Neovascular GlaucomaNCT02260219
Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma
A study testing Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2 in people with Neovascular Glaucoma, run by Asociación para Evitar la Ceguera en México.
Trial summary
Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2. Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Glaucoma
- What is being tested?
- Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Feb 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of Neovascular glaucoma
- High IOP despite topical treatment
Who cannot join
- Pregnant women
- Mental disorders
- Previous glaucoma surgery
- Patients older than 18 years
About this study
Official title: Comparative Study of the Safety and Efficacy of the Ahmed Glaucoma Valve Drainage Device, Model M4 (High Density Porous Polyethylene) and the Model S2 (Polypropylene) in Patients With Neovascular Glaucoma
Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2.
Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). They will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.
- Conditions
- Neovascular Glaucoma
- Being tested
- Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
- Keywords
- Ahmed implant, Neovascular Glaucoma, Intraocular pressure
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2Procedure or surgery
Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP
| Study group | Role | What they receive |
|---|---|---|
| S2 | Active comparator | Surgically Implant an Ahmed Glaucoma Drainage Device Model S2 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP Receives: Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2 |
| M4 | Active comparator | Surgically Implant an Ahmed Glaucoma Drainage Device Model M4 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP Receives: Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse effects
Measured: 1 year
Secondary outcomes (1)
Intraocular pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix Gil-Carrasco, MD, Study director, 52 55 10841400
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260219
- Sponsor's protocol ID
- GL-12-01
- Status last verified
- May 2024
- First submitted
- 17 Jul 2014
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Safety and Efficacy of the Ahmed Glaucoma Valve Drainage Device, Model M4 (High Density Porous Polyethylene) and the Model S2 (Polypropylene) in Patients With Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT02260219
- Acronym / sponsor ID
- GL-12-01
- Conditions
- Neovascular Glaucoma
- Keywords
- Ahmed implant, Neovascular Glaucoma, Intraocular pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: undefined
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Oct 2014 (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.
Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2.
Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). They will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S2 | Active comparator | Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2Surgically Implant an Ahmed Glaucoma Drainage Device Model S2 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP |
| M4 | Active comparator | Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2Surgically Implant an Ahmed Glaucoma Drainage Device Model M4 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of Neovascular glaucoma
- High IOP despite topical treatment
Key exclusion criteria (4 listed)
- Pregnant women
- Mental disorders
- Previous glaucoma surgery
- Patients older than 18 years
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 |
|---|---|---|
| Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP | Procedure or surgery | M4, S2 |
Primary outcome
Number of participants with adverse effects
Time frame: 1 year
1 secondary outcome
Intraocular pressure
Time frame: 1 year
Results and safety
The study was stopped early (reason given: undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Felix Gil-Carrasco, MD study director
52 55 10841400
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2 in people with Neovascular Glaucoma, run by Asociación para Evitar la Ceguera en México.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early (reason given: undefined). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse effects (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 30 May 2024.