Myopia
Conditions
Keywords
Refractive error, Eye disease, Axial length, Myopia control
Brief summary
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children? Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression. Participants will: * Wear the study spectacles * Visit Essilor R&D Centre for follow-up sessions
Interventions
DEVICESVL
Dispensed to one eye in Year 1
DEVICESVL with passive red-light emission
Dispensed to the contralateral eye in Year 1.
DEVICEMCL
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).
DEVICEMCL with passive red-light emission
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).
Sponsors
Essilor International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent. * Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D. * Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D. * Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen). * Be in good general health, based on his/her and parent's/guardian's knowledge. * Agree to wear spectacles for \>12 hours/day and at least 6 days/week. * Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
Exclusion criteria
* Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.) * Any binocular vision anomalies * Amblyopia * Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month. * Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. * Participation in any clinical investigation within 30 days of the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Axial Length | From baseline to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Spherical Equivalent Refraction | From baseline to 12 months |
Countries
Singapore
Contacts
Primary ContactCeline Carimalo
Backup ContactThomas Boudenne
Outcome results
None listed