Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2021-09-30

Brief Summary

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Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.

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Detailed Description

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This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.

Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The three G2-W stents are heparin-coated and manufactured from implant grade titanium.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implant Group

Qualified eyes with refractory glaucoma will be implanted unilaterally with the Glaukos® Trabecular Micro-Bypass System Model iS3 (three G2-W stents per study eye), and will be followed through 12 months postoperative.

Group Type EXPERIMENTAL

Model iS3 three-stent trabecular micro-bypass system

Intervention Type DEVICE

Provided in Arm/Group descriptions.

Interventions

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Model iS3 three-stent trabecular micro-bypass system

Provided in Arm/Group descriptions.

Intervention Type DEVICE

Other Intervention Names

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Implant Group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.
* Phakic or pseudophakic.
* Males or females, 45 years of age or older.

Exclusion Criteria

* Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.
* Active corneal inflammation or edema.
* Retinal disorders not associated with glaucoma.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No