Wilson Disease
Conditions
Keywords
kayser fleischer rings
Brief summary
This is an exploratory study using anterior segment optical coherence tomography (OCT) devices to measure copper in the eye. The investigators hope to use this to diagnosis kayser flesicher rings, an important diagnostic criteria in Wilson's disease.
Interventions
DIAGNOSTIC_TESTDiagnostic procedures
Diagnostic ability of optical coherence tomography in kayser fleischer rings
Sponsors
University Hospitals, Leicester
Royal Surrey County Hospital NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors blinded to patient groups
Intervention model description
Non-inferiority exploratory study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Wilson patients with Kayser Fleischer rings on slit lamp examination and 5 patients without Kayser Fleischer rings on slit lamp examination
Exclusion criteria
* Those who do not have a confirmed diagnosis of Wilson's disease and no previous formal slit lamp examination will be excluded from recruitment. * The investigators will also exclude those patients with known corneal disease, history of intraocular disease, haematological disease, pregnancy, and use of topical or intraocular medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | Baseline examination | Can handheld anterior segment optical coherence tomography (OCT) imaging be used as a reliable and practical methodology in the diagnosis/detection of kayser fleischer rings (KFR) in a non-inferior way compared with slit lamp examination and fixed optical coherence tomography. KFR can be visualised on OCT images in a similar way as they are seem on slit lamp examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the amount of copper in the eye | Baseline examination | Using OCT images, can we determine an objective value for the amount of copper present in the eye. There are no current methods to determine this value as this is exploratory work. |
| Is a handheld OCT device non inferior to a fixed OCT device | Baseline examination | The investigators will compare whether a handheld OCT device can produce images which are non inferior to a fixed OCT device and able to show the presence of Kayser Fleischer rings. |
| Can this test detect Kayser Fleischer rings before current standard of care testing | Baseline examination | Slit lamp examination is the current accepted test for detecting Kayser Fleischer rings in the eye. This can be a subjective examination dependent on operator ability. The investigators will assess whether OCT images can detect Kayser Fleischer rings before they are visible on a slit lamp examination. |
Countries
United Kingdom
Outcome results
None listed