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Updated: Dec 24, 2025
Iris Fixation via External Pentagram Suturing
Published on: May 5, 2022
Safety and Efficacy of Colored Iris Reconstruction Lens Implantation
Hongxing Wang1, JooYeon Jung2, Shawn R Lin2
1Stein Eye Institute and the Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA; Department of Ophthalmology, Beijing Chuiyangliu Hospital, Tsinghua University, Beijing, China.
Purpose:
We sought to evaluate the 1- to 9-year safety and efficacy of colored iris reconstruction lens implantation in eyes with visual disturbances caused by partial or complete aniridia.
Design:
Prospective, interventional case series.
Methods:
Thirty-eight patients were implanted with Ophtec 311 colored iris reconstruction lenses at the University of California, Los Angeles as part of a larger U.S. Food and Drug Administration clinical trial. Patients in group 1 lacked corneal pathology. Patients in group 2 patients had corneal pathology, such as endothelial failure, previous transplants, or scarring. Safety measures included loss of corrected distance visual acuity (CDVA), surgical complications, adverse events, secondary interventions, and corneal endothelial cell loss. Efficacy measures included improvement in uncorrected distance visual acuity (UDVA) and subjective visual disturbances.
Results:
Groups 1 (n = 8) and 2 (n = 30) showed improvements in CDVA (P = .155 and .038), UDVA (P = .002 and P < .001), and subjective visual disturbance scores at year 3. Median CDVA and UDVA declined slightly for both groups after 1-2 years. Group 2 experienced more adverse events, surgical complications, and secondary interventions. Endothelial cell loss was greater for group 2 (19.7%) than group 1 (8.05%), although this difference was not statistically significant (P = .067).
Conclusions:
Colored iris reconstruction lens implantation improved CDVA, UDVA, and subjective visual disturbances 3 years postoperatively and beyond. Adverse events, complications, and subsequent declines in visual acuity were common, however, in these eyes with complex medical and surgical histories.
