Myopia prevention and control
Conditions
Interventions
Trial Group1:Fitted with Xingtong peripheral defocus lenses, daily wear duration at least 12 hours
Trial Group2:Fitted with Xingtong dual-surface composite defocus lenses, daily wear duration at least 12 hours
Control Group:Fitted with single vision lenses, daily wear duration at least 12 hours
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1.Aged 6~14 years old, gender is not limited; 2: Refractive status meets the following conditions: a) Computer optometry after ciliary paralysis the equivalent globular photometry of both eyes was between -0.50D and -6.00D (including -0.50D and -6.00D) b) Computer optometry after ciliary paralysis the astigmatism of both eyes was <=2.0D c) Computer optometry after ciliary paralysis the anisometropia of both eyes was less than 2.00D 3. Normal intraocular pressure in both eyes (<= 21mmHg); 4. The best corrected far vision at any one glance is better than or equal to 1.0; 5. There was no amblyopia or any other ocular pathological changes in both eyes; 6.Parents/guardians understand the scheme and are willing to accept randomization; 7. The patient clearly understands and voluntarily participates in the study, and the informed consent is signed by the patient and the parent/guardian.
Exclusion criteria
Exclusion criteria: 1. People who are allergic to cycloplegics or their components (atropine, cyclopentone, pramecaine or benzalkonium chloride) used during the examination of this study; 2. Any eye has an abnormality of the refractive system, such as keratoconus, conical lens, spherical lens, etc.; 3. Diseases that may affect refractive development or easily progress to high myopia, such as Down syndrome, Marfan syndrome, retinopathy of prematurity, and neonatal hypoxic encephalopathy; 4. Any one eye suffers from other eye abnormalities and diseases that affect vision, such as ptosis, congenital corneal abnormality, corneal leukoplakia, congenital lens abnormality, cataract, macular disease, choroid disease, severe vitreous opacity, retinopathy, etc.; 5. Binocular vision defects or stereoscopic vision defects; 6. History of glaucoma in either eye and/or shallow anterior chamber; 7. Previous or current combination of obvious strabismus, amblyopia or nystagmus; 8. Previous eyelid, strabismus, internal eye or refractive surgery; 9. Systemic or local use of drugs that affect efficacy evaluation within 3 months before screening, such as anticholinergic drugs: atropine and pirenzil; Cholinoid drugs: pilocarpine, etc.; Or drugs that may affect pupil size and regulation, such as belladonna tablets, morphine or sedative sleeping pills; 10. Use of myopic control therapy within one month, including atropine or other antimuscarinic drugs, bifocal/progressive or multifocal contact lenses, bifocal/progressive or multifocal frame glasses, orthokeratology lenses, rigid permeable or other contact lenses used to delay the progression of myopia; 11. Previous or current systemic diseases: immune system diseases, central nervous system diseases, asthma, diabetes, severe cardiopulmonary dysfunction, severe liver and kidney dysfunction; 12. Have a clear family history of high myopia; 13. Participated in other clinical trials within 3 months before randomization; 14. Unable to voluntarily participate in the study or not motivated enough; 15. Unable to cooperate with regular follow-up and various examinations; 16. Lack of expression skills; 17. There are any other circumstances that the investigator considers inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diopter;Axial length; | — |
Countries
China
Contacts
Public ContactTian Lei
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed