Actively Recruiting
Evaluation of the Photorefraction Screener Snapsight Compared With Cycloplegia Table-top Autorefractor for Ametropia Screening in Children Aged 3 to 8 Years, Multicenter French Study
Led by Essilor International · Updated on 2025-04-29
315
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of a photorefraction screener device in children aged 3 to 8 years old to detect ametropia, a type of refractive error. The study aims to compare this device's measurements with those from the gold standard tabletop refractometer and to assess how well the device's results agree with the standard method. The goal is to understand how sensitive, specific, and accurate the photorefraction device is for vision screening in children. Eligible participants will take part in a single evaluation visit where several objective refraction measurements are taken using the investigational photorefraction device, a tabletop refractometer, and another portable vision screener, both with and without cycloplegia (eye drops that temporarily paralyze focusing). Researchers will also assess far vision visual acuity, strabismus (eye alignment), and subjective refraction during this visit. During the visit, investigators will gather data from the different devices and assessments to evaluate the photorefraction screener's performance in detecting refractive errors and amblyopia (lazy eye). They will also monitor for any safety concerns or device failures. All measurements and assessments occur in one day during this single visit, providing a comprehensive comparison of the screening tools.
CONDITIONS
Brief 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 and 8 years at study entry
- Any skin phototype (I to VI according to Fitzpatrick classification)
- May wear glasses or not
- Able to provide valid consent
- Able to follow the study procedures to obtain reliable measurements
- Covered by French medical insurance
You will not qualify if you...
- Using myopia control treatments that affect refractive error (e.g., atropine, orthokeratology)
- Wearing contact lenses
- Having ocular or systemic diseases affecting vision or study measurements (except strabismus)
- Taking medications that may affect vision or study outcomes
- Known allergy or contraindication to eye drops used in the study (Mydriaticum 0.5%, Skiacol 0.5%)
- Known risk of angle-closure glaucoma
- Participating in another study that may affect vision or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a single evaluation visit during which multiple refractive error measurements, visual acuity, and strabismus assessments are performed with the investigational photorefraction device and comparator devices, both with and without cycloplegia.
1 evaluation visit (in-person)
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here