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/NCT06027216</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001878</org_study_id>
      <secondary_id>R01EY031777</secondary_id>
      <nct_id>NCT06027216</nct_id>
    </id_info>
    <brief_title>Multiplexing Prism Fitting for Field Expansion of 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 are testing a simplified design and fitting protocol to provide field&#xD;
        expansion for individuals with acquired monocular vision.&#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>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Field expansion from multiplexing prism</measure>
      <time_frame>Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum extent of nasal visual field with multiplexing prism</measure>
      <time_frame>Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period</time_frame>
      <description>The farthest nasal field of view with multiplexing 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>Field Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism</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>Field Expansion</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;
            -  No medical health issues such as seizures, motor movements problem&#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 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, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Schepens Eye Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jaehyun Jung, Ph.D.</last_name>
      <phone>617-912-2525</phone>
      <email>jaehyun_jung@meei.harvard.edu</email>
    </overall_contact>
    <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>
    </reference>
    <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>
    </reference>
    <reference>
      <citation>Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.</citation>
      <PMID>28727615</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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>Field expansion</keyword>
    <keyword>Collision detection</keyword>
    <keyword>Walking</keyword>
    <keyword>Response time</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/NCT06027216
  org study id: 2023P001878
  secondary id: R01EY031777
  nct id: NCT06027216
  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 are testing a simplified design and fitting protocol to provide field
        expansion for individuals with acquired monocular vision.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Individuals with Acquired Monocular Vision/ Blindness in One Eye
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Field expansion from multiplexing prism
  time frame: Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period
  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.
  measure: Maximum extent of nasal visual field with multiplexing prism
  time frame: Approximately 2 sessions, up to 3 hours for each session, any time within 2 month period
  description: The farthest nasal field of view with multiplexing prism
  arm group label: Field Expansion
  arm group type: Experimental
  description: Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism
  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: Field Expansion
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jaehyun Jung, Ph.D.
  role: Principal Investigator
  affiliation: Schepens Eye Research Institute
  last name: Jaehyun Jung, Ph.D.
  phone: 617-912-2525
  email: jaehyun_jung@meei.harvard.edu
  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
  citation: Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.
  PMID: 28727615
  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