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)
- Conditions
- Glaucoma, Open-Angle
- Interventions
- Device: OMNI® Surgical System
- Registration Number
- NCT04872348
- Lead Sponsor
- Sight Sciences, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Eyes receiving OMNI intervention after medication washout OMNI® Surgical System - Eyes receiving OMNI intervention without medication washout OMNI® Surgical System -
- Primary Outcome Measures
Name Time Method Change in Intraocular Pressure (IOP) 18 months Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline.
Change in Number of Medications 18 months Mean change in the number of ocular hypotensive medications compared to baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University Eye Specialists
🇺🇸Maryville, Tennessee, United States
El Paso Eye Surgeons
🇺🇸El Paso, Texas, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Northern New Jersey Eye Institute
🇺🇸Orange, New Jersey, United States
Minnesota Eye Consultants
🇺🇸Bloomington, Minnesota, United States
Ophthalmology Associates - Fort Worth
🇺🇸Fort Worth, Texas, United States
Grene Vision Group
🇺🇸Wichita, Kansas, United States
Eye Specialists of Georgia
🇺🇸Atlanta, Georgia, United States
Oklahoma Eye Surgeons
🇺🇸Oklahoma City, Oklahoma, United States
Utah Eye Centers
🇺🇸Ogden, Utah, United States