Background
To evaluate the long‐term efficacy and safety of continued repeated low‐level red‐light (RLRL) therapy on myopia control over 2 years, and the potential rebound effect after treatment cessation.
Methods
The Chinese myopic children who originally completed the one‐year randomised controlled trial were enrolled. Children continued RLRL‐therapy were defined as RLRL‐RLRL group, while those who stopped and switched to single‐vision spectacle (SVS) in the second year were RLRL‐SVS group. Likewise, those who continued to merely wear SVS or received additional RLRL‐therapy were SVS‐SVS and SVS‐RLRL groups, respectively. RLRL‐therapy was provided by an at‐home desktop light device emitting red‐light of 650 nm and was administered for 3 min at a time, twice a day and 5 days per week. Changes in axial length (AL) and cycloplegic spherical equivalence refraction (SER) were measured.
Results
Among the 199 children who were eligible, 138 (69.3%) children attended the examination and 114 (57.3%) were analysed (SVS‐SVS: n = 41; SVS‐RLRL: n = 10; RLRL‐SVS: n = 52; RLRL‐RLRL: n = 11). The baseline characteristics were balanced among four groups. In the second year, the mean changes in AL were 0.28 ± 0.14 mm, 0.05 ± 0.24 mm, 0.42 ± 0.20 mm and 0.12 ± 0.16 mm in SVS‐SVS, SVS‐RLRL, RLRL‐SVS and RLRL‐RLRL group, respectively (p < 0.001). The respective mean SER changes were −0.54 ± 0.39D, −0.09 ± 0.55D, −0.91 ± 0.48D, and −0.20 ± 0.56D (p < 0.001). Over the 2‐year period, axial elongation and SER progression were smallest in RLRL‐RLRL group (AL: 0.16 ± 0.37 mm; SER: −0.31 ± 0.79D), followed by SVS‐RLRL (AL: 0.44 ± 0.37 mm; SER: −0.96 ± 0.70D), RLRL‐SVS (AL: 0.50 ± 0.28 mm; SER: −1.07 ± 0.69D) and SVS‐SVS group (AL: 0.64 ± 0.29 mm; SER: −1.24 ± 0.63D). No self‐reported adverse events, functional or structural damages were noted.
Conclusions
Continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression over 2 years. A modest rebound effect was noted after treatment cessation.
Purpose
To compare the treatment efficacy between repeated low-level red light (RLRL) therapy and 0.01% atropine eye drops for myopia control.
Methods
A single-masked, single-center, randomized controlled trial was conducted on children 7 to 15 years old with cycloplegic spherical equivalent refraction (SER) ≤ −1.00 diopter (D) and astigmatism ≤ 2.50 D. Participants were randomly assigned to the RLRL group or low-dose atropine (LDA, 0.01% atropine eye drops) group and were followed up at 1, 3, 6, and 12 months. RLRL treatment was provided by a desktop light therapy device that emits 650-nm red light. The primary outcome was the change in axial length (AL), and the secondary outcome was the change in SER.
Results
Among 62 eligible children equally randomized to each group (31 in the RLRL group, 31 in the LDA group), 60 children were qualified for analysis. The mean 1-year change in AL was 0.08 mm (95% confidence interval [CI], 0.03–0.14) in the RLRL group and 0.33 mm (95% CI, 0.27–0.38) in the LDA group, with a mean difference (MD) of −0.24 mm (95% CI, −0.32 to −0.17;
P
< 0.001). The 1-year change in SER was −0.03 D (95% CI, −0.01 to −0.08) in the RLRL group and −0.60 D (95% CI, −0.7 to −0.48) in the LDA group (MD = 0.57 D; 95% CI, 0.40–0.73;
P
< 0.001). The progression of AL < 0.1 mm was 53.2% and 9.7% (
P
< 0.001) in the RLRL and LDA groups, respectively. For AL ≥ 0.36 mm, progression was 9.7% and 50.0% (
P
< 0.001) in the RLRL and LDA groups, respectively.
Conclusions
In this study, RLRL was more effective for controlling AL and myopia progression over 12 months of use compared with 0.01% atropine eye drops.
Translational Relevance
RLRL therapy significantly slows axial elongation and myopia progression compared with 0.01% atropine; thus, it is an effective alternative treatment for myopia control in children.
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