5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial.
OBJECTIVE
To test the effect of postoperative subconjunctival 5-fluorouracil (5-FU) on the pressure outcome in combined procedure (limbus-based trabeculectomy + clear-cornea phacoemulsification).


METHODS
Prospective randomized, controlled clinical trial; n = 24 eyes (24 patients) with concurrent open-angle glaucoma and cataract; 12 eyes per treatment group; sample size adjusted for a minimal expected difference in the event rate between the 2 treatment groups = 50%, control rate = 20%; type I error = 0.05; power = 95%. Uncomplicated limbus-based trabeculectomy + uncomplicated clear-cornea phacoemulsification + posterior chamber intraocular lens. The 5-FU group = five subconjunctival injections of 5 mg 5-FU, starting from day 8 after surgery, one injection per week. Control group = no injections. The groups were matched for age, preoperative intraocular pressure (IOP), duration of preoperative antiglaucoma treatment, preoperative pilocarpine and adrenergics, preoperative laser trabeculoplasty, and beta-blockers in the fellow eye. The IOP less than or equal to 15 mmHg without treatment 1 year after surgery (IOP = average of the two highest values measured in the diurnal curve, 8 AM to 6 PM, one reading every 2 hours).


RESULTS
Each patient completed a 1-year follow-up. Ten of 12 eyes of the 5-FU group showed an IOP less than or equal to 15 mmHg at the end of follow-up versus 1 of 12 eyes in the control group (Fisher's exact test, P = 0.00064). The IOP range was 10 to 17 mmHg in the 5-FU group and 14 to 22 mmHg in the control group.


CONCLUSIONS
Postoperative 5-FU may improve the 1-year success rate of trabeculectomy combined with clear-cornea phacoemulsification.
Gandolfi
S A
SA
Glaucoma Service, University of Parma, Italy.
Vecchi
M
M
D000963:Antimetabolites / Q000008:administration & dosage*; D002386:Cataract / Q000150:complications; D003315:Cornea / Q000601:surgery*; D005472:Fluorouracil / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology; D007910:Lenses, Intraocular; D008875:Middle Aged; D018918:Phacoemulsification; D011182:Postoperative Care; D011446:Prospective Studies; D014130:Trabeculectomy; D014792:Visual Acuity
D000963:Antimetabolites; D005472:Fluorouracil