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OpenTrials
Completed

NCT Number: NCT06906718

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

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.

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Key information

Conditions

Intraocular Lens

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Berlin

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of an intraocular lens

Device

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

Primary outcomes

  1. Visual Acuity

    Time frame: 12 months

    Visual Acuity at far and intermediate distance.

Sponsors and collaborators

Lead sponsor

Teleon Surgical B.V.

Industry

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

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

Acronym: ChariteBerAN6V

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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