Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-22 @ 12:58 AM
Study NCT ID:
NCT02678468
Status:
UNKNOWN
Last Update Posted:
2017-08-16
First Post:
2016-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Vision Screening in High-risk Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-12', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive predictive value of vision screening', 'timeFrame': 'one year', 'description': 'positive predictive value'}], 'secondaryOutcomes': [{'measure': 'Odds ratio of having amblyopia risk factors', 'timeFrame': 'one year', 'description': 'Odds ratio'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Amblyopia', 'Child']}, 'referencesModule': {'references': [{'pmid': '23791414', 'type': 'BACKGROUND', 'citation': 'Bloomberg JD, Suh DW. The accuracy of the plusoptiX A08 photoscreener in detecting risk factors for amblyopia in central Iowa. J AAPOS. 2013 Jun;17(3):301-4. doi: 10.1016/j.jaapos.2013.03.014.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of early vision screening with automated photorefraction device in high risk children', 'detailedDescription': 'Pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. This project is a cross-sectional controlled study. Our study includes high-risk group and normal group. High-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in FEMH. Normal group enrolled age-matched children without those risk factors. Vision screening by FDA-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children born and regular followed at pediatric clinic in Far Eastern Memorial Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay\n* Normal group: children with normal birth history and normal development\n\nExclusion Criteria:\n\n* Children with known ophthalmic diseases\n* Children with congenital systemic diseases'}, 'identificationModule': {'nctId': 'NCT02678468', 'briefTitle': 'Early Vision Screening in High-risk Children', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Early Vision Screening With Automated Photorefraction in Pre-term, Low-birth- Weight and Development-delay Children in Far-Eastern Memorial Hospital, Taiwan', 'orgStudyIdInfo': {'id': '104077-F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high-risk group', 'description': 'children with birth history of pre-term, low birth weight children with develop delay'}, {'label': 'normal group', 'description': 'children with normal birth history and normal development'}]}, 'contactsLocationsModule': {'locations': [{'zip': '235', 'city': 'New Taipei City', 'state': 'Other', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yao-Lin Liu', 'role': 'CONTACT', 'email': 'liuyaolin.tw@gmail.com', 'phone': '918255820'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Yao-Lin Liu, M.D.', 'role': 'CONTACT', 'email': 'liuyaolin.tw@gmail.com', 'phone': '886-289667000', 'phoneExt': '1349'}], 'overallOfficials': [{'name': 'Yao-Lin Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Yao-Lin Liu', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}