Dichoptic Video Treatment for Amblyopia

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825107
• Other study ID #: Dichoptic Video for Amblyopia
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: Retina Foundation of the Southwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 31, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amblyopia

Intervention

Other:
• patching
covering the fellow eye with an eyepatch to force use of the amblyopic eye
• Dichoptic videos
watching contrast-rebalanced dichoptic videos to allow the two eyes to work together

Locations

Country	Name	City	State
United States	Eileen E Birch	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Retina Foundation of the Southwest

Country where clinical trial is conducted

United States, 

Outcome

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