Quantification of Agreement and Variability of a Newly Developed Visual Field Algorithm With the Reference Standard
NCT ID: NCT02727569
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2017-06-15
2018-06-29
Brief Summary
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The long-term goal is to reduce test variability below that observed in SITA by 20%, whilst producing comparable measurements (contrast threshold values) for comparable test duration.
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Detailed Description
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In clinical settings, the Humphrey Visual Field Analyzer (Zeiss Meditec) is the most used visual field test in the UK. It employs a SAP strategy coupled with the Swedish Interactive Thresholding Algorithm (SITA), which is used to derive retinal sensitivity. Visual field measurements are very variable, requiring many tests over a long period to determine the extent of vision loss. In addition to the inconvenience caused to patients, the contribution of these many tests to the financial burden on the NHS is increasing with the growing aging population. As glaucoma is a chronic disease, patients need lifelong monitoring, requiring multiple tests and clinic visits. To address these unmet needs, the investigators have developed a new algorithm that can be used to monitor glaucoma.
The investigators wish to carry out a study, which will allow them to compare agreement between SITA and a newly developed test algorithm. Measurement variability will be determined and compared between strategies. The long-term goal is to reduce test variability and the test time observed in SITA, whilst producing comparable contrast threshold values.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Feasibility Study
10 subjects. Subjects will performed two different versions of the new visual field algorithm with DLS (differential light sensitivity) strategies. Two repeats of each strategy will be performed.
New visual field algorithm with DLS
Mathematical model (software based) to derive retinal sensitivity.
Clinical evaluation study
100 subjects. Subjects will performed a visual field assessment with the new visual field algorithm with MMDT (Moorfields Motion Displacement Test) and DLS -like stimuli and a commercial available SITA algorithm (DLS-like strategy). Two repeats of each strategy will be performed.
New visual field algorithm with DLS
Mathematical model (software based) to derive retinal sensitivity.
SITA algorithm
Mathematical model (software based) to derive retinal sensitivity. Commercially available.
New visual field algorithm with MMDT
Mathematical model (software based) to derive retinal sensitivity.
Interventions
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New visual field algorithm with DLS
Mathematical model (software based) to derive retinal sensitivity.
SITA algorithm
Mathematical model (software based) to derive retinal sensitivity. Commercially available.
New visual field algorithm with MMDT
Mathematical model (software based) to derive retinal sensitivity.
Eligibility Criteria
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Inclusion Criteria
* No ocular morbidity other than glaucoma; early lens opacity and prior cataract surgery are acceptable
Healthy eyes
* Central 30° visual field within normal limits on the 24-2 test (MD within 95 % CI and glaucoma hemifield test within normal limits).
Glaucoma eyes
* More than two reliable visual fields with reproducible defects
* IOP \< 30 mmHg
Exclusion Criteria
* Inability to steadily fixate on the test (e.g. individuals who have nystagmus or macular degeneration)
* Eyes with unreliable visual fields (defined as false positive responses \>15%)
18 Years
100 Years
ALL
Yes
Sponsors
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Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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David Garway-Heath, MD
Role: PRINCIPAL_INVESTIGATOR
NIHR Biomedical Research Centre, Moorfields Eye Hospital and UCL Institute of Ophthalmology
Locations
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Moorfields Eye Hospital
London, , United Kingdom
Countries
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Other Identifiers
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GART1046
Identifier Type: -
Identifier Source: org_study_id
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