A comparison of myopia control in children with orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, Defocus Incorporated Soft Contact (DISK) lenses, and single-vision spectacles for 12 months

A comparison of myopia control in children with orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, Defocus Incorporated Soft Contact (DISK) lenses, and single-vision spectacles for 12 months | 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 Article A comparison of myopia control in children with orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, Defocus Incorporated Soft Contact (DISK) lenses, and single-vision spectacles for 12 months Lei Zhou, Kaikai Qiu, XiaoLan Wu, FengE Xu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4588107/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract PURPOSE : To evaluate the efficacy of orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, defocus incorporated soft contact (DISK) lens, and single-vision spectacles (SVS) on myopia control over 12 months in one clinical center. METHODS : The study was a non-randomized experimenter-masked prospective controlled study of individuals aged 8~12 years with progressing myopia but no ocular pathology. Participants were allocated, according to patients/parents’ choice, to receive DIMS (Hoya ® MiyoSmart ® ) spectacles, DISK (Defocus Incorporated Soft Contact) lenses, orthokeratology or SVS (control group). The key outcome variables, axial length (AL) and cycloplegic spherical equivalent refraction (SER) were measured at baseline and after 3, 6, 9and 12 months. RESULTS : Among the 103 children who were eligible, 90 (87.39%) children attended the baseline examination and 70 (77.78%) were analyzed (SVS: n = 14; DIMS: n = 13; DISC: n = 20; Orthokeratology: n = 25). At the 12- month mark, the mean changes in AL were 0.49 ± 0.20 mm, 0.25 ± 0.11 mm, 0.19 ± 0.26 mm and 0.21 ± 0.20 mm in SVS, DIMS, DISC and Orthokeratology group, respectively (P = 0.001, ANOVA); And the mean changes in SER after the same 12 months were −1.00 ± 0.33D, −0.36 ± 0.62D, and −0.37 ± 0.48D (p < 0.001) in SVS, DIMS and DISC group, respectively (p = 0.001, ANOVA). CONCLUSIONS : DISC, orthokeratology, DIMS had similar efficacy of myopia control in children. Registered Code :MR-33-22-012252 Health sciences/Biomarkers Health sciences/Diseases Health sciences/Health care Health sciences/Medical research Physical sciences/Optics and photonics myopia control children axial length Figures Figure 1 Figure 2 Backgrounds Myopia and high myopia estimated from 2000 to 2050 suggest significant increases in prevalence globally, with implications for planning tactic and services, including managing and preventing myopia-related ocular complications and vision loss among almost 1 billion people [1]. The increasing prevalence of myopia, particularly in school-age Chinese children, has become a public health concern [2]. Even at the ages of 18-20 years old, myopia progression was still continued; The 8-year myopia and high myopia incidence were 14.0% (95% CI, 11.5%-17.4%) and 0.7% (95% CI, 0.3%-1.2%), respectively. A myopic shift (of 0.50 diopters [D] or greater in at least 1 eye) occurred in 261 participants (37.8%) according to the data of the Raine Study [3]. As a contrast, a 2-year longitudinal study among 2,053 Chinese medical students (mean age 18.27 years), the overall prevalence of myopia increased significantly from 78.5 % to 84.1 % with the mean refractive error increased significantly from -2.52 ± 2.13 D to -2.84 ± 2.16 D over the 2 years [4]. Myopia correction with single vision spectacle (SVS) for most school-age children are often alternative but always the first choice since that the clear distance visual acuity could be achieved with SVS to see the tiny words in the blackboard at class as well as less cost compared to other interventions such as orthokeratology. However, even with the proper correction, the higher frequency of changing lenses due to the myopia progression would still a burden of family [5]. Moreover, myopia control is also crucial as it can prevent or delay the progression of the condition, reducing the risk of developing high myopia and its associated complications such as cataracts, glaucoma, and retinal detachment [6]. Effective tactics of myopia in children requires a combination of strategies that address both correction and control factors for their mental and physical health. Since the common intervention is the regular use of corrective eyewear, such as spectacles or contact lenses, which can help to both correct visual acuity for the distance blur and reduce eye strain to some extent. Additionally, some special designed optical interventions such as Defocus Incorporated Multiple Segments (DIMS) [7-8], Defocus Incorporated Soft Contact (DISC) [9-11], orthokeratology technology [12-15] were reported to statistically slowed down the progression of myopia versus those of single vision spectacles [7-16]. Although, other lighting intervention such as photobiomodulation (PBM) therapy [17-18] and non-optical intervention such as 1% atropine eye drops had been reported the much stronger efficacy to retard the myopia progression than all those above mentioned optical interventions [19-20], both PBM therapy and 1% high concentration atropine therapy would blur the vision temporary [17, 19]. Several above clinical interventions of optical methods in China are currently used for both slowing the progression of myopia and correction the distance vision acuity, including orthokeratology, DIMS spectacles, DISC, and Misight. While the most common intervention for children myopia is still SVS, which is often considered as a control, not an intervention. All the above three interventions (orthokeratology, DIMS, DISC) to control myopia progression were based on the theory of peripheral myopic defocus. And few study has claimed the efficacy difference and priority to recommend the best one for school-age myopia; Some short term study has found that contact lens group (orthokeratology and DISC) could get better control in AL for children of high myopia [20]. And the design of myopic defocus was +3.50D and +2.50D, for DIMS and DISK respectively. Here, we posed the hypothesis that those three optical interventions might have a little bit different efficacy in myopia control compared to the group of SVS but with difference changes of both AL and SER for 12 months. To figure out the best and different efficacy of all, and to make the right recommendation for oculists and patients, we initiated this clinical trial. Methods Study design This 12-month clinical trial was designed to be a non-randomized, parallel, experimenter-masked prospective controlled interventional study with follow-up visits of every 3 months. Potentially eligible children were recruited from the same hospital after a screening visit. The trial was designed to begin in August 2021 and end in March 2024. All subjects were enrolled at the department of optometry, Ningbo Eye Hospital. Our study and protocol conformed to the principles of the Declaration of Helsinki and were approved by the Ethical Committee of Ningbo Eye Hospital on March 26 th , 2022(Acceptance Number: 2019-qtky-06-X1). Eligibility criteria of Participants The inclusion criteria were as below: (1) the subject's guardian agreed to participate in the study and signed a written informed consent form; If the subject could express his or her willingness to participate in the trial, the subject's consent was also obtained; (2) age 8–12 years old (including the boundary values); there were no restrictions regarding gender; (3) the cycloplegic refraction with either spherical equivalent refractive (SER) was − 2.00 D ~ − 5.00 D (including the boundary values), and the total astigmatism was ≤ 1.00; (4) spectacle-corrected monocular VA was 0.00 logMAR or better; (5) willing to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same throughout the trial; (6)the flat curve value of the front central cornea was between 41.00D~44.00D; (7) the axial length (AL) of the study eye should be between 23.00mm and 25.00mm. The exclusion criteria were as follows: (1) patients who had ever used atropine (including 1% high concentration , 0.05%, 0.01% or other low concentration) ; (2) patients wearing peripheral defocus spectacles or duo-focal soft contact lenses in the previous history; (3) patients with eye diseases such as dry eye, keratitis, conjunctivitis, entropion, dry eye disease, glaucoma or retinal lesions; (4) unable to follow-up; (6)other reasons not eligible for contact lens; (7) optic media lesions (e.g., central thick corneal scars, cataract); (5) patients with optic nerve dysfunction; (6) patients with amblyopia; (7) research physicians determined that the subject was not eligible for some reasons. After screening, the participants were selected based on professional inquiry and baseline examination. The participants and their parents or legal guardians were informed about the benefits and risks of this study before providing signed informed consent on behalf of their children. Interventions and visits Only the SVS group as the control group (Group 1) wore the single focus minus lens with full correction for each subject as the first and only intervention throughout the whole procedure. DIMS group (Group 2), DISC group (Group 3) and orthokeratology group (Group 4) had the intervention of special designed lenses, respectively. During the baseline visit, eligibility was evaluated, and baseline measures were conducted. The dates of all subsequent visits were determined based on completion of the baseline examinations. Cycloplegic refraction using an automatic refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan). Subjective trial lenses were recorded at baseline and 12 months, respectively. Cycloplegia was achieved using 3 drops of 0.5% compound tropicamide eye drops administered every 5 minutes, and the spherical equivalent refraction (SER) was determined (obtained with the following formula: SER = spherical diopter + astigmatism/2). The follow-ups were conducted at 3 months, 6 months, 9 months and 12 months. The values of AL (IOLMaster 500, Carl Zeiss Meditec AG, Germany), was also recorded and evaluated at each visit in addition to the baseline visit. Other ophthalmologic examinations included slit-lamp examination (HS-5000(HLG), Huvitz Co. Ltd, Korea), noncontact tonometry (Topcon CT-80, Topcon Inc., Japan), and fundus scan with optical coherent tomography (Spectralis OCT, Heidelberg Engineering GmbH, Germany). Evaluated parameters The primary outcome variable was change in AL compared to baseline at Month 12. AL was measured by calculating the average of five measurements obtained from the same IOLMaster 500. The secondary outcome variables included SER. SER (sphere plus half cylinder) from the pattern of five measurements was measured at least 30 min after instillation of 3 drops of 0.5% compound tropicamide eye drops administered every 5 min. All the four groups were asked to keep the same intervention for at least 8 hours in the daytime based on the self-report of participants or their supervision. Sample size calculation Power analysis and sample size software (PASS 2022) (NCSS, LLC. Kaysville, Utah, USA) was used to determine that the minimum sample size was 64. A previous study found that the rate of AL change was approximately 0.21 mm/year (0.11 mm/year vs. 0.32 mm/year) slower in participants treated with SVS group. The mean AL progression was 0.11 mm and 0.32 mm with a standard deviation (SD) of 0.02 mm after 1 year in the control group based on previous findings [7]. This was based on a two-sided statistical test with 1% type I error threshold, 80% power and a 20% drop-out rate. To achieve an 80% power to detect a 0.21mm (0,10mm of SD) in myopia progression between four groups with an alpha lever of 0.01; The minimum subject number required in each group was 16. Considering 36% dropout rate, the total sample size was 100. Non- randomi zed experimenter-masked prospective controlled study Eligible participants enrolled in the study were assigned to receive single-vision spectacles (SVS), DIMS, DISK, or orthokeratology therapy at a 1:1:1:1 ratio. Researchers who were assessing outcomes and performers (for cycloplegic autorefraction and AL measurements) were still blinded to group allocation, but participants and care providers were not blinded. Adverse events Those who received at least once of any intervention were analyzed for safety. At each follow-up visit, the participants were asked about the symptoms and signs, including ocular symptoms (such as pain, blur, inches, photophobia）and systemic adverse effects (such as headache or dizziness). Other information included the best corrected vision acuity (BCVA), anterior segment with slit-lamps and fundus with optical coherence topograph (OCT). Additionally, each participant was also asked to report the other symptoms and different feelings compared to that of the latest follow-up. Adverse events were reported based on interviews at the 12-month follow-up visit. Results Subject profile Figure 1 is a flow diagram illustrating the number of subjects recruited, enrolled and dropped out during the whole procedure. Among the 103 eligible children, 90 (87.38%) attended the baseline examination, and 70 (67.96%) completed the 12-month follow-up. The baseline characteristics were comparable among the four groups (Table 1 ). The dropout rate was a much higher in the DIMS group (dropout number = 13, accounting for 54.17%) than those dropout rates from the SVS group (dropout number = 4, accounting for 22.22%), the DISK group (dropout number = 0, accounting for 0.00%) or the orthokeratology group (dropout number = 3, accounting for 10.71%). Table 1 Baseline demographics data of all and the completed subjects Mean (SD) ALL Completed Number SVS(n = 18) DIMS(n = 24) DISK(n = 20) OK(n = 28) SVS(n = 14) DIMS(n = 12) DISK(n = 20) OK(n = 25) Age at enrolment(years) 8.89 ± 1.13 9.08 ± 1.06 10.35 ± 1.73 9.11 ± 1.17 8.78 ± 1.12 9.00 ± 1.18 10.35 ± 1.72 9.20 ± 1.19 Gender Male, %(n) 55.56%(10) 52.38%(11) 30.00%(6) 39.29%(11) 57.14%(8) 72.73%(8) 30.00%(6) 40.00% (10) Female, %(n) 44.44%(8) 47.62(10) 70.00%(14) 60.71%(17) 42.86%(6) 27.27%(3) 70.00%(14) 60.00%(15) SER(D) -1.89 ± 1.13 -1.97 ± 0.67 -2.85 ± 0.94 -2.72 ± 0.64 -1.89 ± 0.83 -1.95 ± 0.51 -2.85 ± 0.94 -2.77 ± 0.66 AL (mm) 24.21 ± 0.52 24.28 ± 0.54 24.62 ± 1.09 24.43 ± 0.41 24.16 ± 0.54 24.41 ± 0.45 24.62 ± 1.09 24.42 ± 0.42 SVS, single vision spectacles; DIMS, Defocus Incorporated Multiple Segments spectacle lenses; DISK, Defocus Incorporated Soft Contact lenses; OK, orthokeratology lenses; SER, Spherical equivalent refraction; AL, axial length. Most of the dropout were due to the lost of follow-up without compliance, especially the follow-up was in the COVID-19 pandemic of 2022 ~ 2023, except the DIMS group; Two of DIMS group transferred to other interventions (orthokeratology and photobiomodulation therapy), that is to say, discontinued to wear DIMS spectacles. Baseline characteristics The mean age was 9.33 ± 1.37 years old of all groups. There were no statistically significant differences between SVS, DIMS, DISK and orthokeratology groups in the baseline characteristics (Table 1 ). The mean initial AL of all was 24.39 ± 0.68mm. The baseline mean myopia expressed in SER was − 2.38 ± 0.85D. The male versus female was 41: 49. Changes in the AL and SER For subjects who completed the 12-month trial (Table 2 ), only compared to that of SVS, changes in AL of DIMS, DISK, and orthokeratology group had significant difference with P value of 0.048 (DIMS versus SVS), 0.002 (DISK versus SVS), and 0.001 (orthokeratology versus SVS). Neither of DISM, DISK, nor orthokeratology group had AL elongation statistically significant difference (P > 0.05, P > 0.05, P > 0.05). So did the SER for 12 months, which also had significance either group from DIMS or DISK, compared to that of SVS group (P = 0.001, ANOVA). Table 2 ༎ Changes in the cycloplegic spherical equivalent refraction and axial length (from baseline) in DIMS, DISK, Orthokeratology and SVS groups SVS Group DIMS Group DISK Group OK Group P Value Time/Visit Changes in AL (mm) from baseline, mean values 6 months 0.23 ± 0.13 0.16 ± 0.07 0.07 ± 0.14 0.10 ± 0.12 0.02 12 months 0.49 ± 0.20 0.23 ± 0.11 0.18 ± 0.26 0.17 ± 0.27 0.001 Time/Visit Changes in SER(D) from baseline, mean values 6 months NA -0.19 ± 0.32 0.15 ± 0.29 NA 0.066 12 months -1.00 ± 0.33 -0.36 ± 0.62 -0.37 ± 0.48 NA 0.01 Bold text indicates a statistically significant difference between four groups (ANOVA, p < 0.05). ANOVA, Analysis of Variance. D, diopter; DIMS, Defocus Incorporated Multiple Segments spectacle lens; DISC, Defocus Incorporated Soft Contact lens; SER, spherical equivalent refraction; SVS, single vision spectacle lens; OK, orthokeratology lens; NA: Not applicable. Children wearing DIMS spectacles, DISK soft contact lens, orthokeratology rigid contact lens had significantly less myopia progression by 53.06% (mean difference 0.26mm, P < 0.001), 63.27% (mean difference 0.31mm, P < 0.001), 65.31% (mean difference 0.32mm, P < 0.001), compared with that of SVS group, respectively. Myopia progression of two age groups Changes in AL of two age groups (8–9 year-old group versus 10–12 year-old group) The mean myopia progression measured in AL and in SER over 12 months in the age group of 8 ~ 9 years old (n = 57) and 10–12 years old group(n = 33), was 0.32 ± 0.24 mm(n = 45), -0.71 ± 0.51D (n = 29) and − 0.37 ± 0.57D (n = 17), 0.16 ± 0.19mm (n = 27) respectively (P = 0.002, P = 0.042, respectively). Without the SVS group, the myopia change was 0.25 ± 0.20mm (n = 33), -0.51 ± 0.50D (n = 17) for 8–9 years group, and 0.15 ± 0.19mm (n = 25), -0.28 ± 0.55D (n = 15) for the 10–12 years group (P = 0.05, P = 0.026). Myopia control rate of different interventions 12.90% (n = 8) and 14.30% (n = 10) out of 70 children had no myopia progression over 12 months if the criteria of no myopia progression was set at the AL elongation was ≤ 0 (Criteria 1) and 0.3mm (Criteria 2), respectively. As for the SVS, DIMS, DISK and orthokeratology group, 14.29% (n = 3), 63.64% (n = 7), 85.00%(n = 17), and 56.00%༈n = 12)children had no myopia progression according to the Criteria 2 over 12 months; While according to the Criteria 1, SVS, DISM, DISK and orthokeratology group had AL control rate was much lower than 0.00, 0.00, 25.00% and 12.00% (Table 3 ), respectively. And the myopia control rate with the Criteria 2 was statistically significant (Fisher exact test, P = 0.002); However, neither group among DIMS, DISK, orthokeratology had statistically significant myopia control rate (Chi-square test, P = 0.285, P = 0.121, P = 0.143). Table 3 Comparison of rates of myopia control rate for four groups over 12 months SVS group DIMS group DISK group Ortho-K group Total Total number 14 11 20 25 70 Myopia Control Rate 1 (SER≥-0.50D) 0.00%(n = 0) 63.60%(n = 8) ༊ 47.40%(n = 15) ༊ NA 65.90% (n = 25) Myopia Control Rate 2(AL ≤ 0.30mm) 14.29%(n = 3) 63.64%(n = 7) ༊ 85.00%(n = 17) ༊ 56.00%(n = 12) ༊ 14.30%(n = 10) Myopia Control Rate 3(AL ≤ 0.00mm) 0.00%(n = 0) 0.00%(n = 0) 25.00%(n = 5) 12.00%(n = 4) 12.90%(n = 8) Myopia Control Rate 4 (SER ≥ 0.00D) 0.00%(n = 0) 18.2%(n = 2) 47.37%(n = 9) NA 25.00%(n = 11) ༊ Statistically significant difference among DIMS, DISK, Ortho-k groups (fisher exact test, P < 0.0001).SVS, single vision spectacle; DIMS, defocus incorporated multiple segments; DISK, defocus incorporated soft contact; Ortho-k, orthokeratology; SER, spherical equivalent refraction; AL: axial length; NA, not applicable. For the 0.3 mm/ year standard for AL elongation comparing, At the end of the 12-month period, the mean changes in AL were significantly lower in the DIMS, DISK, and orthokeratology groups compared to the SVS group, respectively (Table 2 ). However, there was not significantly difference among the DIMS, DISK, and orthokeratology group, respectively, although there was the tendency of the mean changes AL changes at 12-month follow-up (Table 2 , Fig. 2 ). Similarly, the mean changes in SER were also more favorable in the three intervention (DIMS, DISK, orthokeratology) groups than the SVS group. Over the 6-month period, the axial elongation was smallest in the DISK group, followed by Orthokeratology and DIMS groups, but without statistically significance among DIMS, DISK, and orthokeratology group, respectively. The changes in AL were statistically significant at 6 months from the DIMS, DISK, orthokeratology lens groups compared to the SVS group (P < 0.001). For Person correlation analysis, the change in AL at Month 12 was significantly correlated with subject’s age (P = 0.014); Neither the gender(P = 0.308), nor the baseline AL(P = 0.189) or baseline SER (P = 0.264) had statistically significant. On the other side, the change of AL at Month 12 was significantly correlated with the change of AL at Month 3 (P < 0.001), Month 6 (P < 0.001), and Month 9 (P < 0.001), respectively. Adverse effects There were no severe complications throughout the study period. Orthokeratology group had obvious mild adverse event as below: 20% of all cornea superficial punctate keratitis (SPK) were noted in the orthokeratology group during the study period. SPK from the orthokeratology group, which occurred on the second day after first overnight wearing this rigid gas permeable contact lens; Among those, two cases prescribed epithelium growth promotion eye drops to help recovery of those reversal SPK; Another subject prescribed the longer day’ of the eyedrops to obtain the complete recovery due to the trichiasis. And both DISK group and orthokeratology group had detected allergic conjunctivitis with prescription of Emedastine difumarate eye drops for 1 week, respectively; And among the above issue periods, the therapy was short-term within 3 days ~ 1 week. And all the participants continued their therapy after the symptoms were completely relieved. As to the DIMS group, only 2 cases had visual discomfort at earlier months, complaining of a little bit blur, but gradually accepted the visual quality in the later follow-up. And no AE was reported from the SVS group. Discussion The findings of our study demonstrated that DIMS, DISK, and orthokeratology were all efficacy interventions in controlling myopia progression among school-age children, with the AL change value of 0.25 ± 0.08mm, 0.18 ± 0.25mm, 0.21 ± 0.20mm after 12 months, which was consistent with Tang T and etc.’ s study. In their retrospective study of 12 months’ interventions with DIMS lenses and orthokeratology lenses, the AL change was 0.22 ± 0.14mm(n = 41) and 0.20 ± 0.12mm(n = 41), respectively, although their participants with the much wider range of ages (6 ~ 14 years old) than that of ours (8 ~ 12 years old). Myopia control was much better in the older age group than that of the younger age group in their study, which was the same story of ours. The older age group showed only half mean AL elongation compared with that of the younger age group with statistical significance (0.32 ± 0.24mm vs 0.16 ± 0.19mm, P = 0.002) when compared group of the 8 ~ 9 years old age versus Group aged 10 ~ 12 (independent t-test)in our study. When compared with the DIMS spectacle lenses slow myopia progression: a 2-year randomized clinical trial, the Chinese children aged 8–13 years, the mean myopia progression value measured in AL elongation was 0.11mm ± 