Prospective, randomized study of the efficacy of systemic cyclosporine in high-risk corneal transplantation.
Author(s): Shimazaki J, Den S, Omoto M, Satake Y, Shimmura S, Tsubota K
Affiliation(s): Department of Ophthalmology, Tokyo Dental College, Chiba, Japan. email@example.com
Publication date & source: 2011-07, Am J Ophthalmol., 152(1):33-39.e1. Epub 2011 May 12.
Publication type: Randomized Controlled Trial
PURPOSE: Immunologic rejection remains a major cause of graft failure in high-risk corneal transplantation. This study was conducted to elucidate the efficacy and safety of systemic cyclosporine (CsA) in high-risk corneal transplantation. DESIGN: Prospective, randomized, open-labeled clinical trial with a parallel-group study. METHODS: Patients underwent high-risk corneal transplantation at the Department of Ophthalmology, Tokyo Dental College, Chiba, Japan. High-risk was defined as corneal neovascularization in more than 1 quadrant or a history of corneal grafting. Patients were assigned to either a systemic CsA group or a control group. Administration of CsA was continued for at least 6 months with blood CsA concentration 2 hours after administration of approximately 800 ng/mL, unless undesirable side effects developed. The main outcome measures were graft clarity, endothelial rejection, and local and systemic complications. RESULTS: Forty patients were enrolled and 39 (18 men, 21 women; mean age, 67.4 +/- 11.9 years) were analyzed. In the CsA group, CsA was discontinued within 6 months in 7 patients because of side effects. With a mean follow-up of 42.7 months, endothelial rejection developed in 6 and 2 eyes in the CsA and control groups, respectively. No differences were observed in the rates of graft clarity loss between the 2 groups (P = .16, Kaplan-Meier analysis). CONCLUSIONS: No positive effect of systemic CsA administration for suppressing rejection in high-risk corneal transplantation was observed. With a relatively high incidence of systemic side effects, the results suggest that this protocol should not be recommended for corneal transplant recipients, especially those of advanced age. Copyright (c) 2011 Elsevier Inc. All rights reserved.