Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT02862405
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of performances in visual tests between different groups according to error rate', 'timeFrame': 'at inclusion', 'description': 'These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.'}, {'measure': 'Comparison of performances in visual tests between different groups according to answer time', 'timeFrame': 'at inclusion', 'description': 'These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.'}], 'secondaryOutcomes': [{'measure': 'Estimation of the score of visual acuity by the logMAR chart', 'timeFrame': 'at inclusion'}, {'measure': 'Measure of lesion size', 'timeFrame': 'at inclusion'}, {'measure': 'Pearson correlation coefficient to determine the correlation between the performance parameters during visual tests (error rate and answer time) and clinical parameters (visual acuity and lesion size)', 'timeFrame': 'at inclusion', 'description': 'These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vision loss', 'Object recognition', 'Space recognition'], 'conditions': ['Vision Loss']}, 'descriptionModule': {'briefSummary': 'The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. However, there are not enough data regarding perception of objects and spaces in this population. Then, the objectives are to study the visual-spatial abilities in individuals with vision loss, and altered cognitive processes, (2) to develop clinics tools for early detection and quantification of visual-spatial deficits and (3)to understand the capacities of normal peripheral vision in order to test the possibility of potential training for use of peripheral vision when central vision is impaired by an ophthalmic pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with eye disease causing loss of central or peripheral vision', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria cases:\n\n* Patients with eye disease causing loss of central or peripheral vision\n* French speakers\n* Age between 18 and 90 years old\n* Written consent\n* Health insurance\n\nInclusion Criteria controls:\n\n* Sex and age matched controls (+/- 5 years)\n* French speakers\n* Normal visual examination with visual acuity of min 9/10\n\nExclusion Criteria:\n\n* Psychiatric disease or neurological pathologies\n* Communication difficulties (deafness / mutism)\n* Drug treatment altering concentration\n* Mental deterioration with MMS \\<24\n* Alcoholism or addiction to drugs\n* Persons under guardianship'}, 'identificationModule': {'nctId': 'NCT02862405', 'acronym': 'ACTIVIS', 'briefTitle': 'Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Evaluation of the Perception of Objects and Natural Scenes in People With Vision Loss (Loss of Central or Peripheral Vision)', 'orgStudyIdInfo': {'id': 'RC-P009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with loss of central vision', 'description': 'Patients coming in ophthalmic consultation will be selected for the study. The diagnosis of this disease is based on clinical examination, and imaging of the retina.Patients with only loss of central vision will be selected.', 'interventionNames': ['Other: vision tests']}, {'label': 'Patients with loss of peripheral vision', 'description': 'Patients coming in ophthalmic consultation will be selected for the study. Patients with loss of peripheral vision will be selected on the bases of presence of tunnel vision.', 'interventionNames': ['Other: vision tests']}, {'label': 'Control group', 'description': 'Patients without loss of vision.', 'interventionNames': ['Other: vision tests']}], 'interventions': [{'name': 'vision tests', 'type': 'OTHER', 'armGroupLabels': ['Control group', 'Patients with loss of central vision', 'Patients with loss of peripheral vision']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thi Ha Chau Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of the Lille Catholic Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Lille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}