Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-09 @ 11:19 PM
Study NCT ID:
NCT02930369
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-11', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical closure grades in OCT', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Change of anatomical closure grades in OCT', 'timeFrame': '3 months, 6 months, 1 year'}, {'measure': 'Change from baseline in BCVA (best corrected visual acuity)', 'timeFrame': '3 months, 6 months, 1 year'}]}, 'conditionsModule': {'conditions': ['Macular Hole']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with IMH\n* patients signed the informed consent form (ICF)\n* patients with course of IMH less than 3 years\n\nExclusion Criteria:\n\n* patients with hyper myopia\n* patients with traumatic macular hole\n* accompanied or secondary of other fundus disease\n* open or reopen after receiving MH surgery\n* patients with retinal detachment\n* received vitrectomy due to other diseases\n* glaucoma cannot be controled by medication\n* patients with other retinal or choroidal disease that may affect VA\n* poor patients compliance\n* poor condition that cannot undertake the surgery\n* dioptric media opacities which make it difficult to exam fundus or measure on OCT'}, 'identificationModule': {'nctId': 'NCT02930369', 'briefTitle': 'Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole', 'orgStudyIdInfo': {'id': 'DAILMP-CHINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4PD diameter of ILM peeling in surgery', 'description': 'patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery', 'interventionNames': ['Procedure: ILM peeling surgery']}, {'type': 'EXPERIMENTAL', 'label': '2PD diameter of ILM peeling in surgery', 'description': 'patients in this group was given 2PD diameter of ILM peeling in surgery', 'interventionNames': ['Procedure: ILM peeling surgery']}], 'interventions': [{'name': 'ILM peeling surgery', 'type': 'PROCEDURE', 'description': '4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)', 'armGroupLabels': ['2PD diameter of ILM peeling in surgery', '4PD diameter of ILM peeling in surgery']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mingwei Zhao, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Mingwei Zhao', 'investigatorAffiliation': "Peking University People's Hospital"}}}}