Performance Evaluation of DIY Digital Visual Acuity Test

NCT07331870 | Completed

• 1 other identifier: Ojenforeningen
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to verify the accuracy of a new Digital Visual Acuity test. The test results obtained with the support of the device will be compared to the current standard of care related to visual acuity testing.

Conditions

Visual Acuity

Keywords

Visual acuity; ETDRS evaluation; Radner test; software based Visual acuity test

Outcome Measures

Primary Outcomes (2)

• Agreement of Digital Visual Acuity Test Scores With ETDRS (Distance) and Radner (Near) Visual Acuity Scores

  Difference and agreement between visual acuity scores obtained using the DIY Digital Visual Acuity Test and scores obtained using the ETDRS chart for distance vision and the Radner chart for near vision, measured in logMAR units.

  up to 90 days

• Repeatability of Visual Acuity Measurements Obtained With the DIY Digital Visual Acuity Test Compared With ETDRS (Distance) and Radner (Near) Charts

  Within-subject repeatability of visual acuity measurements, expressed in logMAR units, across repeated use of the DIY Digital Visual Acuity Test compared with repeated measurements obtained using ETDRS charts for distance vision and Radner charts for near vision.

  up to 90 days

Study Arms (1)

Comparaison to standard of Care

EXPERIMENTAL

The measurements performed with the investigational device are compared to the standard of care (ETDRS and Radner test)

Device: Comparaison of the investigation device measurement with standard of Care

Interventions

Comparaison of the investigation device measurement with standard of Care DEVICE

The patient Visual acuity is measured with the investigational device, the ETDRS method, the radner test and the results are compared.

Comparaison to standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older.
• Subjects must be able to understand and perform the test.
• Subject must have corrected vison (i.e. wearing glasses)

You may not qualify if:

• Subjects not able to understand the implications of participating in a scientific study.
• Subjects not legally independent.
• Subjects not able to perform the test.

Sponsors & Collaborators

• Ojenforeningen: lead
• Veranex Switzerland SA: collaborator

Study Sites (1)

Eye Dept., Zealand University Hospital

Roskilde, Denmark, 4000, Denmark

Location

Study Officials

• Lisbeth Sandfeld, PhD MD

  Zealand University Hospital, Roskilde, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No making applied
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 12, 2026
• Study Start: October 1, 2022
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)