About this trial
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
VisiPlate Glaucoma Implant
DeviceImplant (micro-shunt) for glaucoma patients
Treatment groups
Trial outcomes
Primary outcomes
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%.
Secondary outcomes
Percentage change in mean diurnal IOP
How much the average eye pressure during the day went up or down, shown as a percent.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.