A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometropic Amblyopia

ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Serious touchscreen game combined with occlusion

    Device

    The game designed for amblyopia training feature innovative designs.

  • 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.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Group 1 (Intervention)Experimental treatment 1 intervention
Group B: Group 2 (Intervention)Experimental treatment 1 intervention
Group C: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months after the first visit
2

Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart

Time frame
3 months after the first visit

Secondary outcomes

1

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.

Time frame
3 months after the first visit
2

Medical fear assessed by Child Medical Fear Scale (CMFS)

Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety.

Time frame
3 months after the first visit
3

Anxiety assessed by Child Anxiety Meter-State (CAM-S)

Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety.

Time frame
3 months after the first visit
4

Compliance

User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation.

Time frame
3 months after the first visit

Other outcomes

Sponsors and contacts

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