Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446817
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-23
Brief Title:
Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
Sponsor:
Cutting Edge SAS
Organization:
Cutting Edge SAS
Study Overview
Official Title:
Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
HIGHADD
Brief Summary:
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens
Detailed Description:
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses
The device under investigation is a hydrophobic acrylic multifocal intraocular lens IOL manufactured by the sponsor of this study
The device under investigation is a hydrophobic acrylic multifocal intraocular lens IOL manufactured by the sponsor of this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01904-41 | REGISTRY | French BRC Identification number | None |