Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01461291
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2011-10-25
Brief Title:
Multicenter Study Using Glaukos Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Sponsor:
Glaukos Corporation
Organization:
Glaukos Corporation
Study Overview
Official Title:
A Prospective Randomized Single-Masked Controlled Parallel Groups Multicenter Clinical Investigation of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2022-05
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:
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs cataract surgery only in subjects with mild to moderate primary open-angle glaucoma
Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery compared to cataract surgery only in subjects with mild to moderate primary open-angle glaucoma
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