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

N/ANot Yet RecruitingNCT07472231

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine66 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amblyopia

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.