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Completed

NCT Number: NCT01701700

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

portable electronic magnifier

Procedure

Other names: electronic video magnifier, portable CCTV, electronic vision enhancement system, EVES

optical aids

Procedure

Other names: magnifiers

Primary outcomes

  1. usage of magnifiers

    Time frame: Change from baseline at 2 months and 4 months

    Use of Manchester Low Vision Questionnaire to quantify device usage

  2. reading speed

    Time frame: Change from baseline at 2 months and 4 months

    Reading speed using the device assessed by MNREAD test

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. well-being

    Time frame: Change from baseline at 2 months and 4 months

    use of WHO-5 questionnaire to self-rate wellbeing

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Bangor University
  • Cardiff University
  • National Institute for Health Research, United Kingdom
  • University of Manchester

Registry information

Official study 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

Acronym: p-EVES

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2012
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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