5-FLUOROURACIL IN INITIAL TRABECULECTOMY - A PROSPECTIVE, RANDOMIZED,MULTICENTER STUDY

Purpose: Postoperative subconjunctival 5-fluorouracil (5-FU) injection s increase the success of filtration surgery in eyes with prior filtra tion failure or cataract removal and in eyes with secondary glaucoma. The authors evaluate the safety and benefit of adjunctive 5-FU in eyes undergoing initial trabeculectomy. Methods: Patients with phakic, unc ontrolled, open-angle glaucoma who were undergoing initial trabeculect omy were prospectively assigned to the 5-FU group on the first postope rative day. Patients in this group received five 5-mg injections durin g 2 weeks after surgery. Patients in the control group received no inj ections. Results: Preoperative intraocular pressure (IOP) and number o f antiglaucoma medications were similar in the 5-FU (n = 32) and contr ol(n = 30) groups. Transient superficial punctate keratopathy was the only postoperative complication that occurred more frequently (P < 0.0 5) in the 5-FU (14 eyes) than in the control eyes (3 eyes). Patients w ere followed for a minimum of 1 year or until a study endpoint was rea ched: IOP of 21 mmHg or greater with maximum medical therapy (2 5-FU e yes and 8 control eyes; P < 0.03) or cataract removal after filtration (5 treated and 3 control eyes). At last followup (mean, >20 months), IOP and the number of antiglaucoma medications were significantly lowe r (P < 0.02) in the 5-FU eyes (IOP, 12.0+/-1.3 mmHg; medications, 0.2/-0.1) than in the control eyes(IOP, 16.8+/-1.3 mmHg; medications, 0.8 +/-0.2). Intraocular pressure was 20 mmHg or lower in 94% of 5-FU eyes and in 73% of control eyes (P < 0.03) and 16 mmHg or lower in 84% of 5-FU eyes and in 57% of control eyes (P ( 0.02). Conclusions: Adjuncti ve 5-fluorouracil increases the rate of success, decreases the level o f postoperative IOP, and reduces the need for postoperative antiglauco ma medication in eyes with open-angle glaucoma undergoing initial trab eculectomy.