Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-01 @ 1:57 PM
Study NCT ID:
NCT05141604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-24
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response time', 'timeFrame': 'Through study completion, an average of four months', 'description': 'During the pedestrian detection task, average response time to the colliding pedestrian with and without prisms'}], 'secondaryOutcomes': [{'measure': 'Head movement range', 'timeFrame': 'Through study completion, an average of four months', 'description': 'During the pedestrian detection task, lateral and vertical head movement range to check the head scanning range'}, {'measure': 'Walking speed', 'timeFrame': 'Through study completion, an average of four months', 'description': 'During the pedestrian detection task, the physical walking speed of the subject'}, {'measure': 'Pedestrian detection rate', 'timeFrame': 'Through study completion, an average of four months', 'description': 'Proportion of simulated pedestrians detected (in HMD walking)'}, {'measure': 'Error rate', 'timeFrame': 'Through study completion, an average of four months', 'description': 'Proportion of false alarms and missed targets to total targets'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['walking', 'collision', 'field expansion', 'visual field loss'], 'conditions': ['Hemianopsia', 'Homonymous Hemianopia', 'Tunnel Vision', 'Visual Field Defect, Peripheral', 'Visual Field Constriction Bilateral', 'Visual Field Defect Homonymous Bilateral']}, 'descriptionModule': {'briefSummary': 'The investigators are developing a new test of pedestrian hazard detection in virtual reality (VR) head-mounted display (HMD) headset, which shows virtual oncoming pedestrians in 3D while subjects are walking in real-world environment, for evaluation of visual field expansion to improve mobility in people with visual field loss.', 'detailedDescription': 'The investigators will develop a new pedestrian hazard detection test and conduct a single arm interventional clinical trial to evaluate simulated low vision assistive devices in a sample of field loss subjects. Pedestrian detection performance with and without field expansion information will be tested and compared. The study will include 1 to 4 visits (each 2 to 4 hours) depending on the number of trials and experimental conditions (e.g., with and without simulated assistive devices) the subject is comfortable completing. The time between visits may vary depending on scheduling constraints and availability. During each visit, the subject will complete a series of simulated collision avoidance trials in VR requiring the detection and natural avoidance of a colliding pedestrian (alongside non-colliding pedestrians) while physically walking through an empty corridor. The study will be considered minimal-risk since there will be no physical obstacles that present actual collision risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* At least 14 years of age (no upper age limit)\n* In sufficiently good health to be able to complete sessions lasting 2-3 hours\n* Able to understand English\n* Able to give voluntary, informed consent\n* Able to independently move short distances\n* Binocular vision parameters within normal limits (Stereopsis ≤ 100 arc sec on any stereo test)\n* Visual field loss, either peripheral field loss (\\<30 degrees diameter) or hemianopic field loss (blind in half of visual field)\n* Better than 20/100 visual acuity in the worse eye\n\nExclusion criteria:\n\n* Patients with any self-reported physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study\n* Any person with a self-reported medical history (such as pacemaker use or photosensitive epilepsy) or physical condition listed on the device manual of the Oculus / HMD system used for the experiment as a contraindication\n* Any self-reported history of seizures (any type) in the last 6 months'}, 'identificationModule': {'nctId': 'NCT05141604', 'briefTitle': 'Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Monocular Visual Confusion for Field Expansion', 'orgStudyIdInfo': {'id': '2021P003330'}, 'secondaryIdInfos': [{'id': 'R01EY031777', 'link': 'https://reporter.nih.gov/quickSearch/R01EY031777', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Field expansion view', 'description': 'Various configurations of field expansion views will be additionally displayed on HMD', 'interventionNames': ['Other: Field expansion view']}], 'interventions': [{'name': 'Field expansion view', 'type': 'OTHER', 'description': "Overlaid small window on HMD to show the part of the scene in the blind field into portions of the participants' remaining, seeing, field of vision", 'armGroupLabels': ['Field expansion view']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Schepens Eye Research Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Eli Peli, OD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Scientist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Eye and Ear Infirmary', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Eli Peli', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}