Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07472231

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200092, China

Location status: Recruiting

Location contact

Jianing Ren, MD

CONTACT

[email protected]

+86 18800253186

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Serious touchscreen game combined with occlusion

Device

The game designed for amblyopia training feature innovative designs.

Augmented reality game combined with occlusion

Device

The game designed for amblyopia training feature innovative designs.

Occlusion Therapy

Behavioral

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

Primary outcomes

  1. Number of participants with Objective improvement in visual function

    Time frame: 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.

  2. Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart

    Time frame: 3 months after the first visit

Secondary outcomes

  1. Improvement in functional vision in daily living

    Time frame: 3 months after the first visit

    Functional vision assessed by Cardiff Visual Ability Questionnaire for Children (CVAQC). Total score ranges from 0 to 48. Higher scores indicate better outcome.

  2. Medical fear assessed by Child Medical Fear Scale (CMFS)

    Time frame: 3 months after the first visit

    Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety.

  3. Anxiety assessed by Child Anxiety Meter-State (CAM-S)

    Time frame: 3 months after the first visit

    Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety.

  4. Compliance

    Time frame: 3 months after the first visit

    User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation.

  5. Acceptance

    Time frame: 3 months after the first visit

    User experience assessed by Game Experience Questionnaire (GEQ). Total score ranges from 0 to 50. Higher scores indicate better game experience.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianing Ren

CONTACT

[email protected]

+86 18800253186

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.