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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10EY011751 | U.S. NIH Grant/Contract | View source | |
| 5U10EY011751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near activities | Active Comparator | 2 hours of daily patching combined with near visual activities while patching |
|
| Distance activities | Active Comparator | 2 hours of daily patching combined with distance visual activities while patching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Patch | Device | 2 hours daily patching |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | 17 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Lyon, O.D. | Indiana University | Study Chair |
| Jonathan M. Holmes, M.D. | Mayo Clinic Department of Ophthalmology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Optometry | Bloomington | Indiana | 47405 | United States | ||
| Mayo Clinic Department of Ophthalmology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18789533 | Result | 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. | |
| 22108357 | Derived | 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. |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Near activities | Procedure | near visual activities while patching |
|
| Distance activities | Procedure | distance visual activities while patching |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| 20451898 | Derived | 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. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |