An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children

Essilor

Status

Enrolling

Conditions

Myopia

Refractive Error

Treatments

Device: A.M.L. Series of Lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT07354945

WS10450

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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