AmetropiaNCT06882408
The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.
A study testing Photorefraction device under investigation, Comparator device, Tabletop auto-refractometer and Comparator device, portable photorefraction device in people with Ametropia and Myopia; Refractive Error, run by Essilor International at 2 sites in France.
Trial summary
The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are: Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Ametropia, Myopia; Refractive Error, Myopia; Astigmatism
- What is being tested?
- Photorefraction device under investigation, Comparator device, Tabletop auto-refractometer and Comparator device, portable photorefraction device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 3-8 years when included in the study
- All skin phototypes (I to VI according to the Fitzpatrick classification)
- Wearing glasses or not
- Capacity to give valid consent
- Capacity to follow the protocol to obtain reliable measure
- Under French medical insurance
Who cannot join
- Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)
- Wearing contact lenses
- Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)
- Under medication that may have an impact on vision or may interfere with study measurements
- Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
- Known risk of angle-closure glaucoma
- Participation to another study that may have an impact on vision or may interfere with the study measures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Dr Krafft private practice
Nancy, France, 54000
Véronique Krafft, +336 09 91 93 74, veronique.krafft@me.com
- Recruiting
Hôpital civil de Strasbourg
Strasbourg, France, 67091
Arnaud Sauer, +33369550270, arnaud.sauer@chru-strasbourg.fr
About this study
Official title: Evaluation of the Photorefraction Screener Snapsight in Comparison With Cycloplegia Table-top Autorefractor in Ametropia in Pediatric Population Between 3 and 8yo, Multicenter French Study.
The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are:
- Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer.
- Assess the agreement of the measures obtained with the device with those obtained with the gold standard.
Read the detailed description
Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.
- Conditions
- Ametropia, Myopia; Refractive Error, Myopia; Astigmatism
- Being tested
- Photorefraction device under investigation, Comparator device, Tabletop auto-refractometer, Comparator device, portable photorefraction device, Distance visual acuity assessments, Subjective refraction and far visual acuity
- Medical subject headings
- Refractive Errors, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photorefraction device under investigationDevice
Objective refraction measurement with and without cyclopegia
Comparator device, Tabletop auto-refractometerDevice
Objective refraction measurement with and without cyclopegia
Comparator device, portable photorefraction deviceDevice
Objective refraction measurement with and without cyclopegia
Distance visual acuity assessmentsOther
Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Subjective refraction and far visual acuityOther
Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures
Strabismus assessmentOther
Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
| Study group | Role | What they receive |
|---|---|---|
| Snapsight photorefraction device | Experimental | Not described Receives: Device: Photorefraction device under investigation; Device: Comparator device, Tabletop auto-refractometer; Device: Comparator device, portable photorefraction device; Other: Distance visual acuity assessments; Other: Subjective refraction and far visual acuity; Other: Strabismus assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfomance evaluation for ametropia screening
The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.
Measured: One day (all measurements are taken during a single evaluation visit).
Secondary outcomes (4)
Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer
The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors.
Measured: One day (all measurements are taken during a single evaluation visit).
Perfomance evaluation for ametropia screening
The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer.
Measured: One day (all measurements are taken during a single evaluation visit).
Perfomance evaluation for amblyopia screening
The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer or the masking test and prism bars for strabismus.
Measured: One day (all measurements are taken during a single evaluation visit).
Safety assessment and device failures
Type, frequency and severity of adverse events and device failures are evaluated
Measured: One day (all measurements are taken during a single evaluation visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aranaud Sauer, MD, PhD, FEBO, Principal investigator, Hôpital Civil de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882408
- Sponsor's protocol ID
- WS10386-EPSS
- Other IDs
- 2024-A00780-47
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Photorefraction Screener Snapsight in Comparison With Cycloplegia Table-top Autorefractor in Ametropia in Pediatric Population Between 3 and 8yo, Multicenter French Study.
- ClinicalTrials.gov ID
- NCT06882408
- Acronym / sponsor ID
- WS10386-EPSS
- Conditions
- Ametropia, Myopia; Refractive Error, Myopia; Astigmatism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (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.
The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are:
- Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer.
- Assess the agreement of the measures obtained with the device with those obtained with the gold standard.
Detailed description
Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snapsight photorefraction device | Experimental | Device: Photorefraction device under investigation, Device: Comparator device, Tabletop auto-refractometer, Device: Comparator device, portable photorefraction device, Other: Distance visual acuity assessments, Other: Subjective refraction and far visual acuity, Other: Strabismus assessment |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 3-8 years when included in the study
- All skin phototypes (I to VI according to the Fitzpatrick classification)
- Wearing glasses or not
- Capacity to give valid consent
- Capacity to follow the protocol to obtain reliable measure
Key exclusion criteria (7 listed)
- Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)
- Wearing contact lenses
- Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)
- Under medication that may have an impact on vision or may interfere with study measurements
- Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
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 |
|---|---|---|
| Photorefraction device under investigationObjective refraction measurement with and without cyclopegia | Device | Snapsight photorefraction device |
| Comparator device, Tabletop auto-refractometerObjective refraction measurement with and without cyclopegia | Device | Snapsight photorefraction device |
| Comparator device, portable photorefraction deviceObjective refraction measurement with and without cyclopegia | Device | Snapsight photorefraction device |
| Distance visual acuity assessmentsDistance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia. | Other | Snapsight photorefraction device |
| Subjective refraction and far visual acuitySubjective refraction is assessed and far visual acuity is assessed with the found refraction measures | Other | Snapsight photorefraction device |
| Strabismus assessmentStrabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia. | Other | Snapsight photorefraction device |
Primary outcome
Perfomance evaluation for ametropia screening
Time frame: One day (all measurements are taken during a single evaluation visit).
The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.
4 secondary outcomes
Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer
Time frame: One day (all measurements are taken during a single evaluation visit).
Perfomance evaluation for ametropia screening
Time frame: One day (all measurements are taken during a single evaluation visit).
Perfomance evaluation for amblyopia screening
Time frame: One day (all measurements are taken during a single evaluation visit).
Safety assessment and device failures
Time frame: One day (all measurements are taken during a single evaluation visit).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Aranaud Sauer, MD, PhD, FEBO principal investigator
Hôpital Civil de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photorefraction device under investigation, Comparator device, Tabletop auto-refractometer and Comparator device, portable photorefraction device in people with Ametropia and Myopia; Refractive Error, run by Essilor International at 2 sites 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Cadoni (+33 642665760, cadonis@essilor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfomance evaluation for ametropia screening (time frame: One day (all measurements are taken during a single evaluation visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2025.