Status:
COMPLETED
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)
Lead Sponsor:
Sight Sciences, Inc.
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04872348
Start Date
July 1 2021
End Date
November 2 2023
Last Update
May 22 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Eye Specialists of Georgia
Atlanta, Georgia, United States, 30315
2
Grene Vision Group
Wichita, Kansas, United States, 62708
3
Minnesota Eye Consultants
Bloomington, Minnesota, United States, 55431
4
Northern New Jersey Eye Institute
Orange, New Jersey, United States, 07079