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Recruiting Not applicable

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

NCT07472231 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-07-30

Condition(s) studied

Amblyopia

Investigational drug(s) / intervention(s)

Serious touchscreen game combined with occlusionAugmented reality game combined with occlusionOcclusion therapy

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

Sex
ALL
Min age
4 Years
Max age
7 Years
Healthy volunteers
No
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.

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)

FacilityCityRegionStatus
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07472231 on ClinicalTrials.gov ↗ ← All trials in China