Intraocular Lens
Conditions
Brief 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.
Interventions
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.
Sponsors
Charite University, Berlin, Germany
Teleon Surgical B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 12 months | Visual Acuity at far and intermediate distance. |
Countries
Germany
Outcome results
None listed