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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00893490
Collaborator
(none)
1
Location
3
Arms

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Ahmed Glaucoma Valve (AGV)
  • Drug: Mitomycin C (MMC)
  • Procedure: amniotic membrane coverage
 Phase 1

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Research Center Tehran Iran, Islamic Republic of 166666

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00893490
    Other Study ID Numbers:
    • 8756
    First Posted:
    May 6, 2009
    Last Update Posted:
    May 6, 2009
    Last Verified:
    May 1, 2009
    Additional relevant MeSH terms:
    Glaucoma
    Mitomycins
    Mitomycin

    Study Results

    No Results Posted as of May 6, 2009