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.

Not Applicable

Recruiting

• Conditions: Ametropia; Myopia; Refractive Error; Myopia; Astigmatism

• Registration Number: NCT06882408
• Lead Sponsor: Essilor International

Brief Summary

The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are:

* Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer.

* Assess the agreement of the measures obtained with the device with those obtained with the gold standard.

Detailed Description

Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.

Study Timeline

• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Perfomance evaluation for ametropia screening	One day (all measurements are taken during a single evaluation visit).	The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.

Secondary Outcome Measures

Name	Time	Method
Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer	One day (all measurements are taken during a single evaluation visit).	The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors.
Perfomance evaluation for ametropia screening	One day (all measurements are taken during a single evaluation visit).	The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer.
Perfomance evaluation for amblyopia screening	One day (all measurements are taken during a single evaluation visit).	The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer or the masking test and prism bars for strabismus.
Safety assessment and device failures	One day (all measurements are taken during a single evaluation visit).	Type, frequency and severity of adverse events and device failures are evaluated

Trial Locations

Locations (2)

Dr Krafft private practice; 🇫🇷 Nancy, France

Hôpital civil de Strasbourg; 🇫🇷 Strasbourg, France