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Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00893490
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 4, 2009
May 4, 2009
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No Changes Posted
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Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma
Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma

This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative glaucoma medication and complications. AGV implantation site will be superior or inferior based on indication and these groups will be randomized separately.

Not Provided
Interventional
Phase 1
Primary Purpose: Treatment
Refractory Glaucoma
  • Device: Ahmed Glaucoma Valve (AGV)
    AGV implantation
  • Drug: Mitomycin C (MMC)
    3 minute MMC application
  • Procedure: amniotic membrane coverage
    single layer coverage of amniotic membrane
  • Experimental: Ahmed Glaucoma Valve (AGV) alone
    Intervention: Device: Ahmed Glaucoma Valve (AGV)
  • Experimental: AGV plus MMC
    Interventions:
    • Device: Ahmed Glaucoma Valve (AGV)
    • Drug: Mitomycin C (MMC)
  • Experimental: AGV plus amniotic membrane coverage
    Interventions:
    • Device: Ahmed Glaucoma Valve (AGV)
    • Procedure: amniotic membrane coverage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
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Inclusion Criteria:

  • patients with refractory glaucoma

Exclusion Criteria:

  • children under 7 years old
  • adults above 75 years old
  • uncooperative patients
  • patients underwent the operation for second time
  • patients with major operation with AGV
Both
7 Years to 75 Years
No
Contact: Shahin Yazdani, MD shahinyazdani@yahoo.com
Iran, Islamic Republic of
 
NCT00893490
8756
Yes
Ophthalmic Research Center
Shahid Beheshti Medical University
Not Provided
Not Provided
Shahid Beheshti Medical University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP