<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/NCT01701700</url>
  </required_header>
  <id_info>
    <org_study_id>PB-PG-0211-24105</org_study_id>
    <secondary_id>R01715</secondary_id>
    <nct_id>NCT01701700</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment</brief_title>
  <acronym>p-EVES</acronym>
  <official_title>The Effectiveness of Portable Electronic Vision Enhancement Systems (EVES) in Comparison to Optical Magnifiers for Near Vision Activities in Visual Impairment - The p-EVES Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bangor University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over 1 million people in the UK suffer from untreatable visual impairment, many of them&#xD;
      elderly. The major complaint of visually impaired people is their inability to carry out&#xD;
      simple tasks, especially those involving reading. It is known that this activity limitation&#xD;
      is a major cause of depression in an older population, and it is reflected in reduced quality&#xD;
      of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense&#xD;
      optical magnifiers to allow patients to carry out these tasks again, but these devices do&#xD;
      have limitations (unusual posture, short working distance, monocular viewing). Although&#xD;
      electronic magnifiers have been around since the 1960s, they were initially very large and&#xD;
      expensive. Recent advances in technology have brought about an explosion in the number and&#xD;
      range of portable and moderately-priced aids, which can be used binocularly, in a natural&#xD;
      working position: these are currently not available through the NHS. Evidence is needed as to&#xD;
      whether these portable hand-held electronic magnifiers could offer a significant benefit to&#xD;
      the majority of patients, and therefore whether they should be routinely dispensed in low&#xD;
      vision clinics.&#xD;
&#xD;
      The proposed study is a two-arm randomised crossover trial with existing users of optical&#xD;
      magnifiers being assigned to use a hand-held electronic magnifier in addition to their&#xD;
      existing devices for 2 months. Reading and task performance will be measured with the aid,&#xD;
      and compared to the performance with optical aids, and the patient will be asked to report on&#xD;
      the comparisons between the aids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>usage of magnifiers</measure>
    <time_frame>Change from baseline at 2 months and 4 months</time_frame>
    <description>Use of Manchester Low Vision Questionnaire to quantify device usage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>reading speed</measure>
    <time_frame>Change from baseline at 2 months and 4 months</time_frame>
    <description>Reading speed using the device assessed by MNREAD test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>speed of performance of activities of daily living</measure>
    <time_frame>Change from baseline at 2 months and 4 months</time_frame>
    <description>total time taken to performance 5 selected activities of daily living using aids if required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difficulty with near vision activities</measure>
    <time_frame>Change from baseline at 2 months and 4 months</time_frame>
    <description>Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>Change from baseline at 2 months and 4 months</time_frame>
    <description>Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>well-being</measure>
    <time_frame>Change from baseline at 2 months and 4 months</time_frame>
    <description>use of WHO-5 questionnaire to self-rate wellbeing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Moderate or Severe Vision Impairment, Both Eyes</condition>
  <arm_group>
    <arm_group_label>portable electronic magnifier</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>optical aids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of existing optical aids for 2 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>portable electronic magnifier</intervention_name>
    <arm_group_label>portable electronic magnifier</arm_group_label>
    <other_name>electronic video magnifier</other_name>
    <other_name>portable CCTV</other_name>
    <other_name>electronic vision enhancement system</other_name>
    <other_name>EVES</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>optical aids</intervention_name>
    <arm_group_label>optical aids</arm_group_label>
    <arm_group_label>portable electronic magnifier</arm_group_label>
    <other_name>magnifiers</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of Manchester Royal Eye Hospital&#xD;
&#xD;
          -  Visual impairment secondary to range of stable ocular pathologies (no change in VA &gt; 2&#xD;
             lines in previous 6 months)&#xD;
&#xD;
          -  Currently possess a near vision optical magnifying device.&#xD;
&#xD;
          -  VA &lt;= 6/30 (&lt;=0.7 logMAR) and/or log contrast sensitivity &lt;=1.20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of personal EVES device&#xD;
&#xD;
          -  Hearing inadequate to respond to verbal instruction&#xD;
&#xD;
          -  Habitual language not English&#xD;
&#xD;
          -  A physical disability preventing the participant from operating the device&#xD;
&#xD;
          -  A score of less than 19 on the Mini-Mental State Examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris M Dickinson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manchester Royal Eye Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>portable electronic magnifiers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
  </condition_browse>
  <!-- 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/NCT01701700
org study id: PB-PG-0211-24105
secondary id: R01715
nct id: NCT01701700
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Over 1 million people in the UK suffer from untreatable visual impairment, many of them
      elderly. The major complaint of visually impaired people is their inability to carry out
      simple tasks, especially those involving reading. It is known that this activity limitation
      is a major cause of depression in an older population, and it is reflected in reduced quality
      of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense
      optical magnifiers to allow patients to carry out these tasks again, but these devices do
      have limitations (unusual posture, short working distance, monocular viewing). Although
      electronic magnifiers have been around since the 1960s, they were initially very large and
      expensive. Recent advances in technology have brought about an explosion in the number and
      range of portable and moderately-priced aids, which can be used binocularly, in a natural
      working position: these are currently not available through the NHS. Evidence is needed as to
      whether these portable hand-held electronic magnifiers could offer a significant benefit to
      the majority of patients, and therefore whether they should be routinely dispensed in low
      vision clinics.

      The proposed study is a two-arm randomised crossover trial with existing users of optical
      magnifiers being assigned to use a hand-held electronic magnifier in addition to their
      existing devices for 2 months. Reading and task performance will be measured with the aid,
      and compared to the performance with optical aids, and the patient will be asked to report on
      the comparisons between the aids.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: usage of magnifiers
time frame: Change from baseline at 2 months and 4 months
description: Use of Manchester Low Vision Questionnaire to quantify device usage
measure: reading speed
time frame: Change from baseline at 2 months and 4 months
description: Reading speed using the device assessed by MNREAD test
measure: speed of performance of activities of daily living
time frame: Change from baseline at 2 months and 4 months
description: total time taken to performance 5 selected activities of daily living using aids if required
measure: difficulty with near vision activities
time frame: Change from baseline at 2 months and 4 months
description: Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
measure: health related quality of life
time frame: Change from baseline at 2 months and 4 months
description: Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
measure: well-being
time frame: Change from baseline at 2 months and 4 months
description: use of WHO-5 questionnaire to self-rate wellbeing
arm group label: portable electronic magnifier
arm group type: Experimental
description: Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months
arm group label: optical aids
arm group type: Active Comparator
description: Use of existing optical aids for 2 months
intervention type: Procedure
intervention name: portable electronic magnifier
arm group label: portable electronic magnifier
other name: electronic video magnifier
other name: portable CCTV
other name: electronic vision enhancement system
other name: EVES
intervention type: Procedure
intervention name: optical aids
arm group label: optical aids
arm group label: portable electronic magnifier
other name: magnifiers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Chris M Dickinson, PhD
role: Principal Investigator
affiliation: University of Manchester
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Vision Disorders
mesh term: Vision, Low