RecruitingNot ApplicableNCT07472231

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

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


Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

66 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 7 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria4

  • 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.

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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.


Locations(1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT07472231


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