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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Page 1 of 1 (1 locations)

1

Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd.

Shanghai, Shanghai Municipality, China, 200336

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