GlaucomaNCT02162043
Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma
An observational study of Glaucoma and Diagnostic Self-evaluation, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This project aims to evaluate a self-administered screening test for glaucoma, the second largest cause of blindness in the western world. New approaches to glaucoma screening are needed because a significant number of patients first present to hospitals with advanced-stage glaucoma and late presentation is associated… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Diagnostic Self-evaluation
- How many people
- 168 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to 1 Oct 2017
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the usability trials, volunteers with no previous perimetric experience will be recruited. Subjects will be based at Greater Manchester area. For the hospital- and community- based trials subjects will be recruited by Manchester Royal Eye Hospital's outpatient clinic
Who may be able to join
- No visual field defects
- No previous visual field testing
- No visual field defects
Who cannot join
- Visual field defects MD>2dB
- Previous visual field testing experience
- For the hospital-based trials:
- Visual field defects MD>2dB
- For the community-based trials:
- Subject not owning a PC or tablet
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Eye Hospital
Manchester, Greater Manchester, M13 9WH
About this study
This project aims to evaluate a self-administered screening test for glaucoma, the second largest cause of blindness in the western world. New approaches to glaucoma screening are needed because a significant number of patients first present to hospitals with advanced-stage glaucoma and late presentation is associated with a much higher risk for future blindness. This project will develop a new user-friendly visual field test that will be made available through the internet for self-testing. It will conduct both hospital-based and community-based clinical trials to establish benefits and costs of this new test.
Read the detailed description
Objectives: At a recent (19/4/2013) Priority Setting Partnership workshop, facilitated by the James Lind Alliance, patients, carers and eye health professionals produced a list of the top ten priorities for glaucoma research (http://www.sightlosspsp.org.uk/). Number 4 on the list was: What can be done to improve early diagnosis of sight-threatening glaucoma? The overarching aim of this project is to develop and evaluate a new visual field screening self-test that can be used to improve the early detection of glaucoma and thereby meet one of the aims of the Priority Setting Partnership. We will conduct hospital- and community-based clinical trials on the new test to establish its performance.
Methodology: This project will clinically evaluate the new test deriving measures of sensitivity and specificity. These trials will be conducted on patients attending the outpatient department of Manchester Royal Eye Hospital (MREH) and will use simulated defects to link performance measure with the extent of field damage. Patients without any established field loss will be tested. On completion of hospital-based clinical trials we will undertake locally based community trials to establish performance when self-administered or administered with the aid of friends/family, i.e. without researcher/clinician involvement. We will make the test available (emailed attachment that will install the test on the patients PC, laptop, tablet) to patients attending the glaucoma clinics of MREH with a request to test their friends and relatives. Guidance notes will emphasise the increased risk of developing glaucoma in blood relatives and the increased risk with age to help them target those at higher risk of developing glaucoma. Those failing the screening test, twice, will then undergo further testing by one of the Glaucoma Referral Refinement optometrists in Manchester to derive estimates of true and false referral rates.
- Conditions
- Glaucoma, Diagnostic Self-evaluation
- Keywords
- Glaucoma, Perimetry, Diagnostic self-evaluation, Screening, Visual fields
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Usability assessment | Patients without any experience with visual field testing will be recruited and tested with different versions of the developed self-test. This will help identify usability features that will make the test user-friendly. | |
| Hospital-based clinical trial | The new test will be evaluated on patients attending Manchester Royal Eye Hospital to provide an estimate of its diagnostic performance. | |
| Community-based trial | Patients attending Manchester Royal Eye Hospital's outpatient clinics will be recruited to trial the new test on their friends and family in order to evaluate the uptake and performance of the new test in a home environment without any researchers/clinicians presence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the new self-test for glaucoma screening.
We will measure the diagnostic performance of the new test to a range of simulated defects. We will establish the take up rate and number of true and false positives of the community trial when promoted through patients attending the glaucoma clinics of MREH.
Measured: Two years
Secondary outcomes (1)
Diagnostic performance of the new test on patients suspect to glaucoma
Throughout the development of this screening test, the research will, also, question whether or not the software could be adapted for use on suspect patients currently seen within the Hospital Eye Services (HES).
