ClinicalTrials.gg
CompletedNCT06372548Updated Apr 30, 2026

Rehabilitation Training Games for Children With Amblyopia

An interventional study of Find You! Cure My Animal Friends and DuoBao Vision Training System in Amblyopia, Amblyopia Occlusion and Child Behavior, sponsored by Zhu Dian. Completed at 1 site in China. Open to participants aged 7 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Zhu Dian · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
7 Years to 10 Years
Sex
All
01

Study summary

A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.

Read the detailed description

The experimental group was subjected to a 20-minute daily, 4-week intervention experiment, which included a story background on the start page, eye patches to be put on according to the guidelines, fine eye training, and visual stimulation training, with short breaks between the different modes. The control group was given an experimental intervention using a competing product, with the same duration and format as the experimental group. After completion of the intervention, the participating children completed the MMAS-8 adherence scale with the help of their parents.

02

Conditions studied

  • Amblyopia
  • Amblyopia Occlusion
  • Child Behavior
  • Adherence, Treatment
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's enrollment of 34 is below the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Zhu Dian is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of amblyopia (including refractive amblyopia, strabismic amblyopia and mixed).
  • The child has no significant IQ deficits and has no difficulty communicating with others.
  • The children's teachers and parents gave their to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.

Exclusion criteria

Exclusion Criteria:

  • Severe amblyopia.
  • Suffering from other psychological or physical disorders.
  • Parents did not agree to sign the form or the child was not willing to participate in this experiment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Find You! Cure My Animal Friends

    Participants in the experimental group completed the game in this app. The goal of the game is to guide the amblyopic children to develop the habit of rehabilitation training, so that the amblyopic children will keep their interest in completing the exercises according to the time in the game. A story of an animal intern doctor is constructed, and the player will play the role of an animal doctor according to the guidance of the plot, wear the corresponding eye patches and complete the set visual training tasks in the game. The study aims to improve the overall treatment adherence by increasing the attractiveness of the visual training game to children, cultivating long-term training habits, and mitigating the negative effects of amblyopia treatment. The path to achieve this goal consists of the following components: (1) narrative content, (2) interactive forms combined with masking therapy, (3) incentives, and (4) visual design that is consistent with children's preferences.

    Device: Find You! Cure My Animal Friends

  • Active comparator
    DuoBao Vision Training System

    Software Co.'s DuoBao Vision Training System. A number of visual function tests and ophthalmology strabismus amblyopia specialist examinatio. The data is transmitted to the data center and the expert intelligent system to develop a targeted personalized amblyopia training program. Control group participants completed the training components in this app.

    Device: DuoBao Vision Training System

Interventions

  • DeviceFind You! Cure My Animal Friends

    Introduced cognitive evaluation theory combined with masking therapy to develop a gamified product that guides amblyopic children to develop habits for the purpose of rehabilitation training.

  • DeviceDuoBao Vision Training System

    This is a visual training app where participants are required to complete several training tasks.

06

What researchers measure

Primary outcomes

  1. 8-Item Morisky Medication Adherence Scale (MMAS-8):

    A patient's adherence to therapy can be evaluated using the eight-question Morisky Medication Adherence Scale-8 (MMAS-8).The total score of the MMAS-8 scale is the sum of the scores of the above 8 questions, and the score range is 0\~8. Higher scores indicate better medication adherence. 8 indicates good adherence; 6\~7 indicates moderate adherence; \<6 indicates poor adherence.

    Time frame: baseline and study completion (after 8 weeks)

Secondary outcomes

  1. User Experience Questionnaire (UEQ)

    Enabling prompt and accurate user experience measurement is the primary goal of the UEQ.UEQ was administered post-experiment to swiftly and accurately measure user experience. Covering 26 items across six domains, UEQ evaluated the impact of the amblyopia rehabilitation training product on both children and their parents. Due to its language complexity, the questionnaire was completed with parental assistance.1 for disagree, 7 for strongly agree

    Time frame: study completion (after 8 weeks)

07

Study locations

1 site
  • Shanghai Jiao Tong University
    Shanghai, Shanghai Municipality 200240, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06372548
Lead sponsor
Zhu Dian
Responsible party
Zhu Dian (Principal Investigator, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Apr 18, 2024
Start date
Mar 1, 2023
Primary completion
Jun 1, 2024
Completion
Aug 1, 2024
Last update
Apr 30, 2026

Study contacts

Dian Zhu, Dr
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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