Myopia prevention and control
Conditions
Interventions
Experimental group:Get double-sided defocusing lenses and ask to wear them for at least 12 hours daily
Control group 1:Wear regular defocusing lenses for at least 12 hours a day
Control group 2:Get a single lens and ask to wear the lens for at least 12 hours daily
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, gender is not limited; 2. Refractive status meets the following conditions: (1) After ciliary muscle paralysis, the equivalent globular light of both eyes was measured by computer optometry between -0.50D and -6.00D (including -0.50D and -6.00D); (2) After ciliary muscle paralysis, the astigmatism of both eyes was detected by computer optometry <= 2.0D; (3) The anisometropia of both eyes detected by computer optometry after cycloplegia is 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 the randomization of double-sided defocus lenses, ordinary defocus lenses and ordinary single-light lenses; 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;Axis length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Regulatory response, BCC;Adjustment force, PRA/NRA;Ocular Position;The ratio of regulatory set to regulation, AC/A; | — |
Countries
China
Contacts
Public ContactLei Tian
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed