Trials / Unknown
UnknownNCT03639870
Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- Sponsor
- Glaukos Corporation · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.
Detailed description
This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Model iS3 three-stent trabecular micro-bypass system | Provided in Arm/Group descriptions. |
Timeline
- Start date
- 2018-07-10
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2018-08-21
- Last updated
- 2021-04-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03639870. Inclusion in this directory is not an endorsement.