An interventional study of Non-cycloplegic Objective refraction and Non-cycloplegic conventional subjective refraction in Refractive Assessment, Refractive Disorders and Hyperopia and Myopia, sponsored by Essilor International. Recruiting at 1 site in Portugal. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Essilor International · Not applicable, Interventional, and Screening
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.
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.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 166 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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 · Device: Non-cycloplegic conventional subjective refraction · Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™) · Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™) · Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™) · Device: Cycloplegic Objective refraction · Device: Non-cycloplegic Retinoscopy · Device: Cycloplegic retinoscopy
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 · Device: Non-cycloplegic conventional subjective refraction · Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™) · Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™) · Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™) · Device: Cycloplegic Objective refraction · Device: Non-cycloplegic Retinoscopy · Device: Cycloplegic retinoscopy
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
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
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
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
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
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.
Time frame: 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 (°)
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Subjective Axis (with conventional method, with Vision-R™)
Indicates the orientation of the Cylinder, measured in degrees (°)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment (Day 1) to the end of the study at 7,5 months
Plan to share: No — There is no need to share individual anonymized data.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2025, 7 months after the start.
Of 115 industry-sponsored interventional studies with no phase under Refractive Errors, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's planned 7 months is above that.
Counting every sponsor, half of 172 studies reached it within 7 months; a quarter within 2 and three quarters within 23.
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