Improving Control of Intermittent Exotropia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Improvement in control of intermittent exotropia
研究概览
简要总结
To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically
详细描述
Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.
In this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.
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 (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IXT or XT at Distance & IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)
- •No surgery planned for 6 months
排除标准
- •Prior eye muscle surgery
- •Prior binocular treatment or vision therapy
- •Amblyopia
- •Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache
- •Other eye conditions (refractive error OK)
结局指标
主要结局
Improvement in control of intermittent exotropia
时间窗: 8 weeks
change percent time alignment is present at 8 weeks vs at baseline
次要结局
- Improvement in control of intermittent exotropia(4 weeks)
- Change in suppression(4 weeks)
- Change in suppression(8 weeks)
- Change in distance stereoacuity(4 weeks)
- Change in distance stereoacuity(8 weeks)
- Change in quality of life(8 weeks)
- Improvement in control of intermittent exotropia(12 weeks off-treatment)
- Change in suppression(12 weeks off-treatment)
- Change in distance stereoacuity(12 weeks off-treatment)
- Change in quality of life(12 weeks off-treatment)
研究者
Eileen Birch
Director, Pediatric Vision Laboratory
Retina Foundation of the Southwest