Algorithm-guided eye refraction for children aged 6–12

Algorithm-assisted Subjective Refraction Program Dedicated to Children

This project tests whether an algorithm-guided subjective refraction program (two versions) can give accurate non-cycloplegic eyeglass prescriptions for children 6–12 compared with the usual manual subjective refraction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Essilor International (industry)
• Locations: 1 site (Vila Nova de Famalicão)
• Trial ID: NCT07046065 on ClinicalTrials.gov

What this trial studies

The investigation compares two versions of Essilor's Kids Refraction software (vA, which runs the refraction sequence, and vB, which adds steps to manage a child's attention) used with Vision-R™700 or Vision-S™700 phoropters against a conventional manual subjective refraction with the Vision-R™700. The study is non-cycloplegic and measures agreement in sphere, cylinder, axis, and visual acuity between the algorithm-assisted and conventional methods. Phase A validates vA and Phase B validates vB, with randomization to Vision-R or Vision-S devices for the software arms. Participants are children aged 6–12 who can name Latin letters and meet refractive and acuity limits.

Who should consider this trial

Good fit: Children aged 6–12 who can recognize Latin letters, have pupillary distance ≥49 mm, spherical equivalent between −6.00 and +6.00 D with cylinder ≤3.00 D, and monocular distance visual acuity of at least 0.5 decimal in each eye are ideal candidates.

Not a fit: Children with amblyopia, strabismus, prior ocular surgery, ocular or systemic conditions that affect refraction, pupillary distance under 49 mm, or refractive errors outside the study limits are unlikely to benefit from the software in this study.

Why it matters

Potential benefit: If successful, the software could provide faster, more consistent pediatric refractions and reduce variability between examiners.

How similar studies have performed: Automated and algorithm-based refraction systems have shown reasonable agreement with manual refraction in adults, but dedicated algorithm-assisted subjective refraction specifically designed for children is less well established.

Eligibility criteria

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). -

Where this trial is running

Vila Nova de Famalicão

• Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão — Vila Nova de Famalicão, Portugal (RECRUITING)

Study contacts

• 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 coordinator: Ana Júlia Sousa

Conditions: Refractive Assessment, Refractive Disorders, Hyperopia and Myopia, Astigmatism, Refractive Error Correction, Children, cycloplegic refraction, non-cycloplegic refraction