VisiPlate aqueous shunt to lower eye pressure in refractory open-angle glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm, open-label study enrolling patients with refractory open-angle glaucoma to receive the VisiPlate aqueous shunt. Eligible participants must have preoperative IOP between 20 and 40 mmHg, a visual field mean deviation of -3 dB or worse, and healthy, mobile conjunctiva with Shaffer angle grade ≥2 in the target quadrant. The implant procedure will be performed at three U.S. sites and participants will be followed for IOP changes and safety outcomes. Primary outcomes include intraocular pressure reduction and device-related adverse events, along with the need for additional glaucoma procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Arizona Advanced Eye Research
  Glendale, Arizona, United States Recruiting
• North Bay Eye Associates, Inc.
  Petaluma, California, United States Recruiting
• Sacramento Eye Consultants
  Sacramento, California, United States Recruiting
• ICON Eye Care
  Grand Junction, Colorado, United States Recruiting
• NYC Retina
  New York, New York, United States Recruiting
• Scheie Eye Institute
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Katherine Lee
• Email: kati@avisitech.com
• Phone: 12816100251

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.