OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Trial Parameters
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).
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 inclu