GlaucomaNCT01883856
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
A study testing Silicone plate Ahmed Glaucoma Valve (Model FP7) and Porous Plate Ahmed Glaucoma Valve (Model M4) in people with Glaucoma, run by Peter Netland, MD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Silicone plate Ahmed Glaucoma Valve (Model FP7) and Porous Plate Ahmed Glaucoma Valve (Model M4)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 27 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race ≥ 18 years and ≤ 80 years of age.
- Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
- Elevated intraocular pressure > 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
- Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
- Subject is willing and able to sign the informed consent.
Who cannot join
- Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
- History of prior drainage implant surgery in the study eye.
- History of cyclophotocoagulation of the study eye.
- Pregnancy.
- Prisoner.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
Read the detailed description
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.
- Conditions
- Glaucoma
- Being tested
- Silicone plate Ahmed Glaucoma Valve (Model FP7), Porous Plate Ahmed Glaucoma Valve (Model M4)
- Keywords
- Refractory Glaucoma, Intractable Glaucoma, Primary Open Angle Glaucoma, Neovascular Glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone plate Ahmed Glaucoma Valve (Model FP7)Device
This intervention is conducted as a surgical intervention.
Porous Plate Ahmed Glaucoma Valve (Model M4)Device
This intervention is conducted as a surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Silicone Plate Ahmed Glaucoma Valve | Active comparator | Silicone plate Ahmed Glaucoma Valve Receives: Device: Silicone plate Ahmed Glaucoma Valve (Model FP7) |
| Porous Plate Ahmed Glaucoma Valve | Experimental | Porous Plate Ahmed Glaucoma Valve Receives: Device: Porous Plate Ahmed Glaucoma Valve (Model M4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Measured: 12 months
Secondary outcomes (2)
Anti-Glaucoma Medications
The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.
Measured: 12 months
Surgical Success
Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completion10 Sep 2017
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Netland, MD
- Sponsor type
- University, hospital or other
- Collaborators
- New World Medical, Inc.
- Responsible party
- Sponsor-investigator, Peter Netland, MD, University of Virginia
- Investigators
- Peter A Netland, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883856
- Sponsor's protocol ID
- 16051
- Status last verified
- Sep 2020
- First submitted
- 18 Jun 2013
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/
Publications
Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020.
PubMed 32765127
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
- ClinicalTrials.gov ID
- NCT01883856
- Acronym / sponsor ID
- 16051
- Conditions
- Glaucoma
- Keywords
- Refractory Glaucoma, Intractable Glaucoma, Primary Open Angle Glaucoma, Neovascular Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Peter Netland, MDUniversity, hospital or other
- Collaborators
- New World Medical, Inc.
- Study start
- Feb 2012
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
Detailed description
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone Plate Ahmed Glaucoma Valve | Active comparator | Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)Silicone plate Ahmed Glaucoma Valve |
| Porous Plate Ahmed Glaucoma Valve | Experimental | Device: Porous Plate Ahmed Glaucoma Valve (Model M4)Porous Plate Ahmed Glaucoma Valve |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female of any race ≥ 18 years and ≤ 80 years of age.
- Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
- Elevated intraocular pressure > 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
- Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
- Subject is willing and able to sign the informed consent.
Key exclusion criteria (5 listed)
- Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
- History of prior drainage implant surgery in the study eye.
- History of cyclophotocoagulation of the study eye.
- Pregnancy.
- Prisoner.
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 |
|---|---|---|
| Silicone plate Ahmed Glaucoma Valve (Model FP7)This intervention is conducted as a surgical intervention. | Device | Silicone Plate Ahmed Glaucoma Valve |
| Porous Plate Ahmed Glaucoma Valve (Model M4)This intervention is conducted as a surgical intervention. | Device | Porous Plate Ahmed Glaucoma Valve |
Primary outcome
Change in Intraocular Pressure
Time frame: 12 months
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
2 secondary outcomes
Anti-Glaucoma Medications
Time frame: 12 months
Surgical Success
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32765127Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020.
- Study results indexed on Pub MedLink provided by the sponsor.
- Individual participant dataSharing planned: No. Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/
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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.
Peter A Netland, MD, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone plate Ahmed Glaucoma Valve (Model FP7) and Porous Plate Ahmed Glaucoma Valve (Model M4) in people with Glaucoma, run by Peter Netland, MD at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 19 Oct 2020. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Intraocular Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883856, which also lists 1 linked publication.
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 19 Oct 2020.