An interventional study of Photorefraction device under investigation and Comparator device, Tabletop auto-refractometer in Ametropia, Myopia; Refractive Error and Myopia; Astigmatism, sponsored by Essilor International. Recruiting at 2 sites in France. Open to participants aged 3 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Essilor International · Not applicable, Interventional, and Screening
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:
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.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 315 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Objective refraction measurement with and without cyclopegia
Objective refraction measurement with and without cyclopegia
Objective refraction measurement with and without cyclopegia
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 is assessed and far visual acuity is assessed with the found refraction measures
Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia.
Perfomance evaluation for ametropia screening
The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.
Time frame: One day (all measurements are taken during a single evaluation visit).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: One day (all measurements are taken during a single evaluation visit).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Dec 2025, 8 months later.
Of 115 industry-sponsored interventional studies with no phase under Refractive Errors, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's planned 8 months is above that.
Counting every sponsor, half of 172 studies reached it within 7 months; a quarter within 2 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.