Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT02747368
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field', 'timeFrame': '2 years'}, {'measure': 'Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field', 'timeFrame': '2 years'}, {'measure': 'Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score', 'timeFrame': '2 years'}, {'measure': 'Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score', 'timeFrame': '2 years'}, {'measure': 'Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing', 'timeFrame': '4 years'}, {'measure': 'Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing', 'timeFrame': '4 years'}, {'measure': 'Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores', 'timeFrame': '4 years'}, {'measure': 'Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score', 'timeFrame': '4 years'}, {'measure': 'Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by central visual field testing', 'timeFrame': '2 years'}, {'measure': 'Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by peripheral visual field testing', 'timeFrame': '2 years'}, {'measure': 'Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores', 'timeFrame': '2 years'}, {'measure': 'Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wet age-related macular degeneration', 'Age-related macular degeneration', 'Ocusweep', 'Driving health', 'Visual field', 'Contrast sensitivity'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The aim is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. The study aims to find out how frequently these patients do not meet the European Union health criteria of safe driving and how Ocusweep finds these patients from a population of patients being treated in a busy medical retina clinic. The tests of Ocusweep system are compared against conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests showing anatomical changes related to wet age-related macular degeneration (optical coherence tomography, fundus photography and fluorescein or indocyanine green angiography).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular degeneration or other diagnosed or suspected macular disease\n\nExclusion Criteria:\n\n* Pregnancy\n* Mental disorder\n* Dementia and Alzheimers disease\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT02747368', 'briefTitle': 'Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'T220/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wet age related macular degeneration', 'description': 'Ocusweep system is compared to results of conventional devices.', 'interventionNames': ['Device: Ocusweep system']}], 'interventions': [{'name': 'Ocusweep system', 'type': 'DEVICE', 'description': 'Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.', 'armGroupLabels': ['Wet age related macular degeneration']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Ophthalmology', 'investigatorFullName': 'Vesa Aaltonen', 'investigatorAffiliation': 'Turku University Hospital'}}}}