Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-04-14 @ 9:49 PM
Study NCT ID:
NCT02049567
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)
Sponsor:
PowerVision
Organization:
Study Overview
Official Title:
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2021-05
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 safety and effectiveness of an investigational IOL.
Detailed Description:
Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: