BridgeMD
Tests treatment safety and results for Myopia Progression
Official title Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years
ClinicalTrials.gov ID: NCT07462897
What this study is testing
- What it's testing
- The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye?
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 14
You may be able to join if
- Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
- Astigmatism ≤ 2.00 D for each eye
- Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
- Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
- Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant
You likely can't join if
- Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
- Strabismus (in the test of masking near or far with the best correction)
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
- Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
- History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
See the full eligibility criteria
- Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
- Astigmatism ≤ 2.00 D for each eye
- Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
- Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
- Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant
- Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
- Strabismus (in the test of masking near or far with the best correction)
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
- Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
- History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
- Past or current use of growth hormones
- Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status.
- Wearing contact lenses
- Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%)
- Known allergy or intolerance to eyeglass frame materials
- Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.
- Intolerance to conventional optical corrections
- Lack of cooperation in wearing corrective lenses
The study team makes the final eligibility decision.
Where it's taking place
- Paris, 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, 6 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, 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.