Actively Recruiting
An Evaluation of Visual Comfort, Adaptation and Overall Satisfaction in Myopic Children Using A.M.L. Series of Lenses
Led by Essilor International · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the wearing experience of the A.M.L. series of lenses in children with myopia aged 6 to 12 years. The study aims to find out how quickly and effectively children adapt to these lenses and the proportion who adapt within 4 to 6 days. This research responds to the rising prevalence of myopia in children and focuses on comfort, adaptation, and user satisfaction beyond just vision correction. In this one-arm, interventional study, 40 myopic children will wear the A.M.L. series of lenses continuously for two weeks. Participants will have scheduled visits to assess their adaptation and comfort at day 4 to 6, at one week, and at two weeks. The study focuses solely on this device without a comparison group. During the study, participants will be monitored for adaptation by checking if they experience any symptoms while wearing the lenses. Visual comfort, wearing time, and overall satisfaction will be evaluated using questionnaires at multiple time points. The main outcome is the proportion of children who adapt within 4 to 6 days without symptoms. The total participation lasts two weeks with follow-up visits to track progress and user experience.
CONDITIONS
Brief Title
An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 consent
- Spherical equivalent refraction (SER) between -0.50 D and -4.75 D with astigmatism not more than 2.00 D in both eyes
- Difference in SER (anisometropia) between eyes not exceeding 1.50 D
- Best corrected visual acuity better than or equal to +0.10 LogMAR in each eye
- Good general health based on participant and parent/guardian knowledge
- Willingness and ability to participate and comply with all scheduled visits
You will not qualify if you...
- History of atropine, orthokeratology, or red light treatment
- Strabismus detected by cover test at near or distance with correction
- Amblyopia
- Any ocular or systemic condition affecting refractive status (e.g., keratoconus, diabetes, Down syndrome, or other developmental disorders)
- Current use of ocular or systemic medications affecting pupil size, accommodation, or refractive state
- History of ocular injury or surgery
- Participation in another clinical study within 30 days before baseline
- Deemed inappropriate for the study by the investigator
- Ocular or systemic discomfort (dry eyes, visual fatigue, headaches) affecting lens wearing experience
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants will wear the A.M.L. series of lenses to evaluate adaptation, wearing comfort, and user satisfaction.
Visits at 4 days, 1 week, and 2 weeks
Trial Site Locations
Total: 1 location
1
Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd.
Shanghai, Shanghai Municipality, China, 200336
Actively Recruiting
Research Team
J
Jiaoyan DU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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