One-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression

One-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article One-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression Rafael Iribarren, Carla Lanca, Abel Szeps, Carlos Kotlik, Martin De Tomas, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7192750/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 report the 1-year efficacy of Myofix Defocus spectacles, designed to control the progression of myopia in childhood. Methods: A total of 47 myopic children aged 7 to 15 years were enrolled. Cycloplegic objective refraction (spherical equivalent refraction, SE) and axial length (AL) were measured at baseline, 6 months and 12 months. Linear regression models were used to identify risk factors of 12-month changes in SE and AL. For comparison, two virtual control groups of American children were included. Tolerance was assessed through a questionnaire at each follow-up visit. Results: Of the initial cohort, 11 participants were lost to follow-up after 6 months due to reasons unrelated to lens design (77.1% retention rate). Over 12 months, the mean SE change in all eyes was -0.21±0.30 D, and AL change was 0.19±0.13mm. Progression was significantly different in participants who reported good compared to poor compliance (p<0.001). At the 12-month follow-up, participants with good compliance had a mean SE progression of -0.12±0.25D and a mean AL change of 0.17±0.11 mm. In virtual controls, the mean annual SE progression was -0.47±0.36 diopters, and AL change was 0.26±0.17 mm. In compliant participants, Myofix Defocus lens demonstrated a 75% reduction in SE and 37% reduction in AL compared to virtual controls. Conclusion: After 1 year, Myofix Defocus spectacles slowed myopia progression in children, demonstrating comparable efficacy to other defocus-incorporated spectacle designs. Greater compliance resulted in better treatment effect. Further long-term studies are warranted to confirm these findings. Myopia control spectacles full field defocus design tolerance efficacy Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Refractive errors are considered the second leading cause of visual impairment worldwide. 1 Highly educated populations tend to have higher rates of myopic refractive errors, 2,3 highlighting the need to develop effective treatments to ensure that next generations can pursue advanced education without an increased risk of developing myopia. In 2001, Saw et al., 4 reported a marked increase in the prevalence of myopia among Singapore conscripts within a single generation, suggesting that environmental rather than genetic factors were primarily responsible for this rapid rise. 2 Since then, a myopia epidemic has clearly emerged in East and Southeast Asia. Numerous studies have confirmed this trend, with alarming projections for the development of high myopia in large segments of the population. 5–7 In contrast, Latin-American countries such as Brazil and Argentina have reported myopia prevalence rates of approximately 15–30% in adults, 8 with urban youth populations reaching up to one-third affected. 9 Despite the relatively low prevalence among adults in the city of Buenos Aires, it is important to acknowledge that myopia progression can lead to pathological changes in ocular structures such as the retina, choroid and macula, being the leading cause of legal blindness in large urban settings. 10,11 These degenerative changes are among the leading causes of irreversible vision loss and blindness, particularly in individuals with refractive error exceeding − 5.00 to -6.00 diopters. 6,12 Low-dose atropine (0.01–0.05%) has been used as a first-line of treatment to slow myopia progression. 13–16 However, despite its low concentration, some pediatric ophthalmologists remain concerned about the potential long-term effects of daily use over several years. Therefore, there is growing interest in developing less invasive therapeutic methods for myopia control. 13,17 Recent randomized controlled trials have demonstrated promising outcomes with various designs of peripheral defocus or contrast modulation spectacles and contact lenses. 18 These specially designed spectacles may serve as alternative spectacles to standard single-vision lenses for myopic children, as these may promote myopia progression by imposing peripheral hyperopic defocus. 19 This study investigated compliance and myopia progression over a one-year period using a new defocus spectacle design (Myofix, Novar). 20 Materials and Methods The Myofix Defocus Study was a longitudinal, prospective, interventional, non-randomized research study developed to evaluate the tolerability, compliance, safety, and effectiveness of specially designed spectacles for myopia control in children. Baseline data and methods have been published previously. 20 This study included children aged 7 to 16 years who voluntarily agreed to use the Defocus spectacles for one year. Eligible participants were a consecutive series of children diagnosed with myopia, attending accredited private practice ophthalmology clinics across Argentina. Inclusion criteria were the absence of ocular pathology other than myopia, with spherical equivalent (SE = sphere + [cylinder/2]) between ≤-0.50 D and − 5.00 D, astigmatism less than − 2.00 D, anisometropia less than − 1.00 D, and keratometry less than 47.00 D in the steepest meridian. The corrected distance visual acuity based on subjective refraction was required to be 0.1 logMAR (20/25 Feet Snellen) or better in each eye. Exclusion criteria included myopia with onset before the age of 6 years, any genetic syndromes, or current medical treatment for myopia other than single vision spectacle correction. The power analysis had shown that a sample of 36 subjects would be enough so our target was 45 subjects to account for losses in follow-up. 20 At the baseline visit, all participants underwent a comprehensive ophthalmological evaluation, including subjective refraction and cycloplegic refraction. 20 Cycloplegia was induced with two drops of 1% cyclopentolate, instilled five minutes apart, and the refractive assessment was performed 45 minutes after the first drop. Cycloplegic refraction and axial length (AL) measurements (using optical biometry) were conducted at baseline, 6 months, and 12 months. A detailed questionnaire was administered to collect data on lifestyle habits and family history, including reading and outdoor exposure, hours of schooling, age of first prescription and family history of high myopia. Besides, bedtime use of smartphones, and use of inverted contrast in electronic devices were also explored. Compliance with spectacle use was assessed through two methods at the 6- and 12-month visits. First, a structured questionnaire administered during follow-up visits asked whether the child wore the spectacles full-time or only part of the day (morning or afternoon), and whether they used them at home, outdoors, or both. The questionnaire also included a question on tolerance, asking whether the spectacles were well accepted. In addition, at both follow-up visits, children were asked three specific questions to assess tolerance: whether they experienced any discomfort or difficulty when moving their head while reading, walking, or during lateral gaze. Second, the ophthalmologist independently evaluated and recorded overall compliance as 'good' or 'poor' in the clinical history, providing explanatory comments in the 'observations' section. All participants received a pair of spectacles (Myofix, Novar, USA) with frames (Usual, Argentina) at no cost for the duration of the one-year study. Children were instructed to wear the spectacles every day full-time and were evaluated at 6-month intervals. The Myofix lens design consists of a 9 mm central optical zone for distance correction, surrounded by a peripheral zone providing approximately + 3.50 D of additional power to induce peripheral myopic defocus (Fig. 1 ). A preliminary questionnaire taken by 45 children who were fitted for one month with these spectacles at La Pirámide Optics (Mendoza, Argentina) reported good tolerance in 80% of cases. 20 While most participants experienced some initial adaptation difficulties during the first two days, tolerance improved markedly thereafter. Participants were recruited from 13 optical centers and 15 ophthalmological institutions. These institutions were included after confirming that their affiliated pediatric ophthalmologists were equipped to perform standard myopia assessments, including cycloplegic autorefraction and AL measurements using the Lenstar (Haag Streit), Aladdin (Zeiss), or Myah (Topcon) biometers. Both ophthalmologists and opticians received 6 hours of training to ensure standardized adherence to the study protocol, including the procedures for refraction, biometry and fitting of Myofix spectacles. Training also covered data entry using a secure, encrypted online platform developed by Novar, which was used to record clinical information. Opticians received additional online instructions focused on accurate centration of the lenses and the selection of appropriate frames to ensure proper positioning of the peripheral treatment zone around the visual axis. Reference data For the virtual control group, data were obtained from 114 children followed with cycloplegic refractions by the Pandemic Study Group during 2018-2019. 21 In addition, another virtual control group was derived from a U.S.-based randomized clinical trial that publicly reported cycloplegic refraction and biometry data in a comparable sample of myopic children. The untreated arm in that study served as the control group for evaluating the effect of low-dose atropine. 22 As both control datasets included younger participants, only those aged 7 years or older at baseline were selected for this analysis to match the age distribution of the current study cohort. This resulted in the inclusion of 70 children for the Pandemic Study (Argentina) 21 and 41 children from the American Atropine study 22 (USA). Additionally, axial length growth in our study cohort was compared to recently published emmetropic growth curves from age-matched Caucasian children. 23 Ethics The study protocol was approved by the Ethics Committee of the Argentine Society of Ophthalmology and the Government of Buenos Aires City (March 2023; Registration No. 8638). Patients who exhibited a myopia progression of − 0.50 D or more within 6 months were excluded from further follow-up. As recommended by the ethics committee, these participants were transitioned to treatment with low-dose atropine. The study was conducted in accordance with the Declaration of Helsinki and its amendments, Good Clinical Practice (GCP) guidelines, and Resolution 1480/11 of the Argentine Ministry of Health. Both parents were verbally informed about the study objectives, and written informed consent was obtained from both parents and children. Participant anonymity was strictly preserved, with all identifying information removed from the dataset prior to statistical analysis. Statistical analysis Continuous variables are presented as mean ± standard deviation, and categorical variables are reported as absolute frequencies and percentages. There was a strong correlation between SE values of the right and left eyes at baseline (R = 0.875, p < 0.001), with no significant difference between them (paired t -test, p = 0.085). The statistical analysis was based on the average of SE or AL change of both eyes following similar methods in a previous atropine trial. 24 This approach was supported by similar correlations between the two eyes observed for AL at baseline and for changes in SE and AL during follow-up (data not shown). Differences in myopia progression (SE and AL) between the study group and virtual control groups were analyzed using the Student t-test. To identify predictors of 12-month change in SE and AL, multiple linear regression models were constructed, adjusting for relevant covariates including age, sex, baseline SE, AL, compliance, and parental history of high myopia. To reduce the risk of overfitting due to the relatively small sample size, the number of predictors in each model were limited and progressively simplified in the models across three steps: Model 1 included five predictors: parental history of myopia, age at baseline, sex, mean baseline SE (for the SE model) or mean baseline AL (for the AL model), and treatment compliance at 12 months; Model 2 excluded parental history of myopia for the SE model and mean baseline AL for AL model, retaining four predictors. Model 3 further excluded variables based on statistical insignificance or model fit criteria, leaving three core predictors: mean baseline SE, sex, compliance at 12 months for the SE model, parental history of myopia, age at baseline, and compliance at 12 months for the AL model. Statistical analyses were conducted using Microsoft Excel (Microsoft Corp., USA), SPSS Statistics version 25 (IBM Corp., USA), and R (R Foundation for Statistical Computing, Vienna, Austria) for data visualization. Results A total of 47 patients were enrolled between June 2023 and April 2024, with a planned follow-up duration of one year. By the 6-month visit, 11 children were lost to follow-up (77.1% retention rate). Of these, four discontinued their participation due to personal reasons or relocation to another city or country. Among the remaining seven, one child discontinued use of the spectacles for esthetic reasons, specifically dissatisfaction with the frames, and did not return for replacement. The other six were young children with low baseline myopia (-0.50 to -1.00 D), who were not regular spectacle users and did not wear the study spectacles at all. These children showed a myopic progression of -0.50 D over the first 6 months and, in accordance with the Ethics Committee’s guidance, were withdrawn from the study. They were prescribed standard single-vision