Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
1 other identifier
observational
191
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2016
CompletedDecember 18, 2017
August 1, 2017
2.5 years
April 24, 2013
December 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of sight-threatening adverse events
36 months
Secondary Outcomes (1)
Other ocular adverse events
36 months
Study Arms (1)
iStent
Interventions
Eligibility Criteria
Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites
You may qualify if:
- Consecutive subjects in whom implantation of the iStent is attempted
You may not qualify if:
- Please refer to approved indications in Directions for Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Chico, California, 95926, United States
Unknown Facility
Huntington Beach, California, 92647, United States
Unknown Facility
Napa, California, 94558, United States
Unknown Facility
Santa Maria, California, 93454, United States
Unknown Facility
Ventura, California, 93003, United States
Unknown Facility
Parker, Colorado, 80134, United States
Unknown Facility
Portland, Maine, 04102, United States
Unknown Facility
Quincy, Massachusetts, 02169, United States
Unknown Facility
Bloomington, Minnesota, 55431, United States
Unknown Facility
Westwood, New Jersey, 07675, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Fayetteville, North Carolina, 28304, United States
Unknown Facility
Southern Pines, North Carolina, 28387, United States
Unknown Facility
Brecksville, Ohio, 44141, United States
Unknown Facility
Youngstown, Ohio, 44502, United States
Unknown Facility
Ladson, South Carolina, 29456, United States
Unknown Facility
Sioux Falls, South Dakota, 57108, United States
Unknown Facility
Appleton, Wisconsin, 54914, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
April 26, 2013
Study Start
September 1, 2013
Primary Completion
February 16, 2016
Study Completion
June 21, 2016
Last Updated
December 18, 2017
Record last verified: 2017-08