A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometropic Amblyopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serious touchscreen game combined with occlusion, Augmented reality game combined with occlusion, Occlusion therapy.
- Who it may be relevant to
- Registry conditions: Amblyopia. Basic parameters: 4 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Serious touchscreen game combined with occlusion
The game designed for amblyopia training feature innovative designs. - Device Augmented reality game combined with occlusion
The game designed for amblyopia training feature innovative designs. - Behavioral Occlusion therapy
Wear an eye patch on the sound eye side daily for 4 hours.
Primary outcome measures
- Number of participants with Objective improvement in visual function [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]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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.
- Participation in any other eye-related interventional trial within the past 4 weeks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07472231 · XH-25-009 · 24X010301505