Moderate or Severe Vision Impairment, Both Eyes Clinical Trial
— p-EVESOfficial 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
| Verified date | November 2018 |
| Source | Manchester University NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 95 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Manchester Royal Eye Hospital | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Manchester University NHS Foundation Trust | Bangor University, Cardiff University, National Institute for Health Research, United Kingdom, University of Manchester |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | usage of magnifiers | Use of Manchester Low Vision Questionnaire to quantify device usage | Change from baseline at 2 months and 4 months | |
| Primary | reading speed | Reading speed using the device assessed by MNREAD test | Change from baseline at 2 months and 4 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | well-being | use of WHO-5 questionnaire to self-rate wellbeing | Change from baseline at 2 months and 4 months |