Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-19 @ 2:12 PM
Study NCT ID:
NCT02466932
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2015-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of anterior segment parameters in Full-Term Children by Galilei Dual-Scheimpflug Analyzer', 'timeFrame': '1 day', 'description': 'Corneal parameters, anterior chamber parameters and lens thickness were measured by Galilei Dual-Scheimpflug Analyzer in healthy preschool children.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Birth Weight']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were measured by GD-SA and relationships between all anterior segment parameters obtained by this device and birth weight were analyzed.', 'detailedDescription': 'Preschoolers, who were born heavier, had thicker cornea and lens, longer axial length, and flatter corneal curve. The thicknesses and axial curves of central cornea within 7mm may be particularly associated with BW.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '80 Months', 'minimumAge': '30 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children aged between 3-6- preschoolers- born at term and have birth weight heavier than 2500g', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ages 3- 6 years;\n* birth weight \\>2,500 g;\n* gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) \\>37 weeks;\n* visual acuity \\>0.8 (in decimals);\n* no history of any systemic or ocular diseases;\n* no history of previous ocular surgeries;\n* no retinopathy of prematurity;\n* no current medications; and\n* no retinal or optic disc abnormalities on fundoscopy.\n\nExclusion Criteria:\n\n* ages \\<3 \\>6 years;\n* birth weight \\<2,500 g;\n* gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) \\<37 weeks;\n* visual acuity \\<0.8 (in decimals);\n* history of any systemic or ocular diseases;\n* history of previous ocular surgeries;\n* retinopathy of prematurity;\n* current medications; and\n* retinal or optic disc abnormalities on fundoscopy."}, 'identificationModule': {'nctId': 'NCT02466932', 'briefTitle': 'Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer', 'organization': {'class': 'OTHER', 'fullName': 'Neon Hospital'}, 'officialTitle': 'Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer', 'orgStudyIdInfo': {'id': '2010-171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Birth Weight', 'interventionNames': ['Device: Galilei Dual-Scheimpflug Analyzer']}], 'interventions': [{'name': 'Galilei Dual-Scheimpflug Analyzer', 'type': 'DEVICE', 'description': 'Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer', 'armGroupLabels': ['Birth Weight']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neon Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Volkan YETER', 'investigatorAffiliation': 'Neon Hospital'}}}}