Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial.
Author(s): Kim SJ, Lo WR, Hubbard GB 3rd, Srivastava SK, Denny JP, Martin DF, Yan J, Bergstrom CS, Cribbs BE, Schwent BJ, Aaberg TM Sr
Affiliation(s): Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA. firstname.lastname@example.org
Publication date & source: 2008-09, Arch Ophthalmol., 126(9):1203-8.
Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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.