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临床试验/NCT03804216
NCT03804216已完成不适用

Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
vascular density before hemodialysis

研究概览

简要总结

Little knowledge exist on the short and long-term ophthalmological effect of the dialysis. Some studies stated a variation of the thickness subfoveal choroidal before and after a session of dialyse as well as variations of the coat of optical fibers measured in OCT.

The Optical Coherence Tomography angiography OCT is a not invasive imaging technique which is now a part of examinations of investigation in imaging of retina. This technique allows to study the retinal macula vascularization without injection of contrast agent and thus allows to deepen the knowledge in medical domains where the exploration was to limited because of the invasive character of the examinations.

The hypothesis of this project is that hemodynamic change during the hemodialysis may lead fine variations of the retinal vascularization in the short-term (the day of the dialysis) but also in the longer term (over 1 year).

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Indication of treatment by hemodialysis
  • First session of dialysis
  • Hemodialysis planned for 1 minimum year

排除标准

  • particular ophthalmological Histories: vitreo-retinal surgery, strong nearsightedness, chronic glaucoma
  • Unaffiliated in a national insurance scheme

结局指标

主要结局

vascular density before hemodialysis

时间窗: before hemodialysis

Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

vascular density 1 hour after hemodialysis

时间窗: 1 hour after hemodialysis

Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

次要结局

  • vascular density 12 month after dialysis(12 month after dialysis)
  • size of coat retinal optical fibers 1 hour after dialysis(1 hour after dialysis)
  • vascular density 1 hour after dialysis(1 hour after dialysis)
  • size of coat retinal optical fibers 12 month after dialysis(12 month after dialysis)
  • size of coat retinal optical fibers before dialysis(before dialysis)
  • vascular density 1 month after dialysis(1 month after dialysis)
  • vascular density 6 month after dialysis(6 month after dialysis)
  • size of coat retinal optical fibers 1 month after dialysis(1 month after dialysis)
  • size of coat retinal optical fibers 3 month after dialysis(3 month after dialysis)
  • size of coat retinal optical fibers 6 month after dialysis(6 month after dialysis)
  • vascular density 3 month after dialysis(3 month after dialysis)
  • vascular density before dialysis(before dialysis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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