Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04075591
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2019-08-29
Brief Title:
Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
Sponsor:
AMO Development LLC
Organization:
AMO Development LLC
Study Overview
Official Title:
Post-approval Study of Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
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 12-month prospective multicenter open-label non-comparative non-randomized clinical investigation conducted at 8 to 14 sites A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects resulting in at least 241 evaluable subjects at the point of refractive stability After signing the informed consent subjects meeting all inclusion and exclusion criteria in both eyes may be scheduled for surgery The follow-up visit schedule will be the same for each operative eye
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