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

NCT06668246 | Completed

• 1 other identifier: 29BRC24.0231 - REFRALENS
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors; Ametropia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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 DEVICE

As of today, no published clinical studies have been conducted with the Vision-S™ 700 neither Vision R 800

Pediatric population

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

Related Publications (3)

• 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.

  PMID: 26856962 BACKGROUND

• 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.

  PMID: 18484839 BACKGROUND

• 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.

  PMID: 18235892 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Interventions

Immersion

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: October 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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

Locations

FR (1)