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

Shahid Beheshti University of Medical Sciences

Status: Unknown

Conditions: Bleb

Treatments: Drug: 5-FU and Mitomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00644215

8662

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

5-FU injection has been done

Treatment:

Drug: 5-FU and Mitomycin

2

Experimental group

Description:

Mitomycin drop has been administrated

Treatment:

Drug: 5-FU and Mitomycin