Amblyopia
Conditions
Brief summary
1. To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children 2. To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)
Detailed description
Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
Interventions
OTHERpatching
covering the fellow eye with an eyepatch to force use of the amblyopic eye
OTHERDichoptic videos
watching contrast-rebalanced dichoptic videos to allow the two eyes to work together
Sponsors
Retina Foundation of the Southwest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel for primary outcome; crossover for longterm effectiveness
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* 3 to 7 years old * Amblyopic eye visual acuity 20/32-20/125 * Fellow eye visual acuity 20/16-25 * Interocular visual acuity difference of at least 2 lines * Anisometropia or corrected strabsimus (\<5pd) * in glasses at least 8 weeks or no change in visual acuity over two visits * no prior binocular treatment * must be able to see full video screen
Exclusion criteria
* prematurity of 8 weeks or more * coexisting ocular or systemic disease * developmental delay * poor ocular alignment (\>=5 pd)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity of the amblyopic eye | Baseline vs 2 weeks | HOTV (preferred) or picture chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stereoacuity | Baseline vs 2, 4, 6, 8 weeks | Randot Preschool Stereoacuity test |
| Change in Contrast Balance Index | Baseline vs 2, 4, 6, 8 weeks | Dichoptic Letter chart |
| Change in visual acuity of the amblyopic eye | Baseline vs 4 weeks, 6 weeks, and 8 weeks | HOTV (preferred) or picture charts |
Countries
United States
Outcome results
None listed