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

N/AActive Not RecruitingNCT05127551

Glaukos Corporation179 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

179

Conditions

Glaucoma Glaucoma, Open-Angle

Interventions

iStent InfiniteDEVICE

Implantation of the iStent Infinite

Competitor DeviceDEVICE

Implantation of competitor device

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Glaukos Investigator Sites

Montreal, Qubec, Canada

Outcomes

Primary Outcomes

Change in Mean Diurnal Intraocular Pressure

Change in Mean Diurnal Intraocular Pressure from Baseline over time

Time frame: Month 24

Data from ClinicalTrials.gov

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