Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 6:57 PM
Study NCT ID:
NCT05799950
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Status:
COMPLETED
Status Verified Date:
2025-08
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 post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).
Detailed Description:
The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.
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?:
False
Is an FDA AA801 Violation?: