Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 5:18 PM
Study NCT ID:
NCT01771757
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Retinal Venous Pressure Under Short-term Low-oxygen Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-18', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal venous pressure', 'timeFrame': '1 hour', 'description': 'Quantify the changes in the retinal venous pressure (RVP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['retinal venous pressure', 'reduced ambient pressure', 'oxygen partial pressure', 'short-term hypoxic changes'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that the pressure in the retinal veins increases under a short-term lack of oxygen and leads to a decreased blood circulation. On the basis of measurements in the hypobaric chamber this hypothesis should be verified.', 'detailedDescription': 'Conduct a pilot study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled, reduced ambient and oxygen partial pressure in the pressure chamber of the Aeromedical Institute FAI in Dübendorf, Switzerland. Obtaining evidence of the adaptation behavior of the retinal vascular system in controlled, short-term hypoxic changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n\nExclusion Criteria:\n\n* eye diseases\n* systemic diseases\n* term medication (except contraceptives)\n* pregnancy\n* allergies to the ingredients Alcain, Tropicamide and Phenylephrine\n* blood pressure levels except standard (\\<60 /\\> 140 mmHg)\n* oxygen saturation (SO2) \\<90%'}, 'identificationModule': {'nctId': 'NCT01771757', 'briefTitle': 'Measurement of Retinal Venous Pressure Under Short-term Low-oxygen Environment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Measurement of Retinal Venous Pressure (Retinal Venous Pressure RVP) Under Conditions of Reduced Ambient Pressure and Oxygen Partial Pressure', 'orgStudyIdInfo': {'id': 'USB-2011-327'}}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel, Dept. of Ophthalmology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Josef Flammer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Basel, Dept. of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}