OMNI 3.0 surgical system to lower eye pressure in primary open-angle glaucoma

A Pilot Study of the OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma

This will try the OMNI 3.0 Surgical System to lower intraocular pressure in adults with mild-to-moderate primary open-angle glaucoma who are having cataract surgery or are already pseudophakic.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Sight Sciences, Inc. (industry)
• Locations: 1 site (Panama City)
• Trial ID: NCT06991270 on ClinicalTrials.gov

What this trial studies

The trial uses the OMNI 3.0 Surgical System, an ab interno device that combines canaloplasty and trabeculotomy, to lower intraocular pressure in adults with mild-to-moderate primary open-angle glaucoma. It is an interventional, single-arm device study enrolling patients undergoing phacoemulsification or those pseudophakic at least six months after cataract surgery. Investigators will measure IOP, glaucoma medication usage, and record device- or procedure-related safety events over follow-up. The primary aim is to obtain early safety data and initial evidence of IOP-lowering effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults 45 years or older with mild-to-moderate primary open-angle glaucoma, IOP within the study-specified range, and either requiring cataract surgery or pseudophakic at least six months after cataract removal with a stable medication regimen.

Not a fit: Patients with advanced glaucoma, IOP outside the study criteria, prior implanted glaucoma devices or recent/major prior glaucoma surgeries, or angle-closure glaucoma are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the device could lower eye pressure and reduce the need for glaucoma medications or delay more invasive glaucoma surgeries.

How similar studies have performed: Other MIGS procedures and earlier OMNI/ab interno canaloplasty and trabeculotomy reports have shown modest reductions in IOP and medication use in mild-to-moderate POAG, providing some prior supporting evidence for this approach.

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.

Where this trial is running

Panama City

• Panama Eye Center — Panama City, Panama (RECRUITING)

Study contacts

• Study coordinator: Jaime Dickerson, PhD

Conditions: Primary Open Angle Glaucoma