iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study
- Conditions
- Glaucoma, Open-Angle
- Registration Number
- NCT04624685
- Lead Sponsor
- Glaukos Corporation
- Brief Summary
Long term follow up of subjects in the IDE study for iStent Inject to monitor safety
- Detailed Description
To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 475
- Randomized subject followed for 24 months in the GC-008 study
- Able to understand study requirements
- Willing to attend scheduled follow-up exams for 5 years post-operatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iStent inject Placement and Stability 60 Months Rate of clinically relevant complications associated with iStent inject placement and stability.
- Secondary Outcome Measures
Name Time Method Sight-Threatening Adverse Events 60 Months Rate of occurrence of sight-threatening adverse events
Trial Locations
- Locations (24)
Stiles Eyecare Excellence
🇺🇸Overland Park, Kansas, United States
Chicago Eye Specialists
🇺🇸Chicago, Illinois, United States
Kresge Eye Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
R and R Eye Resarch, LLC
🇺🇸San Antonio, Texas, United States
Arizona Advanced Eye Research Institute
🇺🇸Glendale, Arizona, United States
Vold Vision, PLLC
🇺🇸Fayetteville, Arkansas, United States
North Bath Eye Associates, Inc.
🇺🇸Santa Rosa, California, United States
Eye Center of northern Colorado, PC
🇺🇸Fort Collins, Colorado, United States
Argus Research
🇺🇸Cape Coral, Florida, United States
International Research Center
🇺🇸Tampa, Florida, United States
Center for Sight
🇺🇸Venice, Florida, United States
Clayton Eye Clinical Research, LLC.
🇺🇸Morrow, Georgia, United States
Arbor Center for Eye Care
🇺🇸Orland Park, Illinois, United States
D'Ambrosio Eye Care
🇺🇸Lancaster, Massachusetts, United States
Discover Vision Centers
🇺🇸Independence, Missouri, United States
Northern New Jersey Eye Institute
🇺🇸South Orange, New Jersey, United States
Glaucoma Consultants of the Capital Region
🇺🇸Slingerlands, New York, United States
Keystone Research
🇺🇸Austin, Texas, United States
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States
Parkhurst Nuvision
🇺🇸San Antonio, Texas, United States
Vistar Eye Center
🇺🇸Roanoke, Virginia, United States
The Eye Center of Racine and Kenosha
🇺🇸Racine, Wisconsin, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
Oklahoma eye Surgeons, PLLC
🇺🇸Oklahoma City, Oklahoma, United States