The singapore 5-Fluorouracil trabeculectomy study: effects on intraocular pressure control and disease progression at 3 years.
OBJECTIVE
To report 3-year results of a randomized, controlled trial comparing the use of a single application of 5-fluorouracil (5-FU) with placebo in trabeculectomy surgery.


METHODS
Prospective, randomized, double-blinded treatment trial.


METHODS
Two hundred forty-three Asian patients with primary open-angle or primary angle-closure glaucoma undergoing primary trabeculectomy.


METHODS
One eye of each patient was randomized to receive either intraoperative 5-FU or normal saline (placebo) during trabeculectomy.


METHODS
Primary outcome measure was the level of intraocular pressure (IOP). Secondary outcomes were progression of visual field loss, rates of adverse events, and interventions after surgery.


RESULTS
Of the 288 eligible patients, 243 were enrolled and 228 completed 3 years follow-up; 120 patients received 5-FU and 123 received placebo. Trial failure, according to predefined IOP criteria, was lower in the 5-FU group compared with the placebo group, although the difference was only significant with a failure criterion of IOP >17 mmHg (P = 0.0154). There was no significant difference in progression of optic disc and/or visual field loss over 36 months between 5-FU and placebo (relative risk [RR], 0.67; 95% confidence interval [CI], 0.34-1.31; P = 0.239). Uveitis occurred more often in the 5-FU-treated group (14/115 [12%] vs 5/120 [4%]; P = 0.032).


CONCLUSIONS
This is the first masked, prospective, randomized trial reporting the effect of adjunctive 5-FU in trabeculectomy surgery in an East Asian population. The trial shows that an increased success rate can be achieved for several years after a single intraoperative treatment with 5-FU. We conclude that 5-FU is relatively safe and can be routinely used in low-risk East Asian patients.


BACKGROUND
The authors have no proprietary or commercial interest in any materials discussed in this article.
Wong
Tina T
TT
Singapore National Eye Center, Singapore and Singapore Eye Research Institute, Singapore. ttl_wong@hotmail.com
Khaw
Peng T
PT
Aung
Tin
T
Foster
Paul J
PJ
Htoon
Hla Myint
HM
Oen
Francis T S
FT
Gazzard
Gus
G
Husain
Rahat
R
Devereux
Joe G
JG
Minassian
Darwin
D
Tan
Say-Beng
SB
Chew
Paul T K
PT
Seah
Steve K L
SK
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005500:Follow-Up Studies; D015812:Glaucoma, Angle-Closure / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D005902:Glaucoma, Open-Angle / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology*; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D009898:Optic Disk / Q000473:pathology; D011446:Prospective Studies; D012306:Risk; D012846:Singapore; D014130:Trabeculectomy; D014794:Visual Fields
D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil