Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 3/10/2019 |
| Start Date: | July 10, 2018 |
| End Date: | September 2021 |
| Contact: | Abhi Vilupuru, PhD BS (OD) |
| Email: | avilupuru@glaukos.com |
| Phone: | 9493679600 |
A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
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.
of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in
subjects with refractory glaucoma.
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.
Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be
followed for 12 months postoperatively.
Inclusion Criteria:
- Diagnosis of refractory open-angle glaucoma (including pigmentary and
pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior
conventional incisional intraocular glaucoma surgeries.
- Phakic or pseudophakic.
- Males or females, 45 years of age or older.
Exclusion Criteria:
- Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with
vascular disorders.
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
We found this trial at
1
site
Click here to add this to my saved trials
