Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old (ATS6)

Jaeb Center for Health Research

Status and phase: Completed; Phase 3

Conditions: Amblyopia

Treatments: Procedure: Near activities; Procedure: Distance activities; Device: Eye Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00315198

5U10EY011751 (U.S. NIH Grant/Contract)

NEI-114

2U10EY011751 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 425 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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425 participants in 2 patient groups

Near activities

Active Comparator group

Description:

2 hours of daily patching combined with near visual activities while patching

Treatment:

Device: Eye Patch

Procedure: Near activities

Distance activities

Active Comparator group

Description:

2 hours of daily patching combined with distance visual activities while patching

Treatment:

Device: Eye Patch

Procedure: Distance activities