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The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autostereoscopic 3D Training Group | Experimental |
| |
| Conventional Patching Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autostereoscopic 3D Training | Device | Daily 20-minute autostereoscopic 3D amblyopia training session, 5+ days per week for 6 months. Training consists of 15 minutes of monocular perceptual learning with Gabor patches (adaptive difficulty algorithm) and 5 minutes of binocular vergence training. Home-based training with remote data monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Stereoacuity | baseline to 6 months | |
| Near Stereoacuity | Baseline to 6 months | |
| Contrast Sensitivity Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Yuan | Contact | 010-58366699 | yuanjincornea@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Yuan | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | China |
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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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|
| Conventional Patching | Device | Daily continuous 2-hour occlusion of the non-amblyopic eye using medical adhesive eye patches, 5+ days per week for 6 months. Patients are encouraged to perform near visual activities (reading, writing, puzzles) during patching to enhance amblyopic eye stimulation. Parent-supervised home therapy with daily patching logs. |
|
| Baseline to 6 months |
| Computer Vision Syndrome Questionnaire (CVS-Q) Score | Baseline to 6 months |
| Simulator Sickness Questionnaire (SSQ) Score | Baseline to 6 months |
| Adherence | Baseline to 6 months |
| Intraocular Pressure (IOP) | Baseline to 6 months |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |