Performance Evaluation of DIY Digital Visual Acuity Test

NCT ID: NCT07331870

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-11-15

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.

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.

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Comparaison to standard of Care

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

Group Type: EXPERIMENTAL

Comparaison of the investigation device measurement with standard of Care

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Veranex Switzerland SA

INDUSTRY

Sponsor Role: collaborator

Ojenforeningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisbeth Sandfeld, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital, Roskilde, Denmark

Locations

Eye Dept., Zealand University Hospital

Roskilde, Denmark, Denmark

Countries

Denmark

Other Identifiers

Ojenforeningen

Identifier Type: -

Identifier Source: org_study_id