Trials / Completed
CompletedNCT05044793
A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (actual)
- Sponsor
- Sight Sciences, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213
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
- 2021-09-01
- Primary completion
- 2023-08-21
- Completion
- 2023-08-21
- First posted
- 2021-09-16
- Last updated
- 2025-01-22
- Results posted
- 2025-01-22
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05044793. Inclusion in this directory is not an endorsement.