Dallas, Texas 75231


Purpose:

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)


Study summary:

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.


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)


NCT ID:

NCT03825107


Primary Contact:

Eileen E Birch, PhD
Phone: 2143633911 ext. 113
Email: ebirch@retinafoundation.org


Backup Contact:

Email: reedjost@retinafoundation.org
Reed M Jost, MS
Phone: 2143633911 ext. 113


Location Contact:

Dallas, Texas 75231
United States

Eileen E Birch, PhD
Phone: 214-363-3911
Email: ebirch@retinafoundation.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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