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

NCT07472231 | Recruiting

• 2 other identifiers: XH-25-00924X010301505
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Improvement in functional vision in daily living

  3 months after the first visit

• Medical fear assessed by Child Medical Fear Scale (CMFS)

  3 months after the first visit

• Anxiety assessed by Child Anxiety Meter-State (CAM-S)

  3 months after the first visit

• Compliance

  3 months after the first visit

• Acceptance

  3 months after the first visit

Study Arms (3)

Group 1 (Intervention)

EXPERIMENTAL

Serious touchscreen game combined with occlusion

Device: Serious touchscreen game combined with occlusion

Group 2 (Intervention)

EXPERIMENTAL

Augmented Reality game combined with occlusion

Device: Augmented reality game combined with occlusion

Control Group

ACTIVE COMPARATOR

Occlusion therapy only

Behavioral: Occlusion therapy

Interventions

Serious touchscreen game combined with occlusion DEVICE

The game designed for amblyopia training feature innovative designs.

Group 1 (Intervention)

Occlusion therapy BEHAVIORAL

Wear an eye patch on the sound eye side daily for 4 hours.

Control Group

Augmented reality game combined with occlusion DEVICE

The game designed for amblyopia training feature innovative designs.

Group 2 (Intervention)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Amblyopia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Jianing Ren

CONTACT

+86 18800253186; 981433535@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of the Department of Ophthalmology

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: March 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)