Myopia
Conditions
Brief summary
A multicenter randomized controlled trial, evaluating the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children. Participants included children(aged 6 to 12 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
Detailed description
This multicenter randomized controlled trial will be conducted in three hospitals: Beijing Tongren Hospital, and another two subcenters. The whole study will last for five years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up and the end of the study. The intervention measure used will be 650 nm low-level red-light. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
Interventions
650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina
Sponsors
Beijing Children's Hospital
Children's Hospital of The Capital Institute of Pediatrics
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 6 to 12 years * The cycloplegic spherical equivalent error (SER) is -6D to 1D (\> -6D, ≤1D) in both eyes * Astigmatism of 2.5 D or less (≤2.5D) * Willing to participate in the study and sign the informed consent form
Exclusion criteria
* Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens * With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia * With refractive media opacification (keratopathy, lens opacity, etc.) * Allergy to cycloplegia drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spherical equivalent error | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too. |
| Change in axial length | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an optical biometer to measure the axial length. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in steep keratometry | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an optical biometer |
| Change in flat keratometry | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an optical biometer |
| Change in anterior chamber depth | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an optical biometer |
| Change in central corneal thickness | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an optical biometer |
| Change in length thickness | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an optical biometer |
| Change in Choroid thickness | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Use an enhanced-depth imaging technique (based on Optical coherence tomography ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fundus injury related to 650 nm low-level red-light irridiation | Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up | Any potential fundus injury related to 650 nm low-level red-light irridiation would be checked through Fundus photography and coherence tomography examination |
Countries
China
Outcome results
None listed