Safety and Efficacy of Colored Iris Reconstruction Lens Implantation.

Abstract Purpose To evaluate the 1- to 9-year safety and efficacy of colored iris reconstruction lens implantation in eyes with visual disturbances caused by partial or complete aniridia. Design Prospective, interventional case series. Methods 38 patients were implanted with Ophtec 311 colored iris reconstruction lenses at UCLA as part of a larger United States Food and Drug Administration clinical trial. Patients in Group 1 lacked corneal pathology. Patients in Group 2 patients had corneal pathology such as endothelial failure, previous transplants, or scarring. Safety measures included loss of corrected distance visual acuity (CDVA), surgical complications, adverse events, secondary interventions, and corneal endothelial cell loss. Efficacy measures included improvement in uncorrected distance visual acuity (UDVA) and subjective visual disturbances. Results Groups 1 (n = 8) and 2 (n = 30) showed improvements in CDVA (P = 0.155 and 0.038), UDVA (P = 0.002 and P Conclusions Colored iris reconstruction lens implantation improved CDVA, UDVA, and subjective visual disturbances 3 years postoperatively and beyond. Adverse events, complications, and subsequent declines in visual acuity were common, however, in these eyes with complex medical and surgical histories.