Clincosm LogoSign in Get a demo

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

Sponsor
Guangzhou First People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05952466
Collaborator
(none)
100
Enrollment
1
Location
1.9
Actual Duration (Months)
52.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Feb 1, 2023
    Actual Primary Completion Date :
    Mar 31, 2023
    Actual Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    COVID-19 infection group

    School-age children infected recently with COVID-19
    control group

    School-age children without COVID-19

    Outcome Measures

    Primary Outcome Measures

    1. Macular and peripapillary blood perfusion density [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 [3 minutes]

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

    Secondary Outcome Measures

    1. Fundus lesions [2 minutes]

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

    2. Vascular distribution shape in macular area [2 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Guangzhou First People's Hospital Guangzhou Guangdong China

    Sponsors and Collaborators

    • Guangzhou First People's Hospital

    Investigators

    • Principal Investigator: Yuehong Zhang, Guangzhou First People's Hospital, Guangzhou, Guangdong China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuehong Zhang, Dr., Guangzhou First People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05952466
    Other Study ID Numbers:
    • GuangzhouFPH1
    First Posted:
    Jul 19, 2023
    Last Update Posted:
    Jul 19, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yuehong Zhang, Dr., Guangzhou First People's Hospital
    COVID-19 infection
    retinal microvascular involvement
    choroidal thickness
    school-age children
    Additional relevant MeSH terms:
    Infections
    COVID-19

    Study Results

    No Results Posted as of Jul 19, 2023