NCT07046065

Algorithm-assisted Subjective Refraction Program Dedicated to Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

The goal of the investigation is to evaluate the accuracy of the Kids refraction software results performed with the phoropters Vision-R™700 and Vision-S™700 compared to the conventional subjective refraction method results performed with Vision-R™700. Phase A of the investigation will focus on the validation of the first version (Kids refraction software vA), and phase B will involve the second version (Kids refraction software vB). There are two phases in the investigation: Phase A: To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vA (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition. Phase B: To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vB with additional attention and cooperation stages (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.

Conditions

• Refractive Assessment
• Refractive Disorders
• Hyperopia and Myopia
• Astigmatism
• Refractive Error Correction
• Children

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: Portugal