Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
Sponsor: Essilor International
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.
Official title: 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.
Key Details
Gender
All
Age Range
3 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2025-04
Completion Date
2025-12
Last Updated
2025-04-29
Healthy Volunteers
Yes
Interventions
Photorefraction device under investigation
Objective refraction measurement with and without cyclopegia
Comparator device, Tabletop auto-refractometer
Objective refraction measurement with and without cyclopegia
Comparator device, portable photorefraction device
Objective refraction measurement with and without cyclopegia
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.
Subjective refraction and far visual acuity
Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures
Strabismus assessment
Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Locations (2)
Dr Krafft private practice
Nancy, France, France
Hôpital civil de Strasbourg
Strasbourg, France, France