Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
研究概览
简要总结
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.
However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.
The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common to the three groups:
- •Patient aged 0 to 36 months
- •Diagnosis of known ocular pathology
- •For patients targeted by the questionnaire:
- •- Patient with operable bilateral ocular pathology
- •For negative controls:
- •- Patient without ocular pathology inducing a decrease in vision
- •For positive controls:
- •Patient with inoperable bilateral ocular pathology
- •Patient without light perception
排除标准
- •Patient with unilateral ocular pathology
- •Verbal patients (able to express themselves through speech)
研究组 & 干预措施
Questionnaire
Description : 18 items questionnaire, filled by the parents of the child
干预措施: Questionnaire for visual function assessment of preverbal children (Other)
结局指标
主要结局
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
时间窗: Inclusion
Reliability evaluated by Cronbach's alpha coefficient and its 95% confidence interval. unabbreviated scale title : Assessment of Visual Function in Preverbal Children in Bilateral Ocular Pathology Minimum value : 0 Maximum value : 18 Higher scores mean better outcome
次要结局
未报告次要终点