Effects of Spectacle lenses with highly aspherical lenslets on axial elongation, refractive change and visual function in pre-myopic Chinese children: a retrospective cohort study

Effects of Spectacle lenses with highly aspherical lenslets on axial elongation, refractive change and visual function in pre-myopic Chinese children: a retrospective cohort study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effects of Spectacle lenses with highly aspherical lenslets on axial elongation, refractive change and visual function in pre-myopic Chinese children: a retrospective cohort study Meihua Ding, Tailiang Lu, Xin Wang, Yuanyuan Hu, Yirong Wang, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8199611/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background This clinical study was designed to evaluate the effects of spectacle lenses with highly aspherical lenslets (HAL) on axial elongation, refractive change, and visual function in pre-myopic Chinese children. Methods Retrospective cohort study. This study included 66 Chinese children, aged 6.0 to 16.0 years, with a cycloplegic spherical equivalent refractive error (SER) ranging from > − 0.50 D to ≤ + 0.75 D, who completed the 6-month follow-up. The participants were divided into two groups: the HAL group (n = 32) and the Control group (n = 34). SER, axial length (AL), and accommodative and binocular function (distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, NRA, and PRA) were measured at baseline and 6 months after lenses were dispensed. Results The 6-month axial elongation was 0.14 (0.06, 0.27) mm in the Control group and 0.04 (0.00, 0.11) mm in the HAL group ( P = 0.006). The 6-month AL elongation was categorized into three risk levels: low risk (≤ 0.10 mm), medium risk (0.10–0.20 mm), and high risk (≥ 0.20 mm). In the Control group, low risk accounted for 44.1%, medium risk 23.5%, and high risk 32.4%. However, in the HAL group, low risk accounted for 75.0%, medium risk 6.3%, and high risk 18.8% ( P = 0.025). The changes in SER at the 6-month visit were − 0.06 (-0.25, 0.00) D and 0.00 (0.00, 0.00) D in the Control and HAL groups ( P = 0.134). Compared with the Control group, there were no significant differences in 6-month changes in distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, and PRA (all P > 0.05), with the exception of NRA ( P = 0.032). Conclusions For the pre-myopic children who have a high risk of developing myopia, plano HAL spectacles may be a viable strategy to slow AL elongation with minimal impact on accommodative and binocular function in a 6-month follow-up, with the exception of NRA. highly aspherical lenslets axial length spherical equivalent refractive error visual function myopia prevention pre-myopia Figures Figure 1 Figure 2 Figure 3 Figure 4 Background Myopia ranks among the most prevalent eye conditions globally and presents a significant public health concern. In 2000, there were 1.41 billion people worldwide with myopia, and among them, 160 million had high myopia. This figure is expected to dramatically increase by 2050, with projections suggesting that up to 4.76 billion people will have myopia and 938 million will suffer from high myopia.[ 1 ] The progression of myopia and high myopia can lead to a range of complications, including pathological myopia, cataracts, choroidal atrophy, neovascularization, retinal detachment, posterior staphyloma, myopic macular degeneration, and glaucoma.[ 2 – 4 ] All of these are irreversible, blindness-causing eye diseases. Multiple studies have found that early-onset myopia in school-aged children has been linked to a notably elevated risk of developing high myopia.[ 5 – 7 ] One of the studies revealed that for children who have myopia beginning at age 7–8, the rate of high myopia exceeded 50%, while among those aged 9, the rate of high myopia was 30%.[ 5 ] The likelihood of developing high myopia in adulthood is significantly decreased for every year that the age at onset is delayed. Given the significant public health implications of myopia, it is imperative to implement appropriate interventions promptly to prevent the beginning of myopia or to slow myopia progression. Identifying individuals at the pre-myopia stage can more accurately pinpoint the precursor phase of myopia development, thereby facilitating targeted and timely interventions. Pre-myopia is defined as a refractive state between >-0.50 D and ≤ + 0.75 D in children. When combined with risk factors such as baseline refraction, age, and other quantifiable measures, this profile indicates a high enough risk of future myopia to warrant preventative interventions.[ 8 ] Moreover, both refraction and AL progress more rapidly in premyopic children, with the rate of change decelerating following myopia onset.[ 9 – 10 ] Currently, clinical options for myopia prevention remain limited, including outdoor exposure,[ 11 – 13 ] low-concentration atropine eye drops,[ 14 – 16 ] repeated low-level red-light therapy (RLRL),[ 17 ] and auricular acupressure (AA).[ 18 ] However, each of these interventions has its own limitations and drawbacks. The adverse events of low-concentration atropine reported included photophobia, allergic conjunctivitis, and near-blurred vision.[ 4 , 19 , 20 ] RLRL therapy produced adverse effects on the fundus, encompassing retinal damage, a reduction in paracentral foveal cone density, and other subtle retinal abnormalities.[ 21 – 22 ] The potential adverse events of AA may include allergies, infections, subcutaneous hematomas, bleeding, and so forth.[ 18 ] As an optical intervention for myopia control, HAL lenses utilize peripheral retinal defocus and are widely used in clinical practice due to their high safety, non-invasiveness, convenience, and effectiveness in controlling myopia progression. Clinical studies demonstrated that compared to those wearing single-vision spectacle lenses (SVL), myopic participants wearing HAL spectacles had a reductions in axial elongation of 51% to 64% and SER of 55% to 67%.[ 23 ] To date, there are reports in the literature on the effectiveness of HAL in children without myopia, including low-hyperopic and premyopic children. Zhang et al.[ 24 ] found that the children with low-hyperopia who wore plano HAL lenses for > 30 hours/week had significantly slower AL elongation compared with those wearing SVL. Wang et al.[ 25 ] reported that plano HAL lenses exhibit efficacy in slowing the progression of AL and SER among non-myopic 4- to 9-year-old children, but there was no control group and no cycloplegic refraction. This clinical study aims to evaluate the effects of spectacle lenses with HAL on axial elongation, refractive change, and accommodative and binocular function in pre-myopic ( ≤ + 0.75 D and > − 0.50 D) Chinese children. Material and methods Study design This is a retrospective cohort study, which was carried out in the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, from December 2022 to December 2024. This study adhered to the tenets of the Declaration of Helsinki. Ethics approval for this study was obtained from the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. For all participants, one parent or legal guardian signed a written informed consent. Participants and their parents were instructed on the purpose of wearing spetacles and the importance of consistent wear. Participants, inclusion and exclusion criteria Participants aged 6–16 years had initial cycloplegic SER ranging from > − 0.50 D and ≤ + 0.75 D, astigmatism ≤ 1.50 D in both eyes, uncorrected visual acuity (UCVA) of 20/20 or better, and anisometropia ≤ 1.50 D. The study included 66 children who completed the 6-month follow-up. The participants were divided into two groups based on the correction methods: the HAL group (n = 32) and the Control group (n = 34). Participants in the HAL group were provided with the plano HAL spectacle lenses (Essilor Co., Ltd, Paris, France) with a compliance of at least 5 days per week and a mean daily wear time of no less than 8 hours. Participants in the Control group received no correction (shown in Fig. 1 ). All study subjects were right-eye dominant. The exclusion criteria included (1) children with systemic or ocular diseases and (2) prior use of any pharmacological or optical interventions for myopia control before recruitment. Refraction Objective refraction was performed at baseline under cycloplegia (0.5% compound tropicamide eye drops, Shenyang Xingqi Pharmaceutical Co., Ltd) using an autorefractor (ARK-1, Nidek, Japan). Subjective refraction and visual function were performed using a phoropter (RT-600, Nidek, Japan) at both baseline and the 6-month follow-up visit. The spherical refractive power plus half of the cylindrical refractive power was the definition of SER. Axial Length The axial length was assessed using the IOL Master 500 (Carl Zeiss, Germany), with at least five measurements per eye, and the average value was calculated for analysis. AL measurement was done without cycloplegia. Visual function parameters measured The following tests were administered at both baseline and the 6-month follow-up visit. The distance and near ocular alignment was assessed using the Von Graefe technique on a phoropter. The accommodative convergence/accommodation (AC/A) ratio was determined through the gradient method by assessing ocular alignment through a phoropter with a + 1.00 D lens at a distance of 40 cm with a phoropter. The distance Worth-4-dot was measured with a phoropter. Negative/positive relative accommodation (NRA and PRA) was measured with a phoropter, and the lenses were adjusted in + 0.25 D/-0.25 D steps gradually until the children reported the first slight sustained blur. The accommodative response test was measured using binocular cross cylinder (BCC) with a phoropter, and the lenses were adjusted in + 0.25 D/-0.25 D steps gradually until the children reported that the vertical and horizontal lines appeared equally clear. Statistical Analysis All statistical analyses were performed using SPSS, version 25.0. Changes of parameters were defined by the difference between the baseline and the corresponding 6-month follow-up visit. All continuous variables were tested for normal distribution using the Shapiro-Wilk test. Normally distributed data were displayed as mean ± standard deviation (SD) and compared using t-tests, while non-normally distributed variables were shown as median (P25, P75) and compared using the Wilcoxon test. Categorical variables were compared using the χ² test. P < 0.05 was considered statistically significant. Results 3.1 Baseline biometrics The two groups showed no significant differences in the baseline biometrics, including gender, age, SER, and AL (shown in Table 1 ). Table 1 Baseline biometrics of the pre-myopic children in Control and HAL group Control group (N = 34) HAL group (N = 32) χ 2 /Z/t Value P value Gender (Male/Female) 14/20 15/17 0.217 0.641 Age 9.00(8.00,11.00) 10.00(9.00,11.00) −0.728 0.467 SER 0.00 (−0.25,0.28) 0.00 (−0.25,0.00) −1.715 0.086 AL 23.25 ± 0.87mm 23.52 ± 0.76mm 1.329 0.189 3.2 AL and SER Changes After 6 months, the AL in the Control and HAL groups was 23.47 ± 0.79 mm and 23.62 ± 0.72 mm, respectively, and no significant differences in axial length were observed between the two groups ( t =-0.812, P = 0.420); the SER in the Control and HAL groups was 0.00 (−0.25,0.00) D and−0.13 (−0.25,0.00) D, respectively, and there were no significant differences in refraction between the two groups (Z=-0.316, P = 0.752). (shown in Table 2 , Fig. 2 ) Table 2 The 6-month AL and SER between the Control and HAL group Control group (N = 34) HAL group (N = 32) t/Z Value P value AL 23.47 ± 0.79 mm 23.62 ± 0.72 mm -0.812 0.420 SER 0.00 (−0.25,0.00) D −0.13 (−0.25,0.00) D -0.316 0.752 The 6-month AL elongation was 0.14 (0.06, 0.27) mm in the Control group and 0.04 (0.00, 0.11) mm in the HAL group, respectively. The significant differences in 6-month AL elongation were observed between the two groups (Z=-2.736, P = 0.006). The 6-month changes in SER were − 0.06 (-0.25, 0.00) D and 0.00 (0.00 0.00) D in the Control and HAL groups, respectively. There were no significant differences in 6-month SER changes between the two groups (Z=-1.499, P = 0.134). (shown in Table 3 , Fig. 3 ). Table 3 The 6-month AL elongation and SER changes between the Control and HAL group Group Control group HAL group Median difference and 95% Confidence Interval Wilcoxon Z Value P Value AL elongation 0.14(0.06, 0.27) 0.04(0.00, 0.11) 0.08 (0.02, 0.15) -2.74 0.006* SER changes -0.06(-0.25, 0.00) 0.00(0.00 0.00) −0.06 (−0.25, 0.00) 1.50 0.134 The study[ 26 ] found that an annual axial length change threshold of 0.20 mm in one year could distinguish progressive from non-progressive status, demonstrating that an annual axial elongation of less than 0.20 mm can be considered the boundary for a safe axial growth range in children aged 6 to 10 years. Based on the study, the 6-month AL elongation was categorized into three risk levels: low risk (AL elongation ≤ 0.10 mm), medium risk (AL elongation 0.10–0.20 mm), and high risk (AL elongation ≥ 0.20 mm).