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GlaucomaWSFFMNCT07674069

World Sight Foundation Field Machine (WSFFM) Pilot

A study testing World Sight Foundation Field Machine and Comparator in people with Glaucoma, run by Buckinghamshire Healthcare NHS Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The current situation outside of large cities in lower-income countries, as described above, is suboptimal for the diagnosis of glaucoma. Doctors have no means of assessing visual fields, and as such may not be able to identify the condition until too advanced for any meaningful intervention (ie, to enable… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Glaucoma
What is being tested?
World Sight Foundation Field Machine and Comparator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
29 Apr 2026to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - Patients attending glaucoma outpatient clinic
  • Patients requiring visual field testing, with plan for "SITA-STANDARD" HVF testing
  • Patients 18 years or older and of any gender
  • Patients capable of giving informed consent.

Who cannot join

  • - Patients not requiring visual field testing on that outpatient clinic attendance.
  • Patients requiring visual field testing, with plan for "SITA-FAST" or "SITA-FASTER" HVF testing.
  • Patients who do not attend their outpatient clinic appointment,
  • Patients not able to perform visual field testing (for example due to their visual acuity, physical difficulty in positioning for test duration, or cognitive difficulties in understanding instructions).
  • Patients under the age of 18 years old.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Buckinghamshire Healthcare NHS Trust

    Aylesbury

    Matthew Kinsella, MD, +441296 831378, bht.research@nhs.net

    James Cooper, BSc, MSc, +441296 831378, james.cooper9@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: Clinical Testing Pilot of the World Sight Foundation Field Machine (WSFFM) in Glaucoma Patients - Comparison With Humphrey Visual Field Analyser

The current situation outside of large cities in lower-income countries, as described above, is suboptimal for the diagnosis of glaucoma. Doctors have no means of assessing visual fields, and as such may not be able to identify the condition until too advanced for any meaningful intervention (ie, to enable preservation of vision). Vision loss from glaucoma is irreversible. Understanding, through this pilot study, how well the World Sight Foundation Field Machine (WSFFM) works is an essential step towards trialling its use in lower-income countries. The justification for enabling this is to allow clinicians in the developing world to make more informed assessments of their glaucoma patient's status; this should translate in more timely treatments or referral for further investigation before further irreversible vision loss.

The WSFFM will be compared to the Humphrey Visual Field (HVF) analyser. The HVF analyser is the gold standard method of measuring visual fields; in our hospital eye service it is almost exclusively the method used, and as such the field technicians are particularly skilled in their use. The output data of the HVF enables easy quantification of level of field loss; by comparing the output from the WSFFM it would be possible to allow some form of quantification against "the standard" such that an idea of how well it works may be calculated.

Read the detailed description

This is an exploratory pilot study, to gather information on the use of WSFFM. The investigators do not expect the WSFFM to be equivalent to the HVF and would expect it to be inferior to it; thus, this is not a study of equivalence nor non-inferiority. The trial seeks to instead understand how well the WSFFM works in its purpose of identifying moderate/severe visual field loss in glaucoma patients (which is a different purpose to the HVF analyser, which aims to identify early field loss, as well as monitor for progressive change). The patients the investigators will be investigating will be those attending glaucoma clinic at a single site NHS outpatient hospital eye service. Patients attending glaucoma clinic will have a range of severity of glaucoma (ranging from those in whom a glaucoma diagnosis is still being ascertained, to those with established severe disease) who require assessment by a specialist glaucoma clinician. Patient may not require visual field testing every clinic visit, and not necessarily both eyes (e.g if one eye is blind). The pilot study will be run alongside normal clinical activities. All patients requiring visual fields will be identified in advance of the clinic and approached with a patient information leaflet (detailing the study aims and procedures, and their involvement and rights). Their "trial visit" will be opportunistic as they already will have attended for their appointment; there will be no further follow up after this visit. After their normal initial assessments (as required for all clinical visits), patients will be led to a designated room prior to field testing. Here, an opportunity to answer any queries will be given, before proceeding to consent if the patient wishes to participate. The trial design would most fit a cross-over design. One eye of the participant will be selected at random (unless they were only due for testing of one eye) to have visual fields tested by both devices in a successive time period; the order in which the participants are tested by each device is determined at random. Participants will then undergo visual field testing as per randomisation, for those only clinically requiring one eye testing, they will either undergo WSSFM or HVF testing first, followed by the other (according to randomisation). For those requiring both eyes, the eye to be included will be randomised, in addition to order of device testing for that eye. If the HVF device is randomised first, then one would start with the fellow (non-included) eye to save unnecessary switching between tests.

