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

Official title

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

Overview

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).

Interventions

• Device OMNI 3.0 Surgical System
  Canaloplasty and trabeculotomy.

Primary outcome measures

• Primary Effectiveness Endpoint [Time frame: 3 months]

Secondary outcome measures (2)

• Secondary Effectiveness Endpoint 1 [Time frame: 3 months]
• Secondary Effectiveness Endpoint 2 [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Panama · 1 center

• Panama Eye Center — Panama City

Identifiers

NCT: NCT06991270 · 09712

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