Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Shaheed Beheshti Medical University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shaheed Beheshti Medical University
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00893490
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Glaucoma |
Device: Ahmed Glaucoma Valve (AGV) Drug: Mitomycin C (MMC) Procedure: amniotic membrane coverage |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
Drug Information available for:
Mitomycin
U.S. FDA Resources
Further study details as provided by Shaheed Beheshti Medical University:
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ahmed Glaucoma Valve (AGV) alone |
Device: Ahmed Glaucoma Valve (AGV)
AGV implantation
|
| Experimental: AGV plus MMC |
Device: Ahmed Glaucoma Valve (AGV)
AGV implantation
Drug: Mitomycin C (MMC)
3 minute MMC application
|
| Experimental: AGV plus amniotic membrane coverage |
Device: Ahmed Glaucoma Valve (AGV)
AGV implantation
Procedure: amniotic membrane coverage
single layer coverage of amniotic membrane
|
Eligibility| Ages Eligible for Study: | 7 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893490
Contacts
| Contact: Shahin Yazdani, MD | shahinyazdani@yahoo.com |
Locations
| Iran, Islamic Republic of | |
| Ophthalmic Research Center | Recruiting |
| Tehran, Iran, Islamic Republic of, 166666 | |
| Contact: Shahin yazdani, MD 98 21 22591616 labbafi@hotmail.com | |
Sponsors and Collaborators
Shaheed Beheshti Medical University
More Information
No publications provided
| Responsible Party: | Ophthalmic Research Center |
| ClinicalTrials.gov Identifier: | NCT00893490 History of Changes |
| Other Study ID Numbers: | 8756 |
| Study First Received: | May 4, 2009 |
| Last Updated: | May 4, 2009 |
| Health Authority: | Iran: Ethics Committee |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Mitomycins Mitomycin Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |
ClinicalTrials.gov processed this record on June 17, 2013