NCT07331870

Performance Evaluation of DIY Digital Visual Acuity Test

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ojenforeningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-11-15
• Completion: 2025-11-15
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Denmark