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Clinical Trials |

Topical Ketorolac in Vitreoretinal Surgery:  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. doi:10.1001/archopht.126.9.1203.
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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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Figure 1.

Change in mean pupil diameter from preincision to end of vitreoretinal surgery in patients treated with topical ketorolac tromethamine, 0.4%, or placebo. Light eyes included hazel, amber, green, and gray.

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Figure 2.

Distribution of pain scores on day 1 after vitreoretinal surgery in patients treated with ketorolac topical tromethamine, 0.4%, or placebo (P = .03).

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Figure 3.

Distribution of inflammation severity on day 1 after vitreoretinal surgery in patients treated with topical ketorolac tromethamine, 0.4%, or placebo (P < .001).

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Figure 4.

Box plot of center point thickness (A), central subfield thickness (B), and total macular volume (C) 1 month after vitreoretinal surgery in eyes treated with topical ketorolac tromethamine, 0.4%, or placebo. Horizontal lines denote medians; the bottom and top of the boxes represent 25th and 75th percentiles, respectively; error bars represent 95% confidence intervals; and the dots are outliers.

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Figure 5.

Box plot of visual acuity before and after vitreoretinal surgery in eyes treated with topical ketorolac tromethamine, 0.4%, or placebo. Difference in 1-month visual acuity was significant (P = .001).

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Figure 6.

Box plot of poor (≤ 20/200), intermediate (20/60-20/100), and good (20/20-20/50) preoperative visual acuity before and 1 month after vitreoretinal surgery in eyes treated with topical ketorolac tromethamine, 0.4%, or placebo. Difference between the ketorolac and placebo groups at 1 month was significant for eyes with poor (P = .03) or intermediate (P = .05) but not good (P = .38) preoperative visual acuity.

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