MyopiaNCT07354945
An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children
A study testing A.M.L. Series of Lenses in people with Myopia and Refractive Error, run by Essilor International at 1 site in China.
Trial summary
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: How quickly and effectively children adapt to the A.M.L. series of lenses? The proportion of children who adapted to the A.M.L. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia, Refractive Error
- What is being tested?
- A.M.L. Series of Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2026to 27 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd.
Shanghai, Shanghai Municipality, 200336
Ying Mei, 86+13888233240, 896022787@qq.com
About this study
Official title: An Evaluation of Visual Comfort, Adaptation and Overall Satisfaction in Myopic Children Using A.M.L. Series of Lenses
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:
- How quickly and effectively children adapt to the A.M.L. series of lenses?
- 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:
- Wear A.M.L. series of lenses for a period of 2 weeks
- Visit at day 4-6, week 1 and week 2.
Read the detailed description
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.
- Conditions
- Myopia, Refractive Error
- Being tested
- A.M.L. Series of Lenses
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A.M.L. Series of LensesDevice
Participants will be wearing A.M.L. series of lenses for a period of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A.M.L. Series of Lenses | Experimental | Not described Receives: Device: A.M.L. Series of Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms.
Measured: Day 6
Secondary outcomes (4)
Proportions of children who adapted within 1 day
Measured: Day 4-6
Mean wearing time per week and per day
Measured: 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.
Measured: Day 4-6, Week 2
Overall satisfaction reported at 4 days and 2 weeks
Measured: Day 4-6, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start2 Jan 2026
- Primary completion25 Feb 2026 (estimated)
- Study completion27 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354945
- Sponsor's protocol ID
- WS10450
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drobe B, Yang A, Huang Y, et al. Adaptation and visual comfort in children with new spectacle lenses containing concentric rings of contiguous aspherical micro-lenses for myopia control. Investigative Ophthalmology & Visual Science June 2020, Vol.61, 94.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Visual Comfort, Adaptation and Overall Satisfaction in Myopic Children Using A.M.L. Series of Lenses
- ClinicalTrials.gov ID
- NCT07354945
- Acronym / sponsor ID
- WS10450
- Conditions
- Myopia, Refractive Error
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 27 Apr 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How quickly and effectively children adapt to the A.M.L. series of lenses?
- 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:
- Wear A.M.L. series of lenses for a period of 2 weeks
- Visit at day 4-6, week 1 and week 2.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A.M.L. Series of Lenses | Experimental | Device: A.M.L. Series of Lenses |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A.M.L. Series of LensesParticipants will be wearing A.M.L. series of lenses for a period of 2 weeks. | Device | A.M.L. Series of Lenses |
Primary outcome
The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms.
Time frame: Day 6
4 secondary outcomes
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
Time frame: Day 4-6, Week 2
Overall satisfaction reported at 4 days and 2 weeks
Time frame: Day 4-6, Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- BackgroundDrobe B, Yang A, Huang Y, et al. Adaptation and visual comfort in children with new spectacle lenses containing concentric rings of contiguous aspherical micro-lenses for myopia control. Investigative Ophthalmology & Visual Science June 2020, Vol.61, 94.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A.M.L. Series of Lenses in people with Myopia and Refractive Error, run by Essilor International at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaoyan DU (86+17696115308, du.jiaoyan@essilorchina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms. (time frame: Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.