Dichoptic Video Treatment for Amblyopia

Not Applicable

Completed

• Conditions: Amblyopia
• Interventions: Other: patching; Other: Dichoptic videos

• Registration Number: NCT03825107
• Lead Sponsor: Retina Foundation of the Southwest

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.

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study Start: 2019-01-31
• Study First Posted: 2019-01-31
• Primary Completion: 2021-07-06
• Study Completion: 2021-08-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patching	patching	2 hours per day 7 days per week patching of the fellow eye
Dichoptic Videos	Dichoptic videos	watching 6 dichoptic videos during each 2 week period

Primary Outcome Measures

Name	Time	Method
Change in visual acuity of the amblyopic eye	Baseline vs 2 weeks	HOTV (preferred) or picture chart

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity of the amblyopic eye	Baseline vs 4 weeks, 6 weeks, and 8 weeks	HOTV (preferred) or picture charts
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

Trial Locations

Locations (1)

Eileen E Birch; 🇺🇸 Dallas, Texas, United States