Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00721968
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2008-07-23
Brief Title:
Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
Sponsor:
Glaukos Corporation
Organization:
Glaukos Corporation
Study Overview
Official Title:
A Prospective Randomized Controlled Parallel Groups Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2014-02
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:
To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery compared to cataract surgery only in subjects with mild to moderate open angle glaucoma
Detailed Description:
The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 hereinafter referred to as GTS400 in combination with cataract surgery compared to cataract surgery only in subjects with mild to moderate primary open-angle glaucoma This is a prospective randomized concurrently controlled parallel groups multicenter clinical investigation of the GTS400 Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery Group 1 Investigational Group or cataract surgery only Group 2 Control Group Clinical data through 12 months postoperative will form the basis of a pre-market approval PMA submission Subjects will be followed for two years postoperatively
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