Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02162043
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Emmanouil Tsamis, University of Manchester

Brief 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 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.

Condition or disease
Glaucoma Diagnostic Self-evaluation

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Other
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

For the usability trials:

Inclusion Criteria:

  • No visual field defects
  • No previous visual field testing

Exclusion Criteria:

  • Visual field defects MD>2dB
  • Previous visual field testing experience

For the hospital-based trials:

Inclusion Criteria:

  • No visual field defects

Exclusion Criteria:

  • Visual field defects MD>2dB

For the community-based trials:

Exclusion Criteria:

  • Subject not owning a PC or tablet

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
Royal Eye Hospital
Manchester, Greater Manchester, United Kingdom, M13 9WH
Sponsors and Collaborators
University of Manchester
Investigators
Layout table for investigator information
Study Director: Prof David B Henson University of Manchester
Principal Investigator: Emmanouil Tsamis University of Manchester

Layout table for additonal information
Responsible Party: Emmanouil Tsamis, Research Assistant, University of Manchester
ClinicalTrials.gov Identifier: NCT02162043     History of Changes
Other Study ID Numbers: 2366
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Emmanouil Tsamis, University of Manchester:
Glaucoma
Perimetry
Diagnostic self-evaluation
Screening
Visual fields

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases