An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed With Early-Onset Idiopathic Bilateral Cataracts
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had Positive Genetic Test Results
研究概览
简要总结
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.
详细描述
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of idiopathic bilateral cataracts.
- •Between the ages of 2 to 21 years at the time of diagnosis
排除标准
- •The patient has a diagnosis of cataracts with known etiology other than CTX.
- •The patient has a diagnosis of CTX.
- •The patient has cataracts caused by cataractogenic treatments.
- •The patient has taken or is currently taking cholic acid or chenodeoxycholic acid.
- •The patient has participated in an interventional clinical trial in the past 30 days.
- •The patient and/or their parent/legal guardian, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
结局指标
主要结局
Number of Participants Who Had Positive Genetic Test Results
时间窗: At genetic testing
genetic test results
次要结局
未报告次要终点