This prospective randomized study published in the April issue of Ophthalmology evaluated the efficacy and safety of long-term use of topical corticosteroids after penetrating keratoplasty (PKP). The results indicate that prolonged use of 0.1% fluorometholone was beneficial for the prevention of endothelial rejection after PKP. Because no adverse consequences associated with the use of the drops were noted, the authors recommend continuing the use of low-dose corticosteroids, even in non-high-risk cases.
Since the leading cause of graft failure in PKP is endothelial rejection, its prevention remains a major area for improving outcomes of the procedure. Topical corticosteroids have been the gold standard in the prevention and treatment of endothelial rejection after PKP.
However, no previously published study has examined whether the long-term administration of steroid eye drops is beneficial. Protocols for corticosteroid use after PKP have varied widely, with no consensus reached on optimal methods of administration, dosage or treatment duration. The duration of corticosteroid use has varied from discontinuation within several months to indefinite use.
The authors enrolled 42 patients with a mean age of 65.3 years who underwent PKP and maintained graft clarity for more than one year with topical steroid eye drops. After that time, they were randomly assigned to administration of 0.1% fluorometholone three times a day (steroid group) or discontinuation of steroid eye drops (no steroid group), and followed for 12 months. The mean time between surgery and initiation of the study was more than three years, and 23 eyes had a postoperative follow-up period longer than two years.
Four patients in the steroid group and six in the no steroid group did not complete the trial. Of the remaining patients, one in the steroid group and six in the no steroid group developed endothelial rejection at an average of 5.2 ± 4.5 (mean ± standard deviation) months after enrollment in the study. The difference in the incidence of rejection between the groups was found to be significant by both chi-square (P = 0.027) and Kaplan-Meier analyses (log-rank test, P = 0.032).
No difference was observed between the groups in visual acuity, intraocular pressure, epithelial damage, tear-film break-up time, cataract progression, infection or incidence of systemic side effects.