Prophylactic use of ketorolac tromethamine in cataract surgery: a randomized trial.

Abstract

PURPOSE:

To determine the efficacy of topical ketorolac tromethamine in preventing cystoid macular edema (CME) after uncomplicated cataract surgery.

METHODS:

This single-center, prospective, double-masked, randomized clinical trial consisted of 81 patients who were scheduled for cataract surgery. Patients were randomized to receive hypromellose/dextran 70 as a placebo (n=44) or ketorolac tromethamine 0.4% (n=37) as an adjuvant therapy. These eye drops were administered 4 times daily (QID) for 3 days before surgery and 5 weeks postoperatively. All patients received prednisolone acetate 1% QID during the same period as basal/standard anti-inflammatory therapy. The primary outcome was the incidence of angiographic CME 5 weeks after surgery. The secondary outcomes were mean change in best-corrected visual acuity (BCVA) [Early Treatment Diabetic Retinopathy study (ETDRS)], clinical CME incidence, intraocular pressure, and retinal thickness measured using optical coherence tomography (OCT).

RESULTS:

In the placebo group, 2/44 (4.5%) patients and in the ketorolac group, 2/37 (5.4%) patients presented with angiographic CME (P=0.624). The mean change in postoperative BCVA was 32±15 letters in the placebo group and 26±16 letters in the ketorolac group (P=0.07). There were no statistically significant between-group differences in the mean central subfield thickness (P=0.679), minimal central thickness (P=0.352), or central macular volume (P=0.729).

CONCLUSION:

There was no difference between ketorolac tromethamine and a placebo with regard to BCVA results or prevention of CME after uncomplicated cataract surgery.

• Authors: Flavia G Ticly, Rodrigo P C Lira, Fernando R Zanetti, Maria Cecília Machado, Gustavo B Rodrigues, Carlos Eduardo L Arieta
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 30 Issue 6 Pg. 495-501 (Aug 2014) ISSN: 1557-7732 [Electronic] United States
• PMID: 24735005 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

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

Topics

• Aged
• Anti-Inflammatory Agents (therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Cataract Extraction (methods)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Ketorolac Tromethamine (administration & dosage, therapeutic use)
• Macular Edema (etiology, prevention & control)
• Male
• Middle Aged
• Ophthalmic Solutions
• Prednisolone (analogs & derivatives, therapeutic use)
• Prospective Studies
• Tomography, Optical Coherence
• Treatment Outcome
• Visual Acuity (drug effects)