Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT01220804
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2010-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2010-10-11', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optical reflectivity as measured by optical coherence tomography', 'timeFrame': '14 months', 'description': 'To analyse OCT reflectivity distribution between areas with and without fluorescein leakage in type 2 diabetic eyes. In previous studies our group found differences, when comparing the histograms of the optical reflectivity distribution, suggesting that the optical reflectivity, as measured by OCT, may change under BRB alterations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aibili.pt', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical coherence tomograph (OCT).', 'detailedDescription': 'Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).\n\nInclusion Criteria:\n\nAge over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale); and an area of retinal leakage of at least 25% of the RLA map (macular area).\n\nExclusion Criteria:\n\nPresence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications; and other retinal pathologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area).\n\nExclusion Criteria:\n\n* Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.'}, 'identificationModule': {'nctId': 'NCT01220804', 'acronym': 'CNTM025A OCT', 'briefTitle': 'Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Association for Innovation and Biomedical Research on Light and Image'}, 'officialTitle': 'Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'PTDC/SAU-BEB/103151/2008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NPDR', 'description': 'Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)'}, {'label': 'Control Population', 'description': 'Healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000-548', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'AIBILI', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association for Innovation and Biomedical Research on Light and Image', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação para a Ciência e a Tecnologia', 'class': 'OTHER'}, {'name': 'Instituto Financeiro para o Desenvolvimento Regional', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}