Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-11 @ 1:56 AM
Study NCT ID:
NCT02391558
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2015-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography
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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between examination techniques on the detection of morphological changes in the retina (such as vessels morphology, vascular ischemia, retinal neovascularization, choroidal neovascularization, and other vascular abnormalities).', 'timeFrame': 'Single Visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '27927677', 'type': 'DERIVED', 'citation': 'Soares M, Neves C, Marques IP, Pires I, Schwartz C, Costa MA, Santos T, Durbin M, Cunha-Vaz J. Comparison of diabetic retinopathy classification using fluorescein angiography and optical coherence tomography angiography. Br J Ophthalmol. 2017 Jan;101(1):62-68. doi: 10.1136/bjophthalmol-2016-309424. Epub 2016 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace fluorescein angiography.', 'detailedDescription': 'Fluorescein angiography (FA) is the standard and generally accepted method to identify vascular features in the retina, detecting capillary dropout and neovessel growth. Its value is undeniable and is a routine ophthalmological examination. However, it requires intravenous injection of fluorescein, which can cause nausea, vomiting and, rarely, anaphylaxis and death. New OCT angiography methods can detect, noninvasively red blood cells flow and, therefore, identify well the retinal vasculature. It is crucial and of major interest to evaluate the clinical utility of this new methodology comparing this information with the one obtained from fluorescein angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with clinical indication for fluorescein angiography will be invited to perform OCT angiography in the same day during a period of 6-8 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with clinical indication for fluorescein angiography in their clinical practice\n\nExclusion Criteria:\n\n* Subjects with a pacemaker of similarly critical electronic device\n* Subjects with severe ocular media opacities\n* Subjects with corneal abnormalities'}, 'identificationModule': {'nctId': 'NCT02391558', 'acronym': 'OCTA', 'briefTitle': 'Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Association for Innovation and Biomedical Research on Light and Image'}, 'officialTitle': 'Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography', 'orgStudyIdInfo': {'id': '4C-2015-07'}}, 'contactsLocationsModule': {'locations': [{'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Aibili - Cec', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association for Innovation and Biomedical Research on Light and Image', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}