GlaucomavFASTNCT02727569
Quantification of Agreement and Variability of a Newly Developed Visual Field Algorithm With the Reference Standard
An observational study of Glaucoma and Healthy, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to compare two types of visual field test; retinal sensitivity values obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of the standard visual field test and with a newly developed test algorithm. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- What is being tested?
- New visual field algorithm with DLS, SITA algorithm and New visual field algorithm with MMDT
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2017to 29 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited using three methods: 1. The volunteer database of the Glaucoma Research Unit. Letters will be sent to patients/healthy controls, who in the past agreed to be contacted for research purposes. Written information about the project will be sent with the letters. 2. Records screening. Patients' records will be screened in advance or during their clinical appointment. Persons identified as meeting the inclusion criteria will be invited to join the study, whereupon written information about the project will be given to the patient. Patients will be invited to join the study by letter, prior to their clinical appointment or in person on the day of the appointment. 3. Invitation of accompanying persons and staff. It is anticipated that spouses and acquaintances of existing subjects, as well as staff at the research site, Moorfields Eye Hospital and UCL Institute of Ophthalmology, may offer their participation as healthy volunteers.
Who may be able to join
- Best corrected visual acuity of 6/12 or better in the test eye
- 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
Who cannot join
- Any systemic disease which is likely to affect visual performance in a short period of time
- 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%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Agreement and Variability Characteristics of a Newly Developed Visual Field Algorithm With the Reference Standard: an Observational Study
This study aims to compare two types of visual field test; retinal sensitivity values obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of the standard visual field test and with a newly developed test algorithm. The new test is a visual field test presented on a flat-panel monitor and has two modes: differential light sensitivity (DLS; equivalent to the standard visual field test) and the Moorfields Motion Displacement Test (MMDT). DLS sensitivity and DLS measurement variability will be determined and compared between the SITA algorithm of the standard visual field test and the new visual field test on the flat-panel monitor. The measurement variability of the MMDT will be quantified.
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.
Read the detailed description
Standard Automated Perimetry (SAP) is currently the standard test for screening and monitoring visual loss owing to glaucoma. This test requires the patient to sit at a machine, looking at a central light and pressing a button whenever small spots of light appear in the peripheral vision. Traditionally these spots of light are projected into a bowl (concave surface), but more recently, computer monitors have been used. Other techniques are also now available such as the Moorfields Motion Displacement Test, where patients are required to press a button each time they see a vertical line on the screen wiggle. This test has been shown to have advantages over SAP, namely, to be tolerant to the effects of cataract and refractive error.
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.
- Being tested
- New visual field algorithm with DLS, SITA algorithm, New visual field algorithm with MMDT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New visual field algorithm with DLSDevice
Mathematical model (software based) to derive retinal sensitivity.
SITA algorithmDevice
Mathematical model (software based) to derive retinal sensitivity. Commercially available.
New visual field algorithm with MMDTDevice
Mathematical model (software based) to derive retinal sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: New visual field algorithm with DLS | |
| 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. Receives: Device: New visual field algorithm with DLS; Device: SITA algorithm; Device: New visual field algorithm with MMDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the threshold difference in the test-retest variability of DLS obtained with the new algorithm and the SITA algorithm. To quantify the threshold test-retest variability of the MMDT with the new algorithm.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (6)
To quantify the difference in DLS thresholds measured with the new and SITA algorithms across all retinal locations and for a range of visual field sensitivities.
Measured: Through study completion, an average of 1 year.
To determine whether any differences in thresholds obtained on the two algorithms vary with retinal eccentricity and stimulus energy. Mean difference for each location will be reported in decibels.
Measured: Through study completion, an average of 1 year.
To determine whether any differences in test-retest variability obtained on the two algorithms vary with retinal eccentricity and stimulus energy. Mean difference between test-retest for each location will be reported in decibels.
Measured: Through study completion, an average of 1 year.
Participants preference for a more reliable visual fields test or for having a shorter test (questionnaire).
Measured: Through study completion, an average of 1 year.
Participants preference of test strategy, MMDT or DLS (questionnaire).
Measured: Through study completion, an average of 1 year.
