Footplates for scleral suspension devices and methods of use

Abstract

A scleral suspension device for supporting an implant within an eye including a support structure upon, against, or within which the implant is supported; and a plurality of fixation arms. Each fixation arm of the plurality of fixation arms has a terminal end region with a footplate. Upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality of fixation arms extends through a sclerotomy and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy. Upon tensioning of the plurality of fixation arms, a lower surface of each footplate forms a pressure annulus against the external scleral surface, and a first point of contact between the lower surface and the external scleral surface that creates a focal point of a maximum contact pressure is a distance away from margins of the sclerotomy. Related tools, systems, and methods are provided.

Description

Via Electronic Filing Attorney Docket No. : 058226-509001 WODate of Submission: November 21, 2025 Customer No. : 64046FOOTPLATES FOR SCLERAL SUSPENSION DEVICES AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. Nos 63 / 724,182, filed November 22, 2024, and 63 / 891,866, filed October 1, 2025. The disclosures of the patent applications are incorporated by reference herein in their entireties.FIELD

[0002] The present technology relates generally to medical devices and methods, and more particularly, to footplates for scleral suspension devices and their methods of use.BACKGROUND

[0003] The present disclosure relates generally to the field of ophthalmics, more particularly to footplates for scleral suspension devices for supporting and positioning optical implants, such as optical elements including intraocular lenses (lOLs), miniature telescopes, magnifiers, and camera elements, as well as other devices such as sensors in the eye.

[0004] Implantation of optical elements, such as lOLs, miniature telescopes, and others, requires support within the eye to hold them in the correct position. Often, this is achieved through the native capsular bag suspended by the zonules (fine, thread-like structures). However, these support structures can be compromised either due to intrinsic factors such as pseudoexfoliation, Marfan, or Weill-Marchesani syndromes, or extrinsic factors such as trauma. Additionally, lens support can be compromised iatrogenically either during the time of surgery (either anterior or posterior segment surgery) or as a late complication of previous surgery', for example by capsular phimosis.

[0005] The management of secondary' IOL placement in the absence of sufficient capsular or zonular support continues to evolve. Currently, the only FDA approved solution is placement of an anterior chamber IOL (ACIOL). The ACIOL is a larger lens with the ability to sit anterior to the iris, however over time these lenses can cause Uveitis- Glaucoma-Hyphema (UGH) syndrome as well as endothelial cell loss and comeal decompensation, and as a result are contraindicated in many patients. Modified capsuleAttorney Docket No.: 058226-509001 WO tension rings (Cionni or Ahmed) can be used off-label to provide sutured scleral support to a partially weakened capsule. However, in cases of substantial capsule or zonular compromise the lens must be secured without use of these native supporting structures. Other off-label techniques can be employed, such as iris suturing IOL, but this is technically difficult and can lead to iris pigment loss causing glaucoma. Lastly, scleral suturing lOLs with islets is technically complex, risks rotation, and the durability of the sutures is unknown; there are reported cases of breakage and lens subluxation. Additionally, all of these techniques force the surgeon to use an alternative lens type, instead of their preferred lens for the patient. Lastly, the decision of timing is critical, as frequently lens calculations are inadequate during the initial vitrectomy / lensectomy yet there is the desire to not subject the patient to additional posterior segment surgery, so non-ideal lenses are frequently implanted.

[0006] Other intraocular devices are difficult to implant in a patient where capsular bag support is limited or lacking entirely, particularly where such devices are heavy in relation to the surrounding anatomy. For example, some patients who have lost central vision due to age-related macular degeneration may benefit from some restoration of their visual field by placement of an implantable miniature telescope (IMT). IMTs can be substantially heavier than a conventional intraocular lens and, like, lOLs are impaired by tilt or inadvertent movement of the device within the eye. Thus, fixation and stabilization of the heavier device is particularly problematic.

[0007] Fixation of scleral support devices, particularly where substantially heavier devices are placed, can lead to impaired fixation of the device due to footplates being pulled back through tissue following extemalization. Pull-through of the footplate can progress over several weeks or months.SUMMARY

[0008] In an implementation, provided is a scleral suspension device for supporting an implant within an eye including a support structure upon, against, or within which the implant is supported; and a plurality of fixation arms, each fixation arm of the plurality of fixation arms having a terminal end region comprising a footplate. Upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality of fixation arms extends through a sclerotomy and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy. Upon tensioning of the plurality of fixation arms, a lower surface of a central portion of each footplate forms aAttorney Docket No.: 058226-509001 WO pressure annulus against the external scleral surface. A first point of contact between the lower surface of the central portion and the external scleral surface that creates a focal point of a maximum contact pressure is a distance away from margins of the sclerotomy. The distance can be at least 0.05 mm up to about 0.50 mm. A geometry of the footplate provides a distribution of pressure within the pressure annulus upon application of tension on the plurality of fixation arms. The distribution of pressure within the pressure annulus can move the pressure annulus outward further away from the sclerotomy so that the distance is greater than, for example, about 0.05 mm. The distribution of pressure within the pressure annulus can increase an area of the pressure annulus. The distribution of pressure within the pressure annulus can decrease the maximum contact pressure within the pressure annulus. The lower surface of the central portion of the footplate can relocate the focal point outward to be further away from margins of the sclerotomy. The footplate can be designed to stabilize tension on the device without being pulled through the external scleral surface. The footplate can have a geometry that is designed to preferentially pass through the sclerotomy in an inside-out direction and resist passing through the sclerotomy in an outside-in direction.

[0009] The central portion has a dome diameter across an upper surface of the central portion, a dome height between the upper surface of the central portion and the lower surface of the central portion, and a central axis extending through the central portion from the upper surface into the fixation arm to which the footplate is attached. The lower surface along at least a first axis can form an angle relative to the central axis of the central portion. The angle can be non-perpendicular. The lower surface around 360 degrees relative to the central axis of the central portion can form an angle that is non-perpendicular. The angle can be about 70 - 88 degrees. The angle can reduce the focal point of the maximum contact pressure exerted by the footplate and can distribute the pressure annulus more evenly along the lower surface of the footplate. The angle can increase the distance and move the focal point of the maximum contact pressure further away from the sclerotomy. The angle can reduce scleral erosion and reintemalization of the footplate. The lower surface along at least a first axis can be substantially curved. The lower surface can have a radius of curvature that is steeper than a radius of curvature of the external scleral surface. The radius of curvature can reduce the focal point of the maximum contact pressure exerted by the footplate and distribute the pressure annulus more evenly along the lower surface of the footplate. The radius of curvature can increase the distance and move the focal point of the maximum contact pressure further away from the sclerotomy. The radius of curvature can reduce scleralAttorney Docket No.: 058226-509001 WO erosion and reintemalization of the footplate. The lower surface along the first axis can have the radius of curvature and along a second axis perpendicular to the first axis can be substantially planar.

[0010] The dome diameter of the central portion can be about 0.810 mm - 1 mm. The dome height of the central portion can be about 0.210 mm - 500 mm. The central portion can have a dome volume that is about 0.200 mm3- 0.300 mm3. A diameter of each of the plurality of fixation arms can be about 0.20 mm - 0.50 mm. Dome volume and angulation of the lower surface can redistribute the pressure annulus applied by the footplate against the external scleral surface.

[0011] The footplate can further including at least one peripheral portion extending outward from the central portion. The at least one peripheral portion can be designed to be more easily grasped using an ophthalmic tool for manipulation and extemalization of the footplate than the central portion. The at least one peripheral portion can be sized to be received within a 27-gauge ophthalmic microforceps. The ophthalmic implant can be an intraocular lens, a miniature telescope, magnifier, camera element, intraocular camera, or sensor. The plurality' of fixation arms can be three fixation arms placed under tension to locate and stabilize the scleral suspension device along three points of fixation.

[0012] In an interrelated implementation, provided is a method of supporting an implant within an eye including inserting a scleral suspension device within an eye. The scleral suspension device includes a support structure upon, against, or within which an intraocular lens implant is supported; and a plurality of fixation arms, each fixation arm of the plurality of fixation arms having a terminal end region comprising a footplate. Upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality of fixation arms extends through a sclerotomy^ penetrating a pars plana region of the ciliary body and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy.

[0013] The method can further include tensioning the plurality of fixation arms. A lower surface of a central portion of each footplate can form a pressure annulus against the external scleral surface. A first point of contact between the lower surface of the central portion and the external surface that creates a focal point of a maximum contact pressure can be a distance away from margins of the sclerotomy. The distance can be at least 0.05 mm upAttorney Docket No.: 058226-509001 WO to about 0.50 mm. The footplate can have a geometry that provides a distribution of pressure within the pressure annulus upon application of tension on the plurality of fixation arms. The distribution of pressure within the pressure annulus can move the pressure annulus outward further away from the sclerotomy. The distribution of pressure within the pressure annulus can increase an area of the pressure annulus. The distribution of pressure within the pressure annulus can decrease the maximum contact pressure within the pressure annulus. The lower surface of the central portion of the footplate can relocate the focal point of the maximum contact pressure outward to be further away from margins of the sclerotomy. The focal point of the maximum contact pressure can be a distance from margins of the sclerotomy that is greater than about 0.05 mm up to about a length of the footplate.

[0014] In an interrelated aspect, provided is a scleral suspension device for supporting an implant within an eye. The scleral suspension device includes a support structure upon, against, or within which the implant is supported; and a plurality of fixation arms, each fixation arm of the pl urality of fixation arms having a terminal end region comprising a footplate. Upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality of fixation arms extends through a sclerotomy and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy. Upon tensioning of the plurality of fixation arms, a lower surface of a central portion of each footplate forms a pressure annulus against the external scleral surface. A geometry of the footplate provides a distribution of pressure within the pressure annulus upon application of tension on the plurality of fixation arms.

[0015] The distribution of pressure within the pressure annulus can increase an area of the pressure annulus. The distribution of pressure within the pressure annulus can decrease a maximum contact pressure within the pressure annulus. The pressure annulus can include a focal ring of maximum contact pressure. The lower surface of the central portion of the footplate can relocate the focal ring outward to be further away from margins of the sclerotomy.

[0016] In an interrelated aspect, provided is a footplate for a scleral suspension device for supporting an ophthalmic implant within an eye comprising an external scleral surface. The footplate includes a central portion; a first peripheral portion extending outward from a first side of the central portion; a second peripheral portion extending outward from a second side of the central portion, the second side opposite the first side. A central axis of the footplate extends through a geometric center of an upper surface of the central portion. TheAttorney Docket No.: 058226-509001 WO footplate has a long axis and a short axis perpendicular to the long axis. The long axis extends from a first end of the first peripheral portion through the central portion to a second end of the second peripheral portion.

[0017] A lower surface of the central portion along the long axis optionally does not follow a curve of the external scleral surface of the eye. A lower surface of the central portion along the long axis can be arranged at an angle relative to the central axis. The angle can be less than perpendicular. The angle can be about 70 - 88 degrees. The angle can be greater than a curvature of the external scleral surface. A lower surface of the central portion along the short axis can be substantially flat or curved. The lower surface of the central portion along the short axis can be arranged at an angle relative to the central axis. The angle can be less than perpendicular. The angle can be about 70 - 88 degrees. The angle can be greater than a curvature of the external scleral surface. A lower surface of the central portion can form an angle relative to the central axis that is less than perpendicular. A lower surface of the central portion can follow a curve that is steeper than a radius of curv ature of the external scleral surface of the eye. A taper can be applied circumferentially around the central portion that is greater than a curve of the external scleral surface of the eye. A radius of curvature of a lower surface of the central portion optionally does not follow a curvature of the external scleral surface. The radius of curvature can be greater than the curvature of the external scleral surface. The central portion of the footplate can create a contact annulus where a lower surface of the central portion contacts the external surface of the eye. The pressure annulus of the central portion can have a size and shape that extends along only at least a portion of the contact annulus. The pressure annulus can be located a distance away from margins of a wound through which the footplate is externalized.

[0018] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims. While certain features of the currently disclosed subject matter are described for illustrative purposes, it should be readily understood that such features are not intended to be limiting. The claims that follow the disclosure are intended to define the scope of the protected subject matter.BRIEF DESCRIPTION OF THE DRAWINGSAttorney Docket No.: 058226-509001 WO

[0019] These and other aspects will now be described in detail with reference to the following drawings. The figures are not to scale in absolute terms or comparatively but are intended to be illustrative. Also, relative placement of features and elements may be modified for the purpose of illustrative clarity.

[0020] FIG. 1 A is a perspective view of an implementation of device configured to support an IOL in an eye;

[0021] FIG. IB is a cross-sectional view of the device of FIG. 1A implanted in an eye;

[0022] FIG. 2 is a top plan view of another implementation of a device configured to support an IOL in an eye;

[0023] FIG. 3 A is a top plan view of a device incorporating an implementation of visualization features;

[0024] FIG. 3B is a perspective view of the device of FIG. 3 A;

[0025] FIG. 4A is a side view of an implementation of a footplate for a scleral suspension device;

[0026] FIG. 4B is a perspective top end view of the footplate of FIG. 4A;

[0027] FIG. 4C is an end view of the footplate of FIG. 4A;

[0028] FIG. 4D is a perspective bottom end view of the footplate of FIG. 4A;

[0029] FIG. 4E is a side view of another implementation of a footplate for a scleral suspension device;

[0030] FIG. 4F is a perspective top end view of the footplate of FIG. 4E;

[0031] FIG. 4G is an end view of the footplate of FIG. 4E;

[0032] FIG. 4H is a perspective bottom end view of the footplate of FIG. 4E

[0033] FIG. 5 A is an end view of an implementation of a scleral suspension device;

[0034] FIG. 5B is a side view of a footplate of the scleral suspension device of FIG. 5A;

[0035] FIG. 6A is an end view of another implementation of a scleral suspension device;Attorney Docket No.: 058226-509001 WO

[0036] FIG. 6B is a side view of a footplate of the scleral suspension device of FIG. 6A;

[0037] FIG. 7A is an end view of another implementation of a scleral suspension device;

[0038] FIG. 7B is a side view of a footplate of the scleral suspension device of FIG. 7A;

[0039] FIG. 8A is a schematic illustrating a footplate externalized through a sclera in cross-section;

[0040] FIG. 8B is a schematic illustrating the externalized footplate of FIG. 8 A from above;

[0041] FIG. 8C is a schematic illustrating the contact annulus of the externalized footplate of FIG. 8A;

[0042] FIG. 8D is a schematic illustrating a footplate having an angled lower surface externalized through a sclera in cross-section;

[0043] FIG. 8E is a schematic illustrating the contact annulus of the externalized footplate of FIG. 8D with the angled lower surface;

[0044] FIG. 9A is a cross-sectional, transparent view of the footplate of FIG.4A overlaying a cross-sectional, solid view of the footplate of FIG. 4E along the long axis;

[0045] FIG. 9B is a cross-sectional, transparent view of the footplate of FIG. 4C overlaying a cross-sectional, solid view of the footplate of FIG. 4H along the short axis;

[0046] FIG. 10A illustrates expected in vivo tension or force in grams force (gf) for scleral suspension devices having a fixation arm diameter Da;

[0047] FIG. 10B illustrates pull-through force in a silicone membrane model of scleral suspension devices having different footplate geometries;

[0048] FIG. 11 shows the effect of fixation arm diameter Da on the pull- through force;

[0049] FIGs. 12A-1 to 12A-9 show three footplate embodiments (Gen2, Gen3, Gen4 Rev C) and the effect increasing tension on footplate lift at 0.5, 2.0, and 4.0 gf;Attorney Docket No.: 058226-509001 WO

[0050] FIGs. 12B-1 to 12B-9 show the three embodiments of FIGs. 12A-1 to 12A-9 and the effect increasing tension on the fixation arms has on contact pressure and focal pressure on the wound edges;

[0051] FIG. 12C-1 to 12C-4 show two embodiments of scleral suspension devices with different anchor geometries (Gen4 Rev B and Gen4 Rev C) and the effect increasing tension on the fixation arms has on anchor lift, contact pressure, and focal pressure on the wound edges;

[0052] FIG. 13 shows contact pressure as a function of distance from the sclerotomy edge for different anchor geometries (Gen 2, Gen 3, Gen4 Rev B, and Gen 4 Rev C) to illustrate the impact of central dome height and central dome angulation upon application of tension.

[0053] It should be appreciated that the drawings herein are for illustration only and are not meant to be to scale.DETAILED DESCRIPTION

[0054] The present disclosure relates generally to the field of ophthalmics, more particularly to delivery of ophthalmic devices, including artificial support structures for supporting and positioning intraocular implants having optical elements, such as implantable miniature telescopes (IMT), magnifiers, intraocular cameras, camera element, sensors, intraocular lenses (IOLS), intraocular lens implant, or other ophthalmic implant, particularly when zonular and capsular support has been compromised.

[0055] The most common treatment for aphakia caused by removal of a cataractous lens is placement of an IOL within the native lenticular capsular bag. The capsular bag. which has an anterior component and a posterior component thus creating an inner chamber, is supported by zonules, thus providing a stable structure for IOL support. In some cases, the posterior aspect of the capsular bag is incompetent or ruptured during cataract surgety, necessitating a more reliable platform for positioning an IOL. If the anterior aspect of capsular bag and its associated zonules are intact, an IOL may be placed between the anterior capsule and the iris, a position referred to as the "sulcus.” In another subset of cataract surgery cases, the anterior capsule is incompetent, or the zonules are incompetent, making sulcus placement unsafe or impossible. The devices described herein can be implanted into a posterior chamber of an eye that lacks an intact capsular bag. The devicesAttorney Docket No.: 058226-509001 WO described herein can create an artificial anterior capsule with artificial zonular fixation. The devices described herein can provide a stable platform structure fixated to the eye and thereby recapitulate the native anterior capsular and zonular apparatus allowing for placement of an IOL in the artificially constructed sulcus.

[0056] The devices described herein solve problems of other support / positioning techniques known in the art. Anterior chamber intraocular lenses placed in front of the iris can cause comeal decompensation, glaucoma, and bleeding over time due to their instability in the eye. Tenses sutured to the iris are technically difficult to implant and increase the risks of bleeding and glaucoma due to chafing of the iris. Lenses may also be sutured or otherwise affixed to the sclera, which is also technically difficult. In some cases, suture erosion / breakage requires additional surgery and risk potentially blinding infection. The ciliary body is divided into the pars plicata and the pars plana. The pars plicata is located anterior to the pars plana and has an overall smaller diameter compared to the diameter of the pars plana. The pars plicata of the ciliary' body is composed of ciliary' processes, the lens zonules, the ciliary muscle, and a rich vascular network that supplies the pigmented and non-pigmented epithelium, which is part of the blood-aqueous barrier. The pars plana is located posterior to the pars plicata and has a larger diameter compared to the diameter of the pars plicata. The pars plana of the ciliary' body is thinner (i.e., from the exterior of the eye toward interior of the eye) and less vascular than the pars plicata and has fewer functional components. Because of these differences between the regions of the ciliary body, most penetrating eye procedures, such as vitreoretinal procedures, including posterior vitrectomy and intravitreal injections, are performed through the pars plana not through the pars plicata. In the case of scleral fixation of lenses that are otherwise sized for placement within the capsular bag, the pars plicata is penetrated increasing the risk of hemorrhage, inflammation, and / or dislocation, mechanical failure of the IOL, including broken, loosened, or bent IOL haptics. Pars plana scleral fixation of such lenses would be difficult if not impossible due to the diameter of these lenses and their overall lack of elasticity7to stretch to the larger diameter needed for pars plana fixation. The elasticity of the fixation arms and adjacent footplates allow for variance in the angle of scleral penetration without compromising the Z-plane stability. The angle of scleral penetration can be perpendicular to the tangent of the scleral surface or more oblique to the tangent of the scleral surface without compromising fixation.Attorney Docket No.: 058226-509001 WO

[0057] The devices described herein are implanted trans-sclerally in a sutureless manner, which eliminates the risk of suture breakage. A sutureless trans-scleral fixation method allows for easier placement and secure attachment without concern for loosening or breaking of sutures. The devices described herein are sized and have elastic properties for trans-scleral fixation through the pars plana region of the ciliary body, which avoids penetrating critical structures of the pars plicata and the associated risks. The devices described herein stably hold IOLS providing a reliable refractive result based on known position without concern. The devices also allow for posterior segment placement that greatly reduces risk of damage to iris, angle, or cornea. Implantation posterior to iris and cornea eliminates or reduces risk of corneal injury, iris bleeding and glaucoma. The devices described herein reduce the risk of complications compared to current technologies such as ACIOL, Iris-sutured lens, or Scleral -sutured lens. The devices described herein are designed to accommodate and provide support to a wide variety of intraocular lenses. Thus, the lens of choice can be implanted at the time of surgery or at a later date. The devices described herein replicate a natural lens capsule and in some implementations are particularly suitable for implantation into a posterior chamber of an eye lacking an intact capsular bag. For example, the devices described herein create an artificial anterior capsule with artificial zonular fixation providing a scaffold or stable platform structure and an artificially constructed sulcus where the anterior component of the capsular bag and / or zonules of the natural lens are incompetent. The fixation arms are externalized as needed for scleral support / fixation.

[0058] The scleral suspension devices described herein incorporate footplates specifically designed to improve fixation of the device by preventing tissue pull-through following extemalization and reducing compressive pressure on the sclera that can lead to gradual changes in tissue integrity.

[0059] The scleral suspension devices and footplates will be described in more detail below. It should be appreciated that the implant supported by the devices described herein can vary and that reference to one ty pe of implant herein, such as an IOL, is not intended to be limiting. Other implants that incorporate a lens but are not considered IOLs are considered as well, including for example, implantable miniature telescopes (IMT), magnifiers, or intraocular cameras.

[0060] Additionally, where the implants are described as having a lens or optical element, it should be appreciated that other implants can be supported by the devicesAttorney Docket No.: 058226-509001 WO described herein although they may not incorporate a lens or optical element, including a biological sensor (e.g., pressure, temperature, glucose sensors). Thus, the devices described herein may be referred to interchangeably as an implant support device or a lens support device or a scleral suspension device and the like.

[0061] FIGs. 1A-1B, 2, and 3A-3B show implementations of scleral suspension devices 2100 for supporting an intraocular implant. The device 2100 includes a support structure or posterior platform 2105 upon, against, or within which an intraocular implant is supported and one or more fixation arms 2120. The one or more fixation arms 2120 are preferably trans-scleral fixation arms that are designed to be atraumatically externalized and held in place without any sutures or glue and the like. The fixation arms 2120 are configured to be placed under tension to locate and stabilize the device within the eye, preferably along at least 3 points of fixation. The externalized portion of the device or footplate 2125 (also referred to herein as an anchor or anchoring footplate) at a peripheral end (also referred to herein as a terminal end or a terminal portion) of the fixation arm 2120 sits on a surface of the sclera, for example sub-conjunctivally in sub-Tenon’s space, to anchor the arm 2120 in position. The footplate 2125 of the fixation arm 2120 has a sturdy, but low-profile geometry that is designed to avoid re-entering the eye by being pulled back through the sclera following atraumatic extemalization and prevent centripetal slippage of the posterior platform 2105. The footplates 2125 are also designed to minimally erode the conjunctiva and impart minimal compression against the sclera, even when the fixation arms are placed under tension and the footplates 2125 are pulled inwardly by the arms. The geometry' of the footplates 2125 is designed so the footplate 2125 is easily externalized by the surgeon from inside the eye and through a puncture or incision in the sclera 20 (referred to herein as a sclerotomy) using forceps, trocars, or other surgical tools. The footplate 2125 is designed to stabilize tension on the device throughout its useful life without being pulled back through the sclera 20. The footplates 2125 have a generally low profile and have an edge geometry' (e.g., smooth, rounded, and / or tapering edges) designed to limit conjunctival erosion, scleral erosion, and eyelid irritation through the useful life of the device 2100.

[0062] The footplates 2125 can have variations in thickness, width, and / or height as will be discussed in detail below. In some implementations, such as those shown in FIGs. 1 A-1B, and FIG. 2, the footplate 2125 has a substantially constant thickness between the lower surface of the footplate 2125 (i.e., the surface arranged to contact the sclera) and the upper surface of the footplate 2125 (i.e., the surface arranged to contact the conjunctiva).Attorney Docket No.: 058226-509001 WOThe width across the upper surface of the footplate 2125 can be substantially constant as well. Preferably, the width varies along a length of the footplate 2125. FIG. 1 A shows the footplates 2125 include a wider central portion 2130 between two narrower peripheral portions 2135 that project outward from either side of the central portion 2130. In other implementations, such as the one shown in FIGs. 3A-3B, the footplates 2125 can have variable thickness between the lower surface and the upper surface and also variable widths across the upper surface of the footplate 2125. This results in the central portion 2130 of the footplate forming an enlarged, central dome with greater dome height and diameter between the peripheral portions 2135. FIGs. 4A-4D are various views of a footplate 2125 and FIGs. 4E-4H are various views of another implementation of a footplate 2125. The geometry of the footplate 2125 is designed to preferentially pass through the sclera 20 in a first direction (e.g., inside-out direction) and resist being pulled out in the direction opposite of insertion (<?.g, outside-in direction) to maintain its external position through the lifetime of the device when the arms 2120 of the device are placed under the tension. A geometry for firm fixation that is resistant to re-intemalization may not be ideal for grasping the footplate 2125 with an ophthalmic tool. Each footplate can include a central portion 2130 and at least one peripheral portion(s) 2135 extending outward from the central portion 2130. The peripheral portions 2135 are designed to be more easily grasped using an ophthalmic tool (e.g, 23. 25. or 27 gauge) for manipulation and extemahzation of the footplate 2125 than the central portion 2130. As such, the footplate 2125 can vary in thickness (i.e., height) and / or width (z.e., diameter) across its length, which will be described in detail below. The central portion 2130 is arranged to lie over the wound (i.e., sclerotomy) through which the footplate 2125 was inserted for anchoring purposes. The peripheral portions 2135 are arranged immediately adjacent the wound.

[0063] The central portion 2130 preferably has an increased thickness Tc (i.e., between a lower surface 2132 of the footplate 2125 arranged to contact the sclera to the upper surface 2134 of the footplate 2125 arranged to contact the conjunctiva along a longitudinal axis A of the arm 2120) resulting in a greater dome height compared to the thickness Tp of the peripheral portions 2135 (see FIGs. 6B and 7B). The central portion 2130 of the footplate 2125 can have a maximum thickness Tc that is greater than a corresponding maximum thickness Tp of the peripheral portions 2135. The central portion 2130 of the footplate 2125 may also have a width or diameter De that is greater than a width or diameter Dp of the peripheral portions 2135. The maximum thickness Tc can be between about 1.2 to 5.0 timesAttorney Docket No.: 058226-509001 WO as thick as a maximum thickness Tp of the peripheral portions 2135, preferably about 1.50 - 1 .75 times, as thick as a maximum thickness Tp of the peripheral portions 2135. The central portion 2130 may have a width or diameter De that is between about 1.2 to 5.0 times, preferably about 2.5 - 3.5 times, as wide as the diameter Dp of the peripheral portions 2135.

[0064] The central portion 2130 can provide the primary anchoring function of the footplate 2125 whereas the peripheral portions 2135 can provide the primary grasping function of the footplate 2125. The entire footplate 2125 (central and peripheral portions) is capable of being inserted from within the eye to an external location through an opening in the sclera (e.g., a sclerotomy) or cornea. Reference to the sclera or a sclerotomy is not intended to be limiting and other fixation points are considered herein. As an example, a sclerotomy involves cutting through the sclera either as an incision or a puncture. The size of the wound can vary depending on what size instrument is to be inserted through it. The instrument size can be as large as about 23 gauge down to about 30 gauge. The wound can be sized to ensure self-sealing without any suturing. As an example, the conjunctiva can be dissected away, and a scleral incision formed with a #11 scalpel blade inserted so the sharp tip of the blade punches through the sclera into the posterior chamber or the vitreous. The shape of the wound can vary depending on the method of penetration. The length of the wound can be about 0.25 mm to about 1.5 mm. The wound can be elongated, having a length that is greater than its width. It should be appreciated that the w ound may be formed during extemalization such that the distal end region of the device externalizing the footplate may also create the penetration through the tissue.

[0065] Whatever the method of penetration selected, the diameter De of the central portion 2130 can be selected to ensure the footprint of at least the central portion 2130 is sized to fully cover and surround edges of the wound through w hich the footplate 2125 is externalized. The increased thickness or dome height of the central portion 2130 can add bulk to the area over the wound and thereby reduce the likelihood that tension on the fixation arm 2120 pulls the footplate 2125 back through the wound. The larger diameter and greater bulk overall (z.e., dome volume) allow-s the central portion 2130 to cover the sclerotomy and resist re-intemalization or pull-through to perform the anchoring function of the footplate 2125. The geometry of the bulkier area of the central portion 2130 is designed to resist deformation when under the tensile forces associated with normal use of the device. In some implementations, the bulkier central portion 2130 can collapse inward during extemalization to fold over onto the terminal end 2102 of the arm 2120 to w hich it is attached. Once theAttorney Docket No.: 058226-509001 WO arms 2120 are placed under tension, the bulkier central portion 2130 is incapable of being folded over away from the terminal end 2102 of the arm 2120 onto itself. This favors extemalization and disfavors internalization of the previously externalized footplate 2125 and withdrawal of the footplate 2125 back through the wound. Thus, the central portion 2130 can be externalized through the wound in the first direction (outward from the eye) despite its greater bulk, but is prevented from being pulled through the wound in the second opposite direction (inward towards the eye) because of its greater bulk. The bulk of the central portion 2130, however, can be difficult for a surgeon to reliably grasp, such as with the microforceps used in eye surgeries.

[0066] The size and shape of the peripheral portions 2135 of the footplate 2125 allow a user to grasp the footplate 2125 more easily within the microforceps compared to the central portion 2130, which is designed to prevent reintemalization, when approached from any angle. The upper limit of the size of the central portion 2130 (also referred to herein as a central dome or button) for use with the smallest gauge tool (i.e., 27 G) is about 1 mm diameter De and about 500 pm dome height Tc. The lower limit of the central portion 2130 is based not so much on tool size, but rather on what sufficiently anchors the device in the eye. As an example, the central portion 2130 diameter De can be about 0.800 mm - 1.00 mm, preferably no lower than about 0.825 mm, no low er than about 0.850 mm, no lower than about 0.900 mm, no lower than about 0.950 mm. The central portion 2130 height Tc can be about 0.210 mm - 0.500 mm, or about 0.300 mm - 0.500 mm, preferably about 0.350 mm - 0.450 mm. The central dome volume is a better predictor of footplate 2125 anchoring success than specific heights and / or diameters of the central portion 2130. For example, a central portion 2130 having a greater height Tc and a smaller dome diameter De may be a less effective anchor than a central portion 2130 having a lower dome height Tc and a larger dome diameter De. The dome volume of the central portion 2130 can be about 0. 150 mm3to about 0.350 mm3, preferably about 0.200 mnr’ to about 0.325 mm3, or most preferably about 0.300 mm3. In some implementations, the dome diameter De is about 0.80 mm - 1.00 mm, the arm diameter Da is about 0.30 mm - 0.40 mm, the central thickness Tc is about 0.300 mm - 0.325 mm, and the dome volume is about 0.200 mm3- 0.225 mm3. Table 1 and Table 2 below provide other example devices and various dimensions considered herein for the arm and footplate geometries. The low er surface of the footplates of the devices described herein may also have any of a variety of angled and / or curved portions along one or more axes of the footplates, as described in the detail below.Attorney Docket No.: 058226-509001 WO

[0067] FIGs. 5A, 6A, and 7A are end views of three embodiments of devices 2100 showing the upper surface 2134 of a footplate 2125 with different diameters De for the central portion 2130 of the footplate 2125 providing different dome volumes. FIGs. 5A, 6A, and 7A illustrate footplates 2125 having a central portion 2130 with a diameter De across its upper surface 2134 that is larger than a diameter Dp across the upper surface 2134 of the peripheral portions 2135. The diameter De in FIG. 7A embodiment is larger than the diameter De of the FIG. 6A embodiment and both are larger than the diameter De in FIG. 5A. FIGs. 5B, 6B, and 7B are side views of fixation arms of the three embodiments of devices 2100 showing the difference in thicknesses Tc, Tp between the lower surface 2132 and the upper surface 2134 along the length L of the footplates 2125. FIG. 5B shows the footplate 2125 has a substantially uniform thickness Tp between its lower surface 2132 and its upper surface 2134 between the peripheral portion 2135 and the central portion 2130. FIG. 6B shows the footplate 2125 has greater maximum thickness Tc within the central portion 2130 compared to the maximum thickness Tp of the peripheral portions 2135. FIG. 7B shows the maximum thickness Tc along the central portion 2130 of the footplate 2125 is thicker than the maximum thickness Tp of the peripheral portions 2135, but not as thick as the thickness Tc of the embodiment in FIG. 6B. Thus, the dome height of the embodiment in FIGs. 7A-7B is smaller than the dome height of the embodiment in FIGs. 6A-6B, but the overall diameter De and volume of the dome is greater.

[0068] The length L of a single footplate 2125 (z.e., length spanning from an end of a first peripheral portion 2135 to an opposite end of a second peripheral portion 2135) can vary. The total length L can be about 1.5 mm to about 4 mm, preferably about 2 mm. The length of each peripheral portion 2135 (i.e., from the edge of the central portion 2130 to the end of the portion 2135) can be about 0. 1 mm - 1.0 mm. Forceps used in manipulating the footplates 2125 are designed to open a pre-determined amount (e.g.. about 0.5 mm) so the peripheral portions 2135 are preferably less than this gap from all sides so that the footplate 2125 can be grasped by forceps from any approach.

[0069] The diameter De across the central portion 2130 can vary as well. Preferably, the diameter De is sufficient to cover the sclerotomy. The diameter De can be about 0.50 mm - 1.50 mm, about 0.80 mm - 1.20 mm, about 0.90 mm - 1.10 mm, or about 0.95 mm - 1.0 mm. The diameter Dp across each peripheral portion 2135 can be about 0. 15 mm - 0.50 mm, preferably about 0.30 - 0.40 mm. The maximum thickness Tc of the central portion 2130 (i.e., between lower surface 2132 and the upper surface 2134) can be about 0.20Attorney Docket No.: 058226-509001 WO mm - 0.50 mm, preferably about 0.30 mm - 0.35 mm. The maximum thickness Tp of each peripheral portion 2135 (i.e., between lower surface 2132 and the upper surface 2134) can be about 0. 10 mm - 0.25 mm. FIGs. 5A-5B, 6A-6B, and 7A-7B also illustrate differences in fixation arm diameter Da (i.e., perpendicular to the longitudinal axis A of the fixation arm 2120). The diameter Da of the fixation arms can be about 0.20 mm to about 0.50 mm, preferably about 0.30 mm - 0.40 mm. The diameter Da in the embodiment of FIG. 5B and FIG. 6B is about 0.40 mm whereas the diameter Da in the embodiment of FIG. 7B is about 0.30 mm.

[0070] The lower surface 2132 of the central portion 2130 that is configured to contact the sclera upon implantation can vary in its surface geometry. In some implementations, the lower surface 2132 is substantially planar and arranged substantially perpendicular to the fixation arm. Preferably, the lower surface 2132 is arranged nonperpendicular to the fixation arm and is angled and / or curved proximally toward the base of the fixation arm. The overall shape of the lower surface 2132 need not be uniform or symmetrical. The shape can have one or more flat surfaces, such as flat central region surrounded by a curved or sloping surface leading outward to the outer perimeter of the footplate 2125 forming an inverted cup- or bowl-shape to the lower surface 2132. The lower surface 2132 of the central portion 2130 can be flat along one axis (e.g., across the diameter De along the short axis of the width) and angled or curved along another axis (e.g., across the diameter De along the long axis of length L). In a preferred implementation, the lower surface 2132 of the central portion 2130 curves away from a central axis A of the footplate circumferentially where the curvature is designed not to match a curvature of the scleral surface underneath it. The central axis A of the footplate 2125 is the axis that extends through a geometric center of an upper surface 2134 of the central portion 2130. The central axis A can be coaxial with a long axis of the terminal end of the fixation arm to which the footplate 2125 is attached. The central axis A is illustrated in FIGs. 4A-4H, 8A-8B, 8D, 9A-9B. The long axis LA of the footplate 2125 is the axis that extends from a first end of the first peripheral portion 2135 towards a second end of the second peripheral portion 2135 on an opposite side of the central portion 2130 from the first peripheral portion 2135. The short axis SA of the footplate 2125 can be substantially perpendicular to the long axis LA of the footplate. The short axis SA is illustrated in FIGs. 4B, 4F, 8D, and 9B. The long axis LA is illustrated in FIGs. 4B, 4F, 8A, 8B, and 9A.Attorney Docket No.: 058226-509001 WO

[0071] The geometry of the footplates 2125 described herein provide better distribution of pressure against the scleral surface (e.g., increases distribution of pressure within the pressure annulus), lower the maximum contact pressure applied, and relocate the lower, better distributed pressure to be further away from the margins of the sclerotomy wound. The central portion 2130 of the footplates 2125 having an enlarged, central dome provides a better pressure distribution on the sclera eliminating high pressure points at high tension. Upon application of a tensile force to the fixation arms, the pressure against the sclera applied by the footplate 2125 without the enlarged central dome is less well distributed. A high-pressure point (i.e., maximum contact pressure ring) is created that closely encircles the margins of the sclerotomy. Increasing the central dome volume improves the distribution of the pressure applied against the sclera by the footplate and reduces the high-pressure ring (see, e.g., FIGs. 12B-1 to 12B-9 described below). Angulation or curvature of the lower surface 2132 of the central dome 2130 so the lower surface 2132, around 360-degree circumference of the central portion, has a radius of curvature that is steeper than a radius of curvature of the scleral surface under the footplate 2125 moves the pressure further away from the margins of the sclerotomy. The first point of contact between the sclera and the lower surface 2132 of an angled central portion 2130 that creates a focal point or focal ring of maximum contact pressure occurs at the outer perimeter of the central portion 2130 a distance away from the central axis A of the central portion 2130 and thus, the first focal point or focal ring of maximum contact pressure between the lower surface 2132 of the central portion 2130 and the external scleral surface is spaced a distance away from margins of the sclerotomy. The distance can be at least about 0.05 mm from the margin, preferably greater than 0.05 mm up to about 0.50 mm or a distance from the margin to an outermost edge of the central portion 2130. Angulation of the lower surface 2132 of the central dome 2130 also reduces the maximum contact pressure against the sclera and more evenly distributes the pressure across a greater area. Thus, even at very high pull-through forces, the impacts of the footplate 2125 on the sclera in these devices is minimized by the presence of the angled lower surface of the footplate. This increases the time the footplates 2125 will remain externalized, which means the device remains anchored and is implanted longer without replacement and / or revision surgery.

[0072] The geometry' of the footplates described herein are designed to create a more desirable pressure annulus formed against the external scleral surface upon tensioning of the plurality of fixation arms. The geometry of the footplates described herein can provideAttorney Docket No.: 058226-509001 WO an improved distribution of pressure within the pressure annulus. The pressure annulus can become less focused and more diffuse over a greater area. The pressure annulus can increase in area and / or width (z.e., difference between the inner diameter and outer diameter of the pressure annulus. The pressure annulus can move outward to be further away from the sclerotomy margins. Moving the pressure annulus further outward can increase a distance of the first point of contact between the lower surface of the central portion of the footplate and the sclerotomy margins that creates a focal point or focal ring of maximum contact pressure. The maximum contact pressure within the pressure annulus can be decreased. The footplate geometry can relocate the focal ring further outward to be further away from margins of the sclerotomy. The peak pressure within the pressure annulus can be about 0.05 Mpato about 0.25 Mpa. The location of the first peak pressure can be about 0.05 mm to about 0.50 mm away from the margin of the sclerotomy. The total contact area radius can be about 0.20 mm to about 0.5 mm. More than a single annulus of high pressure can be created such that a first peak pressure and a second lower annulus of pressure is present. The radial difference or separation between the first peak pressure annulus and the second lower pressure annulus can be about 0. 10 mm to about 0.30 mm.

[0073] The range of each of these parameters describing the pressure annulus can vary depending on the geometry of the footplate (e.g., central thickness of the central portion, dome diameter, dome volume, angulation of lower surface, etc ), fixation arm design, as well as the tension applied to the fixation arms. For example, a central portion having a dome diameter of about 1 mm, a central thickness of about 325 pm, and a dome volume of about 0.210 mm3- 0.220 mm3, the maximum contact pressure provided by the footplate upon application of 4 gf tension on the fixation arm can be no greater than about 0.20 MPa, preferably no greater than about 0. 15 MPa and the distance to the focal ring of pressure (if present) within the contact annulus provided by the footplate can be at least about 0.05 mm away from the margins of the sclerotomy. The contact pressure provided by the footplate can be no greater than about 0.10 MPa at a distance of about 0. 10 mm from the margins of the sclerotomy, preferably no greater than about 0.075 MPa. Where the tension applied on the fixation arm is just 2 gf, the maximum contact pressure provided by the footplate can be less than about 0. 10 MPa, preferably no greater than about 0.05 MPa and the distance to the focal ring of pressure (if present) within the contact annulus provided by the footplate can be at least about 0.05 mm away from the margins of the sclerotomy, preferably at least about 0. 10 mm away from the margins of the sclerotomy. The distance between the margins of theAttorney Docket No.: 058226-509001 WO sclerotomy and the focal ring of maximum contact pressure, depending on the tension applied on the fixation arm and the specific geometry of the footplate, can be equal to or greater than about 0.05 mm (e.g., about 0.1 mm - 0.25 mm) up to about 0.50 mm or a distance from the margin to an outermost edge of the central portion 2130.

[0074] FIG. 8A is a cross-section schematic showing a footplate 2125 externalized through the sclera 20. A portion of the fixation arm 2120 is sub-scleral, a portion of the fixation arm is trans-scleral. and the footplate 2125 is supra-scleral. FIG. 8B is a schematic showing the externalized footplate 2125 positioned over the sclera 20. The footplate 2125 has a central portion 2130 with a fully planar lower surface 2132 arranged substantially perpendicular to the fixation arm 2120 forming an angle 0 relative to a central axis A extending through the upper surface 2134 of the central portion 2130 into the fixation arm 2120 to which the central portion 2130 is attached, the angle 0 being about 90 degrees. The lower surface 2132 can be substantially flat such that the perpendicular angle is along an entirety7of the central portion 2130 and around a full circumference of the central portion 2130. The planar lower surface 2132 of the central portion 2130 of the footplate 2125 contacts the sclera 20 surrounding the wound W forming a contact annulus CA having an inner perimeter and an outer perimeter (see FIG. 8C). The contact annulus CA need not be perfectly annular in shape as illustrated in the schematic. The wound W may have any of a variety of shapes, particularly when the fixation arm 2120 extends through it. In turn, the shape of the contact annulus CA may vary, including elongate shapes such as oval or lentoid or fusiform shapes. The flat low er surface of the central portion 2130 of the footplate 2125 of FIGs. 8A-8C contacts the sclera 20 along its entire underside from the inner perimeter of the contact annulus CA abutting the wound margins of the sclerotomy W to the outer perimeter of the central portion 2130.

[0075] The compressive force applied against the contact annulus CA on the sclera 20 can be described as a pressure annulus herein. The pressure annulus need not be perfectly annular in shape either and is merely describing the region surrounding the wound W that a pressure is being applied against the tissue (i.e., the external scleral surface) by the lower surface of the footplate 2125 upon tensioning of the plurality of fixation arms. The inner perimeter of the contact annulus CA for a central portion 2130 of a footplate 2125 may substantially correspond to the wound edges of the sclerotomy W and the outer perimeter of the contact annulus CA may substantially correspond to the outer perimeter of the central portion 2130 (excluding any peripheral portions). As the fixation arm 2120 is tensioned byAttorney Docket No.: 058226-509001 WO applying an inwardly-directed force on the arm 2120. the footplate 2125 applies a compressive force against the sclera 20 along at least a portion of the contact annulus CA. As will be described in more detail below, changing at least one of the volume of the central dome (e.g., dome height Tc and / or dome diameter De of the central portion 2130), the angle 0 between the lower surface 2132 of the central portion 2130 of the footplate 2125 and the central axis A extending through the central portion 2130, and / or the fixation arm diameter Da the size, shape, and location of the pressure annulus relative to the wound W as well as the overall compressive force applied by the footplate 2125 to the sclera 20 can be impacted. For example, a central portion 2130 that is planar as in FIG. 8A or that is curved to match the radius of curvature of the scleral surface (e.g.. about 12-13 degrees) can form a pressure annulus having a shape and size that substantially corresponds to the shape and size of the contact annulus CA for that central portion 2130. Decreasing the angle 0 to be less than 90 degrees such that the lower surface 2132 of the central portion 2130 is non-perpendicular to the central axis A extending through the central dome (e.g, about -6 degree taper applied circumferentially) changes the way in which the central portion 2130 of the footplate 2125 interacts with the scleral tissue surrounding the wound W. Where the radius of curvature of the lower surface is greater than the radius of curvature of the scleral surface, the outer perimeter region of the central portion 2130 will contact the sclera before an inner perimeter region of the central portion 2130 contacts the sclera. In turn, the size and shape of the pressure annulus is no longer substantially the same as the size and shape of the contact annulus CA even at full tension. FIG. 8D is a schematic illustrating a footplate 2125 having a central portion 2130 with an angled lower surface 2132. The angled lower surface 2132 of the footplate 2125 is steeper than the radius of curvature of the scleral surface 20. FIG. 8E is a schematic illustrating the contact annulus CA of the externalized footplate 2125 of FIG. 8D with the angled lower surface 2132. The contact annulus CA has a different size and shape compared to the size and shape of the contact annulus CA of FIG. 8C. The inner perimeter of the contact annulus CA has increased in diameter, so it moves the contact annulus CA further away from the margins of the wound W. This causes the first point of contact between the lower surface of the footplate and the external scleral surface that creates a focal point or focal ring of maximum contact pressure to be further away from margins of the sclerotomy wound W. The force being applied against the sclera 20 by the footplate 2125 upon applying tension on the fixation arm 2120 may also cause the pressure annulus to move outward away from the edges of the wound W, even if the lower surface 2132 eventually flattens to conformAttorney Docket No.: 058226-509001 WO to the eye surface curvature. A flattened lower surface 2132 would cause the contact annulus CA to enlarge inwardly toward the wound W so that the underside of the central portion 2130 is fully in contact with the scleral surface surrounding the wound W. However, the pressure annulus over that contact annulus CA may not. For example, the pressure distribution can move away from the margins of the sclerotomy because most of the force applied by the footplate 2125 is applied at the outer perimeter of the central portion 2130. This decreases damage to the scleral tissue. The maximum contact pressure within the pressure annulus decreases and the location of the maximum contact pressure changes (i.e., moves further outward away from the edges of the wound). The area of the pressure annulus may also increase thereby redistributing the overall compressive force being applied by the footplate 2125 to the sclera. The area of the pressure annulus may be larger, but the maximum contact pressure applied by the footplate 2125 to the sclera upon applying tension on the fixation arm 2120 may be reduced.

[0076] FIG. 9A is a cross-sectional, transparent view of the footplate 2125 of FIGs. 4A-4D taken along line A-A and overlays a cross-sectional solid view of the footplate 2125 of FIGs. 4E-4H taken along line E-E. FIG. 9B is a cross-sectional transparent view of the footplate 2125 of FIGs. 4A-4D taken along line B-B and overlays a cross-sectional solid view of the footplate 2125 of FIG. 4E-4H taken along line F-F. The lower surface 2132a of the central portion 2130a of the footplate of FIGs. 4A-4D along the long axis LA of the footplate (i.e., when viewed from the side along its length L from a first end of the first peripheral portion 2135a to an opposite end of the second peripheral portion 2135a) follow s a curve (see arrows C in FIG. 4D). The radius of curvature of the curved lower surface 2132a is about 12 mm radius arc to substantially match the radius of curvature of the scleral surface of an eye. The lower surface 2132a of the central portion 2130a of the footplate of FIGs. 4A-4D along the short axis SA of the footplate (i.e.. when viewed from the side across or perpendicular to its length L) is substantially flat (arrow F in FIG. 4D). The angle 0 between the lower surface 2132a and the central axis A extending through the central portion 2130 for the embodiment of FIGs. 4A-4D is about 90 degrees or perpendicular (see FIG. 4D and also FIG. 9B).

[0077] Still with respect to FIGs. 9A and 9B, the lower surface 2132e of the central portion 2130e of the footplate of FIGs. 4E-4H along the long axis LA of the footplate does not follow^ the curve of the eye. Instead, the lower surface 2132e is arranged at angles relative to a central axis A of the central portion 2130e (see arrow' A in FIG. 4H). The lowerAttorney Docket No.: 058226-509001 WO surface 2132e of the central portion 2130e of the footplate along the short axis SA of the footplate (arrow F in FIG. 4H) can be flat or curved and arranged at an angle 0 such that the lower surface 2132e does not follow a curvature of the scleral surface (see FIG. 4H and also FIG. 9B). A taper can be applied circumferentially around the entire central portion 2130e that is preferably greater than a curvature of the eye surface. The angle 0 between the lower surface 2132e to the central axis A extending through the upper surface 2134 of the central portion 2130 into the fixation arm 2120 to which the footplate is attached for the embodiment of FIGs. 4E-4H can be less than perpendicular by about 6 degrees, or an angle 0 between the lower surface 2132e and the central axis A extending through the central portion 2130 that is about 84 degrees. The angle 0 around the entire central portion 2130e can be less than perpendicular by about 2 - 20 degrees (about 70-88 degrees), or about 4 - 10 degrees (about 80-84 degrees), preferably 5 - 7 degrees (about 83-85 degrees).

[0078] Thus, the embodiment of the footplate 2125 shown in FIGs. 4A-4D has a lower surface 2132 that is curved when viewed from the long axis of the footplate, but is substantially flat when view from the short axis of the footplate. If the radius of curvature of the lower surface 2132 is similar to the radius of curvature of the scleral surface (e.g., about 12 mm), the pressure annulus of the footplate 2125 has a size and shape that is substantially similar to the contact annulus of the footplate 2125. Preferably, the radius of curvature of the lower surface 2132 does not follow the curvature of the scleral surface and is either at a greater radius of curvature (i.e., is steeper) and / or is angled relative to the central axis A of the central domed portion 2130 so that the pressure annulus of the footplate 2125 has a size and shape so that it extends along only at least a portion of the contact annulus and is located further away from the margins of the wound. As such, the first point of contact between the lower surface 2132 of the central portion 2130 of the footplate 2125 and the external scleral surface that creates a focal point or focal ring of maximum contact pressure is a greater distance away from margins of the sclerotomy. For example, the embodiment of the footplate 2125 shown in FIGs. 4E-4H has a lower surface 2132 that is angled relative to the central portion 2130 when view from both the long axis and the short axis. The angle is greater than the curvature of the eye surface, which moves the focal point of compression within the pressure annulus away from the edges of the sclerotomy and more evenly distributes the pressure within the pressure annulus. The footplates having a lower surface 2132 arranged at more acute angles 0 relative to the central axis of the footplate (i.e.. less than perpendicular) or along a curve that is steeper than a radius of curvature of the scleralAttorney Docket No.: 058226-509001 WO surface moves the focal point of compression away from the edges of the sclerotomy. For example, the distance D from the edge of the wound W to the focal point of contact pressure 2140 for the footplate, the focal point of contact pressure may be in the shape of a ring (i.e., a focal ring of maximum contact pressure), having a radius of curvature that is about 12 mm along the long axis and an angle 0 of 90 degrees along the short axis (i.e., Gen 4 Rev B) was about 0.05 mm upon application of 4.0 gf. The distance D from the edge of the wound W to the focal point of contact pressure 2140 (i.e., focal ring of maximum contact pressure) for the footplate having an angle 0 of 84 degrees around entire 360-degree circumference (i.e., Gen 4 Rev C) was about 0.234 mm (see FIG. 12C-2 and 12C-4). With footplate angles that are closer to 90 degrees and / or that follow a curvature of the scleral surface, the contact pressure is focused within a smaller diameter of the central portion 2130 compared to footplate angles that are more acute or that do not follow the curvature of the scleral surface, which focused the contact pressure to a distance of about 0.05 mm from the edge of the wound.

[0079] Increasing the dome height or central thickness Tc of the central portion 2130 increases the dome volume of the central portion 2130. For a footplate that is curved to match a radius of curvature of the scleral surface along the long axis and substantially planar along the short axis to have an angle 0 of about 90 degrees, a central maximum thickness Tc that is 0.30 mm and a central diameter De that is 1.00 mm renders a volume of 0.211 mm3. For the same footplate, increasing the thickness Tc to 0.325 mm renders a volume of the central portion 2130 that is 0.211 mm3and increasing the thickness Tc to 0.350 mm renders a volume of 0.223 mm3. Decreasing the angle 0 can increase the dome volume by up to about 5%. For a footplate that has an angle 0 that is non-perpendicular (e.g., about 84 degrees or about 70 - 88 degrees) and steeper than a radius of curvature of the scleral surface around entire 360 degrees of the central portion, a central maximum thickness Tc of 0.30 mm and a central diameter De of 1.00 mm renders a volume of the central portion 2130 that is 0.208 mm3. For the same footplate, increasing the thickness Tc to 0.325 mm renders a volume of the central portion 2130 that is 0.220 mm3.

[0080] The central dome volume and angulation of the lower surface of the footplate together improve the distribution of pressure against the sclera. The dome volume and angulation of the lower surface 2132 redistribute pressure applied by the footplate 2125 against the external scleral surface. Increasing the volume of the central dome raises concerns of externalizing the footplate in smaller diameter tools (e g., 27 gauge). Central dome volume that is at least about 0.06 mm3and no greater than about 0.31 mm3ensures theAttorney Docket No.: 058226-509001 WO footplate can be externalized and stays externalized for the life of the device. The angulation of the lower surface purposefully designed not to match the curvature of the scleral surface ensures the outer perimeter region of the central portion 2130 contacts a scleral surface a distance away from the wound margins before the inner perimeter region of the central portion 2130 contacts a scleral surface nearest the wound margins. Even though the flexible material of the footplate may conform to the scleral curvature over time upon application of tension on the fixation arms, the distribution of pressure over the contact annulus is increased and the location of that better distributed pressure has a greater inner diameter to be located further away from the wound margins.

[0081] The footplates 2125 described herein can be incorporated into any of a variety of devices, including any of the devices described herein. Details of the devices described herein are not intended to be limiting to the footplate features, including the details of the geometry described above. The devices are described herein to provide additional context regarding the forces applied to the footplates 2125 during use. Turning once again to FIGs. 1A-1B, 2, and FIGs. 3A-3B, the device 2100 includes a posterior platform 2105 and one or more fixation arms 2120, each arm having a footplate 2125 at a peripheral end of the arm for sutureless, trans-scleral fixation of the device 2100 within the eye.

[0082] The posterior platform 2105 can serve as a support for an IOL or other ophthalmic device for optimal implantation and as a guard against the ophthalmic device falling into the posterior segment during implantation. The posterior platform 2105 can take the place of a native lenticular capsular bag, particularly where the anterior aspect and associated zonules are incompetent making sulcus placement of an IOL unsafe or impossible. Placement of the posterior platform 2105 in a patient without a competent capsular bag can create an anterior capsule device. The fixation arms 2120 can provide artificial zonular fixation stabilizing the support structure as a stable platform for placement of an intraocular lens or lens implant within the artificially constructed sulcus. FIG. IB shows the cornea 5. iris 10, ciliary body 15, sclera 20, and the pupil 30 defined centrally through the iris 10.

[0083] The central aperture 2115 prevents the device 2100 from interfering with the patient’s vision and is adapted to permit passage of light through the aperture 2115 as well as the optical element, such as IOL positioned on the device 2100 or a miniature telescope positioned on, within, or through the aperture 2115. The size of the central aperture 2115 allows light to pass through the device without any optical disturbance. The light may pass through the device towards the retina and is affected only by the optics of the opticalAttorney Docket No.: 058226-509001 WO element. The one or more fixation arms 2120 can locate and stabilize the device 2100 within the eye. The posterior platform 2105 can include an outer perimeter and an inner perimeter wall 2109 and the central aperture 2115 can be bound by the inner perimeter wall 2109. The posterior platform 2105 can be generally ring-shaped although the outer perimeter of the posterior platform 2105 need not be circular as will be discussed in more detail below. The outer perimeter of the posterior platform 2105 can be substantially non-circular where the inner perimeter wall 2109 is substantially circular.

[0084] In some implementations, the posterior platform 2105 can be substantially flat or planar. The posterior platform 2105 can have an anterior-facing surface directed towards a front of the eye when the posterior platform 2105 is in use and a posteriorfacing surface towards a back of the eye when the posterior platform 2105 is in use. The planar posterior platform 2105 can act as a support against which the optical element can be positioned. The planar anterior and posterior surfaces need not include any projections, channels, or capturing components to hold the optical element relative to it. For example, the posterior platform 2105 can create an artificial anterior segment of the capsular bag for the optical element to be positioned against, but need not hold the optical element within an interior surface. Thus, the optical element can remain fully external to the posterior platform 2105 during use and no projections, overhangs, or other surfaces positioned relative to the optical element aside from the substantially planar surfaces of the posterior platform 2105. Thus, each of the anterior-facing and posterior-facing surfaces can be substantially smooth planar surfaces that are free of any projections or overhangs above the surfaces. Each of the anterior-facing and posterior-facing surfaces can also be free of any indentations, grooves, divots, or openings other than the central aperture 2115 extending through it. The substantially flat posterior platform 2105 can taper towards the central aperture 2115. The tapered edge or inner perimeter wall 2109 defining the aperture 2115 has an anterior- to- posterior thickness that is less than an anterior-to-posterior thickness of the support structure away from the aperture 2115.

[0085] In other implementations, the posterior platform 2105 can incorporate one or more projections extending away from at least one of the anterior-facing surface and the posterior-facing surface. In still other implementations, the posterior platform 2105 can optionally or additionally include a recess in at least one of the anterior-facing or posteriorfacing surfaces that is sized and shaped to receive the optical element. In still other implementations, the posterior platform 2105 can be thicker near a central region and define aAttorney Docket No.: 058226-509001 WO central aperture 2115 that has an extended anterior-to-posterior depth to receive at least a portion of an implant, such as a miniature telescope or other optical element as will be described in more detail below. The platform thickness between an anterior surface and a posterior surface of the platform 2105 can be variable such that the greatest thickness of the platform 2105 can be the central part of the platform 2105 through which the central aperture 2115 extends (i.e., inner perimeter w all 2109). The part of the platform 2105 that is the thinnest can be a peripheral region near w here the fixation arms proj ect outw ard away from the platform 2105 (i.e., outer perimeter). The thickness of the platform 2105 tapers from the thicker, central aperture to the thinner, outer perimeter. The centrally thicker platform 2105 prevents or reduces the risk of tilt and decentration.

[0086] The recess can form a lip surrounding the central aperture 2115 that is sized to engage with and support a perimeter of the optic against the lip. The recess in the central 6.0-7.0 mm part of the posterior platform 2105 can limit the translational movement of the optic. The recess can additionally incorporate a concave, dished out section to increase the interfacial surface area of the optical element with the posterior platform 2105. The recess can incorporate one or more features that additionally prevent rotational motion around the visual axis or the central axis C A of the device.

[0087] Whether the posterior platform 2105 is recessed or not and / or incorporates one or more projections from its surface or not, the anterior-to-posterior thickness of the posterior platform 2105 is minimized to avoid impacting the iris 10. In some implementations, the posterior platform 2105 has an anterior-to-posterior thickness that is uniformly thin from the central aperture 2115 to the outer perimeter. In other implementations, the posterior platform 2105 has an anterior-to-posterior thickness that is non-uniform and is thicker near the central aperture and thinner near the outer perimeter. This non-uniform thickness where the posterior platform 2105 tapers moving outw ard away from the central aperture 2115 is particularly helpful in preventing tilt of an optic mated within the central aperture 2115.

[0088] The central aperture 2115 can extend through the full thickness of the posterior platform 2105 from the anterior-facing surface through to the posterior-facing surface such that the posterior platform 2105 additionally includes an inner perimeter w all 2109 having an inner perimeter surface defining the central aperture 2115 and an outer perimeter having an outer perimeter surface defining the overall shape of the posterior platform 2105. This can provide a substantially annular shape to the posterior platform 2105.Attorney Docket No.: 058226-509001 WOHowever, the annular posterior platform 2105 need not be circular on both its inner and outer perimeter surfaces. The inner perimeter surface can have a circumference and form a uniform, substantially circular shape whereas the outer perimeter surface can form a substantially non-circular shape. The inner perimeter surface need not be perfectly circular and can also be somewhat oval or elongate while still different from the substantially noncircular shape of the outer perimeter surface. As will be discussed in more detail below, the non-circular shape of the outer perimeter surface comprises a plurality of shorter sides or lobes 2107 projecting outward from a plurality of elongate sides 2108 (see FIGs. 3A-3B). The plurality of lobes 2107 can project radially away from the central aperture 2115. The plurality of elongate sides 2108 can be substantially flat or concave as described elsewhere herein.

[0089] The thickness of the posterior platform 2105 between the anterior-facing surface and the posterior-facing surface can be between about 0.05 mm and 1.5 mm, or between about 0.15 mm and 1.0 mm, or between about 0.1 mm and 0.5 mm, or between about 0.2 mm and 0.4 mm. The thickness of the posterior platform 2105 can be thinner than 0. 15 mm and still provide sufficient support for an optical element, for example, due to the fixation arms 2120 being under tension. In some implementations, the thickness of the posterior platform 2105 at the central aperture 2115 can be greater than 0.2 mm up to about 2 mm and the thickness of the posterior platform 2105 at the outer perimeter can be less than 0.2 mm down to about 0. 15 mm. The inner perimeter surface or inner perimeter wall 2109 defining the central aperture 2115 can be smooth and free of any concavity, groove, channel, or other surface feature. In some implementations, the inner perimeter surface or inner perimeter wall 2109 is convex and projects towards a central axis CA of the device and the outer perimeter surface or outer perimeter is also convex and projects away from the central axis CA of the device. The convex inner and outer perimeter surfaces can create a cross- sectional shape to the posterior platform 2105 when taken across a center of the central aperture 2115 that forms a pair of rounded rods. In some implementations, the anterior-facing surface and the posterior-facing surface each taper towards the central aperture 2115 such that the inner perimeter surface of the inner perimeter wall 2109 is shaped as a single narrow ridge or point projecting towards the central axis CA of the device.

[0090] The central aperture 2115 can also be the only aperture extending through the support 2105 such that the support 2105 has only a single aperture extending through its full thickness. The inner diameter of the aperture 2115 is designed to be generallyAttorney Docket No.: 058226-509001 WO universal for a wide range of optical elements, such as different IOL types. The aperture 21 15 is sized so the support 2105 avoids overlapping substantially with the optic of the IOL. Conventional IOLS typically have optics with an outer diameter of 6 mm although this size can vary depending on the IOL. A device having a central aperture 2115 inner diameter that is less than 5.0 mm down to about 4.0 mm can be used with some IOLs. A device having a central aperture 2115 inner diameter that is between 5.0 mm to about 6.0 mm can be used with most IOLs such that the device is nearly universal for use with any conventional haptic- stabilized IOL. The minimum inner diameter of the aperture 2115 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 about 10 mm and any range in between.

[0091] The posterior platform 2105 can provide several functions. The posterior platform 2105 can have a surface (anterior-facing surface or posterior-facing surface) forming a stable platform against which an IOL can be placed during use. The posterior platform 2105 can take the place of a capsular bag, particularly one where the postenor and / or anterior aspects of the bag are ruptured or otherwise incompetent. Its geometric and mechanical function not only supports the IOL when in use, it can also serve to assist in the centration of an IOL in the case of an asymmetric eye or asymmetric surgical procedure. The posterior platform 2105 can be coupled to the one or more fixation arms 2120. Where the posterior platform 2105 provides artificial anterior capsule support for the IOL, the fixation arms 2120 provide artificial zonular apparatus. Thus, the device provides a stable platform structure fixated to the eye recapitulating the native anterior capsule and zonular apparatus that would normally allow for placement of an IOL. The posterior platform 2105 geometry and mechanical properties can be designed to allow the fixation arms 2120 to function as intended and withstand any torsional or tensile forces that may be imparted by the fixation arms 2120.

