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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT00644215

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bleb	Drug: 5-FU and Mitomycin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2007

Anticipated Primary Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 5-FU injection has been done	Drug: 5-FU and Mitomycin 5-FU injection 5mg Mitomycin drop 0.02%
Experimental: 2 Mitomycin drop has been administrated	Drug: 5-FU and Mitomycin 5-FU injection 5mg Mitomycin drop 0.02%

Arm

Intervention/Treatment

Experimental: 1

5-FU injection has been done

Drug: 5-FU and Mitomycin

5-FU injection 5mg Mitomycin drop 0.02%

Experimental: 2

Mitomycin drop has been administrated

Drug: 5-FU and Mitomycin

5-FU injection 5mg Mitomycin drop 0.02%

Outcome Measures

Primary Outcome Measures

Iop and Bleb height,extent and vascularity [At least in 3 months of follow up]

Secondary Outcome Measures

complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure []

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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