Virtual Reality Test of Strabismus

NCT04156763 | Terminated

• 1 other identifier: 268329 (100-06-19)
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Strabismus

Keywords

Strabismus Virtual Reality Prism Cover Test

Outcome Measures

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

  2 years

Secondary Outcomes (1)

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

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with restrictive and paretic disturbances of ocular motility

You may not qualify if:

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

Sponsors & Collaborators

• Julie Dawson: lead

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 7, 2019
• Study Start: June 22, 2020
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

GB (1)