Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision

Queen's University Belfast

Status: Unknown

Conditions: Low Vision; Stargardt Disease 3; Retinitis Pigmentosa; Stargardt Disease 1; Albinism; Stargardt Disease 4

Treatments: Device: Virtual Reality Headset based tests

Study type: Observational

Funder types: Other

Identifiers

NCT04281732

17/NI/0002

Details and patient eligibility

About

Purpose:

To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.

Full description

Aims of the Research Project:

1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
2. To quantify the reproducibility of the performance-based tests.
3. To gather acceptability and ease-of-use data from patients.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female participants

2. Age 20-50

3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.

4. Sight impairment criteria are as follows:

   • Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
   • Visual acuity of up to 6 / 24 with a moderate reduction of field of vision

Exclusion criteria

1. Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
2. A history of vertigo or dizziness.

Trial design