Refractory GlaucomaPhase 1NCT00893490
Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma
A Phase 1 study testing Ahmed Glaucoma Valve (AGV), Mitomycin C (MMC) and amniotic membrane coverage in people with Refractory Glaucoma, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Refractory Glaucoma
- What is being tested?
- Ahmed Glaucoma Valve (AGV), Mitomycin C (MMC) and amniotic membrane coverage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with refractory glaucoma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Shahin Yazdani, MD contact
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran, Tehran Province, 166666
Shahin yazdani, MD, 98 21 22591616, labbafi@hotmail.com
About this study
Official title: Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma
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
- Refractory Glaucoma
- Being tested
- Ahmed Glaucoma Valve (AGV), Mitomycin C (MMC), amniotic membrane coverage
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahmed Glaucoma Valve (AGV)Device
AGV implantation
Mitomycin C (MMC)Drug
3 minute MMC application
amniotic membrane coverageProcedure or surgery
single layer coverage of amniotic membrane
| Study group | Role | What they receive |
|---|---|---|
| Ahmed Glaucoma Valve (AGV) alone | Experimental | Not described Receives: Device: Ahmed Glaucoma Valve (AGV) |
| AGV plus MMC | Experimental | Not described Receives: Device: Ahmed Glaucoma Valve (AGV); Drug: Mitomycin C (MMC) |
| AGV plus amniotic membrane coverage | Experimental | Not described Receives: Device: Ahmed Glaucoma Valve (AGV); Procedure: amniotic membrane coverage |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893490
- Sponsor's protocol ID
- 8756
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ahmed Glaucoma Valve Alone,With Amniotic Membrane or With MMC for Treatment of Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT00893490
- Acronym / sponsor ID
- 8756
- Conditions
- Refractory Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with refractory glaucoma
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ahmed Glaucoma Valve (AGV)AGV implantation | Device | AGV plus MMC, AGV plus amniotic membrane coverage, Ahmed Glaucoma Valve (AGV) alone |
| Mitomycin C (MMC)3 minute MMC application | Drug | AGV plus MMC |
| amniotic membrane coveragesingle layer coverage of amniotic membrane | Procedure or surgery | AGV plus amniotic membrane coverage |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahin Yazdani, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ahmed Glaucoma Valve (AGV), Mitomycin C (MMC) and amniotic membrane coverage in people with Refractory Glaucoma, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahin Yazdani, MD (shahinyazdani@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2009.