NCT06668246

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: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 41 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-10-31
• Last updated: 2024-11-01

Locations

1 site across 1 country: France