Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06906718
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario
Sponsor:
Teleon Surgical B.V.
Organization:
Study Overview
Official Title:
Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario (Model AN6V).
Status:
COMPLETED
Status Verified Date:
2025-03
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:
ChariteBerAN6V
Brief Summary:
The aim of the ACUNEX® Vario study was to confirm long-term data on the visual quality and contrast sensitivity of an existing EDOF-IOL, which bears the CE mark and has been on the market since 2019.
Detailed Description:
The monocentric, retro-prospective, uncontrolled clinical study following Art. 82 MDR, §§ 47 MPDG and conducted according ISO 14155 shall confirm the long-term safety and performance of the AN6V - ACUNEX® Vario EDOF-IOL which has been marketed since 2019. This IOL model is designed to provide good distance and intermediate vision.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: