Risk of Endophthalmitis and Other Long-Term Complications of Trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS)

PURPOSE: To report the risk of endophthalmitis and other long-term complications in patients randomized to trabeculectomy in the Collaborative Initial Glaucoma Treatment Study. DESIGN: A longitudinal cohort study using data collected from a multicenter, randomized clinical trial. METHODS: Long-term postoperative complications in the 300 patients randomized to trabeculectomy in the Collaborative Initial Glaucoma Treatment Study were tabulated. Kaplan-Meier analyses were used to estimate the time-related probabilities of blebitis, hypotony, and endophthalmitis. RESULTS: Two hundred eighty-five patients were included in the final trabeculectomy cohort after accounting for declining treatment assignment and other early events. Patients were followed up for an average of 7.2 years. One hundred sixty-three patients (57%) received 5-fluorouracil during surgery. Of the 247 patients with at least 5 years of follow-up, 50 required further treatment for glaucoma. Cataract extraction was performed in 57 patients (20%). Forty patients (14%) required bleb revision at least once. Bleb-related complications included bleb leak (n = 15), blebitis (n = 8), and hypotony (n = 4). Three patients were noted to have endophthalmitis, although the diagnosis in 2 patients was presumptive. The occurrences of blebitis, hypotony, or endophthalmitis were not significantly associated with 5-fluorouracil use. The Kaplan-Meier calculated risks of blebitis and hypotony at 5 years were both 1.5%, whereas the risk of endophthalmitis was 1.1%. CONCLUSIONS: The potential efficacy of trabeculectomy must be weighed against the long-term risk Of complications, especially endophthalmitis, when selecting treatments for patients with open-angle glaucoma. We report a low 5-year risk of endophthalmitis (1.1%) and other bleb-related complications in the trabeculectomy cohort of the Collaborative Initial Glaucoma Treatment Study. (Am J Ophthalmol 2013;155:674-680. (C) 2013 by Elsevier Inc. All rights reserved.)