Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-28 @ 12:41 AM
Study NCT ID:
NCT03807869
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Sponsor:
Medical University of Bialystok
Organization:
Study Overview
Official Title:
Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.
Detailed Description:
The scientific aim of the project is to estimate the average reduction of intraocular pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12 months observation period. The subject must suffer from glaucoma and cataract at the same time, and qualify for a cataract surgery. The group will be composed of 40 patients of the Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract removal surgery. They will be surgically implanted an I-stent by-pass during phacoemulsification.
Study Oversight
Has Oversight DMC:
False
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?: