Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05713253
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-01-25
Brief Title:
A PHASED PROSPECTIVE MULTI-CENTER STUDY OF THE ELITA SYSTEM
Sponsor:
Johnson Johnson Surgical Vision Inc
Organization:
Johnson Johnson Surgical Vision Inc
Study Overview
Official Title:
A PHASED PROSPECTIVE MULTI-CENTER STUDY OF THE ELITA SYSTEM FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS WITH OR WITHOUT ASTIGMATISM
Status:
RECRUITING
Status Verified Date:
2024-10
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 will be a 2-phase prospective multicenter open-label non-comparative non-randomized clinical investigation to confirm the safety and effectiveness of the ELITA system
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None