A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy - 02/09/11
, Louis B Cantor, MD a, Angelita M Palanca-Capistrano, MD a, Joni Hoop a : COT, Nishat P Alvi, MD a, Charles Finley, MD a, Vipul Lakhani, MD a, Alan Burnstein, MD a, Stephenie L Knotts aAbstract |
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.
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 | This study was supported by an unrestricted grant from Research to Prevent Blindness, Inc., New York, New York. |
Vol 134 - N° 4
P. 521-528 - octobre 2002 Retour au numéro
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