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

NCT ID: NCT05952466

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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

Conditions

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COVID-19 Pandemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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COVID-19 infection group

School-age children infected recently with COVID-19

No interventions assigned to this group

control group

School-age children without COVID-19

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuehong Zhang

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuehong Zhang

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First People's Hospital, Guangzhou, Guangdong China

Locations

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Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GuangzhouFPH1

Identifier Type: -

Identifier Source: org_study_id

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