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ACTIVE NOT RECRUITING
NCT06668246

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

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 16 Years

Study Type

OBSERVATIONAL

Enrollment

41

Start Date

2024-10-01

Completion Date

2025-03-31

Last Updated

2024-11-01

Healthy Volunteers

No

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

Locations (1)

Chu Brest

Brest, France