VisuALLeyes-ION
Research type
Research Study
Full title
Virtual Reality-Based Assessment of Visual Function in Inherited Optic Neuropathies
IRAS ID
346568
Contact name
Patrick Yu Wai Man
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (joint sponsors)
Duration of Study in the UK
0 years, 6 months, 15 days
Research summary
Inherited optic neuropathies (IONs) are a group of genetic disorders characterised by optic nerve dysfunction. The most common primary IONs are autosomal dominant optic atrophy (DOA) and Leber’s hereditary optic neuropathy (LHON). Vision loss from IONs is devastating. Currently there are no effective treatments for IONs. In the last 15 years, significant progress has been made in the development of gene therapy techniques for the treatment of inherited disorders. Key considerations when conducting clinical trials for gene therapy in patients with IONs, are the selection of trial outcome measures and the procedures for obtaining these measures. Clinical trials for eye diseases have traditionally focused on measures of visual function, including best corrected visual acuity and visual field mean deviation (MD). The visual field test requires patients to maintain accurate fixation on a target centrally to obtain a reliable, accurate measure of MD. However, vision loss occurs centrally in IONs, potentially rendering the MD value unreliable.
Recent advances in virtual reality (VR) head-mounted displays have been used to create interactive extended reality environments to facilitate testing of visual function. These devices use eye-tracking technology, which can overcome the challenge of poor patient fixation due to central vision loss. The novel, FDA-registered, VR-based device VisuALL has never been studied in patients with ION or used in a clinical trial setting for detecting changes in visual function. Approximately 20 patients aged ≥16 years with genetically confirmed LHON or ADOA will be recruited in this study and attend two study visits at baseline and 6 months. Study procedures will include vision assessments, questionnaires and short interview. The purpose of this study is to determine the feasibility, validity and reliability of the device for use by patients with IONs, including patients participating in a first-in-human clinical trial of gene therapy for DOA.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0188
Date of REC Opinion
8 Oct 2025
REC opinion
Further Information Favourable Opinion