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

Primary Purpose

Bleb

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
5-FU and Mitomycin
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleb focused on measuring injected bleb, mitomycin drop, 5-Fu injection, early bleb failure

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

5-FU injection has been done

Mitomycin drop has been administrated

Outcomes

Primary Outcome Measures

Iop and Bleb height,extent and vascularity

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2008
Last Updated
June 16, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00644215
Brief Title
Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure
Official Title
Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleb
Keywords
injected bleb, mitomycin drop, 5-Fu injection, early bleb failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
5-FU injection has been done
Arm Title
2
Arm Type
Experimental
Arm Description
Mitomycin drop has been administrated
Intervention Type
Drug
Intervention Name(s)
5-FU and Mitomycin
Intervention Description
5-FU injection 5mg Mitomycin drop 0.02%
Primary Outcome Measure Information:
Title
Iop and Bleb height,extent and vascularity
Time Frame
At least in 3 months of follow up
Secondary Outcome Measure Information:
Title
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad pakravan, associated professor
Phone
22590607
Ext
009821
Email
mopakravan@yahoo.com
Facility Information:
Facility Name
labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Pakravan, Associated professor l
Phone
22590607
Email
mopakravan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammad Pakravan, Assosiated professor
First Name & Middle Initial & Last Name & Degree
Arezou Miraftabi, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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