Glaucoma
Conditions
Keywords
refractory
Brief 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.
Interventions
DEVICEModel iS3 three-stent trabecular micro-bypass system
Provided in Arm/Group descriptions.
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The three G2-W stents are heparin-coated and manufactured from implant grade titanium.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary effectiveness endpoint | Month 12 postoperative | The change in mean diurnal IOP from baseline at 12 months |
Countries
United States
Outcome results
None listed