Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755231
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2021-02-11
Brief Title:
Post-Market Clinical Study of the PanOptix Intraocular Lens IOL in a Chinese Population
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
Post-Market Clinical Study of the AcrySof IQ PanOptix Presbyopia Correcting Intraocular Lens in a Chinese Population
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population
Detailed Description:
In this clinical study subjects will be implanted with the PanOptix IOL in both eyes The second eye surgery will occur 7-28 days after the first eye A total of 11 scheduled visits are planned including a screening visit two operative visits and 8 postoperative visits The total expected duration of the subjects participation will be about 14 months This study will be conducted in China
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