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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photorefraction device under investigation, Comparator device, Tabletop auto-refractometer, Comparator device, portable photorefraction device, Distance visual acuity assessments.
- Who it may be relevant to
- Registry conditions: Ametropia, Myopia; Refractive Error, Myopia; Astigmatism. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device Photorefraction device under investigation
Objective refraction measurement with and without cyclopegia - Device Comparator device, Tabletop auto-refractometer
Objective refraction measurement with and without cyclopegia - Device Comparator device, portable photorefraction device
Objective refraction measurement with and without cyclopegia - Other 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. - Other Subjective refraction and far visual acuity
Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures - Other Strabismus assessment
Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Primary outcome measures
- Perfomance evaluation for ametropia screening [Time frame: One day (all measurements are taken during a single evaluation visit).]
Secondary outcome measures (4)
- Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer [Time frame: One day (all measurements are taken during a single evaluation visit).]
- Perfomance evaluation for ametropia screening [Time frame: One day (all measurements are taken during a single evaluation visit).]
- Perfomance evaluation for amblyopia screening [Time frame: One day (all measurements are taken during a single evaluation visit).]
- Safety assessment and device failures [Time frame: One day (all measurements are taken during a single evaluation visit).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 2 centers
- Dr Krafft private practice — Nancy
- Hôpital civil de Strasbourg — Strasbourg
Identifiers
NCT: NCT06882408 · WS10386-EPSS · 2024-A00780-47