Sutured Custom Foldable Silicone Artificial Iris Implantation Combined With Intraocular Lens Implantation and Penetrating Keratoplasty: Safety and Efficacy Outcomes.

[PURPOSE] To assess safety and efficacy outcomes of sutured custom silicone artificial iris and intraocular lens implantation combined with penetrating keratoplasty (triple procedure).

[METHODS] Prospective consecutive surgical case series of patients who underwent the triple procedure between 2010 and 2019 at Stein Eye Institute, UCLA, followed up for 1 year minimum. Safety outcomes were changes from preoperative to last follow-up in corrected distance visual acuity (CDVA), endothelial cell count, intraocular pressure (IOP), and postoperative complications. Efficacy outcomes included changes in subjective glare (none to severe), cosmetic appearance (worse to very much improved), and visual function as assessed by the Visual Function Questionnaire-25 at 1-year follow-up.

[RESULTS] Among 82 eyes implanted with an artificial iris, 14 eyes (17.1%) underwent the triple procedure. The median follow-up was 18.1 months (range 12.0-54.9 months). The median CDVA improved from 2.0 log of minimum angle of resolution (logMAR) (range 0.9-2.3 logMAR) to 0.7 logMAR (range 0.2-2.6 logMAR) (P = 0.02). Average endothelial cell count decreased 57.6% (P < 0.01). Six eyes (42.9%) experienced IOP elevations, 13 eyes (92.3%) developed iritis, and 11 eyes (78.6%) underwent secondary surgery. Graft rejection or secondary graft failure occurred in 7 eyes each (50.0%). Cosmesis improved in 12 eyes (85.7%; P < 0.01). The Visual Function Questionnaire-25 score improved from 72 to 77 (P < 0.01). Glare symptoms did not change significantly.

[CONCLUSIONS] The triple procedure was effective at improving CDVA, cosmesis, and quality of life; however, it was associated with frequent postoperative complications, of which iritis, IOP elevation, and secondary graft failure were the most common.