Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-29 @ 9:34 AM
Study NCT ID:
NCT00797134
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2008-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Thickness Analysis Using 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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2008-11-24', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal thickness.', 'timeFrame': 'After visit(s)'}], 'secondaryOutcomes': [{'measure': 'Choroidal Thickness', 'timeFrame': 'After visit(s)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aibili.pt', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.\n\nThe secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.\n\nThe results of this study will be used exclusively for scientific purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects followed regularly by their ophthalmologist performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of DR\n* Females or Males\n* Age over 18 years\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Cataract or other eye disease that may interfere with fundus examinations\n* Vitreous syneresis or posterior vitreous detachment\n* Dilatation of the pupil \\< 5 mm'}, 'identificationModule': {'nctId': 'NCT00797134', 'briefTitle': 'Retinal Thickness Analysis Using Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Association for Innovation and Biomedical Research on Light and Image'}, 'officialTitle': 'Retinal Thickness Analysis Using Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'CNTM025AOCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DR', 'description': 'Diabetic Retinopathy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000-548', 'city': 'Coimbra', 'state': 'Coimbra District', 'country': 'Portugal', 'facility': 'AIBILI', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}], 'overallOfficials': [{'name': 'José Cunha-Vaz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association for Innovation and Biomedical Research on Light and Image'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association for Innovation and Biomedical Research on Light and Image', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}