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

Glaukos

Status: Unknown

Conditions: Glaucoma

Treatments: Device: Model iS3 three-stent trabecular micro-bypass system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03639870

INFI-106-G2W3 (GC-011)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Implant Group

Experimental group

Description:

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.

Treatment:

Device: Model iS3 three-stent trabecular micro-bypass system