OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma

NCT ID: NCT06991270

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-05-31

Brief Summary

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).

Detailed Description

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).

Conditions

Primary Open Angle Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OMNI 3.0

Canaloplasty and trabeculotomy using the OMNI 3.0 surgical system, combined with phacoemulsification cataract surgery, OR as a standalone procedure in pseudophakic eyes.

Group Type: EXPERIMENTAL

OMNI 3.0 Surgical System

Intervention Type: DEVICE

Canaloplasty and trabeculotomy.

Interventions

OMNI 3.0 Surgical System

Canaloplasty and trabeculotomy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, 45 years or older
• Visually significant age-related cataract and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since cataract surgery.
• Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.
• Diagnosed with mild to moderate primary open angle glaucoma (POAG). Diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage

Exclusion Criteria

• Any of the following prior ocular procedures:

• Laser trabeculoplasty ≤180 days prior to baseline
• Durysta ≤12 months prior to baseline
• Any implanted glaucoma device
• Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
• Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), ≤180 days prior to baseline
• Retinal laser procedure ≤3 months prior to baseline
• 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sight Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Panama Eye Center

Panama City, , Panama

Site Status: RECRUITING

Countries

Panama

Central Contacts

Jaime Dickerson, PhD

Role: CONTACT

jdickerson@sightsciences.com

+1 (817) 845-0859

Facility Contacts

Idabel Orillac

Role: primary

iorillac@panamaeyecenter.com

Other Identifiers

09712

Identifier Type: -

Identifier Source: org_study_id