Devices for supporting and positioning intraocular lens within eye and methods of use thereof

Abstract

To provide ophthalmic devices for supporting and positioning intraocular lenses in the eye.SOLUTION: An implantable device for supporting an intraocular lens in an eye is provided including: a lens support structure having a central aperture; and one or more fixation arms coupled to the lens support structure and configured to locate and stabilize the device within the eye. Related tools, systems, and methods are also provided.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a continuation of co-pending U.S. patent application Ser. No. 16 / 988,519, filed August 7, 2020, and also claims the benefit of priority under 35 U.S.C. § 119(E) to co-pending U.S. provisional patent application Ser. No. 63 / 017,423, filed April 29, 2020, and co-pending U.S. provisional patent application Ser. No. 63 / 053,450, filed July 17, 2020, the disclosures of which are incorporated by reference in their entireties.

[0002] This disclosure relates generally to the field of ophthalmology, and more particularly to ophthalmic devices for supporting and positioning an intraocular lens within the eye. [Background technology]

[0003] Intraocular lens (IOL) implantation requires intraocular support to hold the IOL in place. Typically, this is achieved by the lens capsule, which is suspended by the zonules (thin, thread-like structures). However, these support structures can be compromised by either intrinsic factors, such as lens pseudoexfoliation, Marfan syndrome, or Weill-Marchesani syndrome, or extrinsic factors, such as trauma. Furthermore, lens support can be compromised iatrogenically during surgery (anterior or posterior segment surgery) or as a late complication of a previous surgery, for example, by capsular phimosis. Summary of the Invention [Problem to be solved by the invention]

[0004] The management of secondary intraocular lens placement in the absence of adequate capsule or zonules support continues to evolve. Currently, the only FDA-approved solution is the placement of an anterior chamber intraocular lens (ACIOL). ACIOLs are large lenses positioned anterior to the iris. Over time, ACIOLs can lead to uveitis-glaucoma-hypoglycemia syndrome (UGH), endothelial cell loss, and corneal decompensation, making them contraindicated for many patients. Modified capsule expansion rings (Cionni or Ahmed) can be used off-label to provide scleral support for sutures against a partially weakened capsule. However, substantial capsule or zonules compromise necessitates lens fixation without these native support structures. Other off-label techniques, such as iris-suturing IOLs, are technically challenging and may result in glaucoma due to iris pigment loss. Finally, intraocular lenses with islet scleral sutures are technically complex, pose a risk of rotation, have uncertain suture durability, and there have been reported cases of breakage and lens subluxation. Furthermore, all of these techniques force the surgeon to substitute a different lens type for the patient's preferred lens. Finally, despite an inadequate lens calculation during the initial vitrectomy or lensectomy, a less-than-ideal lens is often implanted due to the patient's desire to avoid additional posterior segment surgery. [Means for solving the problem]

[0005] In one aspect, an implantable device for supporting an intraocular lens within an eye is described, the implantable device including a support structure having an outer circumferential surface, an anterior-facing surface, a posterior-facing surface, and a central opening extending through the entire thickness of the support structure between the anterior and posterior-facing surfaces, the central opening having a continuous inner periphery. The device includes a plurality of fixation arms coupled to the support structure and configured to be under tension to position and stabilize the device within the eye. Each of the plurality of fixation arms has a terminal end coupled to a transscleral anchor for sutureless scleral fixation.

[0006] The transscleral anchor is configured to be externalized atraumatically. The transscleral anchor is positionable outside the sclera and inside the conjunctiva. At least one of the plurality of fixation arms can be substantially non-planar. The plurality of fixation arms can include three fixation arms extending outward from the outer periphery of the support structure. At least a first of the three fixation arms can be biased toward the center of the device. At least a first and a second of the three fixation arms can each be biased toward the center of the device. A third of the three fixation arms can have an increased cross-sectional area compared to the cross-sectional areas of the first and second fixation arms. Increasing the cross-sectional area of the third fixation arm can increase its stiffness compared to the stiffness of either the first or second fixation arms. The three fixation arms can be uniformly distributed around the outer periphery of the support structure.

[0007] The anterior-facing surface can form a stable platform on which the intraocular lens is placed during use. The continuous inner peripheral surface can form a uniform, substantially circular shape, and the outer peripheral surface can form a substantially non-circular shape. In use, the support structure can provide centering of the device without 360-degree contact with the ciliary body along the substantially non-circular outer peripheral surface. In use, the substantially non-circular outer peripheral surface of the support structure can avoid contact with the ciliary body or can contact the ciliary body along less than 120 degrees. In use, the substantially non-circular outer peripheral surface of the support structure can contact the ciliary processes at three distinct points. The outer peripheral surface of the support structure can include multiple lobes projecting outward from multiple substantially flat or concave sides. The multiple lobes can include three convex lobes that give the support structure a substantially rounded triangular shape. The three convex lobes can provide anti-rotational functionality in the Z plane. In use, the three convex lobes can provide non-penetrating contact with the ciliary body.

[0008] The support structure may include one or more slits formed in an inner wall defining a central opening. The support structure may have a thickness that tapers from the anterior-facing surface to the posterior-facing surface toward the central opening. At least one of the multiple fixation arms may include multiple anchors along its length, including a transscleral anchor at its terminal end. In use, the transscleral anchor may be configured to be positioned outside the sclera. The transscleral anchor may have a shape configured to pass through the sclera in a first direction during insertion and to resist passing through the sclera in a second, opposite direction. When at rest, at least one of the multiple fixation arms may incorporate a bent that forms a curved fixation arm between its origin with the support structure and its terminal end coupled to the transscleral anchor. The bend may be between 90 degrees and 270 degrees radially and centripetally from the origin with the support structure. The bend may be 180 degrees from the origin with the support structure. During deployment, the ends of the curved fixation arms can be in a plane different from the plane of the support structure, and the transscleral anchor can be positioned over at least a portion of the support structure. The bent fixation arms can incorporate an elastic material or a deformable hinge to facilitate straightening the bent fixation arms so that the ends approach the plane of the support structure. Two of the fixation arms can be flexible and have an inward bias, and the third fixation arm can be less flexible than the first two fixation arms. Each transscleral anchor of the multiple fixation arms is configured to be positioned external to the sclera. The transscleral anchor can include a central portion and one or more peripheral graspable portions. The central portion can be positioned over a wound where the anchor will be externalized during implantation. The central portion can have an increased thickness, height, and / or width compared to the peripheral graspable portions. One of the multiple fixation arms can be mechanically reinforced. The mechanical reinforcement can bias the device forward during implantation.

[0009] In a related aspect, a method is provided for implanting an anterior lens capsule device with artificial zonular fixation that provides a stable platform for placing an intraocular lens within an artificially constructed sulcus.

[0010] In a related aspect, an implantable device for supporting an intraocular lens in an eye is provided, the device having a support structure that lies substantially in a first plane. The support structure has an outer periphery, an anterior-facing surface, a posterior-facing surface, and a central opening that extends through the entire thickness of the support structure between the anterior and posterior-facing surfaces. The central opening has a continuous inner periphery. The device has three fixation arms coupled to the support structure and configured to position and stabilize the device in the eye. Each of the three fixation arms has a terminal end that is coupled to a transscleral anchor for sutureless fixation to the sclera. In a resting state, at least a first of the three fixation arms has a bend between its origin and terminal end with the support structure, forming a first bent arm. The terminal end of the first bent arm lies in a second plane different from the first plane.

[0011] The transscleral anchor of the first bent arm can be located over at least a portion of the support structure. The transscleral anchor of the bent arm can be located over at least a portion of the central opening. At least a second of the three fixation arms incorporates a bend between its origin and end with the support structure to form a second bent arm. The end of the second bent arm can be in a second plane different from the first plane. The transscleral anchor of the second bent arm can be located over at least a portion of the support structure. The transscleral anchor of the second bent arm can be located over at least a portion of the central opening. The third of the three fixation arms can be straight from its origin and end with the support structure to form a straight-shaped fixation arm. The straight-shaped fixation arm can be less flexible than the first and second bent arms. The first and second bent arms can be biased toward the central axis of the device.

[0012] In a related aspect, an implantable device for supporting an intraocular lens within an eye is provided, the device having a support structure that resides substantially in a first plane. The support structure includes an outer circumferential surface, an anterior-facing surface, a posterior-facing surface, and a central opening extending through the entire thickness of the support structure between the anterior and posterior-facing surfaces. The central opening has an inner circumferential surface having a circumference. The device includes three fixation arms coupled to the support structure and configured to be under tension to position and stabilize the device within the eye. Each of the three fixation arms has a terminal end coupled to a transscleral anchor for sutureless scleral fixation. The inner circumferential surface forms a uniform, substantially circular shape, and the outer circumferential surface forms a substantially non-circular shape.

[0013] The non-circular shape of the outer peripheral surface may include multiple lobes projecting outward from multiple side surfaces. The multiple side surfaces may be substantially flat or concave. Each of the three fixation arms may extend outward from a respective one of the multiple side surfaces. The support structure may have a width varying around the circumference between the outer peripheral surface and the inner peripheral surface. Each of the three fixation arms may be longer than the distance the multiple lobes project outward. The front-facing and rear-facing surfaces of the support structure may be tapered toward the central axis of the device. The inner and outer peripheral surfaces may be convex, with the inner peripheral surface projecting toward the central axis of the device and the outer peripheral surface projecting away from the central axis of the device. The thickness of the support structure from the front-facing surface to the rear-facing surface may be about 0.15 mm to about 1.5 mm. The support structure may be substantially flat. The support structure may incorporate a recess in the front-facing surface. The support structure may incorporate one or more posts projecting upward from the front-facing surface.

[0014] In a related aspect, a device for implantation into the posterior chamber of an eye lacking an intact lens capsule is provided. The device includes a support structure having a central opening. The support structure is configured to provide support for an artificial intraocular lens. After implantation into the eye, the device and the artificial intraocular lens are configured to allow the passage of light through both the central opening and the artificial intraocular lens. The device includes at least three fixation arms extending substantially orthogonally from the support structure. Prior to implantation, one of the at least three fixation arms extends from the support structure in an unfolded configuration, and at least two of the at least three fixation arms extend from the support structure in a folded configuration. One of the at least three fixation arms is biased toward the unfolded configuration, and at least two of the at least three fixation arms are biased toward the folded configuration prior to implantation. During implantation, each of at least two of the at least three fixation arms is unfolded. Each of the at least three fixation arms includes an atraumatic distal anchor portion for sutureless transscleral fixation of the device within the posterior chamber of the eye.

[0015] In a related aspect, a device for implantation into the posterior chamber of an eye lacking an intact lens capsule is provided, the device including a support structure having a central opening extending through the entire thickness of the support structure. The device includes a plurality of fixation arms, each having an originating portion in the support structure and a terminal portion coupled to an atraumatic anchor for sutureless transscleral fixation. Prior to transscleral fixation of the anchor, the plurality of fixation arms are curved between their originating portion and terminal portion, allowing at least a portion of the curved fixation arm to be visualized through the pupil of the eye.

[0016] After transscleral fixation of the anchor, each of the multiple fixation arms can be tensioned between the origin and the terminal end to align the support structure with respect to the Z-plane of the eye. The support structure is configured to provide support for the intraocular lens, and the central opening is configured to allow the passage of light through both the central opening and the intraocular lens supported by the support structure. The curved fixation arms can be curved anteriorly, and the atraumatic anchor can be positioned above at least a portion of the support structure. The curved fixation arms can be curved posteriorly, and the atraumatic anchor can be positioned below at least a portion of the support structure.

[0017] In a related aspect, a method of implanting a device into the posterior chamber of an eye lacking an intact lens capsule is provided. The method includes inserting the device into the posterior chamber. The device includes a lens support structure having a central opening and at least three fixation arms. Each of the at least three fixation arms has an origin portion coupled to the lens support structure and an end portion comprising an anchor. Prior to insertion into the posterior chamber, at least one of the at least three fixation arms is biased toward a straight configuration and at least a second of the at least three fixation arms is biased toward a folded configuration. The folded configuration includes an origin portion extending away from the lens support structure, a central portion comprising a bend, crease, or curve, and an anchor at the end portion located above or below at least one of a portion of the lens support structure and a portion of the central opening. The method includes grasping an anchor of at least one of the at least three fixation arms and externalizing the anchor through and over a first portion of the sclera. The method includes grasping an anchor of a second fixation arm, unfolding a folded configuration of the second fixation arm, and externalizing the anchor of the second fixation arm through and over a second portion of the sclera. The method includes grasping an anchor of a third fixation arm of the at least three fixation arms, applying tension to the third fixation arm, and externalizing the anchor of the third fixation arm through and over the third portion of the sclera to position and stabilize the device in the posterior chamber of the eye.

[0018] In a related aspect, a device for supporting an artificial intraocular lens in an eye is provided. The device includes a lens support structure having a central opening. When the device is implanted in the eye, light may be transmitted through the central opening toward the retina. The device includes at least three fixation arms, each of which includes an origin portion coupled to the lens support structure and extending outwardly from the lens support structure, and a terminal portion having an anchor for transscleral fixation of the device in the eye. Prior to implantation, at least one of the at least three fixation arms is biased toward a folded configuration incorporating a bend between the origin portion and the terminal portion, with the anchor of the terminal portion positioned to overlap at least a portion of the lens support structure.

[0019] The anchor of at least one fixation arm in the folded configuration is located above at least a portion of the lens support structure and anterior to the lens support structure relative to the retina when placed in the eye and before scleral fixation. The anchor located above at least a portion of the lens support structure can be above and anterior to the central opening of the lens support structure relative to the retina. At least a first portion of the anchor can be above and anterior to the central opening, and at least a second portion of the anchor can be above and anterior to the lens support structure relative to the retina. The anchor of at least one fixation arm in the folded configuration is located below at least a portion of the lens support structure and posterior to the lens support structure relative to the retina when placed in the eye and before scleral fixation. The anchor located below at least a portion of the lens support structure can be below and posterior to the central opening of the lens support structure relative to the retina. At least a first portion of the anchor can be below and posterior to the central opening, and at least a second portion of the anchor can be below and posterior to the lens support structure relative to the retina. The folded configuration can include a terminal portion folded over or under an origin portion of the at least one fixation arm. The terminal portion of the at least one fixation arm in the folded configuration can overlap the origin portion. The anchor of the terminal portion of the at least one fixation arm in the folded configuration can be visible through the pupil of the eye when placing the device in the posterior chamber of the eye but before transscleral fixation of the anchor. The anchor of the at least one fixation arm in the folded configuration is located within a distance from the central axis of the device, which extends from anterior to posterior through the central opening. The distance cannot exceed approximately 4.0 mm. The at least one fixation arm in the folded configuration can be curved such that the anchor of the terminal portion of the at least one fixation arm protrudes posteriorly toward the central opening of the device. The anchor is adaptable for sutureless transscleral fixation. The lens support structure can be generally ring-shaped.

[0020] The lens support structure may further have an outer periphery and an inner periphery. The central opening may be surrounded by an inner periphery. The outer periphery of the lens support structure may be substantially non-circular, and the inner periphery may be substantially circular. The lens support structure may include an outer periphery. The outer periphery may include a plurality of lobes projecting radially from the central opening. A first numerical count of the plurality of lobes may be equal to a second numerical count of at least three fixation arms. Each lobe may be disposed between adjacent fixation arms. Each lobe may be disposed symmetrically around the circumference of the lens support structure between adjacent fixation arms. Each of the at least three fixation arms may be disposed symmetrically around the circumference of the lens support structure between adjacent lobes. The plurality of lobes may consist of three lobes. The at least three fixation arms may consist of three fixation arms. The plurality of lobes may include at least three convex lobes that give the lens support structure a substantially rounded triangular shape. When implanted, the at least three convex lobes may provide non-penetrating contact with ciliary body tissue within the eye. At least two of the at least three fixation arms can be biased toward a folded configuration prior to implantation. All of the at least three fixation arms can be biased toward a folded configuration prior to implantation. At least a second of the at least three fixation arms can be biased toward an expanded configuration prior to implantation. The at least second fixation arm can have a larger cross-sectional area compared to a cross-sectional area of at least one of the at least three fixation arms, providing increased stiffness of the at least second fixation arm relative to the stiffness of the at least one of the at least three fixation arms. The lens support structure can form a substantially planar surface. The lens support structure can include a shape configured to mate with the periphery of the intraocular lens or with one or more haptics of the intraocular lens. The shape can be a recess, indentation, channel, or groove forming at least a portion of an inner periphery of the lens support structure.At least one of the at least three fixation arms can include a deformable material to facilitate unbending of the fixation arm from the folded configuration to the deployed configuration to facilitate transscleral fixation. After transscleral fixation of the anchor, the at least one fixation arm can be tensioned in the deployed configuration between the origin and terminal portions to align the lens support structure with respect to the Z-plane of the eye.

[0021] The device may include three fixed arms. Two of the three fixed arms may be flexible and biased toward a folded configuration. A third fixed arm may be less flexible than two of the three flexible fixed arms and biased toward an unfolded configuration. All three fixed arms may be configured to be installed under tension. The folded configuration of each of two of the three fixed arms may bias an end portion toward a central axis of the device. The lens support structure may be biased toward a substantially flat or planar configuration while at least one of the at least three fixed arms is biased toward the folded configuration.

[0022] In a related aspect, a device for supporting an artificial intraocular lens in an eye is provided. The device includes a lens support structure having an inner circumferential surface at least partially defining a central opening. When the device is implanted in the eye, light may be transmitted through the central opening toward the retina. The device includes at least three fixation arms. The at least three fixation arms have an origin portion coupled to the lens support structure and a terminal portion having an anchor for transscleral fixation of the device in the eye. Prior to implantation, at least one of the at least three fixation arms is biased toward a folded configuration. The folded configuration includes an origin portion extending away from the lens support structure, an anchor at the terminal portion located above or below at least one of a portion of the lens support structure and a portion of the central opening, and a bend between the origin portion and the terminal portion.

[0023] The anchor of the at least one fixation arm in the folded configuration can be located above and anterior to a portion of the lens support structure relative to the retina when positioned within the eye and prior to scleral fixation. The anchor of the at least one fixation arm in the folded configuration can be located above and anterior to a portion of the central opening relative to the retina when positioned within the eye and prior to scleral fixation. At least a first portion of the anchor can be above and anterior to a portion of the central opening, and at least a second portion of the anchor can be above and anterior to a portion of the lens support structure relative to the retina. The anchor of the at least one fixation arm in the folded configuration can be located below and posterior to a portion of the lens support structure relative to the retina when positioned within the eye and prior to scleral fixation. The anchor of the at least one fixation arm in the folded configuration can be located below and posterior to a portion of the central opening relative to the retina when positioned within the eye and prior to scleral fixation. At least a first portion of the anchor can be below and posterior to a portion of the central opening, and at least a second portion of the anchor can be below and posterior to a portion of the lens support structure relative to the retina. The folded configuration can include a terminal portion folded over or under the origin portion of the at least one fixation arm. The terminal portion of the at least one fixation arm in the folded configuration can overlap the origin portion. The anchor of the terminal portion of the at least one fixation arm in the folded configuration can be visible through the pupil of the eye when the device is placed in the posterior chamber of the eye but before the anchor is transscleral fixated. The anchor of the at least one fixation arm in the folded configuration can be located within a distance from the central axis of the device, which extends from anterior to posterior through the central opening. The distance cannot exceed approximately 4.0 mm. The at least one fixation arm in the folded configuration can be curved such that the anchor of the terminal portion of the at least one fixation arm protrudes posteriorly toward the central opening of the device. The anchor can be adapted for sutureless transscleral fixation.

[0024] The lens support structure may be generally ring-shaped. The lens support structure may further include an outer periphery and an inner periphery. The outer periphery may be substantially non-circular, and the inner periphery may be substantially circular. The lens support structure may further include an outer periphery including a plurality of lobes projecting radially away from the central opening. A first total number of the plurality of lobes may be equal to a second total number of at least three fixation arms. Each lobe may be disposed between adjacent fixation arms. Each lobe may be disposed symmetrically around the periphery of the lens support structure between adjacent fixation arms. Each of the at least three fixation arms may be disposed symmetrically around the periphery of the lens support structure between adjacent lobes. The plurality of lobes may be comprised of three lobes, and the at least three fixation arms may be comprised of three fixation arms. The plurality of lobes may include at least three convex lobes that give the lens support structure a substantially rounded triangular shape. When implanted, the at least three convex lobes may provide non-penetrating contact with ciliary body tissue within the eye.

[0025] At least two of the at least three fixation arms can be biased toward the collapsed configuration prior to implantation. All of the at least three fixation arms can be biased toward the collapsed configuration prior to implantation. At least a second of the at least three fixation arms can be biased toward the deployed configuration prior to implantation. The at least second fixation arm can have a larger cross-sectional area compared to a cross-sectional area of at least one of the at least three fixation arms, providing an increased stiffness of the at least second fixation arm relative to a stiffness of at least one of the at least three fixation arms.

[0026] The lens support structure can provide a substantially planar surface. The lens support structure can include a shape configured to mate with the periphery of the intraocular lens or with one or more haptics of the intraocular lens. The shape can include a recess, indentation, channel, or groove that forms at least a portion of the inner periphery of the lens support structure.

[0027] At least one of the at least three fixation arms may include a deformable material to facilitate straightening of the fixation arm from the folded configuration to the deployed configuration to facilitate transscleral fixation. After transscleral fixation of the anchor, the at least one fixation arm may be tensioned in the deployed configuration between the origin and end portions to align the lens support structure with the Z-plane of the eye. The device may include three fixation arms. Two of the three fixation arms may be flexible and biased toward the folded configuration. The third fixation arm may be less flexible than the other two of the three flexible fixation arms and biased toward the deployed configuration. All three fixation arms may be configured to be placed under tension. The folded configuration of each of the two of the three fixation arms may be biased such that the end portion is biased toward the central axis of the device. The lens support structure can be biased toward a substantially flat or planar configuration while at least one fixed arm of the at least three fixed arms can be biased toward a folded configuration.

[0028] In some variations, one or more of the following may optionally be included in any feasible combination in the above methods, apparatus, devices, and systems. Further details are provided in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings. [Brief explanation of the drawings]

[0029] [Figure 1] 1 shows a top view of an example device. [Figure 2] 2 shows the device of FIG. 1 positioned on an eye, supporting an intraocular lens. [Figure 3] 2 shows a cross-sectional view of the device of FIG. 1 positioned to support an intraocular lens. [Figure 4]2 shows a cross-sectional view of the device of FIG. 1 implanted in an eye, supporting an intraocular lens. [Figure 5] 2 shows a top view of the device of FIG. 1, with dotted lines indicating how the device is scored to facilitate optic capture. [Figure 6] FIG. 2 is a top view of the device of FIG. 1 having a flap integrated into the lens support structure to facilitate optic capture. [Figure 7A] 1 shows various examples of designs for securing the footplate. [Figure 7B] 1 shows various examples of designs for securing the footplate. [Figure 8A] 10 shows another example of an anchor foot plate coupled to the end of a fixation arm. [Figure 8B] 10 shows another example of an anchor foot plate coupled to the end of a fixation arm. [Figure 8C] 10 shows another example of an anchor foot plate coupled to the end of a fixation arm. [Figure 9] FIG. 10 is a top view of an example device having multiple anchors on each fixation arm. [Figure 10] FIG. 1 is a perspective view showing an example of a device for supporting an intraocular lens, in which two of the fixation arms are curved and biased inward toward the center of the device, and one fixation arm is straight. [Figure 11] FIG. 1 is a top view showing an example of a device for supporting an intraocular lens, in which two of the fixation arms are curved and biased inward toward the center of the device, and one fixation arm is straight. [Figure 12] 1 shows an example of a device for supporting an intraocular lens in which two fixation arms are curved and biased inward toward the center of the device, and one fixation arm is straight and has a shape that makes it more rigid than the other fixation arm. [Figure 13] FIG. 13 is a top view of an eye with the device of FIG. 12 implanted. [Figure 14A]10A-10C illustrate different examples of sclerotomy guide tools that can be used to assist in identifying and marking the sclerotomy site. [Figure 14B] 10A-10C illustrate different examples of sclerotomy guide tools that can be used to assist in identifying and marking the sclerotomy site. [Figure 15A] 10A-10C show various views of another example of a sclerotomy guide tool. [Figure 15B] 10A-10C show various views of another example of a sclerotomy guide tool. [Figure 15C] 10A-10C show various views of another example of a sclerotomy guide tool. [Figure 15D] 10A-10C show various views of another example of a sclerotomy guide tool. [Figure 15E] 15A-15D are shown positioned over the cornea. [Figure 15F] 15A-15D are shown positioned over the cornea. [Figure 15G] 15A-15D are shown positioned over the cornea. [Figure 15H] 15A-15D show the sclerotomy guide tool of FIGS. 15A-15D with crosshairs. [Figure 15I] 15A-15D show the sclerotomy guide tool of FIGS. 15A-15D with crosshairs. [Figure 16A] 15A-15D are additional views of the scleral incision guide tool. [Figure 16B] 15A-15D are additional views of the scleral incision guide tool. [Figure 16C] 15A-15D are additional views of the scleral incision guide tool. [Figure 16D] 15A-15D are additional views of the scleral incision guide tool. [Figure 17A] 13 shows a straight leading fixation arm configured to bias the device forward to prevent posterior drift during externalization of the anchor footplate. [Figure 17B]13 shows a straight leading fixation arm configured to bias the device forward to prevent posterior drift during externalization of the anchor footplate. [Figure 17C] A snare device that is wrapped around the leading fixation arm and used to externalize the anchor footplate. [Figure 17D] A snare device is wrapped around the leading fixation arm and used to externalize the anchor footplate. [Figure 17E] FIG. 17E is a cross-sectional view of the device of FIG. 17D. [Figure 18A] 10 shows an additional illustration of a snare device used to manipulate and externalize the footplate. [Figure 18B] 10 shows an additional illustration of a snare device used to manipulate and externalize the footplate. [Figure 18C] 10 shows an additional illustration of a snare device used to manipulate and externalize the footplate. [Figure 18D] 10 shows an additional illustration of a snare device used to manipulate and externalize the footplate. [Figure 19A] 10 shows another example of the device prior to implantation, with protrusions extending upward from the front-facing surface of the support structure and fixation arms biased inward toward the center of the device. [Figure 19B] 19B shows the device of FIG. 19A after implantation, with the intraocular lens positioned over the central opening and each of the fixation arms in tension. [Figure 19C] 19B shows the device of FIG. 19A after implantation, with the intraocular lens positioned over the central opening and each of the fixation arms in tension. [Figure 20A] 10 shows another example of a device prior to implantation, with recesses in the front-facing surfaces of the support structure and fixation arms biased inward toward the center of the device. [Figure 20B] 20B shows the device of FIG. 20A after implantation, with the intraocular lens positioned over the central opening and each of the fixation arms in tension. [Figure 20C] 20C is a cross-sectional view of the device of FIG. 20B showing the periphery of the optic of the intraocular lens positioned relative to a recess surrounding the central opening. [Figure 21A] 10 shows another example of a device incorporating an enlarged central opening and multiple leaflets. [Figure 21B] 10 shows another example of a device incorporating an enlarged central opening and multiple leaflets. [Figure 22A] 10 shows an example of the interrelationship of the device with the fixed arms biased towards a folded configuration such that the arms curve inward so that the anchor is positioned forward of and overlaps a portion of the lens support structure and a portion of the central opening. [Figure 22B] 10A-10C show an example of an interrelationship of the device with the fixed arms biased towards a folded configuration such that the arms curve inward so that the anchor is positioned forward and overlaps a portion of the lens support structure. [Figure 23A] 13A-B show an illustration of the interrelationship of the device with the fixation arms biased towards a folded configuration such that the fixation arms curve inward so that the anchors remain in the plane of the lens support structure. [Figure 23B] 13A-B show an illustration of the interrelationship of the device with the fixation arms biased towards a folded configuration such that the fixation arms curve inward so that the anchors remain in the plane of the lens support structure. [Figure 24A] 1 shows an example of the interrelationship of a device with an awning configured to house an intraocular lens. [Figure 24B] 10 shows an example of the interrelationship of a device with an awning configured to house an intraocular lens. [Figure 24C] 10 shows an example of the interrelationship of a device with an awning configured to house an intraocular lens. [Figure 24D] 10 shows an example of the interrelationship of a device with an awning configured to house an intraocular lens. [Figure 24E]10 shows an example of the interrelationship of a device with an awning configured to house an intraocular lens. [Figure 24F] 10 shows an example of the interrelationship of a device with an awning configured to house an intraocular lens. [Figure 25A] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 25B] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 25C] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 26A] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 26B] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 26C] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 26D] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 26E] 10 shows another example of a device having an awning configured to house an intraocular lens. [Figure 27] 10 shows another example of a device having an awning configured to house an intraocular lens. DETAILED DESCRIPTION OF THE INVENTION

[0030] These and other aspects are described in detail with reference to the following drawings. Generally, the drawings are not to absolute or relative scale, but are for illustrative purposes. Also, features and relative placement of elements may be altered for clarity of illustration.

[0031] It should be understood that the drawings herein are for illustrative purposes and are not intended to be to scale.

[0032] This disclosure relates generally to the field of ophthalmology, and more particularly to ophthalmic devices including artificial support structures that can be used to support an intraocular lens (IOL) or other ophthalmic implant when zonular support and capsular support are compromised.

[0033] The most common treatment for aphakia caused by the removal of a cataractous lens is the placement of an intraocular lens within the natural lens capsule. The capsule, consisting of an anterior and posterior portion forming a lumen, is supported by the zonules, providing a stable support for the intraocular lens. In some cases, the posterior surface of the capsule becomes dysfunctional or ruptures during cataract surgery, necessitating a more reliable platform for intraocular lens placement. If the anterior surface of the capsule and its associated zonules are intact, the intraocular lens may be placed between the anterior capsule and the iris, a location known as the "sulcus." In another subset of cataract surgery cases, a non-functional anterior capsule or non-functional zonules makes sulcus placement unsafe or impossible. The devices described herein can be implanted in the posterior chamber of eyes lacking an intact lens capsule. The devices described herein can create an artificial anterior capsule with artificial zonular fixation. The device described herein provides a stable platform structure fixed to the eye, thereby replicating the natural anterior capsule and zonular device, allowing placement of an intraocular lens in an artificially constructed sulcus.

[0034] The device described herein overcomes the problems of other support / positioning techniques known in the art. Anterior chamber intraocular lenses placed in front of the iris can become instable within the eye over time, leading to corneal decompensation, glaucoma, and bleeding. Lenses sutured to the iris are technically difficult to implant and carry the risk of bleeding and glaucoma due to iris abrasion. Lenses can also be sutured to the sclera, which is also technically difficult. In some cases, suture erosion / breakage requires additional surgery and carries the risk of infection, potentially leading to blindness.

[0035] The devices described herein can be implanted suturelessly, eliminating the risk of suture breakage. The sutureless transscleral fixation allows for easier placement and secure fixation without the worry of loose or broken sutures. The devices stably hold the intraocular lens, providing reliable refractive results based on a known position without any hassle. The devices also allow for posterior segment placement, significantly reducing the risk of injury to the iris, angle, or cornea. Posterior implantation of the iris and cornea eliminates or reduces the risk of corneal injury, iris hemorrhage, and glaucoma. The devices described herein reduce the risk of complications compared to current technologies, such as ACIOLs, iris-sutured lenses, or scleral-sutured lenses. The devices described herein are configured to accommodate and support a wide variety of intraocular lenses. Therefore, the lens of choice can be implanted at the time of surgery or at a later date. The devices described herein replicate the natural lens capsule and are particularly suitable for implantation in the posterior chamber of eyes lacking an intact lens capsule. For example, the devices described herein can create an artificial anterior capsule with artificial zonular fixation, which provides a scaffold or stable platform structure and an artificially constructed groove where the anterior component of the lens capsule and / or the zonules of the natural lens are non-functional. The fixation arms can be externalized as needed for scleral support / fixation.

[0036] 1-4 illustrate an implementation of device 100. Device 100 may include a lens support structure 105, on which an intraocular lens 110 may be supported, relative to, or within the lens support structure 105, a central opening or aperture 115, and one or more fixation arms 120. The central opening 115 is configured to prevent device 100 from interfering with the patient's vision and to allow the passage of light through the central opening 115 and the intraocular lens 110 disposed on device 100. The size of the central opening 115 allows light to pass through the device without optical obstruction. Light can pass through the device toward the retina and be affected only by the optics of the intraocular lens. One or more fixation arms 120 may position and stabilize device 100 within the eye. Lens support structure 105 may include an outer periphery 111 and an inner periphery 109, and the central opening 115 may be bounded by the inner periphery 109. The lens support structure 105 can be generally ring-shaped, although the outer periphery 111 of the lens support structure 105 need not be circular, as will be explained in more detail below. The outer periphery 111 of the lens support structure is substantially non-circular, and the inner periphery 109 is substantially circular.

[0037] FIG. 1 shows a top view of the device 100, showing the lens support structure 105, central opening 115, and fixation arms 120. FIG. 2 shows a model eye with a three-quarter view of the device 100 deployed to support an intraocular lens 110 (the iris is shown transparent). The lens support structure 105 serves as a support for the intraocular lens 110 during optimal implantation and can also act as a guard against the intraocular lens 110 falling into the posterior chamber during implantation. The lens support structure 105 can replace the natural lenticular lens capsule, particularly in cases where the anterior aspect and associated zonules are ineffective, making intraocular lens sulcus placement risky or impossible. By placing the lens support structure 105 in a patient lacking a suitable lens capsule, an anterior lens capsule device can be created. The fixation arms 120 can provide artificial zonular fixation, stabilizing the lens support structure as a stable platform for placing an intraocular lens within an artificially constructed sulcus. Figure 3 shows a cross-sectional view of a model eye and device 100 deployed to support an intraocular lens 110. Figure 4 shows a model eye in cross-section of how the lens is positioned to support an intraocular lens using the technique of optic capture. Figure 4 shows the cornea 5, iris 10, ciliary body 15, sclera 20, ciliary sulcus 25, and pupil 30 defined in the center of iris 10.

[0038] In some instances, the support structure 105 can be substantially flat or planar. The support structure 105 can have an anterior-facing surface 1210 that faces the front of the eye when the support structure 105 is in use and a posterior-facing surface 1215 that faces the back of the eye when the support structure 105 is in use (see FIG. 17E ). The planar support structure 105 can function as a platform on which an intraocular lens can be placed. The planar anterior and posterior surfaces need not include protrusions, channels, or capture components to hold the intraocular lens against them. For example, the support structure 105 can form an artificial anterior segment of the lens capsule in which the intraocular lens is placed, but need not hold the intraocular lens within its interior surface. Thus, the intraocular lens can remain completely outside the support structure 105 during use, with no protrusions, overhangs, or other surfaces against which the intraocular lens is placed apart from the substantially planar surface of the support structure 105. Thus, each of the front and rear facing surfaces may be substantially smooth and planar, with no protrusions or overhangs thereon. Each of the front and rear facing surfaces may also be free of depressions, grooves, divots, or openings other than the central opening 115 extending therethrough. The substantially planar support structure 105 may taper toward the central opening 115. The tapered edge or inner wall 109 defining the central opening 115 has a thickness in the anterior-posterior direction that is less than the anterior-posterior thickness of the support structure away from the central opening 115.

[0039] In other examples, the support structure 105 can incorporate one or more protrusions extending away from at least one of the anterior and posterior facing surfaces. FIGS. 19A-19C show examples of a support structure 105 having multiple posts 106 projecting upward from the anterior facing surface near the central opening 115. The multiple posts 106 can be positioned around the central opening 115 to surround the optic of the intraocular lens when the intraocular lens is placed over the central opening 115 (see FIGS. 19B-19C). The posts 106 can be adjacent to or adjacently located around the optic to center and receive the intraocular lens, limiting translational and / or rotational movement of the intraocular lens relative to the support structure 105. The posts 106 can also be positioned on the anterior (or posterior) facing surface to engage with regions of the intraocular lens' haptics extending outward from the optic. The post 106 can be universally configured to accommodate most intraocular lens designs.

[0040] In yet other examples, the support structure 105 may optionally or additionally include a recess in at least one of the front- or rear-facing surfaces sized and shaped to receive an intraocular lens (see FIGS. 20A-20C, described in more detail below). The recess may be a central, inward-facing groove for accommodating the intraocular lens and / or intraocular lens haptics, for example, as described in PCT International Publication No. WO 2020 / 086312, published April 30, 2020, which is incorporated herein by reference.

[0041] FIGS. 20A-20C show another example of a device 100 having a support structure 105 including a recess 104 in its anterior-facing surface. The recess 104 can form a lip surrounding a central opening 115, the lip being sized and configured to circumferentially engage and support the optic of an intraocular lens against the lip (see FIG. 20C). The recess 104 in the central 6.0-7.0 mm portion of the support structure 105 can limit translational movement of the optic. The recess 104 can further incorporate a recessed portion to increase the interface area of the intraocular lens with the support structure 105. The recess 104 can also incorporate one or more features to prevent rotational movement about the visual axis or central axis CA of the device. FIGS. 24A-25F, 25A-25C, and 26A-26E show additional examples of devices incorporating a recess in which an intraocular lens is received, as described in more detail below.

[0042] Whether the support structure 105 is recessed and / or incorporates one or more protrusions from its surface, the anterior-posterior thickness of the support structure 105 is minimized to avoid impact on the iris 10.

[0043] The support structure 105 can include one or more surface features in or on the front-facing surface 1210 and / or the rear-facing surface 1215. Figure 1 shows that the support structure 105 can include a surface feature 118 on the front-facing surface 1210 that is used to position the device 100 during implantation. The surface feature 118 can be engaged by forceps or other implantation tools to aid in manipulating the device 100 during implantation.

