An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorEssilor International
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Single group
Treatments tested in this trial
A.M.L. Series of Lenses
DeviceParticipants will be wearing A.M.L. series of lenses for a period of 2 weeks.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: A.M.L. Series of LensesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of children who adapted to the study lenses within 4 to 6 days without reporting any symptoms.
Time frame
Day 6Secondary outcomes
1
Proportions of children who adapted within 1 day
Time frame
Day 4-62
Mean wearing time per week and per day
Time frame
Week 23
Activity-specific visual comfort using questionnaire at 4-day and 2-weeks
Visual Comfort in Different Activities Questionnaire (5-point Likert scale, range 1-5). For negatively worded items, higher score indicate worse visual comfort, whereas positively worded items, higher score indicate better visual comfort.
Time frame
Day 4-6, Week 24
Overall satisfaction reported at 4 days and 2 weeks
Time frame
Day 4-6, Week 2Sponsors and contacts
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Source ClinicalTrials.gov