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

PURPOSE: Fixation approaches for secondary intraocular lenses (IOLs) in the absence of capsular support are varied and 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 was a multicenter, prospective, open-label, single-arm, exploratory, first-in-human investigation.

PARTICIPANTS

Patients with insufficient capsular or zonular integrity, or both, to support an IOL were recruited from 3 retina practices in Sydney, Australia.

METHODS

Patients 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 transsclerally via 3 fixation arms without the use of sutures or scleral pockets.

MAIN OUTCOME MEASURES: The primary end points included the incidence and characterization of adverse events related to the PCB through 12 months after surgery.

RESULTS

Fifteen patients underwent PCB fixation with secondary IOL placement. One device-related serious adverse event occurred: a patient with Marfan's syndrome experienced reinternalization of a single footplate requiring secondary surgical intervention to refixate the footplate. No cases of conjunctival erosion over the footplates occurred, nor were there any cases of IOL dislocation from the PCB. Ninety-three percent of patients showed best-corrected visual acuity (BCVA) within 1 line of the screening BCVA. On average, uncorrected visual acuity (UCVA) improved 12 lines and 71% of patients showed UCVA within 2 lines of the screening BCVA. The PCB provided reliable refractive outcomes with a mean spherical equivalent of 0.12 diopters (D; 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.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.