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NCT04872348 · ClinicalTrials.gov registry record

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)

A clinical trial, sponsored by Sight Sciences.

Completed
Registry status
28
Enrollment target

NCT04872348: Completed study, sponsored by Sight Sciences.

NCT04872348 is a clinical trial that has completed, run by Sight Sciences. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04872348 has completed, sponsored by Sight Sciences.

COMPLETED
Registry status
28 participants
Enrollment target

Study 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.

Primary Outcome

Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline.

Interventions

  • DEVICE OMNI® Surgical System

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2021-07-01
Est. Completion 2023-11-02
Sight Sciences

14 total trials

What the finished NCT04872348 record still lists

NCT04872348 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which OMNI® Surgical System is the first listed.

NCT04872348 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04872348 about?

NCT04872348 is a clinical study titled "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)". 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) a...

What is the current status of trial NCT04872348?

This trial is currently completed. The enrollment target is 28 participants. The study started on 2021-07-01. Estimated completion is 2023-11-02.

What interventions are being tested in trial NCT04872348?

The interventions under investigation include: OMNI® Surgical System (DEVICE).

Who is sponsoring clinical trial NCT04872348?

This trial is sponsored by Sight Sciences, which has 14 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04872348, the US trial registry maintained by the National Library of Medicine. NCT04872348 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.