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Status unknownNCT00644215Updated Jun 17, 2008

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

An interventional study of 5-FU and Mitomycin in Bleb, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bleb

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Keywords

  • injected bleb
  • mitomycin drop
  • 5-Fu injection
  • early bleb failure
03

In context

Blister

44 studies on the registry are indexed under Blister; 2 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 33 interventional studies indexed under Blister.

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Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    1

    5-FU injection has been done

    Drug: 5-FU and Mitomycin

  • Experimental
    2

    Mitomycin drop has been administrated

    Drug: 5-FU and Mitomycin

Interventions

06

What researchers measure

Primary outcomes

  1. Iop and Bleb height,extent and vascularity

    Time frame: At least in 3 months of follow up

Secondary outcomes

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

07

Study locations

1 of 1 sites recruiting
  • labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,
    Tehran, Tehran Province 16666, Iran
    • Mohammad Pakravan, Associated professor l · Contact · mopakravan@yahoo.com · 22590607
    • Mohammad Pakravan, Assosiated professor · Principal investigator
    • Arezou Miraftabi, M.D · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007 and a primary completion of Feb 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2008
First posted
Mar 26, 2008
Start
Jun 2007
Primary completionEst.
Feb 2009
Last update
Jun 17, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00644215
First posted
Mar 26, 2008
Start date
Jun 2007
Primary completion
Feb 2009 (estimated)
Last update
Jun 17, 2008

Study contacts

Mohammad pakravan, associated professor
Contact
mopakravan@yahoo.com
22590607 ext. 009821

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fluorouracil · Mitomycin

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