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Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.
For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N/A this is an observational study of Standard of Care | Device | Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity from baseline to consecutive visits | Change in Visual Acuity from baseline to consecutive visits | 3, 6,12, 24 months |
| Duration of Visual Acuity treatment and number of follow-up visits | Duration of Visual Acuity treatment and number of follow-up visits | 3, 6,12, 24 months |
| Durability of Visual Acuity results post-treatment cessation | Durability of Visual Acuity results post-treatment cessation | 3, 6,12, 24 months |
| Adherence with Luminopia treatment | Adherence with Luminopia treatment | 3, 6,12, 24 months |
| Change in Stereoacuity from baseline to consecutive visits | Change in Stereoacuity from baseline to consecutive visits | 3, 6,12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity analyses will also be conducted by Prior Treatment | Visual Acuity analyses will also be conducted by Prior Treatment | 3, 6,12, 24 months |
| Visual Acuity analyses will also be conducted by Amblyopia Type |
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Inclusion Criteria:
Exclusion Criteria:
-Have participated in prior Luminopia clinical trials
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Patients with a diagnosis of Amblyopia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Physicians | Recruiting | San Ramon | California | 94583 | United States |
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Visual Acuity analyses will also be conducted by Amblyopia Type
| 3, 6,12, 24 months |
| Visual Acuity Analyses will also be conducted by Age | Visual Acuity Analyses will also be conducted by Age | 3, 6,12, 24 months |
| Visual Acuity analyses will also be conducted by Baseline Angle of Deviation | Visual Acuity analyses will also be conducted by Baseline Angle of Deviation | 3, 6,12, 24 months |
| Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity) | Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity) | 3, 6,12, 24 months |
| Visual Acuity analyses will also be conducted by Adherence to Treatment | Visual Acuity analyses will also be conducted by Adherence to Treatment | 3, 6,12, 24 months |
| Visual Acuity Analyses will also be conducted by Prescribed Dose | Visual Acuity Analyses will also be conducted by Prescribed Dose | 3, 6,12, 24 months |
| Sansum Clinic | Recruiting | Santa Barbara | California | 93110 | United States |
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| Okaloosa Ophthalmology | Recruiting | Crestview | Florida | 32536 | United States |
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| Family Focus Eye Care | Recruiting | Gainsville | Florida | 32605 | United States |
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| Eye Physicians of Central Florida | Recruiting | Maitland | Florida | 32751 | United States |
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| Children's Eye Institute of Savannah | Recruiting | Savannah | Georgia | 31406 | United States |
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| Honolulu Eye Clinic | Recruiting | Honolulu | Hawaii | 96813 | United States |
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| Lurie Children's Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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| Riley Children's Hospital at IU Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Nevada Eye Physicians | Recruiting | Las Vegas | Nevada | 89149 | United States |
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| Concord Eye Center | Recruiting | Concord | New Hampshire | 03301 | United States |
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| Children's Hospital Of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Pediatric Eye Specialist | Recruiting | Fort Worth | Texas | 76104 | 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 |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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