Lifestyle Factors in Myopic Spanish Children.

BACKGROUND: Childhood myopia represents a global concern with increasing prevalence in recent decades. Lifestyle factors significantly impact myopia. AIM: To evaluate lifestyle factors in myopic children from a metropolitan area in Europe. METHODS: This was a descriptive study including myopic subjects aged 4-18 years. Patient demographic and clinical data were collected, including cycloplegic refraction in spherical equivalent refraction (SER) and axial length (AL). In addition, a questionnaire on lifestyle factors was conducted between September 2022 and April 2023. RESULTS: A total of 321 myopic children were included, aged 10.72 ± 3.05 years, of whom 51.4% were boys, with SER -2.25 ± 1.9 D and AL 24.54 ± 0.98 mm. The mean age of myopia onset was 7.69 ± 3.05 years. A total of 59.8% had family history of myopia. Those children who had <2 h/day of screen time (on weekdays) presented SER -2 ± 1.91 D, compared to those who had >2 h/day, SER: -2.50 ±1.88 D (p = 0.009). Children who spent <2 h/day doing near work after school were less myopic compared to those who spent >2 h/day (SER: -1.75 ± 1.83 vs. SER: -2.75 ± 1.82, respectively, p = 0.03). However, no significant association was observed between SER and AL and time spent outdoors nor between SER and AL and academic performance (p > 0.05). CONCLUSIONS: Screen time and near-work time appear to be lifestyle factors related to myopia.

Effectiveness of a Spectacle Lens with a Specific Asymmetric Myopic Peripheral Defocus: 12-Month Results in a Spanish Population.

BACKGROUND: Different designs of ophthalmic lenses have been studied to control the progression of myopia in children. This study aims to evaluate the short-term efficacy of a new design of ophthalmic lens with asymmetric myopic peripheral defocus (MPDL) on myopia progression in children compared to a control group wearing a single-vision lens (SVL). METHODS: Children aged 5 to 12 with myopia up to -0.50 D, astigmatism and anisometropia under 1.50 D, and corrected visual acuity over 20/20 were randomized to either the study group (MPDL) or control group (SVL). The myopia progression was evaluated by measuring axial length (AL) growth (IOL Master; Zeiss) over a period of one year. RESULTS: Ninety-two subjects were recruited. Forty-six children were randomly assigned to the control group, and 46 to the study group. In total, 83 children completed the clinical trial, with a mean age of 10.81 [9.53-11.92] years, among which 59.04% were female. After one year of treatment, there was less AL elongation in the study group compared to the control group (0.16 ± 0.16 mm vs. 0.24 ± 0.16 mm, p = 0.034). CONCLUSIONS: The MPDL significantly reduced the absolute growth of AL by 39% (p = 0.014) and relative growth of AL by 37.3% (p = 0.012) after 12 months in comparison to the control group in a Spanish population.

Subjective behavioral measures in myopic and pre-myopic children before and after the COVID lockdown.

Background: There are environmental factors that may contribute to the onset of myopia. This study aims to evaluate the children's lifestyle changes before and after the COVID-19 lockdown and how they can influence their vision. Methods: The same questionnaire was administered to children aged between 5 and 7 in Spain every year in September before (2017-2019) and after the COVID-19 lockdown (2020-2021). All the children also passed a vision exam consisting of the measurement of visual acuity (VA) and determination of objective and subjective refraction. Children were classified as myopes, pre-myopes, or hyperopes. The cut-off points to define the refractive error were established according to the value of the spherical equivalent (SE): hyperopia (SE > +0,75D), myopia (SE ≤ -0,5D), or pre-myopia (-0.5D < SE ≥ +0.75D). Data analysis is performed with the SPSS 27.0 software (SPSS Inc., Chicago, Illinois). Results: In the pre-COVID period, the pre-myopes were the ones who spent the longest time outdoors, and after the COVID lockdown, there were no differences between groups. There neither were any differences in the time spent doing near-work activities between the groups in both periods (p > 0.05). Regarding the spherical equivalent, in the pre-COVID period, the mean value was 0.75 ± 2.09D and after the COVID lockdown, it was 0.47 ± 1.88D (p < 0.001). Conclusion: Pre-myopes spent more time outdoors than myopes in the pre-COVID period, while myopes spent more time using digital devices. All these differences do not exist after the COVID lockdown, with a general increase in the time spent outdoors and a decrease in the use of digital devices. Further studies are needed to know if these lifestyle changes remain and how they influence the onset of myopia.

Changes in the Choroidal Thickness of Children Wearing MiSight to Control Myopia.

