Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06064916
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-09-12
Brief Title:
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Sponsor:
Berkeley Eye Center
Organization:
Berkeley Eye Center
Study Overview
Official Title:
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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 is a non-interventional prospective observational study of the outcomes for post myopic refractive surgery patients following successful uncomplicated cataract surgery with bilateral implantation of the Vivity IOL DATCCWET
Patients will be assessed for monocular and binocular distance intermediate and near vision
Patients will be assessed for monocular and binocular distance intermediate and near vision
Detailed Description:
This is a non-interventional prospective single center bilateral observational study of the outcomes for 40 post myopic refractive surgery patients following successful uncomplicated cataract surgery with bilateral implantation of the Vivity IOL DATCCWET performed by 4 surgeons using similar surgical techniques 40 subjects will be enrolled
Patients will be assessed for monocular and binocular distance intermediate and near vision
The hypothesis is that post-refractive patients that have high spherical aberration SAs will have excellent outcomes and satisfaction with a Vivity IOL
Patients will be assessed for monocular and binocular distance intermediate and near vision
The hypothesis is that post-refractive patients that have high spherical aberration SAs will have excellent outcomes and satisfaction with a Vivity IOL
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?:
None
Is an FDA AA801 Violation?:
None