Clinical trial NCT01701700: The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate or Severe Vision Impairment, Both Eyes
Keywords: portable electronic magnifiers
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Manchester
name: Cardiff University
name: Bangor University
First posted: 2012-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: usage of magnifiers
timeFrame: Change from baseline at 2 months and 4 months
measure: reading speed
timeFrame: Change from baseline at 2 months and 4 months
Secondary outcomes:
measure: speed of performance of activities of daily living
timeFrame: Change from baseline at 2 months and 4 months
measure: difficulty with near vision activities
timeFrame: Change from baseline at 2 months and 4 months
measure: health related quality of life
timeFrame: Change from baseline at 2 months and 4 months
measure: well-being
timeFrame: Change from baseline at 2 months and 4 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
Study officials:
affiliation: University of Manchester
name: Chris M Dickinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: