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临床试验/NCT02003989
NCT02003989已完成不适用

Revealing Increased Axonal Loss in Treated HIV Patients

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients

研究概览

简要总结

HIV patients may suffer sooner from aging than average population, including brain aging. Our hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in HIV patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer (RNFL), compared to non HIV patients of the same age.

详细描述

The investigators aim to compare the thickness of the RNFL and the thickness of the RCGs measured by spectral domain OCT between patients infected by HIV and patients of same age non infected by HIV.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infection known since at least 10 years
  • viral load undetectable under ARV treatment since at least 5 years, whatever the type of ARV
  • lymphocytes CD4 > 350, whatever the CD4 nadir
  • signed informed consent

排除标准

  • History of ocular pathology, eye surgery, or intraocular injection
  • Familial History of glaucoma
  • ametropia (>3 dioptres on the sphere and >1,5 dioptres on the cylinder)
  • known neurological pathology, active or former
  • History of ethambutol or synthetic antimalarial drug consumption
  • History of chemotherapy
  • Active and regular use of drugs
  • non-weaned chronic alcoholism
  • contra indication to MRI
  • cognitive disorders (MoCA<26)
  • non covered by health insurance
  • patient under legal protection
  • pregnant or breast-feeding woman
  • Non inclusion criteria for control patients: known HIV infection

结局指标

主要结局

thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients

时间窗: one day of examinations

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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