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.
Age: 8-10 years old
Low myopia: cycloplegic spherical equivalent refractions (SERs) range from -0.50 (inclusive) to -3.00 diopters (D) and astigmatism less than -2.5 D in either eye.
signed informed consent and was able to participate in the study
Secondary myopia, such as a history of retinopathy of prematurity or other neonatal diseases; syndromic myopia with a known genetic disorder or connective tissue disease, such as Stickler syndrome or Marfan syndrome
Strabismus or other binocular vision abnormalities
Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
Sequential
Repeated Low-level Red-light
DeviceIn 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.
Red LED
DeviceIn 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.
9
Treatment groupsSee each treatment group below.
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.
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).
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.
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.
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.
Click on the lead sponsor to view all of their trials.
