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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Record History

  1. Notable Recruitment opened
    • Primary completion pushed from Aug 2026 to Dec 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2026 to May 1, 2026
    v3
  2. Notable Start date: Mar 2026 to May 2026
    • Primary completion pushed from Jun 2026 to Aug 2026
    • Secondary endpoints: details revised at 5 of 5 entries
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07472231
Lead Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)
Amblyopia
Related terms Amblyopia
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov