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Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS)

NCT06668246 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2026-05-22

No results posted yet for this study

Summary

This study aimed to compare refractive measurements using Vision-S™ 700, an immersive and compact phoropter with a tunable-focus lens, and Vision-R™ 800, a phoropter with a tunable-focus lens without immersion, with cycloplegic refraction serving as the gold-standard.

This a retrospective study aimed to enroll 41 children, aged 6 to 16 years, who underwent refractive assessments with Vision-S™ 700, Vision-R™ 800, and cycloplegic refraction. The primary objective involves a comparison of the spherical equivalent between both devices and compared to cycloplegic refraction. Secondary outcomes include the analysis of astigmatism components (J0° and J45°) and subgroup analyses in myopic and hyperopic children.

Conditions

  • Refractive Errors
  • Ametropia

Interventions

DEVICE

Vision-S™ 700, an immersive and compact phoropter with a tunable-focus lens, and Vision-R™ 800, a phoropter with a tunable-focus lens without immersion, with cycloplegic refraction serving as the gold

As of today, no published clinical studies have been conducted with the Vision-S™ 700 neither Vision R 800

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668246 on ClinicalTrials.gov