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%)
Introduction: Myopia is recognized as a progressive eye disease. The aim of this study was to evaluate the frequency and associated factors of clinically significant axial length (AL) shortening among myopic children following repeated low-level red light (RLRL) therapy. Methods: The clinical data that were collected for the myopic children aged 3-17 years who received an RLRL therapy delivered by homeuse desktop light device that emitted light at 650 nm for at least 1 year, were reviewed. The clinical data included AL, spherical equivalent refraction (SER), and visual acuity measured at baseline and follow-up. The primary outcomes were frequency of AL shortening of [ 0.05 mm, [ 0.10 mm, and [ 0.20 mm per year, and associated factors of AL shortening per year. Results: A total of 434 myopic children with at least 12 months of follow-up data were included. The mean age of participants was 9.7 (2.6) years with SER of -3.74 (2.60) diopters. There were 115 (26.50%), 76 (17.51%), and 20 (4.61%) children with AL shortening based on cutoffs of 0.05 mm/year, 0.10 mm/year, and 0.20 mm/ year, respectively. In the multivariable model, AL shortening was significantly associated with older baseline age, female gender, and longer baseline AL or greater spherical equivalent
Purpose To develop and validate a fully automated program for choroidal structure analysis within a 1500-µm-wide region of interest centered on the fovea (deep learning–based choroidal structure assessment program [DCAP]). Methods A total of 2162 fovea-centered radial swept-source optical coherence tomography (SS-OCT) B-scans from 162 myopic children with cycloplegic spherical equivalent refraction ranging from −1.00 to −5.00 diopters were collected to develop the DCAP. Medical Transformer network and Small Attention U-Net were used to automatically segment the choroid boundaries and the nulla (the deepest point within the fovea). Automatic denoising based on choroidal vessel luminance and binarization were applied to isolate choroidal luminal/stromal areas. To further compare the DCAP with the traditional handcrafted method, the luminal/stromal areas and choroidal vascularity index (CVI) values for 20 OCT images were measured by three graders and the DCAP separately. Intraclass correlation coefficients (ICCs) and limits of agreement were used for agreement analysis. Results The mean ± SD pixel-wise distances from the predicted choroidal inner, outer boundary, and nulla to the ground truth were 1.40 ± 1.23, 5.40 ± 2.24, and 1.92 ± 1.13 pixels, respectively. The mean times required for choroidal structure analysis were 1.00, 438.00 ± 75.88, 393.25 ± 78.77, and 410.10 ± 56.03 seconds per image for the DCAP and three graders, respectively. Agreement between the automatic and manual area measurements was excellent (ICCs > 0.900) but poor for the CVI (0.627; 95% confidence interval, 0.279–0.832). Additionally, the DCAP demonstrated better intersession repeatability. Conclusions The DCAP is faster than manual methods. Also, it was able to reduce the intra-/intergrader and intersession variations to a small extent. Translational Relevance The DCAP could aid in choroidal structure assessment.
Purpose: Repeated low-level red-light (RLRL) therapy has been confirmed as a novel intervention for myopia control in children. This study aims to investigate longitudinal changes in choroidal structure in myopic children following 12-month RLRL treatment. Materials and Methods: The current study is a secondary analysis from a multicenter, randomized controlled trial (NCT04073238). Choroidal parameters were derived from baseline and follow-up swept-source optical coherence tomography scans taken at 1, 3, 6, and 12 months. These parameters included the luminal area (LA), stromal area (SA), total choroidal area (TCA; a combination of LA and SA), and choroidal vascularity index (CVI; ratio of LA to TCA), which were automatically measured by a validated custom choroidal structure assessment tool. Results: A total of 143 children (88.3% of all participants) with sufficient image quality were included in the analysis (n=67 in the RLRL and n=76 in the control groups). At the 12-month visit, all choroidal parameters increased in the RLRL group, with changes from baseline of 11.70×103 μm2 (95% CI: 4.14–19.26×103 μm2), 3.92×103 μm2 (95% CI: 0.56–7.27×103 μm2), 15.61×103 μm2 (95% CI: 5.02–26.20×103 μm2), and 0.21% (95% CI: –0.09% to 0.51%) for LA, SA, TCA, and CVI, respectively, whereas these parameters reduced in the control group. Conclusions: Following RLRL therapy, the choroidal thickening was found to be accompanied by increases in both the vessel LA and SA, with the increase in LA being greater than that of SA. In the control group, with myopia progression, both the LA and SA decreased over time.
AimsTo quantify the profiles of choroidal vascularity index (CVI) using fully artificial intelligence (AI)-based algorithm applied to swept-source optical coherence tomography (SS-OCT) images and evaluate the determinants of CVI in a population-based study.MethodsThis cross-sectional study included adults aged ≥35 years residing in the Yuexiu District of Guangzhou, China, a follow-up population-based study. All participants (n=646) underwent comprehensive ophthalmic examinations, including SS-OCT for quantifying choroidal parameters. The CVI and subfoveal choroidal thickness (SFCT) were measured by a novel AI-based system.ResultsA total of 556 participants were included, with a mean age of 56.4±9.9 years and 44.96% women. The average CVI and SFCT of the overall population were 69.7% (95% CI 69.2 to 70.3) and 263.0 µm (95% CI 257.2 to 268.8), respectively. After adjusting for other factors, older age and longer AL were significantly associated with a lower CVI. The CVI decreased by –0.13% (–0.19 to –0.06, p<0.001) with each 1-year increase in age, –2.10% (–3.29 to –0.92, p=0.001) with each 1 mm increase in AL. Furthermore, significantly positive correlation between CVI and SFCT has been observed, with coefficient of 0.059 (0.052 to 0.065, p<0.001).ConclusionUsing new AI-based choroidal segmentation software, we provided a fast, reliable and objective CVI profile for large-scale samples. Older age and longer AL were independent correlates of choroidal thinning and CVI decline. These factors should be considered when interpreting SS-OCT-based choroidal measurements.
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