xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06024668</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001885</org_study_id>
      <secondary_id>R01EY031777</secondary_id>
      <nct_id>NCT06024668</nct_id>
    </id_info>
    <brief_title>Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision</brief_title>
    <official_title>Monocular Visual Confusion for Field Expansion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts Eye and Ear Infirmary</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Eye Institute (NEI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts Eye and Ear Infirmary</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators are developing an assistive device, known as multiplexing prism that&#xD;
        expands the field of view for individuals with acquired monocular vision (loss of an eye).&#xD;
        The investigators will test the efficacy of the prism in improving the detection of colliding&#xD;
        pedestrians during a simulated walking task.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Individuals with Acquired Monocular Vision/ Blindness in One Eye</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean response time to detect colliding pedestrian</measure>
      <time_frame>Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pedestrian Detection Rate</measure>
      <time_frame>Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>One Eye Blindness</condition>
    <condition>Blind Left Eye</condition>
    <condition>Blind Right Eye</condition>
    <arm_group>
      <arm_group_label>Detection of colliding pedestrian</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Multiplexing Prism</intervention_name>
      <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 &quot;shifted view&quot; from the non-seeing side. It is developed to expand the field of view of individuals with just one eye.</description>
      <arm_group_label>Detection of colliding pedestrian</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  No medical health issues such as seizures, motor movements problem&#xD;
  &#xD;
            -  Loss of vision in one eye (no light perception/enucleation/evisceration) for &gt;1 year&#xD;
  &#xD;
            -  Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction&#xD;
  &#xD;
            -  No visual field defect in the seeing eye (nasal field of at least &gt;45degree)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any physical or mental disabilities, including cognitive dysfunction,&#xD;
               balance problems, or other deficits that could impair their ability to respond to the&#xD;
               stimuli presented in this study will be excluded&#xD;
  &#xD;
            -  Any person with a history (such as pacemaker use or photosensitive epilepsy)&#xD;
  &#xD;
            -  Any person with motor movements problem (e.g., unable to use extremities)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jaehyun Jung, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Schepens Eye Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jaehyun Jung, PhD</last_name>
      <phone>617-912-2525</phone>
      <email>jaehyun_jung@meei.harvard.edu</email>
    </overall_contact>
    <results_reference>
      <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.</citation>
      <PMID>32855881</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>30169357</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>30169356</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts Eye and Ear Infirmary</investigator_affiliation>
      <investigator_full_name>Jaehyun Jung</investigator_full_name>
      <investigator_title>Assistant Scientist</investigator_title>
    </responsible_party>
    <keyword>Simulated Walking</keyword>
    <keyword>Collision</keyword>
    <keyword>Field Expansion</keyword>
    <keyword>One eye blindness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Blindness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06024668
  org study id: 2023P001885
  secondary id: R01EY031777
  nct id: NCT06024668
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Individuals with Acquired Monocular Vision/ Blindness in One Eye
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Mean response time to detect colliding pedestrian
  time frame: 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.
  measure: Pedestrian Detection Rate
  time frame: 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.
  arm group label: Detection of colliding pedestrian
  arm group type: Experimental
  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: Multiplexing Prism
  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.
  arm group label: Detection of colliding pedestrian
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jaehyun Jung, PhD
  role: Principal Investigator
  affiliation: Schepens Eye Research Institute
  last name: Jaehyun Jung, PhD
  phone: 617-912-2525
  email: jaehyun_jung@meei.harvard.edu
  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: 32855881
  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: 30169357
  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.
  PMID: 30169356
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts Eye and Ear Infirmary
  investigator full name: Jaehyun Jung
  investigator title: Assistant Scientist
  mesh term: Blindness
  sharing ipd: No