Algorithm-assisted Subjective Refraction Program Dedicated to Children

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.

Conditions

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

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

Sponsors & Collaborators

• Essilor International

  lead INDUSTRY

Principal Investigators

• José Manuel González- Meijome, PhD · Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal)

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-23

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Portugal

Study Locations