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.
Introduction: Axial length (AL) elongation in myopia is considered irreversible. We aimed to systemically report unexpected AL shortening observed in a randomized clinical trial (RCT) after repeated low-level red-light (RLRL) therapy.Methods: This is a post hoc analysis of a multicenter, single-masked RCT. Two hundred sixtyfour myopic children aged 8-13 years allocated to RLRL treatment (intervention group) or a single vision spectacle (SVS, control group) were included. AL was measured using an IOL-master 500 at baseline, 1-, 3-, 6-, and 12-month followup visits. AL shortening was defined as AL reduction from baseline to follow-up visits at three cutoffs: [ 0.05 mm, [ 0.10 mm, and [ 0.20 mm. Frequency of AL shortening at different cutoffs was calculated. Analysis was done with intent to treat (ITT). Results: At 12-months follow up, frequency of AL shortening [ 0.05 mm was 26/119 (21.85%)
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