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

Primary Purpose

Refractory Glaucoma

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ahmed Glaucoma Valve (AGV)
Mitomycin C (MMC)
amniotic membrane coverage
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Glaucoma

Eligibility Criteria

7 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ahmed Glaucoma Valve (AGV) alone

AGV plus MMC

AGV plus amniotic membrane coverage

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 4, 2009
Last Updated
May 4, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00893490
Brief Title
Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma
Official Title
Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
Ahmed Glaucoma Valve (AGV) alone
Arm Type
Experimental
Arm Title
AGV plus MMC
Arm Type
Experimental
Arm Title
AGV plus amniotic membrane coverage
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ahmed Glaucoma Valve (AGV)
Intervention Description
AGV implantation
Intervention Type
Drug
Intervention Name(s)
Mitomycin C (MMC)
Intervention Description
3 minute MMC application
Intervention Type
Procedure
Intervention Name(s)
amniotic membrane coverage
Intervention Description
single layer coverage of amniotic membrane

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahin Yazdani, MD
Email
shahinyazdani@yahoo.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahin yazdani, MD
Phone
98 21 22591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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