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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2021-01-20

Brief Summary

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

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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)

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 transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System

Group Type ACTIVE_COMPARATOR

OMNI® Surgical System

Intervention Type DEVICE

Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System

Ab-interno transluminal viscoelastic delivery using OMNI surgical System

Group Type ACTIVE_COMPARATOR

OMNI® Surgical System

Intervention Type DEVICE

Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System

iStent Inject implantation

iStent Inject implantation using the iStent device

Group Type ACTIVE_COMPARATOR

iStent inject

Intervention Type DEVICE

Trabecular meshwork implantation

Interventions

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OMNI® Surgical System

Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System

Intervention Type DEVICE

iStent inject

Trabecular meshwork implantation

Intervention Type DEVICE

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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No