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.

NARecruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
AmetropiaMyopia; Refractive ErrorMyopia; Astigmatism
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.

Trial Locations (2)

54000

NOT_YET_RECRUITING

Dr Krafft private practice, Nancy

67091

RECRUITING

Hôpital civil de Strasbourg, Strasbourg

Sponsors
All Listed Sponsors
lead

Essilor International

INDUSTRY