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

Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)0 sites2,208 target enrollmentMay 27, 2019

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)
Enrollment: 2208
Status: Completed
Last Updated: 2 years ago

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)

Registry

who.int

Start Date

May 27, 2019

End Date

May 31, 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)

•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

•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.