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

Phase 1
Conditions
Refractory Glaucoma
Interventions
Device: Ahmed Glaucoma Valve (AGV)
Procedure: amniotic membrane coverage
Registration Number
NCT00893490
Lead Sponsor
Shahid Beheshti University of Medical Sciences
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Ahmed Glaucoma Valve (AGV) aloneAhmed Glaucoma Valve (AGV)-
AGV plus MMCAhmed Glaucoma Valve (AGV)-
AGV plus MMCMitomycin C (MMC)-
AGV plus amniotic membrane coverageAhmed Glaucoma Valve (AGV)-
AGV plus amniotic membrane coverageamniotic membrane coverage-
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ophthalmic Research Center

🇮🇷

Tehran, Iran, Islamic Republic of

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