<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/NCT04424979</url>
  </required_header>
  <id_info>
    <org_study_id>MPP_Feasibility1</org_study_id>
    <secondary_id>R01EY023385</secondary_id>
    <nct_id>NCT04424979</nct_id>
  </id_info>
  <brief_title>Feasibility Tests for Various Prism Configurations for Visual Field Loss</brief_title>
  <official_title>Visual Field Expansion Through Innovative Multi-Periscopic Prism Design</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>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will develop and test different configurations of high-power prisms to&#xD;
      expand the field of vision of patients with visual field loss to assist them with obstacle&#xD;
      detection when walking. The study will involve multiple visits (typically four) to Schepens&#xD;
      Eye Research Institute for fitting and testing with the prism glasses. The overall objective&#xD;
      is to determine best designs and fitting parameters for implementation in prism devices for&#xD;
      future clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 6, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Field of view expansion</measure>
    <time_frame>Through study completion, an average of four months</time_frame>
    <description>Horizontal and vertical extent of the expansion (in degrees) of the field of view</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pedestrian detection rate</measure>
    <time_frame>Through study completion, an average of four months</time_frame>
    <description>Proportion of pedestrians detected (in simulated walking or simulated driving)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hemianopia, Homonymous</condition>
  <condition>Tunnel Vision</condition>
  <condition>Visual Field Defect, Peripheral</condition>
  <condition>Visual Field Constriction Bilateral</condition>
  <condition>Visual Field Defect Homonymous Bilateral</condition>
  <arm_group>
    <arm_group_label>High power prisms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High power prisms</intervention_name>
    <description>High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision</description>
    <arm_group_label>High power prisms</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Visual field loss, either peripheral field loss or hemianopic field loss&#xD;
&#xD;
          -  Visual acuity of at least 20/50 in the better eye&#xD;
&#xD;
          -  In sufficiently good health to be able to complete sessions lasting 2-4 hours&#xD;
&#xD;
          -  Able to independently walk short distances&#xD;
&#xD;
          -  Able to give voluntary, informed consent&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any physical or mental impairments, including cognitive dysfunction, balance problems&#xD;
             or other deficits that could impair the ability to walk or use the prism spectacles&#xD;
&#xD;
          -  A history of seizures in the last 6 months&#xD;
&#xD;
          -  Hemispatial neglect (subjects with hemianopic field loss only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliezer Peli, MSc, OD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schepens Eye Research Institute of Massachusetts Eye and Ear</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sailaja Manda</last_name>
    <phone>617 912 2522</phone>
    <email>sailaja_manda@meei.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alex Bowers, PhD</last_name>
    <phone>617 912 2512</phone>
    <email>alex_bowers@meei.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Schepens Eye Research Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 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>Eli Peli</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>Visual field expansion</keyword>
  <keyword>Prisms</keyword>
  <keyword>Hemianopsia</keyword>
  <keyword>Tunnel vision</keyword>
  <keyword>Visual field loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemianopsia</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04424979
org study id: MPP_Feasibility1
secondary id: R01EY023385
nct id: NCT04424979
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The investigators will develop and test different configurations of high-power prisms to
      expand the field of vision of patients with visual field loss to assist them with obstacle
      detection when walking. The study will involve multiple visits (typically four) to Schepens
      Eye Research Institute for fitting and testing with the prism glasses. The overall objective
      is to determine best designs and fitting parameters for implementation in prism devices for
      future clinical trials.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Field of view expansion
time frame: Through study completion, an average of four months
description: Horizontal and vertical extent of the expansion (in degrees) of the field of view
measure: Pedestrian detection rate
time frame: Through study completion, an average of four months
description: Proportion of pedestrians detected (in simulated walking or simulated driving)
arm group label: High power prisms
arm group type: Experimental
description: Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.
intervention type: Device
intervention name: High power prisms
description: High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision
arm group label: High power prisms
criteria: 
gender: All
minimum age: 7 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eliezer Peli, MSc, OD
role: Principal Investigator
affiliation: Schepens Eye Research Institute of Massachusetts Eye and Ear
last name: Sailaja Manda
phone: 617 912 2522
email: sailaja_manda@meei.harvard.edu
last name: Alex Bowers, PhD
phone: 617 912 2512
email: alex_bowers@meei.harvard.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts Eye and Ear Infirmary
investigator full name: Eli Peli
investigator title: Senior Scientist
mesh term: Hemianopsia
mesh term: Constriction, Pathologic
sharing ipd: No