Safety and Efficacy of Black Iris Diaphragm Implantation in Eyes With Congenital and Acquired Iris Defects
Narrative Responses:
Purpose
To evaluate the safety and efficacy of Morcher 50F iris diaphragm implantation for managing congenital and acquired defects of the human iris
Methods
This is a nonrandomized prospective interventional clinical trial evaluating the safety and efficacy of Morcher iris diaphragms. Demographic, preoperative and postoperative data of subjects implanted with the Morcher 50F modified capsule tension ring and followed to 1 year were reviewed. Safety measures included corrected distance visual acuity (CDVA), perioperative complications, adverse events, and secondary surgical interventions. Efficacy measures included corrected distance glare visual acuity (CDGVA), daytime and nighttime glare symptoms, and cosmesis scores as measured by questionnaires.
Results
Twelve subjects were implanted and followed to 1 year. Median CDVA was 20/70 before surgery and 20/30 after surgery. There were no intraoperative complications, adverse events, or secondary surgical interventions. Median CDGVA was 20/400 before surgery and 20/50 after surgery. Only 1 subject decreased one line of CDVA and CDGVA for reasons unrelated to the device. There were improvements in median daytime and nighttime glare symptom scores of 2.5 and 2 points, respectively. One subject increased day light glare in 1 line. There was an improvement in cosmesis for most subjects.
Conclusion
Morcher 50F iris diaphragm implantation appears to be safe and effective at reducing light and glare sensitivity in eyes with iris defects.