Microvascular Ocular Changes of Systemic Lupus Erythematous
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement of choroidal vascular index
研究概览
简要总结
The goal of this observational study is to to assess the ocular microvascular status of SLE patients with inactive disease and without ocular involvement. The main questions it aims to answer are:
- the choroidal vascular status and thickness in SLE
- the retinal macular microvascular status and structure in SLE
Participants will be assessed with Spectral Domain Optical Coherence Tomography (SD-OCT). Researchers will compare SLE patients with healthy controls matched for age and sex.
详细描述
The investigators will perform a cross-sectional evaluation of 25 SLE patients and 25 healthy controls matched for sex and age, using a Spectral Domain Optical Coherence Tomography (SD-OCT) with Enhanced Depth Imaging for choroidal assessment and with Angiography module to assess the retinal and choriocapillaris vasculature. Processing of image with external software will be performed to calculate the main outcomes: retinal vessel density, foveal avascular zone parameters and the choroidal vascular index.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Measurement of choroidal vascular index
时间窗: 6 months
Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging
Measurement of retinal vessel density
时间窗: 6 months
Comparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography.
次要结局
未报告次要终点