Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure
NCT ID: NCT00644215
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2007-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
5-FU injection has been done
5-FU and Mitomycin
* 5-FU injection 5mg
* Mitomycin drop 0.02%
2
Mitomycin drop has been administrated
5-FU and Mitomycin
* 5-FU injection 5mg
* Mitomycin drop 0.02%
Interventions
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5-FU and Mitomycin
* 5-FU injection 5mg
* Mitomycin drop 0.02%
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Injected bleb due to blebitis
* Bleb leakage
* Flat AC
* Pregnant or nursing mothers
* Injected bleb after bleb reconstruction
8 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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ophthalmic research center
Locations
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labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,
Tehran, Tehran Province, Iran
Countries
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Central Contacts
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Facility Contacts
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Mohammad Pakravan, Associated professor l
Role: primary
Other Identifiers
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8662
Identifier Type: -
Identifier Source: org_study_id