Back to resultsSimulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision
Primary Purpose
One Eye Blindness, Blind Left Eye, Blind Right Eye
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multiplexing Prism
Sponsored by
About this trial
This is an interventional basic science trial for One Eye Blindness focused on measuring Simulated Walking, Collision, Field Expansion, One eye blindness
Eligibility Criteria
Inclusion Criteria: No medical health issues such as seizures, motor movements problem Loss of vision in one eye (no light perception/enucleation/evisceration) for >1 year Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction No visual field defect in the seeing eye (nasal field of at least >45degree) Exclusion Criteria: 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 Any person with a history (such as pacemaker use or photosensitive epilepsy) Any person with motor movements problem (e.g., unable to use extremities)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Detection of colliding pedestrian
Arm 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.
Outcomes
Primary Outcome Measures
Mean response time to detect colliding pedestrian
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.
Secondary Outcome Measures
Pedestrian Detection Rate
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.
Full Information
NCT ID
NCT06024668
First Posted
August 29, 2023
Last Updated
September 5, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT06024668
Brief Title
Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision
Official Title
Monocular Visual Confusion for Field Expansion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
National Eye Institute (NEI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
One Eye Blindness, Blind Left Eye, Blind Right Eye
Keywords
Simulated Walking, Collision, Field Expansion, One eye blindness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Individuals with Acquired Monocular Vision/ Blindness in One Eye
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Detection of colliding pedestrian
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Multiplexing Prism
Intervention 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.
Primary Outcome Measure Information:
Title
Mean response time to detect colliding pedestrian
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.
Time Frame
Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period
Secondary Outcome Measure Information:
Title
Pedestrian Detection Rate
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.
Time Frame
Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No medical health issues such as seizures, motor movements problem
Loss of vision in one eye (no light perception/enucleation/evisceration) for >1 year
Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
No visual field defect in the seeing eye (nasal field of at least >45degree)
Exclusion Criteria:
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
Any person with a history (such as pacemaker use or photosensitive epilepsy)
Any person with motor movements problem (e.g., unable to use extremities)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaehyun Jung, PhD
Phone
617-912-2525
Email
jaehyun_jung@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaehyun Jung, PhD
Organizational Affiliation
Schepens Eye Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32855881
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.
Results Reference
result
PubMed Identifier
30169357
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.
Results Reference
result
PubMed Identifier
30169356
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.
Results Reference
result
Learn more about this trial
Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision
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