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


METHODS
Prospective, single-center, institutional review board-approved study.


METHODS
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.


METHODS
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).


CONCLUSIONS
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.
Price
Marianne O
MO
Cornea Research Foundation of America, Indianapolis, Indiana 46260, USA. mprice@cornea.org
Price
Francis W
FW
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003316:Corneal Diseases / Q000601:surgery; D016039:Corneal Transplantation; D016572:Cyclosporine / Q000008:administration & dosage*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives; D011446:Prospective Studies; D016896:Treatment Outcome
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine; C009935:prednisolone acetate; D011239:Prednisolone