Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-06 @ 7:03 PM
Study NCT ID:
NCT02838004
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2016-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
Sponsor:
SIFI SpA
Organization:
Study Overview
Official Title:
An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Status:
COMPLETED
Status Verified Date:
2020-01
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:
PSM15
Brief Summary:
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
Detailed Description:
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: