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

Regional University Hospital Center (CHRU)

Status: Active, not recruiting

Conditions: Refractive Errors; Ametropia

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT06668246

29BRC24.0231 - REFRALENS

Details and patient eligibility

About

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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 exclusion criteria

Exclusion criteria

• age below 6 years or above 16 years
• presence of other ophthalmological pathologies rather than ametropia
• non-French language proficiency, and absence of parental authorization