Status unknownNCT00893490Updated May 6, 2009

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

A Phase 1 interventional study of Ahmed Glaucoma Valve (AGV) and Mitomycin C (MMC) in Refractory Glaucoma, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 7 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-05-06.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2009), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Ages: 7 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Refractory Glaucoma

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Glaucoma 1,818

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

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Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 7 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

patients with refractory glaucoma

Exclusion criteria

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

Phase: Phase 1
Primary purpose: Treatment

Study arms

Experimental
Ahmed Glaucoma Valve (AGV) alone
Device: Ahmed Glaucoma Valve (AGV)
Experimental
AGV plus MMC
Device: Ahmed Glaucoma Valve (AGV) · Drug: Mitomycin C (MMC)
Experimental
AGV plus amniotic membrane coverage
Device: Ahmed Glaucoma Valve (AGV) · Procedure: amniotic membrane coverage

Interventions

DeviceAhmed Glaucoma Valve (AGV)
AGV implantation
DrugMitomycin C (MMC)
3 minute MMC application
Procedureamniotic membrane coverage
single layer coverage of amniotic membrane

Study locations

1 of 1 sites recruiting

Ophthalmic Research Center
Tehran, 166666, Iran, Islamic Republic of
- Shahin yazdani, MD · Contact · labbafi@hotmail.com · 98 21 22591616
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00893490
Lead sponsor: Shahid Beheshti University of Medical Sciences
First posted: May 6, 2009
Last update: May 6, 2009

Study contacts

Shahin Yazdani, MD

Contact

shahinyazdani@yahoo.com

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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