N/A
N=28
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)
Glaucoma, Open-Angle
Bottom Line
View on ClinicalTrials.gov: NCT04872348 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
May 2025
Primary outcome: Primary: Change in Intraocular Pressure (IOP) — 38.2; 30.1 percent change
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- OMNI® Surgical System (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Sight Sciences, Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure (IOP) |
38.2; 30.1 | — |
| PRIMARY Change in Number of Medications |
-1.13; -0.13 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04872348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.