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Melissa H. Wong, Steve Seah, Rahat Husain, Gus Guzzard, P J Foster, Francis Oen, Tina Wong, PT Khaw, Tin Aung; The Singapore 5 FU trial: Intraocular Pressure Outcomes at 8 years. Invest. Ophthalmol. Vis. Sci. 2011;52(14):655.
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To assess the long term intraocular pressure (IOP) outcomes at 8 years of patients with primary glaucoma who underwent trabeculectomy augmented with either 5-fluorouracil (5FU) or placebo.
As part of a randomized controlled trial, 243 patients underwent trabeculectomy augmented with either 5FU or placebo for primary open angle or angle closure glaucoma. The charts of 170 patients who completed 8 years of follow-up were analyzed. The primary outcome measure was IOP, with complete success defined as IOP<21 mm Hg without any medications. Patients who had repeat glaucoma surgery or who had IOP>21 mm Hg on 2 consecutive visits during the follow-up period were considered failures.
Out of the 170 patients who completed 8 years of follow-up, 86 patients were randomized to 5FU and 84 patients received placebo at the time of trabeculectomy. At 8 years, complete success was achieved in 55.8% (95%CI 39.6%-72%) of subjects in the 5-FU group and in 40.5% (95% CI 30%-50.9%) of subjects in the placebo group (p=0.06). There were 11.6% (95%CI 14.8%-18.4%) failures in the 5FU group and 16.7% (95%CI 8.7%-24.7%) in the placebo group (p = 0.46). A total of 107 out of 170 (62.9%) patients underwent cataract surgery during the follow-up period after trabeculectomy (50 in the 5FU group and 57 in the placebo group), with no significant difference in the mean number of months after trabeculectomy in which cataract surgery was performed (31.7 + 22.6 months in the 5FU group and 29.8 + 22.3 months in the placebo group). The corresponding failure rates in terms of IOP at 3 years were 4.7% in the 5FU group and 6% in the placebo group
The 8-year outcome of trabeculectomy for primary glaucoma in Asians was poor in both 5FU and placebo groups, with failure rates almost double that at 3 years. There was a high rate of cataract surgery after trabeculectomy in both groups over this period.
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