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临床试验/NCT04912622
NCT04912622已完成不适用

Cross Sectional Study: in Vivo Morphometric Characterisation of Human Retinal Pigment Epithelium With Transscleral Optical Phase Imaging in Photoreceptor/ Retinal Pigment Epithelium/ Bruch's Membrane/ Choriocapillaris Complex Disorders

Luzerner Kantonsspital1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年5月19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
210
试验地点
1
主要终点
RPE morphology

研究概览

简要总结

Accumulating evidence suggest that the functional unit of photoreceptor/ retinal pigment epithelium (RPE)/Bruch's membrane/choriocapillaris plays a key role in pathophysiologic processes of a wide range of medical retinal disorders of the eye. Little is known about in vivo morphometric characteristics of human RPE cells as in vivo observation of these cells was so far technically challenging and hence nearly impossible to implement in a clinical setting. Transscleral optical phase imaging is a novel in-vivo microscopy technique allowing human RPE imaging on a cellular level with the potential of clinical application in a multimodal retinal imaging approach for diagnostic purpose in medical retina patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Patients with a medical retinal disease involving the retinal pigment epithelium (age related macular degeneration, diabetic retinopathy, retinal vascular occlusive disease, central serous chorioretinopathy, tapetoretinal degeneration)
  • Participants with healthy eyes for the control group

排除标准

  • Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
  • Aged < 18 years.
  • Pregnancy

结局指标

主要结局

RPE morphology

时间窗: 12 months

RPE cell density (number of cells per mm\^2)

次要结局

  • averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless](12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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