spectacles and initiated low-dose atropine. This subgroup represented 12.5% of non-users at the six-month follow-up. The flow chart is shown in Fig. 2 . The baseline characteristics of the 36 included children are given in Table 1 . Among participants, 5 had mothers with high myopia and 4 had fathers with high myopia. Most children (23/36; 63.9%) attended school for only 4 hours per day. Half of the children (18/36, 50.0%) lived in houses with gardens, while the remainder resided in homes without gardens or high-rise buildings. Seven children attended extracurricular tutorial classes (19.4%). The baseline characteristics of the two virtual control groups (Pandemic 21 and US atropine group 22 ) were 10.8 ± 2.0 and 10.7 ± 1.4 years of age, and a SE of -2.17 ± 1.38 D and − 2.87 ± 1.01 D, respectively. Table 1 Descriptive statistics of the 36 included participants Mean age (SD) (years) 10.9 ± 1.9 Sex (female/male; n) 18/18 Mean interval 6 months follow-up (days) 182 ± 30 Mean interval 12 months follow-up (days) 375 ± 33 Mean spherical equivalent at baseline (diopter) -2.72 ± 1.02 Median spherical equivalent at baseline (diopter) -2.72 Mean keratometry at baseline (diopter) 43.37 ± 1.08 Mean axial length at baseline (mm) 24.57 ± 0.75 Mean age of first spectacle prescription (years) 7.58 ± 1.86 Time per day spent on homework (hours/day) 1.31 ± 0.68 Time per week spent outdoors (hours/day) 20.06 ± 6.55 Daily screen time with tablets or smartphones averaged 2.41 ± 0.79 hours per day. Regarding bedtime habits, 17 out of 33 children (51.5%) reported going to bed with their mobile phone, and 13 (39.4%) reported using inverted contrast settings on their devices (dark mode). The mean change in SE from baseline to 12 months was − 0.21 ± 0.30 diopters, and the mean AL change was 0.19 ± 0.13 mm. SE progression was significantly different in participants with good compliance compared with children with poor compliance (Student t test, p < 0.001, Fig. 3 ). In the good compliance group, children had a mean SE progression of -0.12 ± 0.25 D and a mean AL change of 0.17 ± 0.11mm over 12 months. No significant differences were found in SE progression for sex, family history of high myopia, schooling, type of housing, reading at night with smartphones, age at baseline, or tutorial classes in the univariate analysis. Children who used inverted contrast settings on electronic devices showed a trend for lower SE progression compared to those using standard contrast settings, although this difference did not reach statistical significance (Student t test, p = 0.214; -0.11 D vs. -0.23 D, respectively, see supplementary figures). There was also a trend for lower SE progression in children who used spectacles the whole day vs. half a day (Student t test, p = 0.127; -0.10 vs. -0.25 D, respectively). As said, among the 36 children who completed the 12-month follow-up, there were 11 children classified as having poor compliance with spectacle use. To further explore compliance, we compared questionnaire responses regarding spectacle tolerance with reported compliance levels. Notably, 77.8% of children classified as having poor compliance still reported that they tolerated the lenses well (93.8% of the whole sample tolerated the spectacles well). Overall, 75.4% of children reported no difficulties while walking around or moving head when reading. When asked about wearing habits, seven children (18.9%) indicated that they did not use the spectacles at home, and eleven (29.7%) reported they were not wearing them outdoors. Reported reasons for non-compliance at the 12-month (n = 11) included esthetical concerns in two female children who switched to their previous frames, lost or breakage of spectacles in two children who felt embarrassed to request a replacement and reverted to use their previous prescription, two children who independently chose to wear standard contact lenses (not designed for myopia control), using the Myofix spectacles only few hours per day. The remaining cases of poor compliance involved children with low levels of myopia who did not require full-time spectacle use. Supplementary Figure S1 illustrates the mean changes in SE and AL over 12 months in children wearing Myofix defocus spectacles compared to a virtual control group from Repka et al. 22 At 12 months, the mean SE progression in the Myofix group was − 0.21 D, substantially lower than the − 0.47 D observed in the control group (p < 0.001, Figure S1a ). A clear divergence in SE progression emerged after the 6-month mark, with the Myofix group showing consistently slower progression throughout the follow-up period. Similarly, the mean axial elongation in the Myofix group was 0.19 mm at 12 months, compared to 0.26 mm in the US control group (p < 0.01, Figure S1b ). Although the difference in AL progression was less pronounced than that observed for SE, the trend also significantly favored the Myofix group. Figure 4 shows individual trajectories of SE (diopters) plotted against age (years) for two study groups: the US atropine study control group and in the Myofix treated group. In the control group (left panel), most children showed a clear trend toward increasing myopia over the 12-month follow-up, with relatively consistent rates of progression across individuals. In contrast, the Myofix-treated group (right panel) demonstrated more varied responses over 12 months. While some children experienced minimal progression, others, particularly those with poor compliance (indicated by dotted lines), exhibited greater myopic shifts. These findings suggest that Myofix lenses may help slow myopia progression, especially when worn consistently. Figure 5 shows the individual axial growth trajectories of boys and girls compared to recently developed emmetropic axial growth curves for European children. These curves were designed to facilitate comparison of the slopes of axial growth between normal, compensated axial growth, and myopic progression in studies lacking control groups. The results of the multiple linear regression are shown in Table 2 . Across all three models, treatment adherence at 12 months was consistently associated with significant changes in both SE and AL. Poor compliance was linked to a greater AL elongation and a more myopic SE, indicating worse myopia control. Age at baseline showed a negative association with AL change, suggesting that younger age was linked to greater axial elongation. Other variables, including parental history of high myopia, sex, and baseline SE or AL, were not significantly associated with SE or AL changes in any of the models. Table 2 Regression coefficients (B), 95% confidence intervals, and p-values for predictors of 12-month change in spherical equivalent (SE) and axial length (AL) across three linear regression models. Variables Mean difference SE (D) at 12 months Mean difference AL (mm) at 12 months Coef. (B) 95% CI Lower 95% CI Upper p-value Coef. (B) 95% CI Lower 95% CI Upper p-value Model 1 Parental HM 0.023 -0.167 0.213 0.804 -0.026 -0.101 0.051 0.498 Age at baseline 0.017 -0.029 0.063 0.457 -0.030 -0.048 -0.011 0.003 Mean baseline SE -0.033 -0.109 0.042 0.373 - - - - Mean baseline AL - - - - -0.013 -0.061 0.043 0.576 Sex 0.061 -0.100 0.222 0.444 0.020 -0.047 0.087 0.897 Compliance at 12 months -0.295 -0.481 -0.109 0.003 0.123 0.049 0.197 0.002 Model 2 Parental HM - - - - -0.030 -0.103 0.043 0.405 Age at baseline 0.017 -0.028 0.062 0.444 -0.031 -0.049 -0.013 0.001 Mean baseline SE -0.035 -0.108 0.038 0.335 - - - - Sex 0.062 -0.096 0.220 0.429 0.014 -0.049 0.077 0.652 Compliance at 12 months -0.297 -0.479 -0.115 0.002 0.123 0.050 0.195 0.002 Model 3 Parental HM - - - - -0.029 -0.101 0.043 0.413 Age at baseline - - - - -0.031 -0.048 -0.013 0.001 Mean baseline SE -0.038 -0.110 0.033 0.285 - - - - Sex 0.064 -0.093 0.221 0.412 - - - - Compliance at 12 months -0.274 -0.445 -0.103 0.003 0.122 0.050 0.193 0.002 Discussion The Myofix Defocus Study was designed to evaluate the tolerance and effectiveness of a novel design of full-field peripheral defocus spectacles developed in Argentina. These findings show promising outcomes, with good tolerance reported among children under the age of 15 years (an age group known for its great neural plasticity and adaptability when receiving anisometropic or high astigmatic prescriptions in pediatric ophthalmology practice). In the present trial, children with good compliance (whole day users) and a mean age of 11 years showed minimal progression of -0.12 D over 12 months. These findings highlight the critical role of adherence in influencing the efficacy of the myopia control intervention over 12 months. As shown in Table 3 , when compared with other published studies, this progression rate ranks among the lowest reported in similarly aged cohorts over one year. Comparison with Previous Studies and Virtual Control Data Conducting randomized controlled trials with untreated control groups in myopia research has become increasingly challenging due to ethical concerns and loss of follow-up. 25 As low-dose atropine (e.g., 0.01%) is now widely recognized and endorsed by clinical guidelines as a first-line intervention, withholding treatment in control groups is no longer considered acceptable in many settings. 15,16 Consequently, studies employing natural history control groups often experience high dropout rates, as participants or their guardians seek available therapeutic options to slow myopia progression at nearby ophthalmology centers. This trend reflects an evolving standard of care and highlights the need for alternative control strategies in future research, such as the use of virtual control groups and normative emmetropic growth curves. 23,26,27 For comparison, two virtual control groups were used instead. First, a pre-pandemic cohort of 70 Argentine children, with a mean age of 11 years and myopia less than − 4.00 D, which were followed with cycloplegic refractions between 2018 and 2019. In this group, the mean one-year progression was − 0.48 ± 0.52 D. 21 Moreover, a well-characterized control group that received no treatment from a U.S.-based randomized clinical trial on atropine treatment in similarly-aged children 22 was used as it provided publicly available data on cycloplegic spherical equivalent and biometric changes over one year. These two cohorts represent some of the best-documented examples of untreated myopia progression and were thus selected for comparison. The present study compares its outcomes against one these groups, showing the change in SE over 12 months between our treated cohort and the U.S. control group. The second control group exhibited similar, but slightly lower, SE progression at 12 months, suggesting that our results would have appeared more favorable if that group had been used for comparison. Table 3 summarizes the outcomes of several comparable studies conducted in Asia, allowing for comparison of age ranges and progression in both SE and AL. Our study was intentionally benchmarked against trials with the lowest reported progression rates in untreated control groups of similarly-aged children. Despite this conservative comparison, the Myofix lens demonstrated a 75% reduction in SE change (-0.35 D less progression) and a 37% reduction in axial elongation (98 µm less elongation) among children with good compliance, relative to the natural history control group reported by Repka et al. 22 Notably, the Myofix lens differs from other myopia control spectacles in its simplicity of design and manufacturing. Unlike lenses that require pre-molded treatment zones or proprietary blocks, the Myofix design can be digitally carved using standard equipment and locally sourced lens blanks in any digital lab. This makes it a scalable and accessible option for widespread implementation across countries without the need for complex imports. Table 3 Change in spherical equivalent (SE) and axial length (AL) at 12 months in different studies and virtual control groups. STUDIES WITH TREATED GROUPS FIRST AUTHOR MEAN BASELINE AGE BASELINE SER CHANGE IN SE 12 MONTHS BASELINE AL CHANGE IN AL 12 MONTHS MYOFIX TRIAL (ONLY GOOD COMPLIANCE GROUP) IRIBARREN 11.0 -2.86 -0.12 24.64 0.16 DOT SPECTACLES (USA) TREATED GROUP 28 RAPPON 8.1 -2.00 -0.14 24.09 0.15 INDIAN ATOM STUDY (INDIA) (ATROPINE GROUP) 29 SAXENA 10.8 -3.50 -0.16 - 0.22 MYOSMART TRIAL TREATED GROUP (CHINA) 30 LAM 10.2 -2.97 -0.17 24.60 0.11 MYOFIX TRIAL ALL INCLUDED PARTICIPANTS (ARGENTINA) IRIBARREN 11.0 -2.86 -0.21 24.64 0.19 MYOCARE TREATED GROUP (SPAIN) 31 ALVAREZ 10.0 -2.17 -0.20 24.34 0.09 STELLEST TRIAL TREATED GROUP (CHINA) 32 BAO 8.7 -2.70 -0.27 24.76 0.13 LAMP STUDY ATROPINA 0.05% (CHINA) 24 YAM 8.5 -3.98 -0.27 24.85 0.20 IRANIAN ATROPINE STUDY TREATED GROUP (IRAN) 29 NANGIA 9.6 -4.32 -0.31 - 0.29 MYCON LENSES TREATED GROUP (RUSIA) 33 TARUTTA - - -0.33 - - SHAMIR LENSES TREATED GROUP (ISRAEL) 34 COHEN 9.9 -2.53 -0.48 24.27 0.21 STUDIES WITH CONTROL GROUPS MYOCARE CONTROL GROUP (SPAIN) 31 ALVAREZ 10.0 -1.90 -0.41 24.17 0.23 ATROPINE STUDY CONTROL GROUP (USA) 22 REPKA 10.7 -2.87 -0.47 24.57 0.26 PANDEMIA CONTROL GROUP (ARGENTINA) 21 PICOTTI 9.5 -2.17 -0.48 - - MYCON CONTROL GROUP (RUSIA) 33 TARUTTA - - -0.53 - - DOT LENSES CONTROL GROUP (USA) 28 RAPPON 8.1 -1.95 -0.54 24.03 0.30 MYOSMART LENSES CONTROL GROUP (CHINA) 30 LAM 10.0 -2.76 -0.55 24.70 0.32 MYOCARE CONTROL GROUP (CHINA) 35 LIU 8.5 -2.67 -0.56 24.65 0.26 LAMP STUDY CONTROL GROUP (CHINA) 24 YAM 8.4 -3.85 -0.59 24.82 0.36 SHAMIR LENSES CONTROL GROUP (ISRAEL) 34 COHEN 9.9 -2.74 -0.64 24.39 0.32 STELLEST CONTROLS (CHINA) 32 BAO 8.7 -2.46 -0.81 24.77 0.36 MYOVISON CONTROLS (JAPAN) 36 KANDA 9.8 -3.36 -0.96 24.70 0.39 The myopia progression rate observed in the Argentine Pandemic Study cohort (− 0.48 D per year) 21 closely aligns with that reported in the control group of the U.S.-based Repka trial (− 0.47 D), 22 which served as a benchmark for comparison in the present study. These progression rates, observed in children aged 10–11 years, are consistent with the values reported in International Myopia Institute (IMI) publications for similarly-aged groups. 13,37 Notably, this rate of progression is lower than that typically observed in East Asian populations, which may be partly explained by higher levels of outdoor activity among Argentine children. Previous research conducted in the same region has shown that children spend, on average, more than 20 hours per week outdoors, similar to the children included in the present study. 38 However, in our current regression analysis, no significant association was found between individual differences in outdoor exposure and the rate of myopia progression within the study group. Additional Factors Potentially Influencing Treatment Outcomes Interestingly, none of the commonly recognized risk factors were significantly associated with myopia progression in this treatment group. In this prospective study, myopia progression was studied in relation to the habit of going to bed with a smartphone in darkness and the use of inverted contrast settings on electronic devices. While recent research has indicated that reading with defocus spectacles in dark environments may fail to trigger a choroidal thickening response, 39 a signal associated with slowed eye growth, the lack of a clear effect on progression in our study underscores the need for further investigation in this area. Notably, a small but non-significant trend toward reduced myopia progression was observed in children who used inverted contrast. This preliminary finding supports the rationale for future clinical trials investigating the impact of visual contrast polarity 40 or red-in-focus strategies, 41,42 which have already shown promising outcomes inducing short-term choroidal thickening in experimental settings over the past several years. 43,44 When considering compliance and potential adverse effects of myopia control strategies, spectacle-based interventions with peripheral defocus zones offer a non-invasive alternative that avoids the long-term ocular exposure to pharmacological agents, such as atropine, which may be required daily over many years. In the present study, treatment was limited to children aged 7 and older, with myopia onset after age 6 years, to exclude those with very early onset who are at highest risk for rapid progression to high myopia. Despite this criterion, the mean age of first spectacle prescription was 7 years, suggesting that the cohort may still include many children with a predisposition to rapid progression. It remains unclear whether genetically driven early-onset myopia (onset before 6 years) is responsive to environmental interventions such as increased outdoor exposure. In this sense, outdoor exposure was notably high in our sample, averaging 20 hours per week. Children with onset at 3–5 years likely represent genetically determined cases who may require more intensive or combined treatment strategies. Several studies in East Asian populations have included children with early-onset myopia and reported less favorable outcomes in these subgroups, in contrast to the more encouraging results observed in our present study. In both the present and previous studies, myopia control appeared more effective when measured by changes in SE than by changes in AL. This relative stability in refractive error, despite continued axial elongation, suggests a possible compensatory mechanism involving lens power loss, a phenomenon that remains largely unexplored. The underlying biological basis for how myopia control strategies, such as defocus spectacles or low-dose atropine, might influence crystalline lens power is not well understood. To date, one study from India 45 has reported increased lens power loss in atropine-treated children, which may have partially offset axial elongation and contributed to refractive stability in that group. It is possible that defocus lenses and atropine exert their effects by modulating retinal signaling pathways that regulate ocular growth. 43 It is well established that myopic eyes tend to have lower crystalline lens power compared to emmetropic eyes, 46 and that progressing myopic eyes often exhibit an accelerated loss of lens power at myopia onset. 47 This reduction in power has been linked to both increased zonular tension and internal remodeling of the lens. Axial lens thickness during growth is maintained by a delicate balance between the addition of new fibers at the surface and the compaction of older fibers in the deeper layers. 46 These structural changes can influence the gradient index profile of the lens. Specifically, a slower-growing lens undergoing constant age-related compaction, may develop a steeper gradient index, as has been predicted in optical models. 46 A recent in vivo study assessing the elastic modulus of the crystalline lens in myopic and emmetropic eyes confirmed that myopic lenses exhibit a steeper gradient of increasing stiffness. 48 This suggests that the growing, compacting lens in myopic eyes may possess a form of biomechanical inertia that limits its ability to adapt to changes in axial elongation. Consequently, increased lens power loss could partially compensate for axial elongation, particularly during the first year of treatment with interventions such as defocus spectacles or low-dose atropine. This may be the reason why some studies have reported better outcomes in the first year. Future myopia control studies should consider including calculations of lens power loss as part of their evaluation metrics. Unfortunately, this was not possible in the present study due to the use of biometers that did not measure anterior chamber depth and lens thickness. Recent evidence suggests that Defocus Incorporated Multiple Segments (DIMS) spectacles reduce myopia progression by decreasing the detection of high spatial frequency contrast in the perifoveal region. 49–51 Similarly, studies have shown that both positive 52 and negative defocus lenslets 30 in specially designed spectacles can slow ocular growth, likely through a shared mechanism involving contrast modulation rather than the simple direction of defocus. 49 This shifts the prevailing theory away from the idea that positive defocus alone mimics the effects of plus lenses in animal models, and toward the notion that reduced contrast sensitivity of high frequencies may be key to signaling growth arrest. 53 By limiting high-frequency input, these lenses may leave the perifoveal zone more responsive to low-frequency cues, which are thought to be critical for defocus detection and ocular growth regulation. Interestingly, the Myofix lens design appears to incorporate both mechanisms: it reduces high-frequency contrast through peripheral blur and introduces a low-level full-field positive defocus, with a 9 mm central zone dedicated to clear distance correction, as if it were a positive lens with a central hole in front of the eye. 54–56 Limitations This study has several limitations. First, the absence of a randomized control group limits the strength of causal inferences. However, this study is among the first to adopt the use of virtual control groups in regions where ethical guidelines no longer permit untreated children to follow the natural course of myopia progression. In settings where short-term observational control periods are still permitted, future trials could consider randomization. Notably, the Myofix lens has an aesthetically conventional appearance because the peripheral positive add carving produces less myopic peripheral correction and a thinner lens structure with less frame margin prismatic effects, making it difficult to distinguish from standard spectacles, an advantage in minimizing potential bias in a masked trial. To support lens identification in clinical settings, simple verification methods were developed, for instance, viewing the lens against an Amsler grid or showing the shadow produced when a beam of light is directed towards the spectacle, which clearly reveal the distinct distance and peripheral treatment zones. Another limitation of this study is the lack of investigator masking; researchers knew that participants were using a treatment lens. Nevertheless, the use of objective outcome measures, cycloplegic autorefraction, and optical biometry helps to mitigate this potential bias. Additionally, the marked difference in progression between children with good versus poor compliance further reinforces the likely treatment efficacy of the Myofix lenses. Further limitations are a small sample size with dropouts and the inclusion of several ophthalmological centers with different biometers. However, each participant was measured with the same biometer at different time points. Conclusion In conclusion, Myofix lenses demonstrated good tolerability and effectiveness in controlling myopia progression in Caucasian children over one year. Among those with good compliance, most were able to continue using the same spectacles throughout the study duration. Importantly, non-compliance was not attributed to the spectacle design, indicating that the lens was generally well accepted by the pediatric population. Declarations Funding. The costs of this study and the provision of Myofix lenses were covered by NOVAR company. The spectacle frames were donated by USUAL company. The study protocol was approved by the Ethics Committee of the Argentine Society of Ophthalmology and the Government of Buenos Aires City (March 2023; Registration No. 8638). At the time when this approval was obtained in 2023 authors were not aware about the need to register in an international platform like Clinicaltrials.gov or those listed in WHO guidelines, so the protocol was retrospectively registered in 2025 after one year follow up with the ClinicalTrials.gov Identifier Number: NCT07092072. https://clinicaltrials.gov/study/NCT07092072?cond=myofix&rank=1 Conflict of interest: Abel Szeps, Martin de Tomas, Gabriel Martín and Rafael Iribarren are consultants of NOVAR and OPULENS. Jos Rozema is a consultant for Cooper Vision. Carla Lanca reports a relationship with Eyerising that includes consulting and advisory. Author Contributions Rafael Iribarren : conceptualization; methodology; formal analysis; data curation; writing-original draft; writing-review and editing. Carla Lanca: formal analysis; data curation; writing-original draft; writing-review and editing. Abel Szeps: conceptualization; methodology; writing-review and editing. Carlos Kotlik : conceptualization; methodology; writing-original draft. Martín de Tomas : conceptualization; methodology; formal analysis; data curation; writing-original draft; writing-review and editing. Gabriel Martín : conceptualization; methodology; writing-original draft; writing-review and editing. Jos Rozema: formal analysis; data curation; writing-original draft; writing-review and editing. Data Availability Statement: Carla Lanca and Rafael Iribarren have verified the underlying data. Data are available at a reasonable request contacting the corresponding author. Acknowledgements. The Myofix Defocus Study Group coordinators are Rafael Iribarren and Abel Szeps, and its members are Aldana Isilieri, Alejandro Armesto, Carlos Kotlik, Carolina Picotti, Constanza Bordón, Darío Busto, Dayana Trombetta, Diego Amado, Ernesto García, Fabiana Leiva, Florencia Cortínez, Gabriel Martín, Guillermo Saracco, Idamar León, Karina E. Villacorta, Leonardo Fernández Irigaray, María Julia Zunino, Marta Zardini, Martín de Tomás, Matías Acerbi, Ricardo Impagliazzo, Roberto Albertazzi, Rodolfo Aguirre, Romina Quercia, Sebastián Dankert, Susana Gamio, Valeria Bordese, Victoria Sánchez and Viviana Abudi. We also wish to thank the collaboration of these institutions also involved in the Study: Daponte Ophthalmology Center, Drs. Iribarren Eye Consultants, Szeps Ophthalmology Center, Quilmes Ophthalmology Center, Razzari Ophthalmology Center and Ver Foundation in Córdoba. And we are grateful to the optician stores involved in the adaptation of the Myofix lenses: Banu Optics, Bordese Optics, Eduardo Elvira Optics, Foucault Optics, Guisilieri Optics, La Pirámide Optics, More Vision Optical Center, Punto Óptico, Saracco Optics, La Óptica, Trombetta Optics, Valeria Bordese Espacio Óptico, and Visión Pilar Optics. Our acknowledgement to Esteban Cacciavillani, Alejandro Cacciavillani and Jorge Farall for the provision of the Usual Frames for the study. Authors wish to thank Prof. Celso Cunha (Brazil), Prof. María Inés Pérez Flores (Spain) and Prof. Wei Zhong Lan (China) for their valuable feedback and suggestions during the revision of this manuscript. References Rudnicka AR, Kapetanakis VV, Wathern AK, Logan NS, Gilmartin B, Whincup PH, Cook DG, Owen CG. Global variations and time trends in the prevalence of childhood myopia, a systematic review and quantitative meta-analysis: implications for aetiology and early prevention. 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A Brillouin microscopy analysis of the crystalline lenses of Chinese adults with myopia. Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie 2024; 262 : 3243-52. Gawne TJ, Khanal S, Norton TT. An Alternative Mechanism for the Anti-Myopia Effectiveness of Diffusion Optics Technology (DOT) Lenses. Translational vision science & technology 2025; 14 : 15. Swiatczak B, Scholl HPN, Schaeffel F. Retinal "sweet spot" for myopia treatment. Scientific reports 2024; 14 : 26773. Guggenheim JA, Terry L. Mechanism of optical treatments for myopia: Are lenslets joining the DOTs? Ophthalmic Physiol Opt 2025; 45 : 337-9. Su B, Cho P, Vincent SJ, Zheng J, Chen J, Ye C, Wang T, Zhang J, Zhang K, Lu F, Jiang J. Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial. Ophthalmology 2024; 131 : 1389-97. Neitz J, Neitz M. The Predictive and Explanatory Power of the Contrast Theory of Myopia. Translational vision science & technology 2025; 14 : 11. Chu CH, Deng L, Kee CS. Effects of hemiretinal form deprivation on central refractive development and posterior eye shape in chicks. Vision Res 2012; 55 : 24-31. Smith EL, 3rd, Hung LF, Huang J. Relative peripheral hyperopic defocus alters central refractive development in infant monkeys. Vision Res 2009; 49 : 2386-92. Schippert R, Schaeffel F. Peripheral defocus does not necessarily affect central refractive development. Vision Res 2006; 46 : 3935-40. Additional Declarations The authors declare potential competing interests as follows: Conflict of interest: Abel Szeps, Martin de Tomas, Gabriel Martín and Rafael Iribarren are consultants of NOVAR and OPULENS. Jos Rozema is a consultant for Cooper Vision. Carla Lanca reports a relationship with Eyerising that includes consulting or advisory. Supplementary Files SUPPLEMENTARYMATERIAL.doc One-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7192750","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":493367086,"identity":"f9c412a0-6e8e-45d0-9ca7-a6aef437d15b","order_by":0,"name":"Rafael Iribarren","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA9ElEQVRIiWNgGAWjYFACxgcMCQwSCRBOBRAzMzcQ0MJsgKTlDEiAkQgtQADRwtgGJvFrMW8/zPjh4R6LPP7ZZx8+LpxXG83fDtTyo2IbTi0yZ5KZJRKeSRRLnEs3Np657XjujMOMDYw9Z27j1CLBkH9AIuGARGLDGTY2ad5tx3IbgFqYGdvwaOF/zPwDpGX+GTb237xzjuXOJ6hFIpkNbMsGoC3MvA01uRsIa3nMZgHUUmx4ho1ZmufYgdyNQC0H8fqFP5n55o8DdXlyZ9gYP/PU1OXOO3/44IMfFbi1oIPDYPIA0eqBoI4UxaNgFIyCUTBCAABQfFclT+UOYgAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0002-3719-2195","institution":"Novar Tech.","correspondingAuthor":true,"prefix":"","firstName":"Rafael","middleName":"","lastName":"Iribarren","suffix":""},{"id":493367843,"identity":"8187cb65-5c3e-4d9c-a2ee-aaffd59c27d8","order_by":1,"name":"Carla Lanca","email":"","orcid":"","institution":"4.\tDivision of Science, New York University Abu Dhabi,","correspondingAuthor":false,"prefix":"","firstName":"Carla","middleName":"","lastName":"Lanca","suffix":""},{"id":493367844,"identity":"40b86c59-a5bd-4796-a482-b432cc183964","order_by":2,"name":"Abel Szeps","email":"","orcid":"","institution":"6.\tOphthalmology Dpt., Posadas Hospital, Buenos Aires, Argentina","correspondingAuthor":false,"prefix":"","firstName":"Abel","middleName":"","lastName":"Szeps","suffix":""},{"id":493367845,"identity":"7861bf80-d5d3-4872-9db0-ecd3fc1ef8a3","order_by":3,"name":"Carlos Kotlik","email":"","orcid":"","institution":"7.\tOphthalmology Dpt., Notti Hospital, Mendoza, Argentina","correspondingAuthor":false,"prefix":"","firstName":"Carlos","middleName":"","lastName":"Kotlik","suffix":""},{"id":493367846,"identity":"4299af4b-c2e3-4cb0-bcba-44a9ea731854","order_by":4,"name":"Martin De Tomas","email":"","orcid":"","institution":"Novar Tech","correspondingAuthor":false,"prefix":"","firstName":"Martin","middleName":"","lastName":"De Tomas","suffix":""},{"id":493367847,"identity":"d07aef25-dae2-480d-b0fe-39063c51b289","order_by":5,"name":"Gabriel Martin","email":"","orcid":"","institution":"Novar Tech","correspondingAuthor":false,"prefix":"","firstName":"Gabriel","middleName":"","lastName":"Martin","suffix":""},{"id":493367848,"identity":"1c096fba-0591-452c-a890-d387d13b838e","order_by":6,"name":"Jos Rozema","email":"","orcid":"","institution":"9.\tDept. of Ophthalmology, Antwerp University Hospital, Edegem, Belgium","correspondingAuthor":false,"prefix":"","firstName":"Jos","middleName":"","lastName":"Rozema","suffix":""}],"badges":[],"createdAt":"2025-07-23 06:30:03","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":true,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":true,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-7192750/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7192750/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":88100098,"identity":"f398fad0-e3cd-4bcc-9a21-d1351d343829","added_by":"auto","created_at":"2025-08-01 11:20:04","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":452355,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eLeft, schematic AutoCAD figure of the Myofix design with central 9mm zone for distance myopic correction and peripheral add. Right, photograph of a Myofix -4.00 diopter lens placed over a grid, illustrating the central distance zone and the thinner peripheral plus-powered add zone.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/52ea480f80d99dd2dbad2ad7.png"},{"id":88100112,"identity":"9a0c58c8-4098-4af2-993a-a2d929dc310c","added_by":"auto","created_at":"2025-08-01 11:20:04","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":788050,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/6dd9acea95d4f672067f10ce.png"},{"id":88101913,"identity":"64245ea7-628c-4ad1-8bd1-69b98a92f496","added_by":"auto","created_at":"2025-08-01 11:36:04","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":150743,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eMean spherical equivalent progression in 12 months of participants\u003cbr\u003e\nwith good or poor compliance. Whiskers represent the 95% confidence intervals.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/e97ef856aab659f442fd2d2b.png"},{"id":88100095,"identity":"51a0d67f-bf22-4293-978d-ae2a28f3190f","added_by":"auto","created_at":"2025-08-01 11:20:04","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":188878,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eIndividual trajectories of spherical equivalent refractive error (diopters) plotted against age (years) for two study groups. Left panel: Control group from the USA atropine study, with each solid line representing one participant’s refractive change from baseline to 12 months. Right panel: Myofix-treated group over 12 months. Solid lines represent children with good compliance, while dotted lines indicate children with poor compliance.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/a10f4bb57055d50b539676ec.png"},{"id":88100104,"identity":"bacd740e-c017-4e50-9676-96738c4c7957","added_by":"auto","created_at":"2025-08-01 11:20:04","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":132241,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eIndividual trajectories of axial length growth (mm) in children using Myofix spectacles, for boys and girls, plotted against age (years). The full line represents the emmetropic compensated normal growth slope\u003c/em\u003e\u003ca href=\"#_ENREF_23\" title=\"Naduvilath, 2025 #1869\"\u003e\u003csup\u003e\u003cem\u003e23\u003c/em\u003e\u003c/sup\u003e\u003c/a\u003e\u003cem\u003e for comparison with the slopes of the individual trajectories. Solid lines represent children with good compliance, while dotted lines indicate children with poor compliance.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/881e5ca1c07043a169928eed.png"},{"id":88102908,"identity":"4563d3c4-7e55-4b18-b151-7fcd6e2a921e","added_by":"auto","created_at":"2025-08-01 11:52:05","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3221352,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/6e1c4fef-02e7-4478-bdd3-5c864df56462.pdf"},{"id":88100101,"identity":"b52951cf-3b65-4fd4-bb03-cc4933cf9c54","added_by":"auto","created_at":"2025-08-01 11:20:04","extension":"doc","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":651776,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eOne-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"SUPPLEMENTARYMATERIAL.doc","url":"https://assets-eu.researchsquare.com/files/rs-7192750/v1/c1e140eb6cf5f1cc3c6fe304.doc"}],"financialInterests":"The authors declare potential competing interests as follows: Conflict of interest: Abel Szeps, Martin de Tomas, Gabriel Martín and Rafael Iribarren are consultants of NOVAR and OPULENS. Jos Rozema is a consultant for Cooper Vision. Carla Lanca reports a relationship with Eyerising that includes consulting or advisory. ","formattedTitle":"\u003cp\u003e\u003cstrong\u003eOne-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eRefractive errors are considered the second leading cause of visual impairment worldwide.\u003csup\u003e1\u003c/sup\u003e Highly educated populations tend to have higher rates of myopic refractive errors,\u003csup\u003e2,3\u003c/sup\u003e highlighting the need to develop effective treatments to ensure that next generations can pursue advanced education without an increased risk of developing myopia. In 2001, Saw et al.,\u003csup\u003e4\u003c/sup\u003e reported a marked increase in the prevalence of myopia among Singapore conscripts within a single generation, suggesting that environmental rather than genetic factors were primarily responsible for this rapid rise.\u003csup\u003e2\u003c/sup\u003e Since then, a myopia epidemic has clearly emerged in East and Southeast Asia. Numerous studies have confirmed this trend, with alarming projections for the development of high myopia in large segments of the population.\u003csup\u003e5\u0026ndash;7\u003c/sup\u003e In contrast, Latin-American countries such as Brazil and Argentina have reported myopia prevalence rates of approximately 15\u0026ndash;30% in adults,\u003csup\u003e8\u003c/sup\u003e with urban youth populations reaching up to one-third affected.\u003csup\u003e9\u003c/sup\u003e Despite the relatively low prevalence among adults in the city of Buenos Aires, it is important to acknowledge that myopia progression can lead to pathological changes in ocular structures such as the retina, choroid and macula, being the leading cause of legal blindness in large urban settings.\u003csup\u003e10,11\u003c/sup\u003e These degenerative changes are among the leading causes of irreversible vision loss and blindness, particularly in individuals with refractive error exceeding \u0026minus;\u0026thinsp;5.00 to -6.00 diopters.\u003csup\u003e6,12\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eLow-dose atropine (0.01\u0026ndash;0.05%) has been used as a first-line of treatment to slow myopia progression.\u003csup\u003e13\u0026ndash;16\u003c/sup\u003e However, despite its low concentration, some pediatric ophthalmologists remain concerned about the potential long-term effects of daily use over several years. Therefore, there is growing interest in developing less invasive therapeutic methods for myopia control.\u003csup\u003e13,17\u003c/sup\u003e Recent randomized controlled trials have demonstrated promising outcomes with various designs of peripheral defocus or contrast modulation spectacles and contact lenses.\u003csup\u003e18\u003c/sup\u003e These specially designed spectacles may serve as alternative spectacles to standard single-vision lenses for myopic children, as these may promote myopia progression by imposing peripheral hyperopic defocus.\u003csup\u003e19\u003c/sup\u003e This study investigated compliance and myopia progression over a one-year period using a new defocus spectacle design (Myofix, Novar). \u003csup\u003e20\u003c/sup\u003e\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003e The Myofix Defocus Study was a longitudinal, prospective, interventional, non-randomized research study developed to evaluate the tolerability, compliance, safety, and effectiveness of specially designed spectacles for myopia control in children. Baseline data and methods have been published previously.\u003csup\u003e20\u003c/sup\u003e This study included children aged 7 to 16 years who voluntarily agreed to use the Defocus spectacles for one year. Eligible participants were a consecutive series of children diagnosed with myopia, attending accredited private practice ophthalmology clinics across Argentina. Inclusion criteria were the absence of ocular pathology other than myopia, with spherical equivalent (SE\u0026thinsp;=\u0026thinsp;sphere + [cylinder/2]) between \u0026le;-0.50 D and \u0026minus;\u0026thinsp;5.00 D, astigmatism less than \u0026minus;\u0026thinsp;2.00 D, anisometropia less than \u0026minus;\u0026thinsp;1.00 D, and keratometry less than 47.00 D in the steepest meridian. The corrected distance visual acuity based on subjective refraction was required to be 0.1 logMAR (20/25 Feet Snellen) or better in each eye. Exclusion criteria included myopia with onset before the age of 6 years, any genetic syndromes, or current medical treatment for myopia other than single vision spectacle correction. The power analysis had shown that a sample of 36 subjects would be enough so our target was 45 subjects to account for losses in follow-up.\u003csup\u003e20\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eAt the baseline visit, all participants underwent a comprehensive ophthalmological evaluation, including subjective refraction and cycloplegic refraction.\u003csup\u003e20\u003c/sup\u003e Cycloplegia was induced with two drops of 1% cyclopentolate, instilled five minutes apart, and the refractive assessment was performed 45 minutes after the first drop. Cycloplegic refraction and axial length (AL) measurements (using optical biometry) were conducted at baseline, 6 months, and 12 months. A detailed questionnaire was administered to collect data on lifestyle habits and family history, including reading and outdoor exposure, hours of schooling, age of first prescription and family history of high myopia. Besides, bedtime use of smartphones, and use of inverted contrast in electronic devices were also explored. Compliance with spectacle use was assessed through two methods at the 6- and 12-month visits. First, a structured questionnaire administered during follow-up visits asked whether the child wore the spectacles full-time or only part of the day (morning or afternoon), and whether they used them at home, outdoors, or both. The questionnaire also included a question on tolerance, asking whether the spectacles were well accepted. In addition, at both follow-up visits, children were asked three specific questions to assess tolerance: whether they experienced any discomfort or difficulty when moving their head while reading, walking, or during lateral gaze. Second, the ophthalmologist independently evaluated and recorded overall compliance as 'good' or 'poor' in the clinical history, providing explanatory comments in the 'observations' section.