Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma
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|ClinicalTrials.gov Identifier: NCT02162043|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : May 3, 2018
|Condition or disease|
|Glaucoma Diagnostic Self-evaluation|
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 Type :||Observational|
|Actual Enrollment :||168 participants|
|Official Title:||Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||October 1, 2017|
|Actual Study Completion Date :||October 1, 2017|
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.
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.
- 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.
- Diagnostic performance of the new test on patients suspect to glaucoma [ Time Frame: Two years ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162043
|Royal Eye Hospital|
|Manchester, Greater Manchester, United Kingdom, M13 9WH|
|Study Director:||Prof David B Henson||University of Manchester|
|Principal Investigator:||Emmanouil Tsamis||University of Manchester|