Refractive error
Conditions
Interventions
Experimental group (Wear defocusing lenses produced by Zhuhai Boai Light Technology Co., LTD):None
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1) Age [5-12] years old; 2) Objective optometry after ciliary muscle trouble SER: -0.50 to -5.00 diopter (D); 3) Both astigmatism and anisometropia <=1.50D; 4) The best corrected visual acuity (VA) in one eye is 1.0 or better; 5)Accept newly designed lenses
Exclusion criteria
Exclusion criteria: 1) strabismus and binocular abnormalities; 2) History of corneal surgery or eye surgery within 1 year; 3) Eyelid abnormalities or infection; 4) Have other active eye diseases; 5) Abnormal IOP (IOP 21mmHg or binocular pressure >=5mmHg); 6) Have systemic diseases that may affect the eyes, such as sinusitis, diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, or other diseases that researchers believe are not suitable for wearing a defocus frame lens; 7) Patients who need to use therapeutic eye drops, including antibiotics, mydriatic agents, corticosteroid hormones and compound eye drops containing corticosteroid hormones; 8) Use of myopia prevention and control measures in the past month (such as atropine, orthokeratology, defocusing lenses) 9) Patients with one eye meeting the inclusion criteria; 10) The researcher determined that the candidate could not be accepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of mydriatic computer optometry and axial length from baseline at 24 months ±21 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wearing compliance,;The change value of mydriatic computer optometry and axial length in 6 months ±7 days;visual quality,;vision with glasses;The change value of mydriatic computer optometry and axial length in Twelve months+21 days;The change value of mydriatic computer optometry and axial length in 18 months +21 days; | — |
Countries
China
Contacts
Public ContactChen Zhi
Eye & ENT Hospital of Fudan University
Outcome results
None listed