Prognosis and risk factors for early postoperative wound leaks after trabeculectomy with and without 5-fluorouracil

Am J Ophthalmol. 2001 Nov;132(5):633-40. doi: 10.1016/s0002-9394(01)01178-3.


Purpose: To evaluate the prognosis of patients who develop early postoperative wound leaks after trabeculectomy, to determine risk factors for these leaks, and to document adverse outcomes.

Design: Multicenter randomized clinical trial.

Methods: Two-hundred thirteen patients with previous cataract surgery or failed filtering surgery were randomized to either trabeculectomy (standard group) or trabeculectomy with postoperative subconjunctival 5-fluorouracil injections (5-FU group). Masked measurements of intraocular pressure were performed throughout 5 years of follow-up. Failure was defined as a reoperation to control intraocular pressure or an intraocular pressure greater than 21 mm Hg with or without medication at or after the 1-year examination. An early postoperative wound leak was defined as one that developed within 2 weeks postoperatively, determined by daily topical fluorescein testing.

Results: At 1 year (5 years), the success rate for the 5-FU group was 80% (54%) in eyes without a leak, and 60% (28%) in those with a leak. The 1-year (5-year) success rate in the standard group was 50% (24%) in those without a leak and 44% (15%) with a leak. (P =.018, log-rank test, adjusted for treatment). Leaks were more common in the 5-FU group, 34/105 (32%), than in the standard treatment group, 22/108 (20%), (P =.066, chi(2)). More eyes with one-layer conjunctiva-Tenon capsule closure developed leaks 40/115 (35%) than those with two-layer closure 16/95 (17%) (P =.006, chi(2)). More eyes with a trabeculectomy located inferiorly 29/76 (38%) developed leaks than those done superiorly 27/137 (20%) (P =.006, chi(2)). Patients with leaks were older (66 years) than those without leaks (60 years) (P =.011, t test).

Conclusion: An early postoperative wound leak was a risk factor for trabeculectomy failure. We recommend that trabeculectomy be performed in a superior location with a two-layer closure.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antimetabolites / therapeutic use*
  • Conjunctiva / drug effects
  • Female
  • Fluorouracil / therapeutic use*
  • Follow-Up Studies
  • Glaucoma / surgery*
  • Humans
  • Injections
  • Intraocular Pressure
  • Male
  • Postoperative Complications*
  • Prognosis
  • Risk Factors
  • Trabeculectomy*
  • Treatment Failure
  • Wound Healing*


  • Antimetabolites
  • Fluorouracil