Keratoconus - Screening in Patients With Downs Syndrome
The initial purpose of the study is to determine the true tomographic based age-specific prevalence of keratoconus among Danish patients with Downs Syndrome.
If, as expected, the prevalence is sizeable, the next step is to determine the optimal age for screening - considering both sensitivity and specificity as well as the need for early diagnosis in order to preserve a good visual acuity with glasses.
Lastly, the overall purpose based on the finding in the study is to evaluate if a tomographic screening program for keratoconus among patients with Downs syndrome is beneficial in Denmark.
In addition, a sub-study will further have the purpose to investigate whether patients with Downs syndrome are using optimal correction. With the purpose of generating knowledge about refraction of this specific patient group - independent of whether they are diagnosed with keratoconus or not.
The study will invite all persons with a genetic test either prenatal or postnatal showing trisomi 21 / Downs syndrom in Denmark and between the age og 10 and 20 years of age.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Aarhus、丹麦、8200
- Aarhus University Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- genetic diagnosis of trisomi 21 / downs syndrome
Exclusion Criteria:
- inability to have cornea tomography performed
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Persons with Trisomi 21 / Downs syndrom, 10-20 years of age
The group is identified based on genetic testing either prenatal or postnatal
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Corneal tomography
大体时间:Baseline, single time point when the study participants are included in the study
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Corneal tomography to determine if the participant has keratoconus or not
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Baseline, single time point when the study participants are included in the study
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合作者和调查者
调查人员
- 首席研究员:Sashia Bennett, MD, PhD、University of Aarhus
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.