NCT00893490

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

First QC Date

May 4, 2009

Last Update Submit

May 4, 2009

Conditions

Study Arms (3)

Ahmed Glaucoma Valve (AGV) alone

EXPERIMENTAL
Device: Ahmed Glaucoma Valve (AGV)

AGV plus MMC

EXPERIMENTAL
Device: Ahmed Glaucoma Valve (AGV)Drug: Mitomycin C (MMC)

AGV plus amniotic membrane coverage

EXPERIMENTAL
Device: Ahmed Glaucoma Valve (AGV)Procedure: amniotic membrane coverage

Interventions

AGV implantation

AGV plus MMCAGV plus amniotic membrane coverageAhmed Glaucoma Valve (AGV) alone

3 minute MMC application

AGV plus MMC

single layer coverage of amniotic membrane

AGV plus amniotic membrane coverage

Eligibility Criteria

Age7 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with refractory glaucoma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 166666, Iran

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Shahin Yazdani, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations