Completed

p-EVESThe Effectiveness of Portable Electronic Vision Enhancement Systems (EVES) in Comparison to Optical Magnifiers for Near Vision Activities in Visual Impairment - The p-EVES Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

portable electronic magnifier

+ optical aids

+ optical aids

Procedure
Who is being recruted

Eye Diseases+14

+ Hemic and Lymphatic Diseases

+ Immune System Diseases

From 18 to 95 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorManchester University NHS Foundation Trust
Last updated: December 4, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorManchester University NHS Foundation Trust
Last updated: December 4, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 95 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNervous System DiseasesNeurologic ManifestationsSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsLymphoma, FollicularVision Disorders

Criteria

4 inclusion criteria required to participate
Currently possess a near vision optical magnifying device

Patients of Manchester Royal Eye Hospital

VA <= 6/30 ( <= 0.7 logMAR) and/or log contrast sensitivity <= 1.20

Visual impairment secondary to range of stable ocular pathologies (no change in VA > 2 lines in previous 6 months)

5 exclusion criteria prevent from participating
A physical disability preventing the participant from operating the device

A score of less than 19 on the Mini-Mental State Examination

Current use of personal EVES device

Habitual language not English

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
Use of existing optical aids for 2 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Manchester Royal Eye Hospital

Manchester, United KingdomOpen Manchester Royal Eye Hospital in Google Maps
CompletedOne Study Center