Myopia
Conditions
Interventions
Group 1:Group 1 will use repeated low-level red-level (RLRL) therapy 5 days per week, with each treatment lasting for 3 minutes twice a day at home, with a minimal interval of 4 hours
Group 2:Group 2 will use a placebo sham device (the same treatment device, but operating at less than 0.1% of the original device’s power) therapy 5 days per week, with each treatment lasting for 3 mi
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1) Age: 6 to 12 years at enrolment 2) Myopia: Cycloplegic SER -1.0 to -7.0 diopters (D) in each eye 3) Anisometropia : < 1.5 D 4) Astigmatism: < 1.5 D 5) Best corrected visual acuity (BCVA) 20/25 or better. 6) Informed parental consent
Exclusion criteria
Exclusion criteria: 1) Ophthalmic diseases, conditions, or syndromes other than ammetropia and myelinated nerve fiber layer, or prematurity (less than 36 weeks of gestation) 2) Previous use of optical or pharmacologic treatment for myopia control (e.g., defocusing spectacle or contact lenses, orthokeratology, atropine, or pirenzepine) 3) Systemic diseases (e.g., endocrine, cardiac diseases) and developmental anomalies 4) Inability to attend regular follow up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in spherical equivalent refraction (SER) over 12 months in myopic children;Changes in axial length (AL) over 12 months in myopic children; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the rate of spherical equivalent refraction (SER) and axial length (AL) increase;Changes in other biometric parameters other than axial length (AL);Best corrected visual acuity, intraocular pressures, ocular and systemic symptoms, ocular signs assessed by slit lamp biomicroscopy and binocular indirect ophthalmoscopy, and a self-reported questionnaire for assessment of visual function;Pupil diameter in room light measured by pupillometer; | — |
Countries
China
Contacts
Public ContactYam Cheuk Sing Jason
The Chinese University of Hong Kong
Outcome results
None listed