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Completed

NCT Number: NCT07046507

The Exploratory Handheld Optical Coherence Tomography Study in Wilson's Disease

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.

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Key information

Conditions

Wilson Disease Basal Ganglia Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Hepatolenticular Degeneration Heredodegenerative Disorders, Nervous System Liver Diseases Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Surrey Country Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic procedures

Diagnostic Test

Diagnostic ability of optical coherence tomography in kayser fleischer rings

Primary outcomes

  1. 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

  1. Measurement of the amount of copper in the eye

    Time frame: 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.

  2. Is a handheld OCT device non inferior to a fixed OCT device

    Time frame: 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.

  3. Can this test detect Kayser Fleischer rings before current standard of care testing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

Developing a Handheld Anterior Segment Optical Coherence Tomography Device to Assess Kayser Fleischer Rings in Wilson's Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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