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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial

Brief 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.

Detailed Summary:
Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: Iop and Bleb height,extent and vascularity [ Time Frame: At least in 3 months of follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome: complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

Original Secondary Outcome: Same as current

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: March 24, 2008
Date Started: June 2007
Date Completion:
Last Updated: June 16, 2008
Last Verified: June 2008