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

Sight Sciences

Status: Terminated

Conditions: Open-Angle Glaucoma

Treatments: Device: VISCO360 ab interno canaloplasty surgery; Device: Selective Laser Trabeculoplasty (SLT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02928289

SIGHTVISCO-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

VISCO360 ab interno canaloplasty surgery

Active Comparator group

Description:

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).

Treatment:

Device: VISCO360 ab interno canaloplasty surgery

Selective Laser Trabeculoplasty (SLT)

Active Comparator group

Description:

Subjects randomized to this arm will undergo the SLT procedure.

Treatment:

Device: Selective Laser Trabeculoplasty (SLT)