Multi-Center Prospective Randomized Controlled Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 System in Canaloplasty vs Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Sight Sciences, Inc.
- Enrollment
- 29
- Locations
- 12
- Primary Endpoint
- Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
Study Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
VISCO360 ab interno canaloplasty surgery
Subjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty).
Intervention: VISCO360 ab interno canaloplasty surgery (Device)
Selective Laser Trabeculoplasty (SLT)
Subjects randomized to this arm will undergo the SLT procedure.
Intervention: Selective Laser Trabeculoplasty (SLT) (Device)
Outcomes
Primary Outcomes
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
Time Frame: 12 months
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.
Secondary Outcomes
- Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months(12 months)