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Randomized Comparison of Topical Prednisolone Acetate 1% Versus Fluorometholone 0.1% in the First Year After Descemet Membrane Endothelial Keratoplasty

Price, Marianne O. PhD*; Price, Francis W. Jr MD; Kruse, Friedrich E. MD; Bachmann, Bjöern O. MD; Tourtas, Theofilos MD

doi: 10.1097/ICO.0000000000000206
Clinical Science

Purpose: The aim of this study was to compare the efficacy and side effects of prednisolone acetate 1% versus fluorometholone 0.1% after Descemet membrane endothelial keratoplasty (DMEK).

Methods: DMEK recipients used prednisolone acetate 1% for 1 month, and they were randomized to either prednisolone or fluorometholone for months 2 through 12. Dosing was 4 times daily in months 1 to 3, thrice daily in month 4, twice daily in month 5, and once daily in months 6 to 12. The main outcomes were immunologic rejection episodes and intraocular pressure (IOP) elevation (defined as ≥24 mm Hg or ≥10 mm Hg increase over the preoperative baseline level), assessed by the Kaplan–Meier survival analysis.

Results: The study included 325 eyes (99% were white, 96% had Fuchs dystrophy, and 9% had a previous glaucoma diagnosis). No eyes (0%) assigned to prednisolone versus 2 eyes (1.4%) assigned to fluorometholone experienced a possible (n = 1) or probable (n = 1) rejection episode (P = 0.17). Both rejection episodes resolved successfully with increased topical steroids. In the prednisolone arm, a significantly higher proportion exceeded the defined IOP elevation threshold (22% vs. 6%, P = 0.0005), and glaucoma medications were initiated or increased more often (17% vs. 5%, P = 0.0003). The most frequent reasons for discontinuing the assigned intervention were IOP management (n = 13 eyes assigned to prednisolone) or inflammation management (n = 3 eyes assigned to fluorometholone). One-year endothelial cell loss was comparable in both arms (30% vs. 31%, P = 0.50).

Conclusions: DMEK has a remarkably low rejection episode rate (<1% through 1 year), as confirmed in this prospective randomized study. This provides a unique opportunity to reduce postoperative topical corticosteroid strength and thereby reduce the risk of steroid-associated complications.

*Cornea Research Foundation of America, Indianapolis, IN;

Price Vision Group, Indianapolis, IN; and

Department of Ophthalmology, University of Erlangen, Germany.

Reprints: Marianne O. Price, PhD, Cornea Research Foundation of America, 9002 N. Meridian St, Suite 212, Indianapolis, IN 46260 (e-mail: mprice@cornea.org).

F. Price has received grants and consulting or lecture fees from Alcon, Allergan, and Bausch & Lomb. The other authors have no conflicts of interest to disclose.

Supported by the Cornea Research Foundation of America.

Received May 21, 2014

Accepted June 10, 2014

© 2014 by Lippincott Williams & Wilkins.