World Sight Foundation Field Machine (WSFFM) Pilot

NCT07674069 | Recruiting

• 1 other identifier: RXQ 1220
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  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.

  Day 1

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

  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

  Day 1

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

  Day 1

Study Arms (2)

World Sight Foundation Field Machine

EXPERIMENTAL

Test Device

Device: World Sight Foundation Field Machine

Humphrey Visual Field Analyser

ACTIVE COMPARATOR

gold standard of care comparator

Other: Comparator

Interventions

World Sight Foundation Field Machine DEVICE

Test Intervention

World Sight Foundation Field Machine

Comparator OTHER

Gold Standard of Care (Comparator)

Also known as: Humphrey Visual Field Analyser

Humphrey Visual Field Analyser

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Buckinghamshire Healthcare NHS Trust: lead

Study Sites (1)

Buckinghamshire Healthcare NHS Trust

Aylesbury, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

James Cooper

CONTACT

07816020305; james.cooper9@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: June 29, 2026
• Study Start: April 29, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

GB (1)