Safety and efficacy of custom foldable silicone artificial iris implantation: prospective compassionate-use case series

Purpose: To assess the preliminary safety and efficacy of custom silicone artificial iris implantation. Setting: Stein Eye Institute. Design: Prospective consecutive case series. Methods: Medical records of patients implanted with the artificial iris were reviewed and followed for 1 year. Safety measures included corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell count (ECC), surgical complications, secondary interventions, and adverse events (AEs). Efficacy measures included CDVA with glare, subjective daytime and nighttime glare graded from 0 to 10 (very significant), and subjective cosmetic appearance graded from 0 to 10 (very satisfied). Results: Twenty eyes (19 patients) were implanted. Safety data were mixed. CDVA improved in 13 eyes and worsened in 6. ECC decreased from 1918 +/- 870 to 1405 +/- 705 cells/mm(2) (P = .02). Eight eyes experienced postoperative complications. There were 4 IOP elevations, 2 corneal decompensations, 1 case of cystoid macular edema, and 1 device dislocation. Four eyes underwent secondary surgical interventions including 2 AEs (1 glaucoma surgery and 1 device dislocation). Efficacy outcomes were excellent. CDVA with glare improved from 1.5 +/- 0.6 to 0.7 +/- 0.8 logarithm of the minimum angle of resolution (P <.01). Mean subjective daytime glare decreased from 8.9 +/- 1.8 to 2.7 +/- 2.6 (P <.01) and nighttime glare decreased from 7.9 +/- 1.8 to 2.5 +/- 2.7 (P <.01). Mean cosmesis improved from 2.2 +/- 1.6 to 8.8 +/- 2.1 (P <.01). Conclusions: Custom artificial iris implantation was moderately risky but very effective at reducing light and glare sensitivity and in improving ocular cosmesis.