An interventional study of Implantation of an intraocular lens in Intraocular Lens, sponsored by Teleon Surgical B.V.. Completed at 1 site in Germany. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Teleon Surgical B.V. · Not applicable, Interventional, and Treatment
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.
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.
Teleon Surgical B.V. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.
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.
Visual Acuity
Visual Acuity at far and intermediate distance.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Teleon Surgical B.V.