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

NCT07472231 — Not applicable, Recruiting, 66 participants, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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An Exploratory Study on the Short-Term Additive Efficacy and User Experience of Innovative Gamified Intervention as an Adjunctive Therapy for Children With Monocular Anisometropic Amblyopia

Registry	NCT07472231
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Conditions	Amblyopia
Interventions	Serious touchscreen game combined with occlusion, Augmented reality game combined with occlusion, Occlusion therapy (Device, behavioral)
Dates	start 2026-05-01, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-03-16, last updated 2026-07-30
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1 (Intervention)	Experimental	Device: Serious touchscreen game combined with occlusion	Serious touchscreen game combined with occlusion
Group 2 (Intervention)	Experimental	Device: Augmented reality game combined with occlusion	Augmented Reality game combined with occlusion
Control Group	Active comparator	Behavioral: Occlusion therapy	Occlusion therapy only

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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 4 Years to 7 Years

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.

+Locations (1)

Facility	City	Country	Status
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai, Shanghai Municipality	China	Recruiting