Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03624361
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2018-05-28
Brief Title:
MINIject Glaucoma Implant in European Patients
Sponsor:
iSTAR Medical
Organization:
iSTAR Medical
Study Overview
Official Title:
A Prospective Open Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Status:
COMPLETED
Status Verified Date:
2022-08
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:
STAR-II
Brief Summary:
The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure IOP lowering effects with or without glaucoma medications The procedure will be a stand-alone surgery Overall the patient will be asked to perform several examinations up to 24 months after surgery
Detailed Description:
The primary endpoint is the qualified success rate at 6 months after surgery greater than 60 Qualified success is defined as a diurnal IOP 21mmHg millimeter mercury and 5mmHg with a minimum 20 diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None