Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil: Prospective randomized clinical trial☆

Received 26 October 1999; accepted 1 June 2000.

Abstract

Objective

To evaluate the relative efficacy and safety of 5-fluorouracil (5-FU) and mitomycin C (MMC) when used as adjuncts with primary trabeculectomy in eyes not at high risk for failure.

Design

Prospective multicenter, randomized clinical trial.

Participants

One hundred thirteen patients with primary open-angle, pseudoexfoliative, pigmentary, or angle-closure glaucoma undergoing primary trabeculectomy were recruited.

Methods

One eye of each patient was randomized to receive either 5-FU (50 mg/ml for 5 minutes) or MMC (0.4 mg/ml for 2 minutes).

Main outcome measures

Intraocular pressure (IOP), visual acuity, complications, and interventions were documented at fixed intervals after surgery. The study also examined progression of visual field loss, long-term complications, and bleb appearance 3 years after surgery.

Results

Of the 108 patients with complete perioperative information, 54 eyes received 5-FU and 54 received MMC. The proportion of patients reaching different predefined target IOPs after surgery was slightly higher in the MMC group than in the 5-FU group. This difference was less than 25%, which would have been necessary to achieve statistical significance with a power of 0.8 and the sample size used. Likewise, there was no statistically significant difference between the groups with regard to mean preoperative IOP, complications, or interventions. Mean postoperative follow-up was 309 and 330 days in the 5-FU and MMC groups, respectively (P = 0.593).

Conclusions

5-Fluorouracil and MMC were found to be equally safe and effective adjuncts to primary trabeculectomy in the short- and medium-term postoperative periods.

Manuscript no. 99423.

a Stanford University School of Medicine, Stanford, California, USA

b Johns Hopkins University, Baltimore, Maryland, USA

c Vanderbilt University, Nashville, Tennessee, USA

d Wills Eye Hospital, Philadelphia, Pennsylvania, USA

e Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida, USA

f New York Eye and Ear Infirmary, New York, New York, USA

g University of Washington, Seattle, Washington, USA

h Cincinnati Eye Institute, Cincinnati, Ohio, USA

i Cleveland Clinic Foundation, Cleveland, Ohio, USA

j University of California, Irvine, Irvine, California, USA

Reprint requests to Kuldev Singh, MD, Associate Professor of Ophthalmology, Stanford University Medical Center, 300 Pasteur Drive, Room A-157, Stanford, CA 94305-5308

☆ The authors have no financial interest in any products or devices mentioned herein.

PII: S0161-6420(00)00391-2

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