Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT04801992
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2021-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant
Sponsor:
SIFI SpA
Organization:
Study Overview
Official Title:
Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant
Status:
COMPLETED
Status Verified Date:
2021-03
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 study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo \& Glare Simulator.
Detailed Description:
The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)
Study Oversight
Has Oversight DMC:
True
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?: