CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
OMNI® Surgical Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04872348
NCT04872348N/ACompleted
CompareCT.gov

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)

Sight Sciences, Inc.·observational·Posted May 4, 2021·Updated May 22, 2025

In Brief

An observational study evaluating OMNI® Surgical System for Glaucoma, Open-Angle. Completed, enrolled 28 participants across 10 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Open-Angle
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 4, 2021
Enrollment StartJul 1, 2021
Primary CompletionNov 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.2 years ago

Interventions

OMNI® Surgical Systemdevice

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.