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

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

Tracking Information

• First Submitted Date: July 18, 2023
• First Posted Date: July 19, 2023
• Last Update Posted Date: July 19, 2023
• Actual Study Start Date: February 1, 2023
• Actual Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 18, 2023)

• 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.
• Macular and peripapillary retinal thickness [ Time Frame: 3 minutes ]
  Macular fovea and peripheral retinal thickness, retinal thickness around the optic nerve

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 18, 2023)

• Fundus lesions [ Time Frame: 2 minutes ]
  Such as fundus hemorrhage, exudation, vascular tortuous expansion, etc.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China
• 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
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: COVID-19 Pandemic
• Intervention: Not Provided

Study Groups/Cohorts

• COVID-19 infection group
  School-age children infected recently with COVID-19
• control group
  School-age children without COVID-19

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 18, 2023): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 31, 2023
• Actual Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05952466
• Other Study ID Numbers: GuangzhouFPH1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Yuehong Zhang, Guangzhou First People's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Guangzhou First People's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Guangzhou First People's Hospital
• Verification Date: July 2023