Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort
Launched by GLAUKOS CORPORATION · Apr 18, 2013
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study
- Exclusion Criteria:
- • Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
- • Patients not previously enrolled in Glaukos Study GC-003
About Glaukos Corporation
Glaukos Corporation is a pioneering medical technology company dedicated to transforming the treatment of glaucoma and other eye diseases through innovative surgical and drug delivery solutions. With a strong focus on advancing patient care, Glaukos develops cutting-edge minimally invasive therapies that aim to reduce intraocular pressure and improve visual outcomes. Committed to rigorous clinical research and development, the company collaborates with healthcare professionals to bring forth effective and safe treatment options, enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Kansas City, Missouri, United States
Pittsburgh, Pennsylvania, United States
Miami, Florida, United States
Tampa, Florida, United States
Philadelphia, Pennsylvania, United States
Las Vegas, Nevada, United States
Louisville, Kentucky, United States
Sacramento, California, United States
St. Joseph, Michigan, United States
Boynton Beach, Florida, United States
Santa Maria, California, United States
Edina, Minnesota, United States
Beverly Hills, California, United States
Cincinnati, Ohio, United States
Independence, Missouri, United States
San Clemente, California, United States
Beaumont, Texas, United States
Parker, Colorado, United States
Overland Park, Kansas, United States
Bloomington, Minnesota, United States
Morrow, Georgia, United States
Petaluma, California, United States
Winston Salem, North Carolina, United States
Baton Rouge, Louisiana, United States
Brookville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Patients applied
Trial Officials
Jeff Wells, PharmD, MBA
Study Director
Glaukos Corporation
Jay Katz, MD
Study Chair
Wills Eye Institute; Thomas Jefferson University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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