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NCT07810725
Effect of a Myopia Control Lens on the Astigmatism in Children
Conditions: Astigmatism, Myopia
Sex: All
Ages: 6 Years – 13 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Essilor International
Summary
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
\- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R\&D Centre for scheduled follow-up sessions
Eligibility Criteria
Inclusion Criteria:
* Volunteer participant
* Informed consent of parent or guardian and assent of participant
* Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.
* Refractive error (manifest refraction):
* With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
* Astigmatism should be more than or equal to 1.50D
* Least myopic meridian equal or less than -0.50D
* Most myopic meridian equal or greater than -5.50D.
* Anisometropia should be less than or equal to 1.00D
* Best corrected visual acuity: Better than 0.2 logMAR in each eye
* Willingness and ability to:
* participate in trial for at least 12 months.
* attend scheduled visits.
* not to be involved in other myopia control treatments concurrently.
* No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Exclusion Criteria:
* History or presence of:
* An ocular disease
* Strabismus
* Amblyopia
Source: ClinicalTrials.gov (NCT07810725). StuddyBuddy aggregates publicly available trial information.