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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
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A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Regimen A | Experimental | Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luminopia One | Device | Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amblyopic eye best-corrected visual acuity | Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Amblyopic eye best-corrected visual acuity | Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age | 8 weeks |
| Amblyopic eye best-corrected visual acuity |
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Major Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hunter, MD PhD | Boston Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Physicians of Central Florida | Maitland | Florida | 32751 | United States | ||
| Wheaton Eye Clinic |
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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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A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
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Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
| 4 weeks |
| Adherence | Duration spent using the device divided by duration of treatment prescribed (objectively monitored) | 12 weeks |
| Chicago |
| Illinois |
| 60187 |
| United States |
| Indiana University | Bloomington | Indiana | 47405 | United States |
| Kids Eye Care of Maryland | Frederick | Maryland | 21703 | United States |
| Children's Eye Care of Michigan | Dearborn | Michigan | 48124 | United States |
| Concord Eye Center | Concord | New Hampshire | 03301 | United States |
| Conestoga Eye | Lancaster | Pennsylvania | 17601 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Virginia Pediatric Eye Center | Virginia Beach | Virginia | 23452 | United States |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |