Journal of Cataract & Refractive Surgery
Volume 32, Issue 9 , Pages 1474-1482, September 2006

Preoperative ketorolac tromethamine 0.4% in phacoemulsification outcomes: Pharmacokinetic-response curve

From a private clinical practice, Rockville Centre, New York, USA

Accepted 3 April 2006.

Purpose

To assess the clinical benefit, relative efficacy, and pharmacokinetic-response curve of preoperative and postoperative ketorolac tromethamine 0.4% (Acular LS) to improve outcomes during and after cataract surgery.

Setting

Private clinical practice.

Methods

One hundred patients were randomized in a double-masked fashion to 4 groups of 25 to receive ketorolac for 3 days, 1 day, or 1 hour or a placebo before phacoemulsification. All treatment groups received ketorolac 0.4% for 3 weeks postoperatively; the placebo group received vehicle. Outcomes measures were preservation of preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, complications, and incidence of clinically significant cystoid macular edema (CME).

Results

Maintenance of pupil size with 3-day ketorolac dosing was significantly better than with 1-day dosing (P<.01), which was significantly better than with 1-hour or placebo dosing (P<.01). Both 3-day and 1-day dosing were superior to 1-hour or placebo dosing. No patient receiving ketorolac 0.4% for 1 or 3 days developed CME compared with 12% of patients in the control (placebo) group and 4% in the 1-hour group. Three-day and 1-day dosing of ketorolac reduced surgical time, phacoemulsification time and energy, and endothelial cell loss and improved visual acuity in the immediate postoperative period compared with 1-hour predosing and the placebo (P<.05).

Conclusion

The preoperative use of ketorolac tromethamine 0.4% for 3 days followed by 1-day of predosing provided optimum efficacy and superior outcomes relative to 1-hour pretreatment and a placebo.

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 Presented in part at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Washington, DC, USA, April 2005.Supported in part by an unrestricted grant from Allergan Inc., Irvine, California, and the Lions Eye Bank for Long Island, Long Island, New York, USA.Drs. Donnenfeld, Perry, and Wittpenn are consultants to Allergan Pharmaceuticals. No other author has a financial or proprietary interest in any material or method mentioned.

PII: S0886-3350(06)00657-2

doi:10.1016/j.jcrs.2006.04.009

Journal of Cataract & Refractive Surgery
Volume 32, Issue 9 , Pages 1474-1482, September 2006