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Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patching | Active Comparator | 2 hours per day 7 days per week patching of the fellow eye |
|
| Dichoptic Videos | Experimental | watching 6 dichoptic videos during each 2 week period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patching | Other | covering the fellow eye with an eyepatch to force use of the amblyopic eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity of the amblyopic eye | HOTV (preferred) or picture chart | Baseline vs 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity of the amblyopic eye | HOTV (preferred) or picture charts | Baseline vs 4 weeks, 6 weeks, and 8 weeks |
| Change in Stereoacuity | Randot Preschool Stereoacuity test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen E Birch, PhD | Retina Foundation of the Southwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eileen E Birch | Dallas | Texas | 75231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37619861 | Derived | Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23. | |
| 35264692 | Derived | Jost RM, Hudgins LA, Dao LM, Stager DR Jr, Luu B, Beauchamp CL, Hunter JS, Giridhar P, Wang YZ, Birch EE. Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years. Sci Rep. 2022 Mar 9;12(1):4157. doi: 10.1038/s41598-022-08010-9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2019 | Oct 20, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2019 | Oct 20, 2021 | SAP_001.pdf |
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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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Parallel for primary outcome; crossover for longterm effectiveness
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| Dichoptic videos | Other | watching contrast-rebalanced dichoptic videos to allow the two eyes to work together |
|
| Baseline vs 2, 4, 6, 8 weeks |
| Change in Contrast Balance Index | Dichoptic Letter chart | Baseline vs 2, 4, 6, 8 weeks |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |