About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically diagnosed with monocular anisometropic amblyopia.
Aged 4 to 7 years.
Able to cooperate with all examinations and comply with the amblyopia training regimen.
Provided signed informed consent.
Disqualifiers
Severe developmental delay or cognitive impairment.
Serious systemic diseases.
Presence of organic ocular diseases (e.g., cataract, fundus diseases) or manifest strabismus.
Participation in any other eye-related interventional trial within the past 4 weeks.
Trial design
Parallel
Treatments tested in this trial
Serious touchscreen game combined with occlusion
DeviceThe game designed for amblyopia training feature innovative designs.
Augmented reality game combined with occlusion
DeviceThe game designed for amblyopia training feature innovative designs.
Occlusion therapy
BehavioralWear an eye patch on the sound eye side daily for 4 hours.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with Objective improvement in visual function
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
Secondary outcomes
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.
Medical fear assessed by Child Medical Fear Scale (CMFS)
Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety.
Anxiety assessed by Child Anxiety Meter-State (CAM-S)
Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety.
Compliance
User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation.
Sponsors and contacts
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