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

Not Applicable

• Conditions: Bleb
• Interventions: Drug: 5-FU and Mitomycin

• Registration Number: NCT00644215
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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 Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-16
• Last Update Posted: 2008-06-17
• Primary Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy&phaco which not respond to high frequent topical steroids or removal of releasable sutures

Exclusion Criteria

• Injected bleb due to complications of surgery such as button hole formation
• Injected bleb due to blebitis
• Bleb leakage
• Flat AC
• Pregnant or nursing mothers
• Injected bleb after bleb reconstruction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	5-FU and Mitomycin	5-FU injection has been done
2	5-FU and Mitomycin	Mitomycin drop has been administrated

Primary Outcome Measures

Name	Time	Method
Iop and Bleb height,extent and vascularity	At least in 3 months of follow up

Secondary Outcome Measures

Name	Time	Method
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

Trial Locations

Locations (1)

labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,; 🇮🇷 Tehran, Iran, Islamic Republic of