NCT06906718

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Teleon Surgical B.V. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraocular Lens

Interventions

Type	Name	Description
DEVICE	Implantation of an intraocular lens	Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: Germany