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

Teleon Surgical

Status: Completed

Conditions: Intraocular Lens

Treatments: Device: Implantation of an intraocular lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06906718

EA4/120/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

AN6V Recipients

Other group

Description:

Single arm recipients of the IOL

Treatment:

Device: Implantation of an intraocular lens