search
Back to results

Multiplexing Prism Fitting for Field Expansion of 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
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for One Eye Blindness focused on measuring Field expansion, Collision detection, Walking, Response time

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) No medical health issues such as seizures, motor movements problem 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 motor movements problem (e.g., unable to use extremities)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Field Expansion

    Arm Description

    Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism

    Outcomes

    Primary Outcome Measures

    Field expansion from multiplexing prism
    Field expansion based on the maximum field of view on the nasal side (same side as the blind eye) with and without multiplexing prism. If the nasal field with multiplexing prism is larger than without prism, there is a gain in field expansion.

    Secondary Outcome Measures

    Maximum extent of nasal visual field with multiplexing prism
    The farthest nasal field of view with multiplexing prism

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Massachusetts Eye and Ear Infirmary
    Collaborators
    National Eye Institute (NEI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06027216
    Brief Title
    Multiplexing Prism Fitting for Field Expansion of 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 are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.

    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
    Field expansion, Collision detection, Walking, Response time

    7. Study Design

    Primary Purpose
    Device Feasibility
    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
    Field Expansion
    Arm Type
    Experimental
    Arm Description
    Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism
    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
    Field expansion from multiplexing prism
    Description
    Field expansion based on the maximum field of view on the nasal side (same side as the blind eye) with and without multiplexing prism. If the nasal field with multiplexing prism is larger than without prism, there is a gain in field expansion.
    Time Frame
    Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period
    Secondary Outcome Measure Information:
    Title
    Maximum extent of nasal visual field with multiplexing prism
    Description
    The farthest nasal field of view with multiplexing prism
    Time Frame
    Approximately 2 sessions, up to 3 hours for each session, any time within 2 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) No medical health issues such as seizures, motor movements problem 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 motor movements problem (e.g., unable to use extremities)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jaehyun Jung, Ph.D.
    Phone
    617-912-2525
    Email
    jaehyun_jung@meei.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaehyun Jung, Ph.D.
    Organizational Affiliation
    Schepens Eye Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    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
    background
    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
    background
    PubMed Identifier
    28727615
    Citation
    Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.
    Results Reference
    background

    Learn more about this trial

    Multiplexing Prism Fitting for Field Expansion of Monocular Vision

    We'll reach out to this number within 24 hrs