Myopia
Conditions
Keywords
myopia control, axial length, choroidal thickness
Brief summary
The goal of this clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. The main question it aims to answer is: * How the eye responds, at each timepoint, to the two myopia control lenses by evaluating: 1. Change in axial length 2. Change in choroidal thickness Participants will: * Wear the study spectacles * Visit Essilor R&D Centre for follow-up sessions
Interventions
DEVICEMCL 1
Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.
DEVICEMCL 2
Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.
Sponsors
Essilor International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 but not older than 13 years at the time of informed consent and assent. * Refractive error (manifest refraction): * Equal or less than -0.50 D or equal or greater than -4.75D. * Astigmatism should be less than or equal to 2.00D. * 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 6 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 * Currently or previously on any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Axial Length | Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Choroidal Thickness | Baseline, 1 hour post-dispense, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, and 24 weeks post-dispense. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORAparna Gopalakrishnan
Essilor R&D Centre Singapore
Outcome results
None listed