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| ID | Type | Description | Link |
|---|---|---|---|
| 24X010301505 | Other Grant/Funding Number | the Fundamental Research Funds for the Central Universities(China) |
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This project addresses the challenge of visual function intervention in children with monocular anisometropic amblyopia. It employs two innovatively designed digital games combined with occlusion therapy to conduct visual function training through parent-child interaction in home or multi-scenario environments. The study will compare this combined approach against traditional occlusion therapy alone, evaluating improvements in visual function, intrinsic motivation, and emotion regulation before and after the intervention. The research aims to promote the implementation and dissemination of personalized and engaging healthcare services. Ultimately, it seeks to establish a comprehensive visual function training product and service system suitable for daily use in home settings, with the goals of reducing medical anxiety in children and holistically enhancing treatment efficacy, training compliance, and overall clinical experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Intervention) | Experimental | Serious touchscreen game combined with occlusion |
|
| Group 2 (Intervention) | Experimental | Augmented Reality game combined with occlusion |
|
| Control Group | Active Comparator | Occlusion therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serious touchscreen game combined with occlusion | Device | The game designed for amblyopia training feature innovative designs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Objective improvement in visual function | Contrast sensitivity measured using the standard contrast sensitivity testï¼›Stereopsis measured using the Titmus Fly Testï¼›Simultaneous perception assessed using the Worth 4-dot testï¼›Fusion ability assessed using the synoptophore with line fusion targets. | 3 months after the first visit |
| Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart | 3 months after the first visit |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in functional vision in daily living | Functional vision assessed by Cardiff Visual Ability Questionnaire for Children (CVAQC). Total score ranges from 0 to 48. Higher scores indicate better outcome. | 3 months after the first visit |
| Medical fear assessed by Child Medical Fear Scale (CMFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianing Ren | Contact | +86 18800253186 | 981433535@qq.com |
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Due to participant privacy considerations and the terms of the ethical approval and informed consent documents for this study, individual participant data will not be publicly shared. Aggregated data and study results will be disseminated through academic publications.
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| Augmented reality game combined with occlusion | Device | The game designed for amblyopia training feature innovative designs. |
|
| Occlusion therapy | Behavioral | Wear an eye patch on the sound eye side daily for 4 hours. |
|
Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety. |
| 3 months after the first visit |
| Anxiety assessed by Child Anxiety Meter-State (CAM-S) | Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety. | 3 months after the first visit |
| Compliance | User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation. | 3 months after the first visit |
| Acceptance | User experience assessed by Game Experience Questionnaire (GEQ). Total score ranges from 0 to 50. Higher scores indicate better game experience. | 3 months after the first visit |
| 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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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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