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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Central Manchester University Hospitals NHS Foundation Trust
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Manchester
Cardiff University
Bangor University
Information provided by (Responsible Party):
Prof Chris Dickinson, Central Manchester University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01701700
First received: October 1, 2012
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Moderate or Severe Vision Impairment, Both Eyes
Procedure: portable electronic magnifier
Procedure: optical aids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Central Manchester University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • usage of magnifiers [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]
    Use of Manchester Low Vision Questionnaire to quantify device usage

  • reading speed [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]
    Reading speed using the device assessed by MNREAD test


Secondary Outcome Measures:
  • speed of performance of activities of daily living [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    use of WHO-5 questionnaire to self-rate wellbeing


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: portable electronic magnifier
Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months
Procedure: portable electronic magnifier
Other Names:
  • electronic video magnifier
  • portable CCTV
  • electronic vision enhancement system
  • EVES
Procedure: optical aids
Other Name: magnifiers
Active Comparator: optical aids
Use of existing optical aids for 2 months
Procedure: optical aids
Other Name: magnifiers

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701700

Contacts
Contact: Chris M Dickinson, PhD +44 (0)161 306 3874 chris.dickinson@manchester.ac.uk

Locations
United Kingdom
Manchester Royal Eye Hospital Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Robert A Harper, DPhil       robert.harper@cmft.nhs.uk   
Sponsors and Collaborators
Central Manchester University Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom
University of Manchester
Cardiff University
Bangor University
Investigators
Principal Investigator: Chris M Dickinson, PhD University of Manchester
  More Information

No publications provided

Responsible Party: Prof Chris Dickinson, Professor of Clinical Optometry, Central Manchester University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01701700     History of Changes
Other Study ID Numbers: PB-PG-0211-24105, R01715
Study First Received: October 1, 2012
Last Updated: April 9, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Central Manchester University Hospitals NHS Foundation Trust:
portable electronic magnifiers

ClinicalTrials.gov processed this record on October 23, 2014