Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-04 @ 4:08 PM
Study NCT ID:
NCT01083004
Status:
UNKNOWN
Last Update Posted:
2011-04-18
First Post:
2010-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brilliant Blue Versus Indocyanine Green
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2011-04-15', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected far visual acuity (ETDRS)', 'timeFrame': '1 year postoperative'}], 'secondaryOutcomes': [{'measure': 'Reading ability (Radner)', 'timeFrame': '1 Year'}, {'measure': 'Optical coherence tomography', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['dye', 'internal limiting membrane', 'macular hole', 'macular pucker'], 'conditions': ['Macular Pucker', 'Macular Hole', 'Vitreoretinal Surgery']}, 'descriptionModule': {'briefSummary': 'A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 50\n* macular pucker or macular hole with subjective disturbances\n* All phakic or pseudophakic patients\n* far visual acuity better than 20/400\n* able to read, understand, and willing to sign the informed consent form\n\nExclusion Criteria:\n\n* any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker\n* prior vitreoretinal surgery in the study eye'}, 'identificationModule': {'nctId': 'NCT01083004', 'briefTitle': 'Brilliant Blue Versus Indocyanine Green', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole', 'orgStudyIdInfo': {'id': 'BlueIce001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Indocyanine green arm', 'interventionNames': ['Procedure: Indocyanine green']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brilliant blue', 'interventionNames': ['Procedure: Brilliant blue arm']}], 'interventions': [{'name': 'Indocyanine green', 'type': 'PROCEDURE', 'description': 'Using indocyanine green as intraoperative dye', 'armGroupLabels': ['Indocyanine green arm']}, {'name': 'Brilliant blue arm', 'type': 'PROCEDURE', 'description': 'Using brilliant blue as intraoperative dye', 'armGroupLabels': ['Brilliant blue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Albert Caramoy, MD', 'role': 'CONTACT', 'email': 'acaramoy@yahoo.co.uk', 'phone': '004902214784308'}, {'name': 'Albert Caramoy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bernd Kirchhof, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center of Ophthalmology, University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Albert Caramoy, MD', 'role': 'CONTACT', 'email': 'acaramoy@yahoo.co.uk', 'phone': '004902214784308'}], 'overallOfficials': [{'name': 'Bernd Kirchhof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. B. Kirchhof', 'oldOrganization': 'University of Cologne'}}}}