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
N/A
Interventional Study
Ametropia
Myopia; Refractive Error
Myopia; Astigmatism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 – 8
- Sex
- Any
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 315 (estimated)
- Sponsor
- Essilor International · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 obt…
Trial Locations
Loading…
Loading trial locations…
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…
Contacts