Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT04528069
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
Status:
COMPLETED
Status Verified Date:
2022-01
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 purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.
Detailed Description:
Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye.
Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.
This study will be conducted in Australia.
Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.
This study will be conducted in Australia.
Study Oversight
Has Oversight DMC:
False
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?: