Biocompatibility evaluation of a new material for intraocular lenses.

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 with a commercial reference IOL in a rabbit model.

SETTING

HBI Biotech Sciences, Weizmann Science Park, Ness-Ziona, Israel.

DESIGN

Prospective, comparative, randomized animal study.

METHODS

Bilateral phacoemulsification was performed in 10 rabbits; one eye was implanted with the test IOL, the xPIB IOL, and the other eye was implanted with a reference IOL. Slitlamp examinations were performed at postoperative weeks 1 and 6. The rabbits were killed humanely at 6 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 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 to be noninferior to the reference IOL. Both groups demonstrated the typical, expected ocular reactions of PCO and Soemmerring's ring after IOL implantation in rabbit eyes.