Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479148
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
Clinical Evaluation of the Performance of the enVista Aspire EA Lens
Sponsor:
Bausch Lomb Incorporated
Organization:
Bausch Lomb Incorporated
Study Overview
Official Title:
A Prospective Single-Center Randomized Clinical Investigation to Evaluate the Performance of enVista Aspire EA Intraocular Lens Against a Control and an Active-Comparator in Subjects Undergoing Cataract Extraction and Implantation of an Intraocular Lens
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
A Prospective Single-Center Randomized Clinical Investigation to evaluate the safety and performance of the enVista Aspire EA intraocular lens IOL when compared to the MX60E monofocal IOL control lens and an IOL with a slightly extended depth of focus active comparator lens for potentially improved optical properties
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None