Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

Study Overview
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Brief Summary
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First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.

Official Title
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A Prospective, Randomized, Multicenter Study To Compare The Safety And Effectiveness Of The OMNI® Surgical System And The iStent Inject In Pseudophakic Eyes With Open Angle Glaucoma. The TRIDENT European Trial

Conditions
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Glaucoma, Open-Angle

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 18 years or older Pseudophakic Diagnosis of open angle glaucoma (OAG) On 1-5 ocular hypotensive medications Exclusion Criteria: Any of the following prior treatments for glaucoma: Suprachoroidal stent (e.g. Cypass, iStent Supra) Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU) Any other form of glaucoma other than OAG 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). 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: 18 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 canaloplasty and trabeculotomy (both up to 360 degrees) using the OMNI Surgical System<br> | Device: OMNI® Surgical System<br>* Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy using the OMNI Surgical System<br>|
| Active Comparator: Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System<br> | Device: OMNI® Surgical System<br>* Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System<br>|
| Active Comparator: Ab-interno implantation of iStent inject (2 microstents)<br> | Device: iStent inject<br>* Ab-interno implantation of iStent inject (2 microstents)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination |  | 12 months |