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

Phase 3

Completed

• Conditions: Amblyopia
• Interventions: Device: Eye Patch; Procedure: Distance activities; Procedure: Near activities

• Registration Number: NCT00315198
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-18
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-05
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near activities	Eye Patch	2 hours of daily patching combined with near visual activities while patching
Distance activities	Distance activities	2 hours of daily patching combined with distance visual activities while patching
Distance activities	Eye Patch	2 hours of daily patching combined with distance visual activities while patching
Near activities	Near activities	2 hours of daily patching combined with near visual activities while patching

Primary Outcome Measures

Name	Time	Method
Visual acuity	8 weeks

Secondary Outcome Measures

Name	Time	Method
Visual acuity	17 weeks

Trial Locations

Locations (2)

Indiana University School of Optometry; 🇺🇸 Bloomington, Indiana, United States

Mayo Clinic Department of Ophthalmology; 🇺🇸 Rochester, Minnesota, United States