Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03193736
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2017-05-09
Brief Title:
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Sponsor:
iSTAR Medical
Organization:
iSTAR Medical
Study Overview
Official Title:
A Prospective Open Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Status:
COMPLETED
Status Verified Date:
2021-02
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:
STAR-I
Brief Summary:
The study will evaluate the efficacy and safety of the implant and intra-ocular 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
The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening
The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening
Detailed Description:
None
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