Repeat Low-level Red-Light Therapy Using to Slow the Progression of Medium ~ High Myopia （≥4.00D） in Chinese Children

Abstract

Abstract Purpose：RLRL (repeated low level red light) therapy has recently emerged as a new-type treatment to control myopia. In our study, we will focus on the effect of myopia control between RLRL and PDMSL in the children who had moderate to high Myopia. Its effectiveness have been reported in previous studies. In our study, we aim to compare the effects of RLRL and peripheral defocus modifying spectacle lenses (PDMSL) in Medium ~ High Myopia （≥4.00D）. Methods: It is a Randomized, controlled , clinical trial. This trial is registered with ClinicalTrials.gov (identifier, NCT05184621) and Date 11/01/2022.The participants were 25 Chinese children who had aged 8 to 14 years old with ≥-4.00 diopters (D) of myopia ,and ≤-2.00 diopters (D) of astigmatism. Groups of intervention (RLRL plus SVS) and control (PDMSL) were assigned 1:1. In RLRL group, the participant would use RLRL device. The usage method was: two sessions a day, five time a week, each session lasted three minutes, and there was at least a four-hour interval between sessions. The participant wore SVS daily. The participant wore PDMSL daily, in the control group. The axial length (AL), spherical equivalent refractions (SER) and other ophthalmic examinations were measured at baseline, one, three, six, nine and twelve months. Result: Spherical equivalent refraction （SER ）change was 0.26±0.39D and 0.69±0.39D in 6 -month,0.34±0.51D and 0.93±0.44D in 9-month, 0.28±0.50D and 0.79±0.48D in 12-month, in the RLRL group and PDMSL group , respectively. There were all significant different between the two groups (P=0.000). Treatment-related adverse events were not reported. Axial length (AL) change was -0.13 ±0.11 mm and 0.09 ±0.01mm in 3 -month, -0.18 ±0.13 mm and 0.21 ±0.09mm in 6 -month, -0.21 ±0.16 mm and 0.27 ±0.14mm in 9 -month, and -0.18 ±0.17 mm and 0.34 ±0.13mm in 12 -month, in RLRL group and PDMSL control group , respectively. In the both groups, there were significant differences (P=0.000) . It was not reported that any adverse events were related to the treatment. Conclusions: The RLRL therapy was more effective than PDMSL in Medium~ High Myopia（≥4.00D） control .The RLRL treatment cloud be well tolerated, with few adverse effects related to the treatment.