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

June 16, 2008 updated by: Shahid Beheshti University of Medical Sciences

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohammad pakravan, associated professor
  • Phone Number: 009821 22590607
  • Email: mopakravan@yahoo.com

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 16666
        • Recruiting
        • labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,
        • Contact:
        • Principal Investigator:
          • Mohammad Pakravan, Assosiated professor
        • Sub-Investigator:
          • Arezou Miraftabi, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iop and Bleb height,extent and vascularity
Time Frame: At least in 3 months of follow up
At least in 3 months of follow up

Secondary Outcome Measures

Outcome Measure
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8662

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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