Retinal Vascular Changes in Patients After Coronavirus Disease 2019 (COVID-19) Based on Retinal Oximetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Successful performing of retinal oximetry images in 90% of enrolled patients.
研究概览
简要总结
The study examines changes in retinal oximetry in patients after COVID-19 disease. It aims to analyze and quantify possible retinal microvascular abnormalities that may result from possible post-inflammatory damage to the endothelium of the vessels associated with COVID-19 disease. Retinal vascular involvement may indicate similar changes in the vascular system in other organs.
详细描述
The retinal blood vessels are the only blood vessels in the body that can be observed directly. Patients with COVID-19 pneumonia have been shown to have reduced macular vessel density in the foveal region. As a result, some layers of the retina atrophy, reducing oxygen consumption by the retina. Based on this, it is expected that patients after COVID-19 pneumonia, or after a more severe course of the disease, will have normal arterial retinal oxygen saturation but higher venous retinal oxygen saturation and lower arterio-venous difference than patients after mild disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •age over 18 years
- •history of laboratory-confirmed SARS-CoV2-infection
- •transparent ocular media allowing for fundus photography
- •signed informed consent
排除标准
- •known eye disease that has been shown to affect retinal oxygen saturation (diabetic retinopathy, vascular occlusions, use of antiglaucoma drugs)
- •any other serious eye disease (advanced or decompensated glaucoma, retinitis pigmentosa, age-related macular degeneration, ocular tumors)
- •reduced transparency of the ocular media limiting the visualization of the ocular background and preventing a good quality image from being taken (severe dry eye syndrome, corneal scarring, cataract, significant vitreous haze, vitreous hemorrhage)
- •significant refractive error not allowing for sharpening of imaging examinations
- •previous intraocular surgery except cataract surgery if performed more than 3 months before the examination
- •previous intravitreal application of anti-vascular endothelial growth factor therapy or laser photocoagulation of the retina
- •previous severe eye injury
- •acute eye infection
- •known systemic disease affecting retinal oxygen saturation or causing changes in the ocular background (chronic obstructive pulmonary disease, multiple myeloma, malignant hypertension, hyperglobulinemia)
- •pregnancy, breastfeeding
结局指标
主要结局
Successful performing of retinal oximetry images in 90% of enrolled patients.
时间窗: 3 months
90% of captured fundus images of retinal oximetry are useful for subsequent analysis.
Successful analysis of retinal oxygen saturation in 90% of enrolled patients.
时间窗: 3 months
The parameters analyzed by retinal oximetry are arterial retinal oxygen saturation (%), venous retinal oxygen saturation (%), arterio-venous difference (%), arteriolar and venular diameter (µm).
次要结局
- Successful analysis of optical coherence tomography in 90% of enrolled patients.(3 months)
- Successful performing of optical coherence tomography and angiography in 90% of enrolled patients.(3 months)
- Successful analysis of optical coherence tomography angiography in 90% of enrolled patients.(3 months)
研究者
Zuzana Schreiberova
Principal Investigator
University Hospital Olomouc