Dichoptic Video Treatment for Amblyopia

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

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 Overview

• Status: Completed
• Conditions: Amblyopia
• Intervention / Treatment: Other: patching; Other: Dichoptic videos

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Eileen E Birch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patching; 2 hours per day 7 days per week patching of the fellow eye	Other: patching; covering the fellow eye with an eyepatch to force use of the amblyopic eye; Other Names: occlusion therapy
EXPERIMENTAL: Dichoptic Videos; watching 6 dichoptic videos during each 2 week period	Other: Dichoptic videos; watching contrast-rebalanced dichoptic videos to allow the two eyes to work together

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity of the amblyopic eye	HOTV (preferred) or picture chart	Baseline vs 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity of the amblyopic eye	HOTV (preferred) or picture charts	Baseline vs 4 weeks, 6 weeks, and 8 weeks
Change in Stereoacuity	Randot Preschool Stereoacuity test	Baseline vs 2, 4, 6, 8 weeks
Change in Contrast Balance Index	Dichoptic Letter chart	Baseline vs 2, 4, 6, 8 weeks

Collaborators and Investigators

• Sponsor: Retina Foundation of the Southwest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2019
• Primary Completion (ACTUAL): July 6, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: Dichoptic Video for Amblyopia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No