NCT06882408

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.

Evaluation of the Photorefraction Screener Snapsight in Comparison With Cycloplegia Table-top Autorefractor in Ametropia in Pediatric Population Between 3 and 8yo, Multicenter French Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ametropia
• Myopia; Refractive Error
• Myopia; Astigmatism

Interventions

Type	Name	Description
DEVICE	Photorefraction device under investigation	Objective refraction measurement with and without cyclopegia
DEVICE	Comparator device, Tabletop auto-refractometer	Objective refraction measurement with and without cyclopegia
DEVICE	Comparator device, portable photorefraction device	Objective refraction measurement with and without cyclopegia
OTHER	Distance visual acuity assessments	Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
OTHER	Subjective refraction and far visual acuity	Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures
OTHER	Strabismus assessment	Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-18
• Last updated: 2025-04-29

Locations

2 sites across 1 country: France