Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03027024
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2017-01-16
Brief Title:
Clinical Study to Investigate Visual Performance of IOL FineVision HP
Sponsor:
Beaver-Visitec International Inc
Organization:
Beaver-Visitec International Inc
Study Overview
Official Title:
Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL FineVision HP
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:
This is a prospective non-randomised controlled single-surgeon single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA Therapeutics Goods Authority Australia approved trifocal intraocular lens FineVision Evo PhysIOL Liège Belgium The primary and secondary effectiveness data for visual acuity defocus curves contrast sensitivity and any adverse events will be collected
Detailed Description:
Subjects participating in the trial will attend a total of 8 study visits 1 preoperative 2 operative and 5 postoperative over a period of 3 months same as the surgeons standard follow up protocol for bilateral cataract surgery with IOL implantation Subjects would have the option for unscheduled visits if required medically
Primary endpoint data will be collected at the final visit Data analyses will be done in the end to support the study publication plan
Primary endpoint data will be collected at the final visit Data analyses will be done in the end to support the study publication plan
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