Status:
RECRUITING
An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children
Lead Sponsor:
Essilor International
Conditions:
Myopia
Refractive Error
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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...
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 effic...
Eligibility 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
Key Trial Info
Start Date :
January 2 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 27 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07354945
Start Date
January 2 2026
End Date
April 27 2026
Last Update
January 23 2026
Active Locations (1)
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1
Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd.
Shanghai, Shanghai Municipality, China, 200336