Clinical trial NCT05952466: Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Keywords: COVID-19 infection
retinal microvascular involvement
choroidal thickness
school-age children
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Totally 100 school-age children (6-18 years) were enrolled in this study. All subjects had visited the ophthalmology clinic for routine ocular examinations.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 following age subgroups were used for matching: 6-10, 10-14 and 15-18 years. A list of numbers computer-generated by a research member (Xu Zhang) was used to match the controls. The collected data included demographic and clinical data, as well as retinal and choroidal microvascular parameters.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Macular and peripapillary blood perfusion density
timeFrame: 5 minutes
measure: Macular and peripapillary retinal thickness
timeFrame: 3 minutes
Secondary outcomes:
measure: Fundus lesions
timeFrame: 2 minutes
measure: Vascular distribution shape in macular area
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital, Guangzhou, Guangdong China
name: Yuehong Zhang
role: PRINCIPAL_INVESTIGATOR
References: