Clinical trial NCT06882408: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ametropia
Myopia; Refractive Error
Myopia; Astigmatism
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2025-03-18
Enrollment: 315
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed description: Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.

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

Exclusion Criteria:

* Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)
* Wearing contact lenses
* Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)
* Under medication that may have an impact on vision or may interfere with study measurements
* Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
* Known risk of angle-closure glaucoma
* Participation to another study that may have an impact on vision or may interfere with the study measures

Primary outcomes:
measure: Perfomance evaluation for ametropia screening
timeFrame: One day (all measurements are taken during a single evaluation visit).
Secondary outcomes:
measure: Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer
timeFrame: One day (all measurements are taken during a single evaluation visit).
measure: Perfomance evaluation for ametropia screening
timeFrame: One day (all measurements are taken during a single evaluation visit).
measure: Perfomance evaluation for amblyopia screening
timeFrame: One day (all measurements are taken during a single evaluation visit).
measure: Safety assessment and device failures
timeFrame: One day (all measurements are taken during a single evaluation visit).
Other outcomes:
Locations:
city: Nancy
country: France
facility: Dr Krafft private practice
city: Strasbourg
country: France
facility: Hôpital civil de Strasbourg
Study officials:
affiliation: Hôpital Civil de Strasbourg
name: Aranaud Sauer, MD, PhD, FEBO
role: PRINCIPAL_INVESTIGATOR
References: