Effectiveness of non-surgical intervention in Intermittent exotropia in children below 8 years of age
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement/change in the parameters of intermittent exotropia in children below 8 years of age:
研究概览
简要总结
Title: Effectiveness of Non-Surgical Intervention in Intermittent Exotropia in Children Below 8 Years of Age
Intermittent exotropia (IXT) is one of the most common childhood strabismus disorders, characterized by intermittent outward deviation of one eye. Its progression varies widely, and both surgical and non-surgical interventions are employed, though there is limited consensus on optimal management in young children.
This study aims to evaluate the effectiveness of non-surgical interventions, specifically alternate intermittent occlusion (patching) and binocular vision therapy (BVT)—in improving ocular alignment, deviation control, and binocular vision in children under 8 years of age with IXT.
A prospective cohort study will be conducted from August 2025 to July 2026, enrolling 50 children diagnosed with IXT. Effectiveness will primarily be assessed using the Newcastle Control Score (NCS), along with measures of deviation angle, stereopsis, and caregiver perceptions through qualitative interviews.
The primary objective is to determine the change in NCS following intervention, while secondary objectives include evaluating caregiver perception, as well as the influence of age at onset and treatment on outcomes.
Expected results include improvement in control scores, angle of deviation, and compliance with non-surgical therapy. By integrating both clinical outcomes and caregiver perspectives, this study addresses current gaps in evidence and may help guide standardized non-surgical management protocols for IXT in younger children, potentially reducing the need for early surgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 1.00 Day(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •Children below 8 years of age presenting with Intermittent Exotropia.
- •Children having intermittent exotropia for distance, and intermittent exotropia or exophoria for near.
- •No previous intervention for intermittent exotropia, except refractive correction.
排除标准
- •Children with constant exotropia for distance or near.
- •Exotropia associated with syndromes or neurological disorders.
- •Prior ocular surgery or non-surgical intervention for intermittent exotropia.
结局指标
主要结局
Improvement/change in the parameters of intermittent exotropia in children below 8 years of age:
时间窗: 1 year
-Improvement in the Newcastle control score on follow up at 3 months, compared to the baseline measurement.
时间窗: 1 year
-Improvement in the angle of deviation on follow up at 3 months, compared to the baseline measurement.
时间窗: 1 year
次要结局
- An interview-based improvement in the methods of non-surgical intervention to increase compliance and ease of delivering the treatment.(1 year)
- Better short-term improvement in the angle of deviation and Newcastle score in intermittent exotropia.(1 year)
研究者
Dr Manasi Lad
Sankara Eye Hospital, Bengaluru
