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

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ClinicalTrials.gov Identifier: NCT05952466
Recruitment Status : Completed
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
Yuehong Zhang, Guangzhou First People's Hospital

Study Description
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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.

Condition or disease
COVID-19 Pandemic

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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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
Actual Study Start Date : February 1, 2023
Actual Primary Completion Date : March 31, 2023
Actual Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
COVID-19 infection group
School-age children infected recently with COVID-19
control group
School-age children without COVID-19


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952466


Locations
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China, Guangdong
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Yuehong Zhang Guangzhou First People's Hospital, Guangzhou, Guangdong China
More Information
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Responsible Party: Yuehong Zhang, Dr., Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT05952466    
Other Study ID Numbers: GuangzhouFPH1
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuehong Zhang, Guangzhou First People's Hospital:
COVID-19 infection
retinal microvascular involvement
choroidal thickness
school-age children
Additional relevant MeSH terms:
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Infections
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases