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

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)

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05127551

Enrollment

179

Registered

2021-11-19

Start date

2021-11-27

Completion date

2025-02-28

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Glaucoma, Open-Angle

Keywords

Glaucoma, MIGS

Brief summary

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

Interventions

DEVICEiStent Infinite

Implantation of the iStent Infinite

DEVICECompetitor Device

Implantation of competitor device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Mean Diurnal Intraocular Pressure	Month 24	Change in Mean Diurnal Intraocular Pressure from Baseline over time

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026