Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery

To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. Multicenter clinical study. One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells ( P = 0.002) and flare ( P = 0.009), conjunctival erythema ( P = 0.010), ciliary flush ( P = 0.022), photophobia ( P = 0.027), and pain ( P = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.