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

Not Applicable

Completed

• Conditions: Moderate or Severe Vision Impairment, Both Eyes
• Interventions: Procedure: optical aids; Procedure: portable electronic magnifier

• Registration Number: NCT01701700
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-05
• Study Start: 2013-02
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
optical aids	optical aids	Use of existing optical aids for 2 months
portable electronic magnifier	portable electronic magnifier	Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months
portable electronic magnifier	optical aids	Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Manchester Royal Eye Hospital; 🇬🇧 Manchester, United Kingdom