Myopia
Conditions
Interventions
Trial group 1:Dual-effect lattice-filled microstructured lens
Trial group 2:Dot Diffusion Lens (DOT)
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Age between 6 and 15 years,Under cycloplegia, the spherical equivalent (SE) should be between -4.00 D and -9.00 D inclusive. Specific requirements: a) If the SE is in the range of -4.00 D (inclusive) to -6.00 D (exclusive), both eyes must meet this range; b) If the SE is in the range of -6.00 D (inclusive) to -9.00 D (inclusive), it is sufficient for either eye to meet this range.. 2. Cylinder less than or equal to 2.50 D; anisometropia in spherical equivalent less than or equal to 2.50 D between the two eyes. 3. Best-corrected visual acuity (BCVA) less than or equal to 0.1 LogMAR in both eyes. 4. Willing to participate in this clinical trial and having signed the informed consent form. 5. Has worn single-vision spectacles for the past 3-12 months and can provide axial length measurement results from within the last 3-12 months.
Exclusion criteria
Exclusion criteria: 1. Received any myopia intervention within the past 3 months, including atropine, orthokeratology lenses, multifocal soft contact lenses, low-level red-light therapy or myopia-control spectacle lenses. 2. Active ocular surface inflammation, or coexistence of other ocular diseases such as uveitis or other inflammatory conditions, glaucoma, cataract, retinal diseases, ocular tumors, ocular trauma, manifest strabismus, or any eye disorder that may affect visual function. 3. Systemic diseases associated with immunosuppression, such as diabetes, Down syndrome, rheumatoid arthritis, psychiatric disorders, or any other condition deemed unsuitable for spectacle wear by the investigator. 4. History of ocular trauma or intraocular surgery. 5. Unable to comply with regular follow-up visits. 6. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for inclusion. 7. Intraocular pressure (IOP) in either eye exceeds 21 mmHg, or the interocular IOP difference is greater than 5 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cycloplegic autorefraction;Choroid thickness;Visual comfort questionnaire; | — |
Countries
China
Contacts
Public ContactBao Jinhua
Eye Hospital, Wenzhou Medical University
Outcome results
None listed