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J. A. Hall, D. WuDunn, L. B. Cantor, A. M. Palanca-Capistrano, J. Hoop, L. Morgan; Long Term Outcomes of Intraoperative 5-Fluorouracil versus Intraoperative Mitomycin C in Primary Trabeculectomy Surgery. Invest. Ophthalmol. Vis. Sci. 2008;49(13):4539.
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Long-term follow-up of those subjects previously enrolled in a prospective double masked clinical trial, involving the evaluation of a single intraoperative application of mitomycin C (MMC) versus 5-fluorouracil (5-FU) during primary trabeculectomy.
92 eyes were analyzed, which included those followed beyond 12 months postoperatively and those which failed prior to 1 year. During the initial phase of the study, eyes were prospectively randomized in a double-masked fashion into one of two treatment groups at a single institution. In group one, primary trabeculectomies were performed with topical 5-FU (50 mg/ml for 5 minutes), and in group 2 with topical MMC (0.2 mg/ml for 2 minutes). The primary outcome measure was Kaplan-Meier success for IOP control (IOP >20% reduction from preoperative value and <21 mmHg). Secondary outcome measures included IOP, best-corrected visual acuity, number of glaucoma medications, postoperative interventions, and complications.
115 eyes of 103 patients were enrolled in the original study. Of these, 92 eyes entered the long-term follow-up, 46 of which were included in each study group. At 60 months post-trabeculectomy, 27 eyes from the 5-FU group (60%) and 23 eyes which received MMC (53.5%) were a success. The overall difference in Kaplan-Meier success between the two groups was not statistically significant (P=0.42, log rank test). Complication comparisons can be found in table 1.
Our study suggests that intraoperative topical 5-FU continued to demonstrate at least equal efficacy and safety when compared with intraoperative topical MMC in primary trabeculectomy, at up to 60 months.
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