Long Bridge Medical announces first-in-human clinical results demonstrating the performance of its scleral-fixated prosthetic capsular bag (PCB) for eyes without capsular support. In this prospective, multicenter study, the PCB enabled secure, sutureless posterior chamber IOL fixation with no cases of IOL dislocation or conjunctival erosion. The device delivered strong visual and refractive outcomes, including a 12-line mean improvement in uncorrected visual acuity and highly predictable refractive results. These data position the PCB as a potentially transformative platform for secondary IOL fixation and support continued clinical expansion.
Published April 24, 2026
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Authors: Frank L. Brodie, Ayman Naseri, I-Van Ho, Thomas Pham, Matthew Clarke, Jay M. Stewart, Julie Schallhorn, Eugene De Juan, Matthew P. Simunovic
Abstract
Purpose
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.
Design
This study was a multicenter, prospective, open-label, single-arm, exploratory, first-in-human investigation.
Subjects
Patients with insufficient capsular and/or zonular integrity to support an IOL were recruited from 3 retina practices in Sydney, Australia.
Methods
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.
Main Outcome Measures
The primary endpoints included the incidence and characterization of adverse events related to the PCB through 12 months postoperatively.
Results
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).
Conclusions
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.