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Tests treatment safety and results for Open Angle Glaucoma (OAG)
Official title Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
ClinicalTrials.gov ID: NCT07220876
What this study is testing
- What it's testing
- A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Sacramento, California, United States
- Grand Junction, Colorado, United States
- Sheridan, Colorado, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Kenosha, Wisconsin, United States
- Bloemfontein, South Africa
- Pretoria, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Sacramento, California, United States; Grand Junction, Colorado, United States; Sheridan, Colorado, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.