Health TrialsbyHealthPanel

World Sight Foundation Field Machine (WSFFM) Pilot

ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBuckinghamshire Healthcare NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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.

Disqualifiers

- 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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • World Sight Foundation Field Machine

    Device

    Test Intervention

  • Comparator

    Other intervention

    Gold Standard of Care (Comparator)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: World Sight Foundation Field MachineExperimental treatment 1 intervention
Group B: Humphrey Visual Field AnalyserActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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)

Time frame
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)

Time frame
Day 1

Secondary outcomes

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.

Time frame
Day 1
2

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

Time frame
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

Time frame
Day 1
4

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

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Buckinghamshire Healthcare NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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