Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04086524 |
| Other study ID # |
12345 |
| Secondary ID |
3600-105 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2020 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
University of Waterloo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to test whether a binocular treatment can improve vision and
motor function in young children with amblyopia. The proposed treatment is an animation
series that has been modified so that different characters in the animation are presented to
each eye. The contrast of the images shown to the amblyopic eye is higher than the contrast
of the images shown to the fellow eye. The aim of the treatment is to promote co-operation
between the two eyes and improve visual and motor outcomes. We will compare the benefits of
this binocular treatment to patching, whereby the better eye is occluded with an eye patch
for two hours per day to force the usage of the weaker eye. We hypothesize that the binocular
treatment will improve vision and motor outcomes in young children with amblyopia, and that
these improvements will be superior to any effects of patching.
Description:
This is a prospective study with study sites in Ontario, Canada (University of Waterloo);
Quebec, Canada (University of McGill); Texas, United States of America (Retina Foundation of
the Southwest); and Queensland, Australia (Queensland University of Technology). There are
three study conditions. 1) binocular treatment at home, 2) binocular treatment in office and,
3) standard patching therapy.
Participants will be recruited from university-affiliated clinics and local clinical
practices. Following full informed consent, participants will complete baseline testing to
confirm eligibility and provide pre-treatment measurements of visual acuity, stereopsis,
interocular suppression and motor function. Eligible participants will then be randomized to
either binocular treatment or patching.
The treatment consists of dichoptically presented children's animations with all characters
seen by the amblyopic eye and only a subset of characters seen by the fellow eye. Images
shown to the amblyopic eye will be presented at 100% contrast and images presented to the
fellow eye will be presented at 20% contrast on session 1 and contrast will increment by 10%
of the prior session's contrast level for each subsequent session. Participants will complete
4 x 1-hour sessions per week for two weeks. After 2 weeks of treatment, participants will be
offered the opportunity to complete an additional 2 weeks (8 hours) of treatment. Treatment
will take place in the home or in-office depending on the study site.
The control group will patch for 2 hours every day, at home, for 2 weeks. A calendar will be
provided (to both groups) in order for parents to track compliance. After 2 weeks of
patching, participants in the control group have the option to crossover to the treatment
group for an additional 2 weeks.
The primary analysis will compare visual acuity improvements from baseline between the
binocular treatment and patching groups after 2 weeks of treatment. Secondary analyses will
include comparisons of binocular vision and motor function outcomes between the binocular
treatment and patching groups, comparisons of at-home vs. in-office binocular treatment
outcomes and an evaluation of crossover effects.
