The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens (NCT05886348) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
China249 participantsStarted 2023-07-31
Plain-language summary
The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
Who can participate
Age range
7 Years – 13 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
. Participant and parent (or guardian) are able and willing to provide consent
. Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements
. Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to
. Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study
. Age at time of parent or guardian consent and participant assent: 7 - 13 years old
. Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye.
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.
. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye
. Cycloplegic autorefraction anisometropia of 1.50 D or less
Exclusion criteria
. Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops
. Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development
. (a) Have received treatment of myopic control pharmaceutical medication (e.g., atropine) or light fundus illuminance therapy (e.g., repeated red light therapy) within 6 months prior to entry into this study. (b) Have received treatment of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal or less than 0.50 D SER) etc. within one month prior to entry into this study.
. Participant with clinically significant strabismus (including intermittent tropia)
. Medical history of binocular vision abnormalities
. Participant with amblyopia
. Participation in a clinical trial within 30 days prior to entry into this study or during participation