myopia
Conditions
Interventions
Test Group B:Wearing 1.61 multi-point axial control dual-engine defocus lenses for 12 months
Test Group C:Wearing single-vision lenses for 12 months
Test Group A:Wearing 1.56 multi-point fogging dual-effect defocus lenses for 12 months
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
7 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1. Age 7 to 13 years old (including boundary values), any gender; 2. Under cycloplegic refraction, the subjective spherical equivalent of both eyes is between -1.00D and -5.00D (including boundary values), and the difference in spherical equivalent between both eyes is =1.0; 4. Under cycloplegic refraction, the cylindrical power of both eyes is <=1.50D; 5. Voluntarily participate in this clinical study, sign the informed consent form, and obtain written consent from their guardian.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of eye trauma or intraocular surgery; 2. Abnormal findings in slit-lamp examination (cornea, conjunctival area); 3. Fundus examination results = grade 2 (see Attachment 2 for details); 4. Intraocular pressure 21 mmHg; 5. Presence of other ocular diseases, such as uveitis or other inflammations, glaucoma, cataracts, fundus diseases, ocular tumors, ocular trauma, or manifest strabismus (prism alternate cover test >15?); 6. Presence of diseases that may affect the eyes (e.g., acute or chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, etc.); 7. Individuals with mental disorders or other conditions deemed by the investigator to be unsuitable for wearing prescription glasses; 8. Use of rigid contact lenses, multifocal contact lenses, specially designed myopia control lenses, atropine or similar medications within one month prior to screening or planned during the study period; 9. Participation in other clinical trials within three months prior to screening; 10. Inability to undergo regular eye examinations; 11. Other conditions deemed by the investigator to be unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value of equivalent spherical lens after cycloplegia (objective refraction); | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected Visual Acuity (Near and Distance Vision);Spherical equivalent after cycloplegia (objective refraction);Subjective Refraction without Cycloplegia; Axial Length and Change Value;Stereopsis;Corneal curvature;Subjective experience evaluation with lens wear; | — |
Countries
China
Contacts
Public ContactXu Hua
Children's Hospital of Soochow University
Outcome results
None listed