search
Back to results

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

Primary Purpose

Moderate or Severe Vision Impairment, Both Eyes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
portable electronic magnifier
optical aids
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate or Severe Vision Impairment, Both Eyes focused on measuring portable electronic magnifiers

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manchester Royal Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

portable electronic magnifier

optical aids

Arm Description

Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months

Use of existing optical aids for 2 months

Outcomes

Primary Outcome Measures

usage of magnifiers
Use of Manchester Low Vision Questionnaire to quantify device usage
reading speed
Reading speed using the device assessed by MNREAD test

Secondary Outcome Measures

speed of performance of activities of daily living
total time taken to performance 5 selected activities of daily living using aids if required
difficulty with near vision activities
Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
health related quality of life
Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
well-being
use of WHO-5 questionnaire to self-rate wellbeing

Full Information

First Posted
October 1, 2012
Last Updated
November 30, 2018
Sponsor
Manchester University NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Manchester, Cardiff University, Bangor University
search

1. Study Identification

Unique Protocol Identification Number
NCT01701700
Brief Title
The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
Acronym
p-EVES
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Manchester, Cardiff University, Bangor University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate or Severe Vision Impairment, Both Eyes
Keywords
portable electronic magnifiers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
portable electronic magnifier
Arm Type
Experimental
Arm Description
Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months
Arm Title
optical aids
Arm Type
Active Comparator
Arm Description
Use of existing optical aids for 2 months
Intervention Type
Procedure
Intervention Name(s)
portable electronic magnifier
Other Intervention Name(s)
electronic video magnifier, portable CCTV, electronic vision enhancement system, EVES
Intervention Type
Procedure
Intervention Name(s)
optical aids
Other Intervention Name(s)
magnifiers
Primary Outcome Measure Information:
Title
usage of magnifiers
Description
Use of Manchester Low Vision Questionnaire to quantify device usage
Time Frame
Change from baseline at 2 months and 4 months
Title
reading speed
Description
Reading speed using the device assessed by MNREAD test
Time Frame
Change from baseline at 2 months and 4 months
Secondary Outcome Measure Information:
Title
speed of performance of activities of daily living
Description
total time taken to performance 5 selected activities of daily living using aids if required
Time Frame
Change from baseline at 2 months and 4 months
Title
difficulty with near vision activities
Description
Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
Time Frame
Change from baseline at 2 months and 4 months
Title
health related quality of life
Description
Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
Time Frame
Change from baseline at 2 months and 4 months
Title
well-being
Description
use of WHO-5 questionnaire to self-rate wellbeing
Time Frame
Change from baseline at 2 months and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris M Dickinson, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester Royal Eye Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs