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

NCT07046507 | Completed

• 1 other identifier: 333382
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Wilson Disease

Keywords

kayser fleischer rings

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  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.

  Baseline examination

Secondary Outcomes (3)

• 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

Study Arms (2)

Use of a fixed anterior segment OCT device to detect Kayser Fleischer ring

ACTIVE COMPARATOR

Diagnostic Test: Diagnostic procedures

Use of a handheld anterior segment OCT device to detect Kayser Fleischer rings

ACTIVE COMPARATOR

Diagnostic Test: Diagnostic procedures

Interventions

Diagnostic procedures DIAGNOSTIC_TEST

Diagnostic ability of optical coherence tomography in kayser fleischer rings

Use of a fixed anterior segment OCT device to detect Kayser Fleischer ring; Use of a handheld anterior segment OCT device to detect Kayser Fleischer rings

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Wilson patients with Kayser Fleischer rings on slit lamp examination and 5 patients without Kayser Fleischer rings on slit lamp examination

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Royal Surrey Country Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Hepatolenticular Degeneration

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors blinded to patient groups
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-inferiority exploratory study

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 1, 2025
• Study Start: August 2, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 1, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)