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临床试验/NCT02655432
NCT02655432撤回不适用

Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti

Université de Montréal3 个研究点 分布在 1 个国家开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
3
主要终点
Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population

研究概览

简要总结

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener. The photoscreener results will be compared to the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Secondarily, this study will gather epidemiological information on vision problems in the haitian children population.

详细描述

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener before and after cycloplegia. The photoscreener results will be compared to the complete ophthalmologic evaluation. The ophthalmologic evaluation includes visual acuity, ocular alignment, slit lamp evaluation, cycloplegic refraction and dilated fundus evaluation. First of all, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Second of all, this study will gather epidemiological information on vision problems in the haitian children population.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Haitian children aged 3-6 years of age
  • Signed consent form from a legal guardian

排除标准

  • Previous vision problem diagnostic
  • Unsigned consent form

结局指标

主要结局

Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population

时间窗: 7 days

The epidemiology of vision problems will be evaluated in a sample of haitian children. The ophthalmologic exam will be considered abnormal if it denotes a significant ophthalmologic pathology. A significant ophthalmologic pathology is defined as a significant refractive error, a significant strabismus or a significant media opacity according to the 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS) Guidelines for automated preschool vision screening. An ophthalmologic pathology is also considered significant in cases of severe ophthalmologic pathologies (xerophthalmia, trachoma, cataract \>1mm, glaucoma, retinopathy of prematurity, retinoblastoma).

次要结局

  • Performance of the Spot photoscreeners in comparison with the ophthalmologic exam to denote significant ophthalmologic pathologies according to the 2013 AAPOS guidelines in an haitian pediatric population(7 days)
  • Performance of the Spot photoscreeners in comparison with the ophthalmologic exam to denote severe ophthalmologic pathologies that are not described in the 2013 AAPOS guidelines in an haitian pediatric population(7 days)
  • Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Hamel

Hospital chef of the ophthalmology department, CHU Sainte-Justine

Université de Montréal

研究点 (3)

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