PURPOSE:Trabeculectomy is the procedure of choice for the surgical control of glaucoma, and is often augmented by intraoperative 5-fluorouracil application to reduce scarring. This study aims to assess the validity of this technique with a randomized placebo-controlled trial. METHODS:Patients without risk factors for bleb failure other than previous drop use who were undergoing trabeculectomy surgery as their first ocular procedure were randomized to receive fluorouracil or placebo. The main outcome measures were intraocular pressure and bleb morphology. RESULTS: Results from 40 eyes of 36 patients are presented; 23 eyes were treated withfluorouracil, and 17 eyes were treated with placebo. Mean intraocular pressure at 1 year and at the final follow-up examination was significantly lower than preoperatively, but was not different between fluorouracil and placebo groups. Kaplan-Meier survival analysis also failed to show any difference, though there was a trend toward better survival of an intraocular pressure of 16 mm Hg or lower. Bleb morphology was examined postoperatively in 24 patients, with no differences found between fluorouracil and placebo groups. CONCLUSIONS: No significant difference was found in trabeculectomy outcome between fluorouracil-treated and placebo-treated eyes. The study was too small to state definitively that no such difference exists, but suggests that any treatment effect is likely to be small.
RCT Entities:
PURPOSE: Trabeculectomy is the procedure of choice for the surgical control of glaucoma, and is often augmented by intraoperative 5-fluorouracil application to reduce scarring. This study aims to assess the validity of this technique with a randomized placebo-controlled trial. METHODS:Patients without risk factors for bleb failure other than previous drop use who were undergoing trabeculectomy surgery as their first ocular procedure were randomized to receive fluorouracil or placebo. The main outcome measures were intraocular pressure and bleb morphology. RESULTS: Results from 40 eyes of 36 patients are presented; 23 eyes were treated with fluorouracil, and 17 eyes were treated with placebo. Mean intraocular pressure at 1 year and at the final follow-up examination was significantly lower than preoperatively, but was not different between fluorouracil and placebo groups. Kaplan-Meier survival analysis also failed to show any difference, though there was a trend toward better survival of an intraocular pressure of 16 mm Hg or lower. Bleb morphology was examined postoperatively in 24 patients, with no differences found between fluorouracil and placebo groups. CONCLUSIONS: No significant difference was found in trabeculectomy outcome between fluorouracil-treated and placebo-treated eyes. The study was too small to state definitively that no such difference exists, but suggests that any treatment effect is likely to be small.