Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma

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

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.

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