se of artificial intelligence to identify visual problems in childre

Not Applicable

Completed

• Conditions: Visual dysfunction; Eye Diseases

• Registration Number: ISRCTN17316993
• Lead Sponsor: Fundación Instituto de Investigación Sanitaria de Aragón (IIS Aragón)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-27
• Study Completion: 2020-05-31
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2208

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified