A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Implant (micro-shunt) for glaucoma patients
Arizona Advanced Eye Research
Glendale, Arizona, United States
RECRUITINGSacramento Eye Consultants
Sacramento, California, United States
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%.
Time frame: 12 Months
Percentage change in mean diurnal IOP
How much the average eye pressure during the day went up or down, shown as a percent.
Time frame: 12 months
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ICON Eye Care
Grand Junction, Colorado, United States
RECRUITINGMile High Eye Institute
Sheridan, Colorado, United States
WITHDRAWNCleveland Clinic- Cole Eye Institute
Cleveland, Ohio, United States
NOT_YET_RECRUITINGScheie Eye Institute
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGWills Eye Hospital
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGGlaucoma Associates of Texas
Dallas, Texas, United States
RECRUITINGUniversity of Texas Southwestern
Dallas, Texas, United States
NOT_YET_RECRUITINGThe Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, United States
RECRUITING...and 2 more locations