跳至主要内容
临床试验/NCT06043622
NCT06043622招募中不适用

Normative Database of Healthy Subject Vascular Density Using Spectralis Heidelberg® Optical Coherence Tomography Angiography

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
choriocapillaris density in macular zone

研究概览

简要总结

Optical coherence tomography angiography (OCT-A) is a determinant progress to study retinal and choroidal vasculature without using a dye injection. OCT-A yields interesting results in different pathologies such as diabetes mellitus, age-related macular degeneration, hypertension blood pressure, particularly by affecting vascular density. Normative database are necessary to compare OCT-A parameters between patients and controls. However, OCT-A devices from different manufactures may give different values for the same subject. It seems to be obvious that each OCT-A device should have its own normative database. In the literature, OCT-A normative databases are developing using different types of devices, but none is available for Heidelberg OCT-A in Caucasians. The purpose of this project is to create a normative database of retinal microvascularisation using Spectralis Heidelberg optical coherence tomography angiography (OCT-A) ® in normal controls.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Voluntary adult subjects or legal representative consenting for minor or subjects under protection
  • Intra ocular pression ≤ 21mmHg
  • Spherical refraction comprised between - 6 D and +6 D and/or axial length between 21 and 26mm
  • Patient affiliated to social security system

排除标准

  • Ocular diseases: glaucoma, retinal diseases as diabetic retinopathy, age-related macular degeneration, amblyopia, optic neuropathy
  • Diabetes mellitus
  • Uncontrolled hypertension blood pressure (> 140/90)
  • Recent ocular surgery (< 6 months)
  • Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity ...)
  • OCT-A sufficient quality ≥ 25 (0 = bad quality /40 = excellent quality
  • Not consenting patient
  • Pathological situation or handicap avoiding good installation

结局指标

主要结局

choriocapillaris density in macular zone

时间窗: one day

choriocapillaris density in macular zone

vascular density of deep capillary plexus measurement

时间窗: one day

vascular density of deep capillary plexus measurement

vascular density of superficial capillary plexus measurement

时间窗: one day

vascular density of superficial capillary plexus measurement

choriocapillaris density in peripapillary zone

时间窗: one day

choriocapillaris density in peripapillary zone

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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