Algorithm-assisted Subjective Refraction Program Dedicated to Children
2 other identifiers
interventional
166
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2025
CompletedFirst Submitted
Initial submission to the registry
June 12, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 1, 2025
June 1, 2025
7 months
June 12, 2025
June 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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.
Day 1
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.
Day 1
Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
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™)
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™)
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™)
Indicates the orientation of the Cylinder, measured in degrees (°)
Six months after Day 1
Subjective Sphere (with conventional method with Vision-R™)
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™)
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™)
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™)
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™)
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™)
Corrected visual acuity measure with Conventionnal refraction method results
From enrollment (Day 1) to the end of the study at 7,5 months
Study Arms (2)
Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter
ACTIVE COMPARATORMeasurement 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.
Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter
ACTIVE COMPARATORMeasurement 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.
Interventions
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia
Performed with Vision-R™
Performed with Vision-R™
Performed with Vision-S™
Performed with Vision-R™
Performed with Vision-S™
Performed with Vision-R™
Performed with Vision-S™
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia
Performed with a retinoscope without cycloplegia
Performed with a retinoscope with cycloplegia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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). -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
Vila Nova de Famalicão, 4764-502, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2025
First Posted
July 1, 2025
Study Start
May 23, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
There is no need to share individual anonymized data.