A.M.L. spectacle lenses for children with myopia
An Evaluation of Visual Comfort, Adaptation and Overall Satisfaction in Myopic Children Using A.M.L. Series of Lenses
We will try A.M.L. spectacle lenses in 6- to 12-year-old children with myopia to see how quickly they adapt and how comfortable the lenses feel.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07354945 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, prospective interventional study enrolling 40 myopic children aged 6–12 years who will wear the A.M.L. series spectacle lenses for two weeks. Participants will be seen at day 4–6, week 1, and week 2 to record adaptation, wearing comfort, visual quality, and user satisfaction. Eligibility requires cycloplegic spherical equivalent between −0.50 D and −4.75 D, astigmatism ≤2.00 D, anisometropia ≤1.50 D, and best-corrected visual acuity ≥ +0.10 LogMAR in each eye. The study aims to document how many children adapt within 4–6 days and to characterize short-term wearing experience with these microlens-design myopia-control spectacles.
Who should consider this trial
Good fit: Children aged 6 to 12 years with cycloplegic spherical equivalent between −0.50 D and −4.75 D, astigmatism ≤2.00 D, anisometropia ≤1.50 D, best-corrected visual acuity ≥ +0.10 LogMAR in each eye, good general health, and parental consent/child assent are eligible.
Not a fit: Children with higher myopia outside the specified range, significant astigmatism, amblyopia, strabismus, prior atropine/orthokeratology/red-light treatment, or other ocular/systemic conditions affecting refraction are unlikely to benefit from this specific test.
Why it matters
Potential benefit: If successful, these lenses could make spectacles more comfortable and easier for children with myopia to wear, potentially improving daily vision and adherence to correction.
How similar studies have performed: Other spectacle lenses using optical-defocus microlens designs have shown efficacy in slowing myopia and prior adaptation studies exist, but there are no published data specifically on the A.M.L. series.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteer participant * Informed consent of parent/guardian and assent of participant * Age equal to or greater than 6 years and not older than 12 years at the time of signing informed consent and assent * Spherical equivalent refraction (SER) by cycloplegic autorefraction equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eye * Difference in SER (anisometropia) between two eyes should not exceed 1.50 D * Best corrected visual acuity (BCVA) better than or equal to +0.10 LogMAR in each eye * Be in good general health, based on the participant and the parent's/guardian's knowledge * Willingness and ability to participate in study and comply with all scheduled visits Exclusion Criteria: * History of Atropine, Orthokeratology, or Red Light treatment * Strabismus by cover test at near or distance wearing correction * Amblyopia * Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.) * Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state * History of ocular injury or surgery * Participation in any clinical study within 30 days of the Baseline visit * Study participants deemed inappropriate for the study by the investigator * The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd. — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiaoyan DU
- Email: du.jiaoyan@essilorchina.com
- Phone: 86+17696115308
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.