Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541795
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens IOL models in a real-world setting through routine clinical practice
Detailed Description:
This study includes a retrospective chart review to obtain preoperative operative and post-operative data and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world
This study will be conducted in the US and in Spain
This study will be conducted in the US and in Spain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None