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To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency.
Myopia has emerged as a significant public health concern in East Asia. The excessive elongation of the axial length ( AL)of the eye, particularly as myopia progresses to high myopia, is associated with mechanical stretching and thinning of the choroid and sclera. This can lead to vision-threatening complications such as myopic macular degeneration, macular hemorrhage, retinal detachment, cataracts, and glaucoma. Given the serious consequences of high myopia and its associated complications, early and effective prevention and control of myopia become a primary focus in safeguarding visual health and enhancing quality of life.
In recent years, RLRL holds significant potential as an effective strategy for preventing and controlling myopia in children and adolescents. However, recent researches prompt further questions: Is the current power of RLRL exposure optimal? Can the frequency of exposure be refined? What is the relationship among exposure power, frequency and myopia control? To explore these questions and clarify the effects of various combinations of exposure power and frequency on myopia progression following RLRL therapy, our research group plans to conduct a prospective, double-blind, single-center, randomized controlled clinical trial. This study aims to provide more comprehensive evidence to support this innovative intervention on myopia prevention and control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red light: 2.0 mW/twice daily | Experimental |
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| Red light: 2.0 mW/once daily | Experimental |
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| Red light: 1.0 mW/twice daily | Experimental |
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| Red light: 1.0 mW/once daily | Experimental |
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| Red light: 0.5 mW/twice daily | Experimental |
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| Red light: 0.5 mW/once daily | Experimental |
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| Red light: 0.3 mW/twice daily | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repeated Low-level Red-light | Device | In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence (%) of axial length increase ≤0.05mm after red light for 3 months measured by the IOL master | Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number. | 1 week, 1, 2, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rates (%) of cycloplegic spherical equivalent refraction progressing ≥0.00 D after red light for 3 months measured by the autorefractor | Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He, Prof | Contact | +862153555032 | hxgcrco@shsyf.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention & Treatment Center | Recruiting | Shanghai | Shanghai Municipality | 200041 | China |
Data will be shared as open data after proper anonymization.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Red light: 0.3 mW/once daily | Experimental |
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| Red LED: twice daily | Sham Comparator |
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| Red LED | Device | In addition to SVS with power for correcting distance refraction, red LED will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes. |
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| 1 week, 1, 2, 3 months |
| Changes of axial length (mm) after discontinuation of red light for 1 months measured by the IOL master | Change of axial length is characterized as the difference between each follow-up visit and baseline values. | 4 months |
| Changes of cycloplegic spherical equivalent refraction (D) after discontinuation of red light for 1 months measured by the autorefractor | Change of cycloplegic spherical equivalent refraction is characterized as the difference between each follow-up visit and baseline values. | 4 months |
| Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages | Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. | 1 week, 1, 2, 3, 4 months |
| Change in visual acuity (logMAR) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart | Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart with standard illumination at a distance of 4 meters is used to measure visual acuity. | 1 week, 1, 2, 3, 4 months |
| Changes in choroidal thickness (μm) measured by the swept-source optical coherence tomography and optical coherence tomography angiography | Changes in choroidal thickness (μm) are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on. | 1 week, 1, 2, 3, 4 months |
| Changes in the amplitudes of waves (mV) measured by the full-filed electroretinogram | Changes in the amplitudes of the waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram. | 1 week, 1, 2, 3, 4 months |
| Changes in the the latency of waves (ms) measured by the full-filed electroretinogram | Changes in the latecy of the waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram. | 1 week, 1, 2, 3, 4 months |