NCT02431091已完成不适用
Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder
Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
研究概览
简要总结
The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •Antiretroviral treatment
- •Undetectable plasmatic HIV viral load (viral load<50 copies/ml) for at least 6 months
- •Ability to understand and give approved consent
排除标准
- •Any present or past ophthalmologic illness that may impair OCT results
- •Previous cerebral infection with sequel
- •Previous cerebrovascular disease with sequel
- •Severe psychiatric illness
- •Active alcohol or drug abuse
- •Active chronic hepatitis C
- •Inability to perform french cognitive assessment
- •Inability to perform a MRI
- •Inability to perform a lumbar puncture
结局指标
主要结局
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
时间窗: Baseline
次要结局
- Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation(Baseline)
- Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)(Baseline)
研究者
Agnès Libois
Chef de Clinique
Centre Hospitalier Universitaire Saint Pierre
研究点 (2)
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