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 range6 Years – 8 Years
SexALL
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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.
✓. Compliance with spectacle wear: Parents ensure that the child wears glasses for ≥8 hours per day;
Exclusion criteria
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