drugset / Trial / NCT00644215

Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure

NCT00644215

RandomizedParallel-groupOpen-labelTreatment

Summary

purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure . Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.

Timeline

Start
2007-06
Primary completion
2009-02
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 0.02 %
Subject fluorouracil Small molecule 5 mg

Indications

No indication recorded.