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To assess the preliminary safety and efficacy of custom silicone artificial iris implantation for surgical iris reconstruction.
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.
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).
Custom artificial iris implantation is risky but effective at reducing light and glare sensitivity and improving the cosmetic appearance of the eye.