[0044] The central opening 115 can extend through the entire thickness of the support structure 105 from the front-facing surface 1210 to the rear-facing surface 1215 such that the support structure 105 further includes an inner wall 109 having an inner circumferential surface that defines the central opening 115 and an outer wall 111 having an outer circumferential surface that defines the overall shape of the support structure 105 (see also FIGS. 1 and 17E). This provides the lens support structure 105 with a substantially ring shape. However, a ring-shaped lens support structure 105 need not have both its inner and outer circumferential surfaces be circular. The inner circumferential surface can have a circumference and form a uniform, substantially circular shape, while the outer circumferential surface can form a substantially non-circular shape. As will be described in more detail below, the non-circular shape of the outer circumferential surface is comprised of multiple lobes 107 projecting outward from multiple side surfaces 108. The multiple lobes 107 can project radially away from the central opening 115. The multiple sides 108 can be substantially flat or concave, as described elsewhere herein. In some instances, the device includes at least three fixation arms 120 coupled to a lens support structure 105 configured to be under tension to position and stabilize the device within the eye. Each of the three fixation arms 120 can extend outward from a respective one of the multiple sides 108. Thus, the lens support structure 105 can vary in width circumferentially between its outer and inner peripheral surfaces. The central opening 115 is configured to allow visibility through the device. In some instances, the support structure 105 is substantially flat, and the intraocular lens seats on the front-facing surface (or rear-facing surface) of the support structure 105 but is not retained or accommodated by the central opening 115. In other instances, the support structure 105 is generally planar but includes a recess 104 surrounding the central opening 115 such that an intraocular lens seated on the front-facing surface of the support structure 105 engages a lip formed by the recess 104 (see FIG. 20C ). The support structure (and thus the central opening 115) can have a minimized thickness from front to rear. The thickness of the support structure 105 between the front-facing surface 1210 and the rear-facing surface 1215 can be between about 0.15 mm and 1.5 mm, or between about 0.5 mm and 1.0 mm.The support structure 105 can have a thickness of less than 0.15 mm and still provide sufficient support for the intraocular lens, for example, with the fixation arms 120 under tension. The inner peripheral surface or wall 109 defining the central opening 115 can be smooth and free of any depressions, grooves, channels, or other surface features. In some instances, the inner peripheral surface or wall 109 is convex and protrudes toward the central axis CA of the device. The outer peripheral surface or wall 111 is convex and protrudes away from the central axis CA of the device. The convex inner and outer peripheral surfaces formed by the inner and outer walls 109, 111 can create a cross-sectional shape of the support structure 105 when crossed across the center of the central opening 115 that forms a pair of rounded rods. In some instances, each of the front-facing surface 1210 and the rear-facing surface 1215 tapers toward the central opening 115 so that the inner circumferential surface of the inner wall 109 is shaped as a single narrow ridge or point 1230 that protrudes toward the central axis CA of the device (see FIG. 17E).

[0045] The central opening 115 may be the only opening extending through the support structure 105, such that the support structure 105 has only one opening extending through its entire thickness. The inner diameter of the central opening 115 is configured to be generally universal for a wide range of intraocular lens types. The central opening 115 is sized to avoid substantial overlap of the support structure 105 with the optic of the intraocular lens. Conventional intraocular lenses typically have an optic with an outer diameter of 6 mm, but this size varies depending on the intraocular lens. Some intraocular lenses can be used with central opening 115 inner diameters ranging from less than 5.0 mm to approximately 4.0 mm. Devices with central opening 115 inner diameters of 5.0 mm to approximately 6.0 mm can be used with most intraocular lenses, ensuring compatibility with all conventional haptically stabilized intraocular lenses. The minimum inner diameter of the central opening 115 can be greater than about 4.0 mm, greater than about 4.5 mm, greater than about 5.0 mm, greater than about 5.5 mm, greater than about 6.0 mm, greater than about 6.5 mm, up to about 7.0 mm, up to about 8.0 mm, up to about 9.0 mm, up to 10 mm, and any range therebetween.

[0046] The inner diameter of the central opening 115 can be larger than the outer diameter of the optic of the intraocular lens. Figures 21A-21B illustrate an example of a device 100 having a central opening 115 with an inner diameter larger than the optic of most intraocular lenses. The device 100 can include multiple leaflets 126 configured to support the optic of the intraocular lens. The leaflets 126 can protrude inward to extend into the opening of the central opening 115. The leaflets 126 can support the optic on their anterior-facing surfaces or can be deflected so that the optic passes through and is supported by the posterior-facing surfaces of the leaflets 126. The haptics of the intraocular lens rest on the anterior-facing surfaces of the support structure 105, and the optic of the intraocular lens rests on the posterior-facing surfaces of the leaflets 126, thereby maintaining the Z position of the intraocular lens. The leaflets 126 can be full-thickness or partial-thickness. This means that the leaflets 126 can be as thick as the support structure 105 or thinner than the support structure 105. The leaflets 126 can originate from the anterior-facing surface of the support structure 105 (see FIG. 21A). The leaflets 126 can also originate from the posterior-facing surface of the support structure 105 (see FIG. 21B). When originating from the posterior-facing surface, the optic portion of the intraocular lens is positioned within a recess formed by the central opening 115 and the anterior-facing surface of the leaflets 126. The device 100 can include one, two, three, or more leaflets 126. In an illustrative example, the device 100 includes three leaflets 126 and three fixation arms 120. Each of the three leaflets 126 can be symmetrically positioned around the support structure 105 such that each leaflet 126 is substantially aligned with the origin of a respective one of the fixation arms 120. 21A-21B show that each of the bent fixation arms 120a, 120b curves around from their origin on the support structure 105 to lie substantially above its respective leaflet 126. The leaflet 126 can define an inner diameter that is narrower than the inner diameter of the central opening 115.The narrower inner diameter of the leaflets 126 can be about 4.0 mm to 6.0 mm, or about 5.0 mm to 5.5 mm, or about 5.0 mm. Each leaflet 126 can have a thickness of about 0.10 mm to 0.50 mm, or about 0.15 mm to about 0.35 mm, or about 0.25 mm.

[0047] One or more of the fixation arms 120 can be substantially straight between their origin with the support structure 105 and their terminus. A straight or leading fixation arm 120 can extend along a single longitudinal axis L between the origin 103 and the terminus 102 without bending or curving away from the single longitudinal axis L (see FIGS. 17A-17B). A straight fixation arm 120 can extend perpendicular to the outer circumferential surface of the outer wall 111 of the support structure 105. The longitudinal axis L of the straight fixation arm 120 can be disposed perpendicular to the outer circumferential surface of the outer wall 111. The plane of the front-facing surface 1210 of the support structure 105 and the longitudinal axis L of the straight fixation arm can be parallel to one another, and the plane of the rear-facing surface 1210 of the support structure and the longitudinal axis L can also be parallel to one another.

[0048] One or more of the fixation arms 120 can be transscleral fixation arms configured to be exteriorized atraumatically and held in place solely by their shape and mechanical properties (i.e., without the need for sutures or adhesives). An exteriorized portion or anchor 125 (also referred to herein as an anchor footplate or footplate) at the peripheral end (also referred to herein as a terminal or terminal portion) of the fixation arm 120 can seat under the conjunctiva to secure the fixation arm 120 in place. The anchor 125 of the fixation arm 120 can have a sturdy yet low-profile shape to remain stable, not re-enter the eye, and minimize erode the conjunctiva. Furthermore, the fixation arms 120 of the device 100 can be manufactured to facilitate visualization and manipulation of the device pre-operatively. At least one of the fixation arms 120 can be manufactured to have a substantially non-planar shape upon deployment and then manipulated to a planar configuration during the implantation procedure, e.g., while under tension.

[0049] The device 100 can include one, two, three, or more fixation arms 120. In a preferred embodiment, the device 100 includes three fixation arms 120 positioned symmetrically or equidistantly around the circumference of the support structure 105. The fixation arms 120 can provide sufficient support for long-term stability around the lens support structure 105. In some embodiments, this is achieved with one fixation arm 120. In other embodiments, the one or more fixation arms include three fixation arms 120 positioned symmetrically around the circumference of the lens support structure. The fixation arms 120 can be constructed from a semi-rigid material or can have a shape that provides sufficient structural rigidity.

[0050] The device 100 can also include just two fixation arms 120. These fixation arms 120 can be under equal and opposite tension when implanted and transscleral anchored. Alternatively, the fixation arms 120 can be asymmetric, with one fixation arm 120 under tension and the other having a stiffness and length that acts as a rigid spacing element. Rigid or spring-loaded fixation elements can rely on penetration of adjacent tissue or being pressed into place. Tensioned fixation elements can rely on slight stretching or expansion of the material once deployed. One or both of the fixation arms 120 can be created in an inwardly biased configuration, biasing the fixation arms toward a forward, protruding, curved, or folded configuration, as described elsewhere herein. The fixation arms 120 can have a paddle-like shape that resists rotation when engaged with ocular tissue.

[0051] Device 100 can also include three or more fixation arms 120. Three fixation arms 120 can provide device 100 with a fixation plane defined substantially parallel to the Z-plane (vertical plane) of the eye. Fixation arms 120 can be configured and deployed to put in equal and opposite tension on each fixation arm 120. Alternatively, one or more fixation arms 120 can be configured with a stiffness and length that allows them to act as rigid spacing elements. Zero, one, two, or all of the three or more fixation arms 120 may be fabricated in an inwardly biased configuration or biased toward the center of the device or the central axis CA of the device (see FIGS. 10-13, 17B-17E, 19A, 20A, 21A-21B, 22A-22B, 23A-23B, 24A-24F, 25A-25C, 26A-26E). The inwardly biased fixation arms 120 extend from the support structure and can have a collapsed configuration prior to implantation. At least one (but not all) of the fixation arms may be biased or curved as described herein. At least two (but not all) of the fixation arms may be biased or curved as described herein. In some instances, all of the fixation arms 120 may be biased or curved. The device can include three fixed arms, two of which are flexible and biased toward a folded configuration, and a third fixed arm that is less flexible than the other two and biased toward an unfolded configuration. The folded configuration of each of the fixed arms biases a terminal portion of the fixed arm toward a central axis CA of the device. While the fixed arms are biased toward a folded configuration that is not substantially flat or planar, the lens support structure is biased toward a configuration that is substantially flat or planar.

[0052] Once implanted and transscleral anchored, the inwardly biased arms can straighten or unfold away from the folded, inwardly biased configuration. In a preferred embodiment, two of the fixation arms 120 have an inwardly biased shape, and the third fixation arm 120 has an increased cross-sectional area to increase its stiffness. The inwardly biased fixation arms 120 can incorporate a bend between their origin with the lens support structure 105 and their terminus. The two bent fixation arms 120 are biased toward the central axis CA of the device, toward the folded configuration.

[0053] In one example, device 100 can include at least three fixation arms 120. Prior to implantation, one of the at least three fixation arms can extend from the support structure in an unfolded configuration, and at least two of the at least three fixation arms can extend from the support structure in a folded configuration. Prior to implantation, one of the at least three fixation arms can be biased toward the unfolded configuration, and at least two of the at least three fixation arms can be biased toward the folded configuration. After implantation, each of the arms biased toward the folded configuration can be unfolded.

[0054] Each of the fixation arms 120 can include an origin 103 of the support structure 105 and a terminal end 102 coupled to an atraumatic anchor 125 for sutureless transscleral fixation. Prior to transscleral fixation of the anchor 125, one of the multiple fixation arms 120 (up to all of the fixation arms 120) can include a curved fixation arm 120 that curves between the origin 103 and the terminal end 102 to form a bend B (see FIGS. 22A-22B ) that allows at least a portion of the curved fixation arm 120 to be visualized through the pupil 30 of the eye (see FIG. 13 ). After transscleral fixation of the anchor 125, each of the multiple fixation arms 120 can be tensioned between the origin and terminal ends to align the support structure with respect to the Z-plane of the eye. The support structure 105 is configured to support an intraocular lens. The central opening 115, which extends through the entire thickness of the support structure 105, is configured to allow light to pass through both the central opening 115 and the intraocular lens supported by the support structure 105. The curved fixation arms 120 can be curved forward such that a portion of the arms 120, such as the termini 102 and / or their atraumatic anchors 125, is positioned over at least a portion of the support structure 105 (e.g., over the upper surface of the support structure 105 and / or the area of the central opening 115). Alternatively, the curved fixation arm(s) 120 can be curved backward such that a portion of the arms 120, such as the termini 102 and / or their atraumatic anchors 125, is positioned underneath at least a portion of the support structure 105 (e.g., underneath the lower surface of the support structure 105 and / or the area of the central opening 115).

[0055] 19A and 20A show an example of the device before implantation. 19B-19C and 20B-20C show the device after implantation. Two of the three fixation arms 120 are curved inward to bias them toward a folded configuration at rest. The arms 120 extend outward at a substantially right angle from the support structure 105 (e.g., from their origin 103 on the support structure 105) and bend (forward or backward) to form a curve between the origin 103 and the end 102 of the arm 120. The curvature of the arm 120 causes the end 102 of the arm 120 to be positioned closer to its origin 103. In some examples, the arm 120 is curved forward such that the end 102 of the arm 120 is positioned forward of the arm's origin 103 or over at least a portion of the front-facing surface of the support structure 105 near the arm's origin 103. In other examples, the arm 120 can be curved rearward such that the end 102 of the arm 120 is positioned rearward of the arm's origin 103 or beneath at least a portion of the rear-facing surface of the support structure 105 near the arm's origin 103. In examples, the anchor 125 of the curved fixation arm 120 can be curved away from a first plane of the support structure (e.g., the Z-plane of the eye) into a second plane parallel to the first plane. The second plane can be anterior or posterior to the first plane, depending on whether the arm 120 is curved forward or posterior. The curvature can be substantially transverse (e.g., in the X-plane) to the plane (e.g., the Z-plane) of the lens support structure 105. The diameter of the dilated pupil (depending on the adult or pediatric patient) is up to approximately 8 mm. The curvature is such that the anchors 125 of the curved fixation arms 120 are positioned within the diameter of a circle in a second plane visible within the diameter of the dilated pupil so as not to interfere with visualization by the opaque iris, e.g., from about 3 mm to about 7.5 mm, more preferably about 7 mm. Each anchor 125 of the curved fixation arms 120 can be positioned, for example, no more than about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, or about 4.0 mm from the center of the device.The curved fixation arm 120 provides for positioning the terminal section 102 and / or anchor 125 within this diameter or distance from the center of the device, allowing for easier visualization. The third of the three fixation arms 120 is straight or biased toward an expanded configuration upon deployment. The third fixation arm 120 extends outward at a right angle from the origin 103 on the support structure 105 and does not turn or bend. Rather, the entire third fixation arm 120 is completely straight and extends substantially along one axis. The two fixation arms, which are biased toward a folded configuration upon deployment, are deployed by applying tension to the arms 120, for example, via externalized transscleral anchors.

[0056] The anchoring arms 120 may be uniformly positioned around the device 100 to provide uniform tension. Alternatively, the anchoring arms 120 may be oriented in a non-uniform arrangement, for example, with three anchoring arms 120 at 90 degrees from each other. In this situation, two of the anchoring arms 120 are at 180 degrees from each other and provide opposing tension, while the third anchoring arm 120 serves primarily to prevent the device 100 from rotating.

[0057] The lens support structure 105 can serve several functions. The lens support structure 105 can have a surface (either the anterior-facing surface 1210 or the posterior-facing surface 1215) that forms a stable platform on which the intraocular lens 110 can be placed during use. The lens support structure 105 can replace the lens capsule, particularly when the posterior and / or anterior aspects of the capsule are ruptured or otherwise dysfunctional. Its geometric and mechanical functions not only support the intraocular lens 110 during use, but can also serve to assist in centering the intraocular lens 110 in the case of an asymmetric eye or asymmetric surgical procedure. The lens support structure 105 is coupled to one or more fixation arms 120. When the lens support structure 105 provides artificial anterior capsule support for the intraocular lens, the fixation arms 120 provide an artificial zonular device. Thus, the device provides a stable platform structure fixed to the eye that replicates the natural anterior capsule and zonular device that normally enables intraocular lens placement. The shape and mechanical properties of the lens support structure 105 are configured so that the fixed arms 120 can function as intended and can withstand any torsional or tensile forces that may be imparted by the fixed arms 120 .

[0058] The fixation arms 120 and lens support structure 105 are configured to position the central opening 115 so that a properly fixed device 100 does not interfere with the patient's vision. A surgeon can place an intraocular lens 110 through the lens support structure 105, thereby providing the patient with the necessary refractive correction.

[0059] The ciliary body is substantially circular or elliptical, with a longitudinal axis that is, on average, 0.5 mm longer than the transverse axis. The lens support structure 105 can interact with the patient's ciliary body to provide centering of the device 100 within the eye. The substantially circular or elliptical lens support structure 105 can provide centering with the similarly circular or elliptical ciliary body. However, conforming or 360-degree contact between the lens support structure 105 and the ciliary body can lead to inflammation and injury, adversely affecting lens formation. In a preferred embodiment, the lens support structure 105 has a continuous inner circumferential surface that forms a uniform, substantially circular inner wall 109 that defines a central opening 115, and an outer circumferential surface that forms a substantially non-circular outer wall 111 that gives the lens support structure 105 a substantially non-circular shape (see FIG. 1 ). The non-circular outer circumferential shape of the lens support structure 105 can provide centering of the device 100 without 360-degree contact with the ciliary body along the substantially non-circular outer circumferential surface. The shape of the lens support structure 105 can provide sufficient contact between the lens support structure 105 and the ciliary body to aid in centering and supporting the intraocular lens 110 without causing inflammation or damage. In some implementations, the shape of the lens support structure 105 allows contact with the ciliary body of approximately 120 degrees or less, preferably 1 to 45 degrees, or 1 to 20 degrees. Limiting contact to 120 degrees or less significantly reduces the risk of inflammation and impaired aqueous humor production. A substantially non-circular or elliptical lens support structure 105 allows gentle contact between the device 100 and the ciliary body to provide centering without requiring an exact match to the patient's specific dimensions. The radius of curvature of the lens support structure 105 can be smaller than the radius of curvature of the ciliary processes. Thus, the lens support structure 105 can contact the ciliary processes at three distinct points rather than within a calculable range. For example, during use, the substantially non-circular outer periphery of the lens support structure 105 can contact the ciliary processes at these three distinct points. In other instances, when each fixation arm 120 is implanted and under tension, the lobes 107 of the device 100 are positioned near the ocular tissue (e.g., the ciliary body) but avoid contacting the ocular tissue.This configuration allows the lobes 107 to aid in centering the device and prevent one arm 120 from being overly tensioned relative to the other. If a fixation arm 120 is pulled too tight during externalization of its anchor 125, the adjacent lobes 107 on either side of that fixation arm 120 may lean against the ciliary body during implantation, moving the support structure 105 away from the ciliary body and facilitating a more central alignment of the device 100. Once implanted, the device's lobes 107 are positioned near the ocular tissue (e.g., the ciliary body) with or without touching the ocular tissue. The tensioned fixation arms 120 can pull the support structure 105 substantially evenly around its periphery. Tension applied around the support structure 105 substantially aligns the central axis CA of the device 100, which extends through the central opening 115, with the visual axis of the eye, allowing the plane of the support structure 105 to stabilize substantially parallel to the Z-plane (vertical plane) of the eye. The central axis CA of the device 100 does not need to be perfectly aligned (coincide) with the visual axis of the eye.

