Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

Study Overview
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Brief Summary
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This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).

Detailed Description
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This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.

Official Title
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Prospective, Multi-Center, Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: Transluminal viscoelastic delivery and trabeculotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - (only one eye of each subject is eligible, and all ocular criteria apply to the study eye): Male or female subjects, 22 years or older. Visually significant cataract Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) per AAO/AGS/ICD-10 Glaucoma Stage Definitions.1 At screening, on 1-3 IOP-lowering medications2 with a medicated IOP ≤25 mmHg OR on zero (0) IOP-lowering medications with an IOP 21-30 mmHg. At baseline, unmedicated diurnal IOP 21-30 mmHg and, for subjects who were medicated at screening, IOP at least 3 mmHg higher than screening IOP. Scheduled for cataract extraction followed by abinterno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System. Shaffer grade of ≥ III in all four quadrants Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment Able and willing to comply with the protocol, including all follow-up visits. Understands and signs the informed consent. Exclusion Criteria: - (All criteria apply to the study eye; both eyes of a single subject need not be eligible): Any of the following prior treatments for glaucoma: Laser trabeculoplasty ≤3 months prior to baseline iStent implanted ≤6 months prior to baseline Implanted with Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC Normal tension glaucoma Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma Severe glaucoma by AAO/AGS/ICD-10 guideline Use of oral hypotensive medication treatment for glaucoma History of elevated IOP due to steroid response In the investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications. Ocular pathology or 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, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits). 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.

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 |
| --- | --- |
| Experimental: Viscoeleastic delivery & trabeculotomy<br>Patients with open angle glaucoma and cataract | Device: Transluminal viscoelastic delivery and trabeculotomy<br>* Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean unmedicated diurnal IOP | Reduction in mean unmedicated diurnal IOP from baseline to 12 months | 12 months | 
| Change in mean number of IOP-lowering medications | Reduction in mean number of IOP-lowering medications from screening to 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months |  | 12 months | 
| Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months |  | 12 months |