Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756908
Status:
UNKNOWN
Last Update Posted:
2023-02-14
First Post:
2021-02-12
Brief Title:
Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery
Sponsor:
FSV6 Ltd
Organization:
FSV6 Ltd
Study Overview
Official Title:
Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL A Commercial Multifocal IOL and a Commercial Monofocal IOL
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
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:
This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery
Detailed Description:
This is a prospective multicenter clinical study comparing the safety and performance of the Opira accommodative IOL a commercial monofocal IOL and a commercial multifocal IOL Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses and will be followed postoperatively for 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None