Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 9:32 AM
Study NCT ID:
NCT02683694
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peeling without staining', 'timeFrame': 'intraoperative (10-15 minutes)', 'description': 'number of patients that could be peeled without use of a dye'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epiretinal membrane', 'lamellar holes of the macula', 'macular holes', 'vitreomacular traction syndrome'], 'conditions': ['Macular Diseases']}, 'descriptionModule': {'briefSummary': 'During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula.\n\nEpiretinal membrane (ERM), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.\n\nDifferent study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.', 'detailedDescription': 'The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epiretinal Membrane, lamellar hole of the macula, macular hole and vitreomacular traction syndrome\n\nExclusion Criteria:\n\n* Other diseases of the eye, such as AMD, retinopathia pigmentosa'}, 'identificationModule': {'nctId': 'NCT02683694', 'briefTitle': 'Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases', 'orgStudyIdInfo': {'id': 'iOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study arm', 'description': 'iOCT is performed', 'interventionNames': ['Device: iOCT']}], 'interventions': [{'name': 'iOCT', 'type': 'DEVICE', 'otherNames': ['intraoperative OCT (iOCT)'], 'description': 'the number of subjects that can be peeled without dye are assessed', 'armGroupLabels': ['study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'VIROS', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Oliver Findl, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vienna Institute for Research in Ocular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}