Algorithm-assisted Subjective Refraction Program Dedicated to Children

Essilor

Status: Enrolling

Conditions: Refractive Disorders; Refractive Assessment; Astigmatism; Hyperopia and Myopia; Children; Refractive Error Correction

Treatments: Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™); Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™); Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™); Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™); Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™); Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™); Device: Non-cycloplegic Retinoscopy; Device: Non-cycloplegic Objective refraction; Device: Non-cycloplegic conventional subjective refraction; Device: Cycloplegic retinoscopy; Device: Cycloplegic Objective refraction

Study type: Interventional

Funder types: Industry

Identifiers

NCT07046065

WS10374

CIV-25-03-051757 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 6 and 12 years
2. Subject able to recognize and name the letters of the Latin alphabet
3. Pupillary distance (PD) not less than 49mm
4. Distance refractive error for spherical equivalence (SE) within the range of [-6.00 to +6.00 D] maximum of the two absolute values RE and LE; Cyl ≤ 3.00 D
5. Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
6. Visual acuity difference < 0.20 logMAR between right and left eyes at distance

Exclusion criteria

1. Vulnerability of the subject
2. Amblyopia
3. Strabismus
4. Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state
5. Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...)
6. Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)
7. Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP
8. Any untreated and/or uncontrolled systemic condition which might have an influence on vision or interfere with study assessments
9. Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state
10. History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles
11. Contraindications of cycloplegia (e.g. high Intra-ocular pressure - more than 22mmHg in either eye, narrow anterior angle, history of allergy to cycloplegic agents or seizures, etc)
12. Aphakic or pseudoaphakic (intraocular lens),
13. Prismatic prescription in either Right or Left eye (horizontal or vertical). -

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter

Active Comparator group

Description:

Measurement of the non-cycloplegic refraction with Vision-R™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-R™ phoropter and comparison with non-cycloplegic refraction with Vision-R™ phoropter.

Treatment:

Device: Cycloplegic retinoscopy

Device: Cycloplegic Objective refraction

Device: Non-cycloplegic conventional subjective refraction

Device: Non-cycloplegic Retinoscopy

Device: Non-cycloplegic Objective refraction

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

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

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

Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter

Active Comparator group

Description:

Measurement of the non-cycloplegic refraction with Vision-S™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-S™ phoropter and comparison with non-cycloplegic refraction with Vision-S™ phoropter.

Treatment:

Device: Cycloplegic retinoscopy

Device: Cycloplegic Objective refraction

Device: Non-cycloplegic conventional subjective refraction

Device: Non-cycloplegic Retinoscopy

Device: Non-cycloplegic Objective refraction

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

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

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