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

Kuldev Singh, Kala Metha, Naazli M. Shaikh, James C. Tsai, Marlene R. Moster, Donald L. Budenz, David S. Greenfield, Philip P. Chen, John S. Cohen, George S. Baerveldt, Saad Shaikh, Rommel Bautista, Sally R. Byrd, Steven J. Gedde, Paul F. Palmberg, Karen M. Joos, M. Denise Williams, Kathy Reasonover, Julie Ozier, L. Jay KatzJonathan S. Myers, Kelly Flaherty, Jeffrey M. Liebmann, Robert Ritch, Robert F. Rothman, Martha M. Leen, Linda J. Greff, Edward J. Rockwood, Laura Wash

Research output: Contribution to journalArticle

141 Scopus citations

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. (C) 2000 by the American Academy of Ophthalmology.

Original languageEnglish (US)
Pages (from-to)2305-2309
Number of pages5
JournalOphthalmology
Volume107
Issue number12
DOIs
StatePublished - Dec 12 2000

ASJC Scopus subject areas

  • Ophthalmology

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    Singh, K., Metha, K., Shaikh, N. M., Tsai, J. C., Moster, M. R., Budenz, D. L., Greenfield, D. S., Chen, P. P., Cohen, J. S., Baerveldt, G. S., Shaikh, S., Bautista, R., Byrd, S. R., Gedde, S. J., Palmberg, P. F., Joos, K. M., Denise Williams, M., Reasonover, K., Ozier, J., ... Wash, L. (2000). Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil: Prospective randomized clinical trial. Ophthalmology, 107(12), 2305-2309. https://doi.org/10.1016/S0161-6420(00)00391-2