Efficacy of topical cyclosporine A 2% in prevention of graft rejection in high-risk keratoplasty: a randomized controlled trial.

Purpose: To evaluate the efficacy and safety of topical cyclosporine A 2% in the prevention of graft rejection in high-risk keratoplasty.

Methods: A randomized clinical trial was conducted in which penetrating keratoplasty was performed in 78 eyes that were at high risk for keratoplasty. The study group (n = 39) received topical cyclosporine A 2% drops and control group (n = 39) received polyvinyl alcohol 1.4% drops. In addition, both groups received corticosteroid eye drops after surgery. The main outcome measures were rejection-free interval and reversal of graft rejection.

Results: The most common indication for penetrating keratoplasty was failed previous graft in both groups. The best corrected visual acuity at the end of 1 year was 0.31 +/- 0.18 in the study group and 0.24 +/- 0.17 in the control group (p = 0.14). Seven patients in each group had one episode of graft rejection and one patient in the control group had two episodes of graft rejection. The mean duration after which the patients developed graft rejection after keratoplasty was 7.92 +/- 1.45 months and 6.50 +/- 2.72 months in the study and control group, respectively (p = 0.20). Six patients showed complete reversal of rejection in the study group and four patients showed reversal in the control group (p = 0.03).

Conclusions: Topical cyclosporine A 2% eye drops do not prevent occurrence of graft rejection in high-risk keratoplasty. However, the eyes receiving topical cyclosporine stand a better chance of reversal of the episode of graft rejection.