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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701700
First Posted: October 5, 2012
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Crossover Assignment
Masking: None (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 Prof Chris Dickinson, Central Manchester University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: February 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701700


Locations
United Kingdom
Manchester Royal Eye Hospital
Manchester, United Kingdom, M13 9WL
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

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 ( Other Identifier: CMFT )
First Submitted: October 1, 2012
First Posted: October 5, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Prof Chris Dickinson, Central Manchester University Hospitals NHS Foundation Trust:
portable electronic magnifiers

Additional relevant MeSH terms:
Vision Disorders
Myopia
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Refractive Errors