Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT01758757
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2012-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 347}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-31', 'studyFirstSubmitDate': '2012-12-27', 'studyFirstSubmitQcDate': '2012-12-31', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of retinal breaks', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Incidence of neovascular glaucoma', 'timeFrame': 'One Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proliferative diabetic retinopathy', 'Vitrectomy'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '26202442', 'type': 'DERIVED', 'citation': 'Yokota R, Inoue M, Itoh Y, Rii T, Hirota K, Hirakata A. Comparison of microinsicion vitrectomy and conventional 20-gauge vitrectomy for severe proliferative diabetic retinopathy. Jpn J Ophthalmol. 2015 Sep;59(5):288-94. doi: 10.1007/s10384-015-0396-y. Epub 2015 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.', 'detailedDescription': 'The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months\n\nExclusion Criteria:\n\n* The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.'}, 'identificationModule': {'nctId': 'NCT01758757', 'briefTitle': 'Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'Kyorineye010'}, 'secondaryIdInfos': [{'id': 'Vitrectomy for PDR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Proliferative diabetic retinopathy', 'interventionNames': ['Procedure: Vitrectomy']}], 'interventions': [{'name': 'Vitrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Proliferative diabetic retinopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin Eye Center', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Makoto Inoue, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyorin Eye Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kyorin Eye Center', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}