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临床试验/ISRCTN17316993
ISRCTN17316993已完成未知

Implementation of artificial intelligence for the detection of visual dysfunction in childhood

Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)0 个研究点目标入组 2,208 人开始时间: 2019年5月27日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
2,208

研究概览

简要总结

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32071178/ protocol (added 15/01/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36670638/ (added 14/06/2023)

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • 1. Age between 6 months and 14 years
  • 2. Visual fixation stable enough to allow attentive fixation on the Lang cube
  • 3. Assessments performed for all the following visual outcomes (although in some cases information may not be obtained):
  • 3.1. External examination and red reflex
  • 3.2. Visual acuity
  • 3.3. Ocular motility
  • 3.4. Refraction under cycloplegia
  • 3.5. Funduscopy
  • 4. Informed consent signed by parents or guardians of the child

排除标准

  • 1. Previous ocular, muscular or orbital surgery. Since the main goal of the project is to develop a screening tool to identify children with abnormal visual development, children with any ocular or periocular surgery will be excluded from the study. However, children previously treated with optical correction, minor topic treatments or any therapy for amblyopia, will not be excluded, due to pragmatic reasons. Laser or intravitreal treatment for retinopathy of prematurity will not exclude a child.
  • 2. Bad general health state, which does not allow an examination with DIVE. Lack of collaboration for performing the clinical protocol or the visual exam with DIVE is not an exclusion criterion.

研究者

发起方
Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)

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