A Multicenter Randomized Controlled Fellow Eye Trial of Pulse-Dosed Difluprednate 0.05% Versus Prednisolone Acetate 1% in Cataract Surgery

• Published in: American journal of ophthalmology 2011-10, Vol.152 (4), p.609-617.e1
• Main Authors: Donnenfeld, Eric D, Holland, Edward J, Solomon, Kerry D, Fiore, Jay, Gobbo, Anthony, Prince, Jessica, Sandoval, Helga P, Shull, Emily R, Perry, Henry D
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Biological and medical sciences; Cataracts; Cell Count; Clinical medicine; Cornea - drug effects; Corneal Edema - prevention & control; Double-Blind Method; Endothelium; Endothelium, Corneal - drug effects; Eye surgery; Female; Fluprednisolone - administration & dosage; Fluprednisolone - analogs & derivatives; Glucocorticoids - administration & dosage; Health Insurance Portability & Accountability Act 1996-US; Humans; Inflammation - drug therapy; Inflammation - physiopathology; Intraocular Pressure - drug effects; Lens diseases; Lens Implantation, Intraocular; Male; Medical sciences; Meetings; Middle Aged; Miscellaneous; Ophthalmology; Phacoemulsification; Prednisolone - administration & dosage; Prednisolone - analogs & derivatives; Prospective Studies; Pulse Therapy, Drug; Refraction, Ocular - physiology; Retina; Spinal cord; Standard deviation; Steroids; Stress response; Surgery; Surgical outcomes; Uveitis, Anterior - drug therapy; Uveitis, Anterior - physiopathology; Visual Acuity - physiology
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2011.03.018

Purpose To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery. Design 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/mm2 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.