Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04176965
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2019-11-20
Brief Title:
Investigation of the Safety and Effectiveness of a Trifocal IOL
Sponsor:
Beaver-Visitec International Inc
Organization:
Beaver-Visitec International Inc
Study Overview
Official Title:
Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
This study is a prospective multicenter randomized double masked confirmatory trial comparing an investigational trifocal intraocular lens IOL and a commercially available monofocal IOL
Detailed Description:
The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None