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NCT06057051 Clinical Trial

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

Glaucoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06057051
Other study ID # GLK-401-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date August 2027

Study information
Verified date September 2023
Source Glaukos Corporation
Contact Dari Parizadeh
Phone 949-481-0575
Email dparizadeh@glaukos.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 245
Est. completion date August 2027
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iStent Infinite
iStent Infinite Trabecular Micro-Bypass System

Locations
Country Name City State
United States Glaukos Investigator Site Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction = 20% from Baseline 12 Months
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