Evaluation of topical ciclosporin 0.05% for prevention of rejection in high-risk corneal grafts.

AIM: To evaluate the efficacy of combined treatment with commercially available 0.05% topical ciclosporin and topical corticosteroid compared with treatment with topical corticosteroids only after high-risk keratoplasty. PATIENTS AND METHODS: A total of 47 high-risk keratoplasties were randomly divided into two groups based on the postoperative immunosuppression. Twenty-five eyes (group 1) were treated with 0.05% ciclosporin and dexamethasone 0.1%, and 22 eyes (group 2) were treated with dexamethasone only. The clinical outcome of penetrating keratoplasty was evaluated by the rate of rejection-free graft survival and graft survival evaluation by the Kaplan-Meier logrank test.
RESULTS: The average length of follow-up was 20.2 (SD 7.1) months in group 1 and 18.5 (6.6) months in group 2 (p = 0.421). Rejection-free graft survival rates were 60.8% in group 1 and 54.5% in group 2 (Kaplan-Meier logrank test, p = 0.474). In group 1, the graft survival rate was 73.9%; in group 2, the graft survival rate was 68.1%. The difference in the graft survival rates between the groups was also not statistically significant (Kaplan-Meier logrank test, p = 0.518).
CONCLUSION: In high-risk corneal grafts, the efficacy of 0.05 percent commercially available topical ciclosporin combined with dexamethasone topically was not better than that of dexamethasone alone in preventing rejection.

RCT Entities:   Population Interventions Outcomes