Algorithm-assisted Subjective Refraction Program Dedicated to Children

Not Applicable

Recruiting

• Conditions: Refractive Assessment; Hyperopia and Myopia; Refractive Error Correction; Refractive Disorders; Children; Astigmatism

• Registration Number: NCT07046065
• Lead Sponsor: Essilor International

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.

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 Timeline

• Study Start: 2025-05-23
• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™)	Six months after Day 1	Indicates the orientation of the Cylinder, measured in degrees (°)
Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)	Day 1	Indicates the orientation of the Cylinder, measured in degrees (°)
Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™)	From enrollment (Day 1) to the end of the study at 7,5 months	Corrected visual acuity measure with Kids refraction software vB results
Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™)	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.
Subjective Sphere (with conventional method with Vision-R™)	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.
Subjective Axis (with conventional method, with Vision-R™)	Day 1	Indicates the orientation of the Cylinder, measured in degrees (°)
Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™)	From enrollment (Day 1) to the end of the study at 7,5 months	Corrected visual acuity measure with Kids refraction software vA results
Subjective Cylinder (with conventional method, with Vision-R™)	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.
Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™)	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.
Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™)	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.
Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™)	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.
Visual acuity (with Conventionnal refraction method, with Vision-R™)	From enrollment (Day 1) to the end of the study at 7,5 months	Corrected visual acuity measure with Conventionnal refraction method results

Trial Locations

Locations (1)

Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão; 🇵🇹 Vila Nova De Famalicão, Portugal