Health Trials

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

ConditionOpen Angle Glaucoma (OAG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorAvisi Technologies Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • VisiPlate Glaucoma Implant

Treatment groups

165 Participants
are divided into 1 treatment group

Locations

12
South Africa
Lynette Venter9301, Bloemfontein South Africa
Pretoria Eye Institute0007, Pretoria South Africa
United States
Arizona
Arizona Advanced Eye Research85306, Glendale United States
California
Sacramento Eye Consultants95815, Sacramento United States

Sponsors and collaborators

Avisi Technologies Inc.

Lead sponsor

Source ClinicalTrials.gov