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


METHODS
Prospective multicenter, randomized clinical trial.


METHODS
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).


METHODS
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.
Singh
K
K
Stanford University School of Medicine, Stanford, California, USA. Kuldev.Singh@forsythe.stanford.edu
Mehta
K
K
Shaikh
N M
NM
Tsai
J C
JC
Moster
M R
MR
Budenz
D L
DL
Greenfield
D S
DS
Chen
P P
PP
Cohen
J S
JS
Baerveldt
G S
GS
Shaikh
S
S
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005901:Glaucoma / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure; D007431:Intraoperative Complications; D007432:Intraoperative Period; D008297:Male; D016685:Mitomycin / Q000627:therapeutic use*; D011183:Postoperative Complications; D011446:Prospective Studies; D012449:Safety; D014130:Trabeculectomy / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity; D014794:Visual Fields
D000964:Antimetabolites, Antineoplastic; D016685:Mitomycin; D005472:Fluorouracil