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The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment (p-EVES)

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ClinicalTrials.gov Identifier: NCT01701700
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Manchester
Cardiff University
Bangor University
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE October 1, 2012
First Posted Date  ICMJE October 5, 2012
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • usage of magnifiers [ Time Frame: Change from baseline at 2 months and 4 months ]
    Use of Manchester Low Vision Questionnaire to quantify device usage
  • reading speed [ Time Frame: Change from baseline at 2 months and 4 months ]
    Reading speed using the device assessed by MNREAD test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • speed of performance of activities of daily living [ Time Frame: Change from baseline at 2 months and 4 months ]
    total time taken to performance 5 selected activities of daily living using aids if required
  • difficulty with near vision activities [ Time Frame: Change from baseline at 2 months and 4 months ]
    Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
  • health related quality of life [ Time Frame: Change from baseline at 2 months and 4 months ]
    Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
  • well-being [ Time Frame: Change from baseline at 2 months and 4 months ]
    use of WHO-5 questionnaire to self-rate wellbeing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Moderate or Severe Vision Impairment, Both Eyes
Intervention  ICMJE
  • Procedure: portable electronic magnifier
    Other Names:
    • electronic video magnifier
    • portable CCTV
    • electronic vision enhancement system
    • EVES
  • Procedure: optical aids
    Other Name: magnifiers
Study Arms  ICMJE
  • Experimental: portable electronic magnifier
    Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months
    Interventions:
    • Procedure: portable electronic magnifier
    • Procedure: optical aids
  • Active Comparator: optical aids
    Use of existing optical aids for 2 months
    Intervention: Procedure: optical aids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients of Manchester Royal Eye Hospital
  • Visual impairment secondary to range of stable ocular pathologies (no change in VA > 2 lines in previous 6 months)
  • Currently possess a near vision optical magnifying device.
  • VA <= 6/30 (<=0.7 logMAR) and/or log contrast sensitivity <=1.20

Exclusion Criteria:

  • Current use of personal EVES device
  • Hearing inadequate to respond to verbal instruction
  • Habitual language not English
  • A physical disability preventing the participant from operating the device
  • A score of less than 19 on the Mini-Mental State Examination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701700
Other Study ID Numbers  ICMJE PB-PG-0211-24105
R01715 ( Other Identifier: CMFT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manchester University NHS Foundation Trust
Study Sponsor  ICMJE Manchester University NHS Foundation Trust
Collaborators  ICMJE
  • National Institute for Health Research, United Kingdom
  • University of Manchester
  • Cardiff University
  • Bangor University
Investigators  ICMJE
Principal Investigator: Chris M Dickinson, PhD University of Manchester
PRS Account Manchester University NHS Foundation Trust
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP