A Comparative Study on the Effects of Spherical and Aspheric Orthokeratology Lenses on Myopia Control and Ocular Surface Health in Adolescents: A Retrospective Cohort Study Based on Propensity Score Matching

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Abstract Purpose To compare the 1-year efficacy of spherical versus aspheric base curve orthokeratology (OK) lenses in controlling axial length (AL) elongation in myopic adolescents, and to explore differences in their impact on tear film function and ocular surface health. Methods This retrospective cohort study enrolled 137 adolescent myopic patients (right eye data only) who underwent OK lens fitting between July 2023 and August 2024. Patients were divided into a spherical base curve OK group (SOK group, n = 107) and an aspheric base curve OK group (AOK group, n = 30). The primary outcome was the change in AL at 12 months. Secondary outcomes included tear film break-up time (FBUT), Schirmer I test (SIT), and corneal fluorescein staining (CFS). Propensity score matching (PSM, 1:3) was used to balance baseline confounding factors. Results After PSM, no statistically significant difference was found in AL elongation between the SOK and AOK groups (0.18 mm vs. 0.23 mm, p  = 0.32, 95% CI: −0.04 ~ 0.14 mm). FBUT decreased significantly from baseline in both groups after lens wear ( p  < 0.001), with no intergroup difference. At 12 months, the mean SIT value was significantly higher in the AOK group (14.6 ± 5.5 mm) than in the SOK group (12.4 ± 4.6 mm), with an adjusted mean difference of 2.13 mm ( p  = 0.04, 95% CI: 0.07 ~ 4.20). No significant differences were observed in other ocular surface safety indicators. Conclusions Within the sample size of this study, spherical and aspheric base curve OK lenses showed no statistically significant difference in controlling 1-year AL elongation. However, a clear conclusion of equivalence cannot be drawn due to limited statistical power. Exploratory analysis suggests that the aspheric design may offer advantages in preserving basal tear secretion, which requires validation in large-scale prospective studies.
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A Comparative Study on the Effects of Spherical and Aspheric Orthokeratology Lenses on Myopia Control and Ocular Surface Health in Adolescents: A Retrospective Cohort Study Based on Propensity Score Matching | 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 A Comparative Study on the Effects of Spherical and Aspheric Orthokeratology Lenses on Myopia Control and Ocular Surface Health in Adolescents: A Retrospective Cohort Study Based on Propensity Score Matching Jingjing Cai¹, Guoli Lan², Yingjie Lin², Xianjun Liang², Jiwen Yang¹ This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9449494/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract Purpose To compare the 1-year efficacy of spherical versus aspheric base curve orthokeratology (OK) lenses in controlling axial length (AL) elongation in myopic adolescents, and to explore differences in their impact on tear film function and ocular surface health. Methods This retrospective cohort study enrolled 137 adolescent myopic patients (right eye data only) who underwent OK lens fitting between July 2023 and August 2024. Patients were divided into a spherical base curve OK group (SOK group, n = 107) and an aspheric base curve OK group (AOK group, n = 30). The primary outcome was the change in AL at 12 months. Secondary outcomes included tear film break-up time (FBUT), Schirmer I test (SIT), and corneal fluorescein staining (CFS). Propensity score matching (PSM, 1:3) was used to balance baseline confounding factors. Results After PSM, no statistically significant difference was found in AL elongation between the SOK and AOK groups (0.18 mm vs. 0.23 mm, p = 0.32, 95% CI: −0.04 ~ 0.14 mm). FBUT decreased significantly from baseline in both groups after lens wear ( p < 0.001), with no intergroup difference. At 12 months, the mean SIT value was significantly higher in the AOK group (14.6 ± 5.5 mm) than in the SOK group (12.4 ± 4.6 mm), with an adjusted mean difference of 2.13 mm ( p = 0.04, 95% CI: 0.07 ~ 4.20). No significant differences were observed in other ocular surface safety indicators. Conclusions Within the sample size of this study, spherical and aspheric base curve OK lenses showed no statistically significant difference in controlling 1-year AL elongation. However, a clear conclusion of equivalence cannot be drawn due to limited statistical power. Exploratory analysis suggests that the aspheric design may offer advantages in preserving basal tear secretion, which requires validation in large-scale prospective studies. Orthokeratology Myopia control Axial length Tear film Aspheric design Ocular surface health Figures Figure 1 1. Introduction The global epidemic of myopia in adolescents and its risk of progression to high myopia highlight the urgency of effective interventions.Orthokeratology (OK) has emerged as a critical non-surgical option to delay AL elongation by reshaping the cornea with a rigid gas-permeable contact lens with inverse geometric design worn at night [ 1 – 3 ]. In recent years, optical theory has speculated that aspheric base curve designs may provide better myopia control than traditional spherical designs by optimizing defocus signals and higher-order aberrations in the peripheral retina [ 4 – 6 ].However, this theoretical hypothesis lacks sufficient evidence from rigorous clinical studies [ 7 ].At the same time, OK lens safety, especially its long-term impact on ocular surface health, has attracted much attention.The mechanical action of OK lens may affect tear film stability and meibomian gland function, but the differentiation effect of different base curve designs on the ocular surface microenvironment is not clear[ 8 ].Aspheric designs may have unique mechanical effects on the cornea and conjunctiva due to different curvature properties, thereby potentially affecting tear dynamics [ 9 – 12 ]. At present, high-quality studies are lacking that systematically compare the myopia control efficacy and ocular surface safety of spherical and aspheric base curve OK lenses under consistent key optical parameters (e.g., treatment zone diameter, Jessen factor). Therefore, the aim of this study was to preliminarily compare the efficacy of myopia control and ocular surface safety (especially tear film function) between spherical and aspheric designs of OK lenses in the base curve region through a real-world exploratory cohort study under the premise of unifying key optical parameters in order to provide preliminary evidence and hypothesis basis for subsequent large-sample prospective studies. 2. Methods 2.1 Study design This study was a retrospective cohort study, which was approved by the Ethics Committee and exempted from patient informed consent according to the provisions of the Declaration of Helsinki for retrospective studies. Given the retrospective design and sample size constraints, this study is positioned as exploratory and the results need to be interpreted with caution. 2.2 Participants Consecutive myopic adolescents who underwent OK lens fitting at our hospital between July 2023 and August 2024 were enrolled.Inclusion criteria: aged 8–18 years; spherical equivalent refraction (SER) ranging from −1.00 D to −6.00 D; astigmatism ≤ 1.50 D; and completion of 12 months of follow-up.Exclusion criteria: history of ocular surgery; active ocular diseases; systemic disorders affecting ocular health; baseline Schirmer I test < 5 mm or tear film break-up time (FBUT) < 5 s; concurrent use of atropine; or poor lens wear compliance.Notably, non-randomized lens allocation may have resulted in unmeasured selection bias. 2.3 Grouping and intervention Patients were divided into spherical group (SOK) and aspheric group (AOK) according to the base curve design. To control optical design variables, all lenses were made of the same brand of fluorosilicone acrylate polymer material (oxygen permeability coefficient: 125×10⁻¹¹ cm²/s) with consistent critical parameters: Jessen factor 0.75 D and treatment zone diameter 6.0 mm[13]. Lens selection was based on standard fitting evaluations and patient preferences. 2.4 E valuation indicators The primary outcome measure was axial length (AL) elongation at 12 months (follow-up value minus baseline value), and the secondary outcome measures included tear film stability assessed by tear film break-up time (FBUT), tear secretion function evaluated by non-anesthetized Schirmer I test (SIT), corneal safety determined by corneal fluorescein staining (CCLRU grading criteria), and lens fitting assessment involving lens centration and degree of decentration. 2.5 Statistical analysis This study used rigorous statistical strategies to address confounding bias and sample size imbalance commonly observed in retrospective studies. All statistical analyses were performed using R software (version 4.3.1) and SPSS software (version 26.0), and a two-sided test p < 0.05 was considered statistically significant. 2.5.1 S ample size This study is a retrospective exploratory study. Because the AOK is derived from clinical real-world fitting data, the sample size is relatively limited. Based on previous literature, the sample size of this study was calculated to be statistically powered (Power > 0.8) to detect differences in secondary endpoint measures (basal tear secretion, SIT). For the primary endpoint (AL), the aim of this study was to generate preliminary hypotheses, the results of which need to be interpreted cautiously in conjunction with subsequent large prospective studies. 2.5.2 Baseline Characteristic Comparison and Propensity Score Matching (PSM) Direct comparison might introduce selection bias due to the small sample size of the AOK group and significant between-group differences in baseline characteristics such as age ( p < 0.05) compared with the SOK group, so propensity score matching (PSM) was applied to balance covariates, where 1:3 nearest-neighbor matching was performed using the MatchIt package with age, sex, baseline spherical equivalent refraction (SER), flat K (FK), steep K (SK) , and baseline AL as matching variables and a caliper value of 0.02 set, and before and after matching, continuous variables were compared between groups using independent-samples t-test or Mann–Whitney U test while categorical variables were analyzed using chi-square test or Fisher’s exact test. 2.5.3 Primary outcome Analysis The primary outcome measure was the 12-month AL elongation (follow-up value − baseline value); given the severely insufficient sample size, formal non-inferiority testing was not conducted, instead conventional difference testing combined with effect size estimation was used, and based on the matched cohort, the 95% confidence interval (95% CI) for the between-group difference in axial elongation was calculated, with the note that due to inadequate statistical power, a definitive conclusion of equivalence could not be drawn even if the 95% CI fell within the predefined range. 2.5.4 Multiple linear regression and influencing factor analysis A multiple linear regression model was constructed to identify independent influencing factors of axial elongation and adjust for residual confounding: variables with p < 0.2 in univariate analysis were included in the initial model, backward elimination was used to remove non-significant variables with variables with p < 0.05 retained in the final model, and residual normality and multicollinearity (VIF < 5) were examined for model diagnostics. 2.5.5 Secondary outcome Analysis For continuous variables including FBUT and SIT, analysis of covariance (ANCOVA) was performed, where baseline values were used as covariates to compare adjusted means at the 12-month follow-up, thereby controlling for the influence of baseline differences on treatment efficacy. 2.5.6 Subgroup Analysis and Interaction Testing To explore the stability of intervention effects across different populations, subgroup analyses were conducted according to sex (male/female) and age (8–12 years, 12–14 years, 14–18 years, and interaction effects were tested by introducing a “group × subgroup” interaction term into the regression model, where an interaction p < 0.05 indicated that the efficacy of lens design was modified by the corresponding subgroup factor, and given the exploratory nature of subgroup analyses and multiple comparisons, the results were only used for hypothesis generation. 2.5.7 Multiple comparison correction Given the multiple hypothesis tests involved in subgroup analyses, the Bonferroni correction was applied to p values in subgroup analyses as a sensitivity test to control for type I error inflation. 3. Results 3.1 Baseline characteristics and PSM balance A total of 137 adolescent myopic patients were initially enrolled, including 107 patients in the SOK group and 30 patients in the AOK group. Before PSM, the AOK group was significantly younger than the SOK group (10.07 ± 1.95 years vs. 10.98 ± 2.39 years, p = 0.04), while there were no significant differences in other baseline characteristics between the two groups (Table 1 ). After 1:3 PSM, 30 patients in the AOK group and 90 patients in the SOK group were included (total n = 120). All baseline characteristics, including age, sex, SER, FK, SK, baseline AL, SIT, and FBUT, were well balanced between the two groups (all p > 0.05), indicating that the confounding factors were effectively controlled (Table 2 ). Table 1 Baseline characteristics before matching Characteristic AOK (n = 30) SOK (n = 107) p SMD Age (years) 10.07 ± 1.95 10.98 ± 2.39 0.04 0.47 Female, n (%) 17/30 (56.7%) 52/107 (48.6%) 0.44 -0.16 SE, D -2.85 ± 1.42 -2.86 ± 1.32 0.91 - FK, D 42.67 ± 1.34 42.94 ± 1.17 0.43 0.2 SK, D 43.81 ± 1.42 44.16 ± 1.34 0.36 0.25 AL, mm 24.59 ± 0.70 24.66 ± 0.87 0.57 0.11 SIT, mm 22.00 ± 8.00 23.00 ± 8.00 0.53 - FBUT, s 10.13 ± 2.79 10.67 ± 2.78 0.43 - Note: - indicates variable not included in propensity score matching. AOK: aspheric base curve orthokeratology group; SOK: spherical base curve orthokeratology group; SMD: standardized mean difference; SER: spherical equivalent refraction; FK: Flat K; SK: Steep K; AL: axial length; SIT: Schirmer I test; FBUT: tear film break-up time. Table 2 Baseline characteristics after propensity score matching Characteristic AOK (n = 30) SOK (n = 90)* p SMD Age, years 10.07 ± 1.95 9.90 ± 1.78 0.19 0.08 Female, n (%) 17/30 (56.7%) 45/90 (50.0%) 0.67 -0.13 SER, D -2.85 ± 1.42 -2.68 ± 1.13 0.7 - FK, D 42.67 ± 1.34 42.82 ± 1.40 0.52 0.12 SK, D 43.81 ± 1.42 44.05 ± 1.54 0.42 0.16 AL, mm 24.59 ± 0.70 24.56 ± 0.82 0.71 0.09 SIT, mm 22.00 ± 8.4 23.14 ± 6.68 0.56 - FBUT, s 10.13 ± 2.79 10.30 ± 2.77 0.49 - Note: * indicates SOK group as control for axial length difference; - indicates variable not included in propensity score matching. Abbreviations as in Table 1 . 3.2 Myopia control efficacy Analysis of the primary efficacy outcome (Table 3 ) demonstrated that, over the 12-month follow-up period, the AL elongation in the entire cohort was 0.17 ± 0.22 mm in the SOK group and 0.23 ± 0.19 mm in the AOK group, with no statistically significant difference between the two groups ( p = 0.07). Notably, patients in the AOK group were significantly younger in the initial cohort (Table 1 ), and age is a strong predictor of axial length growth. Table 3 Multivariate regression for AL elongation Variable β (95% CI) SE Standardized β p Age (years) −0.04 (− 0.06 to − 0.03) 0.01 −0.32 < 0.001 Baseline AL (mm) −0.07 (− 0.11 to − 0.03) 0.02 −0.28 0.005 Sex (female vs male) −0.01 (− 0.07 to 0.05) 0.03 −0.02 0.76 Lens design (AOK vs SOK) 0.02 (− 0.05 to 0.09) 0.04 0.03 0.61 Note: Final model adjusted for age, baseline axial length, sex, and OK lens design in the propensity score-matched cohort (N = 120). β: standardized regression coefficient; SE: standard error. To eliminate this confounding bias, we performed 1:3 propensity score matching (PSM). In the matched cohort (30 AOK, 90 SOK), baseline characteristics were completely balanced between the two groups (Table 2 ). Analysis after PSM showed that axial growth was 0.18 ± 0.23 mm in SOK group and 0.23 ± 0.19 mm in AOK group. Although numerically slightly higher in the AOK group, there was no significant difference between groups (0.05 mm, 95% CI: − 0.04 ~ 0.14, p = 0.32). Given the limited sample size of this study, this negative result requires caution and cannot be taken as evidence of equivalence between the two designs. 3.3 Forest Plot of Subgroup Analysis Forest plot of subgroup analysis (Fig. 1 ) showed that the effect of OK lens design on AL elongation was consistent across different genders and age groups, with no significant interaction identified. Gender subgroup: No significant differences between groups were observed in either males (β = 0.08 mm, p = 0.10) or females (β = − 0.04 mm, p = 0.53) ( p = 0.13 for interaction). Age subgroup: Effect estimates were not statistically significant in any of the three age subgroups: 8–12 years, 12–14 years, and 14–18 years. Although a relatively large effect estimate was found in the 14–18 years subgroup (β = 0.17 mm, unadjusted p = 0.042), the Bonferroni correction was applied to control for multiple testing with a corrected significance threshold of 0.008 (0.05/6). The difference was no longer statistically significant after correction (adjusted p > 0.05). These findings suggest that the current evidence does not support that the effect of lens design is modified by age (Table 4 ). Given the exploratory nature of subgroup analyses and the issue of multiple comparisons, the present results should be regarded as hypothesis-generating rather than definitive conclusions. Table 4 Subgroup analysis for AL elongation. Subgroup β 95% CI Lower 95% CI Upper p Interaction p Overall 0.02 -0.06 0.09 0.69 - Gender 0.13 Male 0.08 -0.02 0.18 0.1 - Female -0.04 -0.15 0.08 0.53 - Age 0.83 8 ≤ Age ≤ 12 years 0.01 -0.07 0.1 0.78 - 12 < Age ≤ 14 years 0.14 -0.22 0.49 0.42 - 14 0.05, indicating no statistical significance. 3.4 Ocular surface safety outcomes 3.4.1 Tear Film Stability After wearing OK lenses for 12 months, tear film stability was affected in both groups (Table 5 ). Post-match cohort analysis showed that FBUT decreased significantly from baseline in both SOK and AOK groups (all p < 0.001), but no statistical differences were found between groups. At the end of the follow-up period, the mean FBUT values were 5.93 ± 1.50 s in the SOK group and 5.80 ± 1.58 s in the AOK group ( p = 0.70). Analysis of covariance (ANCOVA) adjusted for baseline FBUT values further confirmed that the difference between the two groups remained insignificant (adjusted SD − 0.13, 95% CI: − 0.77 ~ 0.52, p = 0.70, Table 6 ). This suggests that both base curve designs have a similar degree of mechanical interference with tear film stability. Table 5 Ocular Surface Safety Outcomes at 12-Month Follow-Up After Propensity Score Matching. Outcome Measure SOK, N = 90 AOK, N = 30 p Lens Deposition (Present) 60/90 (71%) 21/30 (70%) > 0.9 SIT (mm) 12.4 ± 4.6 14.6 ± 5.5 0.04 FBUT (s) 5.93 ± 1.50 5.80 ± 1.58 0.7 Meibomian Gland Assessment (Grade 1) 9/90 (10%) 4/30 (13%) 0.7 Right Eye Decentration (Grade 1) 82/90 (91%) 29/30 (97%) 0.8 Right Eye CFS (Negative) 75/90 (83%) 25/30 (83%) > 0.9 Note: FBUT: tear film break-up time; SIT: Schirmer I test; CFS: corneal fluorescein staining. Table 6 Ocular Surface Safety Outcomes at 12-Month Follow-Up After Adjustment for Baseline Ocular Surface Parameters. SIT Adjusted Mean Difference (95% CI) p 2.13 (0.07, 4.20) 0.04 FBUT -0.13 (-0.77, 0.52) 0.7 Note: FBUT: tear film break-up time; SIT: Schirmer I test. 3.4.2 Basal Tear Secretion Function In terms of basal tear secretion function (Schirmer I test, SIT), the two groups showed significant differences. Although the baseline SIT values were balanced between the two groups after matching ( p = 0.56), the mean SIT value in the aspheric group (AOK) (14.6 ± 5.5 mm) was significantly higher than that in the spherical group (SOK) (12.4 ± 4.6 mm) at the 12-month follow-up, with a statistically significant difference between the unadjusted groups ( p = 0.04, see Table 5 ). Although baseline SIT was balanced after matching, we used ANCOVA with baseline SIT as a covariate to allow for correlation between follow-up and baseline values. The results showed that the aspheric group remained robust in maintaining tear secretion: the adjusted mean difference between groups was 2.13 mm (95% CI: 0.07 ~ 4.20, p = 0.04, Table 6 ). This finding suggests that the aspheric base curve design may have less inhibitory effect on basal tear secretion function, but it needs to be regarded as an exploratory finding and needs to be verified by large sample studies considering sample size limitations and single center data. 3.4.3 Corneal Safety and Lens Fit Both groups performed comparably on other ocular surface safety measures. During the follow-up period, there was no statistical difference in the positive rate of corneal fluorescein staining (83% without staining, p > 0.9), incidence of lens protein precipitation (71% vs. 70%, p > 0.9) and meibomian gland morphological changes (10% vs. 13% with grade 1, p = 0.7) between the two groups. In addition, the lens fit was well positioned, with 91% (SOK) and 97% (AOK) of the two groups having an eccentric distance of grade 1, respectively, with no significant difference between groups ( p = 0.8Table 5). The above data showed that both designs performed reliably in terms of mechanical safety and fit stability of the cornea. 4. Discussion This retrospective cohort study, using PSM to balance baseline confounding factors, systematically compared the 1-year myopia control efficacy and ocular surface safety of spherical and aspheric base curve OK lenses under standardized optical parameters. The key findings of this study were that the two lens designs showed similar efficacy in controlling AL elongation in adolescent myopic patients, but the aspheric base curve design had a significant advantage in preserving basal tear secretion. 4.1. Aspheric Design and Potential Protection Mechanisms for Tear Secretion Function The most striking finding of this study was that adolescents wearing AOK had significantly higher basal tear secretion (SIT value) than the SOK group at the 12-month follow-up, with an adjusted mean difference of 2.13 mm, p = 0.04. This phenomenon may be closely related to changes in ocular surface biomechanics (Ocular Biomechanics) after OK lens wear. Theoretically, aspheric base curve designs better match the aspheric physiological characteristics (Q-values) of the anterior corneal surface, thereby achieving a more uniform stress distribution in the region of contact between the lens and the cornea [11, 15]. In contrast, traditional spherical designs may generate relatively concentrated mechanical stress or microcompression in specific areas such as the inversion arc area or the localization arc area when interacting with the cornea of the aspheric surface. This difference in mechanical action may have directly impacted the neuro-tear reflex arc. Basal tear secretion is mainly regulated by neural reflexes in the accessory lacrimal gland, while sensory nerve endings that trigger this reflex are densely distributed in the keratoconjunctival margin and meibomian gland region [16, 17]. We speculate that the local stress concentration generated by the spherical design may act as a chronic microstimulation that interferes with the normal conduction of neural signals, which in turn inhibits reflex tear secretion; while the aspheric design mitigates this mechanical interference through superior morphological adaptation, thus better protecting the neuroregulatory function of the ocular surface and maintaining a better basal tear secretion level [18-20]. 4.2. Interpretation of Neutral Findings Regarding Myopia Control Efficacy In terms of myopia control, no significant difference in axial elongation was detected between the two designs (0.18 mm vs. 0.23 mm, p = 0.32). This result suggests that under the standardized optical parameters applied in this study, especially a 6.0‑mm treatment zone diameter, geometric variations in the base curve zone may not substantially alter the intensity of peripheral retinal defocus signals, or such minor optical differences were insufficient to produce detectable changes in axial length within the sample size of the current study.Notably, myopia progression is modulated by a combination of genetic, environmental, optical, and biomechanical factors [21, 22]. Although optical theories suggest that aspherical designs may optimize defocus patterns, the observed advantage in tear secretion may indicate a potential compensatory mechanism: the aspherical design indirectly maintains ocular physiological homeostasis by improving the ocular surface microenvironment. Although this did not translate into a significant difference in axial elongation during the observation period, its long‑term benefits for ocular surface health deserve further investigation. 5. Conclusions In summary, this study provides important clinical implications. Although FBUT did not differ significantly between groups, maintaining basal tear secretion SIT is critical for adolescents wearing contact lenses long-term. For children with low basal tear secretion or those residing in dry climates, choosing an aspherical OK lens design may help reduce dry eye risk, improve wearing comfort, and enhance compliance. However, as a single-center retrospective study, the present work has several limitations, including a relatively small sample size, particularly in the aspherical group, and a short follow-up duration. While PSM effectively balanced baseline confounders, it cannot fully substitute for the level of evidence afforded by randomized controlled trials. Furthermore, this study did not include dynamic evaluations of higher-order aberrations or accommodative function. Future studies incorporating biomechanical modeling and optical quality analysis are warranted to further verify the long-term benefits of aspherical base curve designs in preserving ocular surface health. Abbreviations OK: Orthokeratology AL: axial length SER: spherical equivalent refraction SE:Standard Error FK: Flat K SK: Steep K SOK: spherical base curve Orthokeratology group AOK: aspheric base curve Orthokeratology group FBUT: tear film break-up time SIT: Schirmer I test CFS: corneal fluorescein staining PSM: propensity score matching SMD: standardized mean difference Declarations Acknowledgements Not applicable. Authors’ contributions Jingjing Cai: Study design, data collection, and manuscript drafting; Guoli Lan: Data analysis and statistical interpretation; Yingjie Lin: Patient recruitment and clinical assessment; Xianjun Liang: Study supervision and manuscript revision; Jiwen Yang: conceived the study, supervised the project, revised the manuscript, and is the corresponding author. All authors read and approved the final manuscript. Funding This study was supported by the Foshan Self-Financed Science and Technology Innovation Project (Grant No. 2420001004593). Data Availability The datasets generated and analysed during the study are not publicly available but are available from the corresponding author on reasonable request. Ethics approval and consent to participate This study was approved by the Ethics Committee of Foshan Aier Zhuoyue Eye Hospital (Approval No.: FSZYEY-2026IRB04). All procedures were conducted in accordance with the Declaration of Helsinki . Informed consent was waived due to the retrospective and anonymized nature of the study, which was approved by the Ethics Committee. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Author details Guangzhou Aier Eye Hospital, Jinan University, No.191, Huanshi Middle Road, Yuexiu District,Guangzhou, 510071, Guangdong, PR China. References Jonas JB, Ang M, Cho P, et al. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021;62(5):6. Chamberlain P, Peixoto-De-Matos SC, Logan NS, et al. 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Biomechanical study of cornea response under orthokeratology lens therapy: A finite element analysis. Int J Numer Method Biomed Eng. 2023;39(10):e3691. Zaabaar E, Asiamah R, Kyei S, et al. Myopia control strategies: A systematic review and meta-meta-analysis. Ophthalmic Physiol Opt. 2025;45(1):160–76. Schmidt DC, Hvid-Hansen A, Jacobsen N, et al. Efficacy of interventions for myopia control in children: A systematic review with network meta-analyses. Acta Ophthalmol. 2025;103(8):939–65. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 10 May, 2026 Reviewers invited by journal 22 Apr, 2026 Editor invited by journal 21 Apr, 2026 Editor assigned by journal 18 Apr, 2026 Submission checks completed at journal 18 Apr, 2026 First submitted to journal 17 Apr, 2026 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-9449494","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":631202329,"identity":"30961f17-eb0b-4734-a8aa-e78ca7564c2e","order_by":0,"name":"Jingjing Cai¹","email":"","orcid":"","institution":"Guangzhou Aier Eye Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jingjing","middleName":"","lastName":"Cai¹","suffix":""},{"id":631202330,"identity":"957dca9b-8af9-415b-80e5-032156c8482b","order_by":1,"name":"Guoli Lan²","email":"","orcid":"","institution":"Foshan Aier Zhuoyue Eye Hospital","correspondingAuthor":false,"prefix":"","firstName":"Guoli","middleName":"","lastName":"Lan²","suffix":""},{"id":631202331,"identity":"87baff61-dcbb-4229-b574-e42b1a82228e","order_by":2,"name":"Yingjie Lin²","email":"","orcid":"","institution":"Foshan Aier Zhuoyue Eye Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yingjie","middleName":"","lastName":"Lin²","suffix":""},{"id":631202332,"identity":"e679ccac-77ac-4caf-a642-3e2905d0b901","order_by":3,"name":"Xianjun Liang²","email":"","orcid":"","institution":"Foshan Aier Zhuoyue Eye Hospital","correspondingAuthor":false,"prefix":"","firstName":"Xianjun","middleName":"","lastName":"Liang²","suffix":""},{"id":631202333,"identity":"b50ca57c-a9ed-4225-b15a-95bc403a0b9c","order_by":4,"name":"Jiwen Yang¹","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA9klEQVRIiWNgGAWjYLACCQMgwd7AcABIJbARr4XnAClaIPoSwFQCQYUGx88efmFRcFjOXPLxwwMf99jl8Uk3P2D4UbENt5YzeWkWEgaHjS1npxkcnPEsuZhN5pgBY8+Z27i1HMgxM5AwuJ244XaCwWGeAwcS2yQSDJgZ2/BoOf8GrKV+w83jHw7/AWtJ/4Bfy40c4wdALQkGN3gMDjOAteTgt0XyxhszYCD/N9xwJqfgYM+BZJAWIAOPX/jO5xh/lviTJm9w/PjmDz8O2CXOn5G+8cGPCtxaFA4wsElLoIsewKkeCOQbGJg/fsCnYhSMglEwCkYBAKy3YgqQChdLAAAAAElFTkSuQmCC","orcid":"","institution":"Guangzhou Aier Eye Hospital","correspondingAuthor":true,"prefix":"","firstName":"Jiwen","middleName":"","lastName":"Yang¹","suffix":""}],"badges":[],"createdAt":"2026-04-17 13:08:29","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9449494/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9449494/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":108401632,"identity":"8eadeb5f-3c1f-45d7-a502-83fc56fe693e","added_by":"auto","created_at":"2026-05-04 09:06:30","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":55023,"visible":true,"origin":"","legend":"\u003cp\u003eSubgroup Analysis Forest Plot\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9449494/v1/d36b3e052a92a3a25c3ea319.jpeg"},{"id":108493624,"identity":"e7f4ae71-2356-45f6-80e7-9fea192533f0","added_by":"auto","created_at":"2026-05-05 10:01:05","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":398155,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9449494/v1/67662a0b-3c2f-4fb1-b5a5-e64583b792e1.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Comparative Study on the Effects of Spherical and Aspheric Orthokeratology Lenses on Myopia Control and Ocular Surface Health in Adolescents: A Retrospective Cohort Study Based on Propensity Score Matching","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eThe global epidemic of myopia in adolescents and its risk of progression to high myopia highlight the urgency of effective interventions.Orthokeratology (OK) has emerged as a critical non-surgical option to delay AL elongation by reshaping the cornea with a rigid gas-permeable contact lens with inverse geometric design worn at night [\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn recent years, optical theory has speculated that aspheric base curve designs may provide better myopia control than traditional spherical designs by optimizing defocus signals and higher-order aberrations in the peripheral retina [\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].However, this theoretical hypothesis lacks sufficient evidence from rigorous clinical studies [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].At the same time, OK lens safety, especially its long-term impact on ocular surface health, has attracted much attention.The mechanical action of OK lens may affect tear film stability and meibomian gland function, but the differentiation effect of different base curve designs on the ocular surface microenvironment is not clear[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].Aspheric designs may have unique mechanical effects on the cornea and conjunctiva due to different curvature properties, thereby potentially affecting tear dynamics [\u003cspan additionalcitationids=\"CR10 CR11\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAt present, high-quality studies are lacking that systematically compare the myopia control efficacy and ocular surface safety of spherical and aspheric base curve OK lenses under consistent key optical parameters (e.g., treatment zone diameter, Jessen factor). Therefore, the aim of this study was to preliminarily compare the efficacy of myopia control and ocular surface safety (especially tear film function) between spherical and aspheric designs of OK lenses in the base curve region through a real-world exploratory cohort study under the premise of unifying key optical parameters in order to provide preliminary evidence and hypothesis basis for subsequent large-sample prospective studies.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cp\u003e\u003cstrong\u003e2.1\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eStudy design\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was a retrospective cohort study, which was approved by the Ethics Committee and exempted from patient informed consent according to the provisions of the Declaration of Helsinki for retrospective studies. Given the retrospective design and sample size constraints, this study is positioned as exploratory and the results need to be interpreted with caution.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.2\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsecutive myopic adolescents who underwent OK lens fitting at our hospital between July 2023 and August 2024 were enrolled.Inclusion criteria: aged 8\u0026ndash;18 years; spherical equivalent refraction (SER) ranging from \u0026minus;1.00 D to \u0026minus;6.00 D; astigmatism \u0026le; 1.50 D; and completion of 12 months of follow-up.Exclusion criteria: history of ocular surgery; active ocular diseases; systemic disorders affecting ocular health; baseline Schirmer I test \u0026lt; 5 mm or tear film break-up time (FBUT) \u0026lt; 5 s; concurrent use of atropine; or poor lens wear compliance.Notably, non-randomized lens allocation may have resulted in unmeasured selection bias.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eGrouping and intervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients were divided into spherical group (SOK) and aspheric group (AOK) according to the base curve design. To control optical design variables, all lenses were made of the same brand of fluorosilicone acrylate polymer material (oxygen permeability coefficient: 125\u0026times;10⁻\u0026sup1;\u0026sup1; cm\u0026sup2;/s) with consistent critical parameters: Jessen factor 0.75 D \u0026nbsp; and treatment zone diameter 6.0 mm[13]. Lens selection was based on standard fitting evaluations and patient preferences.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.4 E\u003c/strong\u003e\u003cstrong\u003evaluation indicators\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome measure was axial length (AL) elongation at 12 months (follow-up value minus baseline value), and the secondary outcome measures included tear film stability assessed by tear film break-up time (FBUT), tear secretion function evaluated by non-anesthetized Schirmer I test (SIT), corneal safety determined by corneal fluorescein staining (CCLRU grading criteria), and lens fitting assessment involving lens centration and degree of decentration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study used rigorous statistical strategies to address confounding bias and sample size imbalance commonly observed in retrospective studies. All statistical analyses were performed using R software (version 4.3.1) and SPSS software (version 26.0), and a two-sided test\u0026nbsp;\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05 was considered statistically significant.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.1 S\u003c/strong\u003e\u003cstrong\u003eample size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is a retrospective exploratory study. Because the AOK \u0026nbsp;is derived from clinical real-world fitting data, the sample size is relatively limited. Based on previous literature, the sample size of this study was calculated to be statistically powered (Power \u0026gt; 0.8) to detect differences in secondary endpoint measures (basal tear secretion, SIT). For the primary endpoint (AL), the aim of this study was to generate preliminary hypotheses, the results of which need to be interpreted cautiously in conjunction with subsequent large prospective studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.2\u003c/strong\u003e\u003cstrong\u003eBaseline Characteristic Comparison and Propensity Score Matching (PSM)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDirect comparison might introduce selection bias due to the small sample size of the AOK group and significant between-group differences in baseline characteristics such as age (\u003cem\u003ep\u003c/em\u003e\u0026lt; 0.05) compared with the SOK group, so propensity score matching (PSM) was applied to balance covariates, where 1:3 nearest-neighbor matching was performed using the MatchIt package with age, sex, baseline spherical equivalent refraction (SER), flat K (FK), steep K (SK) , and baseline AL as matching variables and a caliper value of 0.02 set, and before and after matching, continuous variables were compared between groups using independent-samples t-test or Mann\u0026ndash;Whitney U test while categorical variables were analyzed using chi-square test or Fisher\u0026rsquo;s exact test.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.3\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePrimary outcome\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome measure was the 12-month AL elongation (follow-up value \u0026minus; baseline value); given the severely insufficient sample size, formal non-inferiority testing was not conducted, instead conventional difference testing combined with effect size estimation was used, and based on the matched cohort, the 95% confidence interval (95% CI) for the between-group difference in axial elongation was calculated, with the note that due to inadequate statistical power, a definitive conclusion of equivalence could not be drawn even if the 95% CI fell within the predefined range.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.4\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eMultiple linear regression and influencing factor analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;A multiple linear regression model was constructed to identify independent influencing factors of axial elongation and adjust for residual confounding: variables with\u0026nbsp;\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.2 in univariate analysis were included in the initial model, backward elimination was used to remove non-significant variables with variables with\u0026nbsp;\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05 retained in the final model, and residual normality and multicollinearity (VIF \u0026lt; 5) were examined for model diagnostics.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.5\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eSecondary outcome\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;Analysis\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;For continuous variables including FBUT and SIT, analysis of covariance (ANCOVA) was performed, where baseline values were used as covariates to compare adjusted means at the 12-month follow-up, thereby controlling for the influence of baseline differences on treatment efficacy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.6\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eSubgroup Analysis and Interaction Testing\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo explore the stability of intervention effects across different populations, subgroup analyses were conducted according to sex (male/female) and age (8\u0026ndash;12 years, 12\u0026ndash;14 years, 14\u0026ndash;18 years, and interaction effects were tested by introducing a \u0026ldquo;group \u0026times; subgroup\u0026rdquo; interaction term into the regression model, where an interaction\u0026nbsp;\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05 indicated that the efficacy of lens design was modified by the corresponding subgroup factor, and given the exploratory nature of subgroup analyses and multiple comparisons, the results were only used for hypothesis generation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.7\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eMultiple comparison correction\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGiven the multiple hypothesis tests involved in subgroup analyses, the Bonferroni correction was applied to \u003cem\u003ep\u003c/em\u003e values in subgroup analyses as a sensitivity test to control for type I error inflation.\u003c/p\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003e3.1 Baseline characteristics and PSM balance\u003c/h2\u003e \u003cp\u003eA total of 137 adolescent myopic patients were initially enrolled, including 107 patients in the SOK group and 30 patients in the AOK group. Before PSM, the AOK group was significantly younger than the SOK group (10.07\u0026thinsp;\u0026plusmn;\u0026thinsp;1.95 years vs. 10.98\u0026thinsp;\u0026plusmn;\u0026thinsp;2.39 years, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.04), while there were no significant differences in other baseline characteristics between the two groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). After 1:3 PSM, 30 patients in the AOK group and 90 patients in the SOK group were included (total n\u0026thinsp;=\u0026thinsp;120). All baseline characteristics, including age, sex, SER, FK, SK, baseline AL, SIT, and FBUT, were well balanced between the two groups (all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05), indicating that the confounding factors were effectively controlled (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\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 characteristics before matching\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAOK (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSOK (n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSMD\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.07\u0026thinsp;\u0026plusmn;\u0026thinsp;1.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.98\u0026thinsp;\u0026plusmn;\u0026thinsp;2.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.47\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17/30 (56.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e52/107 (48.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.16\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSE, D\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-2.85\u0026thinsp;\u0026plusmn;\u0026thinsp;1.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-2.86\u0026thinsp;\u0026plusmn;\u0026thinsp;1.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFK, D\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e42.67\u0026thinsp;\u0026plusmn;\u0026thinsp;1.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42.94\u0026thinsp;\u0026plusmn;\u0026thinsp;1.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSK, D\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e43.81\u0026thinsp;\u0026plusmn;\u0026thinsp;1.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44.16\u0026thinsp;\u0026plusmn;\u0026thinsp;1.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAL, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.59\u0026thinsp;\u0026plusmn;\u0026thinsp;0.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.66\u0026thinsp;\u0026plusmn;\u0026thinsp;0.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSIT, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22.00\u0026thinsp;\u0026plusmn;\u0026thinsp;8.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.00\u0026thinsp;\u0026plusmn;\u0026thinsp;8.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFBUT, s\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.13\u0026thinsp;\u0026plusmn;\u0026thinsp;2.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.67\u0026thinsp;\u0026plusmn;\u0026thinsp;2.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNote: - indicates variable not included in propensity score matching. AOK: aspheric base curve orthokeratology group; SOK: spherical base curve orthokeratology group; SMD: standardized mean difference; SER: spherical equivalent refraction; FK: Flat K; SK: Steep K; AL: axial length; SIT: Schirmer I test; FBUT: tear film break-up time.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\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\u003eBaseline characteristics after propensity score matching\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAOK (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSOK (n\u0026thinsp;=\u0026thinsp;90)*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSMD\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.07\u0026thinsp;\u0026plusmn;\u0026thinsp;1.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.90\u0026thinsp;\u0026plusmn;\u0026thinsp;1.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.08\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17/30 (56.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45/90 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.13\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSER, D\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-2.85\u0026thinsp;\u0026plusmn;\u0026thinsp;1.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-2.68\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFK, D\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e42.67\u0026thinsp;\u0026plusmn;\u0026thinsp;1.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42.82\u0026thinsp;\u0026plusmn;\u0026thinsp;1.40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSK, D\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e43.81\u0026thinsp;\u0026plusmn;\u0026thinsp;1.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44.05\u0026thinsp;\u0026plusmn;\u0026thinsp;1.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.16\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAL, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.59\u0026thinsp;\u0026plusmn;\u0026thinsp;0.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSIT, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22.00\u0026thinsp;\u0026plusmn;\u0026thinsp;8.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.14\u0026thinsp;\u0026plusmn;\u0026thinsp;6.68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFBUT, s\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.13\u0026thinsp;\u0026plusmn;\u0026thinsp;2.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.30\u0026thinsp;\u0026plusmn;\u0026thinsp;2.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNote: * indicates SOK group as control for axial length difference; - indicates variable not included in propensity score matching. Abbreviations as in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Myopia control efficacy\u003c/h2\u003e \u003cp\u003eAnalysis of the primary efficacy outcome (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e) demonstrated that, over the 12-month follow-up period, the AL elongation in the entire cohort was 0.17\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22 mm in the SOK group and 0.23\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19 mm in the AOK group, with no statistically significant difference between the two groups (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.07). Notably, patients in the AOK group were significantly younger in the initial cohort (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), and age is a strong predictor of axial length growth.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\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\u003eMultivariate regression for AL elongation\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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=\"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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eβ (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSE\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStandardized β\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026minus;0.04 (\u0026minus;\u0026thinsp;0.06 to \u0026minus;\u0026thinsp;0.03)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026minus;0.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline AL (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026minus;0.07 (\u0026minus;\u0026thinsp;0.11 to \u0026minus;\u0026thinsp;0.03)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026minus;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.005\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex (female vs male)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026minus;0.01 (\u0026minus;\u0026thinsp;0.07 to 0.05)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026minus;0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.76\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLens design (AOK vs SOK)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.02 (\u0026minus;\u0026thinsp;0.05 to 0.09)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.61\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNote: Final model adjusted for age, baseline axial length, sex, and OK lens design in the propensity score-matched cohort (N\u0026thinsp;=\u0026thinsp;120). β: standardized regression coefficient; SE: standard error.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTo eliminate this confounding bias, we performed 1:3 propensity score matching (PSM). In the matched cohort (30 AOK, 90 SOK), baseline characteristics were completely balanced between the two groups (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Analysis after PSM showed that axial growth was 0.18\u0026thinsp;\u0026plusmn;\u0026thinsp;0.23 mm in SOK group and 0.23\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19 mm in AOK group. Although numerically slightly higher in the AOK group, there was no significant difference between groups (0.05 mm, 95% CI: \u0026minus; 0.04\u0026thinsp;~\u0026thinsp;0.14, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.32). Given the limited sample size of this study, this negative result requires caution and cannot be taken as evidence of equivalence between the two designs.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003e3.3 Forest Plot of Subgroup Analysis\u003c/h2\u003e \u003cp\u003eForest plot of subgroup analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) showed that the effect of OK lens design on AL elongation was consistent across different genders and age groups, with no significant interaction identified.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eGender subgroup: No significant differences between groups were observed in either males (β\u0026thinsp;=\u0026thinsp;0.08 mm, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.10) or females (β = \u0026minus; 0.04 mm, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.53) (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.13 for interaction). Age subgroup: Effect estimates were not statistically significant in any of the three age subgroups: 8\u0026ndash;12 years, 12\u0026ndash;14 years, and 14\u0026ndash;18 years. Although a relatively large effect estimate was found in the 14\u0026ndash;18 years subgroup (β\u0026thinsp;=\u0026thinsp;0.17 mm, unadjusted \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.042), the Bonferroni correction was applied to control for multiple testing with a corrected significance threshold of 0.008 (0.05/6). The difference was no longer statistically significant after correction (adjusted \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). These findings suggest that the current evidence does not support that the effect of lens design is modified by age (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Given the exploratory nature of subgroup analyses and the issue of multiple comparisons, the present results should be regarded as hypothesis-generating rather than definitive conclusions.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\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\u003eSubgroup analysis for AL elongation.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSubgroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eβ\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95% CI Lower\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e95% CI Upper\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eInteraction \u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.13\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.08\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.08\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8\u0026thinsp;\u0026le;\u0026thinsp;Age\u0026thinsp;\u0026le;\u0026thinsp;12 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12\u0026thinsp;\u0026lt;\u0026thinsp;Age\u0026thinsp;\u0026le;\u0026thinsp;14 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14\u0026thinsp;\u0026lt;\u0026thinsp;Age\u0026thinsp;\u0026le;\u0026thinsp;18 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eNote: \u003cem\u003ep\u003c/em\u003e values are unadjusted. After Bonferroni correction, all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05, indicating no statistical significance.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003e3.4 Ocular surface safety outcomes\u003c/h2\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003e3.4.1 Tear Film Stability\u003c/h2\u003e\u003cp\u003eAfter wearing OK lenses for 12 months, tear film stability was affected in both groups (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). Post-match cohort analysis showed that FBUT decreased significantly from baseline in both SOK and AOK groups (all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), but no statistical differences were found between groups. At the end of the follow-up period, the mean FBUT values were 5.93\u0026thinsp;\u0026plusmn;\u0026thinsp;1.50 s in the SOK group and 5.80\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58 s in the AOK group (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.70). Analysis of covariance (ANCOVA) adjusted for baseline FBUT values further confirmed that the difference between the two groups remained insignificant (adjusted SD\u0026thinsp;\u0026minus;\u0026thinsp;0.13, 95% CI: \u0026minus; 0.77\u0026thinsp;~\u0026thinsp;0.52, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.70, Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e). This suggests that both base curve designs have a similar degree of mechanical interference with tear film stability.\u003c/p\u003e\u003cp\u003e \u003cdiv class=\"gridtable\"\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\u003eOcular Surface Safety Outcomes at 12-Month Follow-Up After Propensity Score Matching.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome Measure\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSOK, N\u0026thinsp;=\u0026thinsp;90\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAOK, N\u0026thinsp;=\u0026thinsp;30\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLens Deposition (Present)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e60/90 (71%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21/30 (70%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;0.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSIT (mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFBUT (s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.93\u0026thinsp;\u0026plusmn;\u0026thinsp;1.