Refractive ErrorsREFRALENSNCT06668246
Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS)
An observational study of Refractive Errors and Ametropia, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Refractive Errors, Ametropia
- What is being tested?
- 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
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Refractive Errors, Ametropia
- Being tested
- 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
- Keywords
- refractive errors, refractive errors screening, pediatric refractive measurements, preliminary study, tunable focus phoropter
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 goldDevice
As of today, no published clinical studies have been conducted with the Vision-S™ 700 neither Vision R 800
| Study group | Role | What they receive |
|---|---|---|
| Pediatric population | Children aged 6 to 16 presenting isolated refractive errors without other ocular disease who needed refractive assessment Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Oct 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668246
- Sponsor's protocol ID
- 29BRC24.0231 - REFRALENS
- Acronym
- REFRALENS
- Status last verified
- May 2026
- First submitted
- 28 Oct 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 26856962Hoffman 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.
PubMed 18484839Resnikoff 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.
PubMed 18235892
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children
- ClinicalTrials.gov ID
- NCT06668246
- Acronym / sponsor ID
- REFRALENS / 29BRC24.0231 - REFRALENS
- Conditions
- Refractive Errors, Ametropia
- Keywords
- refractive errors, refractive errors screening, pediatric refractive measurements, preliminary study, tunable focus phoropter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric population | – | 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 goldChildren aged 6 to 16 presenting isolated refractive errors without other ocular disease who needed refractive assessment |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 goldAs of today, no published clinical studies have been conducted with the Vision-S™ 700 neither Vision R 800 | Device | Pediatric population |
Primary outcome
Spherical equivalent
Time frame: Day 1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 26856962Pujol 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.
- Background: PubMed 18484839Hoffman 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.
- Background: PubMed 18235892Resnikoff 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Ametropia, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical equivalent (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06668246, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.