Clinical Outcomes of a Prosthetic Capsular Bag for Scleral Fixation of an Intraocular Lens in Eyes without Capsular Support.

Abstract

Fixation approaches for secondary intraocular lenses (IOL) in the absence of capsular support are varied, technically challenging, and can lead to high rates of complications. A scleral-fixated, prosthetic capsular bag (PCB) was developed to provide secure, sutureless fixation of posterior chamber IOLs, and this study reports the first-in-human results of the PCB in eyes without capsular or zonular support. This study was a multicenter, prospective, open-label, single-arm, exploratory, first-in-human investigation. Patients with insufficient capsular and/or zonular integrity to support an IOL were recruited from 3 retina practices in Sydney, Australia. Subjects underwent pars plana vitrectomy with removal of dislocated crystalline lens or IOL as needed. The PCB was inserted using a standard IOL injector with, or without, a preloaded IOL. The PCB was secured trans-sclerally via 3 fixation arms without the use of sutures or scleral pockets. The primary endpoints included the incidence and characterization of adverse events related to the PCB through 12 months postoperatively. Fifteen subjects underwent PCB fixation with secondary IOL placement. There was one device-related serious adverse event: a patient with Marfan's syndrome experienced re-internalization of a single footplate requiring secondary surgical intervention to re-fixate the footplate. There were no cases of conjunctival erosion over the footplates, nor were there any cases of IOL dislocation from the PCB. 93% of subjects had best corrected visual acuity (BCVA) within 1 line of their screening BCVA. On average uncorrected visual acuity (UCVA) improved 12 lines and 71% of subjects had UCVA within 2 lines of their screening BCVA. The PCB provided reliable refractive outcomes, with a mean spherical equivalent of 0.12 diopters (standard deviation = 0.39 D). These first-in-human results suggest that this PCB is a viable platform for secure posterior scleral fixation of an IOL in eyes without capsular support. Additional studies are planned to confirm these findings.