跳至主要内容
临床试验/NCT05204069
NCT05204069已完成不适用

Screening for 3-D Visual Disorders in Preschool Children, VISION Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Screening for 3-dimensional visual disorders

研究概览

简要总结

Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation.

详细描述

Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Methodology: The "Association Française de Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions visual screening to assess whether or not a child presents risk factors of amblyopia such as ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume that a vision screening operated with the AFSOP 3 dimension screening recommendations and conducted by paramedical actors such as orthoptists will prove more sensitive and easier to implement on a national scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Years 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3 to 4 years
  • Enrolled in kindergarten in the first section
  • In the 19th district of Paris
  • Who should benefit from visual screening via the school medical service

排除标准

  • Children who do not speak French
  • Children who are physically or cognitively unable to participate in the screening

研究组 & 干预措施

Three-dimensional screening for visual disorders using the RetinoMax Device

Experimental

Instillation of cyclopentolate of 3 drops of cyclopentolate at T0',T5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device.

干预措施: Instillation of cyclopentolate (Drug)

Non-standardized device for usual vision disorders

Active Comparator

Screening device for usual vision disorders, performed by the school doctor during the usual prevention visit, with the tools used in the school doctor's current practice, non-standardized, according to his preference

干预措施: Instillation of cyclopentolate (Drug)

结局指标

主要结局

Screening for 3-dimensional visual disorders

时间窗: 1 day

Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验