\u003c/p\u003e\u003cp\u003eAll participants received a pair of spectacles (Myofix, Novar, USA) with frames (Usual, Argentina) at no cost for the duration of the one-year study. Children were instructed to wear the spectacles every day full-time and were evaluated at 6-month intervals. The Myofix lens design consists of a 9 mm central optical zone for distance correction, surrounded by a peripheral zone providing approximately\u0026thinsp;+\u0026thinsp;3.50 D of additional power to induce peripheral myopic defocus (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). A preliminary questionnaire taken by 45 children who were fitted for one month with these spectacles at La Pir\u0026aacute;mide Optics (Mendoza, Argentina) reported good tolerance in 80% of cases.\u003csup\u003e20\u003c/sup\u003e While most participants experienced some initial adaptation difficulties during the first two days, tolerance improved markedly thereafter.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eParticipants were recruited from 13 optical centers and 15 ophthalmological institutions. These institutions were included after confirming that their affiliated pediatric ophthalmologists were equipped to perform standard myopia assessments, including cycloplegic autorefraction and AL measurements using the Lenstar (Haag Streit), Aladdin (Zeiss), or Myah (Topcon) biometers. Both ophthalmologists and opticians received 6 hours of training to ensure standardized adherence to the study protocol, including the procedures for refraction, biometry and fitting of Myofix spectacles. Training also covered data entry using a secure, encrypted online platform developed by Novar, which was used to record clinical information. Opticians received additional online instructions focused on accurate centration of the lenses and the selection of appropriate frames to ensure proper positioning of the peripheral treatment zone around the visual axis.\u003c/p\u003e\u003cp\u003e\u003cb\u003eReference data\u003c/b\u003e\u003c/p\u003e\u003cp\u003eFor the virtual control group, data were obtained from 114 children followed with cycloplegic refractions by the Pandemic Study Group during 2018-2019.\u003csup\u003e21\u003c/sup\u003e In addition, another virtual control group was derived from a U.S.-based randomized clinical trial that publicly reported cycloplegic refraction and biometry data in a comparable sample of myopic children. The untreated arm in that study served as the control group for evaluating the effect of low-dose atropine.\u003csup\u003e22\u003c/sup\u003e As both control datasets included younger participants, only those aged 7 years or older at baseline were selected for this analysis to match the age distribution of the current study cohort. This resulted in the inclusion of 70 children for the Pandemic Study (Argentina)\u003csup\u003e21\u003c/sup\u003e and 41 children from the American Atropine study\u003csup\u003e22\u003c/sup\u003e (USA). Additionally, axial length growth in our study cohort was compared to recently published emmetropic growth curves from age-matched Caucasian children.\u003csup\u003e23\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eEthics\u003c/b\u003e\u003c/p\u003e\u003cp\u003e The study protocol was approved by the Ethics Committee of the Argentine Society of Ophthalmology and the Government of Buenos Aires City (March 2023; Registration No. 8638). Patients who exhibited a myopia progression of \u0026minus;\u0026thinsp;0.50 D or more within 6 months were excluded from further follow-up. As recommended by the ethics committee, these participants were transitioned to treatment with low-dose atropine. The study was conducted in accordance with the Declaration of Helsinki and its amendments, Good Clinical Practice (GCP) guidelines, and Resolution 1480/11 of the Argentine Ministry of Health. Both parents were verbally informed about the study objectives, and written informed consent was obtained from both parents and children. Participant anonymity was strictly preserved, with all identifying information removed from the dataset prior to statistical analysis.\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eContinuous variables are presented as mean \u0026plusmn; standard deviation, and categorical variables are reported as absolute frequencies and percentages. There was a strong correlation between SE values of the right and left eyes at baseline (R\u0026thinsp;=\u0026thinsp;0.875, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with no significant difference between them (paired \u003cem\u003et\u003c/em\u003e-test, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.085). The statistical analysis was based on the average of SE or AL change of both eyes following similar methods in a previous atropine trial.\u003csup\u003e24\u003c/sup\u003e This approach was supported by similar correlations between the two eyes observed for AL at baseline and for changes in SE and AL during follow-up (data not shown). Differences in myopia progression (SE and AL) between the study group and virtual control groups were analyzed using the Student t-test. To identify predictors of 12-month change in SE and AL, multiple linear regression models were constructed, adjusting for relevant covariates including age, sex, baseline SE, AL, compliance, and parental history of high myopia. To reduce the risk of overfitting due to the relatively small sample size, the number of predictors in each model were limited and progressively simplified in the models across three steps: Model 1 included five predictors: parental history of myopia, age at baseline, sex, mean baseline SE (for the SE model) or mean baseline AL (for the AL model), and treatment compliance at 12 months; Model 2 excluded parental history of myopia for the SE model and mean baseline AL for AL model, retaining four predictors. Model 3 further excluded variables based on statistical insignificance or model fit criteria, leaving three core predictors: mean baseline SE, sex, compliance at 12 months for the SE model, parental history of myopia, age at baseline, and compliance at 12 months for the AL model. Statistical analyses were conducted using Microsoft Excel (Microsoft Corp., USA), SPSS Statistics version 25 (IBM Corp., USA), and R (R Foundation for Statistical Computing, Vienna, Austria) for data visualization.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 47 patients were enrolled between June 2023 and April 2024, with a planned follow-up duration of one year. By the 6-month visit, 11 children were lost to follow-up (77.1% retention rate). Of these, four discontinued their participation due to personal reasons or relocation to another city or country. Among the remaining seven, one child discontinued use of the spectacles for esthetic reasons, specifically dissatisfaction with the frames, and did not return for replacement. The other six were young children with low baseline myopia (-0.50 to -1.00 D), who were not regular spectacle users and did not wear the study spectacles at all. These children showed a myopic progression of -0.50 D over the first 6 months and, in accordance with the Ethics Committee\u0026rsquo;s guidance, were withdrawn from the study. They were prescribed standard single-vision spectacles and initiated low-dose atropine. This subgroup represented 12.5% of non-users at the six-month follow-up. The flow chart is shown in \u003cb\u003eFig.\u0026nbsp;2\u003c/b\u003e.\u003c/p\u003e\u003cp\u003eThe baseline characteristics of the 36 included children are given in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Among participants, 5 had mothers with high myopia and 4 had fathers with high myopia. Most children (23/36; 63.9%) attended school for only 4 hours per day. Half of the children (18/36, 50.0%) lived in houses with gardens, while the remainder resided in homes without gardens or high-rise buildings. Seven children attended extracurricular tutorial classes (19.4%). The baseline characteristics of the two virtual control groups (Pandemic\u003csup\u003e21\u003c/sup\u003e and US atropine group\u003csup\u003e22\u003c/sup\u003e) were 10.8\u0026thinsp;\u0026plusmn;\u0026thinsp;2.0 and 10.7\u0026thinsp;\u0026plusmn;\u0026thinsp;1.4 years of age, and a SE of -2.17\u0026thinsp;\u0026plusmn;\u0026thinsp;1.38 D and \u0026minus;\u0026thinsp;2.87\u0026thinsp;\u0026plusmn;\u0026thinsp;1.01 D, respectively.\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\u003eDescriptive statistics of the 36 included participants\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean age (SD) (years)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex (female/male; n)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e18/18\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean interval 6 months follow-up (days)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e182\u0026nbsp;\u0026plusmn;\u0026nbsp;30\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean interval 12 months follow-up (days)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e375\u0026thinsp;\u0026plusmn;\u0026thinsp;33\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean spherical equivalent at baseline (diopter)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-2.72\u0026thinsp;\u0026plusmn;\u0026thinsp;1.02\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian spherical equivalent at baseline (diopter)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-2.72\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean keratometry at baseline (diopter)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e43.37\u0026thinsp;\u0026plusmn;\u0026thinsp;1.08\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean axial length at baseline (mm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e24.57\u0026thinsp;\u0026plusmn;\u0026thinsp;0.75\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean age of first spectacle prescription (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7.58\u0026thinsp;\u0026plusmn;\u0026thinsp;1.86\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime per day spent on homework (hours/day)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.68\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime per week spent outdoors (hours/day)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e20.06\u0026nbsp;\u0026plusmn;\u0026nbsp;6.55\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\u003eDaily screen time with tablets or smartphones averaged 2.41 \u0026plusmn; 0.79 hours per day. Regarding bedtime habits, 17 out of 33 children (51.5%) reported going to bed with their mobile phone, and 13 (39.4%) reported using inverted contrast settings on their devices (dark mode).\u003c/p\u003e\u003cp\u003eThe mean change in SE from baseline to 12 months was \u0026minus;\u0026thinsp;0.21 \u0026plusmn; 0.30 diopters, and the mean AL change was 0.19 \u0026plusmn; 0.13 mm. SE progression was significantly different in participants with good compliance compared with children with poor compliance (Student t test, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e3\u003c/span\u003e). In the good compliance group, children had a mean SE progression of -0.12 \u0026plusmn; 0.25 D and a mean AL change of 0.17 \u0026plusmn; 0.11mm over 12 months. No significant differences were found in SE progression for sex, family history of high myopia, schooling, type of housing, reading at night with smartphones, age at baseline, or tutorial classes in the univariate analysis. Children who used inverted contrast settings on electronic devices showed a trend for lower SE progression compared to those using standard contrast settings, although this difference did not reach statistical significance (Student t test, p\u0026thinsp;=\u0026thinsp;0.214; -0.11 D vs. -0.23 D, respectively, see supplementary figures). There was also a trend for lower SE progression in children who used spectacles the whole day vs. half a day (Student t test, p\u0026thinsp;=\u0026thinsp;0.127; -0.10 vs. -0.25 D, respectively).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e As said, among the 36 children who completed the 12-month follow-up, there were 11 children classified as having poor compliance with spectacle use. To further explore compliance, we compared questionnaire responses regarding spectacle tolerance with reported compliance levels. Notably, 77.8% of children classified as having poor compliance still reported that they tolerated the lenses well (93.8% of the whole sample tolerated the spectacles well). Overall, 75.4% of children reported no difficulties while walking around or moving head when reading. When asked about wearing habits, seven children (18.9%) indicated that they did not use the spectacles at home, and eleven (29.7%) reported they were not wearing them outdoors. Reported reasons for non-compliance at the 12-month (n\u0026thinsp;=\u0026thinsp;11) included esthetical concerns in two female children who switched to their previous frames, lost or breakage of spectacles in two children who felt embarrassed to request a replacement and reverted to use their previous prescription, two children who independently chose to wear standard contact lenses (not designed for myopia control), using the Myofix spectacles only few hours per day. The remaining cases of poor compliance involved children with low levels of myopia who did not require full-time spectacle use.\u003c/p\u003e\u003cp\u003e\u003cb\u003eSupplementary Figure S1\u003c/b\u003e illustrates the mean changes in SE and AL over 12 months in children wearing Myofix defocus spectacles compared to a virtual control group from Repka et al.