Health TrialsbyHealthPanel

Algorithm-assisted Subjective Refraction Program Dedicated to Children

ConditionsRefractive AssessmentRefractive DisordersHyperopia and MyopiaAstigmatismRefractive Error CorrectionChildren
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorEssilor International

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age between 6 and 12 years

Subject able to recognize and name the letters of the Latin alphabet

Pupillary distance (PD) not less than 49mm

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

Disqualifiers

Vulnerability of the subject

Amblyopia

Strabismus

Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-cycloplegic Objective refraction

    Device

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

  • Non-cycloplegic conventional subjective refraction

    Device

    Performed with Vision-R™

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

    Device

    Performed with Vision-R™

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

    Device

    Performed with Vision-S™

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

    Device

    Performed with Vision-R™

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

    Device

    Performed with Vision-S™

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

    Device

    Performed with Vision-R™

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

    Device

    Performed with Vision-S™

  • Cycloplegic Objective refraction

    Device

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

  • Non-cycloplegic Retinoscopy

    Device

    Performed with a retinoscope without cycloplegia

  • Cycloplegic retinoscopy

    Device

    Performed with a retinoscope with cycloplegia

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropterActive comparator 8 interventions
Group B: Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropterActive comparator 8 interventions

Trial outcomes

Primary outcomes

1

Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.

Time frame
Day 1
2

Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.

Time frame
Day 1
3

Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

Indicates the orientation of the Cylinder, measured in degrees (°)

Time frame
Day 1
4

Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™)

The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.

Time frame
Six months after Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Essilor International

Lead sponsor

Source ClinicalTrials.gov
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