Myopia
Conditions
Interventions
Trial group :Dual-effect lattice-filled microstructured lens
Control group:HAL Spectacle lenses with highly aspherical lenslets
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
7 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1 Aged 7–13 years, with cycloplegic spherical equivalent (SE): –0.50 D (inclusive) to –5.00 D (exclusive); 2 Cylinder less than or equal to 1.50 D; anisometropia (difference in spherical equivalent between the two eyes) less than or equal to 1.50 D; 3 Best-corrected visual acuity (BCVA) less than or equal to 0.1 LogMAR; 4 Progressive myopia: i) For subjects with historical data: Annualized rate of myopic refractive error progression greater than or equal to –0.50 D/year over the past 6–12 months, or annualized rate of axial length (AL) progression greater than 0.27 mm/year; ii) For subjects without reliable historical data: age less than or equal to 9 years; cycloplegic SE between –0.50 D and –1.50 D; baseline axial length exceeding the 75th percentile of normal values for children of the same age and sex (see table below). Age Axial Length (mm)* Male Female 7 23.36 22.87 8 23.54 23.03 9 23.70 23.18 *Data referenced from the 2024 Expert Consensus on the Application of Axial Length in Myopia Control and Management. 5 Discontinuation of use of low-concentration atropine and myopia control spectacle lenses for more than 1 month; discontinuation of wear of orthokeratology (OK) lenses for at least 2 months. 6 Voluntarily agrees to participate in this clinical trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1 History of myopia intervention using atropine in high concentrations (greater than 0.05%) and repeat red light therapy; 2Shallow anterior chamber or intraocular pressure greater than 21 mmHg; 3 Active ocular surface inflammation, or presence of other ocular diseases such as uveitis and various inflammatory conditions, glaucoma, cataract, fundus diseases, ocular tumors, ocular trauma, manifest strabismus, or any other ocular pathology that may affect visual function; 4 Patients with systemic diseases causing immunosuppression, such as diabetes, Down syndrome, rheumatoid arthritis, psychiatric disorders, or any other condition deemed unsuitable for wearing spectacle lenses by the investigator; 5 History of ocular trauma or intraocular surgery; 6 Individuals unable to comply with regular follow-up visits; 7 Any other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length;Cycloplegic autorefraction;Cycloplegic subjective refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Choroidal Thickness;Assessment of visual comfort;Quick contrast sensitivity function; | — |
Countries
China
Contacts
Public ContactBao Jinhua
Eye Hospital, Wenzhou Medical University
Outcome results
None listed