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Clinical Trials/NCT02928289
NCT02928289TerminatedNot Applicable

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

Sight Sciences, Inc.12 sites in 1 country29 target enrollmentStarted: January 23, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
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

Active Comparator

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)

Active Comparator

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

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