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

November 30, 2018 updated by: Manchester University NHS Foundation Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: portable electronic magnifier
Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months
Procedure: portable electronic magnifier
Other Names:
  • electronic video magnifier
  • portable CCTV
  • electronic vision enhancement system
  • EVES
Procedure: optical aids
Other Names:
  • magnifiers
Active Comparator: optical aids
Use of existing optical aids for 2 months
Procedure: optical aids
Other Names:
  • magnifiers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
usage of magnifiers
Time Frame: Change from baseline at 2 months and 4 months
Use of Manchester Low Vision Questionnaire to quantify device usage
Change from baseline at 2 months and 4 months
reading speed
Time Frame: Change from baseline at 2 months and 4 months
Reading speed using the device assessed by MNREAD test
Change from baseline at 2 months and 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
speed of performance of activities of daily living
Time Frame: Change from baseline at 2 months and 4 months
total time taken to performance 5 selected activities of daily living using aids if required
Change from baseline at 2 months and 4 months
difficulty with near vision activities
Time Frame: Change from baseline at 2 months and 4 months
Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
Change from baseline at 2 months and 4 months
health related quality of life
Time Frame: Change from baseline at 2 months and 4 months
Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
Change from baseline at 2 months and 4 months
well-being
Time Frame: Change from baseline at 2 months and 4 months
use of WHO-5 questionnaire to self-rate wellbeing
Change from baseline at 2 months and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester University NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardiff University
University of Manchester
National Institute for Health Research, United Kingdom
Bangor University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chris M Dickinson, PhD, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PB-PG-0211-24105
  • R01715 (Other Identifier: CMFT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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