Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
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.
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
- 4 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IRDs whose mutations have been identified
- •4~70 years old
- •Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG
排除标准
- •Has participated in other interventional treatment studies;
- •Patients with severe systemic diseases, mental dysplasia, mental illness;
- •Unable to accept eye examination patients;
- •Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis
- •At the initial visit, the patient's binocular vision is displayed as no light.
- •Both eyes have a history of internal eye surgery
结局指标
主要结局
Visual acuity
时间窗: 60 months
A typical Snellen chart that if frequently used for visual acuity testing
次要结局
未报告次要终点
研究者
Xiaodong Sun
Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine