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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glaukos Investigator Sites

Montreal, Qubec, H1A 0A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

iStent Infinite

Device

Implantation of the iStent Infinite

Competitor Device

Device

Implantation of competitor device

Primary outcomes

Change in Mean Diurnal Intraocular Pressure

Time frame: Month 24

Change in Mean Diurnal Intraocular Pressure from Baseline over time

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Nov 19, 2021
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting