Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-02-28 @ 2:10 PM
Study NCT ID:
NCT02059018
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2014-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016861', 'term': 'Cyclooxygenase Inhibitors'}, {'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2014-02-07', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter changes of retinal vessels', 'timeFrame': 'Examination day 1 and 2', 'description': 'Comparing the differences of diameter changes occuring during each of interventions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retinal Hypoxia']}, 'descriptionModule': {'briefSummary': 'The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between \\>19 and \\<61 years\n* No known systemic or ocular diseases\n\nExclusion Criteria:\n\n* Cardio-vascular disease\n* Lung disease\n* Epilepsy\n* Previous ocular disease\n* Previous treatment with medications influencing the intraocular pressure or the metabolism of nitric oxide or prostaglandins\n* Daily intake of medicine except contraceptive pills\n* Pregnancy or breastfeeding\n* Known allergy against any of the drugs used in the interventions'}, 'identificationModule': {'nctId': 'NCT02059018', 'briefTitle': 'The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Underlying Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia', 'orgStudyIdInfo': {'id': 'HypNOCOX-2'}, 'secondaryIdInfos': [{'id': '1-10-72-14-14', 'type': 'OTHER', 'domain': 'Local ethical committe for medical science'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypoxia', 'description': 'Inhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions over two examination days', 'interventionNames': ['Drug: COX-inhibitor', 'Drug: Nitroglycerin', 'Drug: COX-inhibitor + Nitroglycerin']}, {'type': 'EXPERIMENTAL', 'label': 'Normoxia', 'description': 'Breathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions over two examination days', 'interventionNames': ['Drug: COX-inhibitor', 'Drug: Nitroglycerin', 'Drug: COX-inhibitor + Nitroglycerin']}], 'interventions': [{'name': 'COX-inhibitor', 'type': 'DRUG', 'otherNames': ['Eye drops diclofenac 1mg/ml', 'Voltaren eye drops'], 'description': 'Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated', 'armGroupLabels': ['Hypoxia', 'Normoxia']}, {'name': 'Nitroglycerin', 'type': 'DRUG', 'otherNames': ['Glyceryl Nitrate'], 'description': 'Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated', 'armGroupLabels': ['Hypoxia', 'Normoxia']}, {'name': 'COX-inhibitor + Nitroglycerin', 'type': 'DRUG', 'description': 'Combination of COX-inhibitor and nitroglycerin interventions.', 'armGroupLabels': ['Hypoxia', 'Normoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Ophtalmology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Line Pedersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Musa Kaya, stud.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}