June 04, 2004
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Mitomycin, 5-FU equally effective as adjuncts in trabeculectomy study

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FLORENCE, Italy — Both mitomycin-C and 5-fluorouracil appear to be equally effective as adjuncts to primary trabeculectomy, according to interim results of a prospective, randomized study.

Kuldev Singh, MD, presented approximately 3-year follow-up data from the Primary Trabeculectomy Antimetabolite Study here at the European Glaucoma Society meeting.

The ongoing study includes 119 eyes of patients with a range of forms of glaucoma, including primary open-angle, pigmentary, exfoliation and chronic angle-closure glaucomas. All patients in the study are over 40 years of age and considered to have low-risk eyes. Sixty eyes were assigned to treatment with adjunctive 5-fluorouracil (5-FU) and 59 eyes to mitomycin-C (MMC).

Dr. Singh said surgeons participating in the study could choose their own method for applying the antimetabolites but were required to remain consistent in their surgical techniques. The study required that the drugs be applied in specific concentrations for specific durations; 0.4 mg/mL of MMC for 2 minutes, and 50 mg/mL of 5-FU for 5 minutes.

The mean follow-up reported by Dr. Singh was 36 months for MMC patients and 33 months for 5-FU patients. The mean IOP in both groups is 12.5 mm Hg, reduced from preoperative means of 26.3 mm Hg for the 5-FU patients and 24.1 mm Hg for the MMC patients.

Dr. Singh noted that there are no significant differences between groups in the rates of adverse events or postoperative interventions such as bleb needling.