Ophtec iris reconstruction lens United States clinical trial phase I.

PURPOSE: To determine the safety and efficacy of the Ophtec model 311 iris reconstruction lens for treatment of visual disturbances, such as glare or photophobia, related to partial or total absence of the human iris.

DESIGN

Phase I multicenter, nonrandomized, investigational device study.

PARTICIPANTS

Ten iris reconstruction lenses were placed in 10 subjects at 6 sites.

METHODS

Iris reconstruction lenses were placed in 9 patients who had lost all or part of their iris from trauma and in 1 patient who lacked iris pigmentation due to congenital albinism. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1; week 1; and months 1, 3, 6, and 12.

MAIN OUTCOME MEASURES: Efficacy measures were uncorrected visual acuity (UCVA), glare, starbursts, and photophobia. Safety measures were best-corrected visual acuity (VA), surgical complications, and adverse events.

RESULTS

Uncorrected VA improved in all eyes after implantation of the iris reconstruction lens. Best-corrected VA did not change significantly (P = 0.24). Postoperative photophobia was reduced in all 9 eyes that experienced moderate to severe preoperative photophobia. Likewise, postoperative glare was reduced in all 6 eyes with moderate to severe preoperative glare. There were no surgical complications. Adverse events included 2 cases of iritis and 1 case of macular edema.

CONCLUSIONS

Preliminary results suggest that the Ophtec model 311 iris reconstruction lens can improve UCVA and reduce glare and photophobia in patients with partial or total absence of the iris or iris pigmentation.