跳至主要内容
临床试验/NCT03940222
NCT03940222Unknown不适用

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
38
试验地点
1
主要终点
Best Corrected Visual Acuity

研究概览

简要总结

The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM.

In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.

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 (Participant)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye
  • A difference of two BCVA lines of Snellen between the two eyes

排除标准

  • A history of penalization one month prior to the study
  • Bilateral amblyopia
  • BCVA less than 20/200
  • Eccentric fixation
  • Nystagmus
  • Ocular deviation more than 10 prism diopter (pd)
  • Organic amblyopia
  • Uncooperative children those with
  • Mental and physical disability
  • Systemic diseases

研究组 & 干预措施

I-BiT group

Experimental

Amblyopic patients will play I-BiT games without patching.

干预措施: Interactive Binocular Treatment (Device)

Placebo group

Placebo Comparator

Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.

干预措施: Patching Therapy (Procedure)

结局指标

主要结局

Best Corrected Visual Acuity

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Hamideh Sabbaghi

PhD student, Teacher Assistant

Shahid Beheshti University of Medical Sciences

研究点 (1)

Loading locations...

相似试验

Comparison Between Patching and Interactive... | 临床试验