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.

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Photorefraction device under investigation
  Objective refraction measurement with and without cyclopegia
• Устройство Comparator device, Tabletop auto-refractometer
  Objective refraction measurement with and without cyclopegia
• Устройство Comparator device, portable photorefraction device
  Objective refraction measurement with and without cyclopegia
• Другое 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.
• Другое Subjective refraction and far visual acuity
  Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures
• Другое Strabismus assessment
  Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.

Первичные конечные точки

• Perfomance evaluation for ametropia screening [Срок оценки: One day (all measurements are taken during a single evaluation visit).]

Вторичные конечные точки (4)

• Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer [Срок оценки: One day (all measurements are taken during a single evaluation visit).]
• Perfomance evaluation for ametropia screening [Срок оценки: One day (all measurements are taken during a single evaluation visit).]
• Perfomance evaluation for amblyopia screening [Срок оценки: One day (all measurements are taken during a single evaluation visit).]
• Safety assessment and device failures [Срок оценки: One day (all measurements are taken during a single evaluation visit).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 2 центра

• Dr Krafft private practice — Nancy
• Hôpital civil de Strasbourg — Strasbourg

Идентификаторы

NCT: NCT06882408 · WS10386-EPSS · 2024-A00780-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