NCT03754153

Binocularly Balanced Viewing Study

Phase 2a Two-site Randomised Controlled Trial to Determine Safety of and Adherence With a New 'Binocularly Balanced Viewing' Treatment for Unilateral Amblyopia Compared With Standard Treatment in Children Age 3-8 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for years and involve frequent clinic visits. In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double vision), change in the balance between the two eyes and in visual acuity over 16 weeks.

Detailed description

"Lazy eye" (amblyopia) is the commonest sight problem in children, affecting about one in 30 children. It is caused by a difference in spectacle prescription between the eyes and/or a squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for years and involve frequent clinic visits. The Investigators have developed an exciting new treatment: children watch customized movies for an hour a day on a hand-held 3D computer-game console. The Investigators blur the picture that the good eye sees to match it with what the weaker eye sees. They have tested this approach on 22 children, with an average improvement in vision by three lines on the test chart over 8 - 24 weeks, which may be faster than with standard treatment. Parents and children the Investigators have spoken with like both the idea of research in this area and the engaging nature of this device. The Investigators now need to assess how the new treatment compares with standard treatment, but first need to ensure that the new treatment is safe and that families will use it. In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double vision), change in the balance between the two eyes and in visual acuity over 16 weeks. Parents and children have helped develop this pilot - this involvement will be continued throughout the study. At study completion, children and parents will be involved in deciding how best to communicate the findings on hospital websites, in newsletters, at conferences and in medical journals.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Balanced Binocular Viewing (BBV)	The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).
OTHER	Standard Therapy - Occlusion (patching) or blurring (atropine)	The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2018-11-27
• Last updated: 2021-12-23

Locations

1 site across 1 country: United Kingdom