Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00437593
Status:
COMPLETED
Last Update Posted:
2008-09-23
First Post:
2007-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-21', 'studyFirstSubmitDate': '2007-02-19', 'studyFirstSubmitQcDate': '2007-02-20', 'lastUpdatePostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UHR-OCT HD-OCT', 'timeFrame': '12 months'}, {'measure': 'Distance Visual acuity', 'timeFrame': '12 months'}, {'measure': 'Near Visual acuity', 'timeFrame': '12 months'}, {'measure': 'Contrast sensitivtiy', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'OCT Stratus 3000', 'timeFrame': '12 months'}, {'measure': 'Visual Field', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preretinal membrane', 'vitrectomy', 'uhr-oct', 'hd-oct'], 'conditions': ['Retinal Diseases']}, 'descriptionModule': {'briefSummary': 'Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.', 'detailedDescription': 'Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)\n\nMain outcome measures are:\n\nUHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preretinal membrane\n* Age between 18 and 85 years\n* Combined surgery possible(phacoemulsification and vitreoretinal procedure)\n\nExclusion Criteria:\n\n* Age-related macular degeneration\n* Previous retinal detachment surgery\n* Previous laser treatment'}, 'identificationModule': {'nctId': 'NCT00437593', 'briefTitle': 'UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue', 'organization': {'class': 'OTHER', 'fullName': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}, 'officialTitle': 'UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FR-2-CI-2007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ppVE, MP, ICG', 'type': 'PROCEDURE', 'description': 'surgery with ILM staining'}, {'name': 'ppVE, MP, MB', 'type': 'PROCEDURE', 'description': 'Surgery with ERM staining'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1030', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Rudolf Foundation Clinic', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Susanne Binder, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Binder Susanne, Univ. Prof. Dr', 'oldOrganization': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}}}}