Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 8:42 PM
Study NCT ID:
NCT01640756
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AqueSys Microfistula Implant in Refractory Glaucoma
Sponsor:
AqueSys, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma
Status:
COMPLETED
Status Verified Date:
2016-01
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 establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
Detailed Description:
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.
Study Oversight
Has Oversight DMC:
False
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?: