Spectacle lens with passive red light to slow myopia in children
Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
This will test whether glasses that emit passive red light can slow myopia progression in children aged 6 to 11.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06850168 on ClinicalTrials.gov |
What this trial studies
The trial compares standard single-vision and myopia-control spectacle lenses with matching versions that emit passive red light over a two-year period, using single-vision lenses in year one and myopia-control lenses in year two. Children will be asked to wear the assigned spectacles for more than 12 hours per day and attend regular follow-up visits at the Essilor R&D Centre in Singapore. Outcomes include changes in spherical equivalent refraction and axial length, along with safety and compliance monitoring. The design is exploratory and focuses on whether passive red-light emission adds measurable myopia control compared with standard lenses.
Who should consider this trial
Good fit: Children aged 6 to under 11 years with spherical equivalent refraction between −0.75 D and −5.00 D, astigmatism ≤2.50 D, anisometropia ≤1.00 D, good best-corrected visual acuity, no ocular or systemic conditions affecting refraction, and willingness to wear spectacles ≥12 hours/day and complete two years of follow-up.
Not a fit: Children with ocular or systemic diseases that affect refractive status, binocular vision anomalies, amblyopia, prior myopia-control treatments, or inability to meet the wear-time or visit commitments are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these lenses could slow axial elongation and reduce the rate of myopia progression in children, lowering their long-term risk of high myopia.
How similar studies have performed: Some clinical work using repeated low-level red-light therapy has shown promising reductions in axial elongation, but embedding passive red-light emission into everyday spectacles is a newer and less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore
- Essilor R&D Centre Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Andrew Tan — Essilor R&D Centre Singapore
- Study coordinator: Celine Carimalo
- Email: carimalc@essilor.com.sg
- Phone: +65 67134617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.