5-YEAR FOLLOW-UP OF THE FLUOROURACIL FILTERING SURGERY STUDY

PURPOSE: To determine the efficacy and safety of subconjunctival 5-flu orouracil injections after trabeculectomy in patients with poor progno ses, to determine risk factors for surgical failure, and to examine th e relationship of intraocular pressure and visual function. METHODS: I n this multicenter clinical trial, 213 patients with previous cataract surgery or previous failed filtering surgery were randomly assigned t o receive either trabeculectomy alone or trabeculectomy with postopera tive subconjunctival 5-fluorouracil injections. Measurements of intrao cular pressure, visual acuity, and visual fields were performed throug hout the five years, with the clinician masked to the treatment group, Failure was defined as a reoperation to control intraocular pressure o r an intraocular pressure greater than 21 mm Hg at or after the first year examination. RESULTS: Fifty-four (51%) of the 105 eyes in the 5-f luorouracil group and 80 (74%) of the 108 eyes in the standard filteri ng surgery group were classified as failures (P < .001, Mantel-Cox sur vival analysis), Risk factors for failure include high intraocular pre ssure, a short time interval after the last procedure involving a conj unctival incision, the number of procedures with conjunctival incision s, and Hispanic ethnicity. Patients in both treatment groups with cont rolled intraocular pressures were more likely to maintain visual acuit y., Patients in the 5-fluorouracil group had a higher risk of late-ons et bleb leaks (9%, nine of 105) than those in the standard filtering s urgery group (2%, two of 108) (P = .032, Fisher's exact test). CONCLUS IONS: We recommend the use of subconjunctival 5 fluorouracil after tra beculectomy in eyes after previous cataract surgery or unsuccessful fi ltering surgery, but caution against its routine use in patients with good prognoses.