Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT04306718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2019-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-02', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proliferation of Hyalocytes', 'timeFrame': '9 days', 'description': 'hyalocytes from ERM and ILM will be cultured and counted'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epiretinal Membrane']}, 'referencesModule': {'references': [{'pmid': '28622372', 'type': 'BACKGROUND', 'citation': 'Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.', 'detailedDescription': 'Hyalocytes, typically located 20 to 50μm anterior the internal limiting membrane (ILM), have the potential to contribute to development of epiretinal membranes (ERM) in presence of vitreoschisis. For macular holes, hyalocytes located on the ILM are hypothesized to contribute to the closure of the macular hole after application of the inverted ILM flap technique.\n\nILM is routinely excised during surgical repair of macular holes. During peeling of ERM it is excised in case of persisting wrinkling of the retinal surface or partial en bloc excision with the ERM. Furthermore, excision of ILM during ERM peeling is associated with significantly lower recurrence rates of ERM and better Long term visual acuity, according to the results reported by Chang et al. Removal of ERM and ILM is part of the surgical routine during surgical repair of macular holes and peeling of epiretinal membranes. Therefore, cultivation of excised ERM and ILM samples does not increase risks for patients in any way. During study it is planned to cultivate hyalocytes for investigation of their role in macular hole closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular hole or epiretinal Membrane\n\nExclusion Criteria:\n\n* Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)'}, 'identificationModule': {'nctId': 'NCT04306718', 'briefTitle': 'Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study', 'orgStudyIdInfo': {'id': 'hya'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'studyarm', 'description': 'Hyalocytes from ERM and ILM are cultured in alphaMEM to examine their proliferation habits', 'interventionNames': ['Procedure: membrane peeling']}], 'interventions': [{'name': 'membrane peeling', 'type': 'PROCEDURE', 'description': 'ERM and ILM are peeled routinely during surgery', 'armGroupLabels': ['studyarm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'VIROS at Hanuschkrankenhaus', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Oliver Findl, Prof., Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VIROS at Hanuschkrankenhaus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department, Professor', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}