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

Condition(s) studied

Investigational drug(s) / intervention(s)

Serious touchscreen game combined with occlusion: The game designed for amblyopia training feature innovative designs.

Augmented reality game combined with occlusion: The game designed for amblyopia training feature innovative designs.

Occlusion therapy: Wear an eye patch on the sound eye side daily for 4 hours.

Study 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

Primary outcome measure(s)

• 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

Trial sites (1)

More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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