Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
Completed
- Conditions
- Primary Open-angle Glaucoma
- Interventions
- Device: iStent
- Registration Number
- NCT01841437
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
Inclusion Criteria
- Consecutive subjects in whom implantation of the iStent is attempted
Exclusion Criteria
- Please refer to approved indications in Directions for Use
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description iStent iStent -
- Primary Outcome Measures
Name Time Method Rate of sight-threatening adverse events 36 months
- Secondary Outcome Measures
Name Time Method Other ocular adverse events 36 months