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startNov 2014
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanouil Tsamis, University of Manchester
- Investigators
- Prof David B Henson, Study director, University of ManchesterEmmanouil Tsamis, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162043
- Sponsor's protocol ID
- 2366
- Status last verified
- May 2018
- First submitted
- 6 Jun 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma
- ClinicalTrials.gov ID
- NCT02162043
- Acronym / sponsor ID
- 2366
- Conditions
- Glaucoma, Diagnostic Self-evaluation
- Keywords
- Glaucoma, Perimetry, Diagnostic self-evaluation, Screening, Visual fields
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 12 Jun 2014 (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.
This project aims to evaluate a self-administered screening test for glaucoma, the second largest cause of blindness in the western world. New approaches to glaucoma screening are needed because a significant number of patients first present to hospitals with advanced-stage glaucoma and late presentation is associated with a much higher risk for future blindness. This project will develop a new user-friendly visual field test that will be made available through the internet for self-testing. It will conduct both hospital-based and community-based clinical trials to establish benefits and costs of this new test.
Detailed description
Objectives: At a recent (19/4/2013) Priority Setting Partnership workshop, facilitated by the James Lind Alliance, patients, carers and eye health professionals produced a list of the top ten priorities for glaucoma research (http://www.sightlosspsp.org.uk/). Number 4 on the list was: What can be done to improve early diagnosis of sight-threatening glaucoma? The overarching aim of this project is to develop and evaluate a new visual field screening self-test that can be used to improve the early detection of glaucoma and thereby meet one of the aims of the Priority Setting Partnership. We will conduct hospital- and community-based clinical trials on the new test to establish its performance.
Methodology: This project will clinically evaluate the new test deriving measures of sensitivity and specificity. These trials will be conducted on patients attending the outpatient department of Manchester Royal Eye Hospital (MREH) and will use simulated defects to link performance measure with the extent of field damage. Patients without any established field loss will be tested. On completion of hospital-based clinical trials we will undertake locally based community trials to establish performance when self-administered or administered with the aid of friends/family, i.e. without researcher/clinician involvement. We will make the test available (emailed attachment that will install the test on the patients PC, laptop, tablet) to patients attending the glaucoma clinics of MREH with a request to test their friends and relatives. Guidance notes will emphasise the increased risk of developing glaucoma in blood relatives and the increased risk with age to help them target those at higher risk of developing glaucoma. Those failing the screening test, twice, will then undergo further testing by one of the Glaucoma Referral Refinement optometrists in Manchester to derive estimates of true and false referral rates.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usability assessment | – | –Patients without any experience with visual field testing will be recruited and tested with different versions of the developed self-test. This will help identify usability features that will make the test user-friendly. |
| Hospital-based clinical trial | – | –The new test will be evaluated on patients attending Manchester Royal Eye Hospital to provide an estimate of its diagnostic performance. |
| Community-based trial | – | –Patients attending Manchester Royal Eye Hospital's outpatient clinics will be recruited to trial the new test on their friends and family in order to evaluate the uptake and performance of the new test in a home environment without any researchers/clinicians presence. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the usability trials, volunteers with no previous perimetric experience will be recruited. Subjects will be based at Greater Manchester area. For the hospital- and community- based trials subjects will be recruited by Manchester Royal Eye Hospital's outpatient clinic
Key inclusion criteria (3 listed)
- No visual field defects
- No previous visual field testing
- No visual field defects
Key exclusion criteria (6 listed)
- Visual field defects MD>2dB
- Previous visual field testing experience
- Visual field defects MD>2dB
- Subject not owning a PC or tablet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of the new self-test for glaucoma screening.
Time frame: Two years
We will measure the diagnostic performance of the new test to a range of simulated defects. We will establish the take up rate and number of true and false positives of the community trial when promoted through patients attending the glaucoma clinics of MREH.
1 secondary outcome
Diagnostic performance of the new test on patients suspect to glaucoma
Time frame: Two years
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 3 May 2018.
- Individual participant dataSharing planned: No
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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.
Prof David B Henson study director
University of Manchester
Emmanouil Tsamis 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?
An observational study of Glaucoma and Diagnostic Self-evaluation, run by University of Manchester 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 3 inclusion and 6 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 3 May 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?
Diagnostic performance of the new self-test for glaucoma screening. (time frame: Two years). 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 3 May 2018.