Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil - Prospective randomized clinical trial

Objective: To evaluate the relative efficacy and safety of 5-fluorouracil ( 5-FU) and mitomycin C (MMC) when used as adjuncts with primary trabeculecto my in eyes not at high risk for failure. Design: Prospective multicenter, randomized clinical trial. Participants: One hundred thirteen patients with primary open-angle, pseudo exfoliative, pigmentary, or angle-closure glaucoma undergoing primary trabe culectomy were recruited. Methods: One eye of each patient was randomized to receive either 5-FU (50 mg/ml for 5 minutes) or MMC (0.4 mg/ml for 2 minutes). Main Outcome Measures: Intraocular pressure (IOP), visual acuity, complicat ions, and interventions were documented at fixed intervals after surgery. T he study also examined progression of visual field loss, long-term complica tions, and bleb appearance 3 years after surgery. Results: Of the 108 patients with complete perioperative information, 54 ey es received 5-FU and 54 received MMC. The proportion of patients reaching d ifferent predefined target IOPs after surgery was slightly higher in the MM C group than in the 5-FU group. This difference was less than 25%, which wo uld have been necessary to achieve statistical significance with a power of 0.8 and the sample size used. Likewise, there was no statistically signifi cant difference between the groups with regard to mean preoperative IOP, co mplications, or interventions. Mean postoperative follow-up was 309 and 330 days in the 5-FU and MMC groups, respectively (P = 0.593). Conclusions: Ei-Fluorouracil and MMC were found to be equally safe and effe ctive adjuncts to primary trabeculectomy in the short- and medium-term post operative periods. (C) 2000 by the American Academy of Ophthalimology.