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临床试验/NCT07472231
NCT07472231招募中不适用

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1
主要终点
Number of participants with Objective improvement in visual function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Group 1 (Intervention)

Experimental

Serious touchscreen game combined with occlusion

干预措施: Serious touchscreen game combined with occlusion (Device)

Group 2 (Intervention)

Experimental

Augmented Reality game combined with occlusion

干预措施: Augmented reality game combined with occlusion (Device)

Control Group

Active Comparator

Occlusion therapy only

干预措施: Occlusion therapy (Behavioral)

结局指标

主要结局

Number of participants with Objective improvement in visual function

时间窗: 3 months after the first visit

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.

Best-Corrected Visual Acuity (BCVA) assessed by LogMAR chart

时间窗: 3 months after the first visit

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianing Ren

Attending Physician of the Department of Ophthalmology

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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