Elsevier

Ophthalmology

Volume 116, Issue 2, February 2009, Pages 175-184
Ophthalmology

Original article
The Singapore 5-Fluorouracil Trabeculectomy Study: Effects on Intraocular Pressure Control and Disease Progression at 3 Years

https://doi.org/10.1016/j.ophtha.2008.09.049Get rights and content

Purpose

To report 3-year results of a randomized, controlled trial comparing the use of a single application of 5-fluorouracil (5-FU) with placebo in trabeculectomy surgery.

Design

Prospective, randomized, double-blinded treatment trial.

Participants

Two hundred forty-three Asian patients with primary open-angle or primary angle-closure glaucoma undergoing primary trabeculectomy.

Methods

One eye of each patient was randomized to receive either intraoperative 5-FU or normal saline (placebo) during trabeculectomy.

Main Outcome Measures

Primary outcome measure was the level of intraocular pressure (IOP). Secondary outcomes were progression of visual field loss, rates of adverse events, and interventions after surgery.

Results

Of the 288 eligible patients, 243 were enrolled and 228 completed 3 years follow-up; 120 patients received 5-FU and 123 received placebo. Trial failure, according to predefined IOP criteria, was lower in the 5-FU group compared with the placebo group, although the difference was only significant with a failure criterion of IOP >17 mmHg (P = 0.0154). There was no significant difference in progression of optic disc and/or visual field loss over 36 months between 5-FU and placebo (relative risk [RR], 0.67; 95% confidence interval [CI], 0.34–1.31; P = 0.239). Uveitis occurred more often in the 5-FU–treated group (14/115 [12%] vs 5/120 [4%]; P = 0.032).

Conclusions

This is the first masked, prospective, randomized trial reporting the effect of adjunctive 5-FU in trabeculectomy surgery in an East Asian population. The trial shows that an increased success rate can be achieved for several years after a single intraoperative treatment with 5-FU. We conclude that 5-FU is relatively safe and can be routinely used in low-risk East Asian patients.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.

Section snippets

Patients and Methods

Participants were enrolled into a prospective, randomized, double-blind, placebo-controlled trial studying the role intraoperative 5-FU in glaucoma filtration surgery. Subjects were recruited from the Singapore National Eye Centre and the National University Hospital, Singapore. Written, informed consent was obtained from all participants. The study had the approval of the Ethical Review Committee of Singapore National Eye Centre and was carried out in accordance with the tenets of the

Results

A total of 288 participants were recruited. Of these, 45 could not be randomized and were therefore excluded. The main reasons for nonrecruitment were inability to perform visual fields tests and being unsuitable for surgery owing to illness. The remaining 243 patients were randomized to receive placebo or 5-FU during trabeculectomy surgery. The demographic and clinical features of the 2 treatment groups at baseline are summarized in Table 2, Table 3.

By postoperative year 1, 1 patient was lost

Discussion

The long-term outcome of primary trabeculectomy with antimetabolites in Asian eyes has not as yet been reported in detail. A retrospective study from Hong Kong looked at the surgical outcome of trabeculectomy with MMC in Chinese patients. The authors reported a reduction of IOP of <21 mmHg in 73.7% of patients with a mean follow-up of 29 months.23 Similar trabeculectomy survival rates in 5-FU augmented trabeculectomies were found in another retrospective study conducted in Singapore. Wong et al

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    Manuscript no. 2008-323.

    Financial Disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article.

    Supported by the National Medical Research Council of Singapore (NMRC/0044/1998) and Singapore National Eye Centre. Professor Khaw, Dr Foster and Dr Minassian received funding from the Medical Research Council (UK) (Grant number G9330070) and the NIHR Biomedical Research Centre.

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