<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/NCT01670643</url>
  </required_header>
  <id_info>
    <org_study_id>09-11-116</org_study_id>
    <secondary_id>09-11-116</secondary_id>
    <nct_id>NCT01670643</nct_id>
  </id_info>
  <brief_title>Reading Performance With a Video Magnifier</brief_title>
  <official_title>The Effect of Video Camera Magnifier Use on Reading</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mary Lou Jackson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts Eye and Ear Infirmary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most common goal for patients with vision loss who present for vision rehabilitation is&#xD;
      to be able to read. The video magnifier (a device which combines a video camera and a screen&#xD;
      to view the print being magnified) is the device which most often allows low-vision&#xD;
      individuals to read successfully for extended periods of time. Previous studies on the&#xD;
      outcomes of vision rehabilitation have not identified which components of the vision&#xD;
      rehabilitation are effective. The hypothesis of this project is that providing a video camera&#xD;
      magnifier, with basic training in operating the device, will allow patients to enhance both&#xD;
      objective reading ability and subjective report of reading competence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be given a video magnifier at initial consultation or at the end of vision&#xD;
      rehabilitation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">April 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in objective reading performance</measure>
    <time_frame>baseline and one month</time_frame>
    <description>The subject undergoes testing to determine the change in reading performance on an objective scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective reading performance</measure>
    <time_frame>baseline and one month</time_frame>
    <description>The subject is asked to describe subjectively how they feel their ability to read has either improved or decreased since using the reader.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Video camera magnifier</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video camera magnifier</intervention_name>
    <description>reading with video camera magnifier</description>
    <arm_group_label>Video camera magnifier</arm_group_label>
    <other_name>Optelec video magnifier</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Central field loss and decreased visual acuity in the better seeing eye (&lt;20/40 &amp;&#xD;
             &gt;20/400).&#xD;
&#xD;
          -  New patient at MEEI Low Vision Rehabilitation Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia (Mini-Mental State Examination)&#xD;
&#xD;
          -  Clinical depression (Geriatric Depression Scale)&#xD;
&#xD;
          -  Patients who previously received vision rehabilitation&#xD;
&#xD;
          -  Patients who have previously owned a desktop video magnifier&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Lou Jackson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vision Rehabilitation Center MEEI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vision Rehabilitation Clinic Massachusetts Eye and Ear Infirmary</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 6, 2010</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts Eye and Ear Infirmary</investigator_affiliation>
    <investigator_full_name>Mary Lou Jackson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>AMD</keyword>
  <keyword>vision rehabilitation</keyword>
  <keyword>video camera magnifier</keyword>
  <keyword>IVI</keyword>
  <keyword>DASS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</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/NCT01670643
org study id: 09-11-116
secondary id: 09-11-116
nct id: NCT01670643
lead sponsor: 
has dmc: No
The most common goal for patients with vision loss who present for vision rehabilitation is
      to be able to read. The video magnifier (a device which combines a video camera and a screen
      to view the print being magnified) is the device which most often allows low-vision
      individuals to read successfully for extended periods of time. Previous studies on the
      outcomes of vision rehabilitation have not identified which components of the vision
      rehabilitation are effective. The hypothesis of this project is that providing a video camera
      magnifier, with basic training in operating the device, will allow patients to enhance both
      objective reading ability and subjective report of reading competence.
Patients will be given a video magnifier at initial consultation or at the end of vision
      rehabilitation
observational model: Case-Crossover
time perspective: Prospective
measure: Change in objective reading performance
time frame: baseline and one month
description: The subject undergoes testing to determine the change in reading performance on an objective scale.
measure: Change in subjective reading performance
time frame: baseline and one month
description: The subject is asked to describe subjectively how they feel their ability to read has either improved or decreased since using the reader.
arm group label: Video camera magnifier
intervention type: Behavioral
intervention name: Video camera magnifier
description: reading with video camera magnifier
arm group label: Video camera magnifier
other name: Optelec video magnifier
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Lou Jackson, MD
role: Principal Investigator
affiliation: Vision Rehabilitation Center MEEI
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Massachusetts Eye and Ear Infirmary
investigator full name: Mary Lou Jackson
investigator title: Principal Investigator
mesh term: Macular Degeneration
sharing ipd: No