Long-term follow-up of a custom-made prosthetic iris device in patients with congenital aniridia.

PURPOSE: To investigate the effectiveness and safety of a custom-made iris prosthetic device used to reduce photic symptoms in patients with congenital aniridia.

SETTING

Cincinnati Eye Institute, Cincinnati, Ohio, USA.

DESIGN

Retrospective single-surgeon case series.

METHODS

The charts of all eyes of patients diagnosed with congenital aniridia syndrome who underwent implantation of the custom-made iris prosthesis at the setting institution between 2008 and 2018 were reviewed. Eyes with more than 6 months of follow-up were included in evaluation. Charts were carefully reviewed for comorbid conditions, interventions, and outcomes.

RESULTS

Ninety-six eyes of 50 patients were included in the study. Subjective reduction in photophobia and glare was reported in 95.7% and 95.2% of cases, respectively. The incidence of aniridia fibrosis syndrome (AFS) in this study (3.1%; 95% confidence interval, 0.6%-8.9%) was similar to previous studies in the literature.

CONCLUSIONS

The custom-made iris prosthesis was an effective and safe option to reduce photic symptoms in patients with congenital aniridia. The custom, flexible iris implant does not appear to alter the risk for AFS. These highly complex eyes with significant comorbid pathologies demand an individualized approach and careful long-term follow-up.