Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 8
- 主要终点
- Visual acuity
研究概览
简要总结
The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).
Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.
The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.
Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with genetically confirmed diagnosis of LHON
排除标准
- 未提供
结局指标
主要结局
Visual acuity
时间窗: average 0 to 10 years (retrospective)
The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).
次要结局
未报告次要终点