Algorithm-assisted Subjective Refraction Program Dedicated to Children

June 23, 2025 updated by: Essilor International

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Vila Nova De Famalicão, Portugal, 4764-502
        • Recruiting
        • Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Paulo Rodrigues Botelho Fernandes, PhD
        • Principal Investigator:
          • José Manuel González- Meijome, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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). -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter
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.
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 vB with Vision-R™)
Performed with Vision-R™
Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
Performed with Vision-R™
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
Active Comparator: Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter
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.
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: 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
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-S™)
Performed with Vision-S™
Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
Performed with Vision-S™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1
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 (°)
Day 1
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.
Six months after Day 1
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.
Six months after Day 1
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 (°)
Six months after Day 1
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.
Day 1
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.
Day 1
Subjective Axis (with conventional method, with Vision-R™)
Time Frame: Day 1
Indicates the orientation of the Cylinder, measured in degrees (°)
Day 1
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
From enrollment (Day 1) to the end of the study at 7,5 months
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
From enrollment (Day 1) to the end of the study at 7,5 months
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
From enrollment (Day 1) to the end of the study at 7,5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essilor International

Investigators

  • Principal Investigator: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 12, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Estimated)

July 1, 2025

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS10374
  • CIV-25-03-051757 (Other Identifier: INFARMED (Portugal))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no need to share individual anonymized data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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