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Completed

NCT Number: NCT05952466

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

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.

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Key information

Conditions

COVID-19 Pandemic COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Macular and peripapillary blood perfusion density

    Time frame: 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.

  2. Macular and peripapillary retinal thickness

    Time frame: 3 minutes

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

Secondary outcomes

  1. Fundus lesions

    Time frame: 2 minutes

    Such as fundus hemorrhage, exudation, vascular tortuous expansion, etc.

  2. Vascular distribution shape in macular area

    Time frame: 2 minutes

    The measurement parameters of the foveal avascular zone include area, perimeter and non-circular index

Sponsors and collaborators

Lead sponsor

Guangzhou First People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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