Effect of special lenses on slowing myopia in young children
Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children
This study is testing special lenses to see if they can help slow down worsening eyesight in children aged 6 to 8 who are nearsighted.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | All |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06857864 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of test myopia control lenses in slowing the progression of myopia in children aged 6 to 8 years. Conducted at a single center in Singapore, the study will monitor changes in axial elongation and spherical equivalent refraction over a one-year period. A total of 25 children will be fitted with the test lenses, which are designed to modify myopia defocus on the retina without compromising vision. The primary and secondary outcomes will focus on measuring myopia progression through specific refractive metrics.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 8 years with specific refractive errors and no significant ocular or systemic conditions.
Not a fit: Patients with severe myopia or those with ocular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for effectively managing myopia progression in young children.
How similar studies have performed: Previous studies have shown promise in using specialized lenses to reduce myopia progression, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * Equal to or greater than 6 years and less than 9 years at time of informed consent and assent. * Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye. * Astigmatism, if present, of not more than 1.50 D. * Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D. * Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen) * Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status. * Absence of strabismus by cover test at near or distance wearing correction. * Absence of amblyopia * Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. Exclusion Criteria: * Vulnerability of subject * History of myopia control intervention * Participation in any clinical study within 30 days of the Baseline visit.
Where this trial is running
Singapore
- Essilor R&D Centre — Singapore, Singapore (Recruiting)
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.