Safety and Efficacy of Custom Foldable Silicone Artificial Iris Implantation: A Prospective Compassionate-Use Case Series | ASCRS
Presentation
Safety and Efficacy of Custom Foldable Silicone Artificial Iris Implantation: A Prospective Compassionate-Use Case Series
May 2020
Meeting: 2020 Virtual Annual Meeting
Session: SPS-113 Cataract - Challenging Cases
Authors: Clemence Bonnet, MD, Kevin Miller MD
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Purpose
To assess the preliminary safety and efficacy of custom silicone artificial iris implantation for surgical iris reconstruction.

Methods
Prospective consecutive single-surgeon surgical case series. Medical records of patients implanted with the artificial iris and followed for one year were reviewed. Safety data included changes in corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell count (ECC), surgical complications, secondary interventions, and adverse events. Efficacy measures included CDVA with glare, subjective scoring of daytime and nighttime glare, and subjective cosmetic appearance.

Results
20 eyes (19 patients) were implanted. Safety data were mixed. CDVA improved in 12 eyes (60%) and worsened in 6 (30%). 4 eyes (20%) experienced elevated IOP. There was significant ECC loss (1918 ± 870 cells/mm2 versus 1405 ± 705, P = 0.02). 8eyes (40%) experienced postoperative complications. 4 eyes (20%) underwent secondary surgical interventions. Efficacy outcomes were uniformly positive. CDVA with glare improved from 1.49 ± 0.64 logMAR to 0.67 ± 0.79 (P < 0.01). Mean subjective daytime glare decreased from 8.85 ± 1.84 to 2.70 ± 2.58 (P < 0.01) and nighttime glare from 7.85 ± 1.84 to 2.50 ± 2.65 (P < 0.01). Mean cosmetic score improved from 2.15 ± 1.63 to 8.80 ± 2.07 (P < 0.01).

Conclusion
Custom artificial iris implantation is risky but effective at reducing light and glare sensitivity and improving the cosmetic appearance of the eye.
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This presentation is from the session "SPS-113 Cataract - Challenging Cases" from the 2020 ASCRS Virtual Annual Meeting held on May 16-17, 2020.

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