Custom Iris Prosthesis Benefits Aniridic Patients

Benefits included improvements in visual symptoms, self-perceptions of body image – Publish date: APR 01, 2014 Ophthalmology Times | By: Cheryl Guttman Krader

A custom flexible, silicone iris prosthesis (CustomFlex, HumanOptics) provides visual and cosmetic improvements for patients with complete or partial aniridia. – By Cheryl Guttman Krader; Reviewed by Michael E. Snyder, MD

Cincinnati — Five years of experience with in-the-bag implantation of a custom flexible, silicone iris prosthesis (CustomFlex, HumanOptics) demonstrates excellent clinical results for addressing iris defects not amenable to primary iris reconstruction.

“The artificial iris device markedly reduced light sensitivity and photic symptoms,” said Dr. Snyder, a faculty consulting surgeon and board of directors member, Cincinnati Eye Institute, Cincinnati, OH. “Some individuals also had significant improvement in best-corrected visual acuity, although that may be partly associated with the concomitant cataract surgery.”

Dr. Snyder reviewed findings from a series of 60 eyes of 48 patients with the iris prosthesis implanted during cataract surgery. The eyes in the series represented cases of congenital and acquired defects, including partial and complete aniridia. Postoperative follow-up ranged from 3 months to 5 years.

All of the cases were performed under compassionate use exemptions from the FDA. A U.S. multicenter FDA IDE trial of the device was launched in August 2013.