Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT01746693
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurovascular Coupling in Subjects With Amblyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017078', 'term': 'Laser-Doppler Flowmetry'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012212', 'term': 'Rheology'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal Vessel Diameter in Response to Flickering Light (DVA)', 'timeFrame': 'once on the study day'}], 'secondaryOutcomes': [{'measure': 'Retinal (arterial and venous) oxygen saturation', 'timeFrame': 'once on the study day'}, {'measure': 'Retinal blood velocity in response to flickering light', 'timeFrame': 'once on the study day'}, {'measure': 'High resolution functional and anatomical imaging of the visual pathway', 'timeFrame': 'once on the study day'}, {'measure': 'Inner Retinal Function', 'timeFrame': 'once on the study day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['retinal vessel diameter', 'retinal oxygen saturation', 'high resolution functional and anatomical imaging', 'inner retinal function', 'flicker response'], 'conditions': ['Amblyopia ex Strabismus', 'Amblyopia ex Anisometropia']}, 'descriptionModule': {'briefSummary': 'Amblyopia is a developmental condition that is characterized by reduced vision of the eye due to the presence of a sensory impediment during visual development, such as strabismus (ocular misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent studies in humans and animals point towards a cortical locus for the processing deficit in amblyopia, revealing sensory deficits at the signal cell level. If changes in retinal neuronal function are also present, is unknown.\n\nLike in the brain, blood flow in the retina is coupled to neuronal activity. This phenomenon has been measured by different study groups with non invasive techniques in the brain and retina. It has been shown in previous studies that stimulating the retina with diffuse luminant flickering light increases retinal vessel diameter and blood flow. However, it is unknown whether this is also the case in the retina of amblyopic eyes. Additionally, the introduction of blood oxygen level dependent (BOLD) fMRI also makes it possible to directly access the vascular response in the brain to visual stimuli.\n\nTherefore, the aim of the present study is to investigate the effect of luminant flickering light on retinal vessel diameter and retinal blood flow in subjects with amblyopia. Also, oxygen saturation in retinal vessels will be assessed as well as pattern ERG for assessment of retinal function. Additionally, a high resolution image of the visual pathway will be taken with 7 Tesla MRI to investigate whether anatomical or functional alterations are present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged between 18 and 55 years\n* Non-smokers (for at least 6 months)\n* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant\n* Normal ophthalmic findings except amblyopia on one eye resulting from anisometropia or strabismus with a visual acuity of Snellen ≤ 0.3 with best correction on the amblyopic eye and Snellen 0.9 or better in the contralateral eye (for subjects with amblyopia)\n* Normal ophthalmic findings with visual acuity of Snellen ≥ 1.0 in both eyes (for control subjects)\n\nExclusion Criteria:\n\n* Symptoms of a clinically relevant illness in the 3 weeks before the first study day\n* Presence or history of a severe medical condition as judged by the clinical investigator\n* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptives)\n* Blood donation during the previous three weeks\n* Pregnancy, planned pregnancy or lactating\n* Any metallic, electric, electronic or magnetic device or object not removable except dental fillings\n* Claustrophobia\n* Epilepsia, history or family history of seizures'}, 'identificationModule': {'nctId': 'NCT01746693', 'briefTitle': 'Neurovascular Coupling in Subjects With Amblyopia', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Neurovascular Coupling in Subjects With Amblyopia', 'orgStudyIdInfo': {'id': 'OPHT-291012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amblyopia ex anisometropia', 'description': '20 male and female volunteers with amblyopia ex anisometropia', 'interventionNames': ['Device: Dynamic Vessel Analyzer', 'Other: Laser Doppler Velocimetry', 'Device: 7-Tesla MRI', 'Other: Pattern electroretinography', 'Other: Fourier domain optical coherence tomography']}, {'type': 'EXPERIMENTAL', 'label': 'amblyopia ex strabismus', 'description': '20 male and female volunteers with amblyopia ex strabismus', 'interventionNames': ['Device: Dynamic Vessel Analyzer', 'Other: Laser Doppler Velocimetry', 'Device: 7-Tesla MRI', 'Other: Pattern electroretinography', 'Other: Fourier domain optical coherence tomography']}, {'type': 'EXPERIMENTAL', 'label': 'control subjects', 'description': '20 healthy male and female control subjects', 'interventionNames': ['Device: Dynamic Vessel Analyzer', 'Other: Laser Doppler Velocimetry', 'Device: 7-Tesla MRI', 'Other: Pattern electroretinography', 'Other: Fourier domain optical coherence tomography']}], 'interventions': [{'name': 'Dynamic Vessel Analyzer', 'type': 'DEVICE', 'description': 'retinal vessel diameter, retinal oxygen saturation', 'armGroupLabels': ['amblyopia ex anisometropia', 'amblyopia ex strabismus', 'control subjects']}, {'name': 'Laser Doppler Velocimetry', 'type': 'OTHER', 'description': 'retinal blood flow velocity, retinal blood flow', 'armGroupLabels': ['amblyopia ex anisometropia', 'amblyopia ex strabismus', 'control subjects']}, {'name': '7-Tesla MRI', 'type': 'DEVICE', 'description': 'High resolution functional and anatomical imaging of the visual pathway', 'armGroupLabels': ['amblyopia ex anisometropia', 'amblyopia ex strabismus', 'control subjects']}, {'name': 'Pattern electroretinography', 'type': 'OTHER', 'description': 'inner retinal function', 'armGroupLabels': ['amblyopia ex anisometropia', 'amblyopia ex strabismus', 'control subjects']}, {'name': 'Fourier domain optical coherence tomography', 'type': 'OTHER', 'description': 'Blood flow in retina.', 'armGroupLabels': ['amblyopia ex anisometropia', 'amblyopia ex strabismus', 'control subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gerhard Garhoefer, MD', 'role': 'CONTACT', 'email': 'gerhard.garhoefer@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '2981'}, {'name': 'Gerhard Garhoefer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Clinical Pharmacology, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Gerhard Garhoefer, MD', 'role': 'CONTACT', 'email': 'gerhard.garhoefer@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '2981'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. PD Dr.', 'investigatorFullName': 'Gerhard Garhofer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}