A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)
| Registry | NCT05127551 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 179 (Actual) |
| Sponsor | Glaukos Corporation (Industry) |
| Conditions | Glaucoma, Glaucoma, Open-Angle |
| Interventions | iStent Infinite, Competitor Device (Device) |
| Dates | start 2021-11-27, primary completion 2024-02-29, completion 2025-02-28 (estimated), first posted 2021-11-19, last updated 2024-08-15 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Glaucoma All trials for Glaucoma, Open-Angle All trials of iStent Infinite All trials of Competitor Device
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor
| Arm | Type | Interventions | Description |
|---|---|---|---|
| iStent Infinite | Active comparator | Device: iStent Infinite | Subjects implanted with iStent Infinite system |
| Competitor Device | Active comparator | Device: Competitor Device | Subject implanted with competitor device |
Sex: All, ages: 35 Years to 85 Years
Inclusion Criteria: * Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG) Exclusion Criteria: * Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders
| Facility | City | Country | Status |
|---|---|---|---|
| Glaukos Investigator Sites | Montreal, Qubec | Canada |