Clinical trial NCT03825107: Dichoptic Video Treatment for Amblyopia
Official title: Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Lead sponsor: Retina Foundation of the Southwest
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel for primary outcome; crossover for longterm effectiveness
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in visual acuity of the amblyopic eye
timeFrame: Baseline vs 2 weeks
Secondary outcomes:
measure: Change in visual acuity of the amblyopic eye
timeFrame: Baseline vs 4 weeks, 6 weeks, and 8 weeks
measure: Change in Stereoacuity
timeFrame: Baseline vs 2, 4, 6, 8 weeks
measure: Change in Contrast Balance Index
timeFrame: Baseline vs 2, 4, 6, 8 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Eileen E Birch
state: Texas
Study officials:
affiliation: Retina Foundation of the Southwest
name: Eileen E Birch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jost RM, Hudgins LA, Dao LM, Stager DR Jr, Luu B, Beauchamp CL, Hunter JS, Giridhar P, Wang YZ, Birch EE. Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years. Sci Rep. 2022 Mar 9;12(1):4157. doi: 10.1038/s41598-022-08010-9.