NCT02665858Unknown不适用
OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of RNFLT/TRT Thickness
研究概览
简要总结
Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH.
In this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with suspected IIH
排除标准
- •Retinal disease
- •High refractive error
- •Unable to undergo OCT imaging
结局指标
主要结局
Comparison of RNFLT/TRT Thickness
时间窗: One year
次要结局
未报告次要终点
研究者
研究点 (2)
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