NCT02550964Unknown不适用
Incidence and Risk Factor Evaluation for Toxic Maculopathy Associated With Hydroxychloroquine and Chloroquine
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of toxic maculopathy associated with HCQ or CQ
研究概览
简要总结
The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the investigators will screen these patients by baseline examination (Fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who treated with HCQ or CQ due to autoimmune diseases such as RA, SLE
- •Patient who did not previously diagnosed with HCQ/CQ toxic retinopathy
排除标准
- •Aged less than 19 years
结局指标
主要结局
Incidence of toxic maculopathy associated with HCQ or CQ
时间窗: 1 years
次要结局
- Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)(5 years)
- Progression of retinopathy after drug cessation(1 years)
- Risk factor of HCQ/CQ retinopathy(5 years)
研究者
JooYong Lee
Associate Professor
Asan Medical Center
研究点 (1)
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