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

Completed

• Conditions: COVID-19 Pandemic

• Registration Number: NCT05952466
• Lead Sponsor: Guangzhou First People's Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Macular and peripapillary blood perfusion density	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	3 minutes	Macular fovea and peripheral retinal thickness, retinal thickness around the optic nerve

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China