For example:

  • If Right eye included \& WSFFM first: Right WSFFM, Right HVF, Left HVF
  • If Right eye included \& HVF first: Left HVF, Right HVF, Right WSFFM The WSFFM field machine works on a USB connection 5.3 Volt. It can be powered from a phone booster battery or from the USB port of a laptop computer. The machine uses a microprocessor to control stimulus length and brightness.

The patients will firstly be seated in front of the WSFFM which comprises a box with multiple LED lights inside. There is a chin rest and viewing window through which participants are asked to view the lights inside the device. To first ascertain which brightness of light is required, they will be presented with lights of increasing brightness (three levels) until they can see it; this ensures that those with poor vision throughout their whole visual field - e.g. from a cataract, will still be able to be tested for any superadded visual field loss which might be in keeping with glaucoma. There will be a red light at the centre which participants will be then asked to focus on throughout the test to ensure correct fixation. They will then be shown ten different patterns of lights. These lights will light up in a specific sequence and will not always include the same number of lights. Each time a pattern of lights appears, participants will be asked how many lights they can see; if they see fewer lights than presented, they will be asked where the lights are positioned (left, right, up, down). Their responses will be mapped out by the visual field technician to give a representation of visual field in that eye. Participants will then be thanked for their participation in the trial. They will be given a questionnaire (three questions relating to ease of use, and acceptability of the WSFFM) to complete as they wait to conclude their consultation with the glaucoma clinician (or before they leave, if attending virtual clinic, and further consultation on the day not planned).

There would be no further visit nor contact with the participant required or planned.

Conditions
Glaucoma
Being tested
World Sight Foundation Field Machine, Comparator
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • World Sight Foundation Field MachineDevice

    Test Intervention

  • ComparatorOther

    Also called Humphrey Visual Field Analyser

    Gold Standard of Care (Comparator)

Study groups in NCT07674069
Study groupRoleWhat they receive
World Sight Foundation Field MachineExperimentalTest Device
Receives: Device: World Sight Foundation Field Machine
Humphrey Visual Field AnalyserActive comparatorgold standard of care comparator
Receives: Other: Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of the WSFFM - comparing the visual field testing obtained with WSFFM and HVF analyser.

    Comparison of visual field measurements obtained using the World Sight Foundation Field Machine (WSFFM) and the Humphrey Visual Field (HVF) analyser.

    Unit of Measure:

    Quantitative visual field parameters (e.g., mean deviation or equivalent summary metric, as applicable)

    Measured: Day 1

  2. Feasibility of using the WSFFM in a "real-life" setting

    Description:

    Patient-reported ease of performing the WSFFM test using a numeric rating scale.

    Unit of Measure:

    Score on a 1-10 scale (1 = very difficult, 10 = very easy)

    Measured: Day 1

  3. Validation of the WSFFM - comparing the visual field testing obtained with WSFFM and HVF analyser.

    Description:

    Patient-reported comparison of ease of use between WSFFM and HVF testing.

    Unit of Measure:

    Ordinal or categorical comparison (e.g., WSFFM easier / same / HVF easier)

    Measured: Day 1

Secondary outcomes (4)
  1. Quantitative data obtained from the mean (and standard deviation) of patient reported acceptability and ease of testing on a sliding scale of 0-10; compared with HVF score using Students t-test.

    Measured: Day 1

  2. Qualitative data obtained from patient reported outcomes in relation to their experience of visual field testing using the WSFFM.

    Measured: Day 1

  3. The mean time taken to complete WSFFM testing, compared to the mean time for HVF analyser testing, using paired Student's t-test to provide quantitative data

    Measured: Day 1

  4. Field technician qualitative data regarding ease of use, collected over time after each clinical session.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start29 Apr 2026
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07674069
Sponsor's protocol ID
RXQ 1220
Acronym
WSFFM
Status last verified
Jun 2026
First submitted
9 Sep 2025
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing World Sight Foundation Field Machine and Comparator in people with Glaucoma, run by Buckinghamshire Healthcare NHS 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact James Cooper (07816020305, james.cooper9@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of the WSFFM - comparing the visual field testing obtained with WSFFM and HVF analyser. (time frame: Day 1). The study lists 3 primary outcomes in all. 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 29 Jun 2026.

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World Sight Foundation Field Machine (WSFFM) Pilot | AzTrials