NCT00315198

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Eye Patch	2 hours daily patching
PROCEDURE	Near activities	near visual activities while patching
PROCEDURE	Distance activities	distance visual activities while patching

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-04-18
• Last updated: 2010-03-24

Locations

2 sites across 1 country: United States