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A Prospective, Randomized, Placebo-Controlled, Double-Masked Trial

Stephen J. Kim, MD; Wayne R. Lo, MD; G. Baker Hubbard III, MD; Sunil K. Srivastava, MD; John P. Denny, MD; Daniel F. Martin, MD; Jiong Yan, MD; Chris S. Bergstrom, MD; Blaine E. Cribbs, MD; Bryan J. Schwent, MD; Thomas M. Aaberg Sr, MD, MSPH

Arch Ophthalmol. 2008;126(9):1203-1208.

Objective  To evaluate the effects of topical ketorolac in patients undergoing vitreoretinal surgery.

Methods  One hundred nine patients undergoing vitrectomies were randomized to receive either topical ketorolac tromethamine, 0.4%, or placebo. Patients were instructed to begin taking the study medication 3 days preoperatively (4 times daily) and to continue taking it 4 weeks postoperatively.

Main Outcome Measures  Intraoperative pupil diameter, postoperative day 1 pain and inflammation, 1-month postoperative retinal thickness, and preoperative and 1-month postoperative best-corrected visual acuities.

Results  The difference in mean pupil diameters between patients using ketorolac and those taking placebo was 0.06 mm (P = .39). Patients taking ketorolac and those taking placebo had mean pain scores (scale, 1-10) of 0.24 (SD, 0.6) and 1.06 (SD, 2) (P = .03) and mean inflammation grades (grade, 0-4) of 0.59 (SD, 0.7) and 1.16 (SD, 0.9) (P < .001), respectively. Ketorolac reduced central subfield thickness by 8%, but this was not statistically significant. At 1 month, mean visual acuities improved to 0.40 logMAR units (mean Snellen, 20/50; SD, 0.28 logMAR units) in the ketorolac group from 0.83 logMAR units (20/150⁺²; SD, 0.60 logMAR units) at baseline and to 0.67 logMAR units (20/100⁺¹; SD, 0.46 logMAR units) in the placebo group from 0.92 logMAR units (20/150^–2; SD, 0.62 logMAR units) at baseline (P = .001).

Conclusions  Topical ketorolac was well tolerated and safe, reduced postoperative pain and inflammation, and improved visual recovery in this prospective, double-masked trial.

Application to Clinical Practice  Topical ketorolac may benefit patients undergoing vitreoretinal surgery.

Trial Registration  clinicaltrials.gov Identifier: NCT00576329

Author Affiliations: Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia. Dr Kim is now with the Department of Ophthalmology, Vanderbilt University, Nashville, Tennessee.