Purpose: To describe the intraoperative and postoperative complications encountered during the first year of follow-up in the Tube Versus Trabeculectomy (TVT) Study. Design: Multicenter randomized clinical trial. Methods: setting: Seventeen clinical centers. study population: Two hundred twelve patients aged 18 to 85 years who had undergone previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: A 350-mm2 Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). main outcome measures: Surgical complications, reoperation for complications, visual acuity, and cataract progression. Results: Intraoperative complications occurred in seven patients (7%) in the tube group and 10 patients (10%) in the trabeculectomy group (P = .59). Postoperative complications developed in 36 patients (34%) in the tube group and 60 patients (57%) in the trabeculectomy group during the first year of follow-up (P = .001). Surgical complications were associated with reoperation and/or loss of ≥2 lines of Snellen visual acuity in 18 patients (17%) in the tube group and 28 patients (27%) in the trabeculectomy group (P = .12). Conclusions: There were a large number of surgical complications during the first year of follow-up in the study, but most were self-limited. The incidence of postoperative complications was higher after trabeculectomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures.
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