5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial

Ophthalmology. 1997 Feb;104(2):181-6. doi: 10.1016/s0161-6420(97)30336-4.


Purpose: 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.

Conclusion: Postoperative 5-FU may improve the 1-year success rate of trabeculectomy combined with clear-cornea phacoemulsification.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antimetabolites / administration & dosage*
  • Cataract / complications
  • Cornea / surgery*
  • Fluorouracil / administration & dosage*
  • Follow-Up Studies
  • Glaucoma, Open-Angle / complications
  • Glaucoma, Open-Angle / physiopathology
  • Glaucoma, Open-Angle / surgery*
  • Humans
  • Intraocular Pressure / drug effects
  • Intraocular Pressure / physiology
  • Lenses, Intraocular*
  • Middle Aged
  • Phacoemulsification*
  • Postoperative Care
  • Prospective Studies
  • Trabeculectomy*
  • Visual Acuity


  • Antimetabolites
  • Fluorouracil