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

NCT01701700 | Completed

• 2 other identifiers: PB-PG-0211-24105R01715
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate or Severe Vision Impairment, Both Eyes

Keywords

portable electronic magnifiers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• speed of performance of activities of daily living

  Change from baseline at 2 months and 4 months

• difficulty with near vision activities

  Change from baseline at 2 months and 4 months

• health related quality of life

  Change from baseline at 2 months and 4 months

• well-being

  Change from baseline at 2 months and 4 months

Study Arms (2)

portable electronic magnifier

EXPERIMENTAL

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

Procedure: portable electronic magnifier; Procedure: optical aids

optical aids

ACTIVE COMPARATOR

Use of existing optical aids for 2 months

Procedure: optical aids

Interventions

portable electronic magnifier PROCEDURE

Also known as: electronic video magnifier, portable CCTV, electronic vision enhancement system, EVES

portable electronic magnifier

optical aids PROCEDURE

Also known as: magnifiers

optical aids; portable electronic magnifier

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Manchester: collaborator
• Cardiff University: collaborator
• Bangor University: collaborator

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Vision Disorders

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris M Dickinson, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 5, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

GB (1)