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Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

RecruitingNAAges 6 Years - 11 YearsAllEssilor International
NCT06850168 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
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.
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What it tests

  • SVL
  • SVL with passive red-light emission
  • MCL
  • MCL with passive red-light emission
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Where

1 site
Essilor R&D Centre Singapore
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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