Algorithm-assisted Subjective Refraction Program Dedicated to Children

Launched by ESSILOR INTERNATIONAL · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new computer-assisted program designed to help eye specialists check and correct vision in children aged 6 to 12 years. The program uses special software to guide the eye exam, making it more consistent and easier for kids to cooperate during the test. There are two versions of the software: one that completes the vision test steps, and another that also includes extra parts to help keep the child’s attention. The study will compare how well this new method works against the usual way eye exams are done by specialists using traditional equipment.

Children between 6 and 12 years old who can recognize letters and have certain vision measurements within a specified range may be eligible to join. Participants should not have certain eye conditions, previous eye surgeries, or health issues that affect vision. During the trial, children will undergo eye exams using the new software and the traditional method so researchers can see which works better. This study aims to improve how vision checks are done in kids, making the process clearer and more standardized.

Gender

ALL

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). -