Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01052558
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2010-01-13
Brief Title:
GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
Sponsor:
Glaukos Corporation
Organization:
Glaukos Corporation
Study Overview
Official Title:
A Prospective Randomized Controlled Parallel Groupos Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2015-05
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:
The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure IOP in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract
Detailed Description:
Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage It is a leading cause of blindness in the United States affecting 1-2 of individuals aged 60 and over Management of glaucoma requires chronic life-long treatment with a spectrum of therapeutic options including medications laser treatment and surgical implants The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve
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