Efficacy of topical cyclosporine 0.05% for prevention of cornea transplant rejection episodes.

PURPOSE: To assess the incidence of immunologic corneal graft rejection episodes in a prospective case series of patients treated 4 times a day with topical cyclosporine 0.05%.
DESIGN: Prospective, single-center, institutional review board-approved study. PARTICIPANTS: Fifty-two cornea transplant recipients considered low risk for graft rejection.
METHODS: Primary indications for transplantation were keratoconus, Fuchs' dystrophy, or nonherpetic, nonvascularized scars. Subjects completely tapered off prednisolone acetate 1% by 13 weeks after transplantation and used topical cyclosporine 0.05% 4 times a day, beginning either 1 or 10 weeks posttransplant, with use continued until 1 year posttransplant. One subgroup supplemented cyclosporine use with pulsed prednisolone acetate 1% dosing, 4 times a day for 4 days every 6 weeks. The incidence of immunologic corneal graft rejection episodes was compared with that in Fuchs' and keratoconus historical control subjects, who used topical steroids a median of 7 months after penetrating keratoplasty. MAIN OUTCOME MEASURE: Incidence of immunologic graft rejection episodes.
RESULTS: Graft rejection episodes occurred earlier and with higher incidence in subjects using cyclosporine 0.05% compared with historical control subjects who used steroids for a longer period of time (P<0.0001). Cyclosporine subjects who pulse-dosed prednisolone had a significantly higher incidence of graft rejection compared with those who did not pulse steroids (P = 0.04).
CONCLUSION: The results suggest that 4 times daily dosing with topical cyclosporine 0.05% is not as effective as use of topical prednisolone acetate 1% for prevention of graft rejection episodes in low-risk corneal transplants, and that periodic pulsing with corticosteroids may increase the risk of rejection episodes.

RCT Entities:   Population Interventions Outcomes