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)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Eyes receiving OMNI intervention after medication washout
|
Device: OMNI® Surgical System
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.
|
| Eyes receiving OMNI intervention without medication washout
|
Device: OMNI® Surgical System
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.
|
Outcome Measures
Primary Outcome Measures
- Decrease in intraocular pressure (IOP) [12 months]
Decrease in unmedicated mean diurnal IOP (DIOP)
- Decrease in number of medications [12 months]
Mean change in the number of ocular hypotensive medications.
Eligibility Criteria
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.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Grene Vision Group | Wichita | Kansas | United States | 62708 |
| 2 | Minnesota Eye Consultants | Bloomington | Minnesota | United States | 55431 |
| 3 | Oklahoma Eye Surgeons | Oklahoma City | Oklahoma | United States | 73112 |
| 4 | Northern Ophthalmics | Jenkintown | Pennsylvania | United States | 19406 |
| 5 | University Eye Specialists | Maryville | Tennessee | United States | 37803 |
| 6 | El Paso Eye Surgeons | El Paso | Texas | United States | 79902 |
| 7 | Ophthalmology Associates - Fort Worth | Fort Worth | Texas | United States | 76102 |
Sponsors and Collaborators
- Sight Sciences, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07355