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临床试验/NCT05952466
NCT05952466已完成不适用

Optical Coherence Tomography Angiography Evaluation of Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China

Guangzhou First People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Macular and peripapillary blood perfusion density

研究概览

简要总结

We designed this study to examine whether COVID-19 infection could lead to retinal and choroidal microvascular involvement in school-age children (6-18 years) in a pandemic peak in China.

详细描述

This is an observational case-control study. One hundred school-age children who visited the Department of Ophthalmology at Guangzhou First People's Hospital in China from February 1, 2023 to March 31, 2023 were included in this study. Eighty children with COVID-19 infection were included in the case group. Controls without COVID-19 infection were matched to COVID-19 infection cases by a ratio of 1:4 using frequency matching on age and gender. The primary end point of this study is the retinal and choroidal microvascular changes in school-age children during the COVID-19 pandemic. Secondary endpoint is the

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Totally 100 school-age children (6-18 years) were enrolled in this study. All subjects had visited the ophthalmology clinic for routine ocular examinations. Refraction after ciliary muscle paralysis, myopia ≥ -6.0 spherical diopter, astigmatism ≤ 2.5 cylindrical diopter.

排除标准

  • The child or guardian did not agree to participate in the study.
  • Children could cooperate to complete the ocular examination.
  • The child had previous diseases affecting visual function and fundus, except for the diagnosis of refractive error.

结局指标

主要结局

Macular and peripapillary blood perfusion density

时间窗: 5 minutes

The blood flow density represents the proportion of the blood flow signal area in the scanning area to the overall area, expressed in units of mm-1, which can show the blood vessel perfusion and circulation.

Macular and peripapillary retinal thickness

时间窗: 3 minutes

Macular fovea and peripheral retinal thickness, retinal thickness around the optic nerve

次要结局

  • Fundus lesions(2 minutes)
  • Vascular distribution shape in macular area(2 minutes)

研究者

发起方
Guangzhou First People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuehong Zhang

Dr.

Guangzhou First People's Hospital

研究点 (1)

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