Performance Evaluation of DIY Digital Visual Acuity Test (CI01-2022)

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Comparaison of the investigation device measurement with standard of Care

Detailed Description

The investigational device is a software-based application for computers and tablets that enables individuals without professional training to self-assess their near and distance visual acuity. It is a low-risk device and represents an evolution of an already marketed product. The device is intended to support ongoing monitoring for patients with conditions that may affect visual acuity, helping track changes over time. It is not designed to replace a comprehensive eye examination performed by a qualified eye-care professional. For this study, the advanced version of the application will be used.

The study population will include adults with normal, subnormal, and low vision to ensure validation of the test across the full range of visual acuity levels. Participants will include patients attending the Eye Department for treatment of various ocular conditions (low-vision group), as well as patients' spouses and department staff (subnormal and normal vision groups). All participants must be able to make independent judgments. Before participation, each individual will receive information about the study procedures, including the nature of the intervention and their right to withdraw at any time.

The device does not require specialized training. Users will receive a brief initial orientation on how to operate the application. For the home self-test, users will complete the assessment independently and without assistance to evaluate the device's usability and support autonomous testing.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Denmark
    • Roskilde, Denmark, Denmark, 4000
      • Eye Dept., Zealand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparaison to standard of Care; 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; The patient Visual acuity is measured with the investigational device, the ETDRS method, the radner test and the results are compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ojenforeningen
• Collaborators: Veranex Switzerland SA
• Investigators: Principal Investigator: Lisbeth Sandfeld, PhD MD, Zealand University Hospital, Roskilde, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): November 15, 2025
• Study Completion (Actual): November 15, 2025

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Visual acuity; ETDRS evaluation; Radner test; software based Visual acuity test
• Other Study ID Numbers: Ojenforeningen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The current consent obtained by subjects to process their data does not include sharing their data in any form beyond this clinical trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No