The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.

Launched by ESSILOR INTERNATIONAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to test a special device called a photorefraction screener, which helps identify vision problems in children aged 3 to 8 years. The main goal is to see how well this device works compared to a standard tool used by eye doctors, known as a tabletop refractometer. The study will measure how accurately the screener can detect different types of vision issues, such as nearsightedness (myopia) and astigmatism, in children, whether they wear glasses or not.

To participate in this study, children must be between 3 and 8 years old and have the ability to follow instructions during the testing. They can have any skin type and do not need to wear glasses to be eligible. However, children who are currently undergoing treatments for myopia or have certain eye conditions may not be able to join. The trial will take place during a single visit, where participants will undergo various tests to evaluate their vision. It’s a great opportunity to help researchers learn more about improving vision screening for young children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged between 3-8 years when included in the study
• • All skin phototypes (I to VI according to the Fitzpatrick classification)
• • Wearing glasses or not
• • Capacity to give valid consent
• • Capacity to follow the protocol to obtain reliable measure
• • Under French medical insurance
• Exclusion Criteria:
• • Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)
• • Wearing contact lenses
• • Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)
• • Under medication that may have an impact on vision or may interfere with study measurements
• • Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
• • Known risk of angle-closure glaucoma
• • Participation to another study that may have an impact on vision or may interfere with the study measures