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To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).
To assess the safety of the OMNI 3.0 Surgical System and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMNI 3.0 | Experimental | Canaloplasty and trabeculotomy using the OMNI 3.0 surgical system, combined with phacoemulsification cataract surgery, OR as a standalone procedure in pseudophakic eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNI 3.0 Surgical System | Device | Canaloplasty and trabeculotomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Proportion of subjects with a ≥ 20% reduction from baseline in mean IOP at the 3-month post-operative endpoint and on the same or fewer medications as preoperatively. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness Endpoint 1 | Change in mean Intraocular Pressure (IOP) at 3 months post-operatively | 3 months |
| Secondary Effectiveness Endpoint 2 | Average number of ocular hypotensive medications used at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Rate of perioperative and postoperative ocular adverse events (AEs) | 3 months |
| Safety Endpoint | Best Corrected Visual Acuities (BCVA) (% of eyes that lose 2 lines or more (10 ETDRS letters) at Month 3 |
Inclusion Criteria:
Exclusion Criteria:
Any of the following prior ocular procedures:
Any form of glaucoma other than POAG.
Use of topical ocular steroids.
Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet age-related macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits). Dry AMD and Non- proliferative diabetic retinopathy are not excluded.
History of penetrating keratoplasty or another corneal transplant; corneal abnormality that would prevent reliable IOP measurement, e.g. keratoconus or abnormally thick (≥ 620 µM) or thin (≤ 480 µM) cornea.
Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract.
BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Dickerson, PhD | Contact | +1 (817) 845-0859 | jdickerson@sightsciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panama Eye Center | Recruiting | Panama City | Panama |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 3 months |
| 3 months |