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

NCT ID: NCT00893490

Last Updated: 2009-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Refractory Glaucoma

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Ahmed Glaucoma Valve (AGV) alone

Group Type EXPERIMENTAL

Ahmed Glaucoma Valve (AGV)

Intervention Type DEVICE

AGV implantation

AGV plus MMC

Group Type EXPERIMENTAL

Ahmed Glaucoma Valve (AGV)

Intervention Type DEVICE

AGV implantation

Mitomycin C (MMC)

Intervention Type DRUG

3 minute MMC application

AGV plus amniotic membrane coverage

Group Type EXPERIMENTAL

Ahmed Glaucoma Valve (AGV)

Intervention Type DEVICE

AGV implantation

amniotic membrane coverage

Intervention Type PROCEDURE

single layer coverage of amniotic membrane

Interventions

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Ahmed Glaucoma Valve (AGV)

AGV implantation

Intervention Type DEVICE

Mitomycin C (MMC)

3 minute MMC application

Intervention Type DRUG

amniotic membrane coverage

single layer coverage of amniotic membrane

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmic Research Center

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Shahin Yazdani, MD

Role: CONTACT

Facility Contacts

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Shahin yazdani, MD

Role: primary

98 21 22591616

Other Identifiers

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8756

Identifier Type: -

Identifier Source: org_study_id

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