Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)
Not Applicable
Terminated
- Conditions
- Open-Angle Glaucoma
- Registration Number
- NCT02928289
- Lead Sponsor
- Sight Sciences, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
- Pseudophakic with Posterior Chamber IOL (PCIOL)
- Able and willing to attend follow up visits for two years post-operative
- Able and willing to sign informed consent
Exclusion Criteria
- Phakia or aphakia
- Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) [Subjects with one prior SLT application (>3 months prior to screening) or prior ECP (performed > 12 months prior to screening) can be enrolled].
- Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
- Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
- Participation in any clinical trial ≤ 30 days prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change in diurnal IOP (Measured in mm Hg) 12 months Measurement is performed at 12 months following wash-out of glaucoma medication
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP 12 months Measurement is performed at 12 months following wash-out of glaucoma medication
Trial Locations
- Locations (6)
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
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States
Vold Vision🇺🇸Fayetteville, Arkansas, United States