Backgrounds To evaluate the efficacy of 2% topical ciclosporin A in treating and preventing graft rejection episodes after penetrating keratoplasty (PKP) in patients with a history of graft rejection episodes.
Methods In this prospective, randomised, double-blind clinical trial, a group of PKP patients were randomly given 2% topical ciclosporin A (group 1) or a placebo (group 2) in addition to a corticosteroid regimen upon an episode of subepithelial or endothelial graft rejection. The topical ciclosporin and placebo were continued for 6 months. The duration of corticosteroid application and the time to resolution of the rejection episode for which ciclosporin or placebo was started, the number of concurrent and subsequent rejection episodes, and the rate of rejection-free survival were compared between the two groups.
Results 22 eyes of 22 patients (12 men) were in group 1 and 21 eyes of 21 patients (10 men) were in group 2. Mean patient age was 32.48 (11.9) years and 35.48 (11.7) years in groups 1 and 2, respectively (p=0.42). Mean follow-up period was 16.6 (6.1) months and 16.0 (6.3) months (p=0.75) and the episode for which 2% topical ciclosporin or placebo was started completely resolved after 25.6 (21.0) days and 33.2 (16.7) days in groups 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 at month 20 (p=0.89).
Conclusion 2% topical ciclosporin A did not add any advantage to conventional corticosteroid treatment in terms of treating and preventing graft rejection in PKP patients with previous history of rejection episodes.
- graft rejection
- rejection-free graft survival rate
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Funding Sina Daru Pharmacy Co, Tehran, Iran.
Competing interests Ahmad Karbasian is the executive manager of Sina Daru Pharmacy Co, from which 2% topical ciclosporin and placebo were procured. The other authors had no financial or propriety interest in any of the materials used in this article.
Patient consent Obtained.
Ethics approval This study was conducted with the approval of the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Provenance and peer review Not commissioned; externally peer reviewed.