Wilson DiseaseNCT07046507
The Exploratory Handheld Optical Coherence Tomography Study in Wilson's Disease
A study testing Diagnostic procedures in people with Wilson Disease, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wilson Disease
- What is being tested?
- Diagnostic procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wilson patients with Kayser Fleischer rings on slit lamp examination and 5 patients without Kayser Fleischer rings on slit lamp examination
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Handheld Anterior Segment Optical Coherence Tomography Device to Assess Kayser Fleischer Rings 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.
- Conditions
- Wilson Disease
- Being tested
- Diagnostic procedures
- Keywords
- kayser fleischer rings
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresDiagnostic test
Diagnostic ability of optical coherence tomography in kayser fleischer rings
| Study group | Role | What they receive |
|---|---|---|
| Use of a fixed anterior segment OCT device to detect Kayser Fleischer ring | Active comparator | Not described Receives: Diagnostic Test: Diagnostic procedures |
| Use of a handheld anterior segment OCT device to detect Kayser Fleischer rings | Active comparator | Not described Receives: Diagnostic Test: Diagnostic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline examination
Secondary outcomes (3)
Measurement of the amount of copper in the eye
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.
Measured: Baseline examination
Is a handheld OCT device non inferior to a fixed OCT device
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.
Measured: Baseline examination
Can this test detect Kayser Fleischer rings before current standard of care testing
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.
Measured: Baseline examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start2 Aug 2024
- Primary completion31 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority exploratory study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Principal investigator, Aftab Ala, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046507
- Sponsor's protocol ID
- 333382
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not appropriate
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Handheld Anterior Segment Optical Coherence Tomography Device to Assess Kayser Fleischer Rings in Wilson's Disease
- ClinicalTrials.gov ID
- NCT07046507
- Acronym / sponsor ID
- 333382
- Conditions
- Wilson Disease
- Keywords
- kayser fleischer rings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority exploratory study
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Wilson patients with Kayser Fleischer rings on slit lamp examination and 5 patients without Kayser Fleischer rings on slit lamp examination
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic proceduresDiagnostic ability of optical coherence tomography in kayser fleischer rings | Diagnostic test | 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 |
Primary outcome
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.
3 secondary outcomes
Measurement of the amount of copper in the eye
Time frame: Baseline examination
Is a handheld OCT device non inferior to a fixed OCT device
Time frame: Baseline examination
Can this test detect Kayser Fleischer rings before current standard of care testing
Time frame: Baseline examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. Not appropriate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic procedures in people with Wilson Disease, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Baseline examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.