A Phase 4 Randomized, Single-blind Study to Evaluate the Multi-media Training（SJ-RS-WL2015）Software Rehabilitating Ability of Binocular Functions in Hospitalized Adolescent Patients With Intermittent Exotropia After Eye Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change from Baseline Stereopsis at 12 months
研究概览
简要总结
Evaluating the effect of SJ-RS-WL2015 visual training program in children with intermittent exotropia after eye surgery, including the improvement of simultaneous perception (I binocular function), fusion (II binocular function), stereopsis (III binocular function).
详细描述
All the patients are after eye surgery for intermittent exotropia. All the participants with 20/20 or better visual acuity.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Intermittent Exotropia
- •Must be after eye surgery for Intermittent Exotropia
- •Baseline Deviation Range: Esotropia<=5△ or Exotropia<15△ after Eye Surgery
- •Visual Acuity: >=20/20
排除标准
- •A-V patterns deviations
- •Abnormal oblique or vertical rectus
- •Nystagmus
- •Ophthalmoplegia
- •Anisometropia >2.5D
- •With other eye surgery history
- •Mental disorder
- •Neural disease
- •Heart disease
- •Hypertension
- •Severe systemic disease
- •With vision therapy history within 4 weeks
- •Implanted electronic device
- •In other researches within 4 weeks
研究组 & 干预措施
Experimental group with SJ-RS-WL2015
Item code: SJ-RS-WL2015, a visual training software program, 15 minutes of one section, twice a day, and for 1 year
干预措施: SJ-RS-WL2015 visual training program software (Other)
control group
No special treatment, but observation
结局指标
主要结局
Change from Baseline Stereopsis at 12 months
时间窗: 12 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Simultaneous Perception at 12 months
时间窗: 12 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Fusion at 6 months
时间窗: 6 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 3 months
时间窗: 3 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Fusion at 1 month
时间窗: 1 month
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Stereopsis at 3 months
时间窗: 3 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 3 months
时间窗: 3 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Stereopsis at 2 months
时间窗: 2 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Simultaneous Perception at 2 months
时间窗: 2 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 1 month
时间窗: 1 month
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Stereopsis at 6 months
时间窗: 6 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Simultaneous Perception at 1 month
时间窗: 1 month
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,
Change from Baseline Fusion at 12 months
时间窗: 12 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 6 months
时间窗: 6 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Fusion at 2 months
时间窗: 2 months
Measured with Worth 4-dot test and Synoptophore, respectively
次要结局
- Change from Baseline Deviation Degree at 1 year(1 year)
- Visual Acuity(one year)
- Change from Baseline Refractive Error at 1 year(1 year)