Topical Cyclosporin A in the treatment of acute graft rejection: a randomized controlled trial

Background: Corneal graft rejection is the commonest cause of graft failure. Currently, intensive topical steroid is the treatment for graft rejection. We hypothesized that the use of topical Cyclosporin A (CsA) 0.05%, specifically Restasis (Allergan) in addition to intensive steroids would aid in the reversal and treatment of endothelial graft rejection. Methods: In a randomized double masked control study, we recruited 108 patients with acute endothelial graft rejection. They were randomized to two groups. The first group received intensive prednisolone acetate and placebo. The second group received intensive prednisolone acetate and Restasis. Results: There was no difference between the baseline characteristics for the two groups. Nine out of 54 in the placebo group and five out of 54 (16.7% vs. 9.2% P = 0.23) in the treatment group were exited from the study because of worsening signs despite treatment. No significant difference was found between the two groups for time to reversal and resolution. Side-effects of the treatment include increased intraocular pressure and punctate epithelial erosions. These changes most likely relate to the use of intensive prednisolone acetate. Conclusion: The use of commercially available CsA as an adjunct to topical steroids does not appear to improve the outcome of graft rejection.