Status:
RECRUITING
Algorithm-assisted Subjective Refraction Program Dedicated to Children
Lead Sponsor:
Essilor International
Conditions:
Refractive Assessment
Refractive Disorders
Eligibility:
All Genders
6-12 years
Phase:
NA
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 ch...
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 re...
Eligibility Criteria
Inclusion Criteria:
- Age between 6 and 12 years
- Subject able to recognize and name the letters of the Latin alphabet
- Pupillary distance (PD) not less than 49mm
- 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
- Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
- Visual acuity difference < 0.20 logMAR between right and left eyes at distance
Exclusion Criteria:
- Vulnerability of the subject
- Amblyopia
- Strabismus
- Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state
- Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)
- Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP
- Any untreated and/or uncontrolled systemic condition which might have an influence on vision or interfere with study assessments
- Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state
- History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles
- 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)
- Aphakic or pseudoaphakic (intraocular lens),
- Prismatic prescription in either Right or Left eye (horizontal or vertical). -
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT07046065
Start Date
May 23 2025
End Date
December 31 2025
Last Update
July 1 2025
Active Locations (1)
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1
Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
Vila Nova de Famalicão, Portugal, 4764-502