Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario (ChariteBerAN6V)

March 26, 2025 updated by: Teleon Surgical B.V.

Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario (Model AN6V).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité University Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AN6V Recipients
Single arm recipients of the IOL
Device: Implantation of an intraocular lens
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 12 months
Visual Acuity at far and intermediate distance.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teleon Surgical B.V.

Collaborators

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

August 29, 2024

Study Completion (Actual)

August 29, 2024

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • EA4/120/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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