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

NHS Foundation Trust

Status: Completed

Conditions: Moderate or Severe Vision Impairment, Both Eyes

Treatments: Procedure: portable electronic magnifier; Procedure: optical aids

Study type: Interventional

Funder types: Other

Identifiers

NCT01701700

R01715 (Other Identifier)

PB-PG-0211-24105

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

portable electronic magnifier

Experimental group

Description:

Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months

Treatment:

Procedure: optical aids

Procedure: portable electronic magnifier

optical aids

Active Comparator group

Description:

Use of existing optical aids for 2 months

Treatment:

Procedure: optical aids