Compassionate-Use Clinical Trial of Custom Artificial Iris Implantation
Narrative Responses:
Purpose
To report preliminary safety and efficacy results of custom artificial iris implantation in a cohort of subjects implanted under FDA compassionate use device exemptions
Methods
Safety measures included reduction in corrected distance visual acuity (CDVA), adverse events (AE), and secondary surgical interventions (SSI). Efficacy measures included reduction in corrected distance glare visual acuity (CDGVA), subjective reduction in day and night time gare sensitivity, and subjective improvement in cosmetic appearance.
Results
Twenty patients were implanted, one bilaterally. Fifteen eyes have been followed for 12 months, 4 eyes to 6 months, and 2 eyes to 3 months. One patient lost VA from HM to NLP. Median CDVA improved from 20/60-1 preoperatively to 20/30+2 postoperatively. Six patients experienced AEs, most of which did not require reporting. There were 2 SSIs. Median CDGVA improved from 20/400 preoperatively to 20/60 postoperatively. Subjective glare and cosmesis scores improved for almost all patients.
Conclusion
Custom artificial iris implantation appears to be relatively safe and very effective at reducing light and glare sensitivity in patients with congenital and acquired defects of the iris. Additional data is being gathered in the FDA clinical trial, which is currently in progress.