Actively Recruiting

Phase Not Applicable
Age: 3Years - 8Years
All Genders
Healthy Volunteers
ID06882408

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

Age: 3Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

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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

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