Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control (NCT07535658) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control
China255 participantsStarted 2026-04-15
Plain-language summary
The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. The main questions it aims to answer are:
Are photolithography flat microstructure lenses effective and safe in preventing myopia in children? Does the depth of tinted lenses affect visual quality? Researchers will compare photolithography flat microstructure lenses to a spectacle lenses with aspherical lenslets to see if photolithography flat microstructure lenses works to prevent myopia in children.
Participants will:
Wear photolithography flat microstructure lenses or Spectacle Lenses with Aspherical Lenslets more than 8H per day for 1 year.
Visit the clinic once every 3 months for checkups and tests.
Who can participate
Age range
6 Years – 8 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
. Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);
. The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;
. Astigmatism: Cylindrical power of both eyes ≤ 1.00D;
. Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;
. Corrected visual acuity: Best corrected visual acuity (BCVA) of both eyes ≥ 1.0 (decimal notation, 5m);
. General health status: No systemic syndromes that affect ocular development; no long-term use of growth hormone, corticosteroids, or antiepileptic drugs;
. Previous intervention: No use of any myopia control methods within the past 3 months, including but not limited to: multifocal glasses, atropine eye drops, red light therapy, acupuncture, etc.
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.
What they're measuring
1
Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months.
Timeframe: From enrollment to the end of treatment at 12 month
Trial details
NCT IDNCT07535658
SponsorShanghai Eye Disease Prevention and Treatment Center