title: A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery.
abstract: OBJECTIVE
  To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery.
  
  
  METHODS
  Multicenter, randomized, contralateral-eye, double-masked trial.
  
  
  METHODS
  Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery.
  
  
  RESULTS
  Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P < .001), respectively. Endothelial cell density was 195.52 cells/mm(2) higher in difluprednate-treated eyes at day 30 (P < .001). Retinal thickness at day 15 was 7.74 μm less in difluprednate-treated eyes (P = .011).
  
  
  CONCLUSIONS
  In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery.
authors.affiliation: Ophthalmic Consultants of Long Island, Rockville Centre, New York 11570, USA. eddoph@aol.com
authors.forename: Eric D
authors.initials: ED
authors.lastname: Donnenfeld
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Holland
authors.forename: Kerry D
authors.initials: KD
authors.lastname: Solomon
authors.forename: Jay
authors.initials: J
authors.lastname: Fiore
authors.forename: Anthony
authors.initials: A
authors.lastname: Gobbo
authors.forename: Jessica
authors.initials: J
authors.lastname: Prince
authors.forename: Helga P
authors.initials: HP
authors.lastname: Sandoval
authors.forename: Emily R
authors.initials: ER
authors.lastname: Shull
authors.forename: Henry D
authors.initials: HD
authors.lastname: Perry
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002452:Cell Count; D003315:Cornea / Q000187:drug effects; D015715:Corneal Edema / Q000517:prevention & control*; D004311:Double-Blind Method; D004728:Endothelium, Corneal / Q000187:drug effects; D005260:Female; D005477:Fluprednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000503:physiopathology; D007429:Intraocular Pressure / Q000187:drug effects; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D020551:Pulse Therapy, Drug; D012029:Refraction, Ocular / Q000502:physiology; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology
chemical_list: D005938:Glucocorticoids; C009935:prednisolone acetate; D005477:Fluprednisolone; D011239:Prednisolone; C015808:difluprednate