Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 1, 2018 | ||
| 最后更新发布日期 | October 1, 2018 | ||
| 预计研究开始日期 ICMJE | June 1, 2018 | ||
| 预计主要完成日期 | May 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Visual acuity[ Time Frame: 60 months ] A typical Snellen chart that if frequently used for visual acuity testing |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies | ||
| 正式标题 ICMJE | Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies | ||
| 简要概况 | Based on a clinical multi-center study of the natural course of inherited retinal dystrophies in Chinese population, screening fundus imaging indicators for patients with Chinese inherited retinal dystrophies, describing the clinical features of Chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - Follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in China. The research will further improve and enrich the genotype, phenotypic characteristics and natural course of Chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. It is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment. |
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| 详细说明 | |||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
500 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | May 30, 2023 | ||
| 预计主要完成日期 | May 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Patients with IRDs whose mutations have been identified 2. 4~70 years old 3. Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG Exclusion Criteria: 1. Has participated in other interventional treatment studies; 2. Patients with severe systemic diseases, mental dysplasia, mental illness; 3. Unable to accept eye examination patients; 4. Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis 5. At the initial visit, the patient's binocular vision is displayed as no light. 6. Both eyes have a history of internal eye surgery | ||
| 性别 |
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| 年龄 | 最小年龄：4 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Xiaodong Sun，Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
| 研究赞助商 ICMJE | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
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| 研究员 ICMJE |
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| PRS 账户 | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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