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| Name | Class |
|---|---|
| Beijing Children's Hospital | OTHER |
| Children's Hospital of The Capital Institute of Pediatrics | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 650 nm low-level red-light, plus single vision spectacle lenses | Experimental | Children in the treatment group are expected to receive 6 minutes irradiation of 650 nm low-level red-light daily, divided into two times a day, each lasting for 3 minutes. Single vision spectacle lenses are allowed for myopic children. |
|
| Control | No Intervention | Single vision spectacle lenses are allowed for myopic children. No intervention was given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 650 nm low-level red-light | Device | 650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in axial length | Use an optical biometer to measure the 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 |
| Change in spherical equivalent error | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Choroid thickness | Use an enhanced-depth imaging technique (based on Optical coherence tomography ) | 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 |
| Change in steep keratometry |
| Measure | Description | Time Frame |
|---|---|---|
| Fundus injury related to 650 nm low-level red-light irridiation | Any potential fundus injury related to 650 nm low-level red-light irridiation would be checked through Fundus photography and coherence tomography examination | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Jie | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Use an optical biometer |
| 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 |
| Change in flat keratometry | Use an optical biometer | 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 |
| Change in length thickness | Use an optical biometer | 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 |
| Change in anterior chamber depth | Use an optical biometer | 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 |
| Change in central corneal thickness | Use an optical biometer | 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 |