Amblyopia
Conditions
Brief summary
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.
Interventions
DEVICESerious touchscreen game combined with occlusion
The game designed for amblyopia training feature innovative designs.
DEVICEAugmented reality game combined with occlusion
The game designed for amblyopia training feature innovative designs.
BEHAVIORALOcclusion therapy
Wear an eye patch on the sound eye side daily for 4 hours.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically diagnosed with monocular anisometropic amblyopia. 2. Aged 4 to 7 years. 3. Able to cooperate with all examinations and comply with the amblyopia training regimen. 4. Provided signed informed consent.
Exclusion criteria
1. Severe developmental delay or cognitive impairment. 2. Serious systemic diseases. 3. Presence of organic ocular diseases (e.g., cataract, fundus diseases) or manifest strabismus. 4. Participation in any other eye-related interventional trial within the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Objective improvement in visual function | 3 months after the first visit | Contrast sensitivity measured using the standard contrast sensitivity test；Stereopsis measured using the Titmus Fly Test；Simultaneous perception assessed using the Worth 4-dot test；Fusion ability assessed using the synoptophore with line fusion targets. |
| Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart | 3 months after the first visit | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in functional vision in daily living | 3 months after the first visit | Functional vision assessed by Cardiff Visual Ability Questionnaire for Children (CVAQC). Total score ranges from 0 to 48. Higher scores indicate better outcome. |
| Medical fear assessed by Child Medical Fear Scale (CMFS) | 3 months after the first visit | Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety. |
| Anxiety assessed by Child Anxiety Meter-State (CAM-S) | 3 months after the first visit | Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety. |
| Compliance | 3 months after the first visit | User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation. |
| Acceptance | 3 months after the first visit | User experience assessed by Game Experience Questionnaire (GEQ). Total score ranges from 0 to 50. Higher scores indicate better game experience. |
Contacts
CONTACTJianing Ren
Outcome results
None listed