Open Angle Glaucoma (OAG)NCT07220876
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
A study testing VisiPlate Glaucoma Implant in people with Open Angle Glaucoma (OAG), run by Avisi Technologies Inc. at 14 sites in 2 countries.
Trial summary
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- What is being tested?
- VisiPlate Glaucoma Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 7 Nov 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open angle, pseudoexfoliative or pigmentary glaucoma
- IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
- Visual field mean deviation score of -3dB or worse
- Area of healthy, free and mobile conjunctiva in the target quadrant
- Shaffer angle grade ≥ 2 in the target quadrant
Who cannot join
- Angle closure glaucoma
- Congenital, neovascular or other secondary glaucomas
- Previous intraocular surgery, with the exception of uncomplicated cataract surgery
- Previous glaucoma shunt/valve in the target quadrant
- Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
- History of corneal surgery, corneal opacities or corneal disease
- Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
United States12 sites, 10 recruiting
- Recruiting
Glaucoma Associates of Texas
Dallas, Texas, 75231
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
- Recruiting
Arizona Advanced Eye Research
Glendale, Arizona, 85306
- Recruiting
ICON Eye Care
Grand Junction, Colorado, 81501
- Recruiting
Houston Eye Associates
Houston, Texas, 77025
- Recruiting
The Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, 53142
- Withdrawn
Advanced Vision Care
Los Angeles, California, 90067
- Recruiting
NYC Retina
New York, New York, 10003
- Recruiting
North Bay Eye Associates, Inc.
Petaluma, California, 94954
- Recruiting
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104
- Withdrawn
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
- Recruiting
Sacramento Eye Consultants
Sacramento, California, 95815
South Africa2 sites, 2 recruiting
- Recruiting
Lynette Venter
Bloemfontein, 9301
- Recruiting
Pretoria Eye Institute
Pretoria, 0007
About this study
Official title: A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Read the detailed description
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
- Conditions
- Open Angle Glaucoma (OAG)
- Being tested
- VisiPlate Glaucoma Implant
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisiPlate Glaucoma ImplantDevice
Implant (micro-shunt) for glaucoma patients
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Device: VisiPlate Glaucoma Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure
The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%.
Measured: 12 Months
Secondary outcomes (1)
Percentage change in mean diurnal IOP
How much the average eye pressure during the day went up or down, shown as a percent.
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 posted24 Oct 2025
- Study start7 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma (OAG)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avisi Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220876
- Sponsor's protocol ID
- CP0005
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07220876
- Acronym / sponsor ID
- CP0005
- Conditions
- Open Angle Glaucoma (OAG)
- Keywords
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Avisi Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- 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.
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Detailed description
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: VisiPlate Glaucoma Implant |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Open angle, pseudoexfoliative or pigmentary glaucoma
- IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
- Visual field mean deviation score of -3dB or worse
- Area of healthy, free and mobile conjunctiva in the target quadrant
- Shaffer angle grade ≥ 2 in the target quadrant
Key exclusion criteria (7 listed)
- Angle closure glaucoma
- Congenital, neovascular or other secondary glaucomas
- Previous intraocular surgery, with the exception of uncomplicated cataract surgery
- Previous glaucoma shunt/valve in the target quadrant
- Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
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 |
|---|---|---|
| VisiPlate Glaucoma ImplantImplant (micro-shunt) for glaucoma patients | Device | Treatment Arm |
Primary outcome
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure
Time frame: 12 Months
The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%.
1 secondary outcome
Percentage change in mean diurnal IOP
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisiPlate Glaucoma Implant in people with Open Angle Glaucoma (OAG), run by Avisi Technologies Inc. at 14 sites in 2 countries.
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 7 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Lee (12816100251, kati@avisitech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal 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?
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 7 Oct 2026.