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.

Study Overview

• Status: Terminated
• Conditions: Open-Angle Glaucoma
• Intervention / Treatment: Device: VISCO360 ab interno canaloplasty surgery; Device: Selective Laser Trabeculoplasty (SLT)

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Orange, California, United States, 92868
      • Coastal Vision Medical Group
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Dean McGee Eye Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital
  • Texas
    • El Paso, Texas, United States, 79902
      • El Paso Eye Surgeons
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months	Measurement is performed at 12 months following wash-out of glaucoma medication and is the number of subjects with 12 month DIOP that is at least 20% lower than the baseline DIOP divided by the number of subjects and multiplied by 100.	12 months

Collaborators and Investigators

• Sponsor: Sight Sciences, Inc.
• Investigators: Study Director: Anne-Marie Ripley, Sight Sciences, Inc.

Publications and helpful links

General Publications

• Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2017
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimated): October 10, 2016

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: SIGHTVISCO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes