Dichoptic Video Treatment for Amblyopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2021-08-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel for primary outcome; crossover for longterm effectiveness

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patching

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

Group Type ACTIVE_COMPARATOR

patching

Intervention Type OTHER

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

Dichoptic Videos

watching 6 dichoptic videos during each 2 week period

Group Type EXPERIMENTAL

Dichoptic videos

Intervention Type OTHER

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

Interventions

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patching

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

Intervention Type OTHER

Dichoptic videos

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

Intervention Type OTHER

Other Intervention Names

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occlusion therapy

Eligibility Criteria

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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