0.02mm and 0.21 ± 0.02mm at Visit of 12 months and at Visit of 24 months, respectively (n = 79)[ 7 ], which was much better than what here we reported, almost twice the efficacy of myopia control and 10 times less the standard deviations. This might be partly due to the study time were different: August 2014 and July 2017 (Including two summers, myopia progression in Chinese children was slower in summer than in winter [ 22 ]), without COVID-19 pandemics which really happened in our study period. Moreover, they had more strictly wear compliance and checked by phone calls and questionnaires which ours did not conduct. Actually, the population was increasing in China to wear DIMS and similar myopic defocus design spectacles even there were many issues, like reduced stereo acuity as reported by Lam and etc. [ 7 – 8 ]. The mechanisms underlying the myopia control effects of these interventions might a little bit vary. DIMS and DISC spectacles use multi-focal optics to stimulate myopic defocus, which to some extent, slowed down the eyeball growth rate and thus companied of the myopia progression. Orthokeratology, on the other hand, uses specially designed rigid gas-permeable contact lenses to temporarily reshape the center of cornea, reducing refractive error and potentially delaying axial elongation due to the temporary and repeated peripheral hyperopic defocus of the retina through the pupils, which was not yet confirmed. Some studies had found the two orthokeratology regimens, target reduction of 6.00 D and target of 4.00 D, had similar effects in controlling the increase in axial length and refractive error in high-myopia children [ 23 ]. In this study, the only the age lever was the significant factor to cause the myopia control rate, not the baseline SER and baseline AL. Our study adds to the growing evidence supporting the use of non-surgical interventions in managing myopia among children. Given the increasing prevalence of myopia and its associated risks, it is crucial to identify efficacy and safe interventions for myopia control. Future studies should further investigate the 5–10 years long-term effects of these interventions and identify the most eligible candidates for each intervention based on factors such as compliance, cost, and availability. As to those 2 subjects dropouts at 3-month follow-up of DIMS group, it might be no necessary to shift from the DIMS group into the orthokeratology group. The wise chose might be added the atropine eyedrops to the DIMS or orthokeratology if the only intervention of DIMS or orthokeratology was not satisfied within 1 year [ 21 ]. As to the 12-month DISK report from Sankaridurg P et al. [ 9 ], with the age from 7 to 14 years (n = 45, mean age 9.3 years old), their mean progression of myopia was − 0.28 ± 0.28 D (0.24 ± 0.17 mm AL elongation) ; Considering Anstice N S and Phillips J R’s DISK study of 10 months [ 10 ], the mean AL elongation of dual-focus soft contact lens in 11 ~ 14 -years Children was − 0.44 ± 0.33 D with the mean increase in AL was 0.11 ± 0.09 mm. In another 2-year double-blind randomized controlled trial, myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year vs 0.40 D/year). Likewise, there was less axial elongation for children in the DISC versus SVS groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year). Treatment effect correlated positively with DISC lens wearing time (r = 0.342; p = 0.005). While our 12-months’ follow-up was − 0.37 ± 0.48D more myopic SER with 0.18 ± 0.25mm AL elongation. The difference could be the different age levers and baseline SER/AL as well as the compliance about 5 ~ 10 hours daily exactly wearing the DISK contact lenses. And when take orthokeratology intervention of AL elongation, the mean elongation was 0.20 ± 0.15mm/year (n = 37) [ 12 ], 0.22mm/year (n = 31) [ 13 ], 0.39 ± 0.27 mm in the 2-year study period) [ 14 ], and 0.99 ± 0.47 in the 5-year study period; While our study was 0.17 ± 0.27 mm(n = 25), which was comparable and accordant. Although with the ages increasing, the myopia progression significantly slowed down in either group of SVS, DIMS, DISK or orthokeratology if the 8 ~ 9 years group versus 10 ~ 12years group (P < 0.05). Although the DIMS had no statistically significant efficacy compared to the DISK and orthokeratology group, there was higher dropout rate within the spectacles groups, especially the DIMS. Among those 8 dropout cases, 4 subjects stopped the DIMS due to the unsatisfied myopia control efficacy and transferred to the orthokeratology lenses (1 case), photobiomodulation therapy (1 case), atropine therapy (1 case) and other unknown interventions in other hospital (1 case). The other 4 dropouts were lost without exact reasons. The DIMS spectacles and similar myopia control design spectacles were very popular throughout the China in the recent 3 years since it was not medical device and easier marketing available outside hospitals. And in our study, it had the tendency of high dropout rate and lower compliance partly due to the unsatisfied myopia control rate compared to other myopia control interventions except the SVS. The limitations of this study were as below. First, the sample size of each group was not large enough to figure out the statistical difference among the DIMS, DISK and orthokeratology group. Second, this trial had non-randomized design for the feasible of enrollment of participants, especially those supervisions during the Chinese COVID-19 pandemic period. Third, the total dropout rate was 22.22%, a little bit higher than common clinical trial (≤ 20.00%), especially both spectacle groups (DIMS group with 57.14% dropout rate versus SVS group with 22.22% dropout). Fourthly, there were no refractive error record of orthokeratology group since refractive error was almost within ± 0.50D without stopping several days or weeks’ wearing the orthokeratology lenses; Otherwise, the rebound AL elongation of stopping wearing orthokeratology lenses would ruin the myopia control in AL for orthokeratology group. Big sample size, randomized, and sham devices controlled trials are needed to confirm these findings and to assess the 5 ~ 10 years long term safety and efficacy of these interventions. Conclusions Our findings suggest that DIMS, DISK, and Orthokeratology had similar efficacy for myopia control compared to that of SVS in 12 months. We suggest the younger age of 8 ~ 9- year - myopia to wear DIMS, DISK or orthokeratology lenses as the first intervention for both myopia control and correction. Declarations Ethics approval and consent to participate The study was approved by the Ethics Committee of Biomedical Research Involving Humans (Approval No. 2022–002) on March 26 th , 2022 and was conducted in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was signed by supervisions and children with written informed consent forms. Consent for publication Not Applicable. Availability of data and materials Datasets of this study are available from the corresponding author upon reasonable request. Competing interests The authors declare no competing interests. Funding Supported by a grant from the Science and Technology Program of Ningbo, China (grant no. 20201YZQ010028). Authors’ c ontributions L.Z. conceived the research idea. L.Z, W. X., X. F. and other oculists from Ningbo Eye Hospital performed the experiments. L. Z. and W.X., X.F., provided the data. K. Q. analyzed the data and wrote the main manuscript. L.Z., X. W. and K.Q. provided the related references and funding. D.C. ran a thorough check on the use of English for scientific writing. All authors contributed to manuscript revision, and each read and approved the revision and final manuscript. All study subjects provided informed consent. Acknowledgements The authors thank the corporation of local supply with free DIMS lenses, discounted prices of DISK and orthokeratology for providing the optical interventions with lenses devices. In addition, the authors gratefully acknowledge the ophthalmic technicians who helped conduct the testing and corrected the data at Ningbo Eye Hospital. Finally, the authors sincerely thank the families and children who participated in this study. Authors’ information Names of all authors (with Affiliations Information) ①Lei Zhou ＊ 1 ②Kaikai Qiu 2-3 ③Xiaolan Wu 1 ④Fenge Xu 1 Dr. Qiu Kaikai ＊ is the corresponding author (e-mail address: [email protected] ) Affiliation of corresponding author: Fuzhou Southeast institute of visual ophthalmology, Fuzhou(City), China EOSVision MedTech LLC, Suzhou (City), China Sunjing Spactacles and Ophthalmology Clinic, Kunming (City), China. Department of all authors by sequence of author in author list as the followings. 1- - Department of Optometry, Ningbo Eye Hospital, Ningbo(City), China, 315100 (Zip) 2- EOSVision LLC, Suzhou(City), China, 215501 (Zip) 3- Sunjing Spectacles and Ophthalmology Clinic, Kunming(City), China. 650000 (Zip). ORCID of the two authors as below: the 16-digit ORCID of the author- Kaikai Qiu: 0000-0001-5195-7564 the 16-digit ORCID of the author- Lei Zhou: 0000-0002-2895-6819 References Holden B A, Fricke T R, Wilson D A, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 2016: S0161642016000257. Sun J, Zhou J, Zhao P, et al. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Investigative Ophthalmology & Visual Science, 2012, 53(12):7504. Lee SS, Lingham G, Sanfilippo PG, et al. Incidence and Progression of Myopia in Early Adulthood. JAMA Ophthalmol. 2022;140(2):162–169. doi: 10.1001/jamaophthalmol.2021.5067 . Lei L, Zhenghou Z. Pattern of myopia progression in Chinese medical students: a two-year follow-up study[J]. Graefes Archive for Clinical & Experimental Ophthalmology, 2013, 251(1):163–168. Fricke T, Holden B, Wilson D A, et al. Global cost of correcting vision impairment from uncorrected refractive error[J]. Bulletin of the World Health Organization, 2012, 90(10):728–738. Holden B, Sankaridurg P, Smith E, et al. Myopia, an underrated global challenge to vision: where the current data takes us on myopia control[J]. Eye, 2014, 28(2):142–146. Lam CSY, Tang WC, Tse DY, Lee, RPK, Chun RKM, et al. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomized clinical trial. Br J Ophthalmol.2019,0:1–6. Lam, C.S.Y., Tang, W.C., Zhang, H.Y. et al. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep 13, 5475 (2023). https://doi.org/10.1038/s41598-023-32700-7 . Sankaridurg P, Holden B, Smith E, et al. Decrease in Rate of Myopia Progression with a Contact Lens Designed to Reduce Relative Peripheral Hyperopia: One-Year Results. Investigative Ophthalmology & Visual Science, 2011, 52(13):9362. Anstice N S, Phillips J R. Effect of Dual-Focus Soft Contact Lens Wear on Axial Myopia Progression in Children. Ophthalmology, 2011, 118(6):1152–1161. Yin L C S, Tang W C, Yan-Yin T D, et al. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomized clinical trial. British Journal of Ophthalmology, 2014, 98(1):40–45. Pauline C, Sin-Wan C. Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial. Investigative Opthalmology & Visual Science, 2012, 53(11):7077. Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, et al. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes[J]. Investigative Ophthalmology & Visual Science, 2012, 53(8):5060. Tetsuhiko K, Takahiro H, Tetsuro O. Influence of Overnight Orthokeratology on Axial Elongation in Childhood Myopia. Investigative Ophthalmology & Visual Science, 2011, 52(5):2170-. Takahiro H, Tetsuhiko K, Fumiki O, et al. Long-term effect of overnight orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up study. Investigative Ophthalmology & Visual Science, 2012, 53(7):3913. Sankaridurg P, Holden B, Smith E, et al. Decrease in Rate of Myopia Progression with a Contact Lens Designed to Reduce Relative Peripheral Hyperopia: One-Year Results. Investigative Ophthalmology & Visual Science, 2011, 52(13):9362. Zhou L, Tong L, Li Y, Williams BT, Qiu K. Photobiomodulation therapy retarded axial length growth in children with myopia: evidence from a 12-month randomized controlled trial evidence. Sci Rep. 2023;13(1):3321. http://doi:10.1038/s41598-023-30500-7 . Qiu K., David C., Li Y., Tong L, Lin W. A retrospective study of cumulative absolute reduction in axial length after photobiomodulation therapy. BMC Ophthalmology 24. 191(2024). https://doi.org/10.1186/s12886-024-03427-4 . Polling J R, Kok R G, Tideman J W, et al. Effectiveness study of atropine for progressive myopia in Europeans. Eye, 2016, 30(7):998–1004. Iribarren R, Iribarren G, Szwajkowska M, et al. The Role of Atropine Eye Drops in Myopia Control. Current Pharmaceutical Design, 2015, 21(32). Tang T, Lu YC, Li XW, Zhao H, Wang K, Li Y, Zhao MW. Comparison of the long-term effects of atropine in combination with orthokeratology and defocus incorporated multiple segment lenses for myopia control in Chinese children and adolescents. Eye. 2024. Feb 28th. 1–8. Donovan L, Sankaridurg P, Ho A, Chen X, Lin Z, Thomas V, Smith EL 3rd, Ge J, Holden B. Optom Vis Sci. 2012;89(8):1196–202. Myopia progression in Chinese children is slower in summer than in winter. Lyu T, Wang L, Zhou L, Qin J, Ma H, Shi M. Regimen Study of High Myopia-Partial Reduction Orthokeratology. Eye Contact Lens. 2020;46(3):141–146. Additional Declarations No competing interests reported. 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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-4588107","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":326313486,"identity":"f0a479b8-536e-4d20-bee4-79ce19e6bc93","order_by":0,"name":"Lei Zhou","email":"","orcid":"","institution":"Ningbo Eye Hospital, Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Lei","middleName":"","lastName":"Zhou","suffix":""},{"id":326313487,"identity":"bef35347-0b79-4b79-892d-765b5f6c3b49","order_by":1,"name":"Kaikai Qiu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAtklEQVRIiWNgGAWjYBACCR4GhgMMBgxybOzNB0jTYszHcyyBeC0gkDhPIkeBOC2SPYcfHnhTcDi9jSGHgeFHxTbCWqR52wwOzjE4nNvGcPYAY8+Z24S1yPEzGBzmAWlh7EtgZmwjSgv7B5CWdDZmHgPitEjz9oBtSWBjI1aLZM+ZAqBf0g3beNgSDhLlF4kz6Zs/vPljLS8///HBBz8qiNACBtC4AcYp0YCHsJJRMApGwSgYyQAAqPY58fBVs/YAAAAASUVORK5CYII=","orcid":"","institution":"Fuzhou Southeast Institute of Visual Ophthlamology","correspondingAuthor":true,"prefix":"","firstName":"Kaikai","middleName":"","lastName":"Qiu","suffix":""},{"id":326313488,"identity":"0b1c38f3-39f1-41cb-9642-995b2a068f79","order_by":2,"name":"XiaoLan Wu","email":"","orcid":"","institution":"Ningbo Eye Hospital, Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"XiaoLan","middleName":"","lastName":"Wu","suffix":""},{"id":326313489,"identity":"526d5be4-6298-4947-9324-6f914c82a41e","order_by":3,"name":"FengE Xu","email":"","orcid":"","institution":"Ningbo Eye Hospital, Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"FengE","middleName":"","lastName":"Xu","suffix":""}],"badges":[],"createdAt":"2024-06-16 02:08:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4588107/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4588107/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":60530501,"identity":"8bcdcd83-15ad-431e-9b13-54cd3c35c469","added_by":"auto","created_at":"2024-07-17 20:06:14","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":49578,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eStudy Flow Diagram\u003c/strong\u003e. DIMS, defocus incorporated multiple segment spectacle lens; DISK, Defocus Incorporated Soft Contact lens; Ortho-K, orthokeratology contact lens; Control, single vision spectacle lens as the Group Control.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4588107/v1/a79478c7bf3e7fd900e4a555.png"},{"id":60530918,"identity":"a55f9d3e-ef46-4942-8a4e-0392b31d098d","added_by":"auto","created_at":"2024-07-17 20:14:14","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":137685,"visible":true,"origin":"","legend":"\u003cp\u003eAxial length elongation of Four Groups at 3-month, 6-month, 9-month and 12-month follow-up. AL, Axial length; SVS, single vision spectacle; DIMS, defocus incorporated multiple segment spectacle lens; DISK, defocus incorporated soft contact lens; Orhto-K, orthokeratology.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-4588107/v1/fb9052e279007ef5173898f1.png"},{"id":61321101,"identity":"dee9ec30-0e13-4ef9-9d4b-04a103283682","added_by":"auto","created_at":"2024-07-29 13:07:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":733052,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4588107/v1/40b0d421-b156-458d-b790-0db70fbed594.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A comparison of myopia control in children with orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, Defocus Incorporated Soft Contact (DISK) lenses, and single-vision spectacles for 12 months","fulltext":[{"header":"Backgrounds","content":"\u003cp\u003eMyopia and high myopia estimated from 2000 to 2050 suggest significant increases in prevalence globally, with implications for planning tactic and services, including managing and preventing myopia-related ocular complications and vision loss among almost 1 billion people [1]. The increasing prevalence of myopia, particularly in school-age Chinese children, has become a public health concern [2]. Even at the ages of 18-20 years old, myopia progression was still continued; The\u0026nbsp;8-year myopia and high myopia incidence were 14.0% (95% CI, 11.5%-17.4%) and 0.7% (95% CI, 0.3%-1.2%), respectively. A myopic shift (of 0.50 diopters [D] or greater in at least 1 eye) occurred in 261 participants (37.8%) according to the data of the Raine Study [3]. As a contrast, a 2-year longitudinal study among 2,053 Chinese medical students (mean age 18.27 years), the overall prevalence of myopia increased significantly from 78.5 % to 84.1 % with the mean refractive error increased significantly from -2.52 \u0026plusmn; 2.13 D to -2.84 \u0026plusmn; 2.16 D over the 2 years [4].\u003c/p\u003e\n\u003cp\u003eMyopia correction with single vision spectacle (SVS) for most school-age children are often alternative but always the first choice since that the clear distance visual acuity could be achieved with SVS to see the tiny words in the blackboard at class as well as less cost compared to other interventions such as orthokeratology. However, even with the proper correction, the higher frequency of changing lenses due to the myopia progression would still a burden of family [5]. Moreover, myopia control is also crucial as it can prevent or delay the progression of the condition, reducing the risk of developing high myopia and its associated complications such as cataracts, glaucoma, and retinal detachment [6].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEffective tactics of myopia in children requires a combination of strategies that address both correction and control factors for their mental and physical health. Since the common intervention is the regular use of corrective eyewear, such as spectacles or contact lenses, which can help to both correct visual acuity for the distance blur and reduce eye strain to some extent. Additionally, some special designed optical interventions such as Defocus Incorporated Multiple Segments (DIMS) [7-8], Defocus Incorporated Soft Contact (DISC) [9-11], orthokeratology technology [12-15] were reported to statistically slowed down the progression of myopia versus those of single vision spectacles [7-16].\u003c/p\u003e\n\u003cp\u003eAlthough, other lighting intervention such as photobiomodulation (PBM) therapy [17-18] and non-optical intervention such as 1% atropine eye drops had been reported the much stronger efficacy to retard the myopia progression than all those above mentioned optical interventions [19-20], both PBM therapy and 1% high concentration atropine therapy would blur the vision temporary [17, 19].\u003c/p\u003e\n\u003cp\u003eSeveral above clinical interventions of optical methods in China are currently used for both slowing the progression of myopia and correction the distance vision acuity, including orthokeratology, DIMS spectacles, DISC, and Misight. While the most common intervention for children myopia is still SVS, which is often considered as a control, not an intervention. All the above three interventions (orthokeratology, DIMS, DISC) to control myopia progression were based on the theory of peripheral myopic defocus. And few study has claimed the efficacy difference and priority to recommend the best one for school-age myopia; Some short term study has found that contact lens group (orthokeratology and DISC) could get better control in AL for children of high myopia [20]. And the design of myopic defocus was +3.50D and +2.50D, for DIMS and DISK respectively. Here, we posed the hypothesis that those three optical interventions might have a little bit different efficacy in myopia control compared to the group of SVS but with difference changes of both AL and SER for 12 months. To figure out the best and different efficacy of all, and to make the right recommendation for oculists and patients, we initiated this clinical trial.\u0026nbsp;\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis 12-month clinical trial was designed to be a\u0026nbsp;non-randomized, parallel, experimenter-masked prospective controlled interventional study with follow-up visits of every\u0026nbsp;3\u0026nbsp;months. Potentially eligible children were recruited from the\u0026nbsp;same\u0026nbsp;hospital after a screening visit.\u003c/p\u003e\n\u003cp\u003eThe trial was designed to begin in\u0026nbsp;August\u0026nbsp;2021\u0026nbsp;and end in\u0026nbsp;March\u0026nbsp;2024. All subjects were enrolled at the department of optometry, Ningbo Eye Hospital. Our study and protocol conformed to the principles of the Declaration of Helsinki and were approved by the Ethical Committee of Ningbo Eye Hospital\u0026nbsp;on March 26\u003csup\u003eth\u003c/sup\u003e, 2022(Acceptance\u0026nbsp;Number: 2019-qtky-06-X1).\u003c/p\u003e\n\u003ch3\u003eEligibility criteria of Participants\u003c/h3\u003e\n\u003cp\u003eThe inclusion criteria were as below: (1) the subject\u0026apos;s guardian agreed to participate in the study and signed a written informed consent form; If the subject could express his or her willingness to participate in the trial, the subject\u0026apos;s consent was also obtained; (2) age 8\u0026ndash;12 years old (including the boundary values); there were no restrictions regarding gender; (3) the cycloplegic refraction with either spherical equivalent refractive (SER) was \u0026minus;\u0026thinsp;2.00 D\u0026thinsp;~\u0026thinsp;\u0026minus;\u0026thinsp;5.00 D (including the boundary values), and the total astigmatism was\u0026thinsp;\u0026le;\u0026thinsp;1.00; (4) spectacle-corrected monocular VA was 0.00 logMAR or better; (5) willing to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same throughout the trial; (6)the flat curve value of the front central cornea was between 41.00D~44.00D; (7) the axial length (AL) of the study eye should be between 23.00mm and 25.00mm.\u003c/p\u003e\n\u003cp\u003eThe exclusion criteria were as follows: (1) patients who had ever used atropine (including 1% high concentration , 0.05%, 0.01% or other low concentration) ; (2) patients wearing peripheral defocus spectacles or duo-focal soft contact lenses in the previous history; (3) patients with eye diseases such as dry eye, keratitis, conjunctivitis, entropion, dry eye disease, glaucoma or retinal lesions; (4) unable to follow-up; (6)other reasons not eligible for contact lens; (7) optic media lesions (e.g., central thick corneal scars, cataract); (5) patients with optic nerve dysfunction; (6) patients with amblyopia; (7) research physicians determined that the subject was not eligible for some reasons. After screening, the participants were selected based on professional inquiry and baseline examination. The participants and their parents or legal guardians were informed about the benefits and risks of this study before providing signed informed consent on behalf of their children.\u003c/p\u003e\n\u003ch3\u003eInterventions and visits\u003c/h3\u003e\n\u003cp\u003eOnly the SVS group as the control group (Group 1) wore the single focus minus lens with full correction for each subject as the first and only intervention throughout the whole procedure. DIMS group (Group 2), DISC group (Group 3) and orthokeratology group (Group 4) had the intervention of special designed lenses, respectively. During the baseline visit, eligibility was evaluated, and baseline measures were conducted. The dates of all subsequent visits were determined based on completion of the baseline examinations. Cycloplegic refraction using an automatic refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan). Subjective trial lenses were recorded at baseline and 12 months, respectively. Cycloplegia was achieved using 3 drops of 0.5% compound tropicamide eye drops administered every 5 minutes, and the spherical equivalent refraction (SER) was determined (obtained with the following formula: SER\u0026thinsp;=\u0026thinsp;spherical diopter\u0026thinsp;+\u0026thinsp;astigmatism/2). The follow-ups were conducted at 3 months, 6 months, 9 months and 12 months. The values of AL (IOLMaster 500, Carl Zeiss Meditec AG, Germany), was also recorded and evaluated at each visit in addition to the baseline visit. Other ophthalmologic examinations included slit-lamp examination (HS-5000(HLG), Huvitz Co. Ltd, Korea), noncontact tonometry (Topcon CT-80, Topcon Inc., Japan), and fundus scan with optical coherent tomography (Spectralis OCT, Heidelberg Engineering GmbH, Germany).\u003c/p\u003e\n\u003ch3\u003eEvaluated parameters\u003c/h3\u003e\n\u003cp\u003eThe primary outcome variable was\u0026nbsp;change in AL compared to baseline\u0026nbsp;at Month 12. AL was measured by calculating the average of five measurements obtained from the same IOLMaster\u0026nbsp;500. The secondary outcome variables included SER. SER (sphere plus half cylinder) from the pattern of five measurements was measured at least 30 min after instillation of\u0026nbsp;3\u0026nbsp;drops of\u0026nbsp;0.5%\u0026nbsp;compound tropicamide eye drops administered every 5 min.\u0026nbsp;All the four groups were asked to\u0026nbsp;keep the same intervention\u0026nbsp;for\u0026nbsp;at least 8 hours in the daytime\u0026nbsp;based on the self-report of participants or their supervision.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eSample size calculation\u003c/h3\u003e\n\u003cp\u003ePower\u0026nbsp;analysis and\u0026nbsp;sample\u0026nbsp;size\u0026nbsp;software (PASS 2022) (NCSS, LLC. Kaysville, Utah, USA) was used to determine that the minimum sample size was\u0026nbsp;64. A previous study found that the rate of AL change was approximately 0.21\u0026nbsp;mm/year (0.11\u0026nbsp;mm/year vs. 0.32\u0026nbsp;mm/year) slower in participants treated with\u0026nbsp;SVS group. The mean AL progression was 0.11\u0026nbsp;mm and 0.32\u0026nbsp;mm with a standard deviation (SD) of 0.02\u0026nbsp;mm after 1 year in the control group based on previous findings\u0026nbsp;[7]. This was based on a two-sided statistical test with 1% type I error threshold,\u0026nbsp;80% power and a\u0026nbsp;20% drop-out rate.\u0026nbsp;To achieve an 80% power to detect a 0.21mm (0,10mm of SD) in myopia progression between four groups with an alpha lever of 0.01; The minimum subject number required in each\u0026nbsp;group was 16. Considering 36% dropout rate, the total sample size was 100.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNon-\u003c/strong\u003e\u003cstrong\u003erandomi\u003c/strong\u003e\u003cstrong\u003ezed experimenter-masked prospective controlled study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEligible participants enrolled in the study were assigned to receive single-vision spectacles (SVS), DIMS, DISK,\u0026nbsp;or\u0026nbsp;orthokeratology\u0026nbsp;therapy at a 1:1:1:1\u0026nbsp;ratio.\u0026nbsp;Researchers who were assessing outcomes and performers (for cycloplegic autorefraction and AL measurements) were still blinded to group allocation, but participants and care providers were not blinded.\u003c/p\u003e\n\u003ch3\u003eAdverse events\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThose who received at least once of any intervention were analyzed for safety. At each follow-up visit, the participants were asked about the symptoms and signs, including ocular symptoms (such as pain, blur, inches, photophobia）and systemic adverse effects (such as headache or dizziness). Other information included the best corrected vision acuity (BCVA), anterior segment with slit-lamps and fundus with optical coherence topograph (OCT). Additionally, each participant was also asked to report the other symptoms and different feelings compared to that of the latest follow-up. Adverse events were reported based on interviews at the 12-month follow-up visit.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e\u003ch2\u003eSubject profile\u003c/h2\u003e\u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e1\u003c/span\u003e is a flow diagram illustrating the number of subjects recruited, enrolled and dropped out during the whole procedure. Among the 103 eligible children, 90 (87.38%) attended the baseline examination, and 70 (67.96%) completed the 12-month follow-up. The baseline characteristics were comparable among the four groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The dropout rate was a much higher in the DIMS group (dropout number\u0026thinsp;=\u0026thinsp;13, accounting for 54.17%) than those dropout rates from the SVS group (dropout number\u0026thinsp;=\u0026thinsp;4, accounting for 22.22%), the DISK group (dropout number\u0026thinsp;=\u0026thinsp;0, accounting for 0.00%) or the orthokeratology group (dropout number\u0026thinsp;=\u0026thinsp;3, accounting for 10.71%).\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\u003e Baseline demographics data of all and the completed subjects\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e\u003cp\u003eMean (SD)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eALL\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCompleted\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSVS(n\u0026thinsp;=\u0026thinsp;18) DIMS(n\u0026thinsp;=\u0026thinsp;24) DISK(n\u0026thinsp;=\u0026thinsp;20) OK(n\u0026thinsp;=\u0026thinsp;28)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSVS(n\u0026thinsp;=\u0026thinsp;14) DIMS(n\u0026thinsp;=\u0026thinsp;12) DISK(n\u0026thinsp;=\u0026thinsp;20) OK(n\u0026thinsp;=\u0026thinsp;25)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge at enrolment(years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8.89\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13 9.08\u0026thinsp;\u0026plusmn;\u0026thinsp;1.06 10.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.73 9.11\u0026thinsp;\u0026plusmn;\u0026thinsp;1.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.78\u0026thinsp;\u0026plusmn;\u0026thinsp;1.12 9.00\u0026thinsp;\u0026plusmn;\u0026thinsp;1.18 10.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.72 9.20\u0026thinsp;\u0026plusmn;\u0026thinsp;1.19\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\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMale, %(n)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e55.56%(10) 52.38%(11) 30.00%(6) 39.29%(11)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57.14%(8) 72.73%(8) 30.00%(6) 40.00% (10)\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\u003e44.44%(8) 47.62(10) 70.00%(14) 60.71%(17)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e42.86%(6) 27.27%(3) 70.00%(14) 60.00%(15)\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-1.89\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13 -1.97\u0026thinsp;\u0026plusmn;\u0026thinsp;0.67 -2.85\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94 -2.72\u0026thinsp;\u0026plusmn;\u0026thinsp;0.64\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-1.89\u0026thinsp;\u0026plusmn;\u0026thinsp;0.83 -1.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.51 -2.85\u0026thinsp;\u0026plusmn;\u0026thinsp;0.94 -2.77\u0026thinsp;\u0026plusmn;\u0026thinsp;0.66\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\u003e24.21\u0026thinsp;\u0026plusmn;\u0026thinsp;0.52 24.28\u0026thinsp;\u0026plusmn;\u0026thinsp;0.54\u003c/p\u003e\u003cp\u003e24.62\u0026thinsp;\u0026plusmn;\u0026thinsp;1.09 24.43\u0026thinsp;\u0026plusmn;\u0026thinsp;0.41\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e24.16\u0026thinsp;\u0026plusmn;\u0026thinsp;0.54 24.41\u0026thinsp;\u0026plusmn;\u0026thinsp;0.45 24.62\u0026thinsp;\u0026plusmn;\u0026thinsp;1.09 24.42\u0026thinsp;\u0026plusmn;\u0026thinsp;0.42\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eSVS, single vision spectacles; DIMS, Defocus Incorporated Multiple Segments spectacle lenses; DISK, Defocus Incorporated Soft Contact lenses; OK, orthokeratology lenses; SER, Spherical equivalent refraction; AL, axial length.\u003c/p\u003e\u003cp\u003eMost of the dropout were due to the lost of follow-up without compliance, especially the follow-up was in the COVID-19 pandemic of 2022\u0026thinsp;~\u0026thinsp;2023, except the DIMS group; Two of DIMS group transferred to other interventions (orthokeratology and photobiomodulation therapy), that is to say, discontinued to wear DIMS spectacles.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eBaseline characteristics\u003c/h2\u003e\u003cp\u003eThe mean age was 9.33\u0026thinsp;\u0026plusmn;\u0026thinsp;1.37 years old of all groups. There were no statistically significant differences between SVS, DIMS, DISK and orthokeratology groups in the baseline characteristics (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The mean initial AL of all was 24.39\u0026thinsp;\u0026plusmn;\u0026thinsp;0.68mm. The baseline mean myopia expressed in SER was \u0026minus;\u0026thinsp;2.38\u0026thinsp;\u0026plusmn;\u0026thinsp;0.85D. The male versus female was 41: 49.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003eChanges in the AL and SER\u003c/h2\u003e\u003cp\u003eFor subjects who completed the 12-month trial (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e), only compared to that of SVS, changes in AL of DIMS, DISK, and orthokeratology group had significant difference with P value of 0.048 (DIMS versus SVS), 0.002 (DISK versus SVS), and 0.001 (orthokeratology versus SVS). Neither of DISM, DISK, nor orthokeratology group had AL elongation statistically significant difference (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05, P\u0026thinsp;\u0026gt;\u0026thinsp;0.05, P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). So did the SER for 12 months, which also had significance either group from DIMS or DISK, compared to that of SVS group (P\u0026thinsp;=\u0026thinsp;0.001, ANOVA).\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\u003e\u003cb\u003e༎\u003c/b\u003e Changes in the cycloplegic spherical equivalent refraction and axial length (from baseline) in DIMS, DISK, Orthokeratology and SVS groups\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=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSVS Group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDIMS Group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDISK Group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eOK Group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eP Value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime/Visit\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"5\" nameend=\"c6\" namest=\"c2\"\u003e\u003cp\u003eChanges in AL (mm) from baseline, mean values\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6 months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.23\u0026thinsp;\u0026plusmn;\u0026thinsp;0.13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.16\u0026thinsp;\u0026plusmn;\u0026thinsp;0.07\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.07\u0026thinsp;\u0026plusmn;\u0026thinsp;0.14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.10\u0026thinsp;\u0026plusmn;\u0026thinsp;0.12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cb\u003e0.02\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e12 months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.49\u0026thinsp;\u0026plusmn;\u0026thinsp;0.20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.23\u0026thinsp;\u0026plusmn;\u0026thinsp;0.11\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.18\u0026thinsp;\u0026plusmn;\u0026thinsp;0.26\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.17\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cb\u003e0.001\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime/Visit\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"5\" nameend=\"c6\" namest=\"c2\"\u003e\u003cp\u003eChanges in SER(D) from baseline, mean values\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6 months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-0.19\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.15\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.066\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e12 months\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-1.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-0.36\u0026thinsp;\u0026plusmn;\u0026thinsp;0.62\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-0.37\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eBold text indicates a statistically significant difference between four groups (ANOVA, p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). ANOVA, Analysis of Variance.\u003c/p\u003e\u003cp\u003eD, diopter; DIMS, Defocus Incorporated Multiple Segments spectacle lens; DISC, Defocus Incorporated Soft Contact lens;\u003c/p\u003e\u003cp\u003eSER, spherical equivalent refraction; SVS, single vision spectacle lens; OK, orthokeratology lens; NA: Not applicable.\u003c/p\u003e\u003cp\u003eChildren wearing DIMS spectacles, DISK soft contact lens, orthokeratology rigid contact lens had significantly less myopia progression by 53.06% (mean difference 0.26mm, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), 63.27% (mean difference 0.31mm, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), 65.31% (mean difference 0.32mm, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), compared with that of SVS group, respectively.\u003c/p\u003e\u003cdiv id=\"Sec5\" class=\"Section3\"\u003e\u003ch2\u003eMyopia progression of two age groups\u003c/h2\u003e\u003cp\u003eChanges in AL of two age groups (8\u0026ndash;9 year-old group versus 10\u0026ndash;12 year-old group)\u003c/p\u003e\u003cp\u003eThe mean myopia progression measured in AL and in SER over 12 months in the age group of 8\u0026thinsp;~\u0026thinsp;9 years old (n\u0026thinsp;=\u0026thinsp;57) and 10\u0026ndash;12 years old group(n\u0026thinsp;=\u0026thinsp;33), was 0.32\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24 mm(n\u0026thinsp;=\u0026thinsp;45), -0.71\u0026thinsp;\u0026plusmn;\u0026thinsp;0.51D (n\u0026thinsp;=\u0026thinsp;29) and \u0026minus;\u0026thinsp;0.37\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57D (n\u0026thinsp;=\u0026thinsp;17), 0.16\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19mm (n\u0026thinsp;=\u0026thinsp;27) respectively (P\u0026thinsp;=\u0026thinsp;0.002, P\u0026thinsp;=\u0026thinsp;0.042, respectively). Without the SVS group, the myopia change was 0.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.20mm (n\u0026thinsp;=\u0026thinsp;33), -0.51\u0026thinsp;\u0026plusmn;\u0026thinsp;0.50D (n\u0026thinsp;=\u0026thinsp;17) for 8\u0026ndash;9 years group, and 0.15\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19mm (n\u0026thinsp;=\u0026thinsp;25), -0.28\u0026thinsp;\u0026plusmn;\u0026thinsp;0.55D (n\u0026thinsp;=\u0026thinsp;15) for the 10\u0026ndash;12 years group (P\u0026thinsp;=\u0026thinsp;0.05, P\u0026thinsp;=\u0026thinsp;0.026).\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003eMyopia control rate of different interventions\u003c/h2\u003e\u003cp\u003e12.90% (n\u0026thinsp;=\u0026thinsp;8) and 14.30% (n\u0026thinsp;=\u0026thinsp;10) out of 70 children had no myopia progression over 12 months if the criteria of no myopia progression was set at the AL elongation was \u0026le;\u0026thinsp;0 (Criteria 1) and 0.3mm (Criteria 2), respectively. As for the SVS, DIMS, DISK and orthokeratology group, 14.29% (n\u0026thinsp;=\u0026thinsp;3), 63.64% (n\u0026thinsp;=\u0026thinsp;7), 85.00%(n\u0026thinsp;=\u0026thinsp;17), and 56.00%༈n\u0026thinsp;=\u0026thinsp;12)children had no myopia progression according to the Criteria 2 over 12 months; While according to the Criteria 1, SVS, DISM, DISK and orthokeratology group had AL control rate was much lower than 0.00, 0.00, 25.00% and 12.00% (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), respectively. And the myopia control rate with the Criteria 2 was statistically significant (Fisher exact test, P\u0026thinsp;=\u0026thinsp;0.002); However, neither group among DIMS, DISK, orthokeratology had statistically significant myopia control rate (Chi-square test, P\u0026thinsp;=\u0026thinsp;0.285, P\u0026thinsp;=\u0026thinsp;0.121, P\u0026thinsp;=\u0026thinsp;0.143).\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\u003eComparison of rates of myopia control rate for four groups over 12 months\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=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSVS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDIMS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDISK group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eOrtho-K group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal number\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e70\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMyopia Control Rate 1\u003c/p\u003e\u003cp\u003e(SER\u0026ge;-0.50D)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00%(n\u0026thinsp;=\u0026thinsp;0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e63.60%(n\u0026thinsp;=\u0026thinsp;8)\u003csup\u003e༊\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e47.40%(n\u0026thinsp;=\u0026thinsp;15)\u003csup\u003e༊\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e65.90% (n\u0026thinsp;=\u0026thinsp;25)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMyopia Control Rate 2(AL\u0026thinsp;\u0026le;\u0026thinsp;0.30mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14.29%(n\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e63.64%(n\u0026thinsp;=\u0026thinsp;7)\u003csup\u003e༊\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e85.00%(n\u0026thinsp;=\u0026thinsp;17)\u003csup\u003e༊\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e56.00%(n\u0026thinsp;=\u0026thinsp;12)\u003csup\u003e༊\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e14.30%(n\u0026thinsp;=\u0026thinsp;10)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMyopia Control Rate 3(AL\u0026thinsp;\u0026le;\u0026thinsp;0.00mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00%(n\u0026thinsp;=\u0026thinsp;0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.00%(n\u0026thinsp;=\u0026thinsp;0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25.00%(n\u0026thinsp;=\u0026thinsp;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e12.00%(n\u0026thinsp;=\u0026thinsp;4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e12.90%(n\u0026thinsp;=\u0026thinsp;8)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMyopia Control Rate 4\u003c/p\u003e\u003cp\u003e(SER\u0026thinsp;\u0026ge;\u0026thinsp;0.00D)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00%(n\u0026thinsp;=\u0026thinsp;0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e18.2%(n\u0026thinsp;=\u0026thinsp;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e47.37%(n\u0026thinsp;=\u0026thinsp;9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e25.00%(n\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003csup\u003e༊\u003c/sup\u003eStatistically significant difference among DIMS, DISK, Ortho-k groups (fisher exact test, P\u0026thinsp;\u0026lt;\u0026thinsp;0.0001).SVS, single vision spectacle; DIMS, defocus incorporated multiple segments; DISK, defocus incorporated soft contact; Ortho-k, orthokeratology; SER, spherical equivalent refraction; AL: axial length; NA, not applicable.\u003c/p\u003e\u003cp\u003eFor the 0.3 mm/ year standard for AL elongation comparing, At the end of the 12-month period, the mean changes in AL were significantly lower in the DIMS, DISK, and orthokeratology groups compared to the SVS group, respectively (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). However, there was not significantly difference among the DIMS, DISK, and orthokeratology group, respectively, although there was the tendency of the mean changes AL changes at 12-month follow-up (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Similarly, the mean changes in SER were also more favorable in the three intervention (DIMS, DISK, orthokeratology) groups than the SVS group. Over the 6-month period, the axial elongation was smallest in the DISK group, followed by Orthokeratology and DIMS groups, but without statistically significance among DIMS, DISK, and orthokeratology group, respectively. The changes in AL were statistically significant at 6 months from the DIMS, DISK, orthokeratology lens groups compared to the SVS group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\u003cp\u003eFor Person correlation analysis, the change in AL at Month 12 was significantly correlated with subject\u0026rsquo;s age (P\u0026thinsp;=\u0026thinsp;0.014); Neither the gender(P\u0026thinsp;=\u0026thinsp;0.308), nor the baseline AL(P\u0026thinsp;=\u0026thinsp;0.189) or baseline SER (P\u0026thinsp;=\u0026thinsp;0.264) had statistically significant. On the other side, the change of AL at Month 12 was significantly correlated with the change of AL at Month 3 (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), Month 6 (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and Month 9 (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), respectively.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eAdverse effects\u003c/h2\u003e\u003cp\u003eThere were no severe complications throughout the study period. Orthokeratology group had obvious mild adverse event as below: 20% of all cornea superficial punctate keratitis (SPK) were noted in the orthokeratology group during the study period. SPK from the orthokeratology group, which occurred on the second day after first overnight wearing this rigid gas permeable contact lens; Among those, two cases prescribed epithelium growth promotion eye drops to help recovery of those reversal SPK; Another subject prescribed the longer day\u0026rsquo; of the eyedrops to obtain the complete recovery due to the trichiasis. And both DISK group and orthokeratology group had detected allergic conjunctivitis with prescription of Emedastine difumarate eye drops for 1 week, respectively; And among the above issue periods, the therapy was short-term within 3 days\u0026thinsp;~\u0026thinsp;1 week. And all the participants continued their therapy after the symptoms were completely relieved. As to the DIMS group, only 2 cases had visual discomfort at earlier months, complaining of a little bit blur, but gradually accepted the visual quality in the later follow-up. And no AE was reported from the SVS group.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe findings of our study demonstrated that DIMS, DISK, and orthokeratology were all efficacy interventions in controlling myopia progression among school-age children, with the AL change value of 0.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.08mm, 0.18\u0026thinsp;\u0026plusmn;\u0026thinsp;0.25mm, 0.21\u0026thinsp;\u0026plusmn;\u0026thinsp;0.20mm after 12 months, which was consistent with Tang T and etc.\u0026rsquo; s study. In their retrospective study of 12 months\u0026rsquo; interventions with DIMS lenses and orthokeratology lenses, the AL change was 0.22\u0026thinsp;\u0026plusmn;\u0026thinsp;0.14mm(n\u0026thinsp;=\u0026thinsp;41) and 0.20\u0026thinsp;\u0026plusmn;\u0026thinsp;0.12mm(n\u0026thinsp;=\u0026thinsp;41), respectively, although their participants with the much wider range of ages (6\u0026thinsp;~\u0026thinsp;14 years old) than that of ours (8\u0026thinsp;~\u0026thinsp;12 years old). Myopia control was much better in the older age group than that of the younger age group in their study, which was the same story of ours. The older age group showed only half mean AL elongation compared with that of the younger age group with statistical significance (0.32\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24mm vs 0.16\u0026thinsp;\u0026plusmn;\u0026thinsp;0.19mm, P\u0026thinsp;=\u0026thinsp;0.002) when compared group of the 8\u0026thinsp;~\u0026thinsp;9 years old age versus Group aged 10\u0026thinsp;~\u0026thinsp;12 (independent t-test)in our study.\u003c/p\u003e\u003cp\u003eWhen compared with the DIMS spectacle lenses slow myopia progression: a 2-year randomized clinical trial, the Chinese children aged 8\u0026ndash;13 years, the mean myopia progression value measured in AL elongation was 0.11mm\u0026thinsp;\u0026plusmn;\u0026thinsp;0.02mm and 0.21\u0026thinsp;\u0026plusmn;\u0026thinsp;0.02mm at Visit of 12 months and at Visit of 24 months, respectively (n\u0026thinsp;=\u0026thinsp;79)[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], which was much better than what here we reported, almost twice the efficacy of myopia control and 10 times less the standard deviations. This might be partly due to the study time were different: August 2014 and July 2017 (Including two summers, myopia progression in Chinese children was slower in summer than in winter [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]), without COVID-19 pandemics which really happened in our study period. Moreover, they had more strictly wear compliance and checked by phone calls and questionnaires which ours did not conduct. Actually, the population was increasing in China to wear DIMS and similar myopic defocus design spectacles even there were many issues, like reduced stereo acuity as reported by Lam and etc. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe mechanisms underlying the myopia control effects of these interventions might a little bit vary. DIMS and DISC spectacles use multi-focal optics to stimulate myopic defocus, which to some extent, slowed down the eyeball growth rate and thus companied of the myopia progression. Orthokeratology, on the other hand, uses specially designed rigid gas-permeable contact lenses to temporarily reshape the center of cornea, reducing refractive error and potentially delaying axial elongation due to the temporary and repeated peripheral hyperopic defocus of the retina through the pupils, which was not yet confirmed. Some studies had found the two orthokeratology regimens, target reduction of 6.00 D and target of 4.00 D, had similar effects in controlling the increase in axial length and refractive error in high-myopia children [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. In this study, the only the age lever was the significant factor to cause the myopia control rate, not the baseline SER and baseline AL.\u003c/p\u003e\u003cp\u003eOur study adds to the growing evidence supporting the use of non-surgical interventions in managing myopia among children. Given the increasing prevalence of myopia and its associated risks, it is crucial to identify efficacy and safe interventions for myopia control. Future studies should further investigate the 5\u0026ndash;10 years long-term effects of these interventions and identify the most eligible candidates for each intervention based on factors such as compliance, cost, and availability. As to those 2 subjects dropouts at 3-month follow-up of DIMS group, it might be no necessary to shift from the DIMS group into the orthokeratology group. The wise chose might be added the atropine eyedrops to the DIMS or orthokeratology if the only intervention of DIMS or orthokeratology was not satisfied within 1 year [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAs to the 12-month DISK report from Sankaridurg P et al. [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], with the age from 7 to 14 years (n\u0026thinsp;=\u0026thinsp;45, mean age 9.3 years old), their mean progression of myopia was \u0026minus;\u0026thinsp;0.28\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28 D (0.24\u0026thinsp;\u0026plusmn;\u0026thinsp;0.17 mm AL elongation) ; Considering Anstice N S and Phillips J R\u0026rsquo;s DISK study of 10 months [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], the mean AL elongation of dual-focus soft contact lens in 11\u0026thinsp;~\u0026thinsp;14 -years Children was \u0026minus;\u0026thinsp;0.44\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33 D with the mean increase in AL was 0.11\u0026thinsp;\u0026plusmn;\u0026thinsp;0.09 mm. In another 2-year double-blind randomized controlled trial, myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year vs 0.40 D/year). Likewise, there was less axial elongation for children in the DISC versus SVS groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year). Treatment effect correlated positively with DISC lens wearing time (r\u0026thinsp;=\u0026thinsp;0.342; p\u0026thinsp;=\u0026thinsp;0.005). While our 12-months\u0026rsquo; follow-up was \u0026minus;\u0026thinsp;0.37\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48D more myopic SER with 0.18\u0026thinsp;\u0026plusmn;\u0026thinsp;0.25mm AL elongation. The difference could be the different age levers and baseline SER/AL as well as the compliance about 5\u0026thinsp;~\u0026thinsp;10 hours daily exactly wearing the DISK contact lenses.\u003c/p\u003e\u003cp\u003eAnd when take orthokeratology intervention of AL elongation, the mean elongation was 0.20\u0026thinsp;\u0026plusmn;\u0026thinsp;0.15mm/year (n\u0026thinsp;=\u0026thinsp;37) [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], 0.22mm/year (n\u0026thinsp;=\u0026thinsp;31) [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], 0.39\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27 mm in the 2-year study period) [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], and 0.99\u0026thinsp;\u0026plusmn;\u0026thinsp;0.47 in the 5-year study period; While our study was 0.17\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27 mm(n\u0026thinsp;=\u0026thinsp;25), which was comparable and accordant. Although with the ages increasing, the myopia progression significantly slowed down in either group of SVS, DIMS, DISK or orthokeratology if the 8\u0026thinsp;~\u0026thinsp;9 years group versus 10\u0026thinsp;~\u0026thinsp;12years group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e\u003cp\u003eAlthough the DIMS had no statistically significant efficacy compared to the DISK and orthokeratology group, there was higher dropout rate within the spectacles groups, especially the DIMS. Among those 8 dropout cases, 4 subjects stopped the DIMS due to the unsatisfied myopia control efficacy and transferred to the orthokeratology lenses (1 case), photobiomodulation therapy (1 case), atropine therapy (1 case) and other unknown interventions in other hospital (1 case). The other 4 dropouts were lost without exact reasons. The DIMS spectacles and similar myopia control design spectacles were very popular throughout the China in the recent 3 years since it was not medical device and easier marketing available outside hospitals. And in our study, it had the tendency of high dropout rate and lower compliance partly due to the unsatisfied myopia control rate compared to other myopia control interventions except the SVS.\u003c/p\u003e\u003cp\u003eThe limitations of this study were as below. First, the sample size of each group was not large enough to figure out the statistical difference among the DIMS, DISK and orthokeratology group. Second, this trial had non-randomized design for the feasible of enrollment of participants, especially those supervisions during the Chinese COVID-19 pandemic period. Third, the total dropout rate was 22.22%, a little bit higher than common clinical trial (\u0026le;\u0026thinsp;20.00%), especially both spectacle groups (DIMS group with 57.14% dropout rate versus SVS group with 22.22% dropout). Fourthly, there were no refractive error record of orthokeratology group since refractive error was almost within \u0026plusmn;\u0026thinsp;0.50D without stopping several days or weeks\u0026rsquo; wearing the orthokeratology lenses; Otherwise, the rebound AL elongation of stopping wearing orthokeratology lenses would ruin the myopia control in AL for orthokeratology group.\u003c/p\u003e\u003cp\u003eBig sample size, randomized, and sham devices controlled trials are needed to confirm these findings and to assess the 5\u0026thinsp;~\u0026thinsp;10 years long term safety and efficacy of these interventions.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eOur findings suggest that DIMS, DISK, and Orthokeratology had similar efficacy for myopia control compared to that of SVS in 12 months. We suggest the younger age of 8\u0026thinsp;~\u0026thinsp;9- year - myopia to wear DIMS, DISK or orthokeratology lenses as the first intervention for both myopia control and correction.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was approved by the Ethics Committee of Biomedical Research Involving Humans (Approval No. 2022\u0026ndash;002) on March 26\u003csup\u003eth\u003c/sup\u003e, 2022 and was conducted in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was signed by supervisions and children with written informed consent forms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot Applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDatasets of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSupported by a grant from the Science and Technology Program of Ningbo, China (grant no. 20201YZQ010028).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo;\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ec\u003c/strong\u003e\u003cstrong\u003eontributions \u0026nbsp;\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eL.Z. conceived the research idea. L.Z, W. X., X. F. and other oculists from Ningbo Eye Hospital performed the experiments. L. Z. and W.X., X.F., provided the data. K. Q. analyzed the data and wrote the main manuscript. L.Z., X. W. and K.Q. provided the related references and funding. D.C. ran a thorough check on the use of English for scientific writing. All authors contributed to manuscript revision, and each read and approved the revision and final manuscript. All study subjects provided informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the corporation of local supply with free DIMS lenses, discounted prices of DISK and orthokeratology for providing the optical interventions with lenses devices. In addition, the authors gratefully acknowledge the ophthalmic technicians who helped conduct the testing and corrected the data at Ningbo Eye Hospital. Finally, the authors sincerely thank the families and children who participated in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo;\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNames of all authors (with Affiliations Information)\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e①Lei Zhou\u003csup\u003e＊\u003c/sup\u003e\u003csup\u003e1\u003c/sup\u003e\u003c/li\u003e\n \u003cli\u003e②Kaikai Qiu\u003csup\u003e2-3\u003c/sup\u003e\u003c/li\u003e\n \u003cli\u003e③Xiaolan Wu\u003csup\u003e1\u003c/sup\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/li\u003e\n \u003cli\u003e④Fenge Xu\u003csup\u003e1\u003c/sup\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eDr. Qiu Kaikai\u003c/strong\u003e\u003cstrong\u003e\u003csup\u003e＊\u003c/sup\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;is the corresponding author (e-mail address:\u0026nbsp;\u003c/strong\u003e\u003ca href=\"mailto:[email protected]\"\u003e\u003cstrong\[email protected]\u003c/strong\u003e\u003c/a\u003e\u003cstrong\u003e)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAffiliation of corresponding author:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFuzhou Southeast institute of visual ophthalmology, Fuzhou(City), China\u003c/p\u003e\n\u003cp\u003eEOSVision MedTech LLC, Suzhou (City), China\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSunjing Spactacles and Ophthalmology Clinic, Kunming (City), China.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDepartment of all authors by sequence of author in author list as the followings.\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e1- - Department of Optometry, Ningbo Eye Hospital, Ningbo(City), China, 315100 (Zip)\u0026nbsp;\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e2- EOSVision LLC, Suzhou(City), China, 215501 (Zip)\u003c/li\u003e\n \u003cli\u003e3- Sunjing Spectacles and Ophthalmology Clinic, Kunming(City), China. 650000 (Zip).\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eORCID of the two authors as below:\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003ethe 16-digit ORCID of the author- Kaikai Qiu: 0000-0001-5195-7564\u003c/li\u003e\n \u003cli\u003ethe 16-digit ORCID of the author- Lei Zhou: 0000-0002-2895-6819\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHolden B A, Fricke T R, Wilson D A, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 2016: S0161642016000257.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSun J, Zhou J, Zhao P, et al. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Investigative Ophthalmology \u0026amp; Visual Science, 2012, 53(12):7504.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLee SS, Lingham G, Sanfilippo PG, et al. Incidence and Progression of Myopia in Early Adulthood. JAMA Ophthalmol. 2022;140(2):162\u0026ndash;169. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1001/jamaophthalmol.2021.5067\u003c/span\u003e\u003cspan address=\"10.1001/jamaophthalmol.2021.5067\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLei L, Zhenghou Z. Pattern of myopia progression in Chinese medical students: a two-year follow-up study[J]. Graefes Archive for Clinical \u0026amp; Experimental Ophthalmology, 2013, 251(1):163\u0026ndash;168.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFricke T, Holden B, Wilson D A, et al. Global cost of correcting vision impairment from uncorrected refractive error[J]. Bulletin of the World Health Organization, 2012, 90(10):728\u0026ndash;738.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHolden B, Sankaridurg P, Smith E, et al. Myopia, an underrated global challenge to vision: where the current data takes us on myopia control[J]. Eye, 2014, 28(2):142\u0026ndash;146.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLam CSY, Tang WC, Tse DY, Lee, RPK, Chun RKM, et al. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomized clinical trial. Br J Ophthalmol.2019,0:1\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLam, C.S.Y., Tang, W.C., Zhang, H.Y. et al. Long-term myopia control effect and safety in children wearing DIMS spectacle lenses for 6 years. Sci Rep 13, 5475 (2023). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1038/s41598-023-32700-7\u003c/span\u003e\u003cspan address=\"10.1038/s41598-023-32700-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSankaridurg P, Holden B, Smith E, et al. Decrease in Rate of Myopia Progression with a Contact Lens Designed to Reduce Relative Peripheral Hyperopia: One-Year Results. Investigative Ophthalmology \u0026amp; Visual Science, 2011, 52(13):9362.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAnstice N S, Phillips J R. Effect of Dual-Focus Soft Contact Lens Wear on Axial Myopia Progression in Children. Ophthalmology, 2011, 118(6):1152\u0026ndash;1161.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYin L C S, Tang W C, Yan-Yin T D, et al. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomized clinical trial. British Journal of Ophthalmology, 2014, 98(1):40\u0026ndash;45.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePauline C, Sin-Wan C. Retardation of Myopia in Orthokeratology (ROMIO) Study: A 2-Year Randomized Clinical Trial. Investigative Opthalmology \u0026amp; Visual Science, 2012, 53(11):7077.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSantodomingo-Rubido J, Villa-Collar C, Gilmartin B, et al. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes[J]. Investigative Ophthalmology \u0026amp; Visual Science, 2012, 53(8):5060.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTetsuhiko K, Takahiro H, Tetsuro O. Influence of Overnight Orthokeratology on Axial Elongation in Childhood Myopia. Investigative Ophthalmology \u0026amp; Visual Science, 2011, 52(5):2170-.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTakahiro H, Tetsuhiko K, Fumiki O, et al. Long-term effect of overnight orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up study. Investigative Ophthalmology \u0026amp; Visual Science, 2012, 53(7):3913.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSankaridurg P, Holden B, Smith E, et al. Decrease in Rate of Myopia Progression with a Contact Lens Designed to Reduce Relative Peripheral Hyperopia: One-Year Results. Investigative Ophthalmology \u0026amp; Visual Science, 2011, 52(13):9362.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZhou L, Tong L, Li Y, Williams BT, Qiu K. Photobiomodulation therapy retarded axial length growth in children with\u0026ensp;myopia: evidence from a 12-month randomized controlled trial evidence. Sci Rep. 2023;13(1):3321. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://doi:10.1038/s41598-023-30500-7\u003c/span\u003e\u003cspan address=\"http://doi:10.1038/s41598-023-30500-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eQiu K., David C., Li Y., Tong L, Lin W. A retrospective study of cumulative absolute reduction in axial length after photobiomodulation therapy. BMC Ophthalmology 24. 191(2024). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s12886-024-03427-4\u003c/span\u003e\u003cspan address=\"10.1186/s12886-024-03427-4\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePolling J R, Kok R G, Tideman J W, et al. Effectiveness study of atropine for progressive myopia in Europeans. Eye, 2016, 30(7):998\u0026ndash;1004.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIribarren R, Iribarren G, Szwajkowska M, et al. The Role of Atropine Eye Drops in Myopia Control. Current Pharmaceutical Design, 2015, 21(32).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTang T, Lu YC, Li XW, Zhao H, Wang K, Li Y, Zhao MW. Comparison of the long-term effects of atropine in combination with orthokeratology and defocus incorporated multiple segment lenses for myopia control in Chinese children and adolescents. Eye. 2024. Feb 28th. 1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDonovan L, Sankaridurg P, Ho A, Chen X, Lin Z, Thomas V, Smith EL 3rd, Ge J, Holden B. Optom Vis Sci. 2012;89(8):1196\u0026ndash;202. Myopia progression in Chinese children is slower in summer than in winter.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLyu T, Wang L, Zhou L, Qin J, Ma H, Shi M. Regimen Study of High Myopia-Partial Reduction Orthokeratology. Eye Contact Lens. 2020;46(3):141\u0026ndash;146.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"myopia control, children, axial length","lastPublishedDoi":"10.21203/rs.3.rs-4588107/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4588107/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePURPOSE\u003c/strong\u003e: To evaluate the efficacy of orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, defocus incorporated soft contact (DISK) lens, and single-vision spectacles (SVS) on myopia control over 12 months in one clinical center.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMETHODS\u003c/strong\u003e: The study was a non-randomized experimenter-masked prospective controlled study of individuals aged 8~12 years with progressing myopia but no ocular pathology. Participants were allocated, according to patients/parents’ choice, to receive DIMS (Hoya\u003csup\u003e® \u003c/sup\u003eMiyoSmart\u003csup\u003e®\u003c/sup\u003e) spectacles, DISK (Defocus Incorporated Soft Contact) lenses, orthokeratology or SVS (control group). The key outcome variables, axial length (AL) and cycloplegic spherical equivalent refraction (SER) were measured at baseline and after 3, 6, 9and 12 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRESULTS\u003c/strong\u003e: Among the 103 children who were eligible, 90 (87.39%) children attended the baseline examination and 70 (77.78%) were analyzed (SVS: n = 14; DIMS: n = 13; DISC: n = 20; Orthokeratology: n = 25). At the 12- month mark, the mean changes in AL were 0.49 ± 0.20 mm, 0.25 ± 0.11 mm, 0.19 ± 0.26 mm and 0.21 ± 0.20 mm in SVS, DIMS, DISC and Orthokeratology group, respectively (P = 0.001, ANOVA); And the mean changes in SER after the same 12 months were −1.00 ± 0.33D, −0.36 ± 0.62D, and −0.37 ± 0.48D (p \u0026lt; 0.001) in SVS, DIMS and DISC group, respectively (p = 0.001, ANOVA).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONCLUSIONS\u003c/strong\u003e: DISC, orthokeratology, DIMS had similar efficacy of myopia control in children.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegistered Code\u003c/strong\u003e:MR-33-22-012252\u003c/p\u003e","manuscriptTitle":"A comparison of myopia control in children with orthokeratology, defocus-incorporated multiple segment lenses (DIMS) spectacles, Defocus Incorporated Soft Contact (DISK) lenses, and single-vision spectacles for 12 months","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-17 20:06:09","doi":"10.21203/rs.3.rs-4588107/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5ba8c26a-738b-4a54-a9dc-b9ef1e6a4dd5","owner":[],"postedDate":"July 17th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":34532572,"name":"Health sciences/Biomarkers"},{"id":34532573,"name":"Health sciences/Diseases"},{"id":34532574,"name":"Health sciences/Health care"},{"id":34532575,"name":"Health sciences/Medical research"},{"id":34532576,"name":"Physical sciences/Optics and photonics"}],"tags":[],"updatedAt":"2024-07-29T12:59:29+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-17 20:06:09","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4588107","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4588107","identity":"rs-4588107","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}