A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma

Study Overview
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Brief Summary
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To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG).

Official Title
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A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Device: OMNI® Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 22 years or older at the time of surgery History of uncomplicated cataract surgery and posterior chamber IOL implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit. Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record substantiated using funduscopic exam or OCT and at least one visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm. Mean deviation score must be better than or equal to -12.0 dB The visual field test may be historical (within 6 months prior to Screening Visit). If needed, visual field testing may be repeated between the Screening Visit and the Surgery Visit. At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1 with a stable medication regimen for at least 2 months. At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least 3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24 Scheduled for ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System. Shaffer grade of ≥ III in all four quadrants Able and willing to comply with the protocol, including all follow-up visits. Understands and signs the informed consent Exclusion Criteria: Any of the following prior treatments for glaucoma: Laser trabeculoplasty ≤3 months prior to Baseline visit iStent or iStent Inject implanted ≤6 months prior to Baseline visit Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to Baseline visit Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve Prior canaloplasty, goniotomy, or trabeculotomy Hydrus microstent Suprachoroidal stent (e.g. Cypass, iStent Supra) Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.) In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications 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 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). History of penetrating keratoplasty or another corneal transplant BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract Study of OMNI System in POAG BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular opacification (uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is permitted only if there is no vitreous present in or in front of the iris plane at the time of baseline). Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pseudophakic eyes with Open Angle Glaucoma<br>Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. | Device: OMNI® Surgical System<br>* Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) | Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Medications | Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure | 6 months |