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:

  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). -

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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Page 1 of 1 (1 locations)

1

Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão

Vila Nova de Famalicão, Portugal, 4764-502

Algorithm-assisted Subjective Refraction Program Dedicated to Children | DecenTrialz