Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961046
Status:
TERMINATED
Last Update Posted:
2024-06-17
First Post:
2023-07-10
Brief Title:
Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Sponsor:
Laser Corneal Surgery Associates
Organization:
Laser Corneal Surgery Associates
Study Overview
Official Title:
Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL
Detailed Description:
This study Prospective non-interventional single-center single-surgeon single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL Subjects will be assessed at least 3 months postoperatively Clinical evaluations will include administration of a satisfaction questionnaire IOLSAT as well as measurement of binocular and monocular visual acuities defocus curve and manifest refraction
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