Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 11:04 PM
Study NCT ID:
NCT05952466
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular and peripapillary blood perfusion density', 'timeFrame': '5 minutes', 'description': '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.'}, {'measure': 'Macular and peripapillary retinal thickness', 'timeFrame': '3 minutes', 'description': 'Macular fovea and peripheral retinal thickness, retinal thickness around the optic nerve'}], 'secondaryOutcomes': [{'measure': 'Fundus lesions', 'timeFrame': '2 minutes', 'description': 'Such as fundus hemorrhage, exudation, vascular tortuous expansion, etc.'}, {'measure': 'Vascular distribution shape in macular area', 'timeFrame': '2 minutes', 'description': 'The measurement parameters of the foveal avascular zone include area, perimeter and non-circular index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 infection', 'retinal microvascular involvement', 'choroidal thickness', 'school-age children'], 'conditions': ['COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTotally 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.\n\nExclusion Criteria:\n\n1. The child or guardian did not agree to participate in the study.\n2. Children could cooperate to complete the ocular examination.\n3. The child had previous diseases affecting visual function and fundus, except for the diagnosis of refractive error.'}, 'identificationModule': {'nctId': 'NCT05952466', 'briefTitle': 'Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou First People's Hospital"}, 'officialTitle': 'Optical Coherence Tomography Angiography Evaluation of Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China', 'orgStudyIdInfo': {'id': 'GuangzhouFPH1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 infection group', 'description': 'School-age children infected recently with COVID-19'}, {'label': 'control group', 'description': 'School-age children without COVID-19'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yuehong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangzhou First People's Hospital, Guangzhou, Guangdong China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Yuehong Zhang', 'investigatorAffiliation': "Guangzhou First People's Hospital"}}}}