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)
Completed
Conditions studied: Glaucoma, Open-Angle
In brief
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.
Key facts
- Study ID
- NCT04872348
- Run by
- Sight Sciences, Inc.
- People needed
- 28
- Starts
- 2021-07-01
- Expected to finish
- 2023-11-02
- Last updated by the study team
- 2025-05-22
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment.
You may not qualify if…
- Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits.
- Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).
Where it is running
- Eye Specialists of Georgia — Atlanta, Georgia, United States
- Grene Vision Group — Wichita, Kansas, United States
- Minnesota Eye Consultants — Bloomington, Minnesota, United States
- Northern New Jersey Eye Institute — Orange, New Jersey, United States
- Oklahoma Eye Surgeons — Oklahoma City, Oklahoma, United States
- University Eye Specialists — Maryville, Tennessee, United States
- El Paso Eye Surgeons — El Paso, Texas, United States
- Ophthalmology Associates - Fort Worth — Fort Worth, Texas, United States
- Utah Eye Centers — Ogden, Utah, United States
- Virginia Eye Consultants — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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