Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
NCT ID: NCT00315198
Last Updated: 2010-03-24
Study Results
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Basic Information
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COMPLETED
PHASE3
425 participants
INTERVENTIONAL
2005-02-28
2007-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Near activities
2 hours of daily patching combined with near visual activities while patching
Eye Patch
2 hours daily patching
Near activities
near visual activities while patching
Distance activities
2 hours of daily patching combined with distance visual activities while patching
Eye Patch
2 hours daily patching
Distance activities
distance visual activities while patching
Interventions
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Eye Patch
2 hours daily patching
Near activities
near visual activities while patching
Distance activities
distance visual activities while patching
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* More than one month of amblyopia treatment in the past 6 months.
3 Years
6 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER
Responsible Party
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Jaeb Center for Health Research
Principal Investigators
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Don Lyon, O.D.
Role: STUDY_CHAIR
Indiana University
Jonathan M. Holmes, M.D.
Role: STUDY_CHAIR
Mayo Clinic Department of Ophthalmology
Locations
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Indiana University School of Optometry
Bloomington, Indiana, United States
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States
Countries
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References
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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 11.
Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.
Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.
Other Identifiers
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