Actively Recruiting
Algorithm-assisted Subjective Refraction Program Dedicated to Children
Led by Essilor International · Updated on 2025-07-01
166
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Algorithm-assisted Subjective Refraction Program Dedicated to Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 12 years
- Ability to recognize and name letters of the Latin alphabet
- Pupillary distance of at least 49 mm
- Distance refractive error spherical equivalence between -6.00 and +6.00 diopters; cylinder less than or equal to 3.00 diopters
- Monocular visual acuity of 0.5 decimal (0.30 LogMAR) or better in each eye at distance
- Visual acuity difference less than 0.20 LogMAR between right and left eyes at distance
You will not qualify if you...
- Vulnerable subject status
- Presence of amblyopia
- Presence of strabismus
- Any current or developing eye disease or condition affecting vision or refractive state
- Previous ocular surgery affecting vision or study assessments
- Any ocular or systemic condition affecting refractive status (e.g., keratoconus, diabetes, Down's syndrome)
- Neurological or speech disorders affecting ability to understand or communicate
- Untreated or uncontrolled systemic conditions affecting vision or study assessments
- Use of medications affecting pupil size, accommodation, or refractive state
- History of myopia control treatments like atropine, orthokeratology, or rigid gas permeable lenses except myopia control spectacles
- Contraindications to cycloplegia such as high intraocular pressure, narrow anterior angle, allergies to cycloplegic agents, or seizures
- Aphakia or pseudoaphakia (intraocular lens)
- Prismatic prescription in either eye (horizontal or vertical)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
Vila Nova de Famalicão, Portugal, 4764-502
Actively Recruiting
Research Team
A
Ana Júlia Sousa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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