\u003csup\u003e22\u003c/sup\u003e At 12 months, the mean SE progression in the Myofix group was \u0026minus;\u0026thinsp;0.21 D, substantially lower than the \u0026minus;\u0026thinsp;0.47 D observed in the control group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, \u003cb\u003eFigure S1a\u003c/b\u003e). A clear divergence in SE progression emerged after the 6-month mark, with the Myofix group showing consistently slower progression throughout the follow-up period. Similarly, the mean axial elongation in the Myofix group was 0.19 mm at 12 months, compared to 0.26 mm in the US control group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01, \u003cb\u003eFigure S1b\u003c/b\u003e). Although the difference in AL progression was less pronounced than that observed for SE, the trend also significantly favored the Myofix group.\u003c/p\u003e\u003cp\u003eFigure \u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e4\u003c/span\u003e shows individual trajectories of SE (diopters) plotted against age (years) for two study groups: the US atropine study control group and in the Myofix treated group. In the control group (left panel), most children showed a clear trend toward increasing myopia over the 12-month follow-up, with relatively consistent rates of progression across individuals. In contrast, the Myofix-treated group (right panel) demonstrated more varied responses over 12 months. While some children experienced minimal progression, others, particularly those with poor compliance (indicated by dotted lines), exhibited greater myopic shifts. These findings suggest that Myofix lenses may help slow myopia progression, especially when worn consistently.\u003c/p\u003e\u003cp\u003eFigure 5 shows the individual axial growth trajectories of boys and girls compared to recently developed emmetropic axial growth curves for European children. These curves were designed to facilitate comparison of the slopes of axial growth between normal, compensated axial growth, and myopic progression in studies lacking control groups.\u003c/p\u003e\u003cp\u003eThe results of the multiple linear regression are shown in Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e. Across all three models, treatment adherence at 12 months was consistently associated with significant changes in both SE and AL. Poor compliance was linked to a greater AL elongation and a more myopic SE, indicating worse myopia control. Age at baseline showed a negative association with AL change, suggesting that younger age was linked to greater axial elongation. Other variables, including parental history of high myopia, sex, and baseline SE or AL, were not significantly associated with SE or AL changes in any of the models.\u003c/p\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eRegression coefficients (B), 95% confidence intervals, and p-values for predictors of 12-month change in spherical equivalent (SE) and axial length (AL) across three linear regression models.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eVariables\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"4\"\u003e\n \u003cp\u003eMean difference SE (D) at 12 months\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"5\"\u003e\n \u003cp\u003eMean difference AL (mm) at 12 months\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eCoef. (B)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI Lower\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI Upper\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eCoef. (B)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI Lower\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI Upper\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" colspan=\"9\"\u003e\n \u003cp\u003eModel 1\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"1\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eParental HM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.023\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.167\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.213\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.804\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.026\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.101\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.051\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e0.498\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge at baseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.017\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.029\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.063\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.457\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.030\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.048\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.011\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.003\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean baseline SE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.033\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.109\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.042\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.373\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean baseline AL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.013\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.061\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.043\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e0.576\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.061\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.100\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.222\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.444\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.047\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.087\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e0.897\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCompliance at 12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.295\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.481\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.109\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.003\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.123\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.049\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.197\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.002\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"9\"\u003e\n \u003cp\u003e\u003cstrong\u003eModel 2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"1\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eParental HM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.030\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.103\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.043\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e0.405\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge at baseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.017\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.028\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.062\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.444\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.031\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.049\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.013\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.001\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean baseline SE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.035\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.108\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.038\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.335\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.062\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.096\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.220\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.429\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.014\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.049\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.077\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e0.652\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCompliance at 12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.297\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.479\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.002\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.123\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.050\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.195\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.002\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"9\"\u003e\n \u003cp\u003e\u003cstrong\u003eModel 3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"1\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eParental HM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.029\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.101\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.043\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e0.413\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge at baseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.031\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.048\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.013\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.001\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMean baseline SE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.038\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.110\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.033\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.285\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.064\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.093\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.221\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.412\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCompliance at 12 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.274\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.445\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.103\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.003\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.122\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.050\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.193\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.002\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n"},{"header":"Discussion","content":"\u003cp\u003eThe Myofix Defocus Study was designed to evaluate the tolerance and effectiveness of a novel design of full-field peripheral defocus spectacles developed in Argentina. These findings show promising outcomes, with good tolerance reported among children under the age of 15 years (an age group known for its great neural plasticity and adaptability when receiving anisometropic or high astigmatic prescriptions in pediatric ophthalmology practice). In the present trial, children with good compliance (whole day users) and a mean age of 11 years showed minimal progression of -0.12 D over 12 months. These findings highlight the critical role of adherence in influencing the efficacy of the myopia control intervention over 12 months. As shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, when compared with other published studies, this progression rate ranks among the lowest reported in similarly aged cohorts over one year.\u003c/p\u003e\u003cp\u003e\u003cb\u003eComparison with Previous Studies and Virtual Control Data\u003c/b\u003e\u003c/p\u003e\u003cp\u003eConducting randomized controlled trials with untreated control groups in myopia research has become increasingly challenging due to ethical concerns and loss of follow-up.\u003csup\u003e25\u003c/sup\u003e As low-dose atropine (e.g., 0.01%) is now widely recognized and endorsed by clinical guidelines as a first-line intervention, withholding treatment in control groups is no longer considered acceptable in many settings.\u003csup\u003e15,16\u003c/sup\u003e Consequently, studies employing natural history control groups often experience high dropout rates, as participants or their guardians seek available therapeutic options to slow myopia progression at nearby ophthalmology centers. This trend reflects an evolving standard of care and highlights the need for alternative control strategies in future research, such as the use of virtual control groups and normative emmetropic growth curves.\u003csup\u003e23,26,27\u003c/sup\u003e For comparison, two virtual control groups were used instead. First, a pre-pandemic cohort of 70 Argentine children, with a mean age of 11 years and myopia less than \u0026minus;\u0026thinsp;4.00 D, which were followed with cycloplegic refractions between 2018 and 2019. In this group, the mean one-year progression was \u0026minus;\u0026thinsp;0.48\u0026thinsp;\u0026plusmn;\u0026thinsp;0.52 D.\u003csup\u003e21\u003c/sup\u003e Moreover, a well-characterized control group that received no treatment from a U.S.-based randomized clinical trial on atropine treatment in similarly-aged children\u003csup\u003e22\u003c/sup\u003e was used as it provided publicly available data on cycloplegic spherical equivalent and biometric changes over one year. These two cohorts represent some of the best-documented examples of untreated myopia progression and were thus selected for comparison. The present study compares its outcomes against one these groups, showing the change in SE over 12 months between our treated cohort and the U.S. control group. The second control group exhibited similar, but slightly lower, SE progression at 12 months, suggesting that our results would have appeared more favorable if that group had been used for comparison.\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e summarizes the outcomes of several comparable studies conducted in Asia, allowing for comparison of age ranges and progression in both SE and AL. Our study was intentionally benchmarked against trials with the lowest reported progression rates in untreated control groups of similarly-aged children. Despite this conservative comparison, the Myofix lens demonstrated a 75% reduction in SE change (-0.35 D less progression) and a 37% reduction in axial elongation (98 \u0026micro;m less elongation) among children with good compliance, relative to the natural history control group reported by Repka et al.\u003csup\u003e22\u003c/sup\u003e Notably, the Myofix lens differs from other myopia control spectacles in its simplicity of design and manufacturing. Unlike lenses that require pre-molded treatment zones or proprietary blocks, the Myofix design can be digitally carved using standard equipment and locally sourced lens blanks in any digital lab. This makes it a scalable and accessible option for widespread implementation across countries without the need for complex imports.\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\u003eChange in spherical equivalent (SE) and axial length (AL) at 12 months in different studies and virtual control groups.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"7\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSTUDIES WITH TREATED GROUPS\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eFIRST AUTHOR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMEAN BASELINE AGE\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eBASELINE SER\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eCHANGE IN SE 12 MONTHS\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eBASELINE AL\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eCHANGE IN AL 12 MONTHS\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOFIX TRIAL (ONLY GOOD COMPLIANCE GROUP)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIRIBARREN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.86\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.16\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDOT SPECTACLES (USA) TREATED GROUP\u003csup\u003e28\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRAPPON\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.09\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.15\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eINDIAN ATOM STUDY (INDIA) (ATROPINE GROUP)\u003csup\u003e29\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSAXENA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-3.50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.22\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOSMART TRIAL TREATED GROUP (CHINA)\u003csup\u003e30\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLAM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.97\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.60\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOFIX TRIAL ALL INCLUDED PARTICIPANTS (ARGENTINA)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIRIBARREN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.86\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.19\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOCARE TREATED GROUP (SPAIN)\u003csup\u003e31\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eALVAREZ\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.34\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.09\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSTELLEST TRIAL TREATED GROUP (CHINA)\u003csup\u003e32\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBAO\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.70\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.76\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.13\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLAMP STUDY ATROPINA 0.05% (CHINA)\u003csup\u003e24\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eYAM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-3.98\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.85\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.20\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIRANIAN ATROPINE STUDY TREATED GROUP (IRAN)\u003csup\u003e29\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNANGIA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-4.32\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.31\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.29\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYCON LENSES TREATED GROUP (RUSIA)\u003csup\u003e33\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTARUTTA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSHAMIR LENSES TREATED GROUP (ISRAEL)\u003csup\u003e34\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCOHEN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.53\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.21\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eSTUDIES WITH CONTROL GROUPS\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOCARE CONTROL GROUP (SPAIN)\u003csup\u003e31\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eALVAREZ\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-1.90\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.41\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.23\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eATROPINE STUDY CONTROL GROUP (USA)\u003csup\u003e22\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eREPKA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.87\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.57\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.26\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePANDEMIA CONTROL GROUP (ARGENTINA)\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePICOTTI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYCON CONTROL GROUP (RUSIA)\u003csup\u003e33\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTARUTTA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.53\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDOT LENSES CONTROL GROUP (USA)\u003csup\u003e28\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRAPPON\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-1.95\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.54\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.03\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.30\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOSMART LENSES CONTROL GROUP (CHINA)\u003csup\u003e30\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLAM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.76\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.55\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.70\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.32\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOCARE CONTROL GROUP (CHINA)\u003csup\u003e35\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eLIU\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.67\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.56\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.26\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLAMP STUDY CONTROL GROUP (CHINA)\u003csup\u003e24\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eYAM\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-3.85\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.82\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.36\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSHAMIR LENSES CONTROL GROUP (ISRAEL)\u003csup\u003e34\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCOHEN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.74\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.64\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.39\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.32\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSTELLEST CONTROLS (CHINA)\u003csup\u003e32\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBAO\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-2.46\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.81\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.77\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.36\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMYOVISON CONTROLS (JAPAN)\u003csup\u003e36\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eKANDA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-3.36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.96\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e24.70\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0.39\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\u003eThe myopia progression rate observed in the Argentine Pandemic Study cohort (\u0026minus;\u0026thinsp;0.48 D per year)\u003csup\u003e21\u003c/sup\u003e closely aligns with that reported in the control group of the U.S.-based Repka trial (\u0026minus;\u0026thinsp;0.47 D),\u003csup\u003e22\u003c/sup\u003e which served as a benchmark for comparison in the present study. These progression rates, observed in children aged 10\u0026ndash;11 years, are consistent with the values reported in International Myopia Institute (IMI) publications for similarly-aged groups.\u003csup\u003e13,37\u003c/sup\u003e Notably, this rate of progression is lower than that typically observed in East Asian populations, which may be partly explained by higher levels of outdoor activity among Argentine children. Previous research conducted in the same region has shown that children spend, on average, more than 20 hours per week outdoors, similar to the children included in the present study.\u003csup\u003e38\u003c/sup\u003e However, in our current regression analysis, no significant association was found between individual differences in outdoor exposure and the rate of myopia progression within the study group.\u003c/p\u003e\u003cp\u003e\u003cb\u003eAdditional Factors Potentially Influencing Treatment Outcomes\u003c/b\u003e\u003c/p\u003e\u003cp\u003eInterestingly, none of the commonly recognized risk factors were significantly associated with myopia progression in this treatment group. In this prospective study, myopia progression was studied in relation to the habit of going to bed with a smartphone in darkness and the use of inverted contrast settings on electronic devices. While recent research has indicated that reading with defocus spectacles in dark environments may fail to trigger a choroidal thickening response,\u003csup\u003e39\u003c/sup\u003e a signal associated with slowed eye growth, the lack of a clear effect on progression in our study underscores the need for further investigation in this area. Notably, a small but non-significant trend toward reduced myopia progression was observed in children who used inverted contrast. This preliminary finding supports the rationale for future clinical trials investigating the impact of visual contrast polarity\u003csup\u003e40\u003c/sup\u003e or red-in-focus strategies,\u003csup\u003e41,42\u003c/sup\u003e which have already shown promising outcomes inducing short-term choroidal thickening in experimental settings over the past several years.\u003csup\u003e43,44\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eWhen considering compliance and potential adverse effects of myopia control strategies, spectacle-based interventions with peripheral defocus zones offer a non-invasive alternative that avoids the long-term ocular exposure to pharmacological agents, such as atropine, which may be required daily over many years. In the present study, treatment was limited to children aged 7 and older, with myopia onset after age 6 years, to exclude those with very early onset who are at highest risk for rapid progression to high myopia. Despite this criterion, the mean age of first spectacle prescription was 7 years, suggesting that the cohort may still include many children with a predisposition to rapid progression. It remains unclear whether genetically driven early-onset myopia (onset before 6 years) is responsive to environmental interventions such as increased outdoor exposure. In this sense, outdoor exposure was notably high in our sample, averaging 20 hours per week. Children with onset at 3\u0026ndash;5 years likely represent genetically determined cases who may require more intensive or combined treatment strategies. Several studies in East Asian populations have included children with early-onset myopia and reported less favorable outcomes in these subgroups, in contrast to the more encouraging results observed in our present study.\u003c/p\u003e\u003cp\u003eIn both the present and previous studies, myopia control appeared more effective when measured by changes in SE than by changes in AL. This relative stability in refractive error, despite continued axial elongation, suggests a possible compensatory mechanism involving lens power loss, a phenomenon that remains largely unexplored. The underlying biological basis for how myopia control strategies, such as defocus spectacles or low-dose atropine, might influence crystalline lens power is not well understood. To date, one study from India\u003csup\u003e45\u003c/sup\u003e has reported increased lens power loss in atropine-treated children, which may have partially offset axial elongation and contributed to refractive stability in that group. It is possible that defocus lenses and atropine exert their effects by modulating retinal signaling pathways that regulate ocular growth.\u003csup\u003e43\u003c/sup\u003e It is well established that myopic eyes tend to have lower crystalline lens power compared to emmetropic eyes,\u003csup\u003e46\u003c/sup\u003e and that progressing myopic eyes often exhibit an accelerated loss of lens power at myopia onset.\u003csup\u003e47\u003c/sup\u003e This reduction in power has been linked to both increased zonular tension and internal remodeling of the lens. Axial lens thickness during growth is maintained by a delicate balance between the addition of new fibers at the surface and the compaction of older fibers in the deeper layers.\u003csup\u003e46\u003c/sup\u003e These structural changes can influence the gradient index profile of the lens. Specifically, a slower-growing lens undergoing constant age-related compaction, may develop a steeper gradient index, as has been predicted in optical models.\u003csup\u003e46\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eA recent in vivo study assessing the elastic modulus of the crystalline lens in myopic and emmetropic eyes confirmed that myopic lenses exhibit a steeper gradient of increasing stiffness.\u003csup\u003e48\u003c/sup\u003e This suggests that the growing, compacting lens in myopic eyes may possess a form of biomechanical inertia that limits its ability to adapt to changes in axial elongation. Consequently, increased lens power loss could partially compensate for axial elongation, particularly during the first year of treatment with interventions such as defocus spectacles or low-dose atropine. This may be the reason why some studies have reported better outcomes in the first year. Future myopia control studies should consider including calculations of lens power loss as part of their evaluation metrics. Unfortunately, this was not possible in the present study due to the use of biometers that did not measure anterior chamber depth and lens thickness.\u003c/p\u003e\u003cp\u003eRecent evidence suggests that Defocus Incorporated Multiple Segments (DIMS) spectacles reduce myopia progression by decreasing the detection of high spatial frequency contrast in the perifoveal region.\u003csup\u003e49\u0026ndash;51\u003c/sup\u003e Similarly, studies have shown that both positive\u003csup\u003e52\u003c/sup\u003e and negative defocus lenslets\u003csup\u003e30\u003c/sup\u003e in specially designed spectacles can slow ocular growth, likely through a shared mechanism involving contrast modulation rather than the simple direction of defocus.\u003csup\u003e49\u003c/sup\u003e This shifts the prevailing theory away from the idea that positive defocus alone mimics the effects of plus lenses in animal models, and toward the notion that reduced contrast sensitivity of high frequencies may be key to signaling growth arrest.\u003csup\u003e53\u003c/sup\u003e By limiting high-frequency input, these lenses may leave the perifoveal zone more responsive to low-frequency cues, which are thought to be critical for defocus detection and ocular growth regulation. Interestingly, the Myofix lens design appears to incorporate both mechanisms: it reduces high-frequency contrast through peripheral blur and introduces a low-level full-field positive defocus, with a 9 mm central zone dedicated to clear distance correction, as if it were a positive lens with a central hole in front of the eye.\u003csup\u003e54\u0026ndash;56\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eLimitations\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study has several limitations. First, the absence of a randomized control group limits the strength of causal inferences. However, this study is among the first to adopt the use of virtual control groups in regions where ethical guidelines no longer permit untreated children to follow the natural course of myopia progression. In settings where short-term observational control periods are still permitted, future trials could consider randomization. Notably, the Myofix lens has an aesthetically conventional appearance because the peripheral positive add carving produces less myopic peripheral correction and a thinner lens structure with less frame margin prismatic effects, making it difficult to distinguish from standard spectacles, an advantage in minimizing potential bias in a masked trial. To support lens identification in clinical settings, simple verification methods were developed, for instance, viewing the lens against an Amsler grid or showing the shadow produced when a beam of light is directed towards the spectacle, which clearly reveal the distinct distance and peripheral treatment zones.\u003c/p\u003e\u003cp\u003eAnother limitation of this study is the lack of investigator masking; researchers knew that participants were using a treatment lens. Nevertheless, the use of objective outcome measures, cycloplegic autorefraction, and optical biometry helps to mitigate this potential bias. Additionally, the marked difference in progression between children with good versus poor compliance further reinforces the likely treatment efficacy of the Myofix lenses. Further limitations are a small sample size with dropouts and the inclusion of several ophthalmological centers with different biometers. However, each participant was measured with the same biometer at different time points.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, Myofix lenses demonstrated good tolerability and effectiveness in controlling myopia progression in Caucasian children over one year. Among those with good compliance, most were able to continue using the same spectacles throughout the study duration. Importantly, non-compliance was not attributed to the spectacle design, indicating that the lens was generally well accepted by the pediatric population.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding.\u0026nbsp;\u003c/strong\u003eThe costs of this study and the provision of Myofix lenses were covered by NOVAR company. The spectacle frames were donated by USUAL company.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;The study protocol was approved by the Ethics Committee of the Argentine Society of Ophthalmology and the Government of Buenos Aires City (March 2023; Registration No. 8638). At the time when this approval was obtained in 2023 authors were not aware about the need to register in an international platform like Clinicaltrials.gov or those listed in WHO guidelines, so the protocol was retrospectively registered in 2025 after one year follow up with the ClinicalTrials.gov Identifier Number: NCT07092072. https://clinicaltrials.gov/study/NCT07092072?cond=myofix\u0026amp;rank=1\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eConflict of interest:\u003c/strong\u003e Abel Szeps, Martin de Tomas, Gabriel Mart\u0026iacute;n and Rafael Iribarren are consultants of NOVAR and OPULENS. Jos Rozema is a consultant for Cooper Vision. Carla Lanca reports a relationship with Eyerising that includes consulting and advisory.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eRafael Iribarren\u003c/strong\u003e: conceptualization; methodology; formal analysis; data curation; writing-original draft; writing-review and editing. \u003cstrong\u003eCarla Lanca:\u003c/strong\u003e formal analysis; data curation; writing-original draft; writing-review and editing. \u003cstrong\u003eAbel Szeps:\u003c/strong\u003e conceptualization; methodology; writing-review and editing. \u003cstrong\u003eCarlos Kotlik\u003c/strong\u003e: conceptualization; methodology; writing-original draft. \u003cstrong\u003eMart\u0026iacute;n de Tomas\u003c/strong\u003e: conceptualization; methodology; formal analysis; data curation; writing-original draft; writing-review and editing. \u003cstrong\u003eGabriel Mart\u0026iacute;n\u003c/strong\u003e: conceptualization; methodology; writing-original draft; writing-review and editing. \u003cstrong\u003eJos Rozema:\u003c/strong\u003e formal analysis; data curation; writing-original draft; writing-review and editing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eData Availability Statement:\u003c/strong\u003e Carla Lanca and Rafael Iribarren have verified the underlying data. Data are available at a reasonable request contacting the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Acknowledgements.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Myofix Defocus Study Group coordinators are Rafael Iribarren and Abel Szeps, and its members are Aldana Isilieri, Alejandro Armesto, Carlos Kotlik, Carolina Picotti, Constanza Bord\u0026oacute;n, Dar\u0026iacute;o Busto, Dayana Trombetta, Diego Amado, Ernesto Garc\u0026iacute;a, Fabiana Leiva, Florencia Cort\u0026iacute;nez, Gabriel Mart\u0026iacute;n, Guillermo Saracco, Idamar Le\u0026oacute;n, Karina E. Villacorta, Leonardo Fern\u0026aacute;ndez Irigaray, Mar\u0026iacute;a Julia Zunino, Marta Zardini, Mart\u0026iacute;n de Tom\u0026aacute;s, Mat\u0026iacute;as Acerbi, Ricardo Impagliazzo, Roberto Albertazzi, Rodolfo Aguirre, Romina Quercia, Sebasti\u0026aacute;n Dankert, Susana Gamio, Valeria Bordese, Victoria S\u0026aacute;nchez and Viviana Abudi.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe also wish to thank the collaboration of these institutions also involved in the Study: Daponte Ophthalmology Center, Drs. Iribarren Eye Consultants, Szeps Ophthalmology Center, Quilmes Ophthalmology Center, Razzari Ophthalmology Center and Ver Foundation in C\u0026oacute;rdoba. And we are grateful to the optician stores involved in the adaptation of the Myofix lenses: Banu Optics, Bordese Optics, Eduardo Elvira Optics, Foucault Optics, Guisilieri Optics, La Pir\u0026aacute;mide Optics, More Vision Optical Center, Punto \u0026Oacute;ptico, Saracco Optics, La \u0026Oacute;ptica, Trombetta Optics, Valeria Bordese Espacio \u0026Oacute;ptico, and Visi\u0026oacute;n Pilar Optics.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur acknowledgement to Esteban Cacciavillani, Alejandro Cacciavillani and Jorge Farall for the provision of the Usual Frames for the study.\u003c/p\u003e\n\u003cp\u003eAuthors wish to thank Prof. Celso Cunha (Brazil), Prof. Mar\u0026iacute;a In\u0026eacute;s P\u0026eacute;rez Flores (Spain) and Prof. Wei Zhong Lan (China) for their valuable feedback and suggestions during the revision of this manuscript.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eRudnicka AR, Kapetanakis VV, Wathern AK, Logan NS, Gilmartin B, Whincup PH, Cook DG, Owen CG. 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Myopia: why the retina stops inhibiting eye growth. \u003cem\u003eScientific reports\u003c/em\u003e 2022; \u003cstrong\u003e12\u003c/strong\u003e: 21704.\u003c/li\u003e\n\u003cli\u003eSwiatczak B. Chromatic Light Therapy for Inhibiting Myopia Progression: Human Studies. \u003cem\u003eKlinische Monatsblatter fur Augenheilkunde\u003c/em\u003e 2024; \u003cstrong\u003e241\u003c/strong\u003e: 1126-8.\u003c/li\u003e\n\u003cli\u003eSchaeffel F, Swiatczak B. Mechanisms of emmetropization and what might go wrong in myopia. \u003cem\u003eVision Res\u003c/em\u003e 2024; \u003cstrong\u003e220\u003c/strong\u003e: 108402.\u003c/li\u003e\n\u003cli\u003eIngrassia L, Swiatczak B, Schaeffel F. Two different visual stimuli that cause axial eye shortening have no additive effect. \u003cem\u003eVision Res\u003c/em\u003e 2024; \u003cstrong\u003e224\u003c/strong\u003e: 108485.\u003c/li\u003e\n\u003cli\u003eSaxena R, Gupta V, Dhiman R, Phuljhele S, Kumar P, Sharma N, Iribarren R, Rozema J. 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Effects of hemiretinal form deprivation on central refractive development and posterior eye shape in chicks. \u003cem\u003eVision Res\u003c/em\u003e 2012; \u003cstrong\u003e55\u003c/strong\u003e: 24-31.\u003c/li\u003e\n\u003cli\u003eSmith EL, 3rd, Hung LF, Huang J. Relative peripheral hyperopic defocus alters central refractive development in infant monkeys. \u003cem\u003eVision Res\u003c/em\u003e 2009; \u003cstrong\u003e49\u003c/strong\u003e: 2386-92.\u003c/li\u003e\n\u003cli\u003eSchippert R, Schaeffel F. Peripheral defocus does not necessarily affect central refractive development. \u003cem\u003eVision Res\u003c/em\u003e 2006; \u003cstrong\u003e46\u003c/strong\u003e: 3935-40.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"NOVAR TECH","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 spectacles, full field defocus design, tolerance, efficacy","lastPublishedDoi":"10.21203/rs.3.rs-7192750/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7192750/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e: To report the 1-year efficacy of Myofix Defocus spectacles, designed to control the progression of myopia in childhood.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e A total of 47 myopic children aged 7 to 15 years were enrolled. Cycloplegic objective refraction (spherical equivalent refraction, SE) and axial length (AL) were measured at baseline, 6 months and 12 months. Linear regression models were used to identify risk factors of 12-month changes in SE and AL. For comparison, two virtual control groups of American children were included. Tolerance was assessed through a questionnaire at each follow-up visit.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Of the initial cohort, 11 participants were lost to follow-up after 6 months due to reasons unrelated to lens design (77.1% retention rate). Over 12 months, the mean SE change in all eyes was -0.21±0.30 D, and AL change was 0.19±0.13mm. Progression was significantly different in participants who reported good compared to poor compliance (p\u0026lt;0.001). At the 12-month follow-up, participants with good compliance had a mean SE progression of -0.12±0.25D and a mean AL change of 0.17±0.11 mm. In virtual controls, the mean annual SE progression was -0.47±0.36 diopters, and AL change was 0.26±0.17 mm. In compliant participants, Myofix Defocus lens demonstrated a 75% reduction in SE and 37% reduction in AL compared to virtual controls.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eAfter 1 year, Myofix Defocus spectacles slowed myopia progression in children, demonstrating comparable efficacy to other defocus-incorporated spectacle designs. Greater compliance resulted in better treatment effect. Further long-term studies are warranted to confirm these findings.\u003c/p\u003e","manuscriptTitle":"One-year Efficacy and Tolerance of Myofix Defocus Spectacles for the Control of Myopia Progression","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-01 11:19:59","doi":"10.21203/rs.3.rs-7192750/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":"db5d726e-55e4-4bd9-baf4-97f9c013e69e","owner":[],"postedDate":"August 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-08-01T11:19:59+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-01 11:19:59","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7192750","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7192750","identity":"rs-7192750","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}