Topical Tacrolimus for High-risk Corneal Transplantation: A randomized, clinical trial

Abstract

Abstract Immunological rejection after high-risk penetrating keratoplasty (PKP) remains a major problem. We investigated the efficacy and safety of topical tacrolimus (TAC) in these patients. This randomised clinical trial performed at a tertiary referral hospital included eyes of patients with a history of PKP, graft rejection, atopic dermatitis, or deep corneal neovascularisation who underwent PKP. They were randomly assigned to receive 0.1% TAC (TAC group) or artificial tears (AT group) up to week 52 after surgery. Both groups received 0.1% betamethasone up to week 13 after surgery then they received 0.1% fluorometholone up to week 52. Immunological rejection during the observation period was the main outcome measure. Twelve eyes in the TAC group and 13 eyes in the AT group completed the study. TAC was well tolerated, with no serious adverse reactions in the TAC group. While no rejection episodes were noted in the TAC group, one eye in the AT group developed rejection. Graft clarity, best spectacle-corrected visual acuity, intraocular pressure, and corneal endothelial cell density were not significantly different between the two groups. Our results demonstrated good tolerability of topical 0.1% tacrolimus; however, we failed to demonstrate its efficacy in preventing immunological rejection in high-risk patients undergoing PKP.