Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
NCT07046065

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

Age: 6Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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