Visual Acuity
Conditions
Keywords
Visual acuity, ETDRS evaluation, Radner test, software based Visual acuity test
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.
Interventions
DEVICEComparaison 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.
Sponsors
Veranex Switzerland SA
Ojenforeningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No making applied
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of Digital Visual Acuity Test Scores With ETDRS (Distance) and Radner (Near) Visual Acuity Scores | up to 90 days | 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. |
| Repeatability of Visual Acuity Measurements Obtained With the DIY Digital Visual Acuity Test Compared With ETDRS (Distance) and Radner (Near) Charts | up to 90 days | 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. |
Countries
Denmark
Outcome results
None listed