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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: 5-FU and Mitomycin
  • - 5-FU injection 5mg - Mitomycin drop 0.02%

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 5-FU injection has been done
• Experimental: 2
  • Mitomycin drop has been administrated

Primary Measures

• Iop and Bleb height,extent and vascularity
  • Time Frame: At least in 3 months of follow up
    Safety Issue?: Yes

Secondary Measures

• complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure
  • Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shaheed Beheshti Medical University

Overall Clinical Trial Officials and Contacts

Overall Contact: Mohammad pakravan, associated professor 22590607 mopakravan@yahoo.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644215

Study ID Number: 8662

ClinicalTrials.gov Identifier: NCT00644215

Health Authority: Iran: Ethics Committee