[0060] The non-circular outer wall 111 of the lens support structure 105 can include multiple lobes 107 projecting outward (i.e., convexly) from multiple side surfaces 108 that can be substantially flat or concave. This can result in the outer wall 111 of the lens support structure 105 having an alternating pattern of convex lobes and concave or flat sides. In a preferred embodiment, the lens support structure 105 can include three convex lobes 107 or rounded corners projecting between three flat or slightly concave side surfaces 108, giving the lens support structure 105 a triangular or rounded triangular shape (see FIG. 1 ). The lobes 107 can act as bumpers against the ciliary body 15 and / or within the ciliary sulcus 25 to provide anti-rotational functionality in the Z-plane and / or prevent displacement in the Z-plane to maintain proper alignment between the central opening 115 and the visual axis of the eye (see FIG. 4 ). A plurality of securing arms 120 can be disposed on the side surfaces 108, with a plurality of lobes 107 projecting outwardly between the plurality of securing arms 120. Each of the securing arms 120 can be longer than the distance the lobes 107 project outwardly. As described above, the lens support structure 105 can have a circular inner wall 109 defining a central opening 115. The plurality of lobes 107 projecting outwardly from the central opening 115 provide a varying thickness in the plane of the central opening 115 between the inner wall 109 and the outer wall 111. The thickness of the lens support structure 105 between the inner wall 109 and the outer wall 111 at the substantially flat side surfaces 108 is less than the thickness of the lens support structure between the inner wall 109 and the outer wall 111 at the locations of the lobes 107. The number of lobes 107 forming the rounded corners of the lens support structure 105 can be varied to provide the lens support structure with any of a variety of non-circular shapes, including rounded triangles, rounded squares, rounded pentagons, rounded hexagons, trilobes, tetralobes, pentavelobes, etc. These non-circular projections or corners can be rounded to provide gentle, non-penetrating contact with ciliary body tissue, such as the ciliary body. Alternatively, the device 100 can be configured to utilize the pars plana or scleral wall to assist in centering. In this example, the device 100 can be positioned posterior to the ciliary body processes.

[0061] The plurality of lobes 107 can include at least three convex lobes that impart a substantially rounded triangular shape to the lens support structure 105. A first numerical count of the plurality of lobes 107 can be equal to a second numerical count of the at least three fixing arms 120, with each of the lobes 107 located between adjacent fixing arms 120. The lobes 107 can be symmetrically located around the circumference of the lens support structure between adjacent fixing arms. Each of the at least three fixing arms 120 can be symmetrically located around the circumference of the lens support structure 105 between adjacent lobes 107.

[0062] Each fixation arm 120 can have a spring force that is a function of the material's elongation when subjected to a load. In contrast, an open-loop haptic or coil spring can have a spring force provided by bending of the material with a substantially constant length. Once secured to the eye, the fixation arm 120 can be subjected to tension and material elongation. For example, each fixation arm 120 can provide expansion over a radius of about 7.5 mm to about 8.0 mm to accommodate diameters of about 15 mm to about 16 mm. The device has an operable tension range for functionality. As an example, the device can be subjected to a first amount of tension (X tension) upon implantation. The first amount of tension is the amount of tension at the smallest allowable diameter. In other words, the device is under minimal tension to function, but can be under greater tension to accommodate larger diameters. In an example of a fixation arm 120 that can accommodate both 15 mm and 16 mm of extension, each force-transmitting arm can operate under a first tension X and at least a second tension. The second tension can be the sum of the first tension X plus a distance tension (e.g., 0.5 mm tension). The fixation arms can withstand the available tension difference at each extension ratio. To further illustrate the example, if each fixation arm 120 in this example is approximately 4 mm long, the second tension (X tension + 0.5 mm tension) can increase the extension by 12.5% to work with a 15 mm diameter and up to a 16 mm diameter. If the fixation arms 120 in this example are 2 mm long, the second tension (X tension + 0.5 mm tension) can increase the extension by 25% to work with a 15 mm diameter and up to a 16 mm diameter. Assuming the length of the fixation arm in this example is approximately 6 mm, the second tension (X tension + 0.5 mm tension) allows for a 6.25% increase in elongation to function at a diameter of 15 mm and up to a diameter of 16 mm. Reducing the spring force of the fixation arm 120 can improve the safety and function of the device because the tension of the anchor against the ocular tissue is less dependent on variables that are difficult for the surgeon to assess (the specific dimensions of the eye and the particular location of the incision).Additionally, the length of the fixation arms (e.g., between about 2 mm and about 6 mm), as well as the inward curvature (anterior or posterior) of at least one or more of the fixation arms 120, improves access and visualization for the surgeon to locate and fixate the arms during surgery.

[0063] The intraocular lens 110 can be allowed to pass between the device 100 and the ciliary body process with only one, two, or three fixation arms 120 engaged. A lens support structure 105 configured to contact or nearly contact the ciliary body can also reduce the risk of losing the intraocular lens 110 into the posterior chamber during surgery.

[0064] The lens support structure 105 can be constructed to allow surgeons to use an "optic capture" technique for implanting an intraocular lens 110 supported by the device 100. In this technique, the optic 112 of the intraocular lens 110 passes partially or completely through the central opening 115 of the device 100, while the haptics 114 of the intraocular lens 110 remain substantially anterior to the device 100 (see FIG. 3). This technique securely fixes the intraocular lens 110 against movement in the X, Y, and Z axes after surgery and reduces the bulk of the space in front of the lens. This technique also enables the safe use of "square-edge" intraocular lens designs by reducing contact of the intraocular lens with the posterior surface of the iris 10. By allowing surgeons to select the effective position of the lens, they have more flexibility when changing intraocular lens power. This technique also allows for the use of astigmatism-correcting intraocular lenses by limiting intraocular lens rotation. In some situations, limited space may exist between the anterior surface of the lens support structure 105 and the posterior surface of the iris 10. To reduce the risk of iris damage or pupillary block, it would be advantageous to fixate the intraocular lens 110 above or posterior to the plane of the lens support structure 105. Furthermore, fixing the optic while increasing the predictability of refractive position allows for more accurate preoperative lens selection calculations.

[0065] To facilitate the use of optical capture techniques, the lens support structure 105 can allow a surgeon to pass the intraocular lens 110 through the central opening 115 of the device 100. The central opening 115 can have a diameter similar to the diameter of the optic portion of a typical intraocular lens, for example, at least 5.5 mm or 6.0 mm. In this situation, the surgeon can pass the intraocular lens 110 through the central opening 115 with a force parallel to the optical axis or by slightly tilting the intraocular lens 110 to facilitate passage of the intraocular lens 110 through the central opening 115. The central opening 115 can have an inner diameter greater than 5 mm, for example, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, 9.5 mm, and 10.0 mm, up to about 15 mm, and anywhere in between.

[0066] Alternatively, the device 100 can incorporate a feature that allows the diameter of the central opening 115 to be temporarily expanded to allow the intraocular lens 110 to pass through the central opening 115. The support structure 105 can have discontinuous outer and inner peripheral walls such that the support structure 105 forms a split ring with a gap between the ends of the ring. In this example, the inner diameter of the central opening 115 can vary depending on whether the ends of the ring are compressed together or spaced apart. In another example, the outer peripheral wall can be a complete ring or continuous circumference, and the inner peripheral wall defining the central opening 115 can be discontinuous or continuous. A central opening can have a continuous inner circumference without gaps, grooves, or channels. Alternatively, a central opening can have a discontinuous inner circumference. Figure 5 shows an example of a device 100 having one or more slits 113 formed in the inner wall 109 defining the central opening 115. The device 100 can include multiple slits 113, e.g., 2 to 40 slits 113, in the inner wall 109 located circumferentially around the central opening 115. The slits 113 can preferably have a length sufficient to extend 0.25 mm to 2.0 mm radially outward from the inner diameter of the central opening 115, thereby increasing the flexibility of the support structure 105. The intraocular lens 110 can pass through the flexible lens support structure 105. Alternatively, the device 100 can incorporate one or more deflectable flaps 116 molded into the lens support structure 105 (see FIG. 6 ). The device 100 can include two or more deflectable flaps 116, e.g., 2 to 40 flaps 116, that deflect when sufficient force is applied by the surgeon to allow the intraocular lens 110 to pass through the central opening 115. Alternatively, the inner wall 109 can have a brush-like structure that deflects when sufficient force is applied by the surgeon to allow the intraocular lens 110 to pass through. In a further example, the cross-sectional thickness profile of the lens support structure 105 may taper towards the central opening 115 .The outer periphery of the lens support structure 105 near the outer wall 111 will have a greater thickness (e.g., thickness measured from anterior to posterior when the device is placed in the eye) than the thickness of the inner periphery of the lens support structure 105 near the inner wall 109. Thus, the central-most portion of the lens support structure 105 (i.e., the inner wall 109) will have greater flexibility due to the reduced thickness that allows the intraocular lens 110 to pass through the central opening 115 and deflect the inner wall 109 when placed under sufficient force. Despite the greater flexibility near the inner wall 109, whether due to the slit 113, the flap 116, or the reduced thickness, the lens support structure 105 has sufficient strength to support the intraocular lens 110 resting on the anterior surface of the lens support structure 105 or an intraocular lens that is partially or completely posterior to the lens support structure 105.

[0067] 7A and 7B illustrate various fixation arms 120 having terminal footplates or anchors 125. The anchors 125 can be coupled to or located on the outer ends of the fixation arms 120. These shapes are configured to allow for easy externalization by the surgeon and stabilize the tension of the device throughout its useful life. The anchors 125 can have a generally low profile and can have a shape (e.g., a rounded shape) configured to limit conjunctival erosion and eyelid irritation. The ends of the fixation arms 120 can have anchors 125 configured to be located external to the sclera 20 to secure the lens support structure 105 and prevent centripetal slippage. The shape of the anchors 125 allows the surgeon to pass the anchors 125 through a puncture or incision in the sclera 20 using forceps, trocars, or other surgical instruments. Anchor removal snare devices are described in more detail below. The anchor 125 can have a shape resembling a nail head, a T-bar, multiple prongs, or any other shape that can preferentially penetrate the sclera 20 in a first direction and resist withdrawal in the insertion direction to maintain its external position when the arms 120 are under tension expected throughout the life of the device. The anchor 125 is configured to have a profile or shape that will not irritate the eyelid or conjunctiva throughout the life of the device 100. As such, preferred shapes have a minimally thick profile with smooth, rounded, and / or tapered edges. The anchor 125 can have a substantially constant thickness or, as described in more detail below, can have a varying thickness over its length.

[0068] The anchors 125 described herein are configured for easy externalization and resistance to re-internalization after externalization. The anchors are configured to be graspable using an ophthalmic tool (e.g., 23 gauge, 25 gauge, or 27 gauge). A shape ideal for grasping with an ophthalmic tool may not be ideal for secure fixation. FIGS. 8A-8C illustrate additional shapes of anchors 125 that vary in thickness, width, and / or height. The anchor 125 can include a central portion 1255 and one or more graspable portions 1257 surrounding the central portion. The central portion 1255 can be positioned to overlie the wound (sclerotomy) through which the anchor 125 is inserted, and the graspable portions 1257 are positioned immediately adjacent to the wound. The central portion 1255 can have an increased thickness, height, and / or width compared to the surrounding graspable portions 1257. The increased thickness, height, and / or width of the central portion 1255 can add bulk to the area above the wound, thereby reducing the likelihood that tension in the fixation arms will pull the anchor 125 back through the wound. The central portion 1255 of the anchor 125 can have a thickness TC along the longitudinal axis L of the arms 120 that is greater than the thickness TG of the graspable portions 1257. For example, the thickness TC can be approximately 1.2 to 5.0 times the thickness TG of the graspable portions 1257. In other instances, the central portion 1255 can have a width or height that is approximately 1.2 to 5.0 times the width or height of the graspable portions 1257. The shape of the bulky portions is configured to resist deformation when subjected to tension associated with normal use of the device. The bulky central portion 1255 can be folded inward to fold over the end portions of the attached arms 120 during exteriorization. When arms 120 are under tension, bulky central portion 1255 cannot fold back onto itself from the ends of arms 120, preventing externalized anchor 125 from being pulled back through the wound. Thus, despite its greater bulk, central portion 1255 can be pulled through the wound in a first direction (outward from the eye), but its greater bulk prevents it from being pulled through the wound in a second, opposite direction (inward toward the eye).

[0069] The graspable portions 1257 may include any of a variety of shapes, including, for example, an oval, a rectangle, a star pattern, or other shape or geometric configuration that improves gripping of the graspable portions 1257 compared to the central portion 1255. The graspable portions 1257 may have thin, narrow tabs extending from the central portion 1255. Each anchor 125 may include one, two, three, four, five, six, or more graspable portions 1257 to allow a user to grip the anchor, regardless of the configuration of the device.

[0070] In some instances, each fixation arm 120 can have one or more anchors 125. FIG. 9 shows an example of a device 100 having three fixation arms 120, each having a first anchor 125a at the terminal end and a second anchor 125b located internal to the first anchor 125a. The second anchor 125b can further secure the lens support structure 105 by preventing centrifugal slippage. Alternatively, the second anchor 125b can be externalized through the sclera 20 so that the second anchor 125b holds the device 100 in place. In this situation, the surgeon has the option of trimming any material of the fixation arm 120 located around the second anchor 125b (e.g., the first anchor 125a). This multiple-anchor system allows the surgeon to size the device 100 to the patient's eye during surgery. Each fixation arm 120 can include multiple anchors 125 that can be positioned along the length of the fixation arm 120. The plurality of anchors 125 can include two, three, four, five, or more anchors 125 evenly spaced along their length. Because the fixation arms 120 are externalized through the sclera, the length of the fixation arms 120 can also be “customized” depending on the number of anchors 125 to be externalized. The surgeon can externalize as many anchors 125 as needed to center the device 100. Excess material from the fixation arms 120 and anchors 125 around the outer anchor 125 closest to the sclera 20 can be removed, such as by trimming. FIG. 9 shows two anchors 125a, 125b having different outer dimensions, with the inner anchor 125b being narrower than the outermost anchor 125a. It should be understood that the multiple anchors 125 can also have the same dimensions and need not be different in size. The anchors 125 can also have a shape that enhances passage through the sclera in a first direction but impairs passage through the sclera in a second, opposite direction. For example, Figure 9 shows squared edges on anchor 125. However, anchor 125 can have squared edges on its inner surface and smooth tapered edges on its outer surface that aid in passing outward through the sclera.

[0071] Fixation arms 120 that extend into the eyewall can be difficult to manipulate because they may be blocked from view by the peripheral iris 10, limbus, and sclera 20. As described above, one or more of the fixation arms 120 are biased inward toward a folded configuration. Each of the fixation arms 120 initially extends orthogonally outward from the support structure 105 and can then bend forward (or backward) or folded so that a terminal end of the fixation arm 120 is positioned over at least a portion of the fixation arm 120, the support structure 105, or the central opening 115 extending through the support structure 105. At least a portion of the bent fixation arm (i.e., terminal end and / or anchor 125) can be more easily visualized through a dilated pupil, and visualization is not obstructed by the opaque iris 10 (see FIG. 13 ). This inward (centripetal) bias also allows the bent fixation arms 120 to be safely grasped and manipulated during device implantation. Each of the fixed arms 120 of the device 100 can have an inward bias toward the folded configuration, or only a selection of the fixed arms 120 (e.g., one, two, or up to less than all of the fixed arms 120) can have an inward bias.

[0072] The device 100 can be manufactured without an inward bias, and the inward bias can be set using manual manipulation of the device. This manipulation can be performed by the manufacturer or by the surgeon. The purpose of the manipulation is to temporarily position at least a portion of the fixation arms 120 so that they can be easily visualized through a dilated pupil during implantation. This manipulation can include suturing two or more fixation arms 120 together. The sutures can be removed when the surgeon is ready to manipulate the fixation arms 120 individually within the eye. The structure of the device 100 can incorporate one or more features that allow the fixation arms 120 to be temporarily engaged with the lens support structure 105 to aid in visualization of the fixation arms 120. For example, FIG. 9 shows that the inner wall 109 defining the central opening 115 can include one or more notches 117 that can be used to temporarily hold the fixation arms 120 in an inwardly biased position. The shape of each notch 117 is complementary to the shape of the fixation arm 120 so that at least a portion of the fixation arm 120 can be received within the notch 117. The manufacturer or surgeon can fold, twist, or otherwise manipulate the fixation arm 120 into the notch 117. Following insertion into the eye, the surgeon can disengage the fixation arm 120 from the notch 117 and proceed to externalize the fixation arm 120 through the sclera. FIG. 9 shows that the notch 117 is on the inner diameter or wall 109. However, the notch 117 may be on another surface of the device 100, including the periphery (e.g., outer wall 111), an anterior surface, or a posterior surface of the lens support structure 105.

[0073] The fixation arms 120 can also be shaped to incorporate a bend or curve between their origin on the lens support structure 105 and the terminal anchor 125 (see FIGS. 10-12, 17B-17E, 19A, 20A, 21A-21B, 22A-22B, 23A-23B, 24A-24F, 25A-25C, 26A-26E, and 27). The bent fixation arm(s) 120 can be biased toward a folded configuration. For example, one or more of the fixation arms 120 can bend radially and centripetally between 90 and 270 degrees from their origin on the lens support structure 105. Thus, the terminal ends of the bent fixation arms 120 are in a different plane than the plane of the lens support structure 105. When in a resting state prior to placement in the eye, the terminal end of at least a first of the plurality of fixation arms 120 can incorporate a bend between an origin on the lens support structure and its terminal end, forming a bent arm. The bent arm can extend at least a first distance from its origin perpendicular to the lens support structure 105. The bent arm can then bend upward (forward) at least another distance away from the plane of the lens support structure 105. The bent arm 120 can then bend back toward its origin or toward the central axis CA of the device. This can result in the terminal end of the bent arm 120 being in a plane different from the plane of the lens support structure 105. The curvature or bend of the arm 120 can project outward, away from the central axis CA, and away from both the origin 103 and terminal end 102 of the arm. The transscleral anchor 125 and / or the terminal portion of the fixation arm 120 is positioned above or in front of at least a portion of the lens support structure 105 or above at least a portion of the central opening 115. Alternatively, the bent arm(s) 120 can be curved downward (posteriorly) at least a distance away from the plane of the lens support structure 105, and the terminal portion of the transscleral anchor 125 or fixation arm 120 can be positioned below or posterior to at least a portion of the lens support structure 105 and / or below or posterior to at least a portion of the central opening 115.The folded configuration (whether the arms 120 are curved forward or backward) allows at least a portion, such as the end of the bent fixation arm 120 and / or its anchor 125, to be visible through the pupil and unobstructed by the opaque iris. Only one of the fixation arms 120, two of the fixation arms 120, or all of the fixation arms 120 can incorporate a curve.

[0074] Once the device is placed and secured in the eye, the fixation arms 120 are under tension such that the bent arms unfold away from this folded configuration and are no longer bent. The ends of the arms 120 urge the bent fixation arms away from this resting state in which the arms 120 are in the folded configuration and into a straight or unfolded configuration.

