Randomized, controlled study of low-dose 5-fluorouracil in primary trabeculectomy

PURPOSE: To report a randomized clinical trial of postoperative subconjunct ival injections of low-dose 5-fluorouracil in patients undergoing primary t rabeculectomy. METHODS: In a prospective, randomized clinical trial, 40 eyes of 40 patient s were randomized to the low-dose 5-fluorouracil group and received three s ubconjunctival injections of 5 mg each over 11 postoperative days, and 40 e yes of 40 patients mere randomized to trabeculectomy without 5-fluorouracil . RESULTS: Mean (+/-SD) preoperative and 1-year postoperative intraocular pre ssures in the 5-fluorouracil group were 26.9 (+/-9.5) and 15.3 (+/-5.8) mm Hg, respectively. Tn the control group these were 25.9 (+/-8.1) mm Hg, and 15.8 (+/-5.1) mm Hg, respectively. The patients who received 5-fluorouracil had a mean reduction in intraocular pressure of 11.5 (+/-9.1) mm Hg at a m edian follow-up of 52.3 weeks. The control group had a mean reduction in in traocular pressure of 10.2 (+/-8.7) mm Hg at a median follow-up of 52.6 wee ks. These differences were not statistically significant. CONCLUSIONS: Three postoperative subconjunctival 5-fluorouracil injections of 5 mg each after trabeculectomy in eyes at low risk for failure had no st atistically or clinically significant effect on reduction of intraocular pr essure with 1-year follow-up. Enhancement of success in this group of patie nts may require a larger total dose of 5 -fluorouracil. (C) 2000 by Elsevie r Science Inc. All rights reserved.