Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-29 @ 2:00 AM
Study NCT ID:
NCT03646695
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-21', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'closure of the macular hole', 'timeFrame': '3 months', 'description': 'closure of the macular hole will be assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macular Holes']}, 'descriptionModule': {'briefSummary': 'Patients with macular hole \\<400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes', 'detailedDescription': 'Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter \\<400µm. Therefore, patients with macular hole with a diameter \\<400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* macular hole with a diameter \\<400µm\n\nExclusion Criteria:\n\n* Prior ILM peeling'}, 'identificationModule': {'nctId': 'NCT03646695', 'briefTitle': 'ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study', 'orgStudyIdInfo': {'id': 'ILM flap'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ILM flap', 'description': 'vitrectomy with ILM flap transposition and gas-tamponade will be performed', 'interventionNames': ['Procedure: ILM flap transposition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ILM peeling', 'description': 'vitrectomy with ILM peeling and gas-tamponade will be performed', 'interventionNames': ['Procedure: ILM peeling']}], 'interventions': [{'name': 'ILM flap transposition', 'type': 'PROCEDURE', 'description': 'during ILM flap Transposition, an ILM flap is placed on the macular hole', 'armGroupLabels': ['ILM flap']}, {'name': 'ILM peeling', 'type': 'PROCEDURE', 'description': 'during ILM Peeling the ILM is removed around the macular hole', 'armGroupLabels': ['ILM peeling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Oliver Findl, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Department of Ophthalmology, Professor, Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Ophthalmology, Professor, Principal Investigator, MBA', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}