Actively Recruiting
Algorithm-assisted Subjective Refraction Program Dedicated to Children Ages 6 to 12 Using Vision-R200 and Vision-S200 Phoropters
Led by Essilor International · Updated on 2025-07-01
166
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new algorithm-assisted subjective refraction software designed specifically for children aged 6 to 12 years. This study aims to compare the accuracy of two versions of this software, each used with Vision-S™ and Vision-R™ phoropters, against the conventional subjective refraction method performed manually with the Vision-R™ phoropter. The research focuses on improving the standardization and accuracy of refraction assessments in children. The study has two phases: Phase A will validate the first version of the Kids refraction software (vA) and Phase B will evaluate the second version (vB), which includes additional steps to help manage the child's attention and cooperation. Participants will undergo subjective refraction tests using both software versions with Vision-R™ or Vision-S™ devices, as well as conventional subjective refraction with Vision-R™. Measurements will be taken under non-cycloplegic conditions, with some assessments also performed under cycloplegic conditions. Participants will have their visual acuity and refraction results assessed multiple times, including Sphere, Cylinder, and Axis measurements, starting from Day 1 and continuing up to 7.5 months. The study includes comparisons between non-cycloplegic and cycloplegic refraction results using various devices. Researchers will monitor visual acuity throughout the study to evaluate the software's performance. The total duration of participation for each child will be approximately 7.5 months.
CONDITIONS
Brief 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 not less than 49 mm
- Distance refractive error spherical equivalence within -6.00 to +6.00 diopters, cylinder less than or equal to 3.00 diopters
- Monocular visual acuity at least +0.30 LogMAR (0.5 decimal) 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...
- Vulnerability of the subject
- Amblyopia
- Strabismus
- Any current or evolving eye pathology affecting vision or refractive state
- Any previous ocular surgery affecting vision or study assessments
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome)
- Neurological or speech disorders interfering with understanding or communication
- Untreated or uncontrolled systemic conditions affecting vision or assessments
- Current use of medications affecting pupil size, accommodation, or refractive state
- History of myopia control interventions that may affect refraction except myopia control spectacles
- Contraindications to cycloplegia (e.g., high intraocular pressure, narrow anterior angle, allergies to cycloplegic agents, seizures)
- Aphakic or pseudoaphakic eyes (intraocular lens present)
- Presence of prismatic prescription in either eye (horizontal or vertical)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7.5 months
Participants undergo refraction measurements using different phoropters and software versions to evaluate and compare vision accuracy.
1 baseline visit and follow-up assessments over 7.5 months
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
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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