[0092] The ciliary body 15 has a substantially circular or elliptical shape, with the vertical axis being 0.5 mm longer than the horizontal axis on average. The posterior platform 2105 can interface with a patient’s ciliary' body to provide centration of the device 2100 within the eye. A substantially round or elliptical posterior platform 2105 can provide centration with the similarly round or elliptical ciliary body. However, matching of the shapes and 360 degree contact between the posterior platform 2105 and the ciliary body can lead to inflammation or damage, which could negatively impact aqueous production. In aAttorney Docket No.: 058226-509001 WO preferred implementation, the posterior platform 2105 has a continuous inner circumference forming a uniform, substantially circular (or near circular) shaped inner perimeter wall 2109 defining the central aperture 2115 and an outer perimeter surface forming a substantially noncircular shaped outer perimeter providing the support structure 2105 with a substantially noncircular geometry’. The non-circular outer geometry of the posterior platform 2105 can provide centration of the device 2100 without 360 degree contact with the ciliary body along the substantially non-circular shaped outer perimeter surface. The shape of the posterior platform 2105 can provide sufficient contact between the posterior platform 2105 and the ciliary body to aid in centration and support of an IOL without causing inflammation and damage. In some implementations, the shape of the posterior platform 2105 allows for contact with the ci 1 iary body that is about 120 degrees or less, preferably between 1 and 45 degrees, or between 1 and 20 degrees. Limiting the contact to 120 degrees or less significantly reduces the risk of inflammation or impairment of aqueous production. A substantially non-circular or elliptical posterior platform 2105 allows allow for gentle contact between the device 2100 and the ciliary body that provides centration without requiring an exact match with the patient’s specific dimensions. The radius of curvature of the posterior platform 2105 can be less than that of the ciliary processes. Thus, the posterior platform 2105 can contact the ciliary processes at 3 distinct points rather than across a calculable range. For example, when in use, the substantially non-circular shaped outer perimeter surface of the posterior platform 2105 can contact the ciliary processes at these three distinct points. In other implementations, the lobes 2107 (or rounded comers) of the device 2100 are positioned near, but avoid contacting eye tissues (e.g, the ciliary body) once each fixation arm 2120 is implanted and placed under tension. This arrangement allows for the lobes 2107 to help in centration of the device and to avoid over-tensioning one arm 2120 relative to another arm 2120. If a fixation arm 2120 is pulled too far during extemalization of its footplate 2125, the neighboring lobes 2107 on either side of that fixation arm 2120 may abut against the ciliary’ body during implantation urging the posterior platform 2105 away from the ciliary body and promoting the device 2100 into a more central alignment. Once implanted, the lobes 2107 of the device can be positioned near eye tissue (e.g., the ciliary' body) with or without touching the eye tissue. The tensioned fixation arms 2120 can pull on the posterior platform 2105 substantially equally around its perimeter. The tension applied around the posterior platform 2105 can substantially align a central axis CA of the device 2100 extending through the central aperture 2115 with the visual axis of the eye and allow forAttorney Docket No.: 058226-509001 WO the planar surface of the posterior platform 2105 to be stabilized substantially parallel to the Z-plane (vertical plane) of the eye. The central axis CA of the device 2100 need not be perfectly aligned (coincident) with the visual axis of the eye.

[0093] The non-circular outer perimeter of the posterior platform 2105 can include a plurality of shorter sides or lobes 2107 projecting outward (z.e., in a convex manner) from a plurality of elongate sides 2108 that are substantially flat or concave (see FIGs. 3A-3B). This can form an outer wall of the posterior platform 2105 having an alternating pattern of convex lobes and concave or flat sides. In an implementation, the posterior platform 2105 can include two convex lobes 2107 projecting between two flat or slightly concave elongate sides 2108.

[0094] The lobes 2107 can form rounded ends of the device or rounded comers forming a non-circular shape of the device. The shape can include two elongate sides 2108 that are substantially straight along at least a portion of their length and connected by two lobes 2107 that form opposing curved semi-circular ends of the device. The elongate sides 2108 can bow outwardly along a curve for at least a portion of their length and can be straight for at least a portion of the length. A first lobe 2107 forms the trailing end 2106 of the device, which can have a slightly narrower width (e g., about 7.0 mm from side wall 2112 to opposite side wall 21 12) compared to the width of the second lobe 2107 forming the leading end 2101 of the device (e.g., about 7.4 mm from side wall 2112 to opposite side wall 2112). The taper can create a width difference between leading end 2101 and trailing end 2106 that is about 0.1 mm to about 1.0 mm, preferably about 0.20 mm and roughly about a 0.5 - 5.0 degree angle from the center line of the device. The elongate sides 2108 of FIGs. 3A-3B can, but need not be straight along their entire length or lie parallel to one another. The two elongate sides 2108 are connected to the two lobes 2107 by four rounded comers. The rounded comers can, but need not all have the same radius of curvature. The rounded comer in the upper left quadrant can have a radius of curvature that is about 0 to about 3.5 mm, preferably about 1.67 mm. The rounded comer in the upper right quadrant can be its mirror image having the same radius of curvature of the rounded comer on the opposite side of the axis of symmetry along the major axis A of the device. The rounded comer in the lower left quadrant can, but need not have the same radius of curvature as the rounded comers in the upper quadrants, for example, about 0 to about 3.5 mm, preferably about 1.67 mm. The rounded comers in the lower quadrants can be the same so that they are mirror images of one another on the opposite side of the axis of symmetry along the major axis A of the device.Attorney Docket No.: 058226-509001 WOHowever, the comers in the upper and lower quadrants on opposite sides of the minor axis of the device need not be mirror images of one another. Meaning the minor axis need not be a line of symmetry'. The lobes 2107 can have different radius of curvature compared to the radius of curvature of the respective comers. The radius of curvature can be anywhere from a flat line to a radius of about 3.5 mm. A “lobe” as used herein can include a rounded comer of the device or an end of the device where the end projects or is curved outwardly relative to the center axis of the device. The rounded comers can, but need not have the same radius of curvature. The lobes also need not have the same shape and / or length so that a first end of the device may be slightly wider than the opposite end of the device.

[0095] The lobes 2107 can act as bumpers against the ciliary body and / or within the ciliary sulcus to provide anti-rotation function in the Z-plane and / or prevent displacement within the Z-plane to maintain proper alignment between the central aperture 2115 and the eye’s visual axis. The plurality of fixation arms 2120 can be positioned on the elongate sides 2108 and the plurality' of lobes 2107 project outward between the plurality' of fixation arms 2120. The fixation arms 2120 each can have a length that is longer than a distance the lobes 2107 project outward. The fixation arms 2120 can have a uniform length relative to one another or can have different lengths, which will be described in more detail below. As mentioned above, the posterior platform 2105 can have a circular inner perimeter wall 2109 defining the central aperture 2115. The plurality of lobes 2107 projecting outward from the central aperture 2115 provides a varying thickness in the plane of the central aperture 21 15 between the inner perimeter wall 2109 and outer perimeter. The thickness of the posterior platform 2105 between the inner perimeter wall 2109 and the outer perimeter at the location of the substantially flat elongate sides 2108 is less than a thickness of the support structure between the inner perimeter wall 2109 and the outer perimeter at the location of the short sides or lobes 2107. The number of lobes 2107 of the posterior platform 2105 can vary providing the support structure with any of a variety7of non-circular shapes including rounded triangle, rounded rectangle, rounded pentagon, rounded hexagon, trefoil, quatrefoil, cinquefoil, trapezoid, fan shape, stadium shape, obround, discorectangle, squircle, cyclogon, egg, lens, triquestra, vesical piscis. reuleaux polygon, or other geometric or free-form etc. The projections or comers of these non-circular geometries can be rounded or curved to provide gentle, non-penetrating contact with ciliary tissue such as the ciliary body and the side structures can be regular or irregular. Alternatively, the device 2100 can be designed toAttorney Docket No.: 058226-509001 WO utilize the pars plana or scleral wall for centration assistance. In this implementation, the device 2100 can be positioned posterior to the ciliary processes.

[0096] In still further implementations, the posterior platform 2105 may have an overall shape that tapers from a leading end to a trailing end. For example, the device 100 can be configured for insertion through an incision such that a leading end of the posterior platform 2105 (z.e., the end of the device inserted first through the incision) is wider leading end than trailing end such that the overall shape tapers from leading end to trailing end (see, for example, FIG. 1 A). The leading end of the posterior platform 2105 can be a region of the posterior platform 2105 coupled to the leading fixation arm 2120c. The trailing end of the posterior platform 2105 can be a region of the posterior platform 2105 located between the two trailing fixation arms 2120a, 2120b. The region near the leading fixation arm 2120c can have a width that is greater than the region between the trailing arms 2120a, 2120b. This tapered shape from leading end to trailing end of the device 2100 results in it taking on a desired shape when loaded onto an insertion tool and stretch into an insertion configuration, which will be described in more detail below. The taper from leading end to trailing end can exist regardless of the overall shape of the posterior platform 2105.

[0097] The device 2100 can include one, two. three, or more fixation arms 2120. In a preferred implementation, the device 2100 includes three fixation arms 2120 that are arranged symmetrically or equidistant around the perimeter of the posterior platform 2105 that when placed under tension locate and stabilize the scleral suspension device along three points of fixation. The fixation arms 2120 can center the posterior platform 2105 and provide sufficient support for long-term stability. In some implementations, this may be accomplished by a single fixation arm 2120. In other implementations, the one or more fixation arms includes three fixation arms 2120 symmetrically arranged around a perimeter of the support structure. The fixation arm 2120 can be constructed from a semi-rigid material or may have a geometry that provides sufficient structural rigidity. One or more of the fixation arms 2120 can be substantially straight between their origin with the posterior platform 2105 and their terminal ends. The straight fixation arm, which can be the leading fixation arm 2120c from the perspective of direction of implantation into an eye, can extend along a single longitudinal axis between the origin portion 2103 and terminal end 2102 without any bends or curves away from the single longitudinal axis. The straight fixation arm(s) 2120c can extend orthogonal to the outer perimeter surface of the posterior platform 2105. The longitudinal axis of the straight fixation arm(s) 2120c can be positioned orthogonal to theAttorney Docket No.: 058226-509001 WO outer perimeter surface of the outer perimeter. The plane of the anterior-facing surface of the posterior platform 2105 and the longitudinal axis of the straight fixation arm(s) 2120c can be parallel to one another as can the plane of the posterior-facing surface of the support structure and the longitudinal axis.

[0098] The device 2100 can also include just two fixation arms 2120. These fixation arms 2120 may be under equal and opposite tension when implanted and anchored trans-scl erally. Alternatively, the fixation arms 2120 may be asymmetric such that one fixation arm 2120 is under tension and the other fixation arm 2120 has a rigidity and length that it functions as a rigid spacing element. A fixation element that is rigid or capable of applying a spring force can rely on penetration of the adjacent tissue or being wedged into place. A tensioned fixation element can rely on a slight stretch or expansion of the material once placed. One or both of the fixation arms 2120 may be produced with an inward biased configuration in which the fixation arm is biased towards an anterior projecting curve or a folded configuration as described elsewhere herein.

[0099] The device 2100 can also include three or more fixation arms 2120. Three fixation arms 2120 can provide the device 2100 w ith a defined fixation plane that is substantially parallel to the Z-plane (vertical plane) of the eye. The fixation arms 2120 can be designed and deployed in a manner that puts each fixation arm 2120 in equal and opposite tension. Alternatively, one or more fixation arms 2120 may be designed to have a rigidity and length allowing to behave as a rigid spacing element. Zero, one, tw o, or all three or more of the fixation arms 2120 can be manufactured with an inward biased design or biased towards a center of the device or the central axis CA of the device. The inwardly biased fixation arms 2120 can extend from the support structure and have a folded configuration prior to implantation. At least one, but few er than all, of the fixation arms may be biased or curved as described herein. At least two, but fewer than all may be biased or curved as described herein. In some implementations, all the fixation arms 2120 may be biased or curve. The device can include three fixation arms, wherein two of the three fixation arms are flexible and biased towards a folded configuration, and a third fixation arm is less flexible than the other two and is biased towards an unfolded configuration. The folded configuration of each of the fixation arms can bias the terminal end portion of the fixation arms towards a central axis CA of the device. The support structure can be biased towards a substantially flat or planar configuration while the fixation arm(s) is biased towards the folded configuration that is not substantially flat or planar.Attorney Docket No.: 058226-509001 WO

[0100] Once implanted and fixed trans-sclerally, the inwardly biased arms are unbent or unfolded away from their folded, inwardly biased configuration. Tn a preferred implementation, two fixation arms 2120 have an inward bias geometry and the third fixation arm 2120 has increased cross-sectional area — increasing its rigidity. The inwardly biased fixation arms 2120 can incorporate a bend between an origin of the arm with the posterior platform 2105 and their terminal end. The two bent fixation arms 2120 can be biased towards the central axis CA of the device towards a folded configuration.

[0101] In an implementation, the device 2100 can include at least three fixation arms 2120. Prior to implantation, one of the at least three fixation arms can extend in an unfolded configuration from the support structure and at least two of the at least three fixation arms extend in a folded configuration from the support structure. And, prior to implantation, one of the at least three fixation arms can be biased towards 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.

[0102] Each of the fixation arms 2120 can include an origin portion 2103 at the posterior platform 2105 and a terminal end portion 2102 coupled to an atraumatic footplate 2125 for sutureless, trans-scleral fixation. Prior to trans-scleral fixation of the footplates 2125, one of the plurality of fixation arms 2120 (up to all of the fixation arms 2120) can include a curved fixation arm 2120 that is curved between its origin portion 2103 and its terminal end 2102 forming a bend B enabling visualization of at least a portion of the curved fixation arm 2120 through the pupil 30 of the eye. After trans-scleral fixation of the footplates 2125, each of the plurality of fixation arms 2120 can be tensioned between the origin portion and the terminal end to align the support structure relative to the Z-plane of the eye. The posterior platform 2105 is adapted to provide support for an intraocular lens. The central aperture 2115 extending through the full thickness of the posterior platform 2105 is adapted to permit passage of light through both the central aperture 2115 and the optical element supported by the posterior platform 2105. The curved fixation arm 2120 can curve anteriorly such that a portion of the arm 2120 such as the terminal end 2102 and / or its atraumatic footplate 2125 is positioned over at least a portion of the posterior platform 2105 (e.g, the upper surface of the posterior platform 2105 and / or over a region of the central aperture 21 15). Alternatively, the curved fixation arm(s) 2120 can curve posteriorly such that a portion of the arm 2120 such as the terminal end 2102 and / or its atraumatic footplate 2125Attorney Docket No.: 058226-509001 WO is positioned under at least a portion of the posterior platform 2105 (e.g., the lower surface of the posterior platform 2105 and / or under a region of the central aperture 21 15).

[0103] Two of the three fixation arms 2120 curve inward such that they are biased towards a folded configuration at rest. The arms 2120 extend outward substantially orthogonally from the posterior platform 2105, such as from their origin portion 2103 at the posterior platform 2105 and make a turn (anteriorly or posteriorly) forming a curve between the origin portion 2103 and the terminal ends 2102 of the arms 2120. The curve of the arm 2120 can result in the terminal end 2102 of the arm 2120 being positioned nearer to its own origin portion 2103. In some implementations, the arm 2120 curves in an anterior direction such that the terminal end 2102 of the arm 2120 is positioned anterior to the arm's origin portion 2103 or over at least a portion of the anterior-facing surface of the posterior platform 2105 near the arm’s origin portion 2103. In other implementations, the arms 2120 can curve in a posterior direction such that the terminal end 2102 of the arm 2120 is positioned posterior to the arm’s origin portion 2103 or under at least a portion of the posterior-facing surface of the posterior platform 2105 near the arm's origin portion 2103. In an implementation, the footplates 2125 of the curved fixation arms 2120 can curve away from a first plane of the support structure (e.g, Z-plane of the eye) into a second plane that is parallel to the first plane. The second plane can be anterior or posterior to the first plane depending on whether the arms 2120 curve anteriorly or posteriorly. The curve can be in a direction that is substantially transverse (e.g., X-plane) to the plane of the posterior platform 2105 (e.g., Z- plane). The dilated pupil (depending on whether adult or pediatric patient) can have a diameter up to about 8 mm. The curve positions the footplates 2125 of the curved fixation arms 2120 to be positioned within a diameter of a circle in that second plane that is visible within the diameter of a dilated pupil so as to not impede visualization by the opaque iris, for example, between about 3 mm up to about 7.5 mm, more preferably about 7 mm. The footplate 2125 of each of the curved fixation arms 120 can be positioned a distance from the center of the device, for example, about 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, up to an no greater than about 3.5 mm, or no greater than about 4.0 mm from the center of the device. The curved arms 2120 provide for positioning the terminal end portions 2102 and / or the footplates 2125 within this diameter or this distance from the center of the device allowing for ease of visualization. The third of the three fixation arms 2120 is biased into a straight or unfolded configuration at rest. The third arm 2120 extends outward orthogonally from its origin portion 2103 at the posterior platform 2105 and makes no turn or bend. Rather, theAttorney Docket No.: 058226-509001 WO entire third arm 2120 is entirely straight and extends substantially along a single axis. The two fixation arms that, at rest, were biased towards a folded configuration are now in an unfolded configuration, for example, by tensioning the arms 2120 via the trans-scleral footplates being externalized.

[0104] The fixation arms 2120 may be uniformly distributed around the device 2100 to provide uniform tension. Alternatively, the fixation arms 2120 may be oriented in a non-uniform distribution, for example, with three fixation arms 2120 that are 90 degrees from one another. In this circumstance two of the fixation arms 2120 would be 180 degrees from each other, providing opposing tension; while the third fixation arm 2120 serves primarily to prevent the device 100 from rotating.

[0105] Fixation arms 2120 extending to the eye wall can be difficult to manipulate as they can be blocked from view by the peripheral iris 10, limbus and sclera 20. As discussed above, one or more of the fixation arms 2120 can be inwardly biased toward a folded configuration. Each of the fixation arms 2120 may extend initially from the posterior platform 2105 outward in an orthogonal direction and then curve or fold anteriorly (or posteriorly) such that the terminal ends of the fixation arms 2120 are positioned over at least a portion of the fixation arm 2120. the posterior platform 2105, or the central aperture 2115 extending through the posterior platform 2105. At least a portion of the bent fixation arms (i.e., the terminal ends and / or the footplates 2125) can be more easily visualized through a dilated pupil and visualization is not impeded by the opaque iris 10. This inward (centripetal) bias also allows the bent fixation arms 2120 to be safely grasped and manipulated during device implantation. Each of the fixation arms 2120 of the device 2100 can have inward bias toward a folded configuration or just a selection of the fixation arms 2120 can have inward bias (e.g., one, two, up to less than all fixation arms 2120).

[0106] The fixation arm 2120 can also be molded to incorporate a bend or curve between its origin with the posterior platform 2105 and the terminal footplate 2125. The bent fixation arm(s) 2120 can be biased tow ards a folded configuration. For example, one or more of the fixation arms 2120 can bend between 90 degrees and 270 degrees from its origin with the posterior platform 2105 in a radial and centripetal direction. The terminal end of the bent fixation arms 2120 thus, lie in a different plane from a plane of the posterior platform 2105. When in a resting state prior to being positioned in the eye, the terminal end of at least a first fixation arm 2120 of the plurality of fixation arms 2120 can incorporate a bend between its origin with the support structure and its terminal end forming a bent arm.Attorney Docket No.: 058226-509001 WOThe bent arm can extend at least a first distance from its origin orthogonal to the posterior platform 2105. The bent arm can then curve upward (anteriorly) away from the plane of the posterior platform 2105 at least another distance. The bent arm 2120 can then curve back towards its origin or towards the central axis CA of the device. This can result in the terminal end of the bent arm 2120 lying in a different plane than the plane of the posterior platform 2105. The curve or bend in the arm 2120 can be projecting outward away from the central axis CA and away from both the arm’s origin portion 2103 and terminal end 2102. The trans- scleral footplate 2125 and / or a terminal portion of the fixation arm 2120 can be positioned over or anterior to at least a portion of the posterior platform 2105 or positioned over at least a portion of the central aperture 2115. Alternatively, the bent arm(s) 2120 can curve downward (posteriorly) away from the plane of the posterior platform 2105 at least a distance and the trans-scleral footplate 2125 or a terminal portion of the fixation arm 2120 can be positioned under or posterior to at least a portion of the posterior platform 2105 and / or under or posterior to at least a portion of the central aperture 2115. The folded configuration (whether the arms 2120 curve anteriorly or posteriorly) allows for at least a portion of the bent fixation arms 2120 such as the terminal ends of the bent fixation arms 2120 and / or their footplates 2125 to be visualized through the pupil and not impeded by the opaque iris. Only- one arm 2120 of the fixation arms 2120, two arms 2120 of the fixation arms 2120, or all of the fixation arms 2120 can incorporate a curve.

[0107] Once the device is positioned and anchored in the eye, the fixation arms 2120 are placed under tension such that the bent arm is unfurled away from this folded configuration and is no longer bent. The terminal end of the arm 2120 is urged away from this resting state in which the arm 2120 is in a folded configuration to urge the bent fixation arm into a straight or unfolded configuration.

[0108] The bend of the folded configuration can be a gradual, smooth bend having a radius of curvature or can bend to form one or more distinct angles along a length of the arm 2120. The bend can be tight enough to avoid projecting too far anterior while still capable of being unfurled or placed into an unfolded configuration with relative ease without imparting undue stress on the posterior platform 2105. The inward biased geometry can have a curve that is between about 0.10 mm to about 2.5 mm radius of curvature on the inner curve (anterior-facing side) and between about 0.6 mm to about 3.0 mm radius of curvature on the outer curi e (posterior-facing side). In an implementation, the biased fixation arm 2120 curves a full radius of 180 degrees and has an inward biased geometry' that is about 0.63Attorney Docket No.: 058226-509001 WO mm radius of curvature on the inner curve and about 1.13 mm on the outer curve such that the posterior platform 2105 and the biased fixation arm are spaced by about 1 .25 mm. The start point of the curve (near the origin portion 2103 with the posterior platform 2105) and the end point of the curve (near the terminal end 2102 at the trans-scleral footplate 2125) can have a plurality’ of radiuses such that the curve changes over the length of the fixation arm 2120. The curve of the biased fixation arms 2120 can have an average curvature between about 0. 15 mm to about 2 mm on the inner curve.

[0109] The bent fixation arms 2120, after implantation and prior to fixation with the scleral wall, can be visible through the pupil when in an unstressed (resting) state. This visibility' allows the surgeon to easily engage the footplate 2125. When the surgeon engages the fixation arms 2120 by grabbing the body of the fixation arm 2120 or footplate 2125, the surgeon can unfurl the fixation arm 2120 away from the resting, folded configuration in a way' to bring it substantially on plane with the posterior platform 2105. These fixation arms 2120 can have a flexibility’ such that the stresses stored in the material in the deployed state will not impart torsional or tensile forces upon the posterior platform 2105 in a way that compromises device function. The fixation arm(s) 2120 can be molded to have a 90 - 270 degree turn from its lens support origin in a tangential and centripetal direction. The fixation arm(s) 2120 can incorporate elastic materials or deformable hinges to facilitate this manipulation without substantially altering the geometry of the posterior platform 2105. The fixation arm 2120 can have a length such that when the fixation arm 2120 bends 180 degrees back towards its origin with the posterior platform 2105, the terminal end 2102 of the fixation arm 2120 can be positioned over at least a portion of the posterior platform 2105. Each of the fixation arms 2120 of the device 2100 can have a bend or just a selection of the fixation arms 2120 can have a bend (e.g., one. two, up to less than all fixation arms 120).

