A Study on the Efficacy and User Experience of Gamified Intervention for Children With Anisometropic Amblyopia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amblyopia
• Intervention / Treatment: Device: Serious touchscreen game combined with occlusion; Device: Augmented reality game combined with occlusion; Behavioral: Occlusion therapy

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianing Ren; Phone Number: +86 18800253186; Email: 981433535@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Clinically diagnosed with monocular anisometropic amblyopia.
2. Aged 4 to 7 years.
3. Able to cooperate with all examinations and comply with the amblyopia training regimen.
4. Provided signed informed consent.

Exclusion Criteria:

1. Severe developmental delay or cognitive impairment.
2. Serious systemic diseases.
3. Presence of organic ocular diseases (e.g., cataract, fundus diseases) or manifest strabismus.
4. Participation in any other eye-related interventional trial within the past 4 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Intervention); Serious touchscreen game combined with occlusion	Device: Serious touchscreen game combined with occlusion; The game designed for amblyopia training feature innovative designs.
Experimental: Group 2 (Intervention); Augmented Reality game combined with occlusion	Device: Augmented reality game combined with occlusion; The game designed for amblyopia training feature innovative designs.
Active Comparator: Control Group; Occlusion therapy only	Behavioral: Occlusion therapy; Wear an eye patch on the sound eye side daily for 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after the first visit
Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart		3 months after the first visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	3 months after the first visit

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Amblyopia; Digestive System and Oral Physiological Phenomena; Dentistry; Dental Physiological Phenomena; Dental Occlusion
• Other Study ID Numbers: XH-25-009; 24X010301505 (Other Grant/Funding Number: the Fundamental Research Funds for the Central Universities（China）)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No