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

Ojenforeningen

Status

Completed

Conditions

Visual Acuity

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07331870

Ojenforeningen

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.