Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 12:19 PM
Study NCT ID:
NCT06355128
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire data were collected and statistically analyzed.', 'timeFrame': '1/4/2024-30/4/2024', 'description': "Information on demographic characteristics, COVID-19 pathogen test results, Covid-19 related systemic symptoms, ocular symptoms and eye discomfort medication was collected from questionnaires during the pandemic period (Phase A: December 7, 2022 to January 6, 2023, 1968 patients). Electronic medical records in the ophthalmic outpatient department of Zhongnan Hospital of Wuhan University and its medical union hospital- Qichun County People's Hospital were extracted during the pandemic period (Phase A) and the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). The demographic, epidemiological, and clinical information of patients were compared."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022', 'detailedDescription': 'During late 2022 COVID-19 pandemic ocular discomforts were common in people with mild systemic symptoms, but most resolve on their own without any treatment. The disease spectrum of ophthalmology outpatient clinics is affected by the COVID-19 pandemic. In our study, we observed that the incidence of keratitis and acute angle-closure glaucoma in Phase A was significantly higher than that in Phase B and C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People from Hubei Province, China', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. 2022.12.7 to 2023.2.6 People surveyed by wechat Questionnaire Star 2. 2021.12.7 to 2022.1.6 and 2022.11.7 to 2023.1.6 Patients who received ophthalmology treatment in Zhongnan Hospital of Wuhan University and Qichun People's Hospital\n\nExclusion Criteria:\n\n* 1\\. currently hospitalized patients. 2. severe patients. 3. Incomplete information. 4. cannot be contacted by telephone. 5. Refuse questionnaire survey. 6.The electronic medical record information is incomplete. 7. Those who do not go to the ophthalmic clinic after registration. 8.severe patients. 9. Cannot be contacted by phone."}, 'identificationModule': {'nctId': 'NCT06355128', 'briefTitle': 'A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province', 'orgStudyIdInfo': {'id': '20240307'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the pandemic period (Phase A)', 'description': 'the pandemic period (Phase A)', 'interventionNames': ['Other: NOT']}, {'label': 'the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 ).', 'description': 'the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022).', 'interventionNames': ['Other: NOT']}, {'label': 'the prevention and control periods (Phase C: December 7, 2021 to January 6, 2022).', 'description': 'the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022).', 'interventionNames': ['Other: NOT']}], 'interventions': [{'name': 'NOT', 'type': 'OTHER', 'description': 'NOT', 'armGroupLabels': ['the pandemic period (Phase A)', 'the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 ).', 'the prevention and control periods (Phase C: December 7, 2021 to January 6, 2022).']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Qichun People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Ophthalmology', 'investigatorFullName': 'Min Ke', 'investigatorAffiliation': 'Zhongnan Hospital'}}}}