NCT07046065 Algorithm-assisted Subjective Refraction Program Dedicated to Children
| NCT ID | NCT07046065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Essilor International |
| Condition | Refractive Assessment |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 166 participants in total. It began in 2025-05-23 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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). -
Contact & Investigator
José Manuel González- Meijome, PhD
PRINCIPAL INVESTIGATOR
Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal)
Frequently Asked Questions
Who can join the NCT07046065 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Refractive Assessment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07046065 currently recruiting?
Yes, NCT07046065 is actively recruiting participants. Contact the research team at asousa@evidenze.com for enrollment information.
Where is the NCT07046065 trial being conducted?
This trial is being conducted at Vila Nova de Famalicão, Portugal.
Who is sponsoring the NCT07046065 clinical trial?
NCT07046065 is sponsored by Essilor International. The principal investigator is José Manuel González- Meijome, PhD at Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal). The trial plans to enroll 166 participants.