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

Glaukos

Status: Enrolling

Conditions: Glaucoma

Treatments: Device: iStent Infinite

Study type: Interventional

Funder types: Industry

Identifiers

NCT06057051

GLK-401-01

Details and patient eligibility

About

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

Enrollment: 245 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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245 participants in 1 patient group

iStent Infinite

Experimental group

Description:

iStent Infinite Trabecular Micro-Bypass System

Treatment:

Device: iStent Infinite