Moderate or Severe Vision Impairment, Both Eyesp-EVESNCT01701700
The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
A study testing portable electronic magnifier and optical aids in people with Moderate or Severe Vision Impairment, Both Eyes, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Moderate or Severe Vision Impairment, Both Eyes
- What is being tested?
- portable electronic magnifier and optical aids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- portable electronic magnifier, optical aids
- Keywords
- portable electronic magnifiers
- Medical subject headings
- Lymphoma, Follicular, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable electronic magnifierProcedure or surgery
Also called electronic video magnifier, portable CCTV, electronic vision enhancement system, EVES
optical aidsProcedure or surgery
Also called magnifiers
| Study group | Role | What they receive |
|---|---|---|
| portable electronic magnifier | Experimental | Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months Receives: Procedure: portable electronic magnifier; Procedure: optical aids |
| optical aids | Active comparator | Use of existing optical aids for 2 months Receives: Procedure: optical aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
usage of magnifiers
Use of Manchester Low Vision Questionnaire to quantify device usage
Measured: Change from baseline at 2 months and 4 months
reading speed
Reading speed using the device assessed by MNREAD test
Measured: Change from baseline at 2 months and 4 months
Secondary outcomes (4)
speed of performance of activities of daily living
total time taken to performance 5 selected activities of daily living using aids if required
Measured: Change from baseline at 2 months and 4 months
difficulty with near vision activities
Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities
Measured: Change from baseline at 2 months and 4 months
health related quality of life
Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life
Measured: Change from baseline at 2 months and 4 months
well-being
use of WHO-5 questionnaire to self-rate wellbeing
Measured: Change from baseline at 2 months and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate or Severe Vision Impairment, Both EyesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- National Institute for Health Research, United Kingdom, University of Manchester, Cardiff University, Bangor University
- Responsible party
- Sponsor
- Investigators
- Chris M Dickinson, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701700
- Sponsor's protocol ID
- PB-PG-0211-24105
- Other IDs
- R01715
- Acronym
- p-EVES
- Status last verified
- Nov 2018
- First submitted
- 1 Oct 2012
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01701700
- Acronym / sponsor ID
- p-EVES / PB-PG-0211-24105
- Keywords
- portable electronic magnifiers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- National Institute for Health Research, United Kingdom, University of Manchester, Cardiff University, Bangor University
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| portable electronic magnifier | Experimental | Procedure: portable electronic magnifier, Procedure: optical aidsUse of a prescribed electronic magnifier plus existing optical aids for a period of 2 months |
| optical aids | Active comparator | Procedure: optical aidsUse of existing optical aids for 2 months |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| portable electronic magnifierAlso: electronic video magnifier, portable CCTV, electronic vision enhancement system, EVES | Procedure or surgery | portable electronic magnifier |
| optical aidsAlso: magnifiers | Procedure or surgery | optical aids, portable electronic magnifier |
Primary outcome
usage of magnifiers
Time frame: Change from baseline at 2 months and 4 months
Use of Manchester Low Vision Questionnaire to quantify device usage
reading speed
Time frame: Change from baseline at 2 months and 4 months
Reading speed using the device assessed by MNREAD test
4 secondary outcomes
speed of performance of activities of daily living
Time frame: 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
health related quality of life
Time frame: Change from baseline at 2 months and 4 months
well-being
Time frame: Change from baseline at 2 months and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris M Dickinson, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portable electronic magnifier and optical aids in people with Moderate or Severe Vision Impairment, Both Eyes, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usage of magnifiers (time frame: Change from baseline at 2 months and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.