Intraocular LensChariteBerAN6VNCT06906718
Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario
A study testing Implantation of an intraocular lens in people with Intraocular Lens, run by Teleon Surgical B.V. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Intraocular Lens
- What is being tested?
- Implantation of an intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2024to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario (Model AN6V).
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.
Read the 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
- Being tested
- Implantation of an intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of an intraocular lensDevice
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| AN6V Recipients | Other | Single arm recipients of the IOL Receives: Device: Implantation of an intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual Acuity at far and intermediate distance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Feb 2024
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teleon Surgical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906718
- Sponsor's protocol ID
- EA4/120/23
- Acronym
- ChariteBerAN6V
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Visual Acuity Data After Bilateral Implantation of the Aspheric EDOF Lens ACUNEX® Vario (Model AN6V).
- ClinicalTrials.gov ID
- NCT06906718
- Acronym / sponsor ID
- ChariteBerAN6V / EA4/120/23
- Conditions
- Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Teleon Surgical B.V.Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AN6V Recipients | Other | Device: Implantation of an intraocular lensSingle arm recipients of the IOL |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of an intraocular lensSuccessful bilateral IOL implantation into the capsular bag with at least 12 months follow-up. | Device | AN6V Recipients |
Primary outcome
Visual Acuity
Time frame: 12 months
Visual Acuity at far and intermediate distance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of an intraocular lens in people with Intraocular Lens, run by Teleon Surgical B.V. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.