Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
1 other identifier
interventional
360
1 country
14
Brief Summary
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedOctober 20, 2021
October 1, 2021
8.1 years
April 24, 2013
October 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of sight-threatening adverse events
36 months
Secondary Outcomes (1)
Other adverse events
36 months
Other Outcomes (1)
Diurnal IOP reduction ≥ 20%
Baseline and 24 months
Study Arms (2)
iStent
EXPERIMENTALImplantation of one iStent in conjunction with cataract surgery
Cataract surgery
ACTIVE COMPARATORCataract surgery alone
Interventions
Implantation of one iStent in conjunction with cataract surgery
Eligibility Criteria
You may qualify if:
- mild to moderate primary open-angle glaucoma
- currently treated with ocular hypotensive medication
- pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- subject scheduled to undergo cataract surgery
You may not qualify if:
- primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
- retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Irvine, California, 92604, United States
Unknown Facility
Montebello, California, 90640, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Edgewood, Kentucky, 41017, United States
Unknown Facility
Louisville, Kentucky, 40217, United States
Unknown Facility
Jackson, Michigan, 49202, United States
Unknown Facility
Saint Joseph, Michigan, 49085, United States
Unknown Facility
Kansas City, Missouri, 64151, United States
Unknown Facility
St Louis, Missouri, 63131, United States
Unknown Facility
Winston-Salem, North Carolina, 27101, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Mentor, Ohio, 44060, United States
Unknown Facility
Kingston, Pennsylvania, 18704, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
April 26, 2013
Study Start
July 1, 2013
Primary Completion
August 1, 2021
Study Completion
November 1, 2021
Last Updated
October 20, 2021
Record last verified: 2021-10