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Clinical Trials
September 08, 2008

Topical Ketorolac in Vitreoretinal SurgeryA Prospective, Randomized, Placebo-Controlled, Double-Masked Trial

Author Affiliations

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.

Arch Ophthalmol. 2008;126(9):1203-1208. doi:10.1001/archopht.126.9.1203
Abstract

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

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