Trials / Completed
CompletedNCT04872348
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- Sight Sciences, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2023-11-02
- Completion
- 2023-11-02
- First posted
- 2021-05-04
- Last updated
- 2025-05-22
- Results posted
- 2025-05-11
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04872348. Inclusion in this directory is not an endorsement.