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Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma

A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06057051
Enrollment
245
Registered
2023-09-28
Start date
2023-09-01
Completion date
2027-08-31
Last updated
2023-09-28

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

Conditions

Glaucoma

Brief summary

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment

Interventions

DEVICEiStent Infinite

iStent Infinite Trabecular Micro-Bypass System

Sponsors

Glaukos Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of primary open-angle glaucoma * Phakic or pseudophakic * Age 35 years or older

Exclusion criteria

* Traumatic, uveitic, neovascular, angle-closure glaucoma or * glaucoma associated with vascular disorders * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma

Design outcomes

Primary

MeasureTime frame
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline12 Months

Countries

United States

Contacts

Primary ContactDari Parizadeh
dparizadeh@glaukos.com949-481-0575
Backup ContactKerry Stephens
kstephens@glaukos.com949-481-8057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026