Rodenstock spectacle lenses to slow myopia progression in children
Testing the Efficacy of Rodenstock Spectacle Lenses in Myopia Progression: a Two Year Clinical Trial
NA · Rodenstock GmbH · NCT06816446
This will test whether Rodenstock myopia-control spectacle lenses can slow myopia progression in children aged 6–12 over two years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Rodenstock GmbH (industry) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06816446 on ClinicalTrials.gov |
What this trial studies
Children who meet the eligibility criteria will be assigned to wear either Rodenstock myopia-control spectacle lenses or standard single-vision lenses and followed for 24 months. Regular eye examinations, including cycloplegic refraction and axial length measurements, will track changes in prescription and eye growth. The trial enrolls treatment-naïve myopic children with spherical equivalent between −0.5 D and −5.0 D and limits astigmatism and anisometropia to specified ranges. Safety, tolerability, and change in myopia progression will be compared between the lens groups.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve children aged 6–12 with myopia between −0.5 D and −5.0 D, anisometropia ≤1.5 D, corneal astigmatism ≤1.5 D, and good best-corrected visual acuity.
Not a fit: Children already using myopia-control treatments, those with other diagnosed ocular or systemic conditions, irregular or high astigmatism, or contraindications to cycloplegia are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these lenses could slow myopia progression in school-age children and lower the long-term risk of high-myopia complications.
How similar studies have performed: Other optical approaches such as multifocal contact lenses, orthokeratology, and some specially designed spectacle lenses have shown moderate success in slowing myopia, although results vary by design and population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All myopic children aged 6-12 years old * Treatment naïve * Sphere: -0.5 D till -5.00 D * Anisometropia \< 1.5D * Astigmatism \> -1.5D * Monocular best corrected visual acuity +0.1 logMAR or better, and binocular visual acuity 0.0 logMAR or better Exclusion Criteria: * On current myopia control treatments * Any diagnosed ocular conditions besides myopia or astigmatism. * No diagnosed ocularmotor conditions (Nystagmus, strabismus, etc.) * Any diagnosed chronic physical or mental disabilities * Contraindication in cycloplegia (high IOP, etc.) * Corneal astigmatism \> 1.5 D; irregular astigmatism
Where this trial is running
Singapore
- NUH — Singapore, Singapore (RECRUITING)
Study contacts
- Study coordinator: Liyana Nur Farah Binte Makribi
- Email: liyananf@nus.edu.sg
- Phone: 65162085
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.
Conditions: Myopia, Myopia control, Lenses, Light