Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-05 @ 2:00 PM
Study NCT ID:
NCT03821467
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal blood-flow variation over time', 'timeFrame': '14 +/- 3 days', 'description': 'as measured using DOCT'}], 'secondaryOutcomes': [{'measure': 'Flicker induced blood flow alterations', 'timeFrame': '14 +/- 3 days', 'description': 'as measured using DOCT'}, {'measure': 'Flicker induced vasodilatation and hyperemia', 'timeFrame': '14 +/- 3 days', 'description': 'as measured using DOCT and DVA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['doppler optical coherence tomography', 'dynamic vessel analyzer'], 'conditions': ['Ocular Blood Flow']}, 'referencesModule': {'references': [{'pmid': '22893675', 'type': 'BACKGROUND', 'citation': 'Werkmeister RM, Dragostinoff N, Palkovits S, Told R, Boltz A, Leitgeb RA, Groschl M, Garhofer G, Schmetterer L. Measurement of absolute blood flow velocity and blood flow in the human retina by dual-beam bidirectional Doppler fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Sep 12;53(10):6062-71. doi: 10.1167/iovs.12-9514.'}, {'pmid': '24575355', 'type': 'BACKGROUND', 'citation': 'Doblhoff-Dier V, Schmetterer L, Vilser W, Garhofer G, Groschl M, Leitgeb RA, Werkmeister RM. Measurement of the total retinal blood flow using dual beam Fourier-domain Doppler optical coherence tomography with orthogonal detection planes. Biomed Opt Express. 2014 Jan 28;5(2):630-42. doi: 10.1364/BOE.5.000630. eCollection 2014 Feb 1.'}, {'pmid': '23029289', 'type': 'BACKGROUND', 'citation': 'Werkmeister RM, Palkovits S, Told R, Groschl M, Leitgeb RA, Garhofer G, Schmetterer L. Response of retinal blood flow to systemic hyperoxia as measured with dual-beam bidirectional Doppler Fourier-domain optical coherence tomography. PLoS One. 2012;7(9):e45876. doi: 10.1371/journal.pone.0045876. Epub 2012 Sep 18.'}], 'seeAlsoLinks': [{'url': 'https://klpharm.meduniwien.ac.at/', 'label': 'Medical University of Vienna, Department of Clinical Pharmacology'}]}, 'descriptionModule': {'briefSummary': 'Dual beam Doppler Fourier-domain Optical coherence tomography (DOCT) is a noninvasive technique to quantify total retinal blood flow.\n\nTo enable further development of this technique it is essential to assess short- and long-term reproducibility of DOCT blood flow measurements.', 'detailedDescription': 'In the present study, total retinal blood flow will be measured with DOCT at multiple time points to gain information of short- and long-term reproducibility. In addition, provocation with flickering light will be performed, which is known to lead to vasodilatation and an increase in retinal blood flow in healthy subjects. Vessel diameters will also be measured using the Dynamic Vessel Analyzer (DVA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged between 18 and 35 years\n* Non-smokers\n* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant\n* Normal ophthalmic findings, ametropy \\< 3 Dpt.\n\nExclusion Criteria:\n\n* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study\n* Treatment in the previous 3 weeks with any drug (except contraceptives)\n* Symptoms of a clinically relevant illness in the 3 weeks before the first study day\n* Blood donation during the previous 3 weeks\n* Pregnancy, planned pregnancy or lactating\n* History or family history of epilepsia'}, 'identificationModule': {'nctId': 'NCT03821467', 'briefTitle': 'Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study', 'orgStudyIdInfo': {'id': 'OPHT-010418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': 'Dual beam Doppler Fourier-domain OCT (DOCT) Dynamic Vessel Analyzer (DVA) Optical coherence tomography (OCT)', 'interventionNames': ['Device: Dual beam Doppler Fourier-domain OCT (DOCT)', 'Device: Dynamic Vessel Analyzer (DVA)', 'Device: Optical coherence tomography (OCT)']}], 'interventions': [{'name': 'Dual beam Doppler Fourier-domain OCT (DOCT)', 'type': 'DEVICE', 'description': 'Retinal blood flow will be assessed using DOCT.', 'armGroupLabels': ['Healthy subjects']}, {'name': 'Dynamic Vessel Analyzer (DVA)', 'type': 'DEVICE', 'description': 'Retinal vessel diameters and oxygen saturation will be measured with the DVA device.', 'armGroupLabels': ['Healthy subjects']}, {'name': 'Optical coherence tomography (OCT)', 'type': 'DEVICE', 'description': 'Retinal morphology will be imaged using OCT.', 'armGroupLabels': ['Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Doreen Schmidl, MD, PhD', 'role': 'CONTACT'}, {'name': 'Doreen Schmidl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna, Department of Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Doreen Schmidl, MD, PhD', 'role': 'CONTACT', 'email': 'klin-pharmakologie@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '29810'}], 'overallOfficials': [{'name': 'Doreen Schmidl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, Department of Clinical Pharmacology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD, PhD', 'investigatorFullName': 'Doreen Schmidl', 'investigatorAffiliation': 'Medical University of Vienna'}}}}