NCT06906718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 26, 2025

Last Update Submit

March 26, 2025

Conditions

Intraocular Lens

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Visual Acuity at far and intermediate distance.

    12 months

Study Arms (1)

AN6V Recipients

OTHER

Single arm recipients of the IOL

Device: Implantation of an intraocular lens

Interventions

Implantation of an intraocular lensDEVICE

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

AN6V Recipients

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Successful bilateral IOL implantation into the capsular bag with at least 12 months follow-up.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Charité University Berlin

Berlin, State of Berlin, 10117, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

February 1, 2024

Primary Completion

August 29, 2024

Study Completion

August 29, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)