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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162043
• Other study ID #: 2366
• Status: Completed
• Start date: November 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: May 2018
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Self-evaluation
• Glaucoma

Locations

Country	Name	City	State
United Kingdom	Royal Eye Hospital	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two years
Secondary	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).	Two years