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.80\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMeibomian Gland Assessment (Grade 1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9/90 (10%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4/30 (13%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRight Eye Decentration (Grade 1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e82/90 (91%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29/30 (97%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRight Eye CFS (Negative)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75/90 (83%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25/30 (83%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;0.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eNote: FBUT: tear film break-up time; SIT: Schirmer I test; CFS: corneal fluorescein staining.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\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\u003eOcular Surface Safety Outcomes at 12-Month Follow-Up After Adjustment for Baseline Ocular Surface Parameters.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eSIT\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAdjusted Mean Difference\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.13\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(0.07, 4.20)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFBUT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c3\"\u003e \u003cp\u003e(-0.77, 0.52)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eNote: FBUT: tear film break-up time; SIT: Schirmer I test.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section3\"\u003e \u003ch2\u003e3.4.2 Basal Tear Secretion Function\u003c/h2\u003e\u003cp\u003eIn terms of basal tear secretion function (Schirmer I test, SIT), the two groups showed significant differences. Although the baseline SIT values were balanced between the two groups after matching (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.56), the mean SIT value in the aspheric group (AOK) (14.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5 mm) was significantly higher than that in the spherical group (SOK) (12.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6 mm) at the 12-month follow-up, with a statistically significant difference between the unadjusted groups (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.04, see Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). Although baseline SIT was balanced after matching, we used ANCOVA with baseline SIT as a covariate to allow for correlation between follow-up and baseline values. The results showed that the aspheric group remained robust in maintaining tear secretion: the adjusted mean difference between groups was 2.13 mm (95% CI: 0.07\u0026thinsp;~\u0026thinsp;4.20, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.04, Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e). This finding suggests that the aspheric base curve design may have less inhibitory effect on basal tear secretion function, but it needs to be regarded as an exploratory finding and needs to be verified by large sample studies considering sample size limitations and single center data.\u003c/p\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section3\"\u003e \u003ch2\u003e3.4.3 Corneal Safety and Lens Fit\u003c/h2\u003e \u003cp\u003e \u003cp\u003eBoth groups performed comparably on other ocular surface safety measures. During the follow-up period, there was no statistical difference in the positive rate of corneal fluorescein staining (83% without staining, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.9), incidence of lens protein precipitation (71% vs. 70%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.9) and meibomian gland morphological changes (10% vs. 13% with grade 1, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.7) between the two groups. In addition, the lens fit was well positioned, with 91% (SOK) and 97% (AOK) of the two groups having an eccentric distance of grade 1, respectively, with no significant difference between groups (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.8Table 5). The above data showed that both designs performed reliably in terms of mechanical safety and fit stability of the cornea.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis retrospective cohort study, using PSM to balance baseline confounding factors, systematically compared the 1-year myopia control efficacy and ocular surface safety of spherical and aspheric base curve OK lenses under standardized optical parameters. The key findings of this study were that the two lens designs showed similar efficacy in controlling AL elongation in adolescent myopic patients, but the aspheric base curve design had a significant advantage in preserving basal tear secretion.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4.1. Aspheric Design and Potential Protection Mechanisms for Tear Secretion Function\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe most striking finding of this study was that adolescents wearing AOK had significantly higher basal tear secretion (SIT value) than the SOK group at the 12-month follow-up, with an adjusted mean difference of 2.13 mm, \u003cem\u003ep\u003c/em\u003e = 0.04. This phenomenon may be closely related to changes in ocular surface biomechanics (Ocular Biomechanics) after OK lens wear. Theoretically, aspheric base curve designs better match the aspheric physiological characteristics (Q-values) of the anterior corneal surface, thereby achieving a more uniform stress distribution in the region of contact between the lens and the cornea [11, 15]. In contrast, traditional spherical designs may generate relatively concentrated mechanical stress or microcompression in specific areas such as the inversion arc area or the localization arc area when interacting with the cornea of the aspheric surface. This difference in mechanical action may have directly impacted the neuro-tear reflex arc. Basal tear secretion is mainly regulated by neural reflexes in the accessory lacrimal gland, while sensory nerve endings that trigger this reflex are densely distributed in the keratoconjunctival margin and meibomian gland region [16, 17]. We speculate that the local stress concentration generated by the spherical design may act as a chronic microstimulation that interferes with the normal conduction of neural signals, which in turn inhibits reflex tear secretion; while the aspheric design mitigates this mechanical interference through superior morphological adaptation, thus better protecting the neuroregulatory function of the ocular surface and maintaining a better basal tear secretion level [18-20].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4.2. Interpretation of Neutral Findings Regarding Myopia Control Efficacy\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn terms of myopia control, no significant difference in axial elongation was detected between the two designs (0.18 mm vs. 0.23 mm, \u003cem\u003ep\u003c/em\u003e = 0.32). This result suggests that under the standardized optical parameters applied in this study, especially a 6.0‑mm treatment zone diameter, geometric variations in the base curve zone may not substantially alter the intensity of peripheral retinal defocus signals, or such minor optical differences were insufficient to produce detectable changes in axial length within the sample size of the current study.Notably, myopia progression is modulated by a combination of genetic, environmental, optical, and biomechanical factors [21, 22]. Although optical theories suggest that aspherical designs may optimize defocus patterns, the observed advantage in tear secretion may indicate a potential compensatory mechanism: the aspherical design indirectly maintains ocular physiological homeostasis by improving the ocular surface microenvironment. Although this did not translate into a significant difference in axial elongation during the observation period, its long‑term benefits for ocular surface health deserve further investigation.\u003c/p\u003e"},{"header":"5. Conclusions","content":"\u003cp\u003eIn summary, this study provides important clinical implications. Although FBUT did not differ significantly between groups, maintaining basal tear secretion SIT is critical for adolescents wearing contact lenses long-term. For children with low basal tear secretion or those residing in dry climates, choosing an aspherical OK lens design may help reduce dry eye risk, improve wearing comfort, and enhance compliance.\u003c/p\u003e \u003cp\u003eHowever, as a single-center retrospective study, the present work has several limitations, including a relatively small sample size, particularly in the aspherical group, and a short follow-up duration. While PSM effectively balanced baseline confounders, it cannot fully substitute for the level of evidence afforded by randomized controlled trials. Furthermore, this study did not include dynamic evaluations of higher-order aberrations or accommodative function. Future studies incorporating biomechanical modeling and optical quality analysis are warranted to further verify the long-term benefits of aspherical base curve designs in preserving ocular surface health.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eOK: Orthokeratology\u003c/p\u003e\n\u003cp\u003eAL: axial length\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSER: spherical equivalent refraction\u003c/p\u003e\n\u003cp\u003eSE:Standard Error\u003c/p\u003e\n\u003cp\u003eFK: \u0026nbsp;Flat K\u003c/p\u003e\n\u003cp\u003eSK: Steep K\u003c/p\u003e\n\u003cp\u003eSOK: spherical base curve Orthokeratology group\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAOK: aspheric base curve Orthokeratology group \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFBUT: tear film break-up time\u003c/p\u003e\n\u003cp\u003eSIT: Schirmer I test\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCFS: corneal fluorescein staining\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePSM: propensity score matching\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSMD: standardized mean difference\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJingjing Cai: Study design, data collection, and manuscript drafting; Guoli Lan: Data analysis and statistical interpretation; Yingjie Lin: Patient recruitment and clinical assessment; Xianjun Liang: Study supervision and manuscript revision; Jiwen Yang: conceived the study, supervised the project, \u0026nbsp;revised the manuscript, and is the corresponding author. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was supported by the Foshan Self-Financed Science and Technology Innovation Project (Grant No. 2420001004593).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analysed during the study are not publicly available but are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Ethics Committee of Foshan Aier Zhuoyue Eye Hospital (Approval No.: FSZYEY-2026IRB04). All procedures were conducted in accordance with the Declaration of Helsinki . Informed consent was waived due to the retrospective and anonymized nature of the study, which was approved by the Ethics Committee.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor details\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGuangzhou Aier Eye Hospital, Jinan University, No.191, Huanshi Middle Road, Yuexiu District,Guangzhou, 510071, Guangdong, PR China.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eJonas JB, Ang M, Cho P, et al. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021;62(5):6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChamberlain P, Peixoto-De-Matos SC, Logan NS, et al. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019;96(8):556\u0026ndash;67.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHolden BA, Fricke TR, Wilson DA, 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\u003eZhang Z, Chen Z, Chen Z, et al. Change in Corneal Power Distribution in Orthokeratology: A Predictor for the Change in Axial Length. Transl Vis Sci Technol. 2022;11(2):18.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFaria-Ribeiro M, Navarro R, Gonzalez-Meijome JM. Effect of Pupil Size on Wavefront Refraction during Orthokeratology. Optom Vis Sci. 2016;93(11):1399\u0026ndash;408.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJohnson KL, Carney LG, Mountford JA, et al. Visual performance after overnight orthokeratology. Contact Lens Anterior Eye. 2007;30(1):29\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu T, Ma W, Wang J, et al. The effects of base curve aspheric orthokeratology lenses on corneal topography and peripheral refraction: A randomized prospective trial. Cont Lens Anterior Eye. 2023;46(3):101814.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi L, Lai T, Zou J, et al. Effects of orthokeratology lenses on tear film and tarsal glands and control of unilateral myopia in children. Front Cell Dev Biol. 2023;11:1197262.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVincent SJ, Cho P, Chan KY, et al. 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Ocul Surf. 2017;15(3):438\u0026ndash;510.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTsai H, Wang J, Chiu C. Assessment of Corneal Biomechanical Changes After Discontinuation of Long-Term Orthokeratology: A 2-Year Prospective Study. Transl Vis Sci Technol. 2025;14(4):5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi X, Xu J, Hong J, et al. The relationship between corneal biomechanical parameters and treatment outcomes of orthokeratology lenses. BMC Ophthalmol. 2022;22(1):262.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhao G, Zhai H, Xiang H, et al. Biomechanical study of cornea response under orthokeratology lens therapy: A finite element analysis. Int J Numer Method Biomed Eng. 2023;39(10):e3691.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZaabaar E, Asiamah R, Kyei S, et al. Myopia control strategies: A systematic review and meta-meta-analysis. Ophthalmic Physiol Opt. 2025;45(1):160\u0026ndash;76.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchmidt DC, Hvid-Hansen A, Jacobsen N, et al. Efficacy of interventions for myopia control in children: A systematic review with network meta-analyses. Acta Ophthalmol. 2025;103(8):939\u0026ndash;65.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"bmc-ophthalmology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"boph","sideBox":"Learn more about [BMC Ophthalmology](http://bmcophthalmol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/boph","title":"BMC Ophthalmology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Orthokeratology, Myopia control, Axial length, Tear film, Aspheric design, Ocular surface health","lastPublishedDoi":"10.21203/rs.3.rs-9449494/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9449494/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eTo compare the 1-year efficacy of spherical versus aspheric base curve orthokeratology (OK) lenses in controlling axial length (AL) elongation in myopic adolescents, and to explore differences in their impact on tear film function and ocular surface health.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis retrospective cohort study enrolled 137 adolescent myopic patients (right eye data only) who underwent OK lens fitting between July 2023 and August 2024. Patients were divided into a spherical base curve OK group (SOK group, n\u0026thinsp;=\u0026thinsp;107) and an aspheric base curve OK group (AOK group, n\u0026thinsp;=\u0026thinsp;30). The primary outcome was the change in AL at 12 months. Secondary outcomes included tear film break-up time (FBUT), Schirmer I test (SIT), and corneal fluorescein staining (CFS). Propensity score matching (PSM, 1:3) was used to balance baseline confounding factors.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAfter PSM, no statistically significant difference was found in AL elongation between the SOK and AOK groups (0.18 mm vs. 0.23 mm, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.32, 95% CI: \u0026minus;0.04\u0026thinsp;~\u0026thinsp;0.14 mm). FBUT decreased significantly from baseline in both groups after lens wear (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with no intergroup difference. At 12 months, the mean SIT value was significantly higher in the AOK group (14.6\u0026thinsp;\u0026plusmn;\u0026thinsp;5.5 mm) than in the SOK group (12.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6 mm), with an adjusted mean difference of 2.13 mm (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.04, 95% CI: 0.07\u0026thinsp;~\u0026thinsp;4.20). No significant differences were observed in other ocular surface safety indicators.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eWithin the sample size of this study, spherical and aspheric base curve OK lenses showed no statistically significant difference in controlling 1-year AL elongation. However, a clear conclusion of equivalence cannot be drawn due to limited statistical power. Exploratory analysis suggests that the aspheric design may offer advantages in preserving basal tear secretion, which requires validation in large-scale prospective studies.\u003c/p\u003e","manuscriptTitle":"A Comparative Study on the Effects of Spherical and Aspheric Orthokeratology Lenses on Myopia Control and Ocular Surface Health in Adolescents: A Retrospective Cohort Study Based on Propensity Score Matching","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-05-04 09:06:26","doi":"10.21203/rs.3.rs-9449494/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"162786036721994085445601783764486648822","date":"2026-05-10T11:10:38+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-22T06:00:02+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-04-21T11:11:59+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-18T06:55:59+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-18T06:54:59+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Ophthalmology","date":"2026-04-17T12:59:37+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-ophthalmology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"boph","sideBox":"Learn more about [BMC Ophthalmology](http://bmcophthalmol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/boph","title":"BMC Ophthalmology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8bc052ab-e5a8-42e1-9f07-3438c4c9c1d2","owner":[],"postedDate":"May 4th, 2026","published":true,"recentEditorialEvents":[{"type":"reviewerAgreed","content":"162786036721994085445601783764486648822","date":"2026-05-10T11:10:38+00:00","index":39,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-04T09:06:26+00:00","versionOfRecord":[],"versionCreatedAt":"2026-05-04 09:06:26","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9449494","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9449494","identity":"rs-9449494","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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