[ 26 ] In the Control group, low risk accounted for 44.1%, medium risk 23.5%, and high risk 32.4%. However, in the HAL group, low risk accounted for 75.0%, medium risk 6.3%, and high risk 18.8%. There were significant differences between the two groups (χ 2 =7.383, P = 0.025). (Table 4 , Fig. 4 ). Table 4 The 6-month AL elongation in three risk levels between the Control and HAL group Group N Low risk ≤ 0.10 mm Medium risk 0.10–0.20 mm High risk ≥ 0.20 mm Adjusted χ 2 test Adjusted χ 2 Value P Value Control group 34 15(44.1%) 8(23.5%) 11(32.4%) 7.383 0.025* HAL group 32 24(75.0%) 2(6.3%) 6(18.8%) N ≥ 40. 1 cells have expected count less than 5. Adjusted χ 2 test. 3.3 Changes in accommodative or binocular function No significant changes in distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, NRA, and PRA were observed between the baseline and 6-month assessment in either the Control or HAL group (all P >0.05). (Table 5 ). Table 5 Comparison of accommodative or binocular function before and after 6 months in the Control and HAL Group Accommodative or binocular function Group Before After 6 months Z Value P value Distance phoria Control −1.00 (−2.25, 0.00) −1.00(−3.00, 0.00) −0.165 0.869 HAL −1.00(−2.00, 0.00) −1.00(−1.88, 0.00) −1.063 0.288 Near phoria Control −3.00 (−6.00,−1.00) −3.00(−6.25,−1.00) −1.363 0.173 HAL −3.00(−4.75,−1.00) −3.00(−5.00,−1.25) −0.571 0.568 AC/A ratio Control 3.00(3.00, 4.00) 3.00(3.00, 4.00) −0.975 0.329 HAL 3.00(3.00, 3.00) 3.00(3.00, 3.00) −1.510 0.131 BCC Control 0.00 (−0.06, 0.00) 0.00 (0.00, 0.06) −0.360 0.719 HAL 0.00 (0.00, 0.25) 0.00 (0.00, 0.25) −0.442 0.659 Distance Worth−4 dot Control 4.00 (4.00, 4.00) 4.00 (4.00, 4.00) −0.577 0.564 HAL 4.00 (4.00, 4.00) 4.00 (4.00, 4.00) −1.414 0.157 NRA Control 1.75 (1.50, 2.25) 2.25 (1.50, 2.25) −0.861 0.389 HAL 2.00 (1.75, 2.44) 2.00 (1.50, 2.25) −1.933 0.053 PRA Control −2.50 (−3.00,−1.69) −2.50 (−3.00,−1.50) −0.266 0.790 HAL −2.25 (−3.00,−1.50) −2.50 (−3.00,−2.00) −1.306 0.192 No significant differences were observed between the Control and HAL groups in the 6-month changes for the following parameters: distance and near phoria, AC/A ratio, BCC, distance Worth-4-dot, and PRA (all P >0.05), with the exception of NRA (Z=-2.142, P = 0.032). (shown in Table 6 ). Table 6 Comparison of changes in accommodative or binocular function over a 6-month period between the Control and HAL Group Visual function Group 6-month Difference changes Median difference and 95% Confidence Interval Wilcoxon Z Value P Value Distance phoria Control 0.00 (−1.00,1.00) 0.00 (−1.00, 1.00) -0.375 0.708 HAL 0.00 (−0.88, 1.00) Near phoria Control 0.00 (−1.25, 0.00) 0.00 (−1.00, 1.00) -0.315 0.753 HAL 0.00 (−1.75, 0.75) AC/A Control 0.00 (0.00, 0.00) 0.00 (0.00, 0.00) -0.660 0.509 HAL 0.00 (0.00, 0.00) BCC Control 0.00 (0.00, 0.06) 0.00 (0.00, 0.00) -0.554 0.580 HAL 0.00 (−0.19, 0.00) Worth−4 dot Control 0.00 (0.00, 0.00) 0.00 (0.00, 0.00) -0.476 0.634 HAL 0.00 (0.00, 0.00) NRA Control 0.00 (−0.06, 0.50) 0.25 (0.00, 0.50) -2.142 0.032* HAL −0.13 (−0.50, 0.25) PRA Control 0.00 (−0.75, 0.50) 0.25 (−0.25, 0.7) -0.851 0.395 HAL 0.00 (−0.94, 0.25) Discussion This study provides a preliminary exploration of the preventive application of HAL spectacle lenses in pre-myopic children (-0.50<SER ≤ + 0.75) in slowing AL elongation, refractive changes, and visual function changes. Our findings suggest that over a 6-month period, HAL spectacles slowed AL elongation in pre-myopic children with minimal impact on accommodative and binocular function, except for a measured change in NRA. Comparison with other clinical interventions for pre-myopia Current research on clinical interventions for pre-myopia primarily focuses on low-concentration atropine and RLRL. Among these, 0.01% atropine eye drops have been demonstrated to effectively slow AL elongation in pre-myopic children aged 4–12 years over a two-year period, compared to a control group (1 year: 0.12 ± 0.1 mm vs 0.21 ± 0.2 mm, − 0.31 ± 0.3 D vs − 0.76 ± 0.4 D, respectively; 2 years: 0.21 ± 0.2 mm vs 0.48 ± 0.2 mm, − 0.60 ± 0.3 D vs − 1.75 ± 0.4 D, respectively).[ 15 ] However, the LAMP2 study reported no significant difference between 0.01% atropine and placebo.[ 27 ] In contrast, 0.05% atropine significantly reduced the incidence of myopia (28.4%) compared to placebo (53.0%) and 0.01% atropine (45.9%) over two years in pre-myopic children aged 4–9 years. Currently, RLRL is also being investigated in pre-myopia intervention studies. In a one-year study conducted by He et al.[ 17 ] with pre-myopic children aged 6–11 years, RLRL treatment significantly reduced the incidence of myopia (40.8% vs. 61.3%), axial elongation (0.30 mm vs. 0.47 mm), and myopic refractive shift (-0.35 D vs. -0.76 D) compared to the control group. Xiang et al.[ 28 ] found that repeated RLRL intervention significantly increased choroidal thickness in pre-myopic children aged 6–10 years, especially at the subfoveal sector. The possible efficacy may be related to altered scleral collagen crosslinking and increased choroidal thickness, but the specific mechanism of RLRL therapy remains unclear.[ 29 – 30 ] Nevertheless, a case report suggested that RLRL therapy may cause retinal damage.[ 21 ] Moreover, the latest research has found that RLRL may reduce cone density within 0.5 mm of the foveal center's eccentricity, particularly in the 0.3-mm temporal eccentricity.[ 22 ] Additionally, the RLRL group showed a higher incidence of abnormal signals near the fovea, and one participant developed retinal changes that improved after discontinuing RLRL treatment.[ 22 ] These findings suggest potential risks associated with RLRL therapy, which needs further investigation to explore its long-term safety and efficacy. In our study, plano HAL spectacle lenses were effective in preventing the axial elongation in pre-myopic children aged 6–16 years, over the 6-month period relative to the control group (6 months: 0.04 [0.00, 0.11] mm vs 0.14 [0.06, 0.27] mm, respectively). When compared to 0.01% atropine and RLRL therapy, plano HAL spectacle lenses demonstrate a superior effect in controlling AL elongation in pre-myopic children, with a reduction of approximately 0.20 mm per year (0.10 mm/6 months). This compares to reported annual AL reductions of 0.09 mm for 0.01% atropine[ 15 ] and 0.17 mm for RLRL[ 17 ]. Additionally, HAL spectacle lenses offer greater convenience and a favorable safety profile in clinical practice. However, several critical differences across studies warrant emphasis: (1) The definition of pre-myopia: pre-myopia was defined as SER ≤ + 1.00 D with an annual myopic progression > 0.50 D at least for the past two years,[ 15 ] 0.00D ≤ SER ≤ + 1.00 D,[ 27 ] and − 0.50 ≤ SER ≤ + 0.50 D in the more myopic eye plus at least 1 parent with SER ≤ − 3.00 D,[ 17 ] respectively. In contrast, our study adopted the standardized IMI consensus definition of -0.50 D < SER ≤ + 0.75 D.[ 8 ] (2) Age distribution: Previous studies primarily enrolled children, with age ranges of 4–12 years,[ 15 ] 4–9 years,[ 27 ] and 6–11 years,[ 17 ] respectively. In contrast, our study investigated an older and broader cohort (6–16 years), which has different ocular development characteristics. (3) Follow-up duration: the intervention periods in prior trials ranged from 1 to 2 years.[ 15 , 17 , 27 ] Our preliminary findings, based on a shorter 6-month observation period, therefore require confirmation through long-term investigation. Design principle and efficacy of HAL spectacle lenses HAL spectacle lenses incorporate Highly Aspherical Lenslet Target technology, which utilizes concentric rings of aspheric microlenses containing a higher level of positive power to focus a subset of incident light rays anterior to the retina to minimize peripheral hyperopic defocus. Clinical studies have demonstrated that the participants with myopia wearing HAL spectacle lenses experienced a 51%-64% reduction in axial elongation and a 55%-67% reduction in SER progression compared with those wearing SVL.[ 23 , 31 ] Preliminary research is now exploring the application of HAL spectacles in children with low hyperopia. Zhang et al.[ 24 ] reported that the intervention's efficacy of HAL lenses exhibits a dose-dependent relationship in pre-myopic children. 108 Chinese children (aged 6.0-9.9 years) with SER ranging from 0.00 D and + 2.00 D were randomized into HAL and SVL groups. After one year, the changes in SER were − 0.19 D and − 0.23 D, while AL elongation was 0.24 mm and 0.19 mm in the SVL and HAL group, respectively. None of these differences were statistically significant, a finding that appears inconsistent with the outcomes of the present study. However, AL and SER changes in the HAL group were significantly associated with the wear time of the spectacles. Low hyperopic children wearing HAL lenses for > 30 hours/week had significantly slower axial elongation (0.11 mm vs. 0.27 mm), which corresponds to a 59% reduction compared to the SVL group. Our findings are basically consistent with these results (6-month AL elongation: 0.04 mm vs 0.14 mm, respectively), and the participants in our study were required to wear HAL spectacles for at least 5 days per week and a mean daily wear time of no less than 8 hours. Additionally, a recent study found that plano HAL lenses effectively slow AL and SER progression in children without myopia (aged 4–9 years; non-cycloplegic SER: -0.50 to + 0.75 D). The annual rate of AL elongation was reduced by 0.31 mm (from 0.44 mm pre-treatment to 0.13 mm post-treatment), while SER progression was slowed by 0.42 D (from − 0.28 D/year to + 0.14 D/year).[ 25 ] However, this study did not perform cycloplegia, which led to SER measurements being inaccurate and hindered accurate assessment of the children's refractive status (pre-myopic, emmetropic, or hyperopic). Furthermore, non-cycloplegic SER measurements may introduce inaccuracies in assessing SER progression. More importantly, the absence of a control group and reliance on before-after treatment comparisons could compromise result validity.[ 25 ] Our study utilized cycloplegic refraction for baseline measurements in pre-myopic children and included a control group. The effects of HAL spectacle lenses on accommodative and binocular function There are several studies that have examined the impacts of HAL spectacles on visual function, including visual acuity, contrast sensitivity, accommodation, and binocular vision. The study by Huang et al.[ 32 ] revealed that HAL had no significant effects on accommodative function and near phoria, with the exception of larger microfluctuations than SVL. Although short-term HAL use initially reduced VA (including scotopic and low-contrast VA), these values normalized to the level of the SVL group after 12 months. Gao et al.[ 33 ] revealed low contrast VA and reading were slightly decreased, but high contrast VA was unaffected when fixating through the periphery of HAL designs in adults. The new lens designs had no effect on any of the peripheral measurements of vision. Fengchao et al.[ 34 ] found HAL lenses had no significant influence on binocular visual or accommodative function in children with myopia who may or may not have intermittent exotropia, except the short-term accommodative microfluctuation. The current study demonstrates that after 6 months, HAL lenses have no significant effect on accommodation and binocular function, including distance and near phoria, AC/A ratio, BCC, Worth 4-dot, and PRA. This outcome is in alignment with prior research, with the exception of the NRA. Our study revealed a statistically significant ( P = 0.032) but clinically slight reduction (-0.13 D) in NRA in the HAL group, potentially attributable to the optical characteristics of aspherical lenslets affecting accommodative microfluctuations or behavioral adaptation, because the subjects naturally adjust their visual behavior to reduce blur effects caused by the lenslets during near-vision tasks. However, the relatively short follow-up period in our study limits the ability to determine whether these effects represent transient adaptations or persistent changes, which need long-term further investigation. Limitations Our study has several limitations that should be acknowledged. First, the relatively small sample size might compromise the statistical power of the analyses and limit the broad application of the findings. Future research should employ larger cohorts to validate and extend these results. Second, the retrospective cohort design of this study is subject to potential selection bias and information bias due to reliance on pre-existing data. Future prospective studies would strengthen the reliability of findings. Third, the 6-month observation period of this study may be insufficient to fully evaluate the long-term efficacy of the plano HAL spectacle lens in pre-myopia control. Future longitudinal studies with extended follow-up durations are warranted to assess the sustained effects. Finally, at the 6-month follow-up, non-cycloplegic subjective refraction via a phoropter with adequate fogging was prioritized for its clinical practicality, better patient acceptance, and non-invasive nature. We acknowledge that it may introduce some inaccuracy in SER measurements and progression analysis, but AL changes provide a reliable assessment of slowing myopia progression. This may explain why the significant AL reduction occurred without a corresponding SER change. In conclusion, large-scale, multicenter randomized controlled trials are warranted to further investigate this issue and achieve a more comprehensive understanding. Conclusions In conclusion, our study showed that HAL spectacles have a significant control effect on the AL elongation in pre-myopic children (aged 6–16 years) with minimal impact on accommodative and binocular function (distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, and PRA), except for a measured change in NRA, over a 6-month period. HAL spectacles could be a viable strategy and effective method for preventing myopia onset in clinical practice. List of abbreviations HAL Highly aspherical lenslets SER Spherical equivalent refractive error AL Axial length AC/A Accommodative convergence/accommodation BCC Binocular cross cylinder NRA Negative relative accommodation PRA Positive relative accommodation RLRL Repeated low-level red-light therapy AA Auricular acupressure Declarations Ethics approval and consent to participate This study adhered to the tenets of the Declaration of Helsinki. Ethics approval for this study was obtained from the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. For all participants, one parent or legal guardian signed a written informed consent. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Funding This work was supported by Shandong Medical Staff Scientific and Technological Innovation Plan Project (SDYWZGKCJH2024012), Shandong Medical and Health Science and Technology Development Plan Project (202107020913), Shandong Province Traditional Chinese Medicine Science & Technology Project (Z20242006). Author Contribution HB and WS led the overall study, contributed to the research design, and made critical revisions of the manuscript. MD, TL, and XW contributed to the data collection, data analysis, and manuscript edits. YH, YW, and GL collected the clinical data and processed statistical data. All authors read, contributed to the research design, and approved the final manuscript. Acknowledgement The authors thank the colleagues from the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine who made the study possible. Data Availability The datasets used and analysed during the current study are available from the corresponding author on reasonable request. References Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036–42. Guo Y, Duan JL, Liu LJ, Sun Y, Tang P, Lv YY, et al. High myopia in greater Beijing school children in 2016. PLoS ONE. 2017;12(11):e0187396. Guo Y, Sung MS, Park SW. Assessment of superficial retinal microvascular density in healthy myopia. Int Ophthalmol. 2019;39(8):1861–70. Shah R, Vlasak N, Evans BJW. High myopia: Reviews of myopia control strategies and myopia complications. Ophthalmic Physiol Opt. 2024;44(6):1248–60. Hu Y, Ding X, Guo X, Chen Y, Zhang J, He M. Association of Age at Myopia Onset With Risk of High Myopia in Adulthood in a 12-Year Follow-up of a Chinese Cohort. JAMA Ophthalmol. 2020;138(11):1129–34. Wang SK, Guo Y, Liao C, Chen Y, Su G, Zhang G, et al. Incidence of and Factors Associated With Myopia and High Myopia in Chinese Children, Based on Refraction Without Cycloplegia. JAMA Ophthalmol. 2018;136(9):1017–24. Chua SY, Sabanayagam C, Cheung YB, Chia A, Valenzuela RK, Tan D, et al. Age of onset of myopia predicts risk of high myopia in later childhood in myopic Singapore children. Ophthalmic Physiol Opt. 2016;36(4):388–94. Flitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, et al. IMI - Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019;60(3):M20–30. Mutti DO, Hayes JR, Mitchell GL, Jones LA, Moeschberger ML, Cotter SA, et al. Refractive error, axial length, and relative peripheral refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2007;48(6):2510–19. Xiang F, He M, Morgan IG. Annual changes in refractive errors and ocular components before and after the onset of myopia in Chinese children. Ophthalmology. 2012;119(7):1478–84. He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, et al. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015;314(11):1142–8. Jin JX, Hua WJ, Jiang X, Wu XY, Yang JW, Gao GP, et al. Effect of outdoor activity on myopia onset and progression in school-aged children in northeast China: the Sujiatun Eye Care Study. BMC Ophthalmol. 2015;15:73. Wu PC, Chen CT, Lin KK, Sun CC, Kuo CN, Huang HM, et al. Myopia prevention and outdoor light intensity in a school-based cluster randomized trial. Ophthalmology. 2018;125(8):1239–50. Wang W, Zhang F, Yu S, Ma N, Huang C, Wang M, et al. Prevention of myopia shift and myopia onset using 0.01% atropine in premyopic children - a prospective, randomized, double-masked, and crossover trial. Eur J Pediatr. 2023;182(6):2597–606. Jethani J. Efficacy of low-concentration atropine (0.01%) eye drops for prevention of axial myopic progression in premyopes. Indian J Ophthalmol. 2022;70(1):238–40. Fang PC, Chung MY, Yu HJ, Wu PC. Prevention of myopia onset with 0.025% atropine in premyopic children. J Ocul Pharmacol Ther. 2010;26(4):341–5. He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, et al. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(4):e239612. Wang J, Shi Y, Yan X, Wu X, Cao K, Chen L. Evaluation of Auricular Acupressure on Myopia Prevention among Children Aged 6–12 Years with Pre-Myopia in China: Study Protocol of a Prospective Multi-Center Randomized Controlled Trial. Complement Med Res. 2025;32(1):3–12. Gong Q, Janowski M, Luo M, Wei H, Chen B, Yang G, et al. Efficacy and Adverse Effects of Atropine in Childhood Myopia: A Meta-analysis. JAMA Ophthalmol. 2017;135(6):624–30. Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, et al. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012;119(2):347–54. Liu H, Yang Y, Guo J, et al. Retinal Damage After Repeated Low-level Red-Light Laser Exposure. JAMA Ophthalmol. 2023;141(7):693–5. Liu H, Yang Y, Guo J, Peng J, Zhao P. Cone Density Changes After Repeated Low-Level Red Light Treatment in Children With Myopia. JAMA Ophthalmol. 2025;143(6):480–8. Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, et al. Spectacle lenses with aspherical lenslets for myopia control vs single-vision spectacle lenses: a randomized clinical trial. JAMA Ophthalmol. 2022;140(5):472–8. Zhang Z, Zeng L, Gu D, Wang B, Kang P, Watt K, et al. Spectacle Lenses With Highly Aspherical Lenslets for Slowing Axial Elongation and Refractive Change in Low-Hyperopic Chinese Children: A Randomized Controlled Trial. Am J Ophthalmol. 2025;269:60–8. Wang L, Wong YL, Drobe B, Wang X. Effectiveness of spectacle lenses with highly aspherical lenslets in slowing axial elongation among non-myopic children. Clin Exp Optom. 2025; 1–7. Chen J, Liu S, Zhu Z, Bulloch G, Naduvilath T, Wang J, et al. Axial length changes in progressive and non-progressive myopic children in China. Graefes Arch Clin Exp Ophthalmol. 2023;261(5):1493–501. Yam JC, Zhang XJ, Zhang Y, Yip BHK, Tang F, Wong ES, et al. Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial. JAMA. 2023;329(6):472–81. Xiang K, Wang J, Zhu Z, Zhang X, Zhang B, Chen J, et al. Changes in choroidal thickness in pre-myopic children after repeated low-level red-light therapy and their role in predicting myopia prevention and controlling myopic shift. Asia Pac J Ophthalmol (Phila). 2025;14(2):100115. Metlapally R, Wildsoet CF. Scleral Mechanisms Underlying Ocular Growth and Myopia. Prog Mol Biol Transl Sci. 2015;134:241–8. Wu H, Chen W, Zhao F, Zhou Q, Reinach PS, Deng L, et al. Scleral hypoxia is a target for myopia control. Proc Natl Acad Sci U S A. 2018;115(30):E7091–100. Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, et al. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022;106(8):1171–6. Huang Y, Li X, Wang C, Zhou F, Yang A, Chen H, et al. Visual acuity, near phoria and accommodation in myopic children using spectacle lenses with aspherical lenslets: results from a randomized clinical trial. Eye Vis (Lond). 2022;9(1):33. Gao Y, Lim EW, Yang A, Drobe B, Bullimore MA. The impact of spectacle lenses for myopia control on visual functions. Ophthalmic Physiol Opt. 2021;41(6):1320–31. Fengchao Z, Xue L, Yingying H, Yuhao L, Jiali Z, Hao C et al. Effect of Spectacle Lenses with Highly Aspherical Lenslets on Binocular Vision and Accommodation in Myopic Children with and without Intermittent Exotropia. J Ophthalmol. 2022:9306848. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8199611","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":565032944,"identity":"7a1e59ee-b71a-4659-adea-820ba66dc9d0","order_by":0,"name":"Meihua Ding","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Meihua","middleName":"","lastName":"Ding","suffix":""},{"id":565032946,"identity":"411da5ce-44fd-4cc0-b921-439fe2adacbc","order_by":1,"name":"Tailiang Lu","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Tailiang","middleName":"","lastName":"Lu","suffix":""},{"id":565032949,"identity":"92fa969f-2eba-45a9-81e9-1c388c1ba562","order_by":2,"name":"Xin Wang","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Xin","middleName":"","lastName":"Wang","suffix":""},{"id":565032950,"identity":"cd8b5897-6b05-4307-b8f4-65057d25dbd9","order_by":3,"name":"Yuanyuan Hu","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yuanyuan","middleName":"","lastName":"Hu","suffix":""},{"id":565032954,"identity":"5c40b142-33e0-410f-bbad-b2a4b550d686","order_by":4,"name":"Yirong Wang","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yirong","middleName":"","lastName":"Wang","suffix":""},{"id":565032957,"identity":"c51b7efe-8e9e-4346-a37a-00350a478fd1","order_by":5,"name":"Guoping Li","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Guoping","middleName":"","lastName":"Li","suffix":""},{"id":565032968,"identity":"2ae21b42-b461-4006-b4e5-f36578a7b04b","order_by":6,"name":"Wei Sun","email":"","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Wei","middleName":"","lastName":"Sun","suffix":""},{"id":565032972,"identity":"91f235c5-2dcc-4d89-93e5-3e0ab7b3ebd9","order_by":7,"name":"Hongsheng Bi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA40lEQVRIiWNgGAWjYBACAxDB2AAkJBgbDnwwsLEjSUvjwRkFacmkaGFgPszz4RCYjReYs/cefvlzh02efHRzw2EbgwPMDOyHj27Ap8Wy51yaNe+ZtGLDOwcbDucY3OFj4ElLu4HXYTdyzIwZ2w4nbpyRCNLyjJlBgseMoBbDn23/IVosDA4zNhChxfgBb9uBxPkSQC0MRGk5c8aMmbctOXGDzMGGgz0GaclsBP1yvMf44882u8T5s9sff/jxx8aOn/3wMbxagIBNAqz3AIxLQDkIMH8AkfINRCgdBaNgFIyCkQkAjyFWL9O+ykoAAAAASUVORK5CYII=","orcid":"","institution":"Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine","correspondingAuthor":true,"prefix":"","firstName":"Hongsheng","middleName":"","lastName":"Bi","suffix":""}],"badges":[],"createdAt":"2025-11-25 06:38:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8199611/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8199611/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":99222701,"identity":"3dc702dc-bedf-4c0d-8889-5af8223d1cf8","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":1164159,"visible":true,"origin":"","legend":"","description":"","filename":"2025.12.03EffectsofSpectaclelenseswithhighlyasphericallensletsonaxialelongationrefractivechangeandvisualfunctioninpremyopicChinesechildren.docx","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/60fff738fef31d69b750159f.docx"},{"id":99222704,"identity":"c22a8741-33c1-4ceb-8311-912fc17b13ba","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"json","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":9407,"visible":true,"origin":"","legend":"","description":"","filename":"2aed5b642cfc41ff8de8c5fdf91efdf8.json","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/1683a24d2414bd8ece792d43.json"},{"id":99222707,"identity":"7fc8e0ef-19c0-4e8e-9a4f-16d7f58ad2fd","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":118447,"visible":true,"origin":"","legend":"","description":"","filename":"2aed5b642cfc41ff8de8c5fdf91efdf81enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/c7b5eaf67a524614acff4d7c.xml"},{"id":99318776,"identity":"c0fb434b-8fb4-42ba-b71b-3bf77de83182","added_by":"auto","created_at":"2025-12-31 16:34:41","extension":"jpeg","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":502553,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/e89c29d3b230b4c4a11dcf2f.jpeg"},{"id":99320255,"identity":"d075d983-d7f3-4fe0-85ba-27e581f13ef9","added_by":"auto","created_at":"2025-12-31 16:38:25","extension":"jpeg","order_by":5,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":128102,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/0fbd0358d0deaf0209b682e8.jpeg"},{"id":99317445,"identity":"00446608-62a7-436a-b77c-ee589e444f85","added_by":"auto","created_at":"2025-12-31 16:30:14","extension":"jpeg","order_by":6,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":39118,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/fce2b932d20703a6f5281f33.jpeg"},{"id":99320243,"identity":"fda49eff-3cbc-49fd-a7d4-d761472b3d91","added_by":"auto","created_at":"2025-12-31 16:38:25","extension":"jpeg","order_by":7,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":116724,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage4.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/ea6ab263e98f585316e81fa9.jpeg"},{"id":99317541,"identity":"d664b2fc-321e-4af0-8df2-4667124abd2a","added_by":"auto","created_at":"2025-12-31 16:30:20","extension":"jpeg","order_by":8,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":1074,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage5.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/83b74d279f92eeaddcd670ea.jpeg"},{"id":99222712,"identity":"3aeb66ad-dbf0-4499-b5e7-3157e0fac65a","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"jpeg","order_by":9,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":264907,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage6.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/3ea7553d2515840f387cd1a0.jpeg"},{"id":99222710,"identity":"e2b62cc9-ea3a-4dc5-a845-7fbc82eb5139","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"jpeg","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":206004,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage7.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/ac4063af6d2e68ce6094b94d.jpeg"},{"id":99318697,"identity":"1d6ab742-245f-4f13-9463-56d1dcbc3006","added_by":"auto","created_at":"2025-12-31 16:34:01","extension":"jpeg","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":250914,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage8.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/4601728e69d7c83cded1253f.jpeg"},{"id":99320252,"identity":"76f2ceef-b27e-4cff-a352-60d3120722a8","added_by":"auto","created_at":"2025-12-31 16:38:25","extension":"png","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":102019,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/fee3c78581f5148c2eafa057.png"},{"id":99222716,"identity":"3984d6c4-e977-4bea-9826-1dd401877b1d","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"png","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":27200,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/064805e236b8a5da43887542.png"},{"id":99222723,"identity":"6024cfb4-372c-4bf4-922a-a7302366e737","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"png","order_by":14,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":8582,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/59d84a495714a3c2e6b91fbd.png"},{"id":99318449,"identity":"3b7e7f01-af03-49ea-a14f-f3079a795837","added_by":"auto","created_at":"2025-12-31 16:33:13","extension":"png","order_by":15,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":24061,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/8fc1cc561d5a9ac12d613d06.png"},{"id":99222721,"identity":"3b1b8f99-8a69-40c7-834a-f831e1b44975","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"png","order_by":16,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":935,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage5.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/8837f3068b1d9e92683db613.png"},{"id":99318954,"identity":"ca068593-5edd-43dc-884f-49f922c3aaba","added_by":"auto","created_at":"2025-12-31 16:35:48","extension":"png","order_by":17,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":45582,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage6.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/b5480444f947aaefe0d439b8.png"},{"id":99320260,"identity":"f8411955-f2e7-4ee0-b676-11d6d4d35086","added_by":"auto","created_at":"2025-12-31 16:38:25","extension":"png","order_by":18,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":38185,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage7.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/a78c2f9c95e32dec9c578f55.png"},{"id":99222718,"identity":"f20ade47-9564-468a-9af9-23af328a4be0","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"png","order_by":19,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":46757,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage8.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/968077f38461d5e64e09352f.png"},{"id":99222719,"identity":"4ced3511-8072-4a45-b757-aacb4d55f896","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"xml","order_by":20,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":116656,"visible":true,"origin":"","legend":"","description":"","filename":"2aed5b642cfc41ff8de8c5fdf91efdf81structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/e7a8ef92c6b01419cb1b37c4.xml"},{"id":99222720,"identity":"9a83c0d2-3b8e-4807-a3c9-2b41e131c637","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"html","order_by":21,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":129471,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/5e6a9a381c105ee2b8d3473e.html"},{"id":99222698,"identity":"74805be3-0fbf-49c1-9c11-463cc588ddc9","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":75850,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlowchart of the Study Design\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/71e000d60cfcfcf52df4b05c.png"},{"id":99318714,"identity":"5b1697f7-8c8f-4547-b72c-7fb94f21cd65","added_by":"auto","created_at":"2025-12-31 16:34:01","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":90537,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe AL and SER at baseline and 6-month follow-up visit between the Control and HAL group\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/824f6863e5542de1367731c5.png"},{"id":99222702,"identity":"6da8ab71-a128-41f8-860d-77981129a565","added_by":"auto","created_at":"2025-12-30 09:56:44","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":76792,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe 6-month AL elongation and SER changes between the Control and HAL group\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/a43a5bab33a1a6be13f47c47.png"},{"id":99318952,"identity":"aee4fad6-475e-4d51-af6f-37f836e15396","added_by":"auto","created_at":"2025-12-31 16:35:48","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":92131,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe 6-month AL elongation in three risk levels between the Control and HAL group\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/7b9870716cf186a3aa1af922.png"},{"id":100741743,"identity":"876dd545-7c62-426e-b3de-3765fed57c87","added_by":"auto","created_at":"2026-01-21 01:58:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1418205,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8199611/v1/f112273b-5ddb-4a52-b976-d3f4e23118f3.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effects of Spectacle lenses with highly aspherical lenslets on axial elongation, refractive change and visual function in pre-myopic Chinese children: a retrospective cohort study","fulltext":[{"header":"Background","content":"\u003cp\u003eMyopia ranks among the most prevalent eye conditions globally and presents a significant public health concern. In 2000, there were 1.41\u0026nbsp;billion people worldwide with myopia, and among them, 160\u0026nbsp;million had high myopia. This figure is expected to dramatically increase by 2050, with projections suggesting that up to 4.76\u0026nbsp;billion people will have myopia and 938\u0026nbsp;million will suffer from high myopia.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] The progression of myopia and high myopia can lead to a range of complications, including pathological myopia, cataracts, choroidal atrophy, neovascularization, retinal detachment, posterior staphyloma, myopic macular degeneration, and glaucoma.[\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] All of these are irreversible, blindness-causing eye diseases. Multiple studies have found that early-onset myopia in school-aged children has been linked to a notably elevated risk of developing high myopia.[\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] One of the studies revealed that for children who have myopia beginning at age 7\u0026ndash;8, the rate of high myopia exceeded 50%, while among those aged 9, the rate of high myopia was 30%.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] The likelihood of developing high myopia in adulthood is significantly decreased for every year that the age at onset is delayed. Given the significant public health implications of myopia, it is imperative to implement appropriate interventions promptly to prevent the beginning of myopia or to slow myopia progression. Identifying individuals at the pre-myopia stage can more accurately pinpoint the precursor phase of myopia development, thereby facilitating targeted and timely interventions.\u003c/p\u003e \u003cp\u003ePre-myopia is defined as a refractive state between \u0026gt;-0.50 D and \u0026le;\u0026thinsp;+\u0026thinsp;0.75 D in children. When combined with risk factors such as baseline refraction, age, and other quantifiable measures, this profile indicates a high enough risk of future myopia to warrant preventative interventions.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] Moreover, both refraction and AL progress more rapidly in premyopic children, with the rate of change decelerating following myopia onset.[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] Currently, clinical options for myopia prevention remain limited, including outdoor exposure,[\u003cspan additionalcitationids=\"CR12\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] low-concentration atropine eye drops,[\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] repeated low-level red-light therapy (RLRL),[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] and auricular acupressure (AA).[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] However, each of these interventions has its own limitations and drawbacks. The adverse events of low-concentration atropine reported included photophobia, allergic conjunctivitis, and near-blurred vision.[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] RLRL therapy produced adverse effects on the fundus, encompassing retinal damage, a reduction in paracentral foveal cone density, and other subtle retinal abnormalities.[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] The potential adverse events of AA may include allergies, infections, subcutaneous hematomas, bleeding, and so forth.[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eAs an optical intervention for myopia control, HAL lenses utilize peripheral retinal defocus and are widely used in clinical practice due to their high safety, non-invasiveness, convenience, and effectiveness in controlling myopia progression. Clinical studies demonstrated that compared to those wearing single-vision spectacle lenses (SVL), myopic participants wearing HAL spectacles had a reductions in axial elongation of 51% to 64% and SER of 55% to 67%.[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] To date, there are reports in the literature on the effectiveness of HAL in children without myopia, including low-hyperopic and premyopic children. Zhang et al.[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] found that the children with low-hyperopia who wore plano HAL lenses for \u0026gt;\u0026thinsp;30 hours/week had significantly slower AL elongation compared with those wearing SVL. Wang et al.[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] reported that plano HAL lenses exhibit efficacy in slowing the progression of AL and SER among non-myopic 4- to 9-year-old children, but there was no control group and no cycloplegic refraction. This clinical study aims to evaluate the effects of spectacle lenses with HAL on axial elongation, refractive change, and accommodative and binocular function in pre-myopic (\u0026thinsp;\u0026le;\u0026thinsp;+\u0026thinsp;0.75 D and \u0026gt;\u0026thinsp;\u0026minus;\u0026thinsp;0.50 D) Chinese children.\u003c/p\u003e"},{"header":"Material and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis is a retrospective cohort study, which was carried out in the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, from December 2022 to December 2024. This study adhered to the tenets of the Declaration of Helsinki. Ethics approval for this study was obtained from the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. For all participants, one parent or legal guardian signed a written informed consent. Participants and their parents were instructed on the purpose of wearing spetacles and the importance of consistent wear.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eParticipants, inclusion and exclusion criteria\u003c/h3\u003e\n\u003cp\u003eParticipants aged 6–16 years had initial cycloplegic SER ranging from \u0026gt; − 0.50 D and ≤ + 0.75 D, astigmatism ≤ 1.50 D in both eyes, uncorrected visual acuity (UCVA) of 20/20 or better, and anisometropia ≤ 1.50 D. The study included 66 children who completed the 6-month follow-up. The participants were divided into two groups based on the correction methods: the HAL group (n = 32) and the Control group (n = 34). Participants in the HAL group were provided with the plano HAL spectacle lenses (Essilor Co., Ltd, Paris, France) with a compliance of at least 5 days per week and a mean daily wear time of no less than 8 hours. Participants in the Control group received no correction (shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). All study subjects were right-eye dominant. The exclusion criteria included (1) children with systemic or ocular diseases and (2) prior use of any pharmacological or optical interventions for myopia control before recruitment.\u003c/p\u003e\n\u003ch3\u003eRefraction\u003c/h3\u003e\n\u003cp\u003eObjective refraction was performed at baseline under cycloplegia (0.5% compound tropicamide eye drops, Shenyang Xingqi Pharmaceutical Co., Ltd) using an autorefractor (ARK-1, Nidek, Japan). Subjective refraction and visual function were performed using a phoropter (RT-600, Nidek, Japan) at both baseline and the 6-month follow-up visit. The spherical refractive power plus half of the cylindrical refractive power was the definition of SER.\u003c/p\u003e\n\u003ch3\u003eAxial Length\u003c/h3\u003e\n\u003cp\u003eThe axial length was assessed using the IOL Master 500 (Carl Zeiss, Germany), with at least five measurements per eye, and the average value was calculated for analysis. AL measurement was done without cycloplegia.\u003c/p\u003e\n\u003ch3\u003eVisual function parameters measured\u003c/h3\u003e\n\u003cp\u003eThe following tests were administered at both baseline and the 6-month follow-up visit. The distance and near ocular alignment was assessed using the Von Graefe technique on a phoropter. The accommodative convergence/accommodation (AC/A) ratio was determined through the gradient method by assessing ocular alignment through a phoropter with a + 1.00 D lens at a distance of 40 cm with a phoropter. The distance Worth-4-dot was measured with a phoropter. Negative/positive relative accommodation (NRA and PRA) was measured with a phoropter, and the lenses were adjusted in + 0.25 D/-0.25 D steps gradually until the children reported the first slight sustained blur. The accommodative response test was measured using binocular cross cylinder (BCC) with a phoropter, and the lenses were adjusted in + 0.25 D/-0.25 D steps gradually until the children reported that the vertical and horizontal lines appeared equally clear.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eAll statistical analyses were performed using SPSS, version 25.0. Changes of parameters were defined by the difference between the baseline and the corresponding 6-month follow-up visit. All continuous variables were tested for normal distribution using the Shapiro-Wilk test.\u003c/p\u003e \u003cp\u003eNormally distributed data were displayed as mean ± standard deviation (SD) and compared using t-tests, while non-normally distributed variables were shown as median (P25, P75) and compared using the Wilcoxon test. Categorical variables were compared using the \u003cem\u003eχ²\u003c/em\u003e test. \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e \u003cb\u003e3.1 Baseline biometrics\u003c/b\u003e \u003c/p\u003e\u003cp\u003eThe two groups showed no significant differences in the baseline biometrics, including gender, age, SER, and AL (shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline biometrics of the pre-myopic children in Control and HAL group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl group\u003c/p\u003e \u003cp\u003e(N = 34)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHAL group\u003c/p\u003e \u003cp\u003e(N = 32)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eχ\u003csup\u003e2\u003c/sup\u003e/Z/t Value\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGender (Male/Female)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14/20\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15/17\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.217\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.641\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.00(8.00,11.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.00(9.00,11.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e−0.728\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.467\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSER\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.00 (−0.25,0.28)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.25,0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e−1.715\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.086\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23.25 ± 0.87mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.52 ± 0.76mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.329\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.189\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003e \u003cb\u003e3.2 AL and SER Changes\u003c/b\u003e \u003c/p\u003e\u003cp\u003eAfter 6 months, the AL in the Control and HAL groups was 23.47 ± 0.79 mm and 23.62 ± 0.72 mm, respectively, and no significant differences in axial length were observed between the two groups (\u003cem\u003et\u003c/em\u003e=-0.812, \u003cem\u003eP\u003c/em\u003e = 0.420); the SER in the Control and HAL groups was 0.00 (−0.25,0.00) D and−0.13 (−0.25,0.00) D, respectively, and there were no significant differences in refraction between the two groups (Z=-0.316, \u003cem\u003eP\u003c/em\u003e = 0.752). (shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe 6-month AL and SER between the Control and HAL group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl group\u003c/p\u003e \u003cp\u003e(N = 34)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHAL group\u003c/p\u003e \u003cp\u003e(N = 32)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003et/Z Value\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23.47 ± 0.79 mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.62 ± 0.72 mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.812\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.420\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSER\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.00 (−0.25,0.00) D\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−0.13 (−0.25,0.00) D\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.316\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.752\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003eThe 6-month AL elongation was 0.14 (0.06, 0.27) mm in the Control group and 0.04 (0.00, 0.11) mm in the HAL group, respectively. The significant differences in 6-month AL elongation were observed between the two groups (Z=-2.736, \u003cem\u003eP\u003c/em\u003e = 0.006). The 6-month changes in SER were − 0.06 (-0.25, 0.00) D and 0.00 (0.00 0.00) D in the Control and HAL groups, respectively. There were no significant differences in 6-month SER changes between the two groups (Z=-1.499, \u003cem\u003eP\u003c/em\u003e = 0.134). (shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe 6-month AL elongation and SER changes between the Control and HAL group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eControl group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eHAL group\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eMedian difference and 95% Confidence Interval\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eWilcoxon\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eZ\u003c/em\u003e Value\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e Value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAL elongation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.14(0.06, 0.27)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.04(0.00, 0.11)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.08 (0.02, 0.15)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e-2.74\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.006*\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSER changes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.06(-0.25, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.00(0.00 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e−0.06 (−0.25, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.50\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.134\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003eThe study[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] found that an annual axial length change threshold of 0.20 mm in one year could distinguish progressive from non-progressive status, demonstrating that an annual axial elongation of less than 0.20 mm can be considered the boundary for a safe axial growth range in children aged 6 to 10 years. Based on the study, the 6-month AL elongation was categorized into three risk levels: low risk (AL elongation ≤ 0.10 mm), medium risk (AL elongation 0.10–0.20 mm), and high risk (AL elongation ≥ 0.20 mm).[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] In the Control group, low risk accounted for 44.1%, medium risk 23.5%, and high risk 32.4%. However, in the HAL group, low risk accounted for 75.0%, medium risk 6.3%, and high risk 18.8%. There were significant differences between the two groups (χ\u003csup\u003e2\u003c/sup\u003e=7.383, \u003cem\u003eP\u003c/em\u003e = 0.025). (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe 6-month AL elongation in three risk levels between the Control and HAL group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"7\"\u003e\u003c/colgroup\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eLow risk\u003c/p\u003e \u003cp\u003e≤ 0.10 mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eMedium risk\u003c/p\u003e \u003cp\u003e0.10–0.20 mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eHigh risk\u003c/p\u003e \u003cp\u003e≥ 0.20 mm\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eAdjusted χ\u003csup\u003e2\u003c/sup\u003e test\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eAdjusted \u003cem\u003eχ\u003c/em\u003e\u003csup\u003e\u003cem\u003e2\u003c/em\u003e\u003c/sup\u003e Value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e Value\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eControl group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15(44.1%)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8(23.5%)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11(32.4%)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e7.383\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.025*\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHAL group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24(75.0%)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2(6.3%)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6(18.8%)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003eN ≥ 40. 1 cells have expected count less than 5. Adjusted χ\u003csup\u003e2\u003c/sup\u003e test.\u003c/p\u003e\u003cp\u003e \u003cb\u003e3.3 Changes in accommodative or binocular function\u003c/b\u003e \u003c/p\u003e\u003cp\u003eNo significant changes in distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, NRA, and PRA were observed between the baseline and 6-month assessment in either the Control or HAL group (all \u003cem\u003eP\u003c/em\u003e\u0026gt;0.05). (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of accommodative or binocular function before and after 6 months in the Control and HAL Group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAccommodative or binocular function\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBefore\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAfter 6 months\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eZ Value\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eDistance phoria\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−1.00 (−2.25, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e−1.00(−3.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.165\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.869\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−1.00(−2.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e−1.00(−1.88, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−1.063\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.288\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eNear phoria\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−3.00 (−6.00,−1.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e−3.00(−6.25,−1.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−1.363\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.173\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−3.00(−4.75,−1.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e−3.00(−5.00,−1.25)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.571\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.568\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAC/A ratio\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.00(3.00, 4.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.00(3.00, 4.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.975\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.329\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.00(3.00, 3.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.00(3.00, 3.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−1.510\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.131\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eBCC\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.06, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.00 (0.00, 0.06)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.360\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.719\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (0.00, 0.25)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.00 (0.00, 0.25)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.442\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.659\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eDistance Worth−4 dot\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.00 (4.00, 4.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.00 (4.00, 4.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.577\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.564\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.00 (4.00, 4.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.00 (4.00, 4.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−1.414\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.157\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eNRA\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.75 (1.50, 2.25)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.25 (1.50, 2.25)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.861\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.389\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.00 (1.75, 2.44)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.00 (1.50, 2.25)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−1.933\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.053\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePRA\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−2.50 (−3.00,−1.69)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e−2.50 (−3.00,−1.50)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−0.266\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.790\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−2.25 (−3.00,−1.50)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e−2.50 (−3.00,−2.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e−1.306\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.192\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003eNo significant differences were observed between the Control and HAL groups in the 6-month changes for the following parameters: distance and near phoria, AC/A ratio, BCC, distance Worth-4-dot, and PRA (all \u003cem\u003eP\u003c/em\u003e\u0026gt;0.05), with the exception of NRA (Z=-2.142, \u003cem\u003eP\u003c/em\u003e = 0.032). (shown in Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of changes in accommodative or binocular function over a 6-month period between the Control and HAL Group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eVisual function\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e6-month Difference changes\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eMedian difference and 95% Confidence Interval\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eWilcoxon\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eZ\u003c/em\u003e Value\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e Value\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDistance phoria\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−1.00,1.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.00 (−1.00, 1.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-0.375\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.708\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.88, 1.00)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNear phoria\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−1.25, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.00 (−1.00, 1.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-0.315\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.753\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−1.75, 0.75)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAC/A\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-0.660\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.509\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBCC\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (0.00, 0.06)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-0.554\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.580\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.19, 0.00)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWorth−4 dot\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-0.476\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.634\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (0.00, 0.00)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNRA\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.06, 0.50)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.25 (0.00, 0.50)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-2.142\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.032*\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e−0.13 (−0.50, 0.25)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePRA\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.75, 0.50)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.25 (−0.25, 0.7)\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e-0.851\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.395\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eHAL\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.00 (−0.94, 0.25)\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study provides a preliminary exploration of the preventive application of HAL spectacle lenses in pre-myopic children (-0.50\u0026lt;SER ≤ + 0.75) in slowing AL elongation, refractive changes, and visual function changes. Our findings suggest that over a 6-month period, HAL spectacles slowed AL elongation in pre-myopic children with minimal impact on accommodative and binocular function, except for a measured change in NRA.\u003c/p\u003e\u003cp\u003e \u003cb\u003eComparison with other clinical interventions for pre-myopia\u003c/b\u003e \u003c/p\u003e\u003cp\u003eCurrent research on clinical interventions for pre-myopia primarily focuses on low-concentration atropine and RLRL. Among these, 0.01% atropine eye drops have been demonstrated to effectively slow AL elongation in pre-myopic children aged 4–12 years over a two-year period, compared to a control group (1 year: 0.12 ± 0.1 mm vs 0.21 ± 0.2 mm, − 0.31 ± 0.3 D vs − 0.76 ± 0.4 D, respectively; 2 years: 0.21 ± 0.2 mm vs 0.48 ± 0.2 mm, − 0.60 ± 0.3 D vs − 1.75 ± 0.4 D, respectively).[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] However, the LAMP2 study reported no significant difference between 0.01% atropine and placebo.[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] In contrast, 0.05% atropine significantly reduced the incidence of myopia (28.4%) compared to placebo (53.0%) and 0.01% atropine (45.9%) over two years in pre-myopic children aged 4–9 years.\u003c/p\u003e\u003cp\u003eCurrently, RLRL is also being investigated in pre-myopia intervention studies. In a one-year study conducted by He et al.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] with pre-myopic children aged 6–11 years, RLRL treatment significantly reduced the incidence of myopia (40.8% vs. 61.3%), axial elongation (0.30 mm vs. 0.47 mm), and myopic refractive shift (-0.35 D vs. -0.76 D) compared to the control group. Xiang et al.