Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression (NCT06850168) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Singapore35 participantsStarted 2025-06-26
Plain-language summary
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression.
Participants will:
* Wear the study spectacles
* Visit Essilor R\&D Centre for 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:
* Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
* Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
* Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
* Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
* Be in good general health, based on his/her and parent's/guardian's knowledge.
* Agree to wear spectacles for \>12 hours/day and at least 6 days/week.
* Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
Exclusion Criteria:
* Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
* Any binocular vision anomalies
* Amblyopia
* Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
* Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
* Participation in any clinical investigation within 30 days of the baseline visit.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.