A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy.
OBJECTIVE
To compare the safety and efficacy of intraoperative 5-fluorouracil (5-FU) or Intraoperative mitomycin C (MMC) in eyes undergoing primary trabeculectomy.


METHODS
Prospective double-masked randomized clinical trial.


METHODS
One hundred fifteen eyes of 103 patients with uncontrolled intraocular pressure (IOP) despite maximally tolerated medical therapy or laser were prospectively randomized in a double-masked fashion to one of two treatment groups in a single institution setting. Subject's eyes underwent primary trabeculectomy with either topical 5-FU (50 mg/ml for 5 minutes) or topical MMC (0.2 mg/ml for 2 minutes). Primary outcome measures included the number of eyes achieving target pressures of 21, 18, 15, and 12 mm Hg at 6 and 12 months postoperatively. Secondary outcome measures included IOP, best-corrected visual acuity, complications, and interventions.


RESULTS
Of the 115 eyes, 57 received 5-FU while 58 received MMC. A target IOP of 21 mm Hg at 6 months was achieved in 53 of 56 (95%) eyes in the 5-FU group and 54 of 57 (95%) eyes in the MMC group (P = 1.00). At 12 months, 45 of 48 (94%) eyes in the 5-FU group met a target IOP of 21 mm Hg while 48 of 54 (89%) eyes in the MMC group did (P =.49). The most common complications in each group were persistent choroidal effusions and bleb leak.


CONCLUSIONS
Our study suggests that intraoperative topical 5-FU is at least as effective as intraoperative topical MMC in reducing IOP of eyes undergoing primary trabeculectomy.
WuDunn
Darrell
D
Department of Ophthalmology, Indiana University, Indianapolis 46202, USA. dwudunn@iupui.edu
Cantor
Louis B
LB
Palanca-Capistrano
Angelita M
AM
Hoop
Joni
J
Alvi
Nishat P
NP
Finley
Charles
C
Lakhani
Vipul
V
Burnstein
Alan
A
Knotts
Stephenie L
SL
D000963:Antimetabolites / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005901:Glaucoma / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D007432:Intraoperative Period; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014130:Trabeculectomy; D014792:Visual Acuity
D000963:Antimetabolites; D016685:Mitomycin; D005472:Fluorouracil