The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Moderate or Severe Vision Impairment, Both Eyes |
Procedure: portable electronic magnifier Procedure: optical aids |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- usage of magnifiers [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]Use of Manchester Low Vision Questionnaire to quantify device usage
- reading speed [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]Reading speed using the device assessed by MNREAD test
- speed of performance of activities of daily living [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]total time taken to performance 5 selected activities of daily living using aids if required
- difficulty with near vision activities [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
- health related quality of life [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
- well-being [ Time Frame: Change from baseline at 2 months and 4 months ] [ Designated as safety issue: No ]use of WHO-5 questionnaire to self-rate wellbeing
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Procedure: optical aids
Other Name: magnifiers
|
|
Active Comparator: optical aids
Use of existing optical aids for 2 months
|
Procedure: optical aids
Other Name: magnifiers
|
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Chris M Dickinson, PhD | +44 (0)161 306 3874 | chris.dickinson@manchester.ac.uk |
| United Kingdom | |
| Manchester Royal Eye Hospital | Recruiting |
| Manchester, United Kingdom, M13 9WL | |
| Contact: Robert A Harper, DPhil robert.harper@cmft.nhs.uk | |
| Principal Investigator: | Chris M Dickinson, PhD | University of Manchester |
More Information
No publications provided
| Responsible Party: | Prof Chris Dickinson, Professor of Clinical Optometry, Central Manchester University Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01701700 History of Changes |
| Other Study ID Numbers: | PB-PG-0211-24105, R01715 |
| Study First Received: | October 1, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Central Manchester University Hospitals NHS Foundation Trust:
|
portable electronic magnifiers |
Additional relevant MeSH terms:
|
Myopia Vision, Low Vision Disorders Refractive Errors Eye Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013