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

Amblyopia Clinical Trial

— ATS6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315198
• Other study ID #: NEI-114
• Secondary ID: 2U10EY0117515U10
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2006
• Last updated: March 23, 2010
• Start date: February 2005
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Eye Patch
2 hours daily patching

Procedure:
• Near activities
near visual activities while patching
• Distance activities
distance visual activities while patching

Locations

Country	Name	City	State
United States	Indiana University School of Optometry	Bloomington	Indiana
United States	Mayo Clinic Department of Ophthalmology	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology. 2008 Nov;115(11):2071-8. doi: 10.1016/j.ophtha.2008.06.031. Epub 2008 Sep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		8 weeks	No
Secondary	Visual acuity		17 weeks	No

External Links

•   NEI Clinical Studies Database