Prospective, Randomized Study on Efficacy of Systemic Cyclosporine a in High–Risk Corneal Transplantation

Abstract

Purpose: : To study efficacy and safety of systemic of cyclosporine A (CYA) in high–risk corneal transplantation.

Methods: : Thirty–eight high–risk eyes for immunological rejection (regraft, n=37 and neovascularization > 2 quadrants, n=1) obtained informed consent undergoing penetrating keratoplasty between June 2003 and February 2005 were randomly assigned to have corticosteroid eyedrops either with (CYA group, n=20) or without (control group, n=18) systemic CYA. The subjects consisted of 16 males and 22 females with mean age of 69 ± 10 years. The CYA group received oral CYA (Neoral^R, Novartis, Basel, Switzerland) for at least 1 year following surgery unless side effects were developed. Blood CYA concentration was maintained at 500 – 800 ng/ml at 2 hours after administration. Short–term systemic corticosteroid starting from 8mg dexamethasone (Rinderon^R, Shionogi Pharmaceutical Co., Tokyo, Japan) tapered in 3 weeks was also used in the CYA group. Graft clarity, immunological rejection, corneal endothelial density, systemic and local side effects were studied.

Results: : Six patients in the CYA group discontinued CYA administration because of gastric pain/nausea (n=3) or decreased renal function (n=3) that developed in the early postoperative period. These events were promptly disappeared with CYA discontinuation. Grafts clarity rate was 100% (13/13 eyes) in the CYA group and 94% (17/18 eyes) in the control group. One eye in the CYA group developed presumed fungal keratitis 1 week following corneal transplantation, which was successfully treated by anti–fungal medication and discontinuation of CYA. Only one eye in the control group developed endothelial rejection, and the graft regained clarity with intensive steroid therapy. There was no significant difference in the endothelial density.

Conclusions: : Although systemic CYA can be used without irreversible side effects, no significant improvements in either graft survival or prevention of rejection were noted in patients with high–risk corneal transplantation.

Keywords: cyclosporine • transplantation • cornea: clinical science