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Recruiting NCT07354945

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

No phase Interventional Myopia Refractive Error

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A.M.L. Series of Lenses.
Who it may be relevant to
Registry conditions: Myopia, Refractive Error. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Evaluation of Visual Comfort, Adaptation and Overall Satisfaction in Myopic Children Using A.M.L. Series of Lenses

Overview

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.

Interventions

  • Device A.M.L. Series of Lenses
    Participants will be wearing A.M.L. series of lenses for a period of 2 weeks.

Primary outcome measures

  • The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms. [Time frame: Day 6]
Secondary outcome measures (4)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd. — Shanghai

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.

Identifiers

NCT: NCT07354945 · WS10450

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