Participants preference of test algorithm, newly developed algorithms or the SITA algorithm (questionnaire).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start15 Jun 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Garway-Heath, MD, Principal investigator, NIHR Biomedical Research Centre, Moorfields Eye Hospital and UCL Institute of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727569
- Sponsor's protocol ID
- GART1046
- Acronym
- vFAST
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Agreement and Variability Characteristics of a Newly Developed Visual Field Algorithm With the Reference Standard: an Observational Study
- ClinicalTrials.gov ID
- NCT02727569
- Acronym / sponsor ID
- vFAST / GART1046
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare two types of visual field test; retinal sensitivity values obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of the standard visual field test and with a newly developed test algorithm. The new test is a visual field test presented on a flat-panel monitor and has two modes: differential light sensitivity (DLS; equivalent to the standard visual field test) and the Moorfields Motion Displacement Test (MMDT). DLS sensitivity and DLS measurement variability will be determined and compared between the SITA algorithm of the standard visual field test and the new visual field test on the flat-panel monitor. The measurement variability of the MMDT will be quantified.
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.
Detailed description
Standard Automated Perimetry (SAP) is currently the standard test for screening and monitoring visual loss owing to glaucoma. This test requires the patient to sit at a machine, looking at a central light and pressing a button whenever small spots of light appear in the peripheral vision. Traditionally these spots of light are projected into a bowl (concave surface), but more recently, computer monitors have been used. Other techniques are also now available such as the Moorfields Motion Displacement Test, where patients are required to press a button each time they see a vertical line on the screen wiggle. This test has been shown to have advantages over SAP, namely, to be tolerant to the effects of cataract and refractive error.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feasibility Study | – | Device: New visual field algorithm with DLS10 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. |
| Clinical evaluation study | – | Device: New visual field algorithm with DLS, Device: SITA algorithm, Device: New visual field algorithm with MMDT100 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited using three methods: 1. The volunteer database of the Glaucoma Research Unit. Letters will be sent to patients/healthy controls, who in the past agreed to be contacted for research purposes. Written information about the project will be sent with the letters. 2. Records screening. Patients' records will be screened in advance or during their clinical appointment. Persons identified as meeting the inclusion criteria will be invited to join the study, whereupon written information about the project will be given to the patient. Patients will be invited to join the study by letter, prior to their clinical appointment or in person on the day of the appointment. 3. Invitation of accompanying persons and staff. It is anticipated that spouses and acquaintances of existing subjects, as well as staff at the research site, Moorfields Eye Hospital and UCL Institute of Ophthalmology, may offer their participation as healthy volunteers.
Key inclusion criteria (7 listed)
- Best corrected visual acuity of 6/12 or better in the test eye
- 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
Key exclusion criteria (3 listed)
- Any systemic disease which is likely to affect visual performance in a short period of time
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New visual field algorithm with DLSMathematical model (software based) to derive retinal sensitivity. | Device | Clinical evaluation study, Feasibility Study |
| SITA algorithmMathematical model (software based) to derive retinal sensitivity. Commercially available. | Device | Clinical evaluation study |
| New visual field algorithm with MMDTMathematical model (software based) to derive retinal sensitivity. | Device | Clinical evaluation study |
Primary outcome
To quantify the threshold difference in the test-retest variability of DLS obtained with the new algorithm and the SITA algorithm. To quantify the threshold test-retest variability of the MMDT with the new algorithm.
Time frame: Through study completion, an average of 1 year.
6 secondary outcomes
To quantify the difference in DLS thresholds measured with the new and SITA algorithms across all retinal locations and for a range of visual field sensitivities.
Time frame: Through study completion, an average of 1 year.
To determine whether any differences in thresholds obtained on the two algorithms vary with retinal eccentricity and stimulus energy. Mean difference for each location will be reported in decibels.
Time frame: Through study completion, an average of 1 year.
To determine whether any differences in test-retest variability obtained on the two algorithms vary with retinal eccentricity and stimulus energy. Mean difference between test-retest for each location will be reported in decibels.
Time frame: Through study completion, an average of 1 year.
Participants preference for a more reliable visual fields test or for having a shorter test (questionnaire).
Time frame: Through study completion, an average of 1 year.
Participants preference of test strategy, MMDT or DLS (questionnaire).
Time frame: Through study completion, an average of 1 year.
Participants preference of test algorithm, newly developed algorithms or the SITA algorithm (questionnaire).
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Garway-Heath, MD principal investigator
NIHR Biomedical Research Centre, Moorfields Eye Hospital and UCL Institute of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Healthy, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify the threshold difference in the test-retest variability of DLS obtained with the new algorithm and the SITA algorithm. To quantify the threshold test-retest variability of the MMDT with the new algorithm. (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.