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

Not Applicable

• Conditions: Glaucoma
• Interventions: Device: Model iS3 three-stent trabecular micro-bypass system

• Registration Number: NCT03639870
• Lead Sponsor: Glaukos Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implant Group	Model iS3 three-stent trabecular micro-bypass system	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.

Primary Outcome Measures

Name	Time	Method
Primary effectiveness endpoint	Month 12 postoperative	The change in mean diurnal IOP from baseline at 12 months

Trial Locations

Locations (1)

Glaucoma Associates of Tx; 🇺🇸 Dallas, Texas, United States