Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-27 @ 10:21 PM
Study NCT ID:
NCT05835193
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-symptomatic Screening of Visual Acuity in Pre-school Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D015354', 'term': 'Vision, Low'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1098}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best spectacle-corrected distance visual acuity', 'timeFrame': '1 week', 'description': 'Visual acuity of each eye using spectacle correction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kindergarten', 'distance visual acuity', 'pre-school students', 'reading capacity'], 'conditions': ['Visual Acuity', 'Refractive Errors', 'Low Vision', 'Vision Disorders']}, 'descriptionModule': {'briefSummary': 'The present research process is a prospective, non-interventional clinical study that will be conducted -under the auspices of the Democritus University of Thrace (DUTH)- in the pre-school students of the city of Alexandroupolis, Greece.\n\n* The study aims to assess the visual acuity of the kindergarten students.\n* The measurement of monocular best-spectacle corrected visual acuity will be performed using a web-based visual acuity chart', 'detailedDescription': "Study protocol will adhere to the tenets of the Declaration of Helsinki and written informed consent will be obtained by the legal guardians of all participants.\n\nThe measurement of the visual acuity (monocular and binocular) will be performed using DDART, a digital visual acuity tool that has been developed and validated by the Democritus University of Thrace and is also an approved Category 1 Medical Device by the country's National Organization for Medicines, via a web-based digital chart in a high-resolution screen. The same environmental lighting conditions and the same screen brightness will be applied. The examination will be performed at the same predetermined viewing distance.\n\nFinally, according to each participant's visual acuity, appropriate instructions will be given for further examinations directly to the legal guardians in order to comply with the GDPR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pre-school students aged 5-7 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-school students aged 5-7 years old.\n\nExclusion Criteria:\n\n* Age \\>7 years old\n* Students with health conditions that do not allow the evaluation of the visual acuity .'}, 'identificationModule': {'nctId': 'NCT05835193', 'briefTitle': 'Pre-symptomatic Screening of Visual Acuity in Pre-school Students', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Visual Acuity Assessment in Pre-school Students.', 'orgStudyIdInfo': {'id': 'DUTH/EHDE2/20-10-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Pre-school students in Alexandroupolis, Greece', 'interventionNames': ['Other: Diagnostic Test: Distance Visual Acuity Examination']}], 'interventions': [{'name': 'Diagnostic Test: Distance Visual Acuity Examination', 'type': 'OTHER', 'description': 'Best spectacle-corrected distance visual acuity and reading capacity of pre-school students in Alexandroupolis, Greece will be examined via a web-based digital visual acuity chart', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'Democritus University of Thrace', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}], 'overallOfficials': [{'name': 'Georgios Labiris, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Democritus University of Thrace'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (Associate) of Democritus University of Thrace', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}