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NCT00893490 Clinical Trial

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

Refractory Glaucoma Clinical Trial

Official title:
Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00893490
Other study ID # 8756
Secondary ID
Status Recruiting
Phase Phase 1
First received May 4, 2009
Last updated May 4, 2009

Study information
Verified date May 2009
Source hahid Beheshti University of Medical Sciences
Contact Shahin Yazdani, MD
Email shahinyazdani@yahoo.com
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 75 Years
Eligibility 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

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

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