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.