Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myo… (NCT07683481) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children
20 participantsStarted 2026-06
Plain-language summary
The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and \< 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?
Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?
Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.
Participants will:
* Wear the study spectacles for 2 weeks
* Respond to questionnaires 4 days after dispensing and at 2 weeks
* Visit Essilor R\&D Centre for screening, dispensing and follow up sessions
Who can participate
Age range
6 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Volunteer participant who is willing and able to comply with all scheduled study visits.
* Informed consent of parent/guardian and assent of participant.
* Age ≥ 6 years and \< 11 years at the time of signing informed consent and assent.
* Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
* Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
* Best corrected Distance Visual Acuity (BCDVA) 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.
Exclusion Criteria:
* History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
* Strabismus by cover test at near or distance wearing correction.
* History and presence of 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.
* Sibling of existing participant of this study
* Study participants deemed inappropriate for the study by the investigator.
* The inherent ocular/systemic discomfort (dry eyes, visual fa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on how quickly children adapt to these special myopia control lenses within the first week — how would my child's ability to tolerate new glasses right now factor into whether this study might be worth considering?
2Since this trial isn't recruiting yet, how long do you think it might be before it opens, and should we be making decisions about myopia management now rather than waiting to see if my child might be eligible?
3The study is listed as Phase NA, which typically means it's comparing existing devices rather than testing a new drug — does that change what we know about the safety of these lenses compared to standard glasses or other myopia control options my child could try today?
4The trial is measuring visual comfort and satisfaction alongside adaptation — are there already myopia control spectacle lenses available outside of a trial that have good evidence for both effectiveness and comfort in children my child's age?
5If my child were to join a study like this, what would the monitoring schedule look like during that first week of adaptation, and how would that fit around school and daily activities?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful Adaptation Rate Within 1 Week After Dispensing