Abstract

Purpose: To evaluate the uveal and capsular biocompatibility of a new material for intraocular lens (IOL) fabrication, manufactured entirely from a crosslinked polyisobutylene (xPIB) polymer, in comparison to a commercial reference IOL in a rabbit model.

Setting: Envigo CRS Israel Limited, Weizmann Science Park, Ness-Ziona, Israel.

Design: Prospective, comparative, randomized animal study.

Methods: Bilateral phacoemulsification was performed in 10 rabbits; 1 eye was implanted with the test IOL, the xPIB IOL, and the other eye was implanted with a reference IOL. Slit-lamp examinations were performed at postoperative weeks 1 and 6. The rabbits were euthanized at six weeks postoperatively, and the eyes were enucleated. After gross examination with the Miyake-Apple view, all eyes were sectioned and processed for histopathologic examination.

Results: No difference was found in the uveal and capsular biocompatibility of the study and control IOLs in the biomicroscopy, Miyake-Apple posterior view, and histopathologic examination. A trend toward lower incidence and mean group severity of Soemmerring's ring was found in the test IOL group.

Conclusions: The xPIB IOL was found non-inferior to the reference IOL. Both groups demonstrated the typical, expected ocular reactions of PCO and Soemmerring's ring after IOL implantation in rabbit eyes.