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)
1 other identifier
observational
28
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2021
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2023
CompletedResults Posted
Study results publicly available
May 11, 2025
CompletedMay 22, 2025
May 1, 2025
2.3 years
April 29, 2021
March 10, 2025
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Intraocular Pressure (IOP)
Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline.
18 months
Change in Number of Medications
Mean change in the number of ocular hypotensive medications compared to baseline.
18 months
Study Arms (2)
Eyes receiving OMNI intervention after medication washout
Eyes receiving OMNI intervention without medication washout
Interventions
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.
Eligibility Criteria
Subjects treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Eye Specialists of Georgia
Atlanta, Georgia, 30315, United States
Grene Vision Group
Wichita, Kansas, 62708, United States
Minnesota Eye Consultants
Bloomington, Minnesota, 55431, United States
Northern New Jersey Eye Institute
Orange, New Jersey, 07079, United States
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73112, United States
University Eye Specialists
Maryville, Tennessee, 37803, United States
El Paso Eye Surgeons
El Paso, Texas, 79902, United States
Ophthalmology Associates - Fort Worth
Fort Worth, Texas, 76102, United States
Utah Eye Centers
Ogden, Utah, 84403, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Medical and Clinical Affairs
- Organization
- Sight Sciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 4, 2021
Study Start
July 1, 2021
Primary Completion
November 2, 2023
Study Completion
November 2, 2023
Last Updated
May 22, 2025
Results First Posted
May 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share