Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

Study Overview
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Brief Summary
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Ths purpose of this study is to determine whether near activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with distance activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.

Detailed Description
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The value of near visual activities while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn. In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching. This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.

Official Title
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A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

Conditions
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Amblyopia

Intervention / Treatment
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* Device: Eye Patch
* Procedure: Near activities
* Procedure: Distance activities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both. Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines. Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable. Exclusion Criteria: Prior amblyopia treatment other than spectacles in the past month. More than one month of amblyopia treatment in the past 6 months.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Near activities<br>2 hours of daily patching combined with near visual activities while patching | Device: Eye Patch<br>* 2 hours daily patching<br>* Other names: Coverlet, 3M Opticlude, Ortopad®;Procedure: Near activities<br>* near visual activities while patching<br>|
| Active Comparator: Distance activities<br>2 hours of daily patching combined with distance visual activities while patching | Device: Eye Patch<br>* 2 hours daily patching<br>* Other names: Coverlet, 3M Opticlude, Ortopad®;Procedure: Distance activities<br>* distance visual activities while patching<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amblyopia, patching, visual activities