Clinical Trial

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.

Recruiting
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Record status
This record was last updated April 29, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-12.
Status change: Not Yet Recruiting → Recruiting 2025-04-28
Trial Details
NCT Number NCT06882408
Lead Sponsor Essilor International
Conditions Ametropia, Myopia; Refractive Error, Myopia; Astigmatism
Enrollment 315 participants
Start Date 2025-04
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-29