Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-03 @ 4:34 AM
Study NCT ID:
NCT04102605
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2019-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Perceptual Learning for the Treatment of Visual Field Defect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006423', 'term': 'Hemianopsia'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-06', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of Humphrey visual field where sensitivity increased by equal or more than 6 dB relative to baseline', 'timeFrame': '12 weeks', 'description': 'Improved regions have luminance sensitivity that increased by equal or more than 6 dB relative to baseline. The improved area ranges between 0 and 972 degree\\^2, of which larger area indicates better outcome.'}], 'secondaryOutcomes': [{'measure': 'Changes in Humphrey visual field mean deviation relative to baseline', 'timeFrame': '12 weeks', 'description': 'Changes in mean deviation value of whole field or defect field compared with the baseline value. The change of mean deviation ranges between -35 to +35 dB, of which higher value indicates better outcome.'}, {'measure': 'Changes in scores of NEI-VFQ-25(the National Eye Institute Visual Function Questionnaire 25) relative to baseline', 'timeFrame': '12 weeks', 'description': 'Changes in each components of NEI-VFQ-25 scores relative to baseline. The change of scores ranges between -100 to 100, of which higher value indicates better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Visual field defect', 'visual perceptual learning', 'Humphrey visual field'], 'conditions': ['Visual Fields Hemianopsia', 'Hemianopsia, Homonymous']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain damage. Half of participants will receive visual perceptual training using the Nunap Vision, while the other half will receive sham training using the Nunap Vision-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 19-80 years\n* Brain damage-induced visual field defect\n* At least 6 months after brain lesion\n* Minimum of 4 testing locations, where measured threshold ≤ 20dB\n* Verified visual pathway damage using CT or MRI\n* K-MMSE(Korean Mini Mental Status Examination) score ≥ 24\n* Visual acuity equal or better than 20/40\n* Able to use the investigational device\n* Patient/legally authorized representative has signed the informed consent form\n\nExclusion Criteria:\n\n* Unreliable Humphrey visual field test (any of fixation loss, false positive, false negative ≥ 20%)\n* Complete hemianopsia with sensitivity of the whole hemifield ≤ 3 dB\n* Epilepsy, photosensitivity, Parkinson's disease\n* Bilateral visual field defect\n* Hemispatial neglect\n* Ophthalmologic disorder that may interfere the trial\n* Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.\n* Candidate for carotid endarterectomy or stenting\n* Received ophthalmologic surgery within 3 months, except for the cataract surgery\n* Pregnant or breast feeding\n* Participating in other clinical trial\n* Any other condition that, in the opinion of the investigator, precludes participation in the trial"}, 'identificationModule': {'nctId': 'NCT04102605', 'acronym': 'VIVID2', 'briefTitle': 'Visual Perceptual Learning for the Treatment of Visual Field Defect', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nunaps Inc'}, 'officialTitle': 'Efficacy and Safety of Visual Perceptual Learning Using the Nunap Vision for Improvement of Visual Field Defect Caused by Brain Damage: Multi Center, Superiority Prove, Double-blind, Randomized, Confirmatory Study', 'orgStudyIdInfo': {'id': 'DB_NV_P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nunap Vision', 'description': 'Nunap Vision , 5 days a week for 12 weeks', 'interventionNames': ['Device: Nunap Vision']}, {'type': 'SHAM_COMPARATOR', 'label': 'Nunap Vision-C', 'description': 'Nunap Vision-C, 5 days a week for 12 weeks', 'interventionNames': ['Device: Nunap Vision-C']}], 'interventions': [{'name': 'Nunap Vision', 'type': 'DEVICE', 'description': 'Participants receive visual perceptual training using the Nunap Vision software', 'armGroupLabels': ['Nunap Vision']}, {'name': 'Nunap Vision-C', 'type': 'DEVICE', 'description': 'Participants receive sham training using the Nunap Vision-C software', 'armGroupLabels': ['Nunap Vision-C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sun U. Kwon, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nunaps Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}