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

NCT ID: NCT02162043

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-10-01

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• No visual field defects
• No previous visual field testing

• No visual field defects

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Emmanouil Tsamis

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof David B Henson

Role: STUDY_DIRECTOR

University of Manchester

Emmanouil Tsamis

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Royal Eye Hospital

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

Other Identifiers

2366

Identifier Type: -

Identifier Source: org_study_id