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
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
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Glaukos Investigator Site | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Glaukos Corporation |
United States,
| 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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