Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
NCT00315198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 425
Last updated 2010-03-24
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.
Conditions
- Amblyopia
Interventions
- DEVICE
-
Eye Patch
2 hours daily patching
- PROCEDURE
-
Near activities
near visual activities while patching
- PROCEDURE
-
Distance activities
distance visual activities while patching
Sponsors & Collaborators
-
National Eye Institute (NEI)
collaborator NIH -
Jaeb Center for Health Research
lead OTHER
Principal Investigators
-
Don Lyon, O.D. · Indiana University
-
Jonathan M. Holmes, M.D. · Mayo Clinic Department of Ophthalmology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
- Primary Completion
- 2007-12-31
- Completion
- 2007-12-31
Countries
- United States
Study Locations
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