Myopia
Conditions
Interventions
Test group A:Wearing lenses with enhanced high-order aberration diffusion (EHOAD).
Test group B:Wearing lenses with high-order aberration diffusion (HOAD).
Control group C:Wearing Hoya DIMS lenses
Sponsors
Tianjin Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1. Aged 8-13 years, written consent of their guardian is required, regardless of gender; 2. Objective refractive spherical lens degree between -1.00D (inclusive) and -6.00D (inclusive) in both eyes under dilated pupils (based on the average of objective refractive examinations), and best corrected visual acuity >= 1.0 in both left and right eyes on subjective refractive examinations; and refractive error <= 1.50D in both eyes after equivalent spherical lens examinations; 3. Columnar lens degree <= 1.50D; 4. Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of ocular trauma or intraocular surgery; 2. Clinically significant slit lamp findings; 3. Fundus examination findings >= grade 2; 4. Abnormal IOP (IOP 21mmHg or bilateral IOP difference >= 5 mmHg); 5. Combination of other ocular diseases such as various inflammatory conditions such as uveitis, glaucoma, cataract, fundus disease, ocular tumours, ocular trauma, patients with dominant strabismus; and any ocular pathology that affects visual function; 6. Patients with systemic diseases causing immune depression, such as acute or chronic sinusitis, diabetes, Down's syndrome, rheumatoid arthritis, psychiatric patients or other conditions which, in the opinion of the investigator, make them unsuitable for the wearing of spectacles with frames; 7. Those who have participated in a clinical trial of a drug within 3 months; 8. Those who meet the inclusion criteria in only one eye; 9. Those who are unable to undergo regular eye examinations; 10. Those who have participated in any clinical research trial related to myopia control within one month; those who have used or are currently using special design myopia control lenses such as rigid corneal contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses, atropine-based medications, etc. within one month; 11. Those who, in the judgment of the investigator, cannot be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in cycloplegic spherical equivalent refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in axial elongation;Binocular vision function; | — |
Countries
China
Contacts
Public ContactLihua Li
Tianjin Eye Hospital
Outcome results
None listed