Nearsightedness
Conditions
Interventions
Test group A:12-month defocusing lens (Microstructured Lens A)
Test group B:12-month defocusing lens (Microstructured Lens B)
Control group:Wear aspherical lenses for 12 months
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
8 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) Age 8~13 years old (including boundary values), gender is not limited; (2) The spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00D and -6.00D (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50D; (3) Optimal corrected visual acuity >=1.0 in left and right eye after ciliary muscle paralysis; (4) In both eyes with cycloplegia, the degree of the column lens was <=1.50 days; (5) Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian.
Exclusion criteria
Exclusion criteria: (1) Have a history of eye trauma or intraocular surgery; (2) Abnormal results of slit-lamp examination (see Annex 1 for details); (3) fundus examination results >= grade 2 (see Annex 1 for details); (4) Intraocular pressure 21mmHg or intraocular pressure difference >= 5mmHg; (5) Patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumors, eye trauma, dominant strabismus, and any eye lesions affecting visual function; (6) Associated diseases that may affect the eye (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, etc.); (7) suffering from a mental disorder or other disease that the researcher deems unsuitable for wearing frame glasses; (8) Use specially designed myopia control lenses such as hard contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses, and atropine drugs within 1 month before screening or during the planned study period; (9) Participating in other clinical trials within 3 months prior to screening; (10) Those who cannot perform regular eye examination; (11) Other investigators consider it inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value of equivalent spherical lens after cycloplegia (subjective refraction); | — |
Secondary
| Measure | Time frame |
|---|---|
| Spherical equivalent after cycloplegia (subjective refraction);Axial length;Regulating sensitivity;Stereopsis;Corneal curvature;Subjective perception rating for wearing a mirror; | — |
Countries
China
Contacts
Public ContactYao Jingyan
The First Affiliated Hospital of Soochow University
Outcome results
None listed