Dichoptic Video Treatment for Amblyopia

Retina Foundation of the Southwest

Status: Completed

Conditions: Amblyopia

Treatments: Other: patching; Other: Dichoptic videos

Study type: Interventional

Funder types: Other

Identifiers

NCT03825107

Dichoptic Video for Amblyopia

Details and patient eligibility

About

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)

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Patching

Active Comparator group

Description:

2 hours per day 7 days per week patching of the fellow eye

Treatment:

Other: patching

Dichoptic Videos

Experimental group

Description:

watching 6 dichoptic videos during each 2 week period

Treatment:

Other: Dichoptic videos