Interim results of a compassionate-use clinical trial of Morcher iris diaphragm implantation: Report 1

PurposeTo evaluate the safety and efficacy of several different Morcher iris diaphragms in the treatment of partial or complete aniridia.SettingJules Stein Eye Institute and the Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.MethodsThis ongoing prospective single-site nonrandomized interventional clinical trial was designed to evaluate Morcher iris diaphragm models 50D, 50F, 96S, and 96F. Safety measures included changes in best corrected visual acuity (BCVA), surgical complications, adverse events, and postoperative interventions. Efficacy measures included changes in best corrected glare visual acuity and changes in daytime and nighttime glare sensitivity, measured by questionnaire responses.ResultsThirteen patients (13 eyes) completed a 1-year follow-up. Regarding safety, there was a statistically significant improvement in median BCVA of 2 Snellen lines (P = .002). One patient lost 2 letters of BCVA on the 20/20 line. There were 2 adverse events. One was minor bleeding during a posterior synechialysis that resolved without intervention. The second was piggyback intraocular lens decentration from worsening zonular dialysis in an eye with a trauma history. One postoperative intervention was the repositioning of a 50D ring. Regarding efficacy, there was a statistically significant median improvement in best corrected glare acuity of 10 Snellen lines (P≤.001). Subjective daytime glare improved 5 questionnaire scale points (P = .004), and nighttime glare sensitivity improved 3 scale points (P = .001).ConclusionMorcher iris diaphragms were relatively safe and very effective in reducing the light and glare sensitivity associated with partial or complete aniridia.