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临床试验/NCT07709832
NCT07709832尚未招募不适用

A Randomized Controlled Trial Evaluating the Efficacy and Safety of an Autostereoscopic 3D Vision Therapy System for Visual Function Rehabilitation in Children With Unilateral Amblyopia

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Best Corrected Visual Acuity (BCVA)

研究概览

简要总结

The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. The main questions it aims to answer are:

  • Does autostereoscopic 3D vision training improve best corrected visual acuity in the amblyopic eye compared to conventional patching therapy?
  • What side effects or discomfort do participants experience during 3D training versus patching? Researchers will compare the autostereoscopic 3D training system to conventional daily eye patching to see which treatment works better for improving vision in amblyopia.

Participants will:

  • Be randomly assigned to either the 3D training group or the patching group
  • Complete daily home treatment for 6 months - either 20 minutes of 3D vision training or 2 hours of continuous eye patching
  • Visit the clinic at baseline, 1 month, 3 months, and 6 months for eye exams and vision tests
  • Have their treatment progress monitored remotely through training data logs or patching diaries

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
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Unilateral amblyopia (anisometropic, strabismic, or ametropic)
  • Age: 7 to 12 years
  • Amblyopic eye BCVA: 0.1 to 0.8 LogMAR
  • Fellow eye BCVA: ≥ 0.8 LogMAR
  • Stable refractive status (≤ ±0.50D change in past 6 months)
  • Written informed consent from participant and guardian

排除标准

  • Deprivation amblyopia (congenital cataract, ptosis, etc.)
  • Organic ocular disease (glaucoma, retinopathy, optic neuropathy)
  • Previous ocular surgery or trauma
  • Severe dry eye or other ocular surface disorders
  • Uncontrolled systemic diseases (diabetes, hypertension)
  • Neuropsychiatric conditions preventing cooperation
  • Participation in other clinical trials within 3 months

结局指标

主要结局

Best Corrected Visual Acuity (BCVA)

时间窗: baseline to 6 months

次要结局

  • Adherence(Baseline to 6 months)
  • Intraocular Pressure (IOP)(Baseline to 6 months)
  • Distance Stereoacuity(baseline to 6 months)
  • Near Stereoacuity(Baseline to 6 months)
  • Contrast Sensitivity Function(Baseline to 6 months)
  • Computer Vision Syndrome Questionnaire (CVS-Q) Score(Baseline to 6 months)
  • Simulator Sickness Questionnaire (SSQ) Score(Baseline to 6 months)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinyuan,MD

President of Beijing Tongren Hospital

Beijing Tongren Hospital

研究点 (1)

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