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R.I. Fish, A.P. Capistrano, D. WuDunn, L. Cantor, J. Hoop, C. Finley, V. Lakhani, N. Alvi; Intermediate–term Outcomes for Primary Trabeculectomy with Intraoperative 5–Fluorouracil Versus Mitomycin . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4389.
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Purpose: To compare the safety and efficacy of intraoperative 5–FU versus MMC in eyes undergoing primary trabeculectomy Methods: One hundred fifteen eyes of 93 persons (66 ± 12 years) requiring primary trabeculectomy were randomized in a prospective, double–masked fashion to receive either topical intraoperative MMC (0.2mg/cc x 2min) or 5–FU (50mg/cc x 5min). Main outcome variables were success of IOP control, visual acuity, and complications. Success was defined as at least 25% reduction in IOP from baseline, IOP ≤ 21 mmHg with or without medications, and IOP ≥ 6. Major complications and re–operations were considered failures Results: The majority of patients were followed for at least 36 months or until failure occurred. Cumulative survival in the 5–FU group was 0.81 at 24 months and 0.76 at 36 months whereas cumulative survival in the MMC group was 0.76 at 24 months and 0.73 at 36 months (P=0.67, log–rank test). Of the 115 eyes (57 in MMC and 58 in 5–FU), there were a total of 34 failures (18 in MMC group, 16 in 5–FU group). Twenty–three subjects either died or were lost to follow up (12 patients in MMC group and 11 in 5–FU group). Reasons for failure in the 5–FU group included inadequate IOP control in 6 cases, bleb leaks requiring bleb revision in 7 cases, hypotony requiring surgical intervention in 3 cases. Reasons for failure in the MMC group included inadequate IOP control in 3 cases, bleb leak requiring revision in 5 cases, hypotony requiring intervention in 7 cases, endophthalmitis in 2 cases, and bleb dyesthesia requiring revision in 1 case. Twenty four patients in the MMC group and 18 patients in the 5–FU group had cataract surgery during the study period. Conclusions: Our data suggests that 5–FU filtering blebs have similar survival compared to MMC filtering blebs when applied topically according to our protocol. CR: None Support: Supported in part by Research to Prevent Blindness, Inc.
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