[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] found that repeated RLRL intervention significantly increased choroidal thickness in pre-myopic children aged 6–10 years, especially at the subfoveal sector. The possible efficacy may be related to altered scleral collagen crosslinking and increased choroidal thickness, but the specific mechanism of RLRL therapy remains unclear.[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e–\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e] Nevertheless, a case report suggested that RLRL therapy may cause retinal damage.[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] Moreover, the latest research has found that RLRL may reduce cone density within 0.5 mm of the foveal center's eccentricity, particularly in the 0.3-mm temporal eccentricity.[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] Additionally, the RLRL group showed a higher incidence of abnormal signals near the fovea, and one participant developed retinal changes that improved after discontinuing RLRL treatment.[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] These findings suggest potential risks associated with RLRL therapy, which needs further investigation to explore its long-term safety and efficacy.\u003c/p\u003e\u003cp\u003e In our study, plano HAL spectacle lenses were effective in preventing the axial elongation in pre-myopic children aged 6–16 years, over the 6-month period relative to the control group (6 months: 0.04 [0.00, 0.11] mm vs 0.14 [0.06, 0.27] mm, respectively). When compared to 0.01% atropine and RLRL therapy, plano HAL spectacle lenses demonstrate a superior effect in controlling AL elongation in pre-myopic children, with a reduction of approximately 0.20 mm per year (0.10 mm/6 months). This compares to reported annual AL reductions of 0.09 mm for 0.01% atropine[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] and 0.17 mm for RLRL[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Additionally, HAL spectacle lenses offer greater convenience and a favorable safety profile in clinical practice.\u003c/p\u003e\u003cp\u003eHowever, several critical differences across studies warrant emphasis: (1) The definition of pre-myopia: pre-myopia was defined as SER ≤ + 1.00 D with an annual myopic progression \u0026gt; 0.50 D at least for the past two years,[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] 0.00D ≤ SER ≤ + 1.00 D,[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] and − 0.50 ≤ SER ≤ + 0.50 D in the more myopic eye plus at least 1 parent with SER ≤ − 3.00 D,[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] respectively. In contrast, our study adopted the standardized IMI consensus definition of -0.50 D \u0026lt; SER ≤ + 0.75 D.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] (2) Age distribution: Previous studies primarily enrolled children, with age ranges of 4–12 years,[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] 4–9 years,[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] and 6–11 years,[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] respectively. In contrast, our study investigated an older and broader cohort (6–16 years), which has different ocular development characteristics. (3) Follow-up duration: the intervention periods in prior trials ranged from 1 to 2 years.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] Our preliminary findings, based on a shorter 6-month observation period, therefore require confirmation through long-term investigation.\u003c/p\u003e\u003ch3\u003eDesign principle and efficacy of HAL spectacle lenses\u003c/h3\u003e\u003cp\u003eHAL spectacle lenses incorporate Highly Aspherical Lenslet Target technology, which utilizes concentric rings of aspheric microlenses containing a higher level of positive power to focus a subset of incident light rays anterior to the retina to minimize peripheral hyperopic defocus. Clinical studies have demonstrated that the participants with myopia wearing HAL spectacle lenses experienced a 51%-64% reduction in axial elongation and a 55%-67% reduction in SER progression compared with those wearing SVL.[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]\u003c/p\u003e\u003cp\u003ePreliminary research is now exploring the application of HAL spectacles in children with low hyperopia. Zhang et al.[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] reported that the intervention's efficacy of HAL lenses exhibits a dose-dependent relationship in pre-myopic children. 108 Chinese children (aged 6.0-9.9 years) with SER ranging from 0.00 D and + 2.00 D were randomized into HAL and SVL groups. After one year, the changes in SER were − 0.19 D and − 0.23 D, while AL elongation was 0.24 mm and 0.19 mm in the SVL and HAL group, respectively. None of these differences were statistically significant, a finding that appears inconsistent with the outcomes of the present study. However, AL and SER changes in the HAL group were significantly associated with the wear time of the spectacles. Low hyperopic children wearing HAL lenses for \u0026gt; 30 hours/week had significantly slower axial elongation (0.11 mm vs. 0.27 mm), which corresponds to a 59% reduction compared to the SVL group. Our findings are basically consistent with these results (6-month AL elongation: 0.04 mm vs 0.14 mm, respectively), and the participants in our study were required to wear HAL spectacles for at least 5 days per week and a mean daily wear time of no less than 8 hours.\u003c/p\u003e\u003cp\u003eAdditionally, a recent study found that plano HAL lenses effectively slow AL and SER progression in children without myopia (aged 4–9 years; non-cycloplegic SER: -0.50 to + 0.75 D). The annual rate of AL elongation was reduced by 0.31 mm (from 0.44 mm pre-treatment to 0.13 mm post-treatment), while SER progression was slowed by 0.42 D (from − 0.28 D/year to + 0.14 D/year).[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] However, this study did not perform cycloplegia, which led to SER measurements being inaccurate and hindered accurate assessment of the children's refractive status (pre-myopic, emmetropic, or hyperopic). Furthermore, non-cycloplegic SER measurements may introduce inaccuracies in assessing SER progression. More importantly, the absence of a control group and reliance on before-after treatment comparisons could compromise result validity.[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] Our study utilized cycloplegic refraction for baseline measurements in pre-myopic children and included a control group.\u003c/p\u003e\u003ch3\u003eThe effects of HAL spectacle lenses on accommodative and binocular function\u003c/h3\u003e\u003cp\u003eThere are several studies that have examined the impacts of HAL spectacles on visual function, including visual acuity, contrast sensitivity, accommodation, and binocular vision. The study by Huang et al.[\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e] revealed that HAL had no significant effects on accommodative function and near phoria, with the exception of larger microfluctuations than SVL. Although short-term HAL use initially reduced VA (including scotopic and low-contrast VA), these values normalized to the level of the SVL group after 12 months. Gao et al.[\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] revealed low contrast VA and reading were slightly decreased, but high contrast VA was unaffected when fixating through the periphery of HAL designs in adults. The new lens designs had no effect on any of the peripheral measurements of vision. Fengchao et al.[\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e] found HAL lenses had no significant influence on binocular visual or accommodative function in children with myopia who may or may not have intermittent exotropia, except the short-term accommodative microfluctuation. The current study demonstrates that after 6 months, HAL lenses have no significant effect on accommodation and binocular function, including distance and near phoria, AC/A ratio, BCC, Worth 4-dot, and PRA. This outcome is in alignment with prior research, with the exception of the NRA. Our study revealed a statistically significant (\u003cem\u003eP\u003c/em\u003e = 0.032) but clinically slight reduction (-0.13 D) in NRA in the HAL group, potentially attributable to the optical characteristics of aspherical lenslets affecting accommodative microfluctuations or behavioral adaptation, because the subjects naturally adjust their visual behavior to reduce blur effects caused by the lenslets during near-vision tasks. However, the relatively short follow-up period in our study limits the ability to determine whether these effects represent transient adaptations or persistent changes, which need long-term further investigation.\u003c/p\u003e\u003ch2\u003eLimitations\u003c/h2\u003e\u003cul\u003e \u003cli\u003e \u003cp\u003eOur study has several limitations that should be acknowledged. First, the relatively small sample size might compromise the statistical power of the analyses and limit the broad application of the findings. Future research should employ larger cohorts to validate and extend these results. Second, the retrospective cohort design of this study is subject to potential selection bias and information bias due to reliance on pre-existing data. Future prospective studies would strengthen the reliability of findings. Third, the 6-month observation period of this study may be insufficient to fully evaluate the long-term efficacy of the plano HAL spectacle lens in pre-myopia control. Future longitudinal studies with extended follow-up durations are warranted to assess the sustained effects. Finally, at the 6-month follow-up, non-cycloplegic subjective refraction via a phoropter with adequate fogging was prioritized for its clinical practicality, better patient acceptance, and non-invasive nature. We acknowledge that it may introduce some inaccuracy in SER measurements and progression analysis, but AL changes provide a reliable assessment of slowing myopia progression. This may explain why the significant AL reduction occurred without a corresponding SER change. In conclusion, large-scale, multicenter randomized controlled trials are warranted to further investigate this issue and achieve a more comprehensive understanding.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn conclusion, our study showed that HAL spectacles have a significant control effect on the AL elongation in pre-myopic children (aged 6\u0026ndash;16 years) with minimal impact on accommodative and binocular function (distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, and PRA), except for a measured change in NRA, over a 6-month period. HAL spectacles could be a viable strategy and effective method for preventing myopia onset in clinical practice.\u003c/p\u003e"},{"header":"List of abbreviations","content":"\u003cp\u003eHAL Highly aspherical lenslets\u003c/p\u003e\u003cp\u003eSER Spherical equivalent refractive error\u003c/p\u003e\u003cp\u003eAL Axial length\u003c/p\u003e\u003cp\u003eAC/A Accommodative convergence/accommodation\u003c/p\u003e\u003cp\u003eBCC Binocular cross cylinder\u003c/p\u003e\u003cp\u003eNRA Negative relative accommodation\u003c/p\u003e\u003cp\u003ePRA Positive relative accommodation\u003c/p\u003e\u003cp\u003eRLRL Repeated low-level red-light therapy\u003c/p\u003e\u003cp\u003eAA Auricular acupressure\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eThis study adhered to the tenets of the Declaration of Helsinki. Ethics approval for this study was obtained from the Ethics Committee of the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. For all participants, one parent or legal guardian signed a written informed consent.\u003c/p\u003e \u003cp\u003e\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eNot applicable.