Myopia
Conditions
Interventions
PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong):PPML (Photolithography Plano Microstructure Lenses)
Plano microstructure lenses (multi-point defocus design,Aspherical Lenslets, Essilor Stellest):Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stelle
PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong):PPML (Photolithography Plano Microstructure Lenses)
PPML(multi-point defocus design, non-fading, Nuo Tong):PPML (Photolithography Plano Microstructure Lenses)
PPML (designed to reduce contrast, non-fading, Nuo Tong):PPML (Photolithography Plano Microstructure Lenses)
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Eligibility
Sex/Gender
All
Age
6 Years to 8 Years
Inclusion criteria
Inclusion criteria: 1. Age: 6 years = 1.0 (decimal notation, 5m); 6. General health status: No systemic syndromes that affect ocular development; no long-term use of growth hormone, corticosteroids, or antiepileptic drugs; 7. 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.; 8. Compliance with spectacle wear: Parents ensure that the child wears glasses for >= 8 hours per day; 9. Follow-up capability: Ability to attend scheduled follow-ups for 12 months (4 visits in total); 10. Informed consent from guardian: Legal guardian signs the informed consent form; children also sign the assent form.
Exclusion criteria
Exclusion criteria: 1. History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation; 2. Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases; 3. Used any myopia intervention drugs or devices in the past 3 months; 4. Those who have participated in other similar clinical studies in the past 3 months; 5. Diagnosis of amblyopia, constant strabismus, and other congenital eye diseases; 6. Those who are allergic to the lens material or products related to the study; 7. Allergy to mydriatic agents and related ophthalmic medications; 8. Allergy to photochromic materials or related dyes; taking photosensitizing drugs; suffering from photo-induced skin or neurological disorders; 9. Unable to understand the study content or unable to cooperate with the follow-up; 10. Other reasons why the research doctor believes the patient is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in 12-month cycloplegic refraction spherical equivalent from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in 12-month axial length (AL, mm) from baseline; | — |
Countries
China
Contacts
Public ContactWei Xu
Shanghai Eye Disease Prevention and Treatment Center
Outcome results
None listed