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

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ClinicalTrials.gov Identifier: NCT00644215
Recruitment Status : Unknown
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 26, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Bleb Drug: 5-FU and Mitomycin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial
Study Start Date : June 2007
Estimated Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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%



Primary Outcome Measures :
  1. Iop and Bleb height,extent and vascularity [ Time Frame: At least in 3 months of follow up ]

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


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644215


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

Locations
Iran, Islamic Republic of
labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave, Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Mohammad Pakravan, Associated professor l    22590607    mopakravan@yahoo.com   
Principal Investigator: Mohammad Pakravan, Assosiated professor         
Sub-Investigator: Arezou Miraftabi, M.D         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

Responsible Party: Mohammad pakravan ,M.D, ophthalmic research center
ClinicalTrials.gov Identifier: NCT00644215     History of Changes
Other Study ID Numbers: 8662
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
injected bleb
mitomycin drop
5-Fu injection
early bleb failure

Additional relevant MeSH terms:
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors