NCT07472231

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Serious touchscreen game combined with occlusion	The game designed for amblyopia training feature innovative designs.
DEVICE	Augmented reality game combined with occlusion	The game designed for amblyopia training feature innovative designs.
BEHAVIORAL	Occlusion therapy	Wear an eye patch on the sound eye side daily for 4 hours.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2026-03-16
• Last updated: 2026-03-16