An interventional study of Serious touchscreen game combined with occlusion and Augmented reality game combined with occlusion in Amblyopia, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serious touchscreen game combined with occlusion
Device: Serious touchscreen game combined with occlusion
Augmented Reality game combined with occlusion
Device: Augmented reality game combined with occlusion
Occlusion therapy only
Behavioral: Occlusion therapy
The game designed for amblyopia training feature innovative designs.
The game designed for amblyopia training feature innovative designs.
Wear an eye patch on the sound eye side daily for 4 hours.
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.
Time frame: 3 months after the first visit
Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart
Time frame: 3 months after the first visit
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after the first visit
Plan to share: 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.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 58 non-industry interventional studies with no phase under Amblyopia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 72. This study's planned 7 months is below that.
Counting every sponsor, half of 71 studies reached it within 33 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →