AmblyopiaNCT06372548
Rehabilitation Training Games for Children With Amblyopia
A study testing Find You! Cure My Animal Friends and DuoBao Vision Training System in people with Amblyopia and Amblyopia Occlusion, run by Zhu Dian at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Amblyopia, Amblyopia Occlusion, Child Behavior
- What is being tested?
- Find You! Cure My Animal Friends and DuoBao Vision Training System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.
Who cannot join
- Severe amblyopia.
- Suffering from other psychological or physical disorders.
- Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200240
About this study
Official title: The Effect of Cognitive Appraisal Theory on Adherence in Rehabilitation Training Games for Children With Amblyopia
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.
- Conditions
- Amblyopia, Amblyopia Occlusion, Child Behavior, Adherence, Treatment
- Being tested
- Find You! Cure My Animal Friends, DuoBao Vision Training System
- Medical subject headings
- Amblyopia, Child Behavior, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Find You! Cure My Animal FriendsDevice
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.
DuoBao Vision Training SystemDevice
This is a visual training app where participants are required to complete several training tasks.
| Study group | Role | What they receive |
|---|---|---|
| Find You! Cure My Animal Friends | Experimental | 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. Receives: Device: Find You! Cure My Animal Friends |
| DuoBao Vision Training System | Active comparator | 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. Receives: Device: DuoBao Vision Training System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: study completion (after 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhu Dian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Dian, Shanghai Jiao Tong University School of Medicine
- Investigators
- Dian Zhu, Dr, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372548
- Sponsor's protocol ID
- NEADS0004
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Appraisal Theory on Adherence in Rehabilitation Training Games for Children With Amblyopia
- ClinicalTrials.gov ID
- NCT06372548
- Acronym / sponsor ID
- NEADS0004
- Conditions
- Amblyopia, Amblyopia Occlusion, Child Behavior, Adherence, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Zhu DianUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Find You! Cure My Animal Friends | Experimental | Device: Find You! Cure My Animal FriendsParticipants 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. |
| DuoBao Vision Training System | Active comparator | Device: DuoBao Vision Training SystemSoftware 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. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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 informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix.
Key exclusion criteria (3 listed)
- Severe amblyopia.
- Suffering from other psychological or physical disorders.
- Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Find You! Cure My Animal FriendsIntroduced 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. | Device | Find You! Cure My Animal Friends |
| DuoBao Vision Training SystemThis is a visual training app where participants are required to complete several training tasks. | Device | DuoBao Vision Training System |
Primary outcome
8-Item Morisky Medication Adherence Scale (MMAS-8):
Time frame: baseline and study completion (after 8 weeks)
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.
1 secondary outcome
User Experience Questionnaire (UEQ)
Time frame: study completion (after 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dian Zhu, Dr principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Find You! Cure My Animal Friends and DuoBao Vision Training System in people with Amblyopia and Amblyopia Occlusion, run by Zhu Dian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-Item Morisky Medication Adherence Scale (MMAS-8): (time frame: baseline and study completion (after 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.