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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate or Severe Vision Impairment, Both Eyes

Intervention / Treatment
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* Procedure: portable electronic magnifier
* Procedure: optical aids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: portable electronic magnifier<br>Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months | Procedure: portable electronic magnifier<br> <br> * Other names: EVES;Procedure: optical aids<br> <br> * Other names: magnifiers;|
| Active Comparator: optical aids<br>Use of existing optical aids for 2 months | Procedure: optical aids<br> <br> * Other names: magnifiers;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portable electronic magnifiers