Algorithm-assisted Subjective Refraction Program Dedicated to Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorEssilor International

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Non-cycloplegic Objective refraction
  • Non-cycloplegic conventional subjective refraction
  • Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
  • Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
  • Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)
  • Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)
  • Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
  • Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
  • Cycloplegic Objective refraction
  • Non-cycloplegic Retinoscopy
  • Cycloplegic retinoscopy

Treatment groups

166 Participants
are divided into 2 treatment groups

Sponsors and collaborators