Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 4:46 PM
Study NCT ID:
NCT04014933
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2019-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D057066', 'term': 'Low Tension Glaucoma'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coefficients of variation (COV)', 'timeFrame': '1 month', 'description': 'COVs from 3 measurements of ocular blood flow at visit 1 of observer 1 and at visit 1 of observer 1 and from observer 2 will be computed.'}, {'measure': 'intraclass correlation coefficients (ICCs)', 'timeFrame': '1 month', 'description': 'Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed'}], 'secondaryOutcomes': [{'measure': 'Cofounder', 'timeFrame': '1 month', 'description': 'Blood pressure will be checked as potential cofounder'}, {'measure': 'Cofounder', 'timeFrame': '1 month', 'description': 'heart rate will be checked as potential cofounder'}, {'measure': 'Cofounder', 'timeFrame': '1 month', 'description': 'spherical equivalent will be checked as potential cofounder'}, {'measure': 'Cofounder', 'timeFrame': '1 month', 'description': 'intraocular pressure will be checked as potential cofounder'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'retinal blood flow', 'ocular perfusion pressure'], 'conditions': ['Open Angle Glaucoma', 'Normal Tension Glaucoma', 'Healthy']}, 'descriptionModule': {'briefSummary': 'In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.', 'detailedDescription': 'According to the World Health Organization (WHO) glaucoma is the second leading cause of blindness. Glaucoma is a global problem, which is becoming even more important as the human life expectancy increases. Although the causes of glaucoma are uncertain, mainly intraocular pression (IOP), genetics, and ocular blood perfusion pressure in the optic nerve determine the cause of the disease. Increasing evidence suggests that in glaucoma patients retinal blood flow is decreased leading to progression and to damage of the optic nerve.\n\nIn order to measure the peripapillary blood flow a variety of devices using different techniques of flowmetry have been developed. In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is crucial for the clinical value of any measuring device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '3 groups as described above will be recruted from the outpatient department of the Ophthalmology Department at the UniversityHospital Zurich, Zurich, Switzerland and the Ophthalmology Department at the Cantonal Hospital Aarau, Aarau, Switzerland', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed Patient Informed Consent form\n* Be at least 18 years old\n* Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or healthy controls\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* No vulnerable participants will be included in this study.'}, 'identificationModule': {'nctId': 'NCT04014933', 'acronym': 'LSFG Repro', 'briefTitle': 'Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System', 'orgStudyIdInfo': {'id': 'LSFG Repro'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'open-angle glaucoma', 'description': 'patients with a diagnosis of open-angle glaucoma, i.e. untreated IOP \\>21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma', 'interventionNames': ['Diagnostic Test: LASER SPECKLE FLOWGRAPHY']}, {'label': 'normal tension glaucoma', 'description': 'patients with a diagnosis of normal tension glaucoma, i.e. untreated IOP \\</=21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma', 'interventionNames': ['Diagnostic Test: LASER SPECKLE FLOWGRAPHY']}, {'label': 'healthy controls', 'description': 'individuals with normal optic disc and IOP \\</21mmHg and normal visual fields', 'interventionNames': ['Diagnostic Test: LASER SPECKLE FLOWGRAPHY']}], 'interventions': [{'name': 'LASER SPECKLE FLOWGRAPHY', 'type': 'DIAGNOSTIC_TEST', 'description': 'Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region', 'armGroupLabels': ['healthy controls', 'normal tension glaucoma', 'open-angle glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Marc Töteberg-Harms, MD, FEBO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}