The exploratory handheld OCT Study in Wilson’s disease V1.2
Research type
Research Study
Full title
Developing a handheld anterior segment optical coherence tomography device to assess Kayser Fleischer rings in Wilson’s disease
IRAS ID
333382
Contact name
Aftab Ala
Contact email
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Wilson's disease (WD) is a genetic condition affecting 1 in 30,000 which leads to excess copper in the body which appears to be more common than previously thought. Kayser Fleischer rings (KFR) are a key eye feature of Wilson’s disease and forms important criteria in the validated Leipzig diagnostic scoring system. Currently diagnosis relies on examination by an eye specialist with special equipment for detecting it, called a slit lamp which is a strain on NHS resources and delays diagnosis.
Studies have shown that copper is deposited in the front of the eye, varies over time with treatment (shown by resolution with appropriate treatment) and it can be detected using optimal coherence tomography (OCT). The technique when compared to slit lamp was as good as detecting KFR and even detected KFR before a slit lamp was able to do so . OCT is a technology already in use in most high street optometrists, however this is in the form of a fixed device.
OCT can therefore be used to diagnose KFR and importantly recently the technology has become available as a handheld device. This opens the possibility for it to be used as a point of care test that could be operated with potential minimal training.
We wish to conduct exploratory work to assess whether handheld anterior segment optical coherence tomography can be used to diagnose kayser fleischer rings in a non-inferior way to the current gold standard test (slit lamp examination).REC name
South West - Central Bristol Research Ethics Committee
REC reference
24/SW/0014
Date of REC Opinion
1 Feb 2024
REC opinion
Favourable Opinion