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