World Sight Foundation Field Machine (WSFFM) Pilot

Sponsor
Buckinghamshire Healthcare NHS Trust
Study ID
NCT07674069
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • World Sight Foundation Field Machine — DEVICE
    Test Intervention
  • Comparator — OTHER
    Gold Standard of Care (Comparator)

Study Details

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.

Key Dates

First listed
Jun 29, 2026
Start date
Apr 29, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: World Sight Foundation Field Machine
    Test Device
  • Active Comparator: Humphrey Visual Field Analyser
    gold standard of care comparator

Primary Outcome Measure

Validation of the WSFFM - comparing the visual field testing obtained with WSFFM and HVF analyser. [ Time Frame: Day 1 ]

Central Contacts

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