NCT07354945

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 12, 2026

Last Update Submit

January 22, 2026

Conditions

MyopiaRefractive Error

Outcome Measures

Primary Outcomes (1)

  • The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms.

    Day 6

Secondary Outcomes (4)

  • Proportions of children who adapted within 1 day

    Day 4-6

  • Mean wearing time per week and per day

    Week 2

  • Activity-specific visual comfort using questionnaire at 4-day and 2-weeks

    Day 4-6, Week 2

  • Overall satisfaction reported at 4 days and 2 weeks

    Day 4-6, Week 2

Study Arms (1)

A.M.L. Series of Lenses

EXPERIMENTAL
Device: A.M.L. Series of Lenses

Interventions

A.M.L. Series of LensesDEVICE

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

A.M.L. Series of Lenses

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Meishimeijing Ophthalmology Clinic Co., Ltd.

Shanghai, Shanghai Municipality, 200336, China

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Jiaoyan DU

CONTACT

86+17696115308du.jiaoyan@essilorchina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

January 2, 2026

Primary Completion

February 25, 2026

Study Completion

April 27, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)