[0110] The visibility of one or more regions of the device can be improved also by modifying the material of the device components. The device can be formed of silicone elastomer, fluorosilicone elastomer, urethane, flexible acrylic, copolymers or combinations, or other biocompatible elastomers. The material of the device as a whole or one or more distinct regions of the device can be made translucent or opaque for visualization purposes. For example, where the material selected for the fixation arms, footplates, platform, awnings, or other region of the device is normally transparent, one or more additives may be included in the material to make it translucent or opaque. The additive can be a pigment or dye, polymerized or unpolymerized, so that the device or device component is readily visible by aAttorney Docket No.: 058226-509001 WO user within the eye. A white pigment or dye added to an otherwise clear silicone elastomer (e.g., NuSil MED-4830 with white MED-4800-1 pigment) forming the footplate of one or more of the fixation arms 2120 so that they are more easily seen and grasped during extemalization. One or more regions of the chassis of the device may also be opaque with a dye or pigment so that the optical element can be manipulated relative to the device with visual confirmation of the location of the optical element components. An IOL haptic, for example, can be positioned behind a tab or awning of the device that is made opaque so that the haptic is not visible following implantation. The size of the anterior opening prevents the opacity of the one or more device features, such as the tab or awning, from significantly impacting a user’s vision while the device is implanted.

[0111] One or more of the fixation arms 2120 of the devices described herein can be manufactured to have anon-planar geometry at rest and may be biased towards the folded configuration that allows for easy viewing of at least a portion of the fixation arm 2120 through a pupil once the device 2100 is implanted, but prior to extemalization of the footplate 2125. The fixation arm 2120 having this configuration can be more easily grasped and manipulated by a user so that it can be urged into an unfolded configuration for sutureless fixation. A fixation arm 2120 manufactured to have a bias in a resting state or that is curved or bent in a resting state includes a fixation arm 2120 having that shape when the device 2100 is outside the eye and ready for implantation. In some implementations, the fixation arm 2120 can take on the curved, folded, or bent shape after implantation in the eye (e.g. the posterior chamber), but before fixation of the footplates. For example, one or more fixation arms 2120 can be formed of a material that has a first shape outside the eye, takes on a curved shape upon implantation in the eye that is different from the shape of the arm 2120 prior to implantation in the eye, and that can be unfolded into a substantially straight shape upon extemalization of the footplate 2125.

[0112] A fixation arm 2120 that has the bias towards a folded or curved shape (e.g., having a bend along its length between its origin portion 2103 and its terminal end 2102) can be visualized through the pupil, grasped, and manually unfolded and / or stretched to fix the footplate 2125 of the arm 2120 trans-scl erally. The configuration and / or radius of curvature of the curve, bend, or fold as well as the directional orientation of the curve, bend, or fold can vary so long as at least a portion of the fixation arm 2120 (e.g., the footplate 2125 and / or the terminal end portion coupled to the footplate 2125) is visible to a user through the diameter of the pupil of the patient, preferably a dilated pupil of the patient. In someAttorney Docket No.: 058226-509001 WO implementations, this means at least a portion of the fixation arm 2120 is positioned over at least a portion of the posterior platform 2105 and radially inward of its outer perimeter. The distance the portion of the arm 2120 extends radially inward of the outer perimeter can vary. The portion can extend to be over a location adjacent to the outer perimeter that is not over the outer perimeter in the orientation a central axis CA extending anterior-to-posterior through the central opening 21 15. In this implementation, the distance between the central axis CA of the device to the portion extending over is greater than the distance between the central axis CA of the device and the outer perimeter. The portion can extend to be over the outer perimeter. In this implementation, the distance between the central axis CA of the device to the portion is the same as the distance between the central axis CA of the device and the outer perimeter. The portion can extend to be over a location radially inward to the outer perimeter. In this implementation, the distance between the central axis CA of the device to the portion is less than the distance between the central axis CA of the device and the outer perimeter. The portion can extend to be over the central opening 2115. In this implementation, the distance between the central axis CA of the device to the portion is less than the distance between the central axis CA of the device and the inner perimeter wall 2109 defining the central opening 2115.

[0113] A portion of the fixation arm (e.g. , the terminal end and / or the footplate 2125) can be positioned over a portion of the posterior platform 2105 and at the same time also over a portion of the central opening 115. For example, the footplate 2125 can have a dimension such that at least a portion of the footplate 2125 is positioned over at least a portion of the posterior platform 2105 and another portion of the footplate 2125 is positioned over at least a portion of the central opening 2115.

[0114] The fixation arms 2120 biased towards a curved configuration can curv e towards an inner or a central portion of the device, including, but not limited to, the actual center of the device or the central axis CA. The center of the device 2100 is the center of the circle formed by the central aperture 2115 (in the instance where the central aperture 2115 is circular). The central axis CA of the device extends through the center of that circle in an anterior-to-posterior direction (i.e. , a top-to-bottom direction). If the central aperture 2115 is substantially non-circular, the center of the device is a symmetrical center of the central aperture 21 15 along the central axis CA extending anterior-to-posterior direction. A fixation arm that is biased into a folded or curv ed configuration such that its footplate extends towards a center of the device or towards the central axis CA of the device need not require an axisAttorney Docket No.: 058226-509001 WO through the footplate of the arm to intersect the actual center or intersect the central axis CA of the device. “Toward the center” or “toward the central axis” regarding the inwardly biased fixation arms includes an arm having a curve so that the terminal end of the fixation arm extends back toward a portion of the device in a generally inward direction as opposed to the terminal end of the straight fixation arm, which extends in a generally outward direction away from the support structure. The curved fixation arm can be biased toward any central portion of the device and need not point directly at the actual center of the device. The curved fixation arms can be angled relative to the actual center.

[0115] Where the fixation arms are described as being “folded” or “bent” or “curved” or having a configuration that is “folded” or “bent” or “curved”, the angle of the fixation arms relative to a longitudinal axis along its length can change gradually and uniformly, or can change more sharply or abruptly such that an angle is formed. The folded configuration can describe the inward bias of the fixation arm at rest or prior to implantation where the fixation arm extends outward from the support structure along a first axis and curves anteriorly or posteriorly relative to a plane of the support structure back towards a central portion of the device. The support structure of the device when implanted is configured to lie substantially parallel to the Z-plane (vertical plane) of the eye. The folded configuration can include a geometry in which the fixation arm curves away from this plane of the support structure (e.g., within a transverse plane) so that at least a portion of the fixation arm is positioned anterior to another portion of the device (e.g., over itself, the support structure, and / or the central opening). The folded configuration need not mean the fixation arm portions are over and also in contact with each other. Preferably, the portions of the fixation arm are spaced a distance aw ay from each other, the distance being along the central axis CA of the device. The folded configuration also need not mean a creased or sharply angled folding. The folded configuration can mean a radius of curvature exists between the origin of the fixation arm at the support structure and the terminal end of the fixation arm.

[0116] A portion of the arm 2120 that is positioned over at least a portion of the posterior platform 2105 can include that portion being over as w ell as positioned radially inward of an outer perimeter of the posterior platform 2105. The portion of the arm 2120 that is positioned over at least a portion of the posterior platform 2105 can include that portion being positioned radially inward of and over the central opening 2115. In these instances, “radially inward” need not also mean within the same plane. Preferably, the portion of theAttorney Docket No.: 058226-509001 WO arm 2120 is positioned over the portion of the support structure within a different plane from the plane of the support structure. The portion of the fixation arm 2120 (e.g., footplate 2125 and / or terminal end 2102) can terminate anterior or posterior to the posterior platform 2105 at a diameter that is central to the outer perimeter of the posterior platform 2105. The portion can be located over the portion of the support structure relative to the central axis CA of the device that extends anterior-to-posterior through the central opening 2115. Where the portion of the fixation arm 2120 is described as being over the portion of the support structure, the portion of the fixation arm 2120 may also be over the central opening 2115 defined by the posterior platform 2105.

[0117] Where a portion of the arm 2120 is described herein as being ‘‘over ’ another portion of the device 2100 (e.g., itself, the posterior platform 2105. and / or the central opening 21 15), the portion of the arm 2120 can generally overlap that portion of the device in space and need not require a particular direction relative to the retina. Thus, “over” may be used generically herein to refer to an overlap in the space surrounding the device and can, but need not require the spatial overlap to be in a generally anterior direction relative to the retina. A portion that is described as being “over” another portion can, during use, be positioned posterior to it relative to the retina. The arm 2120 that is biased into the folded configuration may only be referred to herein as “over” or “overlapping” another part of the device even though it may also, during use, be positioned “under” or “posterior” to another part of the device relative to the retina. For the sake of simplicity, each alternative may not be reiterated at each instance throughout the disclosure. The arms can be curved to position at least a portion of the arm over an anterior-facing portion of the device such that the portion is generally vaulted above the device along the central axis CA. The arms can be curved to position at least a portion of the arm over a posterior-facing portion of the device such that the portion is generally vaulted below the device along the central axis CA. The arms can be curved to position at least a portion of the arm within the same plane so that it is neither over the anterior-facing portion nor over the posterior-facing portion of the device. Any of a variety of configurations of the fixation arms are considered herein so that at least a portion of the arms are visible through a dilated pupil. The mechanisms can vary by which the bent fixation arms 2120 that are biased towards the folded configuration become unfolded to take on a straight configuration. The arms can be unfolded mechanically, electromagnetically, and / or thermally.Attorney Docket No.: 058226-509001 WO

[0118] The fixation arms 2120 can be formed of a flexible material that has memory and is not malleable. The flexible material of the fixation arms 2120 can include any of a variety of biocompatible elastomers including silicone elastomer, fluorosilicone elastomer, urethane, flexible acry lic, copolymers or combinations, polyurethanes, hydrophobic acry lics, hydrophilic acrylics, Nylon, Polyimide, PVDF. natural polyisoprene, cis-l,4-polyisoprene natural rubber (NR), trans- 1,4-polyisoprene gutta-percha, synthetic polyisoprene (1R for isoprene rubber), Polybutadiene (BR for butadiene rubber) Chloroprene rubber (CR), poly chloroprene, Neoprene, Baypren etc., Butyl rubber (copolymer of isobutylene and isoprene, 11R), Halogenated butyl rubbers (chloro butyl rubber: C11R, bromo butyl rubber: BHR), Styrene-butadiene Rubber (copolymer of styrene and butadiene, SBR), Nitrile rubber (copolymer of butadiene and acrylonitrile, NBR), also called BunaN rubbers Hydrogenated Nitrile Rubbers (HNBR) Therban 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 and Dai-El, Perfluoroelastomers (FFKM) Tecnoflon PFR, Kalrez, Chemraz, Perlast, Poly ether block amides (PEBA), Chlorosulfonated polyethylene (CSM), (Hypalon), Ethylene-vinyl acetate (EVA), Thermoplastic elastomers (TPE), resilin and elastin. Polysulfide rubber, and Elastolefm.

[0119] The arms 2120 made of a flexible material that is formed into a shape can be flexed away from the formed shape, but has memory to return to the formed shape. In other words, the flexible fixation arms 2120 can be flexed or unfolded away from their folded configuration, but cannot be urged into a different shape that is retained without some kind of anchoring fixation. For example, one or more of the flexible fixation arms 2120 can be formed into a bent shape. For example, the arm can include a 180-degree bend from its origin portion 2103 with the posterior platform 2105 to the terminal end 2102 near the footplate 2125. The arm 2120 can maintain this bent shape when the device is at rest and no forces are applied to the arm 2120 such that the arm 2120 is biased towards a folded configuration. In other words, the arm 2120 in its unbiased state is bent. The bent fixation arm 2120 can be flexed away from this bent shape to take on a straight shape or an unfolded configuration such that the entire arm 2120 extends and is positioned straight relative to the longitudinal axis L. When flexed into a straight shape, the arm 2120 is biased to return to theAttorney Docket No.: 058226-509001 WO bent shape or the folded configuration. If the flexing force on the fixation arm 2120 is released, the arm 2120 will return to its resting bent shape. However, when in use, the fixation arm 2120 is anchored trans-sclerally and the footplate 2125 at the terminal end 2102 of the arm 2120 positioned outside the sclera. The arm 2120 is tensioned to remain in the straight shape.

[0120] The one or more fixation arms 2120 can have a Young’s modulus that is 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. The one or more fixation arms 2120 can have a Young’s modulus that is less than about 20 MPa, for example, between about 0.01 - about 1.0 MPa, or between about 0.5 - about 5.0 MPa. The fixation arms 2120 can be very soft and apply very little force because they are designed to be under tension to anchor the posterior platform 2105 rather than having a compression spring force to anchor the posterior platform 2105 or a more rigid penetrating force that a barb or other fixation haptic can provide. The softer the material of the fixation arms 2120, the less force the fixation arms impart onto the footplate while under tension (or that the footplates impart onto the sclera while the arms are under tension). If the material is too soft, the material can become floppy and tacky, which is difficult to manipulate, but generally there is no real limit with very low modulus materials.

[0121] In some implementations, the fixation arms 2120 can each have a length between the origin portion 2103 and the terminal end 2102 that is about 1 mm to about 6 mm, or about 2 mm to about 3 mm, or about 2.5 mm to about 2.8 mm. The fixation arms 2120 each can have the same length or can have different lengths from one another. The length of the fixation arms 2120 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 arms 2120 extend. The maximum width of the trans-scleral portion of the fixation arms near the terminal end 2120 where the footplate 2125 is positioned can be no greater than about 2.0 mm, no greater than about 1.5 mm, no greater than about 1 .0 mm, no greater than 0.75 mm, no greater than 0.50 mm. In still further implementations, the arms 2120 have a width along an entire length between the origin portion 2103 and the terminal end 2102 that is no greater than about 0.50 mm, preferably about 0.30 mm to about 0.40 mm.

[0122] The devices described herein can be used together with lOLs having any of a variety of conventional designs, including multi-piece as well as one-piece designs. IOL can include a central optic and two haptics. The haptics can be conventional open loopAttorney Docket No.: 058226-509001 WO haptics such as C-loop, J-loop. modified J-loop. or other haptics. The IOL may be positioned above (or below) the central opening 21 15 of the device so that the central axis CA extending anterior-to-posterior through the central opening 2115 extends through the optic of the IOL. The haptics of the IOL may project upwards or anteriorly away from (or toward, if positioned below) the posterior platform 2105 as described elsewhere herein. One-piece IOLS can have open loop haptics similar to conventional three-piece IOLs do. One-piece IOLs may also incorporate monobloc-plate style haptics. Where the device is described with one type of IOL (e.g., the multi-piece IOLs or one-piece IOL), it should be appreciated that another type of IOL can be mated with the device. The devices described herein can be used with any A pe of IOL as described elsewhere herein, including multi-piece as well as one-piece designs. Similarly, the haptics of the IOL can be of any of a variety of configurations. Other sorts of implants having an optical element can incorporate a haptic system to ensure fixation within an eye, including, for example, IMTs. The devices described herein can be used together with any of a variety of implants having haptic designs.

[0123] The posterior platform 2105 can have a geometry adapted to mate with a perimeter of the optical element or with one or more haptics of the optical element. The geometry can include a concavity, recess, channel, or groove forming at least a portion of an inner perimeter of the support structure.

[0124] The posterior platform 2105 can support the IOL, for example, taking the place of a native lenticular capsular bag. The device 2100 can include one or more leaflets or awnings 2126 positioned over an anterior-facing surface of the posterior platform 2105 so that one or more recesses 2104 are formed within which at least a portion of the IOL may be positioned. The recesses 2104 may at least partially surround the central aperture 2115 and be sized to accommodate at least a portion of the IOL, such as the haptics. The optic of the IOL is preferably positioned over the central opening 2115 and a perimeter region of a posterior-facing surface of the optic is preferably positioned against the anterior- facing surface of the posterior platform 2105. Each of the haptics of the IOL can be positioned substantially within the respective recesses 2104 and a majority of the optic of the IOL remains outside the recesses 2104. The recesses 2104 can be defined by an anterior- facing surface of the posterior platform 2105 and the overhanging leaflet or awning 2126. The volume of the recesses 2104 formed by the space between the anterior-facing surface of the posterior platform 2105 and the posterior-facing surface of the awning 2126 is sufficient to receive the respective one of the haptics in both depth anterior-to-posterior as well asAttorney Docket No.: 058226-509001 WO distance away from the central axis CA of the opening 2115. The awnings 2126 can have a smooth geometry and can serve to protect the iris from any sharp edges of the IOL once positioned on the device 2100. Additionally, the central -facing surfaces of the awnings 2126 (facing toward a center axis CA of the device 2100) can additionally serve to provide a surface against which the haptics may abut. These surfaces can provide counter pressure to the haptics and thereby aid in centering the IOL on the device 2100. The awnings 2126 also can limit Z-axis movement of the haptics and help to secure the IOL to the device 2100. The reliable fixation of the IOL, including one-piece lOLs, allow for the use of IOLS that require tight centration tolerances (e.g., torics. multi-focal lenses, extended depth of focus (EDOF) IOLs, and accommodating IOLs).

[0125] The IOL may be positioned within the device 2100 prior to implantation in the eye or after implantation in the eye. Similarly, the IOL may be removed from the device 2100 and replaced postoperatively. In some implementations, the IOL is pre-loaded within the device and the loaded device injected into the eye using an IOL injector or other type of tool. The devices can be assembled together within the operating room and injected together, or the devices can be injected separately and mated once inside the eye. Methods of implantation of the device will be described in more detail below.

[0126] The device 2100 can have an outer perimeter that has a major axis and a minor axis. Thus, the inner perimeter wall 2109 may define a circular central aperture 2115 and the outer perimeter may define a non-circular shape. The recesses 2104 formed by the awnings 2126 are positioned opposite one another relative to the major axis so that the span of the IOL haptics may be accommodated within the recesses 2104. The non-circular outer perimeter in FIGs. 1 A, 2, and 3 A-3B is a rounded rectangle. Where a shape is referred to here as being “rectangular” it should be appreciated that the shape need not have comers that form right angles or that the sides be perfectly parallel with one another. The term is used to suggest a particular non-circular shape that is elongate having a pair of opposing sides that are longer than a pair of opposing ends to have a major or long axis and a minor or short axis. The rounded rectangle or stadium shape may have two substantially flat or slightly curved, elongate sides 2108 and two substantially rounded, short sides or lobes 2107. The shape of the outer perimeter can be symmetrical along each line of symmetry’ that would be present in the geometric shape. For example, a stadium shape or rounded rectangle geometrically includes two lines of symmetry due to the opposing sides being parallel and the opposing ends being identical. However, the opposing sides of a stadium shape device need not beAttorney Docket No.: 058226-509001 WO parallel and the opposing ends can have a slightly altered shape compared to one another. The opposing elongate sides 2108 of the device can be non-parallel so that the trailing end 2106 of the stadium shaped device is narrower than the opposite leading end 2101 of the device (see FIG. 1 A, 2, and 3 A). The outer perimeter of this stadium shaped device would not be symmetrical along one of two lines of symmetry that would normally be present in a rectangle or stadium shape. The elongate sides 2108 of the rounded rectangle or stadium shaped perimeter need not be parallel. FIGs. 1 A, 2 and 3A show elongate sides that bow outward slightly along their length such that they are not perfectly parallel. The elongate sides intersect the parallel lines near the trailing end 2106 of the device and diverge out from parallel lines moving toward leading end 2101. It should also be appreciated that other features of the device such as the awnings, haptic covers, and fixation arms can impact the lines of symmetry as well. In some embodiments, the device as a whole (including awnings, haptic covers, and fixation arms) has no line of symmetry.

[0127] The recesses 2104 formed by the awnings 2126 may project out over the anterior-facing surface of the posterior platform 2105 such that they are positioned generally opposite one another along a major axis of the rectangle and spaced to accommodate the span of the IOL haptics. For example, the awnings 2126 may project out over the anterior-facing surface of the posterior platform 2105 on the short sides of the rounded rectangle ( / .<?., at the location of the lobes 2107) to accommodate the span of the IOL therebetween within the recesses 2104 along the long sides 2108.

[0128] Although the span of the recesses 2104 can accommodate the span of the IOL haptics, the span of the recesses may be slightly undersized compared to the span of the IOL haptics so that the haptics are placed under slight compression by the inner bearing surfaces of the side walls 2112. The IOL can rest in a position relative to the device 2100 such that the haptics are at least partially flexed. If the haptics are flexed too severely due to the fit being too tight, the optic of the IOL can become distorted. If the haptics are not in contact with the side w alls 2112 due to the fit being too loose, the optic of the IOL may not be stable relative to the device such that it shifts and / or falls out of the device 2100. The one or more recesses 2104 can be sized to accommodate at least a portion of the IOL, for example, along as a thickness aspect within the Z-axis), as an arc length to provide wiggle room for IOL rotation relative to the device 2100 during implantation, or as a width providing a degree of coverage to hide the haptic edge from contacting the iris. The depth of the recesses 2104 between an inner surface of the awnings 2126 and the anterior-facing surfaceAttorney Docket No.: 058226-509001 WO of the platform 2105 can be between about 0.05 mm and about 1.50 mm. preferably about 0.50 mm - 0.70 mm. The width across the platform 2105 between side walls 21 12 along the minor axis can be between about 5.0 mm and about 11.0 mm, preferably about 7 mm - 8 mm. The span between opposing recesses 2104 can be between about 7.5 mm and about 12.5 mm, preferably about 9 mm - 11 mm. In an implementation, the length of the platform 2105 is about 10.9 mm, the width is about 7.4 mm, and the depth is about 0.65 mm. In another implementation, the length of the platform is about 10.2 mm, the width is about 7.0 mm, and the depth is about 0.60 mm. In further implementations, the platform along the long axis of the device can have an external length of about 9.2 mm and an internal length along the same axis that is about 8.5 mm such that a thickness of the side wall is about 0.7 mm. In still further implementations, the platform along the long axis can be increased to about 11 mm and an internal length along the same axis that is about 9.8 mm. As a result, the side wall is thicker at about 0.6 mm on each side or a 1.2 mm delta when both sides are counted. The thickness of the side walls 2112 can be uniform around the perimeter of the device or can vary in thickness as will be discussed in more detail below. The device can be fixated through the pars plana and thus, posterior to the apex of the ciliary body, such that even if the device on the plane of the ciliary' apex is too wide, there can still be space for implanting the larger IOL housing (see FIG. IB). As discussed elsewhere herein, the ciliary’ body is divided into the pars plicata and the pars plana. The pars plicata is located anterior to the pars plana and has an overall smaller diameter compared to the diameter of the pars plana. The pars plicata of the ciliary body is composed of ciliary' processes, the lens zonules, the ciliary' muscle, and a rich vascular netyvork that supplies the pigmented and non-pigmented epithelium, which is part of the blood-aqueous barrier. The pars plana is located posterior to the pars plicata and has a larger diameter compared to the diameter of the pars plicata. The pars plana of the ciliary body is thinner (i.e., from the exterior of the eye toyvard interior of the eye) and less vascular than the pars plicata and has fewer functional components. The devices described herein are sized large enough and / or are flexible enough for trans-scleral fixation through the pars plana region of the ciliary' body, which avoids penetrating critical structures of the pars plicata and the associated risks.

[0129] Three fixation arms 2120 can be coupled to a region of the device such as the posterior platform 2105 or region of the device that is located more anteriorly than the posterior platform 2105 such as a portion of the side w all 2112. The arm 2120 can extend from the posterior platform 2105 such that a majority of the device projects anterior to theAttorney Docket No.: 058226-509001 WO arm 2120. The more posterior position of the fixation arm 2120 stabilizes the device reducing Z-axis deformation when the fixation arms 2120 of the device are placed under maximum tension. Each of the fixation arms 2120 on the device can be positioned relative to the side wall 2112 at a similar anterior-to-posterior location. In some implementations, the leading fixation arm 2120c that is not bent may be positioned at a different anterior-topostenor location compared to the anterior-to-posterior location of the trailing fixation arms 2120a, 2120b. For example, the leading fixation arm 2120c may be positioned more posteriorly on its side wall compared to the trailing fixation arms 2120a, 2120b or vice versa.

[0130] At least one of the fixation arm 2120a, 2120b can be biased into the folded configuration as described elsewhere herein. One fixation arm 2120c can be a leading fixation arm that extends along a single axis orthogonally relative to the posterior platform 2105 so that its terminal end 2102 coupled to the footplate 2125 projects outward away from the center axis CA of the aperture 2115. The leading fixation arm 2120c can be coupled to the posterior platform 2105 at a location of a lobe 2107 and the other fixation arms 2120a, 2120b can be coupled away from the lobe 2107 of the leading fixation arm. for example, on opposite elongate sides 2108 so that the opposite short lobes 2107 projects outward between the arms 2120a, 2120b (see FIGs. 3A-3B). This arrangement can create an overall tapered shape to the posterior platform 2105 from leading end to trailing end, with the trailing end of the platform 2105 somewhat narrower than the leading end of the platform 2105. FIG. 1A, 2 and also FIGs. 3A-3B show the posterior platform 2105 and awnings 2126 forming a chassis having a rectangular shape that has a leading end 2101 and a tapered trailing end 2106. The trailing end 2106 of the chassis between the trailing fixation arms 2120a, 2120b may be narrower than a width of the leading end 2101 of the chassis near the leading fixation arm 2120c. The trailing end 2106 of the chassis can be at least about 0.2 mm. about 0.3 mm, about 0.4 mm, about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm narrower than a width of the leading end 2101 of the chassis.

[0131] The non-circular shape of the outer perimeter may have a plurality of lobes 2107 projecting outward from a plurality of elongate sides 2108 as described elsewhere herein. Each of the three fixation arms 2120 can extend outward from a respective one of the plurality of elongate sides 2108. The awnings 2126 may project out over the anterior-facing surface of the posterior platform 2105 such that they are positioned generally opposite one another. A first awning 2126 may be positioned near, for example, an origin portion 2103 of the leading fixation arm 2120c and a second awning 2126 may be positioned on a lobe 2107Attorney Docket No.: 058226-509001 WO between the other two fixation arms 2120a, 2120b. The span of the recesses 2104 defined by the awnings 2126 and the posterior platform 2105 is sufficient to accommodate a span of the IOL haptics therebetween.

[0132] The central opening 2115 may have a diameter as described elsewhere herein so that the optic of the IOL may be supported on the anterior-facing surface of the posterior platform 2105 without the optic slipping through its diameter (e.g., between about 4 mm up to about 6 mm). The IOL may be inserted within the recesses 2104 under the awnings 2126. Thus, the diameter between the first and second opposing awnings 2126 is sufficient for IOL insertion. IOLS are typically foldable and therefore the diameter between the first and second awnings 2126 can vary' widely. In some implementations, the opposing awnings 2126 are fully connected to one another along the elongate sides 2108. The opposing awnings 2126 can include extensions along each of the elongate sides 2108 forming a complete overhanging surface above the posterior platform 2105 that defines an upper aperture or anterior opening 2127 (see FIGs. 3A-3B). The anterior opening 2127 can have a maximum diameter that is larger than a maximum diameter of the central aperture 2115 of the posterior platform 2105. For example, the anterior opening 2127 (which can be a freeform shape as shown in FIGs. 3A-3B) can be greater than about 6 mm along at least one dimension so that the IOL can be manipulated into place and fully unfurl into position with the recesses 2104. The diameter of the anterior opening 2127 can be greater than 6 mm up to about 8 mm. The central aperture 2115 is preferably circular, but the anterior opening 2127 need not be circular. The anterior opening 2127 can have any of a variety of geometric or free-form shapes. In some implementations, the anterior opening 2127 can incorporate one or more out-croppings configured to extend over and cover selected areas of the IOL, as described in more detail elsewhere herein. The anterior opening 2127 can also incorporate one or more centrally-extending features 2117 to directly visualize the device 2100 through the pupil during implantation even if the pupil narrows in size mid-surgery. The centrally- extending features can project to define at least one narrower diameter around the circumference of the anterior opening 2127 that is less than about 7 mm down to about 5 mm, preferably about 6 mm.

[0133] The IOL may be positioned against the posterior platform 2105 above the central aperture 2115 so that the central axis CA extending antenor-to-posterior through the central aperture 2115 extends through the optic of the IOL. Light is permitted to pass through the aperture 2115 as well as the IOL positioned on the posterior platform 2105. TheAttorney Docket No.: 058226-509001 WO central aperture 2115 can be substantially co-axial with the optical axis of the IOL once the IOL is positioned against the posterior platform 2105. The central aperture 21 15 has a diameter sized to allow the optic of the IOL to be supported on the anterior-facing surface of the posterior platform 2105 without the IOL falling through into the posterior chamber. The diameter of the central aperture 2115 avoids the posterior platform 2105 from overlapping substantially with the optic of the IOL so that it allows light to pass through the device without any optical disturbance as it passes towards the retina. The diameter of the aperture 2115 is designed to be generally universal for a wide range of IOL types. Conventional IOLS typically have optics with an outer diameter of 6 mm although this size can vary depending on the IOL. A central aperture 2115 having a diameter that is less than 5.0 mm down to about 4.0 mm, preferably about 4.25 mm - 4.75 mm, can be used with some IOLs. A central aperture 2115 having a diameter that is between 5.0 mm to about 6.0 mm can be used with most IOLs such that the device is nearly universal for use with any conventional haptic- stabilized IOL. The minimum inner diameter of the aperture 2115 can be greater than about 3.0 mm, greater than about 3.5 mm, 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 about 10 mm, up to about 15 mm, and any range in between. The central aperture 2115 inner diameter can be between about 4 mm to about 8 mm, or between about 4.3 mm up to 6.0 mm. The inner diameter of the central aperture 2115 can approach the outer diameter of a common IOL optic, for instance at least about 5.5 mm or 6.0 mm. In an implementation, the minimum inner diameter of the aperture 2115 can be small enough to create a pin-hole effect to create an extended depth of focus. In this implementation, the inner diameter of the aperture 2115 can be less than about 3.0 mm down to about 1.5 mm, including 2.0 mm and 2.5 mm inner diameter.

[0134] The aperture diameter can be selected to maintain a particular hoop strength to limit the risk of accidentally passing the IOL through the aperture 2115 upon implantation. Smaller aperture diameters can increase the hoop strength compared to larger aperture diameters. A stiffer chassis or housing limits distortion of the aperture 2115 when placed under tension and / or compression. The increased stiffness of the IOL housing can also facilitate easier insertion of the IOL following fixation in the eye. In other implementations, the implant preferably extends at least in part through the aperture 2115 when positioned within the device. In these implementations, the aperture 2115 is preventedAttorney Docket No.: 058226-509001 WO from distortion while mated with the implant even though the aperture 2115 may undergo some distortion during insertion of the implant through or into the aperture 2115. Regardless, the configuration, once the implant and the device are positioned relative to one another and relative to the eye anatomy, the aperture 2115 and other parts of the device supporting the implant are generally stiff enough to prevent distortion and undergoing changes in shape that would negatively impact the patient’s visual quality through the optical element(s) of the system.

[0135] The posterior support structure or platform 2105 of the device 2100 can have an anterior-facing, support surface directed towards a front of the eye when the platform 2105 is in use and a posterior-facing surface directed towards a back of the eye against the capsular bag when the platform 2105 is in use. The posterior platform 2105 can provide several functions. The posterior platform 2105 can have a surface (the anterior-facing surface or posterior-facing surface) forming a stable platform against which an IOL can be placed during use. The posterior platform 2105 can take the place of a capsular bag and can set the effective lens position of the IOL within the eye. The geometric and mechanical function of the posterior platform 2105 not only supports the IOL when in use, it can also serve to assist in the centration of an IOL in the case of an asymmetric eye or asymmetric surgical procedure. The posterior platform 2105 provides artificial anterior capsule support for the IOL and a stable platform structure in the eye recapitulating the native anterior capsule. The posterior platform 2105 can be substantially flat or planar between the anterior-facing surface and the posterior-facing surface. The thickness of the posterior platform 2105 between the anterior-facing surface and the posterior-facing surface can be minimized while still providing sufficient support to the IOL. The thickness can be between about 0.02 mm and 1.5 mm, about 0.25 mm - 1.0 mm, or between about 0.5 mm and 0.8 mm. The posterior platform 2105 can be about 0.20 mm - about 0.35 mm. The thickness of the posterior platform 2105 can be thinner than 0.2 mm and still provide sufficient support for an IOL. For example, the posterior platform 2105 can be reinforced with a stiffer material to reinforce it and limit its distortion despite being only 0.2 mm thick. Alternatively, the posterior platform 2105 can have an increased thickness (e.g, about 0.50 mm up to about 1.0 mm) and the material thickness sufficient to limit distortion of the device even when placed under tension and / or compression. Increased stiffness of the support structure can facilitate easier insertion of the IOL following implantation. This can additionally increase the hoop strength of an aperture 2115 extending through the posterior platform 2105 as described in more detailAttorney Docket No.: 058226-509001 WO below, which can limit the risk of the IOL accidentally passing through the aperture 2115 upon implantation of the TOL in the device 2100. Reinforcement of the devices described herein to avoid distortion and risk of the IOL passing through the device is discussed in more detail below. In some implementations, a central region of the device defining the aperture 2115 may have a greater thickness than a perimeter region of the device such that the region supporting the implant is prevented from distortion and inadvertent tilt of flip of the implant being supported. For example, an IMT may be inserted at least partially through the aperture 2115 and supported by a thicker central region of the device that is shaped to mate with a corresponding waist of the IMT.

[0136] The posterior platform 2105 and the side walls 2112 can be reinforced due to increased material thickness of those regions of the device. The posterior platform 2105 can be, for example, about 0.50 mm) and the side wall 21 12 can be, for example, about 0.35 mm up to about 0.60 mm or up to about 1.5 mm. The increased stiffness of the support structure provided by the increased material thickness can facilitate easier insertion of the IOL following implantation. The increased material thickness can additionally increase the hoop strength of the central aperture 2115 extending through the posterior platform 2105, which can limit the risk of the IOL accidentally passing through the aperture 2115 upon implantation of the IOL in the device 2100.

[0137] The diameter of the central aperture 2115 also can be reduced to increase the hoop strength of the posterior platform 2105. For example, the central aperture 2115 can have a diameter that is less than about 5.0 mm down to about 4.0 mm, preferably about 4.40 mm - about 4.75 mm so as not to interfere with the optics of the IOL. As discussed elsewhere herein the material of one or more regions of the device can be translucent or opaque for visualization purposes. A platform 2105 that is non-transparent would interfere with the optics of the IOL unless it incorporated a central aperture 2115 to allow light to pass through the IOL unhindered. Thus, the central aperture 2115 is selected to have a size that is large enough to prevent significant interference, but small enough to support the IOL and prevent the optic from falling through the aperture 2115.

[0138] The aperture size alone or in combination with the posterior platform thickness and / or side wall thickness can resist distortion of the device that could otherwise be caused by the tensioned fixation arms. The aperture diameter can also limit the risk of accidentally passing the IOL through the aperture 2115 upon implantation due to not just the size, but the increased hoop strength of the aperture 2115. Smaller aperture diameters canAttorney Docket No.: 058226-509001 WO increase the hoop strength compared to larger aperture diameters. A stiffer IOL housing limits distortion of the aperture 21 15 when placed under tension and / or compression. The increased stiffness of the IOL housing can also facilitate easier insertion of the IOL following fixation in the eye.

[0139] The thicker side walls 2112 of the device can reduce the space within which the IOL can be manipulated. To provide more space for IOL manipulation within the recess 2104, the external length along the long axis of the device can be increased to accommodate the thicker side walls 2112 and provide an internal length of the recess along the same axis for IOL insertion and manipulation. The posterior platform 2105 along the long axis of the device can have an external length of about 9.2 mm and an internal length along the same axis that is about 8.5 mm such that a thickness of each side wall is about 0.35 mm. To provide additional reinforcement to the device 2100, the side wall cross-sectional thickness can be increased to about 0.60 mm. The platform along the long axis can be increased to about 11 mm such that an internal length along the same axis is about 9.8 mm. The increased cavity length can provide more space within which the IOL can be manipulated that, combined with the increased side wall thickness, provides an external length of the device that is increased. The longer device can be fixated through the pars plana and thus, posterior to the apex of the ciliary body and the pars plicata, such that even if the device on the plane of the ciliary apex is too wide, there can still be space for implanting the larger IOL housing. The short axis width can be impacted by the thicker side walls 2112 as well. The posterior platform 2105 along the short axis of the device can have an external width of about 6.60 mm and an internal width along the same axis that is about 5.90 mm such that a thickness of each side wall 2112 is about 0.35 mm. Each side wall 2112 cross- sectional thickness can be increased to 0.60 mm as discussed above. The platform 2105 along the short axis can be increased to about 7.4 mm such that an internal width along the same axis is about 6.2 mm.

[0140] The devices described herein are used to support an optical element, such as an IOL, within an eye. The devices described herein can incorporate one or more features configured to engage with at least a portion of the capsular bag, if present, for centration or fixation in the eye. The devices described herein can incorporate one or more features configured to fix and center the device in the eye even where capsular bag support is lacking, for example, due to iatrogenically compromised lens support during the time of surgery' or as a late complication of a previous surgery'. Whether there is capsular bagAttorney Docket No.: 058226-509001 WO support or not, visualization of the device during implantation is important. In some implementations, the curved or biased fixation arms 2120 can allow for direct visualization of the device through the pupil such that the arms 2120 may be more readily grasped, which is particularly useful during extemalization and fixation of the device within the eye. One or more of the fixation arms 2120 can be non-transparent so that they are more easily visualized through the pupil during implantation. In some implementations, only a portion of the fixation arm 2120 designed to project out from behind the iris so as to be visualized directly through the pupil is non-transparent.

[0141] The devices described herein can be viewed directly through the pupil even if there are no fixation arms 2120. In some implementations, the anterior geometry of the device 2100 is modified to improve anterior visualization through the pupil. For example, the anterior awnings 2126 can be sized and shaped to have at least a portion that projects inwardly or more centrally than an adjacent portion (e.g., towards a center axis extending through the central aperture 2115) such that the centrally-projecting portion of the aw ning 2126 is visible anteriorly through a dilated pupil without being substantially blocked by the iris. The awnings 2126 can be formed of a non-transparent material to improve this direct visualization. The geometry of the awnings 2126 can be visible relative to the IOL being implanted without impacting the optics of the IOL. This can increase the likelihood that the IOL will be properly secured within the recess 2104 of the device 2100. Post-operative lens dislocation can occur when the IOL haptic is left in a position that is anterior to the device 2100. Uncertainty of lens position can increase surgical time and the potential for tissue trauma as surgeons manipulate the device and / or tissue to confirm lens position relative to the device. Direct visualization of the device 2100 through the pupil lessens this uncertainty, particularly where intra-operative pupil diameter decreases mid-surgery.

[0142] FIGs. 3A-3B illustrates an example of the anterior awnings 2126 having a centrally-projecting visualization feature 2117 and two junction covers 2131. The visualization feature(s) 2117 can project centrally to allow for direct visualization of the device 2100 while avoiding substantially interfering with optics of the IOL after implantation by having a minimum inner diameter of about 4 mm. The junction covers 2131 provide coverage of the IOL haptic where it forms a junction with the optic of the IOL to prevent this region of the IOL from contacting the iris 10. The visualization features 2117 can project sufficiently towards a central axis of the central aperture 21 15, for example, at least about 2.5 mm to about 3 mm aw ay from the central axis so that the features 2117 are visible throughAttorney Docket No.: 058226-509001 WO the pupil during an implantation procedure. The centrally-projecting visualization feature 21 17 can narrow an inner dimension of the anterior opening 2127, for example, a distance of the anterior opening 2127 along the long axis of the device while the overall dimensions of the anterior opening 2127 remain relatively large for accessing the internal recess 2104. The distance along the long axis of the device between the central-most edges of the anterior opening 2127 formed by the opposing awnings’ visualization features 2117 can be at least about 7.0 mm down to about 5.0 mm, preferably about 6.0 mm. This distance is selected to be larger than the diameter of the central aperture 2115. For example, the diameter of the central aperture 2115 can be about 4.75 mm and the distance between the visualization features 2117 can be about 5.00 mm, about 5.25 mm, about 5.50 mm, about 5.75 mm, about 6.00 mm up to about 7.00 mm. Thus, even where the awnings 2126 incorporate the one or more visualization features 2117, the dimension of the anterior opening 2127 defined by the features 2117 can be larger than the diameter of the central aperture 2115.

[0143] The features 2117 can project centrally away from the leading fixation arm 2120c such that coverage provided by the awning 2126 near this arm is greater than coverage provided by the awning 2126 near the ends or comers of the device 2100 where the short sides 2107 meets the long sides 2108. The pair of features 2117 can therefore be positioned on the short sides 2107 of the device and project along the long axis. The visualization features 2117 can alternatively be positioned on the long sides 2108 of the device and project along the short axis (i.e., turned 90 degrees relative to what is shown in the figure). The visualization features 2117 can be located anywhere around the perimeter of the anterior region of the device so long as they extend sufficiently inw ard to be visible out from behind the iris fringe when the device is positioned in the eye. Discrete visualization features 2117 avoid narrowing the anterior opening 2127 around its full circumference providing anterior visualization without significantly impairing the user’s ability to position the 1OL through the anterior opening 2127 within the recess 2104 anterior to the platform 2105.

[0144] The discrete visualization features 2117 in combination with the one or more junction covers 2131 create a free-form shape to the anterior opening 2127 (see FIGs. 3A-3B). The undulating inner perimeter forming the free-form shape of the anterior opening 2127 can be relatively larger along at least one direction (e.g.. between the long sides) and relatively smaller along another direction (e.g., between the short sides). The free-form shape also can create an even larger distance between edges of the perimeter in a particular orientation around the anterior opening 2127 that can be leveraged for insertion of the IOLAttorney Docket No.: 058226-509001 WO into the recess. The free-form shape of an anterior opening 2127 can be different than the circular shape of the inner perimeter 2109 defining the posterior opening 2115. As discussed above, the distance between the visualization features 2117 projecting inwardly from the short sides 2107 of the device can be less than, for example, a distance between the long sides 2108 of the device. The distance between the visualization features 2117 as well as the distance between the long sides 2108 of the device can be larger than the diameter of the central aperture 2115. For example, the undulating free-form shape of the anterior opening 2127 can also define a distance comer-to-comer across the center of the central aperture 2115 that is larger than the distance between the visualization features 2117, larger than the distance between the junction covers 2131, and also larger than the distance between the long sides 2108 of the device. The IOT can be inserted (or removed) through the anterior opening 2127 taking advantage of the asymmetrical free-form shape of the anterior opening 2127 by orienting the widest dimension of the IOL to slide between the widest part of the anterior opening 2127. Once inserted through the anterior opening 2127, the IOL can be rotated or adjusted around the visual axis to orient the IOL within the recess.

[0145] The devices described herein have a chassis sized large enough and / or fixation arms that are long and / or flexible enough for trans-scleral fixation through the more posterior, larger diameter region of the ciliary body (i.e., the pars plana). Fixation through this region of the ciliary body avoids penetrating critical structures of the pars plicata and the associated risks. As discussed in detail above, the fixation arms 2120 of the device are designed to be placed under tension to locate and stabilize the device within the eye. The geometry of the device can ensure that even when the arms are placed under tension, the device remains substantially within a single Z-plane and does not undergo distortion that causes lift of the awnings 2126 and / or visualization features 2117, particularly at the location of the leading fixation arm 2120c or any location of the device with narrowing radius under tension that are particularly prone to lifting of a visualization feature 2117. Each fixation arm 2120 can have a spring force that is a function of elongation of the material when under a load compared to, for example, an open loop haptic or coil spring may have a spring force provided due to bending of a material that has a substantially fixed length. The fixation arms 2120 once anchored in the eye can be under tensile stress and material elongation. For example, each fixation arm 2120 can provide for extension over a radius of between about 8.0 mm to 10.5 mm to accommodate diameters between about 16 mm to about 21 mm. Diameters in this range are further away from the limbus and as a result further away fromAttorney Docket No.: 058226-509001 WO the iris. The device has an operable range of tension for function. As an example, the device can be under a first amount of tension once implanted (X tension). The first amount of tension is the amount of tension in the minimum acceptable diameter. In other words, the device is under a minimum amount of tension in order to function, but is capable of being placed under greater tension to accommodate larger diameters. In the example of fixation arms 2120 capable of accommodating both 16 mm and 21 mm extension, each force transfer arm can operate while under the first tension X and while under at least a second tension. The second tension can be the sum of the first tension X plus a distance of tension (e.g., 0.5 mm of tension). The fixation arms can withstand the differential tension available in each extension ratio. To further illustrate the example, if each fixation arm 2120 in this implementation is about 4 mm long, then the second tension (X tension + 0.5 mm of tension) can undergo a 12.5% increase in elongation to function at the 16 mm diameter and also function up to the 21 mm diameter. If the fixation arms 2120 in this example are 2 mm long, then the second tension (X tension + 0.5 mm of tension) can undergo a 25% increase in elongation to function at the 16 mm diameter and also function up to the 21 mm diameter. If the fixation arms in this implementation that are about 6 mm long, then the second tension (X tension + 0.5 mm of tension) can undergo a 6.25% increase in elongation to function at the 16 mm diameter and also function up to the 21 mm diameter. The decreased spring force of the fixation arms 2120 can enhance the safety and function of the device because the tension of the footplate on the ocular tissue is less dependent on variables that are difficult for the surgeon to assess — the eye’s inherent dimensions and the specific location of the incisions. Additionally, the length of the fixation arm (e.g., between about 2 mm to 6 mm) as well as the inward curve (anteriorly or posteriorly) of at least one or more fixation arm 2120 improves access and visualization for the surgeon to find and fix the arm during the operation. The device can have a relaxed fixation diameter that is between about 16 mm up to about 21 mm, preferably between about 16.50 mm up to about 18.00 mm, where the radius of the circle is measured from the center of the central aperture 2115 to an inner facing surface of the footplate 2125 of the straight fixation arm 2120.

[0146] The chassis of the device is designed to have minimal bulk allowing for the device to be inserted via small incisions while still providing enough space for the IOL to reside within it. The chassis geometry is also designed to minimally distort under varying loads. The chassis achieves these goals by having an asymmetric geometry (e.g.. wider at the leading end 2101 than the trailing end 2106) and three-point fixation with the arms 2120.Attorney Docket No.: 058226-509001 WOThe leading fixation arm 2120c can extend at an angle from the midline of the device (i.e.. the midline between the leading and trailing ends) that is about 90 degrees to be substantially perpendicular. The trailing fixation arms 2120a, 2120b can each extend at an angle from the midline of the device that is about 30 degrees. The leading and trailing fixation arms provide the three-point fixation. The leading fixation arm 2120c can pull along the long axis of the chassis (i.e., at about 90 degrees) while the trailing fixation arms 2120a, 2120b can pull at about 30 degrees from the short axis of the chassis. As discussed elsewhere herein, the leading fixation arm 2120c can be straight while the trailing fixation arms 2120a, 2120b can be biased inward. The fixation arms need not have uniform length due to the shape of the chassis (e.g., two elongate sides and two short sides) and the presence of three-point fixation. The fixation arms can have different lengths to distribute the stress on the arms in different ways around the device perimeter. For example, the straight leading fixation arm 2120c can be shorter than the inwardly-biased fixation arms 2120a, 2120b. This distributes the stress on the shorter leading arm 2120c at larger fixation diameters differently than the stress on the inwardly biased arms 2120a, 2120b at the larger fixation diameter. The tension applied to the chassis causes distortion in select areas around the perimeter resulting in a change in radius. The distortion causes some of those areas to undergo an increase in radius whereas other areas around the perimeter undergo a decrease in radius. The chassis side wall 2112 can be designed to encourage some areas to increase and others to decrease in radii upon the application of tension on the device due to the fixation arms. Areas of the side wall 2112 where tension causes radii to increase can be designed to be thinner whereas areas of the side wall 2112 where tension causes radii to decrease can be designed to be thicker. The wall thickness around the perimeter of the device may vary thereby removing another point of symmetry.

[0147] To mitigate inadvertent distortion of the device such as awning lift, the geometry of the anterior region of the device can be designed to have awnings 2126 that extend minimally toward the central axis CA of the device (e.g., less than about 1 mm) or to have no awnings near the origin portion 2103 of the fixation arms 2120 or where there is a decrease in radii. The visualization feature(s) can extend radially inwardly from the outer perimeter at a location that increases in radius or at a location that does not change in radius when the plurality of fixation arms are placed under tension. The trailing end 2106 of the device can have an awning 2126 with a centralized visualization feature 2117 that projects toward the central axis CA and is located between the trailing fixation arms 2120a. 2120bAttorney Docket No.: 058226-509001 WO(see FIGs. 3A-3B). The visualization feature 2117 of the awning 2126 can be located to a side of the origin portion 2103 of the fixation arm 2120c so that it is projecting from a location near the outer perimeter having a radius that increases in radius or that does not change in radius upon placing the fixation arm under tension.

[0148] Placing the one or more visualization features 2117 along the elongate sides 2108 away from the location of the fixation arms and / or near the comers where the radius increases while the device is under tension mitigates deflection of the visualization features 21 17 away from their plane. The location of the visualization features 2117 off-set from or to the side of the origin of the fixation arms ensures the visualization features 2117 extend substantially within the horizontal plane prior to and after placing the fixation arms under tension.

[0149] In some implementations, the visualization features 2117 are designed to deflect upon the application of tension, but they are designed to deflect away from the iris. For example, the geometry of the anterior region of the device can be designed to encourage the visualization features 2117 to deflect towards the IOL within the recess 2104 when the arms 2120 are placed under tension.

[0150] The side wall 2112 of the chassis including along the elongate sides 2108 and along the shorter sides 2107) can have a thickness that is relatively uniform around the perimeter of the device including in the comers and in the location of each fixation arm 2120. The side wall 21 12 of the chassis can also have a thickness that changes around the perimeter of the device. The greatest thickness of the side walls 2112 can be at the location of the two trailing fixation arms 2120a, 2120b along the elongate sides 2108. The thickness of the side wall 2112 at the location of the leading fixation arm 2120c (z.e., along the short side 2107) can be less than the thickness of the side wall 2112 at the location of the trailing fixation arms 2120a, 2120b (z.e., along the elongate sides 2108). The thickness of the side wall 2112 at the location of the visualization feature(s) 2117 can be less than the thickness of the side wall 2112 along the elongate sides 2108 and the thickness of the side wall 2112 at the location of the leading fixation arm 2120c. The wall thickness around the perimeter of the device varies thereby removing another point of symmetry.

[0151] The optical element can be inserted within the device in a variety of ways. The optical element can be injected from an injector that is located anterior to the device so that release of the optical element from the injector positions the optical element onAttorney Docket No.: 058226-509001 WO top of the device prior to a user manipulating the device to insert it through the anterior opening 2127. The optical element can be allowed to unfurl prior to inserting the optical element through the anterior opening 2127 of the device. In other methods, the optical element can be manipulated into the device while it is at least partially folded. The optical element can also be injected by the injector through the anterior opening 2127 so that, the case of an IOL, at least one haptic of the IOL is injected directly into the chassis of the device. The optical element can be allowed to unfold while at least partially implanted within the device and then the remainder of the lens manipulated into position within the device. The optical element can be manipulated by a user through one or more trocar cannulae.

[0152] Implementations of the support structure may have an outer perimeter of various geometrical shapes, axes and symmetries or non-symmetries. For example, the device may have a long axis and a short axis, two shorter sides and two longer sides. FIGs. 3A-3B illustrates an outer perimeter having a long axis A and a short axis Z with two longer sides 2108 and two shorter sides 2107. The shorter sides may be straight and parallel to one another, straight and slightly angled with respect to one another, or at least partially or entirely curved outwardly away from the central axis of the device that passes through the aperture. The longer sides may also include both a straight portion and a portion curved outwardly away from the device’s central axis. If a longer side includes both a straight portion and a slightly curved portion, then the slightly curved portion may be adjacent the junction between the outer perimeter and the fixation arm associated with the longer side. A region of the elongate sides 2108 on the trailing end 2106 of the device can be curved so it does not lie parallel to straight lines. A region of the elongate sides 2108 on the leading end 2101 of the device can straighten out so that this segment does lie substantially parallel to straight lines. Thus, each elongate side 2108 can have both straight and curved portions or can be completely straight or can be completely curved. The trailing end 2106 of the device can be narrower than the leading end 2101 due to the elongate sides 2108 not being perfectly parallel along their length.

[0153] The longer sides may be parallel or nominally parallel (in the case of slight curvature of at least a portion of the longer sides), to produce an outer perimeter akin to a rectangle, with shorter, straight, or rounded sides joined to the longer sides at rounded comers. Or the longer sides may be partially or entirely slightly angled or nominally angled with respect to one another (in the case of slight curvature of at least a portion of the longerAttorney Docket No.: 058226-509001 WO sides), to produce an outer perimeter akin to a slightly tapered trapezoid, with shorter straight or rounded sides joined to the longer sides at rounded comers.

[0154] As used herein, the term "about” or ‘'nominally” means a range of values including the specified value, which a person of ordinary skill in the art would consider reasonably similar to the specified value. In aspects, about or nominally means within a standard deviation using measurements generally acceptable in the art. In aspects, about or nominally means a range extending to + / - 10% of the specified value. In aspects, about or nominally includes the specified value.

[0155] A radius of curvature of at least a portion of each longer side may be much larger than a radius of curvature of a shorter side, thereby producing a much more gradual or subtle bowing of the longer side compared to the degree of curvature of the shorter side. The comers may have a radius of curvature smaller or much smaller than a radius of curvature of either the longer sides or shorter sides, thereby providing a support structure with an outer perimeter having at least two or three or more different radii of curvature to produce the desired outer perimetrical shape. In a preferred embodiment, a support structure has longer sides with a large radius of curvature to produce very slight outward bowing (e.g., about 3.5 mm up to a flat line), shorter sides with a smaller radius of curvature by at least one order of magnitude compared to the radius of curvature of the longer sides, to produce more exaggerated bowing for the shorter sides, and rounder comers having a much smaller radius of curvature (e.g., no radius up to about 3.5 mm or about 5.0 mm).

[0156] The support structure may have an outer perimeter that is symmetrical with respect to the long axis of the device such that each side of the outer perimeter is a mirror-image of the other about the long axis and is also symmetrical with respect to the short axis of the device, or may have an outer perimeter that is symmetrical with respect to the long axis of the device, but which is non-symmetrical with respect to the short axis of the device.

[0157] A support structure may have opposed awnings on opposite sides of the central axis of the device that passes through the central aperture. Each of these aw nings forms a recess underneath the awning for securing one of an IOL'S haptics when an IOL engages the support structure. As disclosed herein, each such awning may have a contour formed of various inwardly projecting portions, including, for example, a centrally -projecting visualization feature that extends sufficiently inwardly towards the central axis so as to be visible behind an iris during implantation of the device in the patient’s eye, and / or one orAttorney Docket No.: 058226-509001 WO more additional projections extending inwardly so as to at least partially cover a portion of an IOL haptic when the haptic is placed underneath the awning. In some embodiments, the awnings are arranged such that each awning is a mirror-image of the other around the device's short axis and symmetrical with respect to the short axis. In these cases, the entire lens support device may be symmetrical with respect to either or both of the device's long axis and short axis. Alternatively, the awnings may be arranged such that they are non- symmetrical with respect to either or both of the device’s long axis and short axis, and may be of such configuration that no axis of symmetry exists within the device for the aw nings. In addition, when such awnings are coupled with the various outer perimetrical shapes available for the device, a lens support device may have outer perimetrical symmetry about one or both of the device’s long axis and short axis, and also have two awnings that are either symmetrical about one or both of the device’s long axis and short axis, or which are non- symmetrical with respect to both long and short axes.

[0158] The support structure may have an outer perimeter shape that has one configuration with the device at rest before implantation, and a second, different geometrical configuration when the structure is implanted and under tension. For example, with the device at rest, in a device having two shorter sides and tw o longer sides, the entire length of, or a portion of, each of the longer sides may be slightly angled tow ards one another so that the lens support body is slightly tapered. When such a slightly tapered device is made of suitable dimensions and suitably flexible materials, the device, when placed under tension through implantation of the fixation arms into contact with the sclera of the eye, the outer perimeter geometrical shape may change from a slightly tapered configuration to a less slightly tapered configuration or a configuration more closely akin to a rectangle, with longer sides that are closer to being, or are actually or nominally, parallel. This modification of outer perimetrical shape may be helpful to create the desired shape of the support structure when implanted, when the device is such that tensioning tends to distort the original at-rest shape of the device.

[0159] The devices described herein can serve to support implantable intraocular devices including devices having optical elements, such as intraocular lenses (IOLS) as described above even where there is insufficient or absent capsular support. The devices described herein can support other types of implantable ophthalmic devices that are configured to be implanted long-term within the eye, devices with optical elements including implantable miniature telescope (IMT), magnifiers, cameras, and the like, as well as devicesAttorney Docket No.: 058226-509001 WO without optical elements such as an artificial iris, drug eluting ring implants for posterior segment drug delivery, biosensors for continuous monitoring of an intraocular characteristic (e.g., pressure, glucose, inflammation), and others. The devices provides this support with minimal-to-no suturing. The devices are particularly useful for supporting heavier implants such as IMTs, which can be difficult to support particularly where capsular bag integrity is compromised, preventing inadvertent tilt and dislocation of the implant relative to the eye anatomy.

[0160] Suitable materials or combinations of materials for the preparation of the various components of the devices disclosed herein are provided throughout. It should be appreciated that other suitable materials are considered. The device can be constructed from any implant grade material that can provide the functions required of the posterior platform, fixation arms, and footplates. Materials that may be employed in this device could be but are not limited to silicone elastomer, fluorosilicone elastomer, polyurethane, hydrophilic or hydrophobic acrylics, polyolefins, nylons, PVDF, PMMA, polyimide, nitinol, titanium, stainless steel, or other implant grade materials. The device may be made from a combination of materials that are geometrically mated together, chemically bonded or welded to one another, overmolded, encapsulated, or other means for joining multiple materials. A given device element may be made of multiple materials. The fixation arms may be constructed from an inelastic or semi-rigid material common to ophthalmic applications such as polypropylene. Nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylics, or high durometer silicones. The fixation arms can incorporate or be formed of elastic materials such as acrylics, polyurethanes, silicone elastomers or copolymers thereof that facilitate manipulation of the fixation arm during implantation. In still further implementations, the fixation arm can be formed of a semi-rigid or rigid plastic material such as polypropylene, Nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylics, or high durometer silicones embedded or coated with a soft, elastomeric material such as acrylics, polyurethanes, silicone elastomers or copolymers thereof. As discuss elsewhere herein, one or more inorganic pigments or organic dyes can be incorporated into the material of one or more components of the device for visualization purposes to cause the otherwise transparent material to become translucent or opaque. The pigment or dye can vary including white pigments such as titanium dioxide, or pigments of other colors including purple, blue, green, yellow, orange, red, brown, and black.

[0161] EXAMPLESAttorney Docket No.: 058226-509001 WO

[0162] Example 1

[0163] Pull-through force is the amount of force required to reintemalize the footplate through a sclerotomy after extemalization of the footplate. To assess the expected pull-through force imparted onto an eye across a variety of fixation ranges, model devices were implanted in a model eye set-up. A footplate and fixation arm combination model of 30 durometer silicone was created with an attachment for compatibility with a force gauge. A membrane with similar properties to human sclera was clamped and tightened to a uniform tension for each test. The membrane was a 0.005” thick silicone membrane punctured with a 23-gauge trocar cannula system and the footplate model pulled through the membrane with a 25-gauge microforceps. The opposite end of the footplate model was attached to a force gauge secured to a motorized linear stage. The linear stage was moved away from the membrane at a rate of 1 mm / second such that it imparted a tension on the fixation arm and footplate. Once the footplate pulled through the 23-gauge hole in the membrane, the test was stopped and the force at which the footplate pulled through the membrane recorded.

[0164] Table 1 below lists relevant dimensions of footplates and fixation arms tested on silicone membrane models to determine the effect of dome volume, central thickness Tc. central diameter De, and arm diameter Da on pull-through force.

[0165] Table 1

[0166] FIG. 10A illustrates the expected in vivo tension (or force) in grams force (gf) for devices having a fixation arm diameter Da of 0.40 mm. The x-axis of FIG. 10A represents the total fixation diameter of a device including three fixation arms, each with a footplate positioned at a terminal end. When the device is implanted, the arms are unfurled and extended. The three fixation points sit at a total fixation diameter of about 16 mm to about 21 mm depending on the size of the eye when fixed about 4 mm from the limbus. FIG. 10A shows the amount of tension on the device across the fixation range (e.g., 0.5 gf, 1.0 gf,Attorney Docket No.: 058226-509001 WO2.0 gf, etc.) and the expected force imparted onto an eye at the high end of the fixation range. The slope is useful for comparing devices with variable arm diameter Da.

[0167] FIG. 10B shows the effect of arm diameter DI and dome volume (which is a function of central thickness Tc and central diameter De) on pull-through force of the footplate upon application of force on the fixation arm. Footplates having uniform thickness across the length L of the footplate (“Gen 2"’) where the dome height Tc at the central portion is the same as the thickness Tp at peripheral portions achieved the least amount of pull- through force (i.e., about 15 gf) even with an increased diameter De of the central portion 2130 that was large enough to cover the sclerotomy (De of 0.80 mm). Footplates having a greater central thickness Tc (also referred to herein as “dome height”) compared to the thickness Tp at the peripheral portions achieved greater pull-through force than footplates with uniform thickness. Footplates having a central thickness Tc of 350 pm and a diameter De of 0.80 mm (“Gen 3”) achieved a pull-through force of about 20 gf. Footplates having a central thickness Tc of 300 pm and a diameter De of 1.00 mm (“Gen 4 300”) achieved a pull- through force of about 22 gf. Footplates having a central thickness Tc of 350 pm and a diameter De of 1.00 mm (“Gen 4 350”) achieved a pull-through force of about 31 gf.

[0168] FIG. 11 shows the effect of fixation arm diameter Da on the pull- through force for various footplates. The maximum expected tension of the fixation arms having larger fixation arm diameter Da of 400 pm was 3.4 g compared to the maximum expected tension of the fixation arms having narrower fixation arm diameter Da of 300 pm which was 2.0 g. Narrowing the fixation arm diameter from 400 pm to 300 pm reduces the amount of force necessary to elongate the arm to the same fixation diameter as the thicker fixation arm by approximately 60%. A device with thinner fixation arms exerted less force on the sclera compared to a device with thicker arms when fixated at the same diameter within an eye.

[0169] In this testing set-up, increasing the dome volume, such as by increasing the diameter of the central portion (De) and / or height of the central portion (Tc), required a greater force to pull the footplate through the hole in the membrane. The same resistance to pull-through was achieved by increasing the diameter of the central portion (De) and reducing the arm diameter (Da). Because increasing the height of the central portion (Tc) can elevate the risk of eyelid irritation and conjunctival erosion, increasing central portion diameter (De) to increase dome volume, in combination with reduced fixation arm diameter (Da), are preferred ways to improve fixation of the footplate.Attorney Docket No.: 058226-509001 WO

[0170] Example 2

[0171] A non-linear quasi-static Finite Element Model (FEM) was created in Abaqus (Microsoft) that simulates the pull-through mechanics of the footplate retention system. Virtual representations of the sclera, fixation arm, and footplate were assigned material properties based on the materials of the device and of the natural anatomy that determine how the features behave under load. Conditions were set to dictate how and where the load is applied. A quarter model of the suspension device was developed. The sclera model was approximately 0.50 mm thick and a 0.50 mm diameter hole was created for the fixation arm to pass through. The globe diameter was 24 mm. Hyperelastic material properties were used for both the sclera and the fixation arms to allow for convergence under large strains. These were converted from available linear material elastic material properties. Contact was defined with a friction coefficient of 0. 1 and a penalty formulation. A proximal tensile load was applied to the arm that ramps up linearly to 1 gram force (gf). When the quarter symmetric is factored in, this was equated to 4-gram force over the full fixation arm. Strain and contact pressure were the primary output variables of interest. A variety of devices were simulated to compare the difference in these outputs. It was found that increases in the load can be sustained before pull-through starts to develop by relieving the geometry near the scleral hole and allowing the contact pressure to have a wide distribution area.

[0172] FIGs. 12A-1 to 12A-9 show the effect of increasing compressive force by a footplate 2125. FIGs. 12A-A, 12A-4, and 12A-7 illustrate Gen 2 devices having uniform thickness across the length L of the footplate 2125 of about 0.20 mm. a dome diameter De of 0.8 mm, and a fixation arm diameter Da of 400 pm. The footplate 2125 was a flexible material that is designed to hug the curvature of the sclera upon extemalization. Applying an inwardly -directed force on the fixation arms caused the flexible material of the footplates 2125 positioned outside the eye to press up against the sclera surrounding the sclerotomy (i.e., forming the contact annulus). The lower surface 2132 of the footplate 2125 nearest the sclerotomy (i.e.. the inner perimeter of the contact annulus) compressed against the wound edges of the sclera and the outer ends of the peripheral portions 2135 (i.e., the outer diameter of the contact annulus) lifted away from the sclera by a distance. The peripheral portions 2135 of the footplates 2125 began to lift up away from the surface of the eye. particularly at the outer ends of the peripheral portions 2135 at pressures as low at 0.5 grams force (gf) and as the force applied to the arms 2120 increased (0.5 gf, 2.0 gf, and 4.0 gf), the distance the outer ends lifted away from the sclera increased.Attorney Docket No.: 058226-509001 WO

[0173] FIGs. 12B-1, 12B-4, and 12B-7 show that application of the force to the arms 2120 of a footplate embodiment (0.5 gf, 2.0 gf, and 4.0 gf) created a focal ring 2140 of compressive pressure applied within a pressure annulus. The location of the focal ring 2140 at 0.5 gf was relatively central within the pressure annulus. As the force applied to the arms increased both the pressure annulus and the focal ring 2140 within the pressure annulus moved inward towards an inner perimeter of the contact annulus to be very near the wound edges. A focal ring 2140 of maximum contact pressure appeared that was located a distance of about 0.06 mm from the wound edge upon application of 0.5 gf (see FIG. 12B-1), was located a distance D of about 0.05 mm from the wound edge upon application of 2.0 gf (see FIG. 12B-4), and was located a distance D of about 0.04 mm from the wound edge upon application of 4.0 gf (see FIG. 12B-7). The maximum contact pressure achieved, as determined by FEA (Finite Element Analysis), was 0.297 MPa when assessed at a maximum expected force for each configuration in vivo (see FIG. 13).

[0174] FIGs. 12A-2, 12A-5, and 12A-8 show the effect of increasing the thickness Tc of the central portion 2130 for a greater dome height compared to the peripheral portion thickness Tp when comparing it to FIGs. 12A-1, 12A-4, and 12A-7. FIGs. 12A-2, 12A-5, and 12A-8 show data for Gen 3 devices having a central thickness Tc of 350 pm compared to peripheral thickness Tp of 200 urn, a dome diameter De of 0.8 mm, and a fixation arm diameter Da of 400 pm. Applying an inwardly-directed force on the fixation arms 2120 caused the footplates 2125 positioned outside the eye to press up against the sclera surrounding the sclerotomy forming the contact annulus. The peripheral portions 2135 of the footplate 2125 remained flush and did not lift up away from the surface of the eye, even at the outer ends of the peripheral portions 2135 and at forces as high as 4.0 gf. The lower surface 2132 of the footplate 2125 nearest the sclerotomy (i.e., the inner perimeter of the contact annulus) contacted the wound edges of the sclera, but the compressive pressure was redistributed across the bulk of the central dome.

[0175] FIGs. 12B-2, 12B-5, and 12B-8 show that as the force applied to the arms increased, no focal ring 2140 of compressive pressure within the pressure annulus forms so that the compressive pressure was better distributed across the entire pressure annulus. There were two focal rings of similar pressure. The first focal ring was located about 0.05 mm from the edge of the wound with a peak contact pressure of about 0.20 MPa. The second focal ring was located about 0.12 mm from the edge of the wound with a peak contact pressure of about 0.21 MPa.Attorney Docket No.: 058226-509001 WO

[0176] FIGs. 12A-3. 12A-6, and 12A-9 show the effect of angling the lower surface 2132 of the footplate 2125 relative to the central axis A of the footplate to be more acute. The thickness Tc of the central portion 2130 was 300 pm, the thickness Tp of the peripheral portion 2135 was 200 pm, the dome diameter De was 1.0 mm, and the fixation arm diameter Da of 300 pm. The angle 0 was 84 degrees. Applying an inwardly-directed force on the fixation arms 2120 caused the footplates 2125 positioned outside the eye to press up against the sclera surrounding the sclerotomy forming the contact annulus. The outer ends of the peripheral portions 2135 remained flush and did not lift up away from the eye surface, even at forces as high as 4.0 gf. The lower surface 2132 of the footplate 2125 nearest the sclerotomy (z.e., the inner perimeter of the contact annulus) may contact the wound edges of the sclera, but the compressive pressure gets redistributed across the bulk of the central dome and away from the wound edges.

[0177] FIGs. 12B-3, 12B-6, and 12B-9 show that the force applied to the arms created a focal ring 2140 of maximum contact pressure within the pressure annulus, but the location of the pressure annulus and focal ring 2140 moved outward away from the wound edges (see FIG. 12B-3). The inner perimeter of the pressure annulus was much larger than what is show n for FIGs. 12B-1, 12B-4, and 12B-7 or FIGs. 12B-2, 12B-5, and 12B-8. The overall pressure of the focal ring 2140 was as high as what was found in Gen 2, but the location of that focal ring 2140 moved outward. As the pressure increased, the overall area of the pressure annulus increased, but the maximum contact pressure applied within the pressure annulus (i.e., the focal ring 2140) was reduced. The focal ring 2140 in FIG. 12B-3 was a distance D of about 0.21 mm from the w ound edge upon application of 0.5 gf and substantially disappears upon application of 2.0 gf (see FIG. 12B-6). The footplate 2125 redistributed the compressive pressure across the pressure annulus and relative to the wound edges. The maximum FEA contact pressure achieved upon application of 4 gf was 0. 13 MPa and upon application of 2 gf was 0.061 MPa (see FIG. 13).

[0178] FIG. 13 show s contact pressure (MPa) as a function of distance (mm) from the sclerotomy edge for different anchor geometries discussed above with regard to FIGs. 12A-1 to 12A-9, FIGs 12B-1 to 12B-9, and FIGs 12C-1 to 12C-4 and shown in Table 2 to illustrate the impact of central dome volume and central dome angulation upon application of tension.

[0179] Table 2Attorney Docket No.: 058226-509001 WO

[0180] As mentioned above and as shown in FIG. 13, Gen 2 resulted in a maximum contact pressure of about 0.30 MPa upon application of 4 gf that was located approximately 0.035 mm from the edge of the sclerotomy. A majority of the contact pressure was applied within a distance of about 0.01 mm to about 0. 10 mm from the sclerotomy. Gen 3 had the same dome diameter as Gen 2 (0.8 mm), but the dome height was increased (350 pm) providing a greater dome volume compared to Gen 2. Gen 3 also had a larger fixation arm diameter of 400 pm compared to Gen 2. Gen 3 resulted in a lower maximum contact pressure than Gen 2 (0.21 MPa upon application of 4 gf) that was located further away from the edge of the sclerotomy. A first peak of contact pressure was located about 0.05 mm from the edge of the sclerotomy and a second peak of contact pressure was located about 0. 125 mm from the edge of the sclerotomy. A majority of the contact pressure was applied within a distance of about 0.025 mm to about 0. 14 mm away from the sclerotomy. Gen 4 Rev B and Gen 4 Rev C also had increased dome volume compared to Gen 2 due to the increased dome diameter (1 .0 mm) and more modestly increased dome height of 325 pm compared to Gen 3. Gen 4 Rev B and Gen 4 Rev C also had smaller fixation arm diameter of 300 pm compared to Gen 2 or Gen 3. Gen 4 Rev B had a lower surface of the central dome along the long axis that was curved to match a curvature of the eye and flat along the short axis whereas Gen 4 Rev C had an angled low er surface as described above that did not match the curvature of the eye. Gen 4 Rev B resulted in a maximum contact pressure of that was very similar to Gen 3 at about 0.20 MPa upon application of 4 gf that was located about 0.05 mm from the edge of the sclerotomy. The first peak of contact was followed by a gradual decline in contact pressure over a distance of about 0.20 mm. Gen 4 Rev C with the angled lower surface that did not match the curvature of the eye resulted in the lowest maximum contact pressure of about 0. 13 MPa upon application of 4 gf and about 0.06 MPa upon application of 2 gf and was located about 0.05 mm from the edge. The first peak of contact was followed by a gradual decline in contact pressure over a distance of about 0.25 mm including a secondAttorney Docket No.: 058226-509001 WO small peak of contact pressure of about 0. 12 MPa that was located about 0.225 mm from the edge of the sclerotomy.

[0181] The data show that increasing the dome volume decreases the maximum contact pressure created by the footplates near the sclerotomy (e.g., 0.30 MPa upon application of 4 gf for Gen 2 compared to 0.21 MPa upon application of 4 gf for Gen 3) by 30%. Increasing the dome volume also moves the maximum contact pressure further away from the sclerotomy edge. Angling the lower surface of the dome further decreases the maximum contact pressure applied near the sclerotomy (e.g, 0.20 MPa upon application of 4 gf for Gen 4 Rev B compared to 0. 13 MPa upon application of 4 gf (or 0.06 MPa upon application of 2 gf for Gen 4 Rev C). Decreasing the fixation arm diameter may improve distribution of the contact pressure over a larger area and distribute that pressure outward away from the edge.

[0182] In various implementations, description is made with reference to the figures. However, certain implementations may be practiced without one or more of these specific details, or in combination with other known methods and configurations. In the description, numerous specific details are set forth, such as specific configurations, dimensions, and processes, to provide a thorough understanding of the implementations. In other instances, well-known processes and manufacturing techniques have not been described in particular detail in order to not unnecessarily obscure the description. Reference throughout this specification to ‘’one embodiment,” '‘an embodiment,” ‘'one implementation, “an implementation,” or the like, means that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment or implementation. Thus, the appearance of the phrase “one embodiment,” “an embodiment,” “one implementation, “an implementation,” or the like, in various placed throughout this specification are not necessarily referring to the same embodiment or implementation. Furthermore, the particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more implementations.

[0183] The devices and systems described herein can incorporate any of a variety of features. Elements or features of one implementation of a device and system described herein can be incorporated alternatively or in combination with elements or features of another implementation of a device and system described herein. For the sake of brevity, explicit descriptions of each of those combinations may be omitted although theAttorney Docket No.: 058226-509001 WO various combinations are to be considered herein. Additionally, the devices and systems described herein can be positioned in the eye and need not be implanted specifically as shown in the figures or as described herein. The various devices can be implanted, positioned and adjusted etc. according to a variety of different methods and using a variety of different devices and systems. The various devices can be adjusted before, during as well as any time after implantation. Provided are some representative descriptions of how the various devices may be implanted and positioned, however, for the sake of brevity explicit descriptions of each method with respect to each implant or system may be omitted.

[0184] The use of relative terms throughout the description may denote a relative position or direction or orientation and is not intended to be limiting. For example, “distal” may indicate a first direction away from a reference point. Similarly, “proximal” may indicate a location in a second direction opposite to the first direction. Use of the terms “upper.” “lower,” “top”, “bottom,” “front.” “side,” and “back” as well as “anterior.” “posterior,” “caudal,” “cephalad” and the like or used to establish relative frames of reference, and are not intended to limit the use or orientation of any of the devices described herein in the various implementations.

[0185] As used herein, the term “about” means a range of values including the specified value, which a person of ordinary' skill in the art w ould consider reasonably similar to the specified value. In aspects, about means within a standard deviation using measurements generally acceptable in the art. In aspects, about means a range extending to + / - 10% of the specified value. In aspects, about includes the specified value. One inch or 1” corresponds to 2.54 cm (Si-units).

[0186] While this specification contains many specifics, these should not be construed as limitations on the scope of what is claimed or of w hat may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or aAttorney Docket No.: 058226-509001 WO variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.

[0187] In the descriptions above 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 in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited 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 each intended to mean “A alone, B alone, or A and B together. ” A similar interpretation is also intended for lists including three or more 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 each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.”

[0188] Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

Claims

Attorney Docket No.: 058226-509001 WOCLAIMSWhat is claimed is:

1. A scleral suspension device for supporting an implant within an eye, the scleral suspension device comprising: a support structure upon, against, or within which the implant is supported; and a plurality of fixation arms, each fixation arm of the plurality of fixation arms having a terminal end region comprising a footplate, wherein, upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality7of fixation arms extends through a sclerotomy and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy, wherein, upon tensioning of the plurality of fixation arms, a lower surface of a central portion of each footplate forms a pressure annulus against the external scleral surface, and wherein a first point of contact between the lower surface of the central portion and the external scleral surface that creates a focal point of a maximum contact pressure is a distance away from margins of the sclerotomy.

2. The scleral suspension device of claim 1, wherein the distance is at least 0.05 mm up to about 0.50 mm.

3. The scleral suspension device of claim 1 or claim 2, wherein a geometry7of the footplate provides a distribution of pressure within the pressure annulus upon application of tension on the plurality7of fixation arms.

4. The scleral suspension device of claim 3, wherein the distribution of pressure within the pressure annulus moves the pressure annulus outward further away from the sclerotomy so that the distance is greater than about 0.05 mm.

5. The scleral suspension device of claim 3, wherein the distribution of pressure within the pressure annulus increases an area of the pressure annulus.

6. The scleral suspension device of claim 3, wherein the distribution of pressure within the pressure annulus decreases the maximum contact pressure within the pressure annulus.

7. The scleral suspension device of any one of claims 1-6, wherein the lower surface of the central portion of the footplate relocates the focal point outward to be further away from margins of the sclerotomy.Attorney Docket No.: 058226-509001 WO8. The scleral suspension device of any one of claims 1-7, wherein the footplate is designed to stabilize tension on the device without being pulled through the external scleral surface.

9. The scleral suspension device of any one of claims 1-8, wherein the footplate has a geometry that is designed to preferentially pass through the sclerotomy in an inside-out direction and resist passing through the sclerotomy in an outside-in direction.

10. The scleral suspension device of any one of claims 1-9, wherein the central portion has a dome diameter across an upper surface of the central portion, a dome height between the upper surface of the central portion and the lower surface of the central portion, and a central axis extending through the central portion from the upper surface into the fixation arm to which the footplate is attached.

11. The scleral suspension device of claim 10, wherein the lower surface along at least a first axis forms an angle relative to the central axis of the central portion.

12. The scleral suspension device of claim 11, wherein the angle is nonperpendicular.

13. The scleral suspension device of claim 11 or claim 12, wherein the lower surface around 360 degrees relative to the central axis of the central portion forms an angle that is non-perpendicular.

14. The scleral suspension device of any one of claims 11-13, wherein the angle is about 70 - 88 degrees.

15. The scleral suspension device of any one of claims 11-14, wherein the angle reduces the focal point of the maximum contact pressure exerted by the footplate and distributes the pressure annulus more evenly along the lower surface of the footplate.

16. The scleral suspension device of claim 15, wherein the angle increases the distance and moves the focal point of the maximum contact pressure further away from the sclerotomy.

17. The scleral suspension device of claim 15 or 16, wherein the angle reduces scleral erosion and reintemalization of the footplate.

18. The scleral suspension device of claim 10, wherein the lower surface along at least a first axis is substantially curved.

19. The scleral suspension device of claim 18, wherein the lower surface has a radius of curvature that is steeper than a radius of curvature of the external scleral surface.Attorney Docket No.: 058226-509001 WO20. The scleral suspension device of claim 19, wherein the radius of curvature reduces the focal point of the maximum contact pressure exerted by the footplate and distributes the pressure annulus more evenly along the lower surface of the footplate.

21. The scleral suspension device of claim 19 or claim 20, wherein the radius of curvature increases the distance and moves the focal point of the maximum contact pressure further away from the sclerotomy.

22. The scleral suspension device of any one of claims 19-21, wherein the radius of curvature reduces scleral erosion and reintemalization of the footplate.

23. The scleral suspension device of any one of claims 19-22, wherein the lower surface along the first axis has the radius of curvature and along a second axis perpendicular to the first axis is substantially planar.

24. The scleral suspension device of any one of claims 10-23, wherein the dome diameter of the central portion is about 0.810 mm - 1 mm.

25. The scleral suspension device of any one of claims 10-24, wherein the dome height of the central portion is about 0.210 mm - 500 mm.

26. The scleral suspension device of any one of claims 10-25, wherein the central portion has a dome volume that is about 0.200 mm3- 0.300 mm’.

27. The scleral suspension device of any one of claims 1-26, wherein a diameter of each of the plurality of fixation arms is about 0.20 mm - 0.50 mm.

28. The scleral suspension device of any one of claims 10-27, wherein dome volume and angulation of the lower surface redistribute the pressure annulus applied by the footplate against the external scleral surface.

29. The scleral suspension device of any one of claims 1-28, wherein the footplate further comprises at least one peripheral portion extending outward from the central portion.

30. The scleral suspension device of claim 29, wherein the at least one peripheral portion is designed to be more easily grasped using an ophthalmic tool for manipulation and extemalization of the footplate than the central portion.

31. The scleral suspension device of claim 29 or claim 30, wherein the at least one peripheral portion is sized to be received within a 27-gauge ophthalmic microforceps.

32. The scleral suspension device of any one of claims 1-31, wherein the ophthalmic implant is an intraocular lens, a miniature telescope, magnifier, camera element, intraocular camera, or sensor.Attorney Docket No.: 058226-509001 WO33. The scleral suspension device of any one of claims 1-32, wherein the plurality of fixation arms comprises three fixation arms placed under tension to locate and stabilize the scleral suspension device along three points of fixation.

34. A method of supporting an implant within an eye, the method comprising: inserting a scleral suspension device within an eye, the scleral suspension device comprising: a support structure upon, against, or within which an intraocular lens implant is supported; and a plurality of fixation arms, each fixation arm of the plurality of fixation arms having a terminal end region comprising a footplate, wherein, upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality of fixation arms extends through a sclerotomy penetrating a pars plana region of the ciliary body and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy.

35. The method of claim 34, further comprising tensioning the plurality of fixation arms, wherein a lower surface of a central portion of each footplate forms a pressure annulus against the external scleral surface, wherein a first point of contact between the lower surface of the central portion and the external surface that creates a focal point of a maximum contact pressure is a distance away from margins of the sclerotomy.

36. The method of claim 35, wherein the distance is at least 0.05 mm up to about 0.50 mm.

37. The method of claim 35 or claim 36, wherein the footplate has a geometry that provides a distribution of pressure within the pressure annulus upon application of tension on the plurality of fixation arms.

38. The method of claim 37, wherein the distribution of pressure within the pressure annulus moves the pressure annulus outward further away from the sclerotomy.

39. The method of claim 37 or claim 38, wherein the distribution of pressure within the pressure annulus increases an area of the pressure annulus.

40. The method of any one of claims 37-39, w herein the distribution of pressure within the pressure annulus decreases the maximum contact pressure within the pressure annulus.Attorney Docket No.: 058226-509001 WO41. The method of any one of claims 35 - 40. wherein the lower surface of the central portion of the footplate relocates the focal point of the maximum contact pressure outward to be further away from margins of the sclerotomy.

42. The method of claim 41, wherein the focal point of the maximum contact pressure is a distance from margins of the sclerotomy that is greater than about 0.05 mm up to about a length of the footplate.

43. A scleral suspension device for supporting an implant within an eye, the scleral suspension device comprising: a support structure upon, against, or within which the implant is supported; and a plurality of fixation arms, each fixation arm of the plurality of fixation arms having a terminal end region comprising a footplate, wherein, upon deployment of the scleral suspension device inside the eye, each fixation arm of the plurality of fixation arms extends through a sclerotomy and the footplate of each fixation arm anchors against an external scleral surface surrounding the sclerotomy, wherein, upon tensioning of the plurality of fixation arms, a lower surface of a central portion of each footplate forms a pressure annulus against the external scleral surface, and wherein a geometry of the footplate provides a distribution of pressure within the pressure annulus upon application of tension on the plurality of fixation arms.

44. The scleral suspension device of claim 43, wherein the distribution of pressure within the pressure annulus increases an area of the pressure annulus.

45. The scleral suspension device of claim 43 or claim 44. wherein the distribution of pressure within the pressure annulus decreases a maximum contact pressure within the pressure annulus.

46. The scleral suspension device of any one of claims 43-46, wherein the pressure annulus comprises a focal ring of maximum contact pressure, wherein the lower surface of the central portion of the footplate relocates the focal nng outward to be further away from margins of the sclerotomy.

47. A footplate for a scleral suspension device for supporting an ophthalmic implant within an eye comprising an external scleral surface, the footplate comprising: a central portion;Attorney Docket No.: 058226-509001 WO a first peripheral portion extending outward from a first side of the central portion; a second peripheral portion extending outward from a second side of the central portion, the second side opposite the first side, wherein a central axis of the footplate extends through a geometric center of an upper surface of the central portion, and wherein the footplate comprises a long axis and a short axis perpendicular to the long axis, wherein the long axis extends from a first end of the first peripheral portion through the central portion to a second end of the second peripheral portion.

48. The footplate of claim 47, wherein a lower surface of the central portion along the long axis does not follow a curve of the external scleral surface of the eye.

49. The footplate of claim 47 or claim 48, wherein a lower surface of the central portion along the long axis is arranged at an angle relative to the central axis.

50. The footplate of claim 49, wherein the angle is less than perpendicular.

51. The footplate of claim 49 or claim 50, wherein the angle is about 70 - 88 degrees.

52. The footplate of claim 49, wherein the angle is greater than a curvature of the external scleral surface.

53. The footplate of claim 49, wherein a lower surface of the central portion along the short axis is substantially flat or curved.

54. The footplate of claim 49, wherein the lower surface of the central portion along the short axis is arranged at an angle relative to the central axis.

55. The footplate of claim 54, wherein the angle is less than perpendicular.

56. The footplate of claim 54 or claim 55, wherein the angle is about 70 - 88 degrees.

57. The footplate of claim 54, wherein the angle is greater than a curvature of the external scleral surface.

58. The footplate of claim 47, wherein a lower surface of the central portion forms an angle relative to the central axis that is less than perpendicular.

59. The footplate of claim 47, wherein a lower surface of the central portion follows a curve that is steeper than a radius of curvature of the external scleral surface of the eye.

60. The footplate of claim 47, wherein a taper is applied circumferentially around the central portion that is greater than a curve of the external scleral surface of the eye.Attorney Docket No.: 058226-509001 WO61. The footplate of claim 47, wherein a radius of curvature of a lower surface of the central portion does not follow a curvature of the external scleral surface.

62. The footplate of claim 61, wherein the radius of curvature is greater than the curvature of the external scleral surface.

63. The footplate of any one of claims 47 - 62. wherein the central portion of the footplate creates a contact annulus where a lower surface of the central portion contacts the external surface of the eye, wherein the pressure annulus of the central portion has a size and shape that extends along only at least a portion of the contact annulus.

64. The footplate of claim 63, wherein the pressure annulus is located a distance away from margins of a wound through which the footplate is externalized.

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