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

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate or Severe Vision Impairment, Both Eyes
• Intervention / Treatment: Procedure: portable electronic magnifier; Procedure: optical aids

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: magnifiers
Active Comparator: optical aids; Use of existing optical aids for 2 months	Procedure: optical aids; Other Names: magnifiers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
usage of magnifiers	Use of Manchester Low Vision Questionnaire to quantify device usage	Change from baseline at 2 months and 4 months
reading speed	Reading speed using the device assessed by MNREAD test	Change from baseline at 2 months and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
speed of performance of activities of daily living	total time taken to performance 5 selected activities of daily living using aids if required	Change from baseline at 2 months and 4 months
difficulty with near vision activities	Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities	Change from baseline at 2 months and 4 months
health related quality of life	Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life	Change from baseline at 2 months and 4 months
well-being	use of WHO-5 questionnaire to self-rate wellbeing	Change from baseline at 2 months and 4 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Cardiff University; University of Manchester; National Institute for Health Research, United Kingdom; Bangor University
• Investigators: Principal Investigator: Chris M Dickinson, PhD, University of Manchester

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (Estimate): October 5, 2012

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: portable electronic magnifiers
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: PB-PG-0211-24105; R01715 (Other Identifier: CMFT)