Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT01509092
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2011-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2011-12-28', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'macular hole closure rate', 'timeFrame': '6 month after injury'}], 'secondaryOutcomes': [{'measure': 'central foveal thickness', 'timeFrame': '6 month after hole closure'}, {'measure': 'length of inner-segment outer-segment junction defect', 'timeFrame': '6 month after hole closure'}, {'measure': 'final visual acuity', 'timeFrame': '6 month after hole closure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['traumatic macular hole', 'vitrectomy', 'observation'], 'conditions': ['Trauma', 'Macular Hole']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.', 'detailedDescription': 'Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* closed globe injury\n* identification of full-thickness macular hole by optical coherence tomography within one month after trauma\n\nExclusion Criteria:\n\n* open globe injury\n* coexistence of idiopathic macular hole\n* severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)\n* combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)\n* coexistence of high myopia\n* coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola\n* coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)'}, 'identificationModule': {'nctId': 'NCT01509092', 'briefTitle': 'Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'PekingUTH-TMH-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'obervation', 'description': 'patients in this arm received 6-months observation alone after injury'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical intervention', 'description': 'patients in this arm received vitrectomy surgery as soon as possible after injury', 'interventionNames': ['Procedure: vitrectomy surgery']}], 'interventions': [{'name': 'vitrectomy surgery', 'type': 'PROCEDURE', 'description': '"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole', 'armGroupLabels': ['Surgical intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': 'Eye Hospital of Hebei Province', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'city': 'Weifang', 'state': 'Shandong', 'country': 'China', 'facility': 'Weifang Eye Hospital', 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Beijing', 'country': 'China', 'facility': 'China - Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Southwest Eye hospital of Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhi-Zhong Ma, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhi-zhong Ma', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}