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Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effectiveness of the VisiPlate aqueous shunt, a device that drains fluid from the eye. It is for people with hard-to-treat open-angle glaucoma, an eye disease that can damage vision.

A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have open-angle, pseudoexfoliative or pigmentary glaucoma. These types involve open drainage angles, tiny flakes or pigment in the eye.
  • Have eye pressure between 20 and 40 mmHg at the visit before surgery.
  • Have a visual field test score of -3 dB or worse. This test measures how much you can see around you.
  • Have healthy tissue covering the eye that moves freely in the area planned for surgery.
  • Have a drainage angle rated 2 or higher on the Shaffer scale in the area planned for surgery.

Who can't join

  • Have angle-closure glaucoma, where the eye’s drainage angle is blocked.
  • Have glaucoma present from birth, caused by new blood vessels or another secondary cause.
  • Have had surgery inside the eye, except cataract surgery without complications.
  • Have had a glaucoma drain or valve placed in the area planned for surgery.
  • Have had significant swelling, irritation or infection in the study eye within 30 days before surgery.
  • Have had surgery, clouding or disease of the cornea, the clear front part of the eye.
  • Have a worsening disorder of the retina or optic nerve that is not linked to the glaucoma. These parts of the eye sense light and send signals to the brain.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Study sites (12)

AZ

CA

CO

NY

PA

TX

WI