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The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.
The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Group | Patients have bilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 each eye. |
| |
| Unilateral Group | Patients have unilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 in the amblyopic eye; and interocular difference of best-corrected visual acuity at least two logMAR lines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescription glasses for bilateral amblyopia | Other | Correction of refractive error with prescription glasses both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity change from the baseline | visual acuity change from the baseline in logMAR | 8 weeks |
| adherence with optical treatment | The adherence recorded with the microsensor will be calculated as a percentage. | 8 weeks |
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Inclusion Criteria:
Inclusion criteria for bilateral amblyopia:
The major eligibility criteria include:
Best-corrected visual acuity of <20/30 each eye.
For hypermetropia:
For astigmatism without hypermetropia criteria above or myopia criteria below:
For myopia:
Inclusion criteria for unilateral amblyopia:
The major eligibility criteria include:
Presence of anisometropia or constant unilateral strabismus.
Best-corrected visual acuity in the amblyopic eye <20/30; and interocular difference of best-corrected visual acuity at least two logMAR lines.
For anisometropia:
For constant unilateral strabismus where spectacle prescription is indicated. Examples where spectacle prescription is indicated include esotropia caused at least in part by an accommodative component or where significant refractive error in either eye warrants spectacle prescription for improved vision.
Exclusion Criteria:
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Children age at 3 to < 10 years, who is newly diagnosed as amblyopia and prescribed with glasses.
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Hatch, OD | Salus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus University | Elkins Park | Pennsylvania | 19027 | 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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| Prescription glasses for unilateral amblyopia | Other | Correction of asymmetric refractive errors with lenses |
|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |