A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma

Study Overview
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Brief Summary
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To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.

Detailed Description
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First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)

Official Title
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A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Device: OMNI® Surgical System
* Device: iStent inject


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 22 years or older Visually significant cataract Mild to moderate open angle glaucoma On 1-5 IOP-lowering medications 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. Understand and sign the informed consent. Exclusion Criteria: Any of the following prior treatments for glaucoma: Laser trabeculoplasty ≤3 months prior to baseline Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record. 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). 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System<br>Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System | Device: OMNI® Surgical System<br>* Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System<br>|
| Active Comparator: Ab-interno transluminal viscoelastic delivery using OMNI surgical System<br>Ab-interno transluminal viscoelastic delivery using OMNI surgical System | Device: OMNI® Surgical System<br>* Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System<br>|
| Active Comparator: iStent Inject implantation<br>iStent Inject implantation using the iStent device | Device: iStent inject<br>* Trabecular meshwork implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Unmedicated Diurnal Intraocular Pressure (DIOP) | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. | 1 week | 
| Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. | 1 week | 
| Change in the Number of Ocular Hypotensive Medications Compared to Screening | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. | 1 week | 
| Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. | 1 week |