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RECRUITING
NCT07046065
NA

Algorithm-assisted Subjective Refraction Program Dedicated to Children

Sponsor: Essilor International

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

166

Start Date

2025-05-23

Completion Date

2025-12-31

Last Updated

2025-07-01

Healthy Volunteers

Yes

Interventions

DEVICE

Non-cycloplegic Objective refraction

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

DEVICE

Non-cycloplegic conventional subjective refraction

Performed with Vision-R™

DEVICE

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

Performed with Vision-R™

DEVICE

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

Performed with Vision-S™

DEVICE

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

Performed with Vision-R™

DEVICE

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

Performed with Vision-S™

DEVICE

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

Performed with Vision-R™

DEVICE

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

Performed with Vision-S™

DEVICE

Cycloplegic Objective refraction

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

DEVICE

Non-cycloplegic Retinoscopy

Performed with a retinoscope without cycloplegia

DEVICE

Cycloplegic retinoscopy

Performed with a retinoscope with cycloplegia

Locations (1)

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

Vila Nova de Famalicão, Portugal