Topical Cyclosporine A for Recurrent Episodes of Graft Rejection after Penetrating Keratoplasty

To investigate the efficacy of topical cyclosporine A 2% in treating and preventing recurrent graft rejection episodes after penetrating keratoplasty (PKP) in patients with history of previous rejection episodes. In this clinical trial, eligible PKP patients were randomly given topical cyclosporine A 2% or placebo in addition to a standard corticosteroid regimen for an episode of recurrent subepithelial or endothelial graft rejection. Primary indications for transplantation were keratoconus, Fuchs’ endothelial dystrophy, corneal stromal dystrophy, and nonvascularized scars. Topical cyclosporine and placebo were continued for 6 months. The duration of corticosteroid therapy and resolution of graft rejection episode, the number of concurrent and subsequent rejection episodes and the rate of rejection-free survival was compared between the study groups. Twenty-two eyes of 22 patients (12 men) received a combination of topical cyclosporine A 2% and betamethasone 0.1% (group 1) and 21 eyes of 21 patients (10 men) received topical betamethasone 0.1% and placebo (group 2) for an episode of recurrent graft rejection. Mean patient age was 32.48±11.9 and 35.48±11.7 years in group 1 and 2, respectively (P=0.42). Mean follow-up period was 16.6±6.1 months in group 1 and 16.0±6.3 months in group 2 (P=0.75). The episode for which topical cyclosporine 2% or placebo was started completely resolved after 25.6±21.0 and 33.2±16.7 days in group 1 and 2, respectively (P=0.22). The rejection-free graft survival rate was 34.8% in group 1 and 31.7% in group 2 (P=0.89). Adding topical cyclosporine A 2% had no further advantage over corticosteroid therapy alone to treat and prevent graft rejection in repeated rejection.