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Efficacy and Safety of Long-term Corticosteroid Eye Drops after Penetr

Shimazaki J, Iseda A, Satake Y, Shimazaki-Den S.
Source
Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan; Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.

Abstract
PURPOSE:

Endothelial rejection remains a major cause of graft failure after penetrating keratoplasty (PKP). Topical corticosteroids are the gold standard for preventing rejection; however, protocols for corticosteroid treatment have been diverse. The aim of the present study was to examine the efficacy and safety of long-term use of corticosteroid eye drops after PKP in a randomized, clinical trial.

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Ophthalmology. 2012 Jan 18. [Epub ahead of print]

DESIGN:
Randomized, nonblinded, clinical trial.

PARTICIPANTS:
We enrolled 42 patients (21 males and 21 females) with a mean age of 65.3 years who underwent PKP and maintained graft clarity for >1 year with topical steroid eye drops.

INTERVENTION:
Patients were randomly assigned to 1 of 2 groups: Administration of 0.1% fluorometholone 3 times a day (steroid group) or discontinuation of steroid eye drops (no steroid group). All patients were followed for 12 months.

MAIN OUTCOME MEASURES:
Proportion of eyes without endothelial rejection and the proportion of eyes with clear grafts and the incidence of local or systemic side effects.

RESULTS:
Of the initial 42 patients, 4 in the steroid group and 6 in the no steroid group did not complete the trial. Of the patients who completed the trial, 1 patient in the steroid group and 6 in the no steroid group developed endothelial rejection at an average of 5.2±4.5 (mean ± standard deviation) months after study enrollment. The difference in the incidence of rejection between 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 2 groups in visual acuity, intraocular pressure, epithelial damage, tear-film break-up time, cataract progression, infection, or incidence of systemic side effects.

CONCLUSIONS:
Prolonged use of 0.1% fluorometholone was beneficial for the prevention of rejection after PKP. Because no adverse consequences were noted, we recommend continuing use of the low-dose corticosteroids, even in non-high-risk cases.

FINANCIAL DISCLOSURE(S):
The authors have no proprietary or commercial interest in any of the materials discussed in this article.

Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.