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New treatment option for Ametropia
Official title 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.
ClinicalTrials.gov ID: NCT06882408
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 8. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nancy, France, France
- Strasbourg, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 8 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nancy, France, France; Strasbourg, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.