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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of a fixed anterior segment OCT device to detect Kayser Fleischer ring | Active Comparator |
| |
| Use of a handheld anterior segment OCT device to detect Kayser Fleischer rings | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic procedures | Diagnostic Test | Diagnostic ability of optical coherence tomography in kayser fleischer rings |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline examination |
| Is a handheld OCT device non inferior to a fixed OCT device |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey Country Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D006527 | Hepatolenticular Degeneration |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
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Non-inferiority exploratory study
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Assessors blinded to patient groups
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. |
| 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. | Baseline examination |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008664 | Metal Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |