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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06668246
Acronym
REFRALENS
Enrollment
43
Registered
2024-10-31
Start date
2022-10-01
Completion date
2023-04-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ametropia, Refractive Errors

Keywords

refractive errors, refractive errors screening, pediatric refractive measurements, preliminary study, tunable focus phoropter

Brief 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.

Interventions

DEVICEVision-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

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* 6 to 16 years old patients followed in the Brest University Hospital Center, in France, between the 1st of November 2022 and the 30th of April 2023 and requiring a cycloplegic refraction not presenting an

Design outcomes

Primary

MeasureTime frameDescription
Spherical equivalentDay 1The primary outcome of this study was to compare the spherical equivalent, obtained using two different devices: Vision-S™ 700, an immersive phoropter with a tunable-focus lens, and Vision-R™ 800, a phoropter with a tunable-focus lens without immersion. The study aimed to assess the overall agreement of these measurements with cycloplegic refraction, considered the gold standard in this context.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026