A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometro… (NCT07472231) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometropic Amblyopia
66 participantsStarted 2026-05
Plain-language 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. 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.
Who can participate
Age range
4 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Objective improvement in visual function
Timeframe: 3 months after the first visit
2
Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart
Timeframe: 3 months after the first visit
Trial details
NCT IDNCT07472231
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine