Status:
COMPLETED
Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario
Lead Sponsor:
Teleon Surgical B.V.
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Intraocular Lens
Eligibility:
All Genders
30+ years
Phase:
NA
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 - ACU...
Eligibility Criteria
Inclusion
- Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.
Exclusion
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06906718
Start Date
February 1 2024
End Date
August 29 2024
Last Update
April 2 2025
Active Locations (1)
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1
Charité University Berlin
Berlin, State of Berlin, Germany, 10117