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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893490
First Posted: May 6, 2009
Last Update Posted: May 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Refractory Glaucoma Device: Ahmed Glaucoma Valve (AGV) Drug: Mitomycin C (MMC) Procedure: amniotic membrane coverage Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Arms Assigned Interventions
Experimental: Ahmed Glaucoma Valve (AGV) alone Device: Ahmed Glaucoma Valve (AGV)
AGV implantation
Experimental: AGV plus MMC Device: Ahmed Glaucoma Valve (AGV)
AGV implantation
Drug: Mitomycin C (MMC)
3 minute MMC application
Experimental: AGV plus amniotic membrane coverage Device: Ahmed Glaucoma Valve (AGV)
AGV implantation
Procedure: amniotic membrane coverage
single layer coverage of amniotic membrane

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00893490


Contacts
Contact: Shahin Yazdani, MD shahinyazdani@yahoo.com

Locations
Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of, 166666
Contact: Shahin yazdani, MD    98 21 22591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

Responsible Party: Ophthalmic Research Center
ClinicalTrials.gov Identifier: NCT00893490     History of Changes
Other Study ID Numbers: 8756
First Submitted: May 4, 2009
First Posted: May 6, 2009
Last Update Posted: May 6, 2009
Last Verified: May 2009

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