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

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Device: iStent Infinite

• Registration Number: NCT06057051
• Lead Sponsor: Glaukos Corporation

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-01
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-26
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 245

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iStent Infinite	iStent Infinite	iStent Infinite Trabecular Micro-Bypass System

Primary Outcome Measures

Name	Time	Method
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline	12 Months

Trial Locations

Locations (1)

Glaukos Investigator Site; 🇺🇸 Cincinnati, Ohio, United States