title: Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial.
abstract: OBJECTIVE
  To compare intraocular pressure (IOP) elevation and graft rejection with loteprednol etabonate 0.5% gel and prednisolone acetate 1% solution after Descemet membrane endothelial keratoplasty (DMEK).
  
  
  METHODS
  In this prospective, evaluator-masked trial, 167 patients were randomized to loteprednol or prednisolone in a 1:1 ratio 1 month after DMEK; 66 fellow eyes were enrolled and assigned to the opposite treatment. Dosing was 4 times daily for 2 months, thrice daily for 1 month, twice daily for 1 month, and once daily for 7 months. The main outcomes were IOP elevation (defined as IOP ≥ 24 mm Hg or an increase of ≥10 mm Hg over the baseline preoperative level) and immunologic rejection episodes, assessed by Kaplan-Meier survival analysis and proportional hazards modeling.
  
  
  RESULTS
  A total of 233 eyes were assigned to treatment. Loteprednol etabonate 0.5% gel and prednisolone acetate 1% solution were equally effective in preventing immunologic rejection episodes; none (0%) occurred with either treatment (P = 1). IOP elevation was twice as likely in the prednisolone-treated eyes (relative risk = 2.3, 95% confidence interval: 1.2-4.5, P = 0.016). The proportion with IOP elevation was 25% in prednisolone-treated eyes versus 11% in loteprednol-treated eyes (P = 0.013). In 66 subjects with fellow eyes assigned to opposite treatments, an IOP increase of ≥10 mm Hg was significantly more likely in the prednisolone-treated eye (P = 0.031).
  
  
  CONCLUSIONS
  Loteprednol etabonate 0.5% gel was as effective as prednisolone acetate 1% solution in preventing immunologic graft rejection episodes after DMEK and was significantly less likely to cause IOP elevation.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01853696.
authors.affiliation: *Cornea Research Foundation of America, Indianapolis, IN; and †Price Vision Group, Indianapolis, IN.
authors.forename: Marianne O
authors.initials: MO
authors.lastname: Price
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Feng
authors.forename: Amanda
authors.initials: A
authors.lastname: Scanameo
authors.forename: Francis W
authors.initials: FW
authors.lastname: Price
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D055954:Corneal Endothelial Cell Loss / Q000175:diagnosis; D057111:Descemet Stripping Endothelial Keratoplasty; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000069559:Loteprednol Etabonate / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011239:Prednisolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D005782:Gels; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; C009935:prednisolone acetate; D011239:Prednisolone; D000069559:Loteprednol Etabonate