April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
The Singapore 5 FU trial: Intraocular Pressure Outcomes at 8 years
Author Affiliations & Notes
  • Melissa H. Wong
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
  • Steve Seah
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
  • Rahat Husain
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
  • Gus Guzzard
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
    Singapore Eye Research Institute, Singapore, Singapore
  • P J Foster
    Singapore Eye Research Institute, Singapore, Singapore
  • Francis Oen
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
  • Tina Wong
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
    Singapore Eye Research Institute, Singapore, Singapore
  • PT Khaw
    Singapore Eye Research Institute, Singapore, Singapore
  • Tin Aung
    Ophthalmology, Singapore National Eye Centre, Singapore, Singapore
    Singapore Eye Research Institute, Singapore, Singapore
  • Footnotes
    Commercial Relationships  Melissa H. Wong, None; Steve Seah, None; Rahat Husain, None; Gus Guzzard, None; P J Foster, None; Francis Oen, None; Tina Wong, None; PT Khaw, None; Tin Aung, None
  • Footnotes
    Support  NMRC/0044/1998,G9330070
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 655. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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.

Methods: : 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.

Results: : 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

Conclusions: : 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.

Clinical Trial: : http://www.clinicaltrials.gov R340/33/2003

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure 
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