Developing a Handheld Anterior Segment Optical Coherence Tomography Device to Assess Kayser Fleischer Rings in Wilson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Primary outcome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessors blinded to patient groups
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Use of a fixed anterior segment OCT device to detect Kayser Fleischer ring
Intervention: Diagnostic procedures (Diagnostic Test)
Use of a handheld anterior segment OCT device to detect Kayser Fleischer rings
Intervention: Diagnostic procedures (Diagnostic Test)
Outcomes
Primary Outcomes
Primary outcome
Time Frame: 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 Outcomes
- Measurement of the amount of copper in the eye(Baseline examination)
- Is a handheld OCT device non inferior to a fixed OCT device(Baseline examination)
- Can this test detect Kayser Fleischer rings before current standard of care testing(Baseline examination)
Investigators
Aftab Ala
Principal Investigator
Royal Surrey County Hospital NHS Foundation Trust