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Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).
Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.
Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.
Demonstrate recruitment potential of subjects to participate in a dietary intervention study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine 20 mg | Active Comparator | Patching plus once daily caffeine for 12 weeks |
|
| Caffeine 40 mg | Active Comparator | Patching plus once daily caffeine for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | 20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Quantitative improvement in high resolution visual acuity measured at 3 meters | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire | A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael X Repka, MD, MBA | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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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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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |