Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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COVID-19 Pandemic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 infection group<br>School-age children infected recently with COVID-19 | |
| control group<br>School-age children without COVID-19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular and peripapillary blood perfusion density | 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. | 5 minutes | 
| Macular and peripapillary retinal thickness | Macular fovea and peripheral retinal thickness, retinal thickness around the optic nerve | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundus lesions | Such as fundus hemorrhage, exudation, vascular tortuous expansion, etc. | 2 minutes | 
| Vascular distribution shape in macular area | The measurement parameters of the foveal avascular zone include area, perimeter and non-circular index | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 infection, retinal microvascular involvement, choroidal thickness, school-age children