RecruitingNot ApplicableNCT07046065

Algorithm-assisted Subjective Refraction Program Dedicated to Children


Sponsor

Essilor International

Enrollment

166 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing software. Two different versions of the software have been developed: the first incorporating only the steps needed to perform an entire subjective refraction process (vA), and the second, identical to the first but incorporating additional steps useful for managing the child's attention and cooperation (vB). The software performance in terms of subjective refraction results will be compared to a conventional subjective refraction method performed with the Vision-R™700 phoropter in manual mode.


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cycloplegic Objective refraction, a medical device called Cycloplegic retinoscopy, and others for people with astigmatism, children, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENon-cycloplegic Objective refraction

Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia

DEVICENon-cycloplegic conventional subjective refraction

Performed with Vision-R™

DEVICENon-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)

Performed with Vision-R™

DEVICENon-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)

Performed with Vision-S™

DEVICENon-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)

Performed with Vision-R™

DEVICENon-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)

Performed with Vision-S™

DEVICECycloplegic subjective refraction (Kids refraction software vA with Vision-R™)

Performed with Vision-R™

DEVICECycloplegic subjective refraction (Kids refraction software vA with Vision-S™)

Performed with Vision-S™

DEVICECycloplegic Objective refraction

Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia

DEVICENon-cycloplegic Retinoscopy

Performed with a retinoscope without cycloplegia

DEVICECycloplegic retinoscopy

Performed with a retinoscope with cycloplegia


Locations(1)

Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão

Vila Nova de Famalicão, Portugal

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NCT07046065


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