The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.
This is a randomized study comparing viscodilation with the VISCO360 device to selective laser trabeculoplasty. Subjects with mild to moderate primary open-angle glaucoma undergo IOP-lowering medication washout at baseline and at Month 12. Subjects will be followed through Month 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
360 degrees of viscodilation of Schlemm's canal
360 degrees of selective laser trabeculoplasty
Vold Vision
Fayetteville, Arkansas, United States
Coastal Vision Medical Group
Orange, California, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
The mean of the difference between the baseline DIOP and the 12 month DIOP for each subject. Measurements at baseline and 12 months are following wash-out of glaucoma medication.
Time frame: 12 months
Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months
Measurement is performed at 12 months following wash-out of glaucoma medication and is the number of subjects with 12 month DIOP that is at least 20% lower than the baseline DIOP divided by the number of subjects and multiplied by 100.
Time frame: 12 months
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El Paso Eye Surgeons
El Paso, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States