[0075] The bend in the folded configuration can be a gradual, smooth bend with a radius of curvature, or it can be bent to form one or more distinct angles along the length of the arm 120. The bend can be tight enough so that it does not protrude too far forward, while still being able to be positioned relatively easily in the expanded configuration without excessive stress on the lens support structure 105. The inwardly biased shape can have a radius of curvature of about 0.10 mm to about 2.5 mm on the inner curve (front-facing side) and about 0.6 mm to about 3.0 mm on the outer curve (rear-facing side). In an illustrative example, the terminus of the inwardly biased fixation arm can be spaced from the lens support structure 105, forming a gap G (see FIG. 17B). The gap G can be about 0.2 mm to about 2.5 mm. In the illustrative example, the biased fixation arm 120 has an inwardly biased geometry with a radius of curvature of about 0.63 mm on the inner curvature and about 1.13 mm on the outer curvature, such that the biased fixation arm curves a full radius of 180 degrees and the lens support structure 105 and the biased fixation arm are separated by about 1.25 mm. The beginning of the curve (near the origin 103 with the lens support structure 105) and the end of the curve (near the end 102 of the transcleral anchor 125) can have multiple radii such that the curvature varies over the length of the fixation arm 120. The curve of the biased fixation arm 120 can have an average curvature of between about 0.15 mm and about 2 mm on the inner curvature.

[0076] After implantation and prior to fixation with the scleral wall, the bent fixation arms 120 are visible through the pupil when in an unstressed (resting) state (see FIG. 13). This visibility allows the surgeon to easily engage the anchors 125. Once the surgeon engages the fixation arms 120 by grasping the body of the fixation arms 120 or the anchors 125, the surgeon can deploy the fixation arms 120 away from the resting, folded configuration so that the fixation arms 120 are substantially flush with the lens support structure 105. These fixation arms 120 can be flexible so that stresses stored in the material in the deployed state do not impart torsional or tensile forces to the lens support structure 105 that would impair device function. The fixation arms(s) 120 can be shaped to have 90-270 degrees of tangential and centripetal rotation from their lens support origins (see FIGS. 23A-23B). The fixed arm(s) 120 can incorporate a resilient material or a deformable hinge to facilitate this manipulation without substantially altering the geometry of the lens support structure 105. The fixed arms 120 can have a length such that when the fixed arms 120 are bent 180 degrees toward their origin with the lens support structure 105, the end 102 of the fixed arms 120 is positioned over at least a portion of the lens support structure 105, as shown in FIGS. 10-11. Each of the fixed arms 120 of the device 100 can have a bend, or only a selection of the fixed arms 120 can have a bend (e.g., one, two, or fewer than all of the fixed arms 120). FIGS. 10-11 show two of the fixed arms 120 having a bend such that one is substantially flush with the plane of the lens support structure 105.

[0077] One or more of the fixation arms 120 of the devices described herein can be fabricated to have a non-planar shape at rest and may be biased toward a folded configuration in which at least a portion of the fixation arm 120 is easily visible through the pupil when the device 100 is implanted but prior to externalization of the anchors 125. A fixation arm 120 having this configuration can be more easily grasped and manipulated by a user so that it can be urged into the deployed configuration for sutureless fixation. A fixation arm 120 fabricated to have a bias at rest, or a fixation arm 120 that is curved or bent at rest, includes a fixation arm 120 that has that shape when the device 100 is outside the eye and ready for implantation. In some instances, the fixation arm 120 can assume a curved, folded, or bent shape after implantation within the eye (e.g., the posterior chamber) but prior to anchor fixation. For example, one or more fixation arms 120 can be made of a material that has a first shape outside the eye, assumes a curved shape upon implantation into the eye that is different from the shape of the arms 120 prior to implantation into the eye, and expands to a substantially straight shape upon externalization of anchor 125.

[0078] The fixation arm 120, which has a bias toward a folded or curved shape (e.g., has a bend along its length between its origin 103 and its terminus 102), can be visualized through the pupil, grasped, and manually deployed and / or extended to transscleral secure the anchor 125 of the arm 120. The configuration and / or radius of curvature of the bend, bend, or fold, as well as the directionality of the bend, bend, or fold, can be varied, as long as at least a portion of the fixation arm 120 (e.g., the anchor 125 and / or the terminus coupled to the anchor 125) is visible to the user through the diameter of the patient's pupil, preferably the patient's dilated pupil. In some instances, this means that at least a portion of the fixation arm 120 is located above and radially inward of the outer wall 111 of at least a portion of the lens support structure 105. The distance that the portion of the arm 120 extends radially inward of the outer wall 111 can vary. The portion can extend so as to be above a position adjacent to the outer wall 111, not above the outer wall 111 in the direction of the central axis CA extending from front to rear through the central opening 115. In this example, the distance from the central axis CA of the device to the portion extending above is greater than the distance from the central axis CA of the device to the outer wall 111. The portion can extend so as to be above the outer wall 111. In this example, the distance between the central axis CA of the device and the portion is the same as the distance between the central axis CA of the device and the outer wall 111. The portion can extend so as to be at a position radially inward from the outer wall 111. In this example, the distance between the central axis CA of the device and the portion is smaller than the distance between the central axis CA of the device and the outer wall 111. The portion can extend so as to be above the central opening 115. In this example, the distance between the central axis CA of the device and the portion is shorter than the distance between the central axis CA of the device and the inner wall 109 that defines the central opening 115.

[0079] A portion of the fixation arm (e.g., terminus and / or anchor 125) can overlie a portion of the lens support structure 105 and simultaneously overlie a portion of the central opening 115. For example, the anchor 125 can be sized such that at least a portion of the anchor 125 overlies at least a portion of the lens support structure 105 and another portion of the anchor 125 overlies at least a portion of the central opening 115.

[0080] A fixation arm 120 biased toward a curved configuration can bend toward an inner or central portion of the device, including, but not limited to, the actual center or central axis CA of the device. The center of the device 100 is the center of the circle formed by the central opening 115 (in an example where the central opening 115 is circular). The central axis CA of the device extends in the anterior-posterior direction (i.e., up-down direction) through the center of the circle. If the central opening 115 is substantially non-circular, the center of the device is the center of symmetry of the central opening 115 along the central axis CA, which extends in the anterior-posterior direction. A fixation arm biased toward a folded or curved configuration such that its anchor extends toward the center of the device or toward the central axis CA of the device does not require that the axis through the anchor of the arm intersect the actual center or the central axis CA of the device. "Towards the center" or "towards the central axis" with respect to inwardly biased fixation arms includes arms that have a curve such that the ends of the fixation arms extend back towards a portion of the device in a generally inward direction, as opposed to straight fixation arms that end in a generally outward direction, away from the lens support structure. A curved fixation arm can be biased towards any central portion of the device and need not point directly towards the actual center of the device. A curved fixation arm can be angled relative to the actual center.

[0081] 22A-22B and 23A-23B show examples of devices in which at least a portion of the fixation arms extend rearward toward the center of the device. FIG. 22A shows device 100 having a lens support structure 105 and three fixation arms 120. Two of fixation arms 120a, 120b are biased toward a folded configuration in which a bend B exists between the arm's origin 103 and end 102. The third fixation arm 120c is substantially straight, with no bend B between its origin 103 and end 102, and extends along one axis substantially perpendicular to the lens support structure 105. Anchors 125 of each fixation arm 120a, 120b project rearward toward the center of the device. The anchors 125 of the fixation arms 120a, 120b have at least a first portion that overlaps at least a portion of the lens support structure 105 and / or at least a second portion that overlaps at least a portion of the central opening 115 (see FIG. 22A). An axis can be drawn through the anchors 125 of each arm 120a, 120b, illustrating the direction in which the anchors 125 project toward the center of the device, away from the bend B between the arm's origin 103 and its terminus 102. Axis LI and axis L2 do not intersect the central axis CA. FIG. 22B shows a similar device 100 with two fixation arms 120a, 120b biased into a folded configuration. Each has a bend B between the arm's origin 103 and its terminus 102. The anchors 125 of each fixation arm 120a, 120b extend backward toward the center of the device. Axis L1 and axis L2 intersect central axis CA. Thus, the arms are biased toward a collapsed configuration in which the anchors protrude toward the center of the device, but do not necessarily extend along an axis that intersects central axis CA or the actual center of the device.

[0082] When a fixation arm is described as "folded," "bent," or "curved," or as having a "folded," "bent," or "curved" configuration, the angle of the fixation arm relative to the longitudinal axis along its length can change gradually and uniformly, or it can change more rapidly or abruptly to form an angle. A folded configuration can describe an inward bias of the fixation arm at the time of installation or implantation, where the fixation arm extends outward from the support structure along a first axis and curves forward or backward relative to the plane of the support structure back toward the central portion of the device. When implanted, the support structure of the device is configured to be substantially parallel to the Z-plane (vertical plane) of the eye. A folded configuration can include a shape in which the fixation arm curves away from this plane of the support structure (e.g., in a transverse plane), as shown in Figures 22A-22B. As a result, at least a portion of the fixation arm is positioned forward of another portion of the device (e.g., itself, the lens support structure, and / or over the central opening). The folded configuration does not necessarily mean that the fixation arm portions overlap and touch each other. Preferably, the fixation arm portions are spaced apart from each other, the distance being along the central axis CA of the device. Also, the folded configuration does not necessarily mean that there is a crease or a sharp fold. The folded configuration can mean that there is a radius of curvature between the start of the fixation arm on the support structure and the end of the fixation arm.

[0083] The folded configuration can also include a fixed arm that curves within the plane of the lens support structure, rather than away from the plane of the lens support structure. Figures 23A-23B illustrate another example of a device 100 having a lens support structure 105 and three fixed arms 120. Two of the fixed arms 120a, 120b are biased into a folded configuration in which a bend B exists between the arm's origin 103 and end 102. The third fixed arm 120c is substantially straight, extending along an axis substantially perpendicular to the lens support structure 105, and does not have a bend B between its origin 103 and end 102. The anchors 125 of the straight fixed arm 120c project outward away from the center of the device along the axis of the fixed arm. In contrast, the anchors 125 of each of the fixed arms 120a, 120b project inward from the bend B of the fixed arm. The anchors 125 remain substantially in the same plane as the plane of the lens support structure (see FIG. 23B). An axis can be drawn through the anchors 125 of each bent fixation arm 120a, 120b, indicating the direction in which the anchors 125 project toward the center of the device, away from the bend B between the fixation arm origin 103 and the fixation arm terminus 102. Fixation arms 120a, 120b that are biased toward the folded configuration have anchors 125 that project toward the center of the device. Axes LI and L2 may, but need not, intersect the central axis CA. Axes LI and L2 are shown in FIG. 23A extending toward the center but not intersecting the central axis CA.

[0084] The portion of the fixation arm 120 located above at least a portion of the support structure 105 may include the portion being located above and radially inward of the outer wall 111 of the support structure 105. The portion of the fixation arm 120 located above at least a portion of the support structure 105 may include the portion being located radially inward of and above the central opening 115. In this case, "radially inward" does not necessarily mean being in the same plane. Preferably, the portion of the fixation arm 120 is located above the portion of the support structure in a plane different from the plane of the support structure. A portion of the fixation arm 120 (e.g., anchor 125 and / or termination 102) can terminate at the front or rear of the lens support structure 105 at a diameter that is centered around the periphery of the lens support structure 105. The portion can be located above the portion of the lens support structure relative to a central axis CA of the device that extends from front to rear through the central opening 115. When a portion of the fixed arm 120 is described as overlying a portion of the lens support structure, the portion of the fixed arm 120 may overlie the central opening 115 defined by the lens support structure 105 .

[0085] When a portion of the fixation arm 120 is described herein as being “above” another portion of the device 100 (e.g., itself, the lens support structure 105, and / or the central opening 115), the portion of the fixation arm 120 can generally overlap that portion of the device in space and need not require a particular orientation relative to the retina. Thus, “above” can be used herein to refer to overlap in space surrounding the device, and can require, but need not require, that spatial overlap to be generally anterior to the retina. A portion described as being “above” another portion can be located posterior to that portion relative to the retina during use. A fixation arm 120 biased into a folded configuration may be referred to herein only as “above” or “overlapping” another portion of the device, even though it may be located “below” or “behind” that portion of the device relative to the retina during use. For simplicity, each alternative may not be repeated in each example throughout this disclosure. The fixation arm can be curved to position at least a portion of the fixation arm over a forward-facing portion of the device such that the portion generally arches above the device along the central axis CA. The fixation arm can be curved to position at least a portion of the fixation arm over a rearward-facing portion of the device such that the portion generally arches below the device along the central axis CA. The fixation arm can be curved to position at least a portion of the fixation arm in the same plane such that the portion is neither above the forward-facing portion nor the rearward-facing portion of the device. Any of various fixation arm configurations are contemplated herein such that at least a portion of the fixation arm is visible through a dilated pupil. The mechanism by which a bent fixation arm 120 biased toward a folded configuration unfolds to a straight configuration can be varied. The fixation arm can be deployed mechanically, electromagnetically, and / or thermally.

[0086] In some instances, the fixation arm 120 may be mechanically deployed along one axis of the fixation arm. The fixation arm 120 during deployment need not be biased into a folded configuration with a bend or curve. For example, the fixation arm 120 may be biased into a folded configuration in which the fixation arm 120 is longitudinally compressed along one axis. The fixation arm 120 extends along one axis perpendicularly outward from the lens support structure between its origin 103 and its terminal 102. The length of the fixation arm 120 in the folded configuration may be shortened between the origin 103 and terminal 102 so that the anchor 125 of the fixation arm 120 is more centrally located within a smaller diameter than in the deployed configuration. Once the device is implanted in the eye but before externalization of the anchor 125, the fixation arm 120 may be telescoped outward to extend its length for externalization. Telescopic mechanical deployment can also result from nested components of the fixation arm 120 that slide over one another to provide a long dimension when deployed and a short dimension when collapsed. Telescopic mechanical deployment can also result from one resilient component configured to collapse onto itself in a short dimension for visualization through the pupil and expand from itself in a long dimension upon externalization.

[0087] In some instances, the fixation arms 120 may be thermally unfolded or folded. For example, the fixation arms 120 may be in a first shape (folded or straight) at room temperature and change to a second shape at or near body temperature (heated to 35° C.). This can also be achieved by chemical means (e.g., hydration) or mechanical means (disconnection of the restricting function).

[0088] The fixation arm 120 can be fabricated from an elastic or non-elastic material. For example, the fixation arm 120 can be formed from a non-elastic material and have a three-dimensional shape that provides elasticity. The three-dimensional shape can be varied to include a C-shape, Z-shape, S-shape, or other three-dimensional shape, as described elsewhere in this specification. The fixation arm 120 provides sufficient support to maintain the intraocular lens 110 or other device while avoiding excessive force on the scleral tissue. An optimal design will have a wide operable range of tension and stability to meet both parameters in eyes of various sizes and incisions in various locations. One means of modifying the fixation arm design is to incorporate a spring-like structure. These include traditional compression-based haptic designs, such as J-loops, C-loops, closed loops, Kellman haptics, plate haptics, or other haptic designs common to intraocular lenses. Alternatively, the device 100 can incorporate tension-based haptics, such as simple linear elastic cords. Alternatively, the tension design can be modified with V-, Z-, or S-shaped features to reduce the tension resistance of the fixed arm 120 .

[0089] The fixation arm 120 can have a texture or feature that allows it to be pulled through the sclera in one direction, but provides resistance in the opposite direction, minimizing the possibility of the fixation arm 120 slipping. The texture or feature can be provided by the material itself or configured into the fixation arm 120. For example, the fixation arm 120 can be formed from a barbed material integrated into the outer structure. In this way, an inner barbed structure may be able to function as a barb while hiding the sharp edges typically associated with barbs, such as a hard plastic structure embedded within a soft elastomeric structure.

[0090] The fixing arm 120 can be made of a flexible material that has memory but is not malleable. The flexible material of the fixing arm 120 can be polyurethane, hydrophobic acrylic, hydrophilic acrylic, nylon, polyimide, PVDF, natural polyisoprene, cis-1,4-polyisoprene natural rubber (NR), trans-1,4-polyisoprene guata-percha, synthetic polyisoprene (isoprene rubber IR), polybutadiene (butadiene rubber BR), chloroprene rubber (CR), polychloroprene, neoprene, biprene, etc., butyl rubber (copolymer of isobutylene and isoprene, IIR), halogenated butyl rubber (chlorobutyl rubber: CIIR, bromobutyl rubber: BIIR), styrene butadiene rubber (copolymer of styrene and butadiene, SBR), nitrile rubber (butadiene and acrylonitrile rubber, SBR), etc. copolymers of NBR), hydrogenated nitrile rubber (HNBR), also known as Buna N rubber, Terban and Zetpol, EPM (ethylene propylene rubber, a copolymer of ethylene and propylene) and EPDM rubber (ethylene propylene diene rubber, a terpolymer of ethylene, propylene, and a diene component), epichlorohydrin rubber (ECO), polyacrylic rubber (ACM, ABR), silicone rubber (SI, Q, VMQ), fluorosilicone rubber (FVMQ), fluoroelastomers (FKM and FEPM) Viton, Tecnoflon, Fluorel, Aflas, Daiel, perfluoroelastomer (FFKM) Tecnoflon PFR, Kalrez, Chemraz, Perlast, polyether It can include any of a variety of elastomers, including block amides (PEBA), chlorosulfonated polyethylene (CSM), (Hypalon), ethylene vinyl acetate (EVA), thermoplastic elastomers (TPE), resilin and elastin, polysulfide rubber, and Elastoreform.

[0091] A fixing arm 120 made of a flexible material that is formed into a certain shape can bend away from the formed shape but has memory to return to the formed shape. In other words, the flexible fixing arm 120 can bend or unfold away from its folded configuration, but cannot be urged into another shape that would be retained without some kind of anchoring. For example, one or more of the flexible fixing arms 120 can be formed into a bent shape. For example, the fixing arm can include a 180-degree bend from its origin 103 with the support structure 105 to its terminus 102 near the anchor 125. The fixing arm 120 can maintain this bent shape when the device is at rest and no force is being applied to the fixing arm 120 to bias it toward the folded configuration. In other words, the fixing arm 120 in an unbiased state is bent. The bent fixation arm 120 can be bent away from this bent shape to assume a straight or deployed configuration such that the entire fixation arm 120 extends and lies straight relative to the longitudinal axis L. When the fixation arm 120 is bent to a straight shape, the fixation arm 120 is biased to return to the bent or folded configuration. Releasing the bending force on the fixation arm 120 causes the fixation arm 120 to return to its bent, resting shape. However, in use, the fixation arm 120 is transscleral anchored, with the anchor 125 at the end 102 of the fixation arm 120 located outside the sclera. The fixation arm 120 is under tension to maintain its straight shape.

[0092] In other instances, fixation arm 120 can be formed of or incorporate a material that is malleable, allowing fixation arm 120 to bend or form into a particular shape. Malleable fixation arm 120 can be formed of materials such as gold, silver, platinum, stainless steel, nitinol, nickel, titanium, polypropylene, polyethylene, nylon, PVDF, polyimide, acetal, and implant-grade metals or plastics, including PEEK.

[0093] One or more of the anchoring arms 120 can have a Young's modulus of less than about 1000 MPA, or less than about 500 MPA, or less than about 250 MPA, or less than about 100 MPA, or less than about 50 MPA, or less than about 25 MPA. One or more of the anchoring arms 120 can have a Young's modulus of less than about 20 MPA, for example, about 0.01 to about 1.0 MPA. The anchoring arms 120 are very soft and can apply very little force because they are configured to have tension to secure the support structure 105 rather than a spring force to secure the support structure 105 or a stiffer penetration force that a hook or other anchoring haptic can provide.

