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An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)

NCT04872348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2025-05-22

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.

Conditions

  • Glaucoma, Open-Angle

Interventions

DEVICE

OMNI® Surgical System

The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Sponsors & Collaborators

  • Sight Sciences, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-11-02
Completion
2023-11-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872348 on ClinicalTrials.gov