Myopia
Conditions
Interventions
Experimental Group:Use double focus lens
Control Group:Single focus lens
Sponsors
Eye Hospital, Wenzhou Meidical Uniersity, Zhejiang Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and informed consent signed by the subject himself and his legal guardian; 2. Aged range from 8 to 12 years (including 8 and 12 years old) at the time of signing the first informed consent, no gender limit; 3. At baseline, the subject's myopia in both eyes (spheroscope of main sense optometry) was between -0.75D and -4.00D (including -0.75D and -4.00D); 4. The best corrected visual acuity in both eyes (i.e., each eye) can reach 0.1 logMAR; 5. Anisometropia <= 1.50D in both eyes of the subject; 6. Binocular astigmatism <= 0.75D (non-cycloplegic main vision optometry); 7. Subjects with no corneal diseases or abnormalities except trichiasis, and other subjects with eye diseases or abnormalities may be included at the discretion of the investigator; 8. Currently in good health; 9. Agree to use randomly assigned lenses; 10. Be able to understand the nature of the study and be willing and able to comply with the instructions set out in the programme; 11. Ability to follow study procedures including computer optometry of both eyes for visual acuity, axial length and cycloplegia; 12. Able to follow the visit schedule; 13. Willing to participate in the trial for 4 years; 14. Willing to wear contact lenses for at least 10 hours a day, at least 6 days a week; 15. Glasses that can be worn and can achieve visual correction (0.3 logMAR or better) are available before assignment (in case of initial myopia, spare frame glasses are recommended on the day of enrollment and meet the requirements).
Exclusion criteria
Exclusion criteria: 1. Currently using or previously using any medication or other method for myopia control, such as bifocal, progressive multifocal lenses, atropine, pirenzepine, or any other myopia control therapy; 2. Use any systemic or local ophthalmological drugs or over-the-counter artificial tears that interfere with contact lens fitting, pupil size, adjustment or refractive status, or require lens removal during the day; 3. Have worn or are currently wearing rigid gas permeable contact lenses, including orthokeratology lenses; 4. During screening and baseline visit, the following specific contraindications exist for lenses: (1) Patients with a variety of eye diseases, such as acute or chronic inflammation of the eye, glaucoma, corneal dysesthesia, corneal epithelial defect, corneal endothelial cell depletion, dry eye disease, etc., should not be worn by researchers; (2) Have systemic diseases that may affect the eyes and cannot be worn as judged by the researcher; (3) Allergic history of contact lens or contact lens care products; (4) It is not suitable to wear soft contact lenses in living or working environment, such as dispersed dust, medicine, aerosol (such as hair spray, volatile chemicals), dust, etc.; (5) In the judgment of the researcher, the personal hygiene conditions do not meet the necessary hygiene conditions for wearing the soft contact lens; 5. Patients with a history of the following eye conditions: (1) Corneal ulcer, corneal infiltration, ocular viral or fungal infection or other recurrent ocular infection; (2) Giant papillary conjunctivitis; (3) Allergic reactions to ocular surface or ocular appendages that may be induced or aggravated by wearing contact lenses; (4) Known to be allergic to fluorescein, oxybuprocaine, proparacaine or tropicamide; (5) Decreased corneal sensation (decreased corneal sensitivity); 6. Keratoconus or irregular cornea; 7. Dominant strabismus or amblyopia; 8. Participated in drug or medical device clinical trials (except registration studies) within 30 days prior to signing the informed consent; 9. The researcher thinks it is not suitable to participate in the study (the researcher should indicate the reason for exclusion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length;Cycloplegic spherical equivalent refractive error (SERE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual symptoms;Impact on participants' daily activities of life;The incidence of exposure adjustment with slit lamp examination results>level 2; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital, Wenzhou Meidical Uniersity, Zhejiang Eye Hospital
Outcome results
None listed