\u003c/p\u003e \u003cp\u003e\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompeting interests\u003c/strong\u003e \u003c/p\u003e\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e \u003cp\u003e\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis work was supported by Shandong Medical Staff Scientific and Technological Innovation Plan Project (SDYWZGKCJH2024012), Shandong Medical and Health Science and Technology Development Plan Project (202107020913), Shandong Province Traditional Chinese Medicine Science \u0026amp; Technology Project (Z20242006).\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eHB and WS led the overall study, contributed to the research design, and made critical revisions of the manuscript. MD, TL, and XW contributed to the data collection, data analysis, and manuscript edits. YH, YW, and GL collected the clinical data and processed statistical data. All authors read, contributed to the research design, and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eThe authors thank the colleagues from the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine who made the study possible.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets used and analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHolden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuo Y, Duan JL, Liu LJ, Sun Y, Tang P, Lv YY, et al. High myopia in greater Beijing school children in 2016. PLoS ONE. 2017;12(11):e0187396.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuo Y, Sung MS, Park SW. Assessment of superficial retinal microvascular density in healthy myopia. Int Ophthalmol. 2019;39(8):1861\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShah R, Vlasak N, Evans BJW. High myopia: Reviews of myopia control strategies and myopia complications. Ophthalmic Physiol Opt. 2024;44(6):1248\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHu Y, Ding X, Guo X, Chen Y, Zhang J, He M. Association of Age at Myopia Onset With Risk of High Myopia in Adulthood in a 12-Year Follow-up of a Chinese Cohort. JAMA Ophthalmol. 2020;138(11):1129\u0026ndash;34.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang SK, Guo Y, Liao C, Chen Y, Su G, Zhang G, et al. Incidence of and Factors Associated With Myopia and High Myopia in Chinese Children, Based on Refraction Without Cycloplegia. JAMA Ophthalmol. 2018;136(9):1017\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChua SY, Sabanayagam C, Cheung YB, Chia A, Valenzuela RK, Tan D, et al. Age of onset of myopia predicts risk of high myopia in later childhood in myopic Singapore children. Ophthalmic Physiol Opt. 2016;36(4):388\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFlitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, et al. IMI - Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019;60(3):M20\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMutti DO, Hayes JR, Mitchell GL, Jones LA, Moeschberger ML, Cotter SA, et al. Refractive error, axial length, and relative peripheral refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2007;48(6):2510\u0026ndash;19.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXiang F, He M, Morgan IG. Annual changes in refractive errors and ocular components before and after the onset of myopia in Chinese children. Ophthalmology. 2012;119(7):1478\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHe M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, et al. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015;314(11):1142\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJin JX, Hua WJ, Jiang X, Wu XY, Yang JW, Gao GP, et al. Effect of outdoor activity on myopia onset and progression in school-aged children in northeast China: the Sujiatun Eye Care Study. BMC Ophthalmol. 2015;15:73.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu PC, Chen CT, Lin KK, Sun CC, Kuo CN, Huang HM, et al. Myopia prevention and outdoor light intensity in a school-based cluster randomized trial. Ophthalmology. 2018;125(8):1239\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang W, Zhang F, Yu S, Ma N, Huang C, Wang M, et al. Prevention of myopia shift and myopia onset using 0.01% atropine in premyopic children - a prospective, randomized, double-masked, and crossover trial. Eur J Pediatr. 2023;182(6):2597\u0026ndash;606.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJethani J. Efficacy of low-concentration atropine (0.01%) eye drops for prevention of axial myopic progression in premyopes. Indian J Ophthalmol. 2022;70(1):238\u0026ndash;40.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFang PC, Chung MY, Yu HJ, Wu PC. Prevention of myopia onset with 0.025% atropine in premyopic children. J Ocul Pharmacol Ther. 2010;26(4):341\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHe X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, et al. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(4):e239612.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang J, Shi Y, Yan X, Wu X, Cao K, Chen L. Evaluation of Auricular Acupressure on Myopia Prevention among Children Aged 6\u0026ndash;12 Years with Pre-Myopia in China: Study Protocol of a Prospective Multi-Center Randomized Controlled Trial. Complement Med Res. 2025;32(1):3\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGong Q, Janowski M, Luo M, Wei H, Chen B, Yang G, et al. Efficacy and Adverse Effects of Atropine in Childhood Myopia: A Meta-analysis. JAMA Ophthalmol. 2017;135(6):624\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChia A, Chua WH, Cheung YB, Wong WL, Lingham A, et al. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012;119(2):347\u0026ndash;54.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu H, Yang Y, Guo J, et al. Retinal Damage After Repeated Low-level Red-Light Laser Exposure. JAMA Ophthalmol. 2023;141(7):693\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu H, Yang Y, Guo J, Peng J, Zhao P. Cone Density Changes After Repeated Low-Level Red Light Treatment in Children With Myopia. JAMA Ophthalmol. 2025;143(6):480\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBao J, Huang Y, Li X, Yang A, Zhou F, Wu J, et al. Spectacle lenses with aspherical lenslets for myopia control vs single-vision spectacle lenses: a randomized clinical trial. JAMA Ophthalmol. 2022;140(5):472\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang Z, Zeng L, Gu D, Wang B, Kang P, Watt K, et al. Spectacle Lenses With Highly Aspherical Lenslets for Slowing Axial Elongation and Refractive Change in Low-Hyperopic Chinese Children: A Randomized Controlled Trial. Am J Ophthalmol. 2025;269:60\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang L, Wong YL, Drobe B, Wang X. Effectiveness of spectacle lenses with highly aspherical lenslets in slowing axial elongation among non-myopic children. Clin Exp Optom. 2025; 1\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChen J, Liu S, Zhu Z, Bulloch G, Naduvilath T, Wang J, et al. Axial length changes in progressive and non-progressive myopic children in China. Graefes Arch Clin Exp Ophthalmol. 2023;261(5):1493\u0026ndash;501.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYam JC, Zhang XJ, Zhang Y, Yip BHK, Tang F, Wong ES, et al. Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial. JAMA. 2023;329(6):472\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXiang K, Wang J, Zhu Z, Zhang X, Zhang B, Chen J, et al. Changes in choroidal thickness in pre-myopic children after repeated low-level red-light therapy and their role in predicting myopia prevention and controlling myopic shift. Asia Pac J Ophthalmol (Phila). 2025;14(2):100115.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMetlapally R, Wildsoet CF. Scleral Mechanisms Underlying Ocular Growth and Myopia. Prog Mol Biol Transl Sci. 2015;134:241\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu H, Chen W, Zhao F, Zhou Q, Reinach PS, Deng L, et al. Scleral hypoxia is a target for myopia control. Proc Natl Acad Sci U S A. 2018;115(30):E7091\u0026ndash;100.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBao J, Yang A, Huang Y, Li X, Pan Y, Ding C, et al. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022;106(8):1171\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuang Y, Li X, Wang C, Zhou F, Yang A, Chen H, et al. Visual acuity, near phoria and accommodation in myopic children using spectacle lenses with aspherical lenslets: results from a randomized clinical trial. Eye Vis (Lond). 2022;9(1):33.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGao Y, Lim EW, Yang A, Drobe B, Bullimore MA. The impact of spectacle lenses for myopia control on visual functions. Ophthalmic Physiol Opt. 2021;41(6):1320\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFengchao Z, Xue L, Yingying H, Yuhao L, Jiali Z, Hao C et al. Effect of Spectacle Lenses with Highly Aspherical Lenslets on Binocular Vision and Accommodation in Myopic Children with and without Intermittent Exotropia. J Ophthalmol. 2022:9306848.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"highly aspherical lenslets, axial length, spherical equivalent refractive error, visual function, myopia prevention, pre-myopia","lastPublishedDoi":"10.21203/rs.3.rs-8199611/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8199611/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThis clinical study was designed to evaluate the effects of spectacle lenses with highly aspherical lenslets (HAL) on axial elongation, refractive change, and visual function in pre-myopic Chinese children.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eRetrospective cohort study. This study included 66 Chinese children, aged 6.0 to 16.0 years, with a cycloplegic spherical equivalent refractive error (SER) ranging from \u0026gt;\u0026thinsp;\u0026minus;\u0026thinsp;0.50 D to \u0026le;\u0026thinsp;+\u0026thinsp;0.75 D, who completed the 6-month follow-up. The participants were divided into two groups: the HAL group (n\u0026thinsp;=\u0026thinsp;32) and the Control group (n\u0026thinsp;=\u0026thinsp;34). SER, axial length (AL), and accommodative and binocular function (distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, NRA, and PRA) were measured at baseline and 6 months after lenses were dispensed.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe 6-month axial elongation was 0.14 (0.06, 0.27) mm in the Control group and 0.04 (0.00, 0.11) mm in the HAL group (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.006). The 6-month AL elongation was categorized into three risk levels: low risk (\u0026le;\u0026thinsp;0.10 mm), medium risk (0.10\u0026ndash;0.20 mm), and high risk (\u0026ge;\u0026thinsp;0.20 mm). In the Control group, low risk accounted for 44.1%, medium risk 23.5%, and high risk 32.4%. However, in the HAL group, low risk accounted for 75.0%, medium risk 6.3%, and high risk 18.8% (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.025). The changes in SER at the 6-month visit were \u0026minus;\u0026thinsp;0.06 (-0.25, 0.00) D and 0.00 (0.00, 0.00) D in the Control and HAL groups (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.134). Compared with the Control group, there were no significant differences in 6-month changes in distance and near phoria, AC/A ratio, BCC, distance worth-4 dot, and PRA (all \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05), with the exception of NRA (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.032).\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eFor the pre-myopic children who have a high risk of developing myopia, plano HAL spectacles may be a viable strategy to slow AL elongation with minimal impact on accommodative and binocular function in a 6-month follow-up, with the exception of NRA.\u003c/p\u003e","manuscriptTitle":"Effects of Spectacle lenses with highly aspherical lenslets on axial elongation, refractive change and visual function in pre-myopic Chinese children: a retrospective cohort study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-30 09:56:39","doi":"10.21203/rs.3.rs-8199611/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"79e49e99-e70f-4517-a612-79fdd8aed0e9","owner":[],"postedDate":"December 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-01-21T01:57:49+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-30 09:56:39","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8199611","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8199611","identity":"rs-8199611","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}