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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2022-11-18

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.

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Detailed Description

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A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System

Sequential canaloplasty (up to 360 degrees) and trabeculotomy (up to 360 degrees)

Group Type ACTIVE_COMPARATOR

Canaloplasty and trabeculotomy with the OMNI system.

Intervention Type DEVICE

Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy

Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System

Canaloplasty alone (up to 360 degrees)

Group Type ACTIVE_COMPARATOR

Canaloplasty

Intervention Type DEVICE

Ab-interno canaloplasty (360 degrees) using the OMNI

Ab-interno implantation of iStent inject (2 microstents)

Implantation of trabecular micro bypass stents as per manufacturer's instructions.

Group Type ACTIVE_COMPARATOR

iStent inject

Intervention Type DEVICE

Ab-interno implantation of iStent inject (2 microstents)

Interventions

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Canaloplasty and trabeculotomy with the OMNI system.

Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy

Intervention Type DEVICE

iStent inject

Ab-interno implantation of iStent inject (2 microstents)

Intervention Type DEVICE

Canaloplasty

Ab-interno canaloplasty (360 degrees) using the OMNI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects, 18 years or older
2. Pseudophakic
3. Diagnosis of open angle glaucoma (OAG)
4. On 1-5 ocular hypotensive medications

Exclusion Criteria

1. 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)
2. Any other form of glaucoma other than OAG
3. 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).
4. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No