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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00644215
First received: March 24, 2008
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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 Intervention
Bleb
Drug: 5-FU and Mitomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Iop and Bleb height,extent and vascularity [ Time Frame: At least in 3 months of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
  More Information

No publications provided

Responsible Party: Mohammad pakravan ,M.D, ophthalmic research center
ClinicalTrials.gov Identifier: NCT00644215     History of Changes
Other Study ID Numbers: 8662
Study First Received: March 24, 2008
Last Updated: June 16, 2008
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Blister
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Mitomycins
Mitomycin
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014