Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

Purpose: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects.

Design: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial.

Participants: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both.

Results of topography-guided laser in situ keratomileusis custom ablation treatment with a refractive excimer laser.

Purpose: To evaluate the safety and effectiveness of topography-guided custom ablation treatment (T-CAT) to correct myopia and myopic astigmatism with laser in situ keratomileusis (LASIK).

Setting: Nine clinical sites in the USA.

Design: Prospective observational nonrandomized unmasked study.