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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| World Sight Foundation Field Machine | Experimental | Test Device Receives: Device: World Sight Foundation Field Machine |
| Humphrey Visual Field Analyser | Active comparator | gold standard of care comparator Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
Qualitative data obtained from patient reported outcomes in relation to their experience of visual field testing using the WSFFM.
Measured: Day 1
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
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.
- First posted29 Jun 2026
- Study start29 Apr 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Testing Pilot of the World Sight Foundation Field Machine (WSFFM) in Glaucoma Patients - Comparison With Humphrey Visual Field Analyser
- ClinicalTrials.gov ID
- NCT07674069
- Acronym / sponsor ID
- WSFFM / RXQ 1220
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| World Sight Foundation Field Machine | Experimental | Device: World Sight Foundation Field MachineTest Device |
| Humphrey Visual Field Analyser | Active comparator | Other: Comparatorgold standard of care comparator |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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.
Key exclusion criteria (5 listed)
- - 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.
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 |
|---|---|---|
| World Sight Foundation Field MachineTest Intervention | Device | World Sight Foundation Field Machine |
| ComparatorAlso: Humphrey Visual Field AnalyserGold Standard of Care (Comparator) | Other | Humphrey Visual Field Analyser |
Primary outcome
Validation of the WSFFM - comparing the visual field testing obtained with WSFFM and HVF analyser.
Time frame: Day 1
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)
Feasibility of using the WSFFM in a "real-life" setting
Time frame: Day 1
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)
Validation of the WSFFM - comparing the visual field testing obtained with WSFFM and HVF analyser.
Time frame: Day 1
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)
4 secondary outcomes
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.
Time frame: Day 1
Qualitative data obtained from patient reported outcomes in relation to their experience of visual field testing using the WSFFM.
Time frame: Day 1
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
Time frame: Day 1
Field technician qualitative data regarding ease of use, collected over time after each clinical session.
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Related trials for Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
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.
1 site in 1 country: see every site and its status.
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.