Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)

Study Overview
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Brief Summary
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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.

Official Title
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Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma

Conditions
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Open-Angle Glaucoma

Intervention / Treatment
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* Device: VISCO360 ab interno canaloplasty surgery
* Device: Selective Laser Trabeculoplasty (SLT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VISCO360 ab interno canaloplasty surgery<br>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). | Device: VISCO360 ab interno canaloplasty surgery<br>* 360 degrees of viscodilation of Schlemm's canal<br>|
| Active Comparator: Selective Laser Trabeculoplasty (SLT)<br>Subjects randomized to this arm will undergo the SLT procedure. | Device: Selective Laser Trabeculoplasty (SLT)<br>* 360 degrees of selective laser trabeculoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in diurnal IOP (Measured in mm Hg) | Measurement is performed at 12 months following wash-out of glaucoma medication | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP | Measurement is performed at 12 months following wash-out of glaucoma medication | 12 months |