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

NCT ID: NCT01701700

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Moderate or Severe Vision Impairment, Both Eyes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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portable electronic magnifier

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

Group Type EXPERIMENTAL

portable electronic magnifier

Intervention Type PROCEDURE

optical aids

Intervention Type PROCEDURE

optical aids

Use of existing optical aids for 2 months

Group Type ACTIVE_COMPARATOR

optical aids

Intervention Type PROCEDURE

Interventions

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portable electronic magnifier

Intervention Type PROCEDURE

optical aids

Intervention Type PROCEDURE

Other Intervention Names

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electronic video magnifier portable CCTV electronic vision enhancement system EVES magnifiers

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role collaborator

Cardiff University

OTHER

Sponsor Role collaborator

Bangor University

OTHER

Sponsor Role collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris M Dickinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R01715

Identifier Type: OTHER

Identifier Source: secondary_id

PB-PG-0211-24105

Identifier Type: -

Identifier Source: org_study_id

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