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

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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Ametropia
• Intervention / Treatment: 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
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric population; Children aged 6 to 16 presenting isolated refractive errors without other ocular disease who needed refractive assessment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical equivalent	The 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.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

General Publications

• Resnikoff S, Pascolini D, Mariotti SP, Pokharel GP. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bull World Health Organ. 2008 Jan;86(1):63-70. doi: 10.2471/blt.07.041210.
• Pujol J, Ondategui-Parra JC, Badiella L, Otero C, Vilaseca M, Aldaba M. Spherical subjective refraction with a novel 3D virtual reality based system. J Optom. 2017 Jan-Mar;10(1):43-51. doi: 10.1016/j.optom.2015.12.005. Epub 2016 Feb 5.
• Hoffman DM, Girshick AR, Akeley K, Banks MS. Vergence-accommodation conflicts hinder visual performance and cause visual fatigue. J Vis. 2008 Mar 28;8(3):33.1-30. doi: 10.1167/8.3.33.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: refractive errors; refractive errors screening; pediatric refractive measurements; preliminary study; tunable focus phoropter
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Investigative Techniques; Immersion
• Other Study ID Numbers: 29BRC24.0231 - REFRALENS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No