A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy.

PURPOSE: To compare the safety and efficacy of intraoperative 5-fluorouracil (5-FU) or Intraoperative mitomycin C (MMC) in eyes undergoing primary trabeculectomy. DESIGN: Prospective double-masked randomized clinical trial. METHODS: One hundred fifteen eyes of 103 patients with uncontrolled intraocular pressure (IOP) despite maximally tolerated medical therapy or laser were prospectively randomized in a double-masked fashion to one of two treatment groups in a single institution setting. Subject's eyes underwent primary trabeculectomy with either topical 5-FU (50 mg/ml for 5 minutes) or topical MMC (0.2 mg/ml for 2 minutes). Primary outcome measures included the number of eyes achieving target pressures of 21, 18, 15, and 12 mm Hg at 6 and 12 months postoperatively. Secondary outcome measures included IOP, best-corrected visual acuity, complications, and interventions. RESULTS: Of the 115 eyes, 57 received 5-FU while 58 received MMC. A target IOP of 21 mm Hg at 6 months was achieved in 53 of 56 (95%) eyes in the 5-FU group and 54 of 57 (95%) eyes in the MMC group (P = 1.00). At 12 months, 45 of 48 (94%) eyes in the 5-FU group met a target IOP of 21 mm Hg while 48 of 54 (89%) eyes in the MMC group did (P =.49). The most common complications in each group were persistent choroidal effusions and bleb leak. CONCLUSION: Our study suggests that intraoperative topical 5-FU is at least as effective as intraoperative topical MMC in reducing IOP of eyes undergoing primary trabeculectomy.

Conjunctival advancement versus nonincisional treatment for late-onset glaucoma filtering bleb leaks.

OBJECTIVE: To compare the outcomes of conjunctival advancement and nonincisional management of late-onset glaucoma filtering bleb leak. DESIGN: Retrospective, nonrandomized, comparative interventional trial. PARTICIPANTS: Fifty-one eyes of 48 persons who underwent management of late-onset glaucoma filtering bleb leak from December 1986 through December 1999 were included. Thirty-seven eyes were included in the nonincisional treatment group (aqueous suppression with lubrication or patching, bandage contact lenses, cyanoacrylate glue, autologous blood injection, or a combination thereof) and 34 eyes were included in the surgical revision group (conjunctival advancement with preservation of the preexisting bleb). Twenty eyes underwent nonincisional treatment before surgical revision and were included in each treatment group. METHODS: Retrospective chart review of bleb leaks occurring at least 2 months after trabeculectomy. Successful treatment was defined as the resolution of the bleb leak, a final intraocular pressure (IOP) of 21 mmHg or less, and no significant complications such as blebitis, endophthalmitis, or bleb dysesthesia requiring a bleb revision. MAIN OUTCOME MEASURES: Cumulative success of closure of the filtering bleb leak, complications resulting from the intervention, IOP before and after treatment, and number of glaucoma medications before and after treatment. RESULTS: The Kaplan-Meier cumulative probability of success at 12 and 24 months were 0.45 and 0.42, respectively, for the nonincisional treatment group and 0.80 and 0.80, respectively, for the surgical revision group. The overall difference between the cumulative success of surgical and nonincisional treatment was statistically significant (P = 0.0001, log-rank test). In the nonincisional treatment group, only 20 of 37 eyes (54%) achieved initial sealing of the bleb leak after the treatment, and of those, almost half (8/20) eventually failed. Reasons for failure included persistent or recurrent leak (n = 21), blebitis or endophthalmitis (n = 6, including 4 with persistent leak), and bleb dysesthesia (n = 2). All eyes in the surgical group achieved closure of the leak, however 7 eventually failed because of leak recurrence (n = 2), elevated IOP (n = 3), or bleb dysesthesia (n = 2), and 11 required additional glaucoma medications. CONCLUSIONS: Patients with late bleb leaks managed with conjunctival advancement were more likely to have successful outcomes and less likely to have serious intraocular infections than those managed more conservatively.