Actively Recruiting
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.
Led by Essilor International · Updated on 2025-04-29
315
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Under myopia control solution that may impact refractive error (such as atropine, orthokeratology)
- Wearing contact lenses
- Ocular or systemic pathology that may impact vision or interfere with study measures (except strabismus)
- Under medication that may impact vision or interfere with study measurements
- Known contraindication to the active substance or excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
- Known risk of angle-closure glaucoma
- Participation in another study that may impact vision or interfere with study measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dr Krafft private practice
Nancy, France, France, 54000
Not Yet Recruiting
2
Hôpital civil de Strasbourg
Strasbourg, France, France, 67091
Actively Recruiting
Research Team
S
Sara Cadoni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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