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NCT Number: NCT07046065

Algorithm-assisted Subjective Refraction Program Dedicated to Children

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.

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Key information

Conditions

Refractive Assessment Astigmatism Children Eye Diseases Hyperopia Hyperopia and Myopia Myopia Refractive Disorders Refractive Error Correction Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vila Nova de Famalicão, 4764-502, Portugal

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
  • Visual acuity difference < 0.20 logMAR between right and left eyes at distance

Exclusion criteria

  • 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
  • Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)
  • Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)
  • Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP
  • Any untreated and/or uncontrolled systemic condition which might have an influence on vision or interfere with study assessments
  • Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state
  • History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles
  • 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)
  • Aphakic or pseudoaphakic (intraocular lens),
  • Prismatic prescription in either Right or Left eye (horizontal or vertical). -

Treatment and study plan

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

Primary outcomes

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

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

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

    Time frame: Six months after Day 1

    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.

  5. Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™)

    Time frame: Six months after Day 1

    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.

  6. Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™)

    Time frame: Six months after Day 1

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

  7. Subjective Sphere (with conventional method with Vision-R™)

    Time frame: Day 1

    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.

  8. Subjective Cylinder (with conventional method, with Vision-R™)

    Time frame: Day 1

    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.

  9. Subjective Axis (with conventional method, with Vision-R™)

    Time frame: Day 1

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

  10. Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

    Time frame: From enrollment (Day 1) to the end of the study at 7,5 months

    Corrected visual acuity measure with Kids refraction software vA results

  11. Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™)

    Time frame: From enrollment (Day 1) to the end of the study at 7,5 months

    Corrected visual acuity measure with Kids refraction software vB results

  12. Visual acuity (with Conventionnal refraction method, with Vision-R™)

    Time frame: From enrollment (Day 1) to the end of the study at 7,5 months

    Corrected visual acuity measure with Conventionnal refraction method results

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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