Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor

Not Applicable

Active, not recruiting

• Conditions: Glaucoma; Glaucoma, Open-Angle
• Interventions: Device: iStent Infinite; Device: Competitor Device

• Registration Number: NCT05127551
• Lead Sponsor: Glaukos Corporation

Brief Summary

A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-11-19
• Study Start: 2021-11-27
• Primary Completion: 2024-02-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG)

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Exclusion Criteria

• Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStent Infinite	iStent Infinite	Subjects implanted with iStent Infinite system
Competitor Device	Competitor Device	Subject implanted with competitor device

Primary Outcome Measures

Name	Time	Method
Change in Mean Diurnal Intraocular Pressure	Month 24	Change in Mean Diurnal Intraocular Pressure from Baseline over time

Trial Locations

Locations (1)

Glaukos Investigator Sites; 🇨🇦 Montréal, Qubec, Canada