Developing a Handheld Anterior Segment Optical Coherence Tomography Device to Assess Kayser Fleischer Rings in Wilson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors blinded to patient groups
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wilson patients with Kayser Fleischer rings on slit lamp examination and 5 patients without Kayser Fleischer rings on slit lamp examination
排除标准
- •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.
研究组 & 干预措施
Use of a fixed anterior segment OCT device to detect Kayser Fleischer ring
干预措施: Diagnostic procedures (Diagnostic Test)
Use of a handheld anterior segment OCT device to detect Kayser Fleischer rings
干预措施: Diagnostic procedures (Diagnostic Test)
结局指标
主要结局
Primary outcome
时间窗: 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.
次要结局
- 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)
研究者
Aftab Ala
Principal Investigator
Royal Surrey County Hospital NHS Foundation Trust