title: Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty.
abstract: OBJECTIVE
  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.
authors: *Cornea Research Foundation of America, Indianapolis, IN; †Price Vision Group, Indianapolis, IN; and ‡Department of Ophthalmology, University of Erlangen, Germany.
authors: Marianne O
authors: MO
authors: Price
authors: Francis W
authors: FW
authors: Price
authors: Friedrich E
authors: FE
authors: Kruse
authors: Bjöern O
authors: BO
authors: Bachmann
authors: Theofilos
authors: T
authors: Tourtas
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002452:Cell Count; D055954:Corneal Endothelial Cell Loss / Q000175:diagnosis; D057111:Descemet Stripping Endothelial Keratoplasty; D005260:Female; D005469:Fluorometholone / Q000008:administration & dosage* / Q000009:adverse effects; D005642:Fuchs' Endothelial Dystrophy / Q000601:surgery; D005901:Glaucoma / Q000150:complications; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006084:Graft Rejection / Q000175:diagnosis*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011446:Prospective Studies
chemical_list: D005938:Glucocorticoids; D009883:Ophthalmic Solutions; C009935:prednisolone acetate; D011239:Prednisolone; D005469:Fluorometholone