Recipient organisationNIHR Wellcome Trust Cambridge Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Ongoing
In plain English
AI plain-English summary
A virtual reality headset is being tested to see if it can reliably measure vision loss in people with inherited optic nerve disorders, where standard eye tests often fail. This matters because inherited optic neuropathies like Leber’s hereditary optic neuropathy and dominant optic atrophy cause central vision loss, and the standard visual field test—which requires patients to stare at a fixed central point—becomes unreliable when that very point is blind. The VR device, called VisuALL, uses eye-tracking technology to follow where the patient is actually looking, rather than assuming they are fixating correctly. This could solve a long-standing measurement problem that has hampered clinical trials for gene therapies targeting these conditions. If the device proves feasible and reliable in this study of 20 patients, it could become a standard outcome measure in future gene therapy trials for inherited optic neuropathies. That would give researchers a more accurate way to detect whether a treatment is working, potentially speeding up the development of the first effective therapies for these currently untreatable diseases.
View original technical description
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.
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