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TerminatedNCT04156763Updated Dec 22, 2023

Virtual Reality Test of Strabismus

An observational study in Strabismus, sponsored by Julie Dawson. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Julie Dawson · Observational

Why this study was terminated
CI has left the trust
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
19
Ages
18 Years and older
Sex
All
01

Study summary

Strabismus, or squint, describes any misalignment of the eyes, and can affect both children and adults. As a result, the images of the outside world conveyed to the brain from the two eyes do not correspond, which can result in diplopia, or 'double vision'. As well as impacting on a patient's functionality, strabismus can have cosmetic and psychosocial ramifications. Furthermore, if left untreated in childhood, strabismus can lead to life-long visual impairment, despite best spectacle correction.

Current treatment is guided by the exact nature of the strabismus and the patient's age; options include spectacle prescription to correct underlying refractive error, use of prisms to control deviation, or in certain cases, surgery. In order to investigate the size and type of strabismus present, and determine the best management, tests of ocular deviation are performed in Eye Clinics.

Quantitative objective assessment of the angle of horizontal and vertical strabismus is currently performed using the prism cover test - the patient is asked to look at a fixation target, and prisms of increasing power are placed in front of one eye until the ocular deviation is neutralised (i.e. there is no movement of the eyes to take up fixation). The test can provide accurate numerical recordings to aid in monitoring and surgical planning.

However, the prism cover test requires a range of different prisms, the presence of a near and distance fixation target, a trained examiner, and a patient able to fixate at an appropriate target without moving their head for the duration of the test. In this study, it will be investigated whether a virtual reality headset-based test can produce comparable measurements of ocular deviation to the traditional prism cover test, without the need for prisms, or control of head posture.

Read the detailed description

Purpose

  1. To establish whether a virtual reality headset-based test can produce accurate and reliable data on ocular deviation in those with disturbances of ocular motility, by comparing its performance to those of established tests of ocular deviation currently in use in clinical practice (prism cover test).
  2. To assess the practicality, and subjective experience of a virtual reality headset- based Lancaster red-green test, using questionnaire surveys

Background

Strabismus, or squint, describes any misalignment of the eyes, and can affect both children and adults. As a result, the images of the outside world conveyed to the brain from the two eyes do not correspond, which can result in diplopia, or 'double vision'. As well as impacting on a patient's functionality, strabismus can have cosmetic and psychosocial ramifications. Furthermore, if left untreated in childhood, strabismus can lead to life-long visual impairment, despite best spectacle correction.

Current treatment is guided by the exact nature of the strabismus and the patient's age; options include spectacle prescription to correct underlying refractive error, use of prisms to control deviation, or in certain cases, surgery. In order to investigate the size and type of strabismus present, and determine the best management, tests of ocular deviation are performed in Eye Clinics.

Quantitative objective assessment of the angle of horizontal and vertical strabismus is currently performed using the prism cover test - the patient is asked to look at a fixation target, and prisms of increasing power are placed in front of one eye until the ocular deviation is neutralised (i.e. there is no movement of the eyes to take up fixation). The test can provide accurate numerical recordings to aid in monitoring and surgical planning.

However, the prism cover test requires a range of different prisms, the presence of a near and distance fixation target, a trained examiner, and a patient able to fixate at an appropriate target without moving their head for the duration of the test. In this study, it will be investigated whether a virtual reality headset-based test can produce comparable measurements of ocular deviation to the traditional prism cover test, without the need for prisms, or control of head posture.

Design and Methodology

Research participants will be recruited from the pool of patients presenting to the Eye department for their regular appointment.

Those who meet the inclusion criteria will have the study explained to them by a member of the research team in the department, and given a leaflet to read about the study. Should they wish to take part, they will have verbal and written consent taken, and then undergo two tests:

  1. Prism cover test
  2. Virtual reality headset-based test

Each test will last approximately 10 minutes. At the end of the two tests, they will be asked to fill in a questionnaire on their experience of the tests. They will require no additional visits to clinic as part of enrolling in the study.

Statistical Analysis

The angles of deviation of the eyes will be extracted from each of the three tests, and Bland Altman analysis will be applied to the data to check for agreement.

The subjective experience of the virtual reality headset-based Lancaster red-green test measured by the questionnaire, and compared to the subjective experience of the two established tests of ocular deviation using a paired t-test.

02

Conditions studied

  • Strabismus

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Keywords

  • Strabismus Virtual Reality Prism Cover Test
03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's enrollment of 19 is below the median of 96 across 54 observational studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Julie Dawson is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Research participants will be recruited from the pool of patients presenting to the Eye department for their regular appointment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with restrictive and paretic disturbances of ocular motility

Exclusion criteria

Exclusion criteria:

  • Patients without capacity to consent
  • Patients unwilling to participate
  • Patients aged under 18
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
19 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment

    The degree of agreement between the prism cover test and virtual reality headset-based test of ocular misalignment

    Time frame: 2 years

Secondary outcomes

  1. The subjective experience of the virtual reality headset-based test measured by questionnaire

    The subjective experience of the virtual reality headset-based test measured by questionnaire

    Time frame: 2 years

07

Study locations

1 site
  • Norfolk & Norwich University Hospitals NHS Foundation Trust
    Norwich, Norfolk NR4 7UY, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Jun 2022, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2019
First posted
Nov 7, 2019
StartActual
Jun 22, 2020
Primary completionActual
Jun 8, 2022
CompletionActual
Jun 8, 2022
Last update
Dec 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04156763
Lead sponsor
Julie Dawson
Responsible party
Julie Dawson (Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust) — Sponsor-investigator
First posted
Nov 7, 2019
Start date
Jun 22, 2020
Primary completion
Jun 8, 2022
Completion
Jun 8, 2022
Last update
Dec 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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