Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT06643403
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Age-related Changes in Retinal Oxygen Extraction in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal oxygen extraction in different age groups', 'timeFrame': '15 minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants', 'Retinal Oxygen Extraction']}, 'descriptionModule': {'briefSummary': 'It has been found that several systemic and ocular diseases are associated with impaired retinal oxygen extraction. In the present study, retinal oxygen extraction will be measured in different age groups in order to identify age related changes in otherwise healthy subjects. In addition, the study will explore short-term changes in retinal metabolism induced by breathing pure oxygen. Measurements will be performed with dynamic vessel analyzer and laser speckle flowgraphy to evaluate retinal blood flow and retinal oxygen saturation, in order to calculate retinal oxygen extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged between 18 and 80 years\n* Signed informed consent\n* Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study\n* Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study\n* Nonsmokers\n\nExclusion Criteria:\n\n* Abuse of alcoholic beverages or drugs\n* Participation in a clinical trial in the 3 weeks preceding the study\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* Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT06643403', 'briefTitle': 'Age-related Changes in Retinal Oxygen Extraction in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Age-related Changes in Retinal Oxygen Extraction in Healthy Subjects', 'orgStudyIdInfo': {'id': 'OPHT-26052024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for max. 45 minutes', 'interventionNames': ['Drug: Oxygen 100% Gas for Inhalation']}], 'interventions': [{'name': 'Oxygen 100% Gas for Inhalation', 'type': 'DRUG', 'description': 'SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria\n\nDose:\n\nmin. 95.5%, breathing for max. 45 minutes', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Doreen Schmidl-Schordje, MD', 'role': 'CONTACT', 'email': 'doreen.schmidl@meduniwien.ac.at', 'phone': '+43 1 40400', 'phoneExt': '29810'}], 'facility': 'Department of Clinical Pharmacology, Medical University of Vienna, Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Doreen Schmidl-Schordje, MD', 'role': 'CONTACT', 'email': 'doreen.schmidl@meduniwien.ac.at', 'phone': '+43 1 40400', 'phoneExt': '29810'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Priv.-Doz. Dr.med.univ. PhD', 'investigatorFullName': 'Doreen Schmidl', 'investigatorAffiliation': 'Medical University of Vienna'}}}}