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

NCT05952466 | Completed DMC

• 1 other identifier: GuangzhouFPH1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Keywords

COVID-19 infection; retinal microvascular involvement; choroidal thickness; school-age children

Outcome Measures

Primary Outcomes (2)

• Macular and peripapillary blood perfusion density

  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.

  5 minutes

• Macular and peripapillary retinal thickness

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

  3 minutes

Secondary Outcomes (2)

• Fundus lesions

  2 minutes

• Vascular distribution shape in macular area

  2 minutes

Study Arms (2)

COVID-19 infection group

School-age children infected recently with COVID-19

control group

School-age children without COVID-19

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuehong Zhang

  Guangzhou First People's Hospital, Guangzhou, Guangdong China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 19, 2023
• Study Start: February 1, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

CN (1)