Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-26 @ 6:30 PM
Study NCT ID:
NCT01758718
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2012-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eyelash Line Resection for Entropion Associated With Down's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D004774', 'term': 'Entropion'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-27', 'studyFirstSubmitDate': '2012-12-27', 'studyFirstSubmitQcDate': '2012-12-27', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grading scale of superficial punctate keratopathy', 'timeFrame': 'one year', 'description': 'The degree of superficial punctate keratopathy was assessed by the area and density classification which was scored with the area of superficial punctate keratopathy graded from A0 through A3, and the density graded from D0 through D3.'}], 'secondaryOutcomes': [{'measure': 'Score of wearing glasses', 'timeFrame': 'one ear', 'description': 'The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Down's syndrome", 'entropion', 'lid plasty'], 'conditions': ["Down's Syndrome"]}, 'referencesModule': {'references': [{'pmid': '24831720', 'type': 'DERIVED', 'citation': "Suzuki Y, Hama Y, Yoshikawa-Kobayashi I, Tomita K, Inoue M, Hirakata A. Eyelash line resection for cilial entropion in patients with Down's syndrome. Br J Ophthalmol. 2014 Oct;98(10):1442-7. doi: 10.1136/bjophthalmol-2014-304946. Epub 2014 May 15."}]}, 'descriptionModule': {'briefSummary': "Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patients with entropion with Down's syndrome\n\nExclusion Criteria:\n\n* The patients of Down's syndrome who do not have entropion."}, 'identificationModule': {'nctId': 'NCT01758718', 'briefTitle': "Eyelash Line Resection for Entropion Associated With Down's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': "Eyelash Line Resection for Entropion Associated With Down's Syndrome", 'orgStudyIdInfo': {'id': 'Kyorineye009'}, 'secondaryIdInfos': [{'id': "Entropion with Down's syndrome"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Entropion with Down's syndrome", 'description': "Eyelash resection surgery was performed for entropion with Down's syndrome", 'interventionNames': ['Procedure: Eyelash line resection']}], 'interventions': [{'name': 'Eyelash line resection', 'type': 'PROCEDURE', 'otherNames': ['Lid plastic surgery'], 'description': "Eyelash resection surgery was performed for entropion with Down's syndrome", 'armGroupLabels': ["Entropion with Down's syndrome"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin Eye Center', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Akito Hirakata, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyorin Eye Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Ophthalmology', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}