AmblyopiaNCT07472231
A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometropic Amblyopia
A study testing Serious touchscreen game combined with occlusion, Augmented reality game combined with occlusion and Occlusion therapy in people with Amblyopia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Serious touchscreen game combined with occlusion, Augmented reality game combined with occlusion and Occlusion therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Jianing Ren, MD, +86 18800253186, 981433535@qq.com
About this study
Official 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
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.
- Conditions
- Amblyopia
- Being tested
- Serious touchscreen game combined with occlusion, Augmented reality game combined with occlusion, Occlusion therapy
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious touchscreen game combined with occlusionDevice
The game designed for amblyopia training feature innovative designs.
Augmented reality game combined with occlusionDevice
The game designed for amblyopia training feature innovative designs.
Occlusion therapyBehavioural
Wear an eye patch on the sound eye side daily for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Intervention) | Experimental | Serious touchscreen game combined with occlusion Receives: Device: Serious touchscreen game combined with occlusion |
| Group 2 (Intervention) | Experimental | Augmented Reality game combined with occlusion Receives: Device: Augmented reality game combined with occlusion |
| Control Group | Active comparator | Occlusion therapy only Receives: Behavioral: Occlusion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Objective improvement in visual function
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.
Measured: 3 months after the first visit
Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart
Measured: 3 months after the first visit
Secondary outcomes (5)
Improvement in functional vision in daily living
Functional vision assessed by Cardiff Visual Ability Questionnaire for Children (CVAQC). Total score ranges from 0 to 48. Higher scores indicate better outcome.
Measured: 3 months after the first visit
Medical fear assessed by Child Medical Fear Scale (CMFS)
Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety.
Measured: 3 months after the first visit
Anxiety assessed by Child Anxiety Meter-State (CAM-S)
Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety.
Measured: 3 months after the first visit
Compliance
User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation.
Measured: 3 months after the first visit
Acceptance
User experience assessed by Game Experience Questionnaire (GEQ). Total score ranges from 0 to 50. Higher scores indicate better game experience.
Measured: 3 months after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianing Ren, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472231
- Sponsor's protocol ID
- XH-25-009
- Other IDs
- 24X010301505
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to participant privacy considerations and the terms of the ethical approval and informed consent documents for this study, individual participant data will not be publicly shared. Aggregated data and study results will be disseminated through academic publications.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07472231
- Acronym / sponsor ID
- XH-25-009
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Intervention) | Experimental | Device: Serious touchscreen game combined with occlusionSerious touchscreen game combined with occlusion |
| Group 2 (Intervention) | Experimental | Device: Augmented reality game combined with occlusionAugmented Reality game combined with occlusion |
| Control Group | Active comparator | Behavioral: Occlusion therapyOcclusion therapy only |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Serious touchscreen game combined with occlusionThe game designed for amblyopia training feature innovative designs. | Device | Group 1 (Intervention) |
| Augmented reality game combined with occlusionThe game designed for amblyopia training feature innovative designs. | Device | Group 2 (Intervention) |
| Occlusion therapyWear an eye patch on the sound eye side daily for 4 hours. | Behavioural | Control Group |
Primary outcome
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.
Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart
Time frame: 3 months after the first visit
5 secondary outcomes
Improvement in functional vision in daily living
Time frame: 3 months after the first visit
Medical fear assessed by Child Medical Fear Scale (CMFS)
Time frame: 3 months after the first visit
Anxiety assessed by Child Anxiety Meter-State (CAM-S)
Time frame: 3 months after the first visit
Compliance
Time frame: 3 months after the first visit
Acceptance
Time frame: 3 months after the first visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. Due to participant privacy considerations and the terms of the ethical approval and informed consent documents for this study, individual participant data will not be publicly shared. Aggregated data and study results will be disseminated through academic publications.
Related trials for Amblyopia
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious touchscreen game combined with occlusion, Augmented reality game combined with occlusion and Occlusion therapy in people with Amblyopia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianing Ren (+86 18800253186, 981433535@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Objective improvement in visual function (time frame: 3 months after the first visit). The study lists 2 primary outcomes in all. 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 Jul 2026.