Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03754153 |
| Other study ID # |
DALA1031 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 28, 2019 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Moorfields Eye Hospital NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
