Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Glaukos Corporation
- Study ID
- NCT06057051
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 35 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- iStent Infinite — DEVICEiStent Infinite Trabecular Micro-Bypass System
Study Details
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
Key Dates
- Start date
- Sep 1, 2023
- Status verified
- Sep 2023
- Primary completion
- Aug 31, 2025
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 245 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: iStent InfiniteiStent Infinite Trabecular Micro-Bypass System
Primary Outcome Measure
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline [ Time Frame: 12 Months ]
Central Contacts
- Dari Parizadeh949-481-0575
- Kerry Stephens949-481-8057
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Glaukos Investigator Site | Cincinnati | Ohio | 45242 | Dari Parizadeh |
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