[0094] In some instances, each of the fixation arms 120 can have a length between the origin 103 and the terminus 102 that is about 2 mm to about 6 mm. Each of the fixation arms 120 can have the same length. The length of the fixation arm 120 that extends through the sclera can have a thickness or width that is minimized to reduce the overall size of the wound through which the fixation arm 120 extends. The maximum width of the transscleral portion of the fixation arm near the terminus 102 where the anchor 125 is located can be about 2.0 mm or less, about 1.5 mm or less, about 1.0 mm or less, 0.75 mm or less, or 0.50 mm or less.

[0095] FIG. 12 shows an example of a device 100 having two locking arms 120a, 120b with an inward bias and a third locking arm 120c that is straight and does not have an inward bias. Furthermore, the third locking arm 120c has a less flexible shape than the other locking arms 120a, 120b. The third locking arm 120c can incorporate a region between the beginning 103 and the end 102 that can be wider and have a larger cross-sectional area than the other two locking arms 120a, 120b. FIG. 8B shows a region of the locking arm 120 that is wider. The width W1 of the locking arm 120 near the end 102 can be smaller than the width W2 of the locking arm 120 away from the end 102 of the locking arm 120. The width W2 of the fixation arm 120 away from the end 102 can provide some bulk and stability, while the width W1 near the end 102 can minimize the transcleral portion of the fixation arm 120.

[0096] Each fixation arm 120a, 120b, 120c can be positioned one at a time during a surgical procedure. As described elsewhere herein, the leading fixation arm 120c can be straight, while the trailing fixation arms 120a, 120b can be curved (see FIGS. 17A-17D). The weight of the device can cause the first implanted, or leading, fixation arm 120c to bend following externalization, such that the device 100 tilts posteriorly toward the retina. In this scenario, the surgeon can position the device in a more posterior position. However, this may increase the risk of intraoperative tissue damage due to manipulation of tools near the retina. In some instances, the leading fixation arm 120c can be mechanically and / or geometrically reinforced to reduce the likelihood of posterior slippage. The leading fixation arm 120c can be fabricated from a material that can withstand such deformation. The material can be any implant-grade plastic or metal that allows the device to be cantilevered following externalization of the anchor 125 of the leading fixation arm 120c. Suitable materials include, but are not limited to, PMMA, rigid silicone, nylon, hydrophilic and hydrophobic acrylics, PEEK, polyimide, stainless steel, titanium, nitinol, and the like. A more rigid material can be used to form the entire leading fixation arm 120c or only a portion of the leading fixation arm 120c. The leading fixation arm 120c may also be formed of a more flexible material embedded with a more rigid material. In an illustrative example, the leading fixation arm 120c can include a region 1205 of mechanical reinforcement between its origin 103 at the support structure 105 and its end 102 where it is coupled to the anchor 125 (see FIG. 17A). The region 1205 can be achieved by increasing the thickness of the fixation arm 120c or by embedding a rigid section of plastic in a more flexible material. 17A shows an increased thickness in region 1205 of the mechanical reinforcement (arrow T) compared to the thickness of the fixation arm near its origin with the support structure 103 (arrow O). Region 1205 can be positioned at a distance from the support structure 105, for example, near or adjacent to anchor 125.Region 1205 can have an increased thickness (see FIGS. 17A-17D) configured to specifically reduce the likelihood of device 100 drifting posteriorly while not affecting the ability of fixation arms 120 to externalize anchors 125. For example, fixation arms 120 can have a tapered thickness configured to limit posterior deflection. The tapered shape can be thinnest near footplate anchors 125 and thicker in the center. The posterior surface of the fixator can serve to bias the device anteriorly relative to the eye. The contact angle between the posterior surface of fixation arms 120 and the wound can bias device 100 in a manner that reduces the actual risk of posterior deflection of fixation arms 120. Additional bulk can further limit device deflection and proximity to the retina.

[0097] The transscleral fixation arms 120 and / or anchors 125 can have light- or water-reactive elements to aid in sizing or fixation of the fixation arms. To adjust the length of the fixation arms intraoperatively or postoperatively, a portion of the fixation arms can be expanded or contracted to enlarge or reduce their shape. Alternatively, by expanding the anchors following externalization of the fixation arms, the anchors become more effective in providing secure fixation with reduced risk of slippage.

[0098] The cross anchors of the fixation arms can slide along the fixation arms 120 with some resistance. By adjusting the fixation arms 120 intraoperatively, the surgeon can size the device 100 for a given patient. Custom sizing reduces the risk of effective lens displacement or modulation. Once the fixation arms 120 are set to the proper tension, excess material can be removed, such as by trimming.

[0099] The device 100 may be made of materials or include geometries that can function as a drug delivery device, including refillable drug delivery devices. A securely secured device with access to the subconjunctival space provides an opportunity to deliver drugs to the posterior and anterior segments of the eye. Examples of therapeutic agents may include one or more intraocular pressure-reducing drugs (anti-glaucoma drugs), steroids, anti-vascular endothelial growth factor (anti-VEGF), gene therapy drugs, antibacterial drugs, antiviral drugs, chemotherapeutic drugs, non-steroidal anti-inflammatory drugs, and other biological agents for treating ocular or systemic diseases.

[0100] The device 100 can include a structure to which the intraocular lens haptics 114 are secured. In some situations, the intraocular lens haptics 114 are secured within grooves. However, it may be advantageous to provide a location for haptic securement within the device itself. The structure of the device 100 can be one or more pockets on the inner wall 109 of the lens support structure 105 that are sized and shaped to receive the intraocular lens haptics 114. Alternatively, the anterior or posterior surface of the device 100 can include slots or catches that can receive and secure the intraocular lens haptics 114 in place. The lens support structure 105 can have one or more holes through which the intraocular lens haptics 114 can pass. Alternatively, the haptic shape can be configured so that the intraocular lens haptics 114 are wrapped around one or more of the fixation arms 120. The fixation arms 120 can have holes through which the intraocular lens haptics 114 can pass.

[0101] The device 100 may be configured to host any form of intraocular lens 110 with any haptic design and any optical design. The device 100 may be configured to accommodate a particular intraocular lens design with a shape specifically configured to mate with the lens support structure 105. The design may be particularly suited to allow for lens interchangeability. The lens support structure 105 may be manufactured with an integral lens 110 that provides refractive correction. Corrections may include, but are not limited to, monofocal, extended depth of focus, accommodative, phototunable, multi-piece / interchangeable, or multifocal intraocular lens optics.

[0102] The devices described herein can be used with intraocular lenses having any of a variety of conventional designs, including multi-piece and one-piece designs. The intraocular lens 110 includes a central optic 112 and two haptics 114 (see, e.g., Figures 19B-19C, 20B-20C, 24B, 24C, 24F, 25B, 25C, 26B, 26C, and 26E). The haptics 114 can be conventional open-loop haptics, such as a C-loop, J-loop, or modified J-loop. The intraocular lens 110 can be positioned above (or below) the central opening 115 of the device such that a central axis CA extending in the anterior-posterior direction through the central opening 115 extends through the optic 112 of the intraocular lens 110. The haptics 114 of the intraocular lens 110 may project upward or forward away from (or toward, if positioned below) the lens support structure 105, as described elsewhere herein. One-piece intraocular lenses can have open-loop haptics, similar to conventional three-piece intraocular lenses. One-piece intraocular lenses can also incorporate monoblock plate-style haptics. While a device is shown with one type of intraocular lens (e.g., the multi-piece intraocular lens shown in Figures 19B-19C and 20B-20C or the one-piece intraocular lens shown in Figures 24B, 24C, 24F, 25B, 25C, 26B, 26C, and 26E), it should be understood that other types of intraocular lenses can be mated with the device. The devices described herein can be used with any type of intraocular lens, including multi-piece and one-piece designs, as described elsewhere herein. Similarly, the haptics of the intraocular lens can be in any of a variety of configurations.

[0103] The lens support structure 105 can have a shape configured to mate with the periphery of the intraocular lens or with one or more haptics of the intraocular lens. The shape can include a recess, indentation, channel, or groove that forms at least a portion of the inner periphery of the lens support structure.

[0104] Figures 24A-24F, 25A-25C, and 26A-26E illustrate various examples of devices configured to mate with an intraocular lens such that at least a portion of the intraocular lens is covered by at least a portion of the inner surface of the device.

[0105] 24A-24F show an example of a device 2100 having a lens support structure 2105, a central opening 2115, and a plurality of fixation arms 2120. The central opening 2115 is bounded by an inner periphery or wall 2109 of the lens support structure 2105. The central opening 2115 can be circular, while the outer periphery or wall 2111 of the lens support structure 2105 can be non-circular. As described elsewhere herein, the periphery of the lens support structure 2105 can have any of a variety of shapes, including circular, non-circular, oval, elliptical, rounded rectangular ( FIGS. 25A-25C ), and rounded triangular ( FIGS. 26A-26E ). The lens support structure 2105 can support an intraocular lens 110, for example, in place of the natural lenticular lens capsule. The device 2100 can include one or more leaflets or awnings 2126 positioned over the front-facing surface of the lens support structure 2105, thereby forming one or more recesses 2104 in which at least a portion of the intraocular lens 110 is positioned. The recesses 2104 may at least partially surround a central opening 2115 and be dimensioned to accommodate at least a portion of the intraocular lens, such as the haptics 114. FIGS. 24B, 24C, and 24F show the intraocular lens 110 engaged with the device 2100. The optic 112 of the intraocular lens 110 is positioned over the central opening 2115, with a peripheral region of the posterior-facing surface of the optic 112 positioned against the front-facing surface of the lens support structure 2105. Each of the haptics 114 of the intraocular lens 110 can be positioned substantially within a respective recess 2104, with the majority of the optic 112 of the intraocular lens 110 remaining outside the recess 2104. The recess 2104 is defined by the front-facing surface of the lens support structure 2105 and the overhanging leaflet or awning 2126. The volume of the recess 2104 formed by the space between the front-facing surface of the lens support structure 2105 and the rear-facing surface of the awning 2126 is sufficient to accommodate each one of the haptics 114 in both its front-to-rear depth as well as its distance away from the central axis CA of the opening 2115.The awning 2126 can have a smooth shape and, when placed on the device 2100, can serve to protect the iris from any sharp edges of the intraocular lens. Additionally, the central facing surface of the awning 2126 (facing the central axis CA of the device 2100) can also serve to provide a surface against which the haptics 114 abut. These surfaces can provide counter-pressure to the haptics, thereby assisting in centering the intraocular lens 110 on the device 2100. The awning 2126 can limit Z-axis movement of the haptics 114 and help secure the intraocular lens 110 to the device 2100. Secure fixation of intraocular lenses, including one-piece intraocular lenses, enables the use of intraocular lenses that require tight centering tolerances (e.g., toric, multifocal, extended depth of focus (EDOF) intraocular lenses, and optically accommodating intraocular lenses).

[0106] The intraocular lens 110 may be positioned within the device 2100 prior to implantation into the eye or after implantation into the eye. Similarly, the intraocular lens 110 may be removed from the device 2100 and replaced post-operatively.

[0107] 24A-24F illustrate an example of a device 2100 having a substantially elliptical periphery 2111 having a major axis and a minor axis. Thus, the inner periphery 2109 may define a circular central opening 2115, and the outer periphery 2111 may define a non-circular shape. Recesses 2104 formed by awnings 2126 are positioned on opposite sides of the major axis such that the spans of the haptics 114 of the intraocular lens 110 are received within the recesses 2104.

[0108] 25A-25C illustrate another example of a device 2100 having a circular central opening 2115 and a non-circular periphery 2111. The non-circular periphery 2111 in FIGS. 25A-25C is a rounded rectangle having two substantially flat, elongate sides 2108 and two substantially rounded shorter sides or lobes 2107. The recesses 2104 formed by the awnings 2126 may be positioned generally opposite each other along the long axis of the rectangle and may protrude above the front-facing surface of the lens support structure 2105 so as to be spaced apart to accommodate the span of the haptics 114 of the intraocular lens 110. For example, the awnings 2126 may protrude above the front-facing surface of the lens support structure 2105 at the short sides of the rounded rectangle (i.e., at the locations of the lobes 2107) to accommodate the span of the intraocular lens therebetween within the recesses 2104 along the long sides 2108.

[0109] Three fixation arms 2120 are coupled to the lens support structure 2105. At least one of the fixation arms 2120a, 2120b is biased to a folded configuration, as described elsewhere herein. One fixation arm 2120c can be a leading fixation arm extending along an axis perpendicular to the lens support structure 2105 such that its end 2102, coupled to the anchor 2125, projects outward away from the central axis CA of the central opening 2115. The leading fixation arm 2120c can be coupled to the lens support structure 2105 at a lobe 2107, and the other fixation arms 2120a, 2120b can be coupled to opposite sides 2108, e.g., at a location away from the lobe 2107 of the leading fixation arm, such that the opposite lobe 2107 projects outward between the fixation arms 2120a, 2120b (see FIGS. 25A-25B).

[0110] 26A-26E illustrate another example of a device 2100 having a circular central opening 2115 and a non-circular periphery 2111. The non-circular shape of the periphery 2111 may be a rounded triangle with multiple lobes 2107 projecting outward from multiple sides 2108, as described elsewhere herein. Each of the three fixed arms 2120 may extend outward from a respective one of the multiple sides 2108. Awnings 2126 may project above the front-facing surface of the lens support structure 2105 such that they are located generally opposite one another. For example, a first awning 2126 may be located on the side 2108 near the origin 2103 of the leading fixed arm 2120c, and a second awning 2126 may be located in the lobe 2107 between the other two fixed arms 2120a, 2120b (see FIGS. 26A-26B). The placement of the awnings 2126 relative to one another can be rotated so that the first awning 2126 is positioned on the lobe 2107 adjacent the origin 2103 of the leading fixation arm 2120c, and the second awning 2126 is positioned on the side 2108 of one of the curved fixation arms 2120a, 2102B closer to the origin 2103. Regardless of orientation, the span of the recess 2104 defined by the awning 2126 and the lens support structure 2105 is sufficient to accommodate the span of the intraocular lens haptics 114 therebetween (see FIG. 26C ).

[0111] The central opening 2115 may have a diameter as described elsewhere herein such that the optic 112 of the intraocular lens can be supported on the front-facing surface of the lens support structure 2105 without slipping through its diameter (e.g., between about 4 mm and about 6 mm). The intraocular lens may be inserted into the recess 2104 below the awning 2126. Thus, the diameter between the opposing first and second awnings 2126 is sufficient for intraocular lens insertion. Because intraocular lenses are typically foldable, the diameter between the first and second awnings 2126 can vary widely. In some instances, the opposing awnings 2126 are fully connected to each other along their sides 2108 (see FIG. 24C ). The opposing awnings 2126 may include extensions along each of the sides 2108 that form a surface that fully overhangs the lens support structure 2105, defining the top opening 2127. The top opening 2127 can have a diameter larger than the diameter of the central opening 2115 of the lens support structure 2105. For example, the top opening 2127 can be larger than about 6 mm to allow the intraocular lens to be manipulated into place and fully expanded into the recess 2104. The diameter of the top opening 2127 can be greater than 6 mm and up to about 8 mm.

[0112] FIG. 27 shows an interrelated example of the device 2100 having an awning 2126 that further incorporates multiple bumpers 2119 to aid in centering the device 2100 within the eye. The device 2100 can include four bumpers 2119 protruding outward from each corner of the lens support structure 2105. The bumpers 2119 can be substantially ring-shaped or can be an incomplete ring having a C-shape. The ring-shaped bumper 2119 can include a first end and a second end that are both coupled to the lens support structure 2105. The C-shaped bumper 2119 can have one end coupled to the lens support structure 2105 and a second end that remains separate from the lens support structure 2105. Regardless of the shape or configuration, the bumpers 2119 can distance the device 2100 from adjacent ocular tissue. In some instances, the bumpers 2119 can deform slightly upon contact with the ciliary body structure. The deformation can be temporary, allowing the bumper to return to its original shape and push the device 2100 back toward a central position within the eye. As with other examples described herein, the device 2100 can include multiple fixation arms 2120, with at least one biased to a folded configuration. Preferably, the bumper 2119 avoids remaining in contact with the ciliary body structure once the device 2100 is implanted. The bumper 2119 can act as a guide during externalization of the fixation arm 2120. The bumper 2119 can protrude sufficiently far from the periphery 2111 of the lens support structure 2105 to contact the ciliary body 15 and / or within the ciliary sulcus 25 to prevent displacement in the Z-plane and maintain proper alignment between the central opening 2115 and the visual axis of the eye during fixation.

[0113] Needles or guidewires (with or without sutures) can be molded into the terminal footplate or anchors 125 so that the fixation arms 120 can be exteriorized from within the eye. If necessary, the needles or guidewires can be exteriorized in the correct location before inserting the main body of the device 100 into the eye. Once the surgeon is satisfied with the needle or guidewire locations, the device 100 can be inserted into the eye and each fixation arm 120 can be secured in place with the appropriate procedure to ensure centering and Z-axis location. Once the device 100 is properly secured, the surgeon can trim the sutures and / or needles from the device 100, leaving the anchors 125 in place. Alternatively, modified sharp-tipped forceps / grabbers can be inserted through the primary corneal wound (used for inserting the lens fixation device) and then used to engage and exteriorize the fixation arms 120. This allows both the creation of the sclerotomy and the exteriorization of the fixation arm anchors 125 to occur in a single pass.

[0114] Device 100 can be inserted through a corneal or scleral incision using forceps or other common ophthalmic instruments. Alternatively, device 100 can be inserted using an injector system similar to an intraocular lens injector. The injector allows device 100 to unfold, sequentially presenting fixation arms 120 to the surgeon. Alternatively, the injector can present full device 100 within the anterior or posterior chamber in a configuration that limits the risk of surgical error. For example, the injector can ensure that device 100 is inserted "right-side up." Additionally, the injector can limit the risk of damage to the iris 10, endothelium, capsule, or zonules during implantation.

[0115] The device 100 described herein provides a stable platform and serves as an artificial anterior surface of the capsular bag for placement of the intraocular lens 110. Reliable centering and axial positioning of the lens support structure 105 are important for optimal operation of the device 100. In some instances, a guide system can be used to align the sclerotomy site. The guide system can employ features similar to intraoperative toric markers and preoperative toric bubble markers. In addition to marking the correct meridional location, the markers aid in aligning the incision relative to the limbus. Acceptable sclerotomy locations include posterior to the limbus and anterior to the ora serra. In the human eye, the sclerotomy can be placed approximately 0.1 mm to approximately 4 mm posterior to the limbus. By varying the anterior / posterior sclerotomy location relative to the limbus between approximately 0.1 mm and approximately 4 mm (Z-axis) or approximately 1.5 mm and approximately 4 mm, the tension of the fixation arms can be controlled within an acceptable range. By varying the diameter of the marker / device pair, the optimal size and position of the device 100 can be determined with the guide / marking system. FIGS. 14A-14B and 15A-15I show an exemplary sclerotomy guide tool 1000 incorporating multiple marking features 1005 used to assist in identifying and marking a sclerotomy site for insertion of the fixation arms 120 of the device 100. The tool 1000 may incorporate three marking features 1005 protruding from a distal end region 1015 of a handle 1010. The handle 1010 can extend along a first axis A, and the distal end region 1015 can be angled away from the first axis A. The distal end region 1015 of the tool 1000 can form a tripod 1020 with a feature 1005 protruding from each prong 1025 of the tripod 1020 (see FIG. 14A ). The distal end region 1015 of the tool 1000 can include a ring 1030, with marking features 1005 protruding from the distal-facing surface of the ring 1030 (see FIG. 14B). The ring 1030 can provide a centering function. The surgeon can use the limbus, pupil, and white-white as references. The marking features 1005 can create at least three contact points to define the location of the sclerotomy.The contact points of the tool 1000 provided by the marking features 1005 can correspond to the number of sclerotomy incisions desired for fixation of the device 100 .

[0116] Each marking feature 1005 can protrude not only outward but also distally from the ring 1030 (or tripod 1020). FIGS. 15A-15D show examples of tool 1000 incorporating a greater standoff from the marking features 1005 relative to the ring 1030 compared to the examples shown in FIGS. 14A-14B. The marking features 1005 can have a length between their origin on the ring 1030 and their distal-most tip 1035 that provides a standoff of between about 1 mm and about 10 mm, or between about 3 mm and about 6 mm. The tool 1000 can avoid interaction with ophthalmic instruments, such as specula, trocars, and the like, that are on the surface of the eye during surgery. In some examples, the ring 1030 can additionally incorporate crosshairs 1040 for centering (see FIGS. 15H-15I). The distance between the distal-most tip 1035 of each marking feature 1005 and the ring 1030 provides a sufficiently high standoff to prevent the ring 1030 (or crosshairs 1040, if present) from contacting the cornea during use (see Figures 15E-15G).

[0117] The inner diameter of the ring 1030 can be about 5 mm to about 15 mm (see FIG. 16A). The overall diameter defined by the distal-most tip 1035 of the tool 1000 can be between about 11 mm and about 18 mm, or between about 13 mm and about 17 mm (see FIG. 16B). The marking features 1005 can be symmetrically distributed around the circumference of the ring 1030. For example, if there are three marking features 1005, each can be located circumferentially at about 120 degrees from one another. Each marking feature 1005 can incorporate a bevel or double bevel leading to the distal-most tip 1035 so that the distal-most tip 1035 forms a generally sharp, pointed point suitable for marking the sclera, such as by forming a depression (see FIGS. 16A-16D). The bevel used to create the point at the distal-most tip 1035 can extend a length that is about 0.15 mm to about 1.5 mm. The distal-most tip 1035 can be angled inward toward the center of the ring 1030, and the distal-most tip 1035 can be offset from the outermost extent of the marking feature 1005 (see FIG. 16D ). The offset of the tip 1035 relative to the outermost extent of the marking feature 1005 can be a distance from the outermost extent that is between about 0.15 mm and about 1.5 mm. Each marking feature 1005 can have a length between about 3 mm and about 10 mm, and the beveled portion leading to the distal-most tip 1035 can be between 0.15 mm and about 1.5 mm of this length. The distal-most tip 1035 does not need to be sharply pointed to provide a marking function on the sclera. The distal-most tip 1035 can be blunt, as shown in FIGS. 14A-14B , and still be used to mark the sclera. The distal-most tips 1035, whether blunt or pointed, can be used to mechanically mark the sclera by creating multiple indentations or by applying another visual marker to the sclera. For example, the lower end of each distal-most tip 1035 can be used to transfer a transferable amount of ink or other visually appropriate material from the distal-most tip 1035 to the sclera.

[0118] Externalization of the anchor 125 can be accomplished using standard tools used in ophthalmology. Figures 17C-17D illustrate a snare device 200 for externalization of the anchor 125. As described elsewhere herein, the footplate or anchor 125 is configured to be externalized through a sclerotomy (e.g., a 23-, 25-, or 27-gauge sclerotomy). The snare device 200 is configured to grasp and release the anchor 125 and / or fixation arms 120 of the device and secure them transscleral. The snare device 200 can include an adjustable loop 205 configured to expand and contract in size. The loop 205 can pass partially or completely over the anchor 125. The loop 205 can be tightened to reduce the opening of the loop 205 and securely engage the anchor and / or fixation arms. Using a device 200 with a minimized loop 205 surrounding the fixation arm / anchor, a surgeon can externalize the anchor 125 with minimal risk of losing grip on the anchor 125. Once the anchor 125 is externalized, the loop 205 can be at least partially reopened to increase the open area of the loop 205 and release the anchor 125. In a fully or partially open configuration, the loop 205 can have an inner circumference of about 1.5 mm to about 10.0 mm. In a closed capture configuration, the inner circumference of the loop 205 can be about 0.25 mm to about 2.5 mm. The snare device 200 is configured to allow the loop to atraumatically grasp the anchor 125 and / or fixation arm 120 so as not to damage the device 100. For example, the snare device 200 may not have sharp corners. The material of the loop 205 can provide mechanical properties that allow the loop 205 to atraumatically capture the arm 120 and repeatedly transition between a large circumference configuration, a small circumference configuration, and back again to the large circumference configuration. The material of the loop 205 can provide a firm grip with an atraumatic interaction with the fixation arm 120 or anchor 125. The loop 205, while grasping the fixation arm 120 or anchor 125, can deform to a significant extent during the externalization process. At least a portion of the snare device 200 can bend.For example, the snare device 200 can be manufactured with a bend near the distal end region, or can be manually bent by the user during use to suit ergonomic needs.

[0119] The loop 205 can be a wire-like structure with a full radius of curvature. The wire-like structure can be a rigid material such as a metal, such as stainless steel, titanium, or nitinol. Alternatively, the wire-like structure can be constructed from a plastic, such as polypropylene, polyethylene, nylon, Gortex, polyimide, PMMA, or other plastic. Alternatively, the wire-like structure of the loop 205 can be made from an elastomeric material, such as a flexible acrylic, polyurethane, silicone, SIBS, or other elastomeric polymer with similar mechanical properties.

[0120] The snare device 200 can be configured to perform a sclerotomy and / or function as an intraocular lens grasper. FIGS. 18A-18D show examples of snare device 200. A loop 205 or other snare feature can extend from the device's lumen. The opening from the lumen can be at the distal end, as shown in FIGS. 17C-17D. The opening from the lumen can be located proximal to the distal end through the sidewall of the device, as shown in FIGS. 18A-18B, or the sharpened tip can be swaged so that it extends distal to the orifice where the loop 205 exits the lumen, as shown in FIGS. 18C-18D. The device may have additional features to prevent the snare material and the device from being damaged by the sharp edges of the distal tip 210. For example, the sharpened distal tip 210 of the needle may be covered by a sheath or other element configured to have a lumen and extend beyond the distal tip 210. The outer sheath can provide an atraumatic surface against which the loop 205 can be clamped. Alternatively, the piercing tip 210 can be positioned a distance from the opening 215 through which the loop 205 is manipulated, for example, about 0.2 mm to 10 mm from the opening 215. The device 200 can incorporate a distal tip 210 suitable for performing a sclerotomy. The distal tip 210 can have a variety of shapes, such as a non-coring trocar tip as shown in FIGS. 18A-18B or a back-bevel needle cannula tip as shown in FIGS. 18C-18D. The geometric shape of the distal tip 210 can include, but is not limited to, a bevel, a three-sided trocar, a cone, a diamond, a pencil point, a swaged, a skived, or other pointed shape.

[0121] In yet another example, the anchor 125 can be exteriorized (removed from the body) using a forceps-type device. The forceps can be straight or angled. The forceps device can incorporate a locking feature to enhance the surgeon's grip. The forceps device for exteriorization can transition from a locked state to an unlocked state, or vice versa, via any of a variety of mechanical actions, including twisting, squeezing, or sliding mechanisms, which, once engaged, reduce the forceps' range of motion. In some examples, the locking forceps have two gripping surfaces that lock in a restricted configuration. In other examples, the forceps have three or four gripping surfaces that can lock into a restricted configuration. The locking or restricted configuration can also encase the anchor 125 within a sheath that aids in the exteriorization procedure. Completely encasing the anchor 125 can limit interference between the anchor and the sclera when the anchor is inserted through a wound. The sheath can define an outermost surface during exteriorization that is configured to optimally interact with ocular tissue. For example, the outermost surface of the sheath can have a rounded profile (e.g., circular, elliptical, oval, etc.). The sheath can also have a coating to reduce friction with tissue during exteriorization. The sheath can be sufficiently rigid to substantially retain its shape during exteriorization.

[0122] The devices described herein can be implanted in the posterior chamber of an eye lacking an intact lens capsule. As described elsewhere herein, at least one of the at least three fixation arms can be biased toward a straight configuration and at least a second of the at least three fixation arms can be biased toward a folded configuration prior to insertion into the posterior chamber. The folded configuration includes an originating portion of the fixation arm extending away from the lens support structure and a central portion of the fixation arm having a bend, fold, or curve such that an anchor at the terminal portion is positioned above or below at least one of a portion of the lens support structure and a portion of the central opening. When the device is inserted into the posterior chamber, at least a portion of the fixation arms in the folded configuration are visualized through the pupil. The anchor of the straight fixation arm can be grasped and externalized through and over a first portion of the sclera. The anchor of the curved fixation arm can be grasped, unfolded, and externalized through and over a second portion of the sclera. The third portion of the fixation arm can then be grasped through and over the third portion of the sclera, applying tension and externalizing it to position and stabilize the device within the posterior chamber of the eye.

[0123] Materials or combinations of materials suitable for the preparation of the various components of the devices disclosed herein are provided throughout. It should be understood that other suitable materials are contemplated. The device 100 can be constructed from any implant-grade material capable of providing the necessary functionality for the lens support structure 105, fixation arms 120, and anchors 125. Materials that can be used in this device include, but are not limited to, silicone elastomers, fluorosilicone elastomers, polyurethanes, hydrophilic or hydrophobic acrylics, polyolefins, nylons, PVDF, PMMA, polyimides, nitinol, titanium, stainless steel, or other implant-grade materials. The device can be fabricated from a combination of materials that are geometrically bonded, chemically bonded or welded to each other, overmolded, encapsulated, or otherwise joined together. A given device element may be made of multiple materials. The fixation arm 120 is constructed from a non-elastic or semi-rigid material common in ophthalmic applications, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or high durometer silicone. The fixation arm 120 can incorporate or be formed from a resilient material, such as acrylic, polyurethane, silicone elastomer, or copolymers thereof, which facilitates manipulation of the fixation arm 120 during implantation. In yet another example, the fixation arm 120 can be formed from a semi-rigid or rigid plastic material, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or high durometer silicone embedded or coated with a soft elastomeric material, such as acrylic, polyurethane, silicone elastomer, or copolymers thereof.

[0124] Various examples will be described with reference to the drawings. However, particular examples may be practiced without one or more of these specific details or in combination with other known methods and configurations. This description sets forth numerous specific details, such as specific configurations, dimensions, and steps, to provide a thorough understanding of the examples. In other instances, well-known processes and manufacturing techniques not specifically described are detained so as not to unnecessarily obscure the description. References throughout this specification to "one embodiment," "an embodiment," "one example," "an example," or the like mean that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment or example. As such, the appearance of "one embodiment," "an embodiment," "one example," "an example," or the like in various places throughout this specification do not necessarily refer to the same embodiment or example. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more examples.

[0125] The devices and systems described herein may incorporate any of a variety of features. Elements or features of one example of the devices and systems described herein may be incorporated alternatively or in combination with elements or features of another example of the devices and systems described herein. For the sake of brevity, explicit descriptions of each of these combinations may be omitted, although various combinations are contemplated herein. Furthermore, the devices and systems described herein may be placed within the eye and need not be specifically implanted as shown in the drawings or described herein. The various devices may be implanted, positioned, adjusted, etc., according to a variety of different methods and using a variety of different devices and systems. The various devices may be adjusted before, during, or after implantation. Some representative descriptions of how the various devices are implanted and positioned are provided, although for the sake of brevity, explicit descriptions of each method for each implant or system may be omitted.

[0126] The use of relative terms throughout the description can indicate relative positions or directions or orientations and is not intended to be limiting. For example, "distal" can indicate a first direction away from a reference point. Similarly, "proximal" can indicate a position in a second direction opposite the first direction. The use of the terms "upper," "lower," "top," "bottom," "front," "side," "rear," and "forward," "rearward," "distal," and "leading" is used to establish a relative frame of reference and is not intended to limit the use or orientation of any of the devices described herein in various instances.

[0127] While this specification contains many specific details, these should not be construed as limitations on the claims, but rather as descriptions of specific features for particular examples. Certain features described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, while features may be described above as working in a particular combination and may even initially be claimed as such, one or more features from the claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination. Similarly, although the figures depict operations in a particular order, this should not be understood as requiring such operations to be performed in the particular order shown, or sequentially, or to perform all of the operations shown, to achieve desirable results. Only a few examples and examples are disclosed. It should be noted that variations, modifications, and extensions to the described examples and examples, as well as other examples, may be made based on the disclosed content.

[0128] In the above description and in the claims, phrases such as "at least one of" or "one or more of" may occur followed by a conjunctive list of elements or features. The term "and / or" may also occur with a list of two or more elements or features. Unless implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to refer to any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A only, B only, or both A and B," respectively. A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A only, B only, C only, both A and B, both A and C, both B and C, or all of A, B, and C," respectively.

[0129] Use of the term "based on" above and in the claims is intended to mean "based at least in part on," allowing for unrecited features or elements.

Claims

1. 1. An implantable device for supporting an intraocular lens within an eye, comprising: a support structure including an outer periphery, a front facing surface, a rear facing surface, and a central opening extending through the entire thickness of the support structure between the front and rear facing surfaces, the central opening having a continuous inner periphery; a plurality of fixation arms coupled to the support structure and configured to be under tension to position and stabilize the device within the eye, each of the plurality of fixation arms having a terminal end coupled to a transscleral anchor for sutureless scleral fixation.

2. The device of claim 1 , wherein the transcleral anchor is configured for atraumatic externalization.

3. The device of claim 2 , wherein the transscleral anchor is positionable outside the sclera and inside the conjunctiva.

4. The device of claim 1 , wherein at least one of the plurality of anchoring arms is substantially non-planar.

5. The device of claim 1 , wherein the plurality of anchoring arms comprises three anchoring arms extending outwardly from a periphery of the support structure.

6. The device of claim 5 , wherein at least a first of the three locking arms is biased toward a center of the device.

7. The device of claim 6 , wherein at least the first and second of the three locking arms are each biased toward a center of the device.

8. 8. The device of claim 7, wherein a third of the three fixation arms has an increased cross-sectional area compared to the cross-sectional areas of the first and second fixation arms.

9. 9. The device of claim 8, wherein the increased cross-sectional area of the third fixation arm increases its stiffness compared to the stiffness of either the first fixation arm or the second fixation arm.

10. The device of claim 5 , wherein the three fixed arms are evenly distributed around the periphery of the support structure.

11. The device of claim 1 , wherein the front-facing surface forms a stable platform on which an intraocular lens is placed during use.

12. The device of claim 1 , wherein the continuous inner circumferential surface defines a uniform, substantially circular shape, and the outer circumferential surface defines a substantially non-circular shape.

13. 13. The device of claim 12, wherein, in use, the support structure provides centering of the device without 360 degree contact with the ciliary body along the substantially non-circular circumferential surface.

14. 13. The device of claim 12, wherein, in use, the substantially non-circular circumferential surface of the support structure avoids contact with the ciliary body or contacts the ciliary body along less than 120 degrees.

15. 13. The device of claim 12, wherein, in use, the substantially non-circular circumferential surface of the support structure contacts the ciliary processes at three different points.

16. The device of claim 1 , wherein the outer peripheral surface of the support structure comprises a plurality of lobes projecting outwardly from a plurality of substantially flat or concave sides.

17. 17. The device of claim 16, wherein the plurality of lobes comprises three convex lobes that provide the support structure with a substantially rounded triangular shape.

18. The device of claim 17 , wherein the three convex lobes provide anti-rotation functionality in the Z plane.

19. 18. The device of claim 17, wherein, in use, the three convex lobes provide non-penetrating contact with the ciliary body.

20. The device of claim 1 , wherein the support structure comprises one or more slits formed in an interior wall that defines the central opening.

21. The device of claim 1 , wherein the support structure has a thickness from the front-facing surface to the rear-facing surface that tapers toward the central opening.

22. The device of claim 1 , wherein at least one of the plurality of fixation arms comprises a plurality of anchors along its length, including the transcleral anchor at the terminal end.

23. The device of claim 1 , wherein, in use, the transscleral anchor is configured to be located outside the sclera.

24. 24. The device of claim 23, wherein the transscleral anchor comprises a shape configured to pass through the sclera in a first direction during insertion and to resist passing through the sclera in a second, opposite direction.

25. 24. The device of claim 23, wherein when in a resting state, at least one fixation arm of the plurality of fixation arms incorporates a bend between its origin with the support structure and its terminus coupled to a transcleral anchor to form a bent fixation arm.

26. 26. The device of claim 25, wherein the bend is greater than or equal to 90 degrees and less than or equal to 270 degrees from the origin in both radial and centripetal directions.

27. 26. The device of claim 25, wherein the bend is 180 degrees from the origin with the support structure.

28. 26. The device of claim 25, wherein when in a resting state, the terminus of the bent fixation arm is in a plane different from the plane of the support structure, and the transcleral anchor is located over at least a portion of the support structure.

29. 30. The device of claim 28, wherein the bent fixation arm incorporates a resilient material or a deformable hinge to facilitate straightening the bent fixation arm so that the terminus approaches the plane of the support structure.

30. 26. The device of claim 25, wherein two of the fixation arms are flexible and have an inward bias, and the third fixation arm is less flexible than the two fixation arms.

31. The device of claim 1 , wherein the transcleral anchor of each of the plurality of fixation arms is configured to be located outside the sclera.

32. 32. The device of claim 31 , wherein the transscleral anchor comprises a central portion and one or more peripheral graspable portions, the central portion positioned to overlie a wound into which the transscleral anchor will be exteriorized upon implantation.

33. 33. The device of claim 32, wherein the central portion has an increased thickness, height, and / or width compared to the peripheral graspable portion.

34. The device of claim 1 , wherein one of the plurality of fixation arms is mechanically reinforced.

35. 35. The device of claim 34, wherein the mechanical reinforcement biases the device forward upon implantation.

36. A method comprising implanting an anterior lens capsule device having artificial zonular fixation that provides a stable platform for placement of an intraocular lens within an artificially constructed sulcus.

37. 1. An implantable device for supporting an intraocular lens within an eye, comprising: a support structure lying substantially in a first plane, the support structure including an outer periphery, a front facing surface, a rear facing surface, and a central opening extending through an entire thickness of the support structure between the front and rear facing surfaces, the central opening having a continuous inner periphery; three fixation arms coupled to the support structure and configured to position and stabilize the device within the eye, each of the three fixation arms having a terminal end coupled to a transscleral anchor for sutureless scleral fixation; When in a resting state, at least a first of the three fixed arms incorporates a bend between its origin with the support structure and its terminal end forming a first bent arm, the terminal end of the first bent arm lying in a second plane different from the first plane.

38. 38. The device of claim 37, wherein the transcleral anchor of the first bent arm is located over at least a portion of the support structure.

39. 38. The device of claim 37, wherein the transcleral anchor of the bent arm overlies at least a portion of the central opening.

40. 38. The device of claim 37, wherein at least a second of the three fixation arms incorporates a bend between its origin with the support structure and its terminus forming a second bent arm, the terminus of the second bent arm lying in a second plane different from the first plane.

41. 41. The device of claim 40, wherein the transcleral anchor of the second bent arm is located over at least a portion of the support structure.

42. 41. The device of claim 40, wherein the transcleral anchor of the second bent arm is located over at least a portion of the central opening.

43. 41. The device of claim 40, wherein a third of the three fixation arms is straight between its origin with the support structure and its terminus forming a straight fixation arm, the straight fixation arm being less flexible than the first bent arm and the second bent arm.

44. 44. The device of claim 43, wherein the first bent arm and the second bent arm are biased toward a central axis of the device.

45. 1. An implantable device for supporting an intraocular lens within an eye, comprising: a support structure lying substantially in a first plane, the support structure including an outer periphery, a front facing surface, a rear facing surface, and a central opening extending through an entire thickness of the support structure between the front and rear facing surfaces, the central opening having an inner periphery with a circumference; three fixation arms coupled to the support structure and configured to be under tension to position and stabilize the device within the eye, each of the three fixation arms having a terminal end coupled to a transscleral anchor for sutureless scleral fixation; The device wherein the inner circumferential surface forms a uniform, substantially circular shape and the outer circumferential surface forms a substantially non-circular shape.

46. 46. The device of claim 45, wherein the non-circular shape of the outer periphery comprises a plurality of lobes projecting outwardly from a plurality of sides.

47. 47. The device of claim 46, wherein the sides are substantially flat or concave.

48. 47. The device of claim 46, wherein each of the three fixed arms extends outwardly from a respective one of the plurality of sides.

49. 46. The device of claim 45, wherein the support structure has a width between the outer circumferential surface and the inner circumferential surface that varies around the circumference.

50. 47. The device of claim 46, wherein each of the three anchoring arms has a length greater than the distance the plurality of lobes project outwardly.

51. 46. The device of claim 45, wherein the front and rear facing surfaces of the support structure taper toward a central axis of the device.

52. 46. The device of claim 45, wherein the inner circumferential surface and the outer circumferential surface are convex such that the inner circumferential surface projects toward a central axis of the device and the outer circumferential surface projects away from the central axis of the device.

53. 46. The device of claim 45, wherein the thickness of the support structure from the front-facing surface to the rear-facing surface is between about 0.15 mm and about 1.5 mm.

54. 46. The device of claim 45, wherein the support structure is substantially flat.

55. 46. The device of claim 45, wherein the support structure incorporates a recess in the front-facing surface.

56. 46. The device of claim 45, wherein the support structure incorporates one or more posts projecting upwardly from the front-facing surface.

57. 1. A device for implantation into the posterior chamber of an eye lacking an intact lens capsule, comprising: a support structure having a central opening, the support structure configured to provide support for an artificial intraocular lens, such that after implantation in the eye, the device and the artificial intraocular lens are configured to allow the passage of light through both the central opening and the artificial intraocular lens; at least three fixation arms extending substantially orthogonally from the support structure, wherein prior to implantation, one of the at least three fixation arms extends from the support structure in an unfolded configuration and at least two of the at least three fixation arms extend from the support structure in a folded configuration, one of the at least three fixation arms being biased towards the unfolded configuration, and at least two of the at least three fixation arms being biased towards the folded configuration prior to implantation; Upon implantation, each of the at least two fixation arms of the at least three fixation arms are deployed, and each of the at least three fixation arms further comprises an atraumatic distal anchor portion for sutureless transscleral fixation of the device within the posterior chamber.

58. 1. A device for implantation into the posterior chamber of an eye lacking an intact lens capsule, comprising: a support structure having a central opening extending through the entire thickness of the support structure; a plurality of fixation arms, each of the plurality of fixation arms having an originating portion at the support structure and a terminal portion coupled to an atraumatic anchor for sutureless transscleral fixation; A device wherein, prior to transcleral fixation of the anchor, the plurality of fixation arms are curved between their starting and ending portions, providing curved fixation arms that allow at least a portion of the curved fixation arms to be visualized through the pupil of the eye.

59. 59. The device of claim 58, wherein after transcleral fixation of the anchor, each of the plurality of fixation arms is in tension between the origin portion and the terminal portion, aligning the support structure with respect to the Z-plane of the eye.

60. 60. The device of claim 59, wherein the support structure is configured to provide support for an intraocular lens, and the central opening is configured to allow the passage of light through both the central opening and the intraocular lens supported by the support structure.

61. 59. The device of claim 58, wherein the curved fixation arms are curved forward and the atraumatic anchors thereof are positioned over at least a portion of the support structure.

62. 59. The device of claim 58, wherein the curved fixation arms are curved backward with their atraumatic anchors positioned beneath at least a portion of the support structure.

63. 1. A method of implanting a device into the posterior chamber of an eye lacking an intact lens capsule, comprising: a lens support structure having a central opening; at least three fixation arms, each having a starting portion coupled to the lens support structure and a terminal portion including an anchor; prior to insertion into the posterior chamber, at least one fixation arm of the at least three fixation arms is biased toward a linear configuration and at least a second fixation arm of the at least three fixation arms is biased toward a folded configuration; and The folded configuration comprises: an origin portion extending away from the lens support structure; a central portion having a bend, crease, or curve; an anchor at the end portion located above or below at least one of a portion of the lens support structure and a portion of the central opening; grasping the at least one fixation anchor of the at least three fixation arms to externalize the anchor through and onto a first portion of the sclera; grasping the anchor of the second fixation arm, unfolding the folded configuration of the second fixation arm, and externalizing the anchor of the second fixation arm through and onto a second portion of the sclera; grasping an anchor of a third fixation arm of the at least three fixation arms and applying tension to the third fixation arm to externalize the anchor of the third fixation arm through and onto a third portion of the sclera to position and stabilize the device within the posterior chamber of the eye.

64. 1. A device for supporting an artificial intraocular lens in an eye, comprising: a lens support structure having a central opening through which light can pass toward the retina when the device is implanted in the eye; at least three fixation arms, each of which is coupled to the lens support structure and includes an origin portion extending outwardly from the lens support structure and an end portion comprising an anchor for transscleral fixation of the device in the eye; Prior to implantation, at least one of the at least three fixation arms is biased toward a folded configuration incorporating a bend that positions the anchor of the terminal portion between the origin portion and the terminal portion overlapping at least a portion of the lens support structure.

65. 65. The device of claim 64, wherein the anchor of the at least one fixation arm in the folded configuration is located above the at least a portion of the lens support structure when positioned in the eye and prior to scleral fixation, and is located anterior to the lens support structure relative to the retina.

66. 66. The device of claim 65, wherein the anchor located on the at least a portion of the lens support structure is above and anterior to the central opening of the lens support structure relative to the retina.

67. 66. The device of claim 65, wherein at least a first portion of the anchor is above and anterior to the central opening and at least a second portion of the anchor is above and anterior to the lens support structure relative to the retina.

68. 65. The device of claim 64, wherein the anchor of the at least one fixation arm in the folded configuration is located below the at least a portion of the lens support structure when positioned in the eye and prior to scleral fixation and is located posterior to the lens support structure relative to the retina.

69. 69. The device of claim 68, wherein the anchor located beneath the at least a portion of the lens support structure is below and posterior to the central opening of the lens support structure relative to the retina.

70. 69. The device of claim 68, wherein at least a first portion of the anchor is below and posterior to the central opening and at least a second portion of the anchor is below and posterior to the lens support structure relative to the retina.

71. 65. The device of claim 64, wherein the folded configuration comprises the terminal portion of the at least one fixed arm folded over or under the origin portion.

72. 65. The device of claim 64, wherein the terminal portion of the at least one fixed arm in the folded configuration overlaps the origin portion.

73. 65. The device of claim 64, wherein the anchor at the terminal portion of the at least one fixation arm in the folded configuration is visible through the pupil of the eye upon placement of the device in the posterior chamber of the eye and prior to transscleral fixation of the anchor.

74. 65. The device of claim 64, wherein the anchor of the at least one fixation arm in the folded configuration is located within a distance from a central axis of the device, the central axis extending from front to rear through the central opening, the distance being no greater than approximately 4.0 mm.

75. 65. The device of claim 64, wherein the at least one fixation arm in the folded configuration is curved such that the anchor at the terminal portion of the at least one fixation arm protrudes rearwardly toward the central opening of the device.

76. 65. The device of claim 64, wherein the anchor is adapted for sutureless transscleral fixation.

77. 65. The device of claim 64, wherein the lens support structure is generally ring-shaped.

78. 65. The device of claim 64, wherein the lens support structure further comprises an outer periphery and an inner periphery, the central opening being bounded by the inner periphery, and the outer periphery of the lens support structure is substantially non-circular and the inner periphery is substantially circular.

79. 65. The device of claim 64, wherein the lens support structure comprises a periphery comprising a plurality of lobes projecting radially away from the central opening.

80. 80. The device of claim 79, wherein a first total number of said plurality of lobes is equal to a second total number of said at least three fixation arms, each of said lobes being disposed between adjacent fixation arms.

81. 81. The device of claim 80, wherein each of the lobes is symmetrically positioned around the circumference of the lens support structure between adjacent fixation arms, and each of the at least three fixation arms is symmetrically positioned around the circumference of the lens support structure between adjacent lobes.

82. 81. The device of claim 80, wherein the plurality of lobes consists of three lobes and the at least three fixation arms consists of three fixation arms.

83. 80. The device of claim 79, wherein the plurality of lobes comprises at least three convex lobes that give the lens support structure a substantially rounded triangular shape.

84. 84. The device of claim 83, wherein when implanted, the at least three convex lobes provide non-penetrating contact with ciliary body tissue in the eye.

85. 65. The device of claim 64, wherein at least two of the at least three fixation arms are biased toward the collapsed configuration prior to implantation.

86. 65. The device of claim 64, wherein all of the at least three fixation arms are biased toward the collapsed configuration prior to implantation.

87. 65. The device of claim 64, wherein at least a second of the at least three fixation arms is biased toward the deployed configuration prior to implantation.

88. 88. The device of claim 87, wherein the at least a second fixation arm has a larger cross-sectional area relative to a cross-sectional area of the at least one fixation arm of the at least three fixation arms, providing increased stiffness of the at least a second fixation arm relative to a stiffness of the at least one fixation arm of the at least three fixation arms.

89. 65. The device of claim 64, wherein the lens support structure comprises a substantially planar surface.

90. 65. The device of claim 64, wherein the lens support structure comprises a shape configured to mate with the periphery of an intraocular lens or with one or more haptics of the intraocular lens.

91. 91. The device of claim 90, wherein the shape comprises a depression, recess, channel, or groove forming at least a portion of an inner periphery of the lens support structure.

92. 65. The device of claim 64, wherein the at least one fixation arm of the at least three fixation arms comprises a deformable material to facilitate straightening of the fixation arm from the folded configuration to the deployed configuration to facilitate the transcleral fixation.

93. 65. The device of claim 64, wherein after transscleral fixation of the anchor, the at least one fixation arm applies tension to the deployed configuration between the starting portion and the terminal portion to align the lens support structure with respect to the Z-plane of the eye.

94. 65. The device of claim 64, wherein the device comprises three fixation arms, two of the three fixation arms being flexible and biased toward a folded configuration, and a third fixation arm being less flexible than the two of the three flexible fixation arms and biased toward an unfolded configuration.

95. 95. The device of claim 94, wherein all three fixation arms are configured to be under tension.

96. 95. The device of claim 94, wherein the folded configuration of each of the two of the three fixation arms biases the terminal portion toward a central axis of the device.

97. 65. The device of claim 64, wherein the at least one fixed arm of the at least three fixed arms is biased toward the folded configuration while the lens support structure is biased toward a substantially flat or planar configuration.

98. 1. A device for supporting an artificial intraocular lens in an eye, comprising: a lens support structure having an inner periphery at least partially defining a central opening, wherein when the device is implanted in the eye, light can pass through the central opening toward the retina; at least three fixation arms, each comprising a starting portion coupled to the lens support structure and a terminal portion comprising an anchor for transscleral fixation of the device in the eye; Prior to implantation, at least one fixation arm of the at least three fixation arms is biased toward a folded configuration, the folded configuration comprising the origin portion extending away from the lens support structure, the anchor at the end portion located above or below at least one of a portion of the lens support structure and a portion of a central opening, and a bend between the origin portion and the end portion.

99. 99. The device of claim 98, wherein the anchor of the at least one fixation arm in the folded configuration is located above and anterior to the portion of the lens support structure relative to the retina when positioned on the eye and prior to scleral fixation.

100. 99. The device of claim 98, wherein the anchor of the at least one fixation arm in the folded configuration is located above and anterior to the portion of the central opening relative to the retina when positioned on the eye and prior to scleral fixation.

101. 99. The device of claim 98, wherein at least a first portion of the anchor is above and anterior to the portion of the central opening and at least a second portion of the anchor is above and anterior to the portion of the lens support structure relative to the retina.

102. 99. The device of claim 98, wherein the anchor of the at least one fixation arm in the folded configuration is located below and posterior to the portion of the lens support structure relative to the retina when positioned on the eye and prior to scleral fixation.

103. 99. The device of claim 98, wherein the anchor of the at least one fixation arm in the folded configuration is located below and posterior to the portion of the central opening relative to the retina when positioned on the eye and prior to scleral fixation.

104. 99. The device of claim 98, wherein at least a first portion of the anchor is below and posterior to the portion of the central opening and at least a second portion of the anchor is below and posterior to the portion of the lens support structure relative to the retina.

105. 99. The device of claim 98, wherein the folded configuration comprises the terminal portion of the at least one fixed arm folded over or under the origin portion.

106. 99. The device of claim 98, wherein the terminal portion of the at least one fixed arm in the folded configuration overlaps the origin portion.

107. 99. The device of claim 98, wherein the anchor at the terminal portion of the at least one fixation arm in the folded configuration is visible through the pupil of the eye when the device is placed in the posterior chamber of the eye but prior to transscleral fixation of the anchor.

108. 99. The device of claim 98, wherein the anchor of the at least one fixation arm in the folded configuration is located within a distance from a central axis of the device, the central axis extending from front to rear through the central opening, the distance being no greater than approximately 4.0 mm.

109. 99. The device of claim 98, wherein the at least one fixation arm in the folded configuration is curved such that the anchor at the terminal portion of the at least one fixation arm protrudes rearwardly toward the central opening of the device.

110. 99. The device of claim 98, wherein the anchor is suitable for sutureless transscleral fixation.

111. 99. The device of claim 98, wherein the lens support structure is generally ring-shaped.

112. 99. The device of claim 98, wherein the lens support structure further comprises an outer periphery, the outer periphery of the lens support structure being substantially non-circular and the inner periphery being substantially circular.

113. 100. The device of claim 98, wherein the lens support structure further comprises a periphery, the periphery comprising a plurality of lobes projecting radially away from the central opening.

114. 114. The device of claim 113, wherein a first total number of the plurality of lobes is equal to a second total number of the at least three fixation arms, each of the lobes being disposed between adjacent fixation arms.

115. 115. The device of claim 114, wherein each of the lobes is symmetrically positioned around the circumference of the lens support structure between adjacent fixation arms, and each of the at least three fixation arms is symmetrically positioned around the circumference of the lens support structure between adjacent lobes.

116. 115. The device of claim 114, wherein the plurality of lobes consists of three lobes and the at least three fixation arms consists of three fixation arms.

117. 114. The device of claim 113, wherein the plurality of lobes comprises at least three convex lobes that impart a substantially rounded triangular shape to the lens support structure.

118. 118. The device of claim 117, wherein when implanted, the at least three convex lobes provide non-penetrating contact with ciliary body tissue in the eye.

119. 99. The device of claim 98, wherein at least two of the at least three fixation arms are biased toward the collapsed configuration prior to implantation.

120. 99. The device of claim 98, wherein all of the at least three fixation arms are biased toward the collapsed configuration prior to implantation.

121. 99. The device of claim 98, wherein at least a second of the at least three fixation arms is biased toward the deployed configuration prior to implantation.

122. 122. The device of claim 121, wherein at least a second fixation arm has a larger cross-sectional area compared to a cross-sectional area of the at least one fixation arm of the at least three fixation arms, providing increased stiffness of the at least second fixation arm relative to the stiffness of the at least one fixation arm of the at least three fixation arms.

123. 99. The device of claim 98, wherein the lens support structure comprises a substantially planar surface.

124. 99. The device of claim 98, wherein the lens support structure comprises a shape configured to mate with the periphery of an intraocular lens or with one or more haptics of the intraocular lens.

125. 125. The device of claim 124, wherein the shape comprises a depression, recess, channel, or groove forming at least a portion of an inner periphery of the lens support structure.

126. 99. The device of claim 98, wherein the at least one fixation arm of the at least three fixation arms comprises a deformable material to facilitate straightening of the fixation arm from the collapsed configuration to the expanded configuration to facilitate transcleral fixation.

127. 99. The device of claim 98, wherein after transscleral fixation of the anchor, the at least one fixation arm applies tension to the deployed configuration between the starting portion and the terminal portion to align the lens support structure with respect to the Z-plane of the eye.

128. 99. The device of claim 98, wherein the device comprises three fixation arms, two of the three fixation arms being flexible and biased toward the folded configuration, and a third fixation arm being less flexible than the two of the three flexible fixation arms and biased toward the unfolded configuration.

129. 129. The device of claim 128, wherein all three fixation arms are configured to be under tension.

130. 129. The device of claim 128, wherein the folded configuration of each of the two of the three fixation arms biases the terminal portion toward a central axis of the device.

131. 99. The device of claim 98, wherein the lens support structure is biased toward a substantially flat or planar configuration while the at least one fixed arm of the at least three fixed arms is biased toward the folded configuration.

132. 46. The device of claim 45, further comprising one or more awnings overlying the front-facing surface of the support structure and forming one or more recesses forward of the front-facing surface.

133. 133. The device of claim 132, wherein the one or more recesses are sized and configured to accommodate at least a portion of the intraocular lens.

134. 133. The device of claim 132, wherein the one or more awnings have a smooth shape configured to protect the iris of the eye from the edge of the intraocular lens.

135. 133. The device of claim 132, wherein the one or more awnings comprise a central facing surface configured to provide counter pressure to the haptics of the intraocular lens.

136. 133. The device of claim 132, wherein the substantially non-circular shape comprises multiple lobes and is triangular, elliptical, or rectangular.

137. 133. The device of claim 132, wherein the substantially non-circular shape is rectangular with multiple lobes, and the outer periphery defines a pair of short sides and a pair of elongated sides.

138. 138. The device of claim 137, wherein the one or more awnings comprise a first awning and a second awning protruding above the front-facing surface near the pair of short sides, and the intraocular lens comprises a one-piece intraocular lens having a pair of haptics, and the first awning and the second awning accommodate a span of the haptics between the first awning and the second awning.

139. 139. The device of claim 138, wherein the first awning and the second awning are connected to one another along the pair of elongated sides by extensions, thereby defining an upper opening.

140. 140. The device of claim 139, wherein the top opening has a diameter and the central opening has a diameter, the diameter of the top opening being larger than the diameter of the central opening of the support structure.

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