Clinical trial NCT02162043: Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma
Official title: Development and Evaluation of a Self-administered/Assisted Visual Field Screening Tool for Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Diagnostic Self-evaluation
Keywords: Glaucoma
Perimetry
Diagnostic self-evaluation
Screening
Visual fields
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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

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.

Eligibility 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

Primary outcomes:
measure: Diagnostic performance of the new self-test for glaucoma screening.
timeFrame: Two years
Secondary outcomes:
measure: Diagnostic performance of the new test on patients suspect to glaucoma
timeFrame: Two years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Royal Eye Hospital
state: Greater Manchester
Study officials:
affiliation: University of Manchester
name: Prof David B Henson
role: STUDY_DIRECTOR
affiliation: University of Manchester
name: Emmanouil Tsamis
role: PRINCIPAL_INVESTIGATOR
References: