Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT06882408
Recruiting Not applicable

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.

NCT06882408 · tracked via the Priya Life Science France tracker
Sponsor
Essilor International
Phase
Not applicable
Started
2025-04
Last updated
2025-04-29

Condition(s) studied

AmetropiaMyopia; Refractive ErrorMyopia; Astigmatism

Investigational drug(s) / intervention(s)

Photorefraction device under investigationComparator device, Tabletop auto-refractometerComparator device, portable photorefraction deviceDistance visual acuity assessmentsSubjective refraction and far visual acuityStrabismus assessment

Photorefraction device under investigation: Objective refraction measurement with and without cyclopegia

Comparator device, Tabletop auto-refractometer: Objective refraction measurement with and without cyclopegia

Comparator device, portable photorefraction device: Objective refraction measurement with and without cyclopegia

Distance visual acuity assessments: Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.

Subjective refraction and far visual acuity: Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures

Strabismus assessment: Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.

Study 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
8 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Perfomance evaluation for ametropia screening — One day (all measurements are taken during a single evaluation visit).
    The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.

Trial sites (2)

FacilityCityRegionStatus
Dr Krafft private practice Nancy France Not Yet Recruiting
Hôpital civil de Strasbourg Strasbourg France Recruiting

More Essilor International trials in France

A Study on Body Posture and Eye Movements During Screen Usage on Adults Aged 18 to 65 Wearing Various Types of Eyeglasses Recruiting
Visual and Postural Behavior in Myopic and Non-Myopic Teenagers Recruiting
Understanding How Young Adults Perceive Blurred Image Quality and Creating a Model Predicting Their Quality Ratings Starting soon
Study on the Effect of Filters on Discomfort Glare on Healthy Adults Starting soon
Essilor® Stellest® Lenses Multicentre European Study (SLOMES) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06882408 on ClinicalTrials.gov ↗ ← All trials in France