in some modular IOLs 10, the threshold angle of incidence (Φ) may be greater than 25 degrees, while in other modular IOLs 10, the threshold angle of incidence (Φ) may be greater than 30 degrees.

[0032] The front and rear surfaces of the flange are contoured to reduce or even prevent glare

[0033] In order to reduce or even prevent glare or other adverse effects of off-axis light 44 passing through the optics 14 and the flange 34, Figure 3 The depicted flange 34 includes a flange front surface 38 having a first profile and a flange rear surface 40b having a second profile that is non-parallel to the first profile. For example, the flange rear surface 40b may have a profile or shape that includes a protrusion or extension of convex curvature.

[0034] To assist in understanding the benefits of forming an IOL 10 with a flange 34 wherein the profile of the flange anterior surface 38 is not parallel to the profile of the flange posterior surface 40b, reference is made to Figure 4A and 4B Describe the discussion of plate effects. Figure 4A A first simplified diagram of light passing through the optic 14 and a thin plate (ie, having approximately zero thickness) is depicted, showing how light 42 is expected to be transmitted through the IOL in the eye. Figure 4A As depicted, coaxial light leaves the light source and passes through optics 14. Optics 14 focuses the light at a first convergence rate toward a point at a first focal length (FL1) until the light encounters plate P1. If the thickness of plate P1 is substantially zero, then the light continues substantially at the first convergence rate until it reaches a point at the first focal length (FL1). In the human eye, the first focal length corresponds to the retina.

[0035] Figure 4B A simplified diagram depicting light transmitted through the optic 14 and a thick plate focusing the light at a second focal point (FL2) farther from the optic 14 illustrates how mechanical features in the IOL may cause a plate effect that may otherwise cause off-axis light to be perceived as glare. Figure 4B In FIG. 1 , coaxial light leaves the light source and passes through optical device 14. Optical device 14 focuses the light toward a point at a first focal length (FL1) at a first convergence rate. However, Figure 4B Describes the Figure 4A The depicted plate P1 is thicker than the plate P2. Thus, instead of focusing the light at a first focal length FL1, the plate P2 focuses the light at a second convergence rate until the light reaches a point at a second focal length (FL2). In the human eye, if the point at FL1 corresponds to the retina, but the light is focused at a point at FL2, then the image will not be rendered correctly.

[0036] refer to Figure 2 and Figure 3 , parallel to the optical axis (e.g. Figure 1 The light 42 may be expected to pass only through the optical device 14. The light 42 may behave similarly to the light 42 in the optical axis OA) depicted, or at any angle relative to the optical axis less than the threshold angle of incidence (Φ). Figure 4A The depicted diagram shows light passing through the optics 14 and the plate P1 .

[0037] However, light 44 that is transmitted off-axis (i.e., at an angle equal to or greater than the threshold angle of incidence (Φ)) can pass through the optic 14 and also through the flange 34, so that the off-axis light 44 can behave similarly to the Figure 4B For example, if this off-axis light 44 passes through the optic 14 and the flange 34, where the flange rear surface 40a is parallel to the flange front surface 38 (e.g. Figure 2 38), a plate effect may occur and result in visible glare artifacts or other undesirable effects. To reduce the likelihood of glare, double-image photopsia, and other adverse effects, an embodiment of the IOL 10 includes a flange 34 that is formed with a profile of a flange posterior surface 40b that is non-parallel to the flange anterior surface 38 (e.g., Figure 3 34) such that off-axis light 44 that passes through the optic 14 and the flange 34 is defocused. Defocusing the light may include redistributing the off-axis light 44 so that for light that enters the IOL 10 at an incident angle greater than a threshold angle and is transmitted through both the optic 14 and the flange 34, there is no focal distance.

[0038] Plate effect based on flange design

[0039] To illustrate the effect of flange design on off-axis light distribution, Figure 5A and Figure 5B Depicted are simulated light distributions for IOLs 10 formed with flange anterior surfaces 38 and flange posterior surfaces 40 formed parallel and non-parallel to one another, respectively. Figure 5A The flange 34 (eg, Figure 2 The simulated light distribution associated with the image (depicted) shows the glare artifacts. Figure 5A , a first portion 54 of the light distribution is associated with light 42 that passes through the optics 14 at angles less than a threshold angle of incidence (Φ), while a second portion 56 of the light distribution is associated with off-axis light 44 that passes through the optics 14 and the flange 34. The second portion 56 may result in glare artifacts that are visible to the patient and is generally undesirable.

[0040] Figure 5B The flange 34 (eg, Figure 3 ) illustrates how a flange 34 formed with a flange rear surface 40b that is non-parallel to the flange front surface 38 can reduce or even mitigate the plate effect in the IOL 10. Figure 5B , a first portion 54 of the light distribution is associated with light 42 that passes through the optics 14 at an angle less than a threshold angle of incidence (Φ), while a second portion 58 of the light distribution is associated with off-axis light 44 that passes through the optics 14 and the flange 34. The effect of defocusing the second portion 58 of the light 44 to overlap with the first portion 54 can reduce glare caused by the plate effect of the flange 34, or prevent a patient from seeing glare artifacts.

[0041] The method of manufacturing IOL 10 may include selecting an optic 14 for implantation in a patient, including determining the radius of curvature of anterior surface 14a of the optic, the radius of curvature of posterior surface 14b of the optic, and thickness 14c of the optic. Once optic 14 is selected, ring 16 may be selected or formed to ensure that off-axis light transmitted through optic 14 and flange 34 does not produce glare effects. In some embodiments, Figure 2 The depicted ring 16 may be selected as a starting design, and a ray tracing program or other computer simulation may help determine the likelihood that the ring 16 will produce a glare effect. If a glare effect is likely, the IOL 10 may be modified to ensure that the flange posterior surface 40b is not parallel to the flange anterior surface 38, such as Figure 3 Depicted.

[0042] The flange anterior surface 38 and the flange posterior surface 40b can each be straight or curved, can be concave or convex, and have other profiles, as long as the profile of the flange posterior surface 40b is not parallel to the profile of the flange anterior surface 38. For example, the flange anterior surface 38 and the flange posterior surface 40b can both be concave, as long as the flange posterior surface 40b is not parallel to the flange anterior surface 38. In addition, the outer diameter of the flange 34 (i.e., where the flange anterior surface 38 transitions to the posterior edge anterior surface 30) can depend on one or more factors or features of the IOL 10. For example, the outer diameter of the flange 34 can depend on the optic 14, the threshold incident angle (Φ) at which off-axis light may cause glare, and the profile of the flange posterior surface 40b or the flange anterior surface 38. The profile of the flange posterior surface 40b can be modified to focus light at a focal length before or after the focal length associated with the optic 14, or can generally defocus the light.

[0043] Once the optic 14 and the ring 16 having the flange 34 with the flange posterior surface 40 b being non-parallel to the flange anterior surface 38 are selected, the optic 14 and the ring 16 may be assembled to form the IOL 10 .

[0044] The modular IOL 10 including the base 12 and the optic 14 can be implanted using various surgical techniques. The modular IOL 10 can be implanted by first delivering the base 12 into the capsular bag in a rolled configuration using an injector (also referred to as an inserter or delivery tube) that is inserted into the capsular bag through a corneal incision, by capsulotomy.

[0045] The base 12 can be ejected from the injector and allowed to expand. Through gentle manipulation, the haptic 18 of the base 12 engages the inner equator of the lens capsule and centers the ring 16 relative to the capsulotomy. The haptic 18 can assist in the handling of the base 12 and indicate the orientation of the base 12.

[0046] The optic 14 can also be delivered in a rolled configuration using an injector, positioning its distal tip adjacent to the base 12. The optic 14 can be expelled from the injector and allowed to unfold. With gentle manipulation, the optic 14 is centered relative to the capsulorhexis. The optic 14 can have features (not shown) to ease insertion into the capsular bag, removal of the optic 14 from the capsular bag, and to aid in alignment of the optic 14 relative to the base 12.

[0047] Once the optic 14 has been delivered and deployed in the capsular bag, the optic 14 may be positioned in the loop 16 in the base 12 .

[0048] If desired, IOL 10, including optic 14 and base 12, may be removed by generally reversing the above-described steps.

[0049] A probe or similar device may enter the capsular bag containing the modular IOL 10. The probe or similar device may engage the optic 14. Through gentle manipulation, the optic 14 may be lifted so that the optic 14 and the base 12 are disconnected. The probe may remove one or more of the optic 14 and the base 12.

[0050] A modular intraocular lens (IOL) having a flange for defocusing light associated with off-axis light transmitted through the optics and the flange has been described. The system has been described in accordance with the exemplary embodiments shown, and one of ordinary skill in the art will readily recognize that the embodiments may be varied and that any variations will be within the spirit and scope of the described methods and systems. Accordingly, many modifications may be made by one of ordinary skill in the art without departing from the spirit and scope of the appended claims.

Claims

1. A modular intraocular lens (IOL), comprising: an optical device comprising a front surface and a rear surface; as well as An annular ring, the annular ring comprising: a front edge having a front opening; and a rear edge having a flange, wherein: The front edge and the rear edge form an inwardly facing recess; The flange front surface defines a first profile; and The flange rear surface defines a second profile, wherein the second profile is non-parallel to the first profile, and wherein the flange rear surface includes a convex curvature having a protrusion extending rearwardly.

2. The modular IOL of claim 1, wherein: The flange defines a rear edge opening having an inner diameter that is smaller than a diameter of the front edge opening.

3. The modular IOL of claim 2, wherein: The optical device is shaped to focus light transmitted parallel to the optical axis at a first focal length; and The flange is configured to defocus light transmitted through the optical device at an incident angle that deviates from the optical axis.

4. The modular IOL of claim 3, wherein: The incident angle is greater than 25 degrees off-axis.

5. The modular IOL of claim 1, wherein: The flange front surface is shaped to support the optical device.

6. An intraocular lens (IOL) assembly, comprising: an optic defined by an optic front surface having a first curvature and an optic back surface having a second curvature; a ring for positioning the optical device in the intracapsular bag, the ring comprising: a front edge defining a front edge opening having an inner diameter sized to allow insertion of the optic into the ring; an inwardly facing recess for retaining the optical device in the ring; a rear edge defining a rear edge opening; and a flange formed on the rear edge, comprising an inner flange diameter that is less than a diameter of the optical device, wherein: The flange front surface defines a first profile; and The flange rear surface defines a second profile, wherein the second profile is non-parallel to the first profile, and wherein the flange rear surface includes a convex curvature having a protrusion extending rearwardly.

7. The IOL assembly of claim 6, wherein: The flange has an outer diameter that is greater than an inner diameter of the front edge and is smaller than a diameter of the inwardly facing recess.

8. A method of manufacturing a ring for an intraocular lens (IOL), the method comprising: forming a front edge having a front edge opening, the front edge opening having a diameter smaller than a diameter of the optic; forming a rear edge defining a rear edge opening; as well as A flange is formed relative to the rear edge, comprising: forming a flange front surface having a first profile; as well as A flange rear surface is formed having a second profile that is non-parallel to the first profile, and wherein the flange rear surface includes a convex curvature having a protrusion extending rearwardly.

9. The method of claim 8, wherein: One or more of a cross-sectional profile of the flange front surface, a cross-sectional profile of the flange rear surface, and an axial distance between the flange front surface and the flange rear surface are formed to defocus off-axis energy passing through the ring.

10. The method of claim 8, further comprising: An inwardly facing recess is formed on an inner surface of the ring for retaining an optical device in the ring.

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