An interventional study of A.M.L. Series of Lenses in Myopia and Refractive Error, sponsored by Essilor International. Recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Essilor International · Not applicable, Interventional, and Other
The goal of this research study is to understand the wearing experience of A.M.L. series of lenses in myopic children. The main questions it aims to answer are:
The proportion of children who adapted to the A.M.L. series of lenses within 4 to 6 days?
40 myopic children aged 6 to 12 years will be recruited as participants, and all of them will be wearing A.M.L. series of lenses.
Participants will:
Myopia prevalence among Chinese children has increased markedly in recent years, representing a major public health concern. As myopia management options expand, expectations have shifted beyond efficacy alone to include wearing comfort, adaptation, and visual quality. Spectacle lenses remain the primary modality for myopia correction and play a critical role in daily visual experience. Optical defocus-based spectacle lenses with microlens designs have demonstrated efficacy in slowing myopia progression. Although existing studies have reported on the adaptation of spectacle lenses incorporating microlens designs, there are currently no data available for the A.M.L. series of lenses. This study aims to evaluate adaptation, wearing comfort, and user satisfaction with the A.M.L. series spectacle lenses.
This is a one arm, prospective, interventional study, it will include 40 children, with adaptation, comfort, and satisfaction evaluated after 4 days, 1 week, and 2 weeks of lens wear.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: A.M.L. Series of Lenses
Participants will be wearing A.M.L. series of lenses for a period of 2 weeks.
The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms.
Time frame: Day 6
Proportions of children who adapted within 1 day
Time frame: Day 4-6
Mean wearing time per week and per day
Time frame: Week 2
Activity-specific visual comfort using questionnaire at 4-day and 2-weeks
Visual Comfort in Different Activities Questionnaire (5-point Likert scale, range 1-5). For negatively worded items, higher score indicate worse visual comfort, whereas positively worded items, higher score indicate better visual comfort.
Time frame: Day 4-6, Week 2
Overall satisfaction reported at 4 days and 2 weeks
Time frame: Day 4-6, Week 2
Plan to share: No
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