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

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05952466
• Other study ID #: GuangzhouFPH1
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: Guangzhou First People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Infections

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Macular and peripapillary retinal thickness	Macular fovea and peripheral retinal thickness, retinal thickness around the optic nerve	3 minutes
Secondary	Fundus lesions	Such as fundus hemorrhage, exudation, vascular tortuous expansion, etc.	2 minutes
Secondary	Vascular distribution shape in macular area	The measurement parameters of the foveal avascular zone include area, perimeter and non-circular index	2 minutes