Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial

Arch Ophthalmol. 2008 Sep;126(9):1203-8. 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Double-Blind Method
  • Female
  • Humans
  • Inflammation / drug therapy
  • Ketorolac Tromethamine / administration & dosage*
  • Ketorolac Tromethamine / adverse effects
  • Male
  • Middle Aged
  • Ophthalmic Solutions / administration & dosage
  • Ophthalmic Solutions / adverse effects
  • Pain Measurement
  • Pain, Postoperative / prevention & control
  • Prospective Studies
  • Pupil / drug effects
  • Retinal Diseases / surgery*
  • Visual Acuity / drug effects
  • Vitrectomy*
  • Vitreous Body / surgery*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Ophthalmic Solutions
  • Ketorolac Tromethamine

Associated data

  • ClinicalTrials.gov/NCT00576329