A.M.L. spectacle lenses for children with myopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.