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OpenTrials
Completed

NCT Number: NCT03825107

Dichoptic Video Treatment for Amblyopia

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)

Completed

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eileen E Birch

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patching

Other

covering the fellow eye with an eyepatch to force use of the amblyopic eye

Other names: occlusion therapy

dichoptic videos

Other

watching contrast-rebalanced dichoptic videos to allow the two eyes to work together

Primary outcomes

  1. Change in visual acuity of the amblyopic eye

    Time frame: Baseline vs 2 weeks

    HOTV (preferred) or picture chart

Secondary outcomes

  1. Change in visual acuity of the amblyopic eye

    Time frame: Baseline vs 4 weeks, 6 weeks, and 8 weeks

    HOTV (preferred) or picture charts

  2. Change in Stereoacuity

    Time frame: Baseline vs 2, 4, 6, 8 weeks

    Randot Preschool Stereoacuity test

  3. Change in Contrast Balance Index

    Time frame: Baseline vs 2, 4, 6, 8 weeks

    Dichoptic Letter chart

Sponsors and collaborators

Lead sponsor

Retina Foundation of the Southwest

Other

Registry information

Official study title

Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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