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

NCT ID: NCT06906718

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-29

Brief Summary

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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

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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.

Conditions

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Intraocular Lens

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AN6V Recipients

Single arm recipients of the IOL

Group Type OTHER

Implantation of an intraocular lens

Intervention Type DEVICE

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

Interventions

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Implantation of an intraocular lens

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Teleon Surgical B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Charité University Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA4/120/23

Identifier Type: -

Identifier Source: org_study_id

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