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
  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 Medical University:

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

Ages Eligible for Study:   7 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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 Medical University
  More Information

No publications provided

Responsible Party: Ophthalmic Research Center
ClinicalTrials.gov Identifier: NCT00893490     History of Changes
Other Study ID Numbers: 8756
Study First Received: May 4, 2009
Last Updated: May 4, 2009
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on July 29, 2014