Binocular Amblyopia Treatment

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

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2025-12-31

Brief Summary

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To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

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Detailed Description

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To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.

Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA \>0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.

Conditions

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Contrast Increment

Group Type ACTIVE_COMPARATOR

Binocular games for treatment of amblyopia

Intervention Type OTHER

playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

Reduced Contrast Increment

Group Type EXPERIMENTAL

Binocular games for treatment of amblyopia

Intervention Type OTHER

playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

No Contrast Increment

Group Type EXPERIMENTAL

Binocular games for treatment of amblyopia

Intervention Type OTHER

playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

Interventions

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Binocular games for treatment of amblyopia

playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 4-10 y
* male and female
* strabismic, anisometropic, or combined mechanism amblyopia
* amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
* fellow eye best-corrected visual acuity ≤0.1 logMAR
* interocular visual acuity difference ≥0.3 logMAR
* wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits

* 4 weeks apart.
* child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
* parent's informed consent
* child must demonstrate understanding and ability to play binocular games

Exclusion Criteria

* prematurity ≥8 weeks
* coexisting ocular or systemic disease
* developmental delay
* strabismus \>5pd
* any binocular amblyopia treatment in the past 3 months

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No