Astigmatism, Myopia
Conditions
Keywords
Myopia control, Astigmatism, axial length, cylinder
Brief 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
Interventions
DEVICELenslet-based myopia control spectacle lens
Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings.
Sponsors
Essilor International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Cylinder value through non cycloplegic autorefraction | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Keratometry value measured using a Keratometer | 12 months | — |
| Change from baseline in the Axial Length value measured using a biometer | 12 months | — |
| Quality of Life while wearing the study lenses measured through Questionnaire | Baseline, 6 and 12 months | PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall. The Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree The parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes |
Contacts
CONTACTCeline Carimalo
CONTACTThomas Boudenne
PRINCIPAL_INVESTIGATORSi Ying Lim
EssilorLuxottica
Outcome results
None listed