Randomized, controlled study of low-dose 5-fluorouracil in primary trabeculectomy.
OBJECTIVE
To report a randomized clinical trial of postoperative subconjunctival injections of low-dose 5-fluorouracil in patients undergoing primary trabeculectomy.


METHODS
In a prospective, randomized clinical trial, 40 eyes of 40 patients were randomized to the low-dose 5-fluorouracil group and received three subconjunctival injections of 5 mg each over 11 postoperative days, and 40 eyes of 40 patients were randomized to trabeculectomy without 5-fluorouracil.


RESULTS
Mean (+/-SD) preoperative and 1-year postoperative intraocular pressures in the 5-fluorouracil group were 26.9 (+/-9.5) and 15.3 (+/-5.8) mm Hg, respectively. In 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 median follow-up of 52.3 weeks. The control group had a mean reduction in intraocular pressure of 10.2 (+/-8.7) mm Hg at a median follow-up of 52.6 weeks. 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 statistically or clinically significant effect on reduction of intraocular pressure with 1-year follow-up. Enhancement of success in this group of patients may require a larger total dose of 5-fluorouracil.
Chaudhry
I A
IA
Department of Ophthalmology and Visual Sciences, Yale University School of Medicine and Yale-New Haven Hospital, New Haven, Connecticut, USA.
Pasha
M A
MA
O'Connor
D J
DJ
Weitzman
M L
ML
Caprioli
J
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000963:Antimetabolites / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D003228:Conjunctiva; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005901:Glaucoma / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D007267:Injections; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D014130:Trabeculectomy; D016896:Treatment Outcome
D000963:Antimetabolites; D005472:Fluorouracil