Evaluation of Long-term Visual Acuity Data After Bilatera... | NCT06906718

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

NCT06906718

Sponsor

Teleon Surgical B.V.

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Intraocular Lens

Interventions

Implantation of an intraocular lens

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Aug 29, 2024Actual

Completion Date

Aug 29, 2024Actual

First Submitted Date

Mar 26, 2025

First Submission Date that Met QC Criteria

Mar 26, 2025

First Posted Date

Apr 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 2, 2025Actual

Name	Class
Charite University, Berlin, Germany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AN6V Recipients	Other	Single arm recipients of the IOL	Device: Implantation of an intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of an intraocular lens	Device	Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.	AN6V Recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Acuity	Visual Acuity at far and intermediate distance.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University Berlin		Berlin	State of Berlin	10117	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided