Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01836042
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2013-04-17
Brief Title:
Post-approval Study of The Glaukos iStent Trabecular Micro-bypass Stent Extended Follow-up of the Premarket Cohort
Sponsor:
Glaukos Corporation
Organization:
Glaukos Corporation
Study Overview
Official Title:
Post-approval Study of The Glaukos iStent Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery Extended Follow-up of the Premarket Cohort
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the long-term safety of the Glaukos iStent Trabecular Micro-Bypass Stent Model GTS100RL in subjects previously enrolled in Glaukos Study GC-003
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None