Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-05 @ 1:35 AM
Study NCT ID:
NCT06024668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2023-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001766', 'term': 'Blindness'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Individuals with Acquired Monocular Vision/ Blindness in One Eye'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean response time to detect colliding pedestrian', 'timeFrame': 'Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period', 'description': 'The investigators will compare the mean response time to detect colliding pedestrians coming from the nasal (same side as the blind eye) and temporal (same side as the seeing eye) visual field with and without multiplexing prism. The comparison will be made between these four: Nasal without prism, Temporal without prism, Nasal with prism, and Temporal with prism.'}], 'secondaryOutcomes': [{'measure': 'Pedestrian Detection Rate', 'timeFrame': 'Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period', 'description': 'The investigators will measure the rate of correct detection rate of colliding pedestrians in the nasal (same side as the blind eye) and temporal (same side as the seeing eye) with and without multiplexing prism. Comparisons will be made for these: nasal without prism, temporal without prism, nasal with prism,and temporal with prism.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Simulated Walking', 'Collision', 'Field Expansion', 'One eye blindness'], 'conditions': ['One Eye Blindness', 'Blind Left Eye', 'Blind Right Eye']}, 'referencesModule': {'references': [{'pmid': '32855881', 'type': 'RESULT', 'citation': 'Jung JH, Castle R, Kurukuti NM, Manda S, Peli E. Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. Transl Vis Sci Technol. 2020 Jul 23;9(8):35. doi: 10.1167/tvst.9.8.35. eCollection 2020 Jul.'}, {'pmid': '30169357', 'type': 'RESULT', 'citation': 'Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277.'}, {'pmid': '30169356', 'type': 'RESULT', 'citation': 'Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators will test the efficacy of the prism in improving the detection of colliding pedestrians during a simulated walking task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No medical health issues such as seizures, motor movements problem\n* Loss of vision in one eye (less than 20/200) for \\>1 year\n* Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction\n* No visual field defect in the seeing eye (nasal field of at least \\>45degree)\n\nExclusion Criteria:\n\n* Patients with any 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 will be excluded\n* Any person with a history (such as pacemaker use or photosensitive epilepsy)\n* Any person with motor movements problem (e.g., unable to use extremities)'}, 'identificationModule': {'nctId': 'NCT06024668', 'briefTitle': 'Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Monocular Visual Confusion for Field Expansion', 'orgStudyIdInfo': {'id': '2023P001885'}, 'secondaryIdInfos': [{'id': 'R01EY031777', 'link': 'https://reporter.nih.gov/quickSearch/R01EY031777', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Detection of colliding pedestrian', 'description': 'Participants will perform a simulated walking task in which surrounding pedestrians will walk towards and make a collision. Participants will respond by pressing buttons to indicate the direction of the colliding pedestrians. Participants will perform the task with and without the multiplexing prism in random orders.', 'interventionNames': ['Device: Multiplexing Prism']}], 'interventions': [{'name': 'Multiplexing Prism', 'type': 'DEVICE', 'description': 'Multiplexing prism is designed for spatial vision multiplexing. It allows partial light transmission through the prism allow the observer to simultaneously see the physical world through the prism and see the "shifted view" from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.', 'armGroupLabels': ['Detection of colliding pedestrian']}]}, '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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schepens Eye Research Institute'}]}, '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'}}}}