Background: Due to the importance of choroidal thickness in the development of myopia, this study examined the effect of MiSight contact lenses (CLs) on the choroidal thickness of myopic children and the differences between responders and non-responders to the treatment with these CLs. Methods: A total of 41 myopic children were fitted with MiSight CLs and 33 with single-vision spectacles. They were followed up for two years. Subfoveal choroidal thickness and choroidal thickness 1 and 3 mm temporal and nasal to the fovea were measured by OCT at baseline and one and two years after the treatment. Differences in all the choroidal thickness parameters were assessed in each group over time. Patients from the MiSight group were classified based on a specific range of changes in axial length at the end of the second year of treatment as "responders" (AL change < 0.22 mm/per year) and "non-responders", and the choroidal thickness of both groups was analyzed. Results: The subfoveal choroidal thickness of the MiSight and single-vision spectacle groups did not show any changes over time. Wearing MiSight CLs induced relative choroidal thickening in the responder group in the first year of treatment. Conclusion: Choroidal thickness might work as a predictor of the effectiveness of MiSight in myopia treatment.

Predicting factors for progression of the myopia in the MiSight assessment study Spain (MASS).

PURPOSE: To investigate which baseline factors are predictive for success in controlling myopia progression in a group of children wearing MiSight Contact Lens (CLs). METHODS: Myopic patients (n=41) fitted with MiSight CLs and followed up two years were included in this study. Bivariate analysis, a logistic regression analysis (LG) and a decision tree (DT) approach were used to screen for the factors influencing the success of the treatment. To assess the response, axial length (AL) changes were considered as main variable. Patients were classified based on a specific range of change of axial length at the end of each year of treatment as "responders" (R) (AL change <0.11mm/per year) and "non-responders" (NR) (AL change ≥0.11mm/per year). RESULTS: Of a total of forty-one Caucasian patients treated with MiSight CLs, 21 and 16 were considered responders in the first and the second year of follow-up, respectively. LG analysis showed that the only factor associated with smaller axial length growth was more time spent outdoors (p=0.0079) in the first year of treatment. The decision tree analysis showed that in the responding group spending more than 3 and 4h outdoors per week was associated with the best response in the first year and in the second year of treatment respectively. CONCLUSIONS: The LR and the DT approach of this pilot study identifies time spent outdoors as a main factor in controlling axial eye growth in children treated with MiSight CLs.

Impact of COVID-19 Home Confinement in Children's Refractive Errors.

BACKGROUND: Myopia is a public health problem, with estimations that 50% of the world population will be myopic by 2050. Some environmental factors, such as time spent outdoors, doing near work, and using digital devices, influence the development of myopia in children. Home confinement in Spain has increased these risk factors, so this study aims to investigate the impact of home confinement during the COVID-19 outbreak in the vision of school-aged children; Methods: A cross-sectional study in children between 5 and 7 years old that completed a visual screening and a questionnaire about their lifestyles at opticians in Spain in September and October of 2019 and 2020. Statistical analysis to compare lifestyles pre and post confinement, and vision in 2020 versus a similar cohort examined at the same opticians in 2019, was conducted; Results: Spanish children spent less time outdoors and more time doing near work in 2020 than in 2019 (p ≤ 0.001). There was a significant decrease of the spherical equivalent (mean ± standard deviation; 0.66 ± 2.03 D in 2019 vs. 0.48 ± 1.81 D in 2020; p ≤ 0.001); Conclusions: Lifestyles of Spanish children changed during the home confinement at the beginning of 2020. Together with changes in their lifestyles, spherical equivalents have decreased, which implies higher figures of myopia for children aged between 5 and 7.

Ocular and corneal aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS).

BACKGROUND: To compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period. METHODS: Children aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were randomly assigned to the lens study group (MiSight) or the control group (single-vision spectacles). The root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular (total) RMS (RMS_T), ocular high order RMS (HO_RMS_T), ocular low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular SA (SA_T) were calculated by aberrometry measures at the baseline, on 12-months and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed. RESULTS: Seventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). RMS_T significantly changed (0.57 ± 0.20 µm, p = 0.029) after 24-months in the control group. In the MiSight group no significant changes were registered (p > 0.05). The SA_C and SA_T did not reveal significant changes between visits or between groups (p > 0.05). CONCLUSIONS: Along 2 years, MiSight CL did not induce significant changes in RMS of anterior cornea or total ocular RMS. Contrary, in control group the RMS_T significantly changed as response of greater eye growth and myopia progression. The results obtained in present study allow to predict corneal or total aberration changes, in children, in response of wearing of MiSight lens along the time. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01917110.

Rebound Effect in the Misight Assessment Study Spain (Mass).

PURPOSE: To investigate whether cessation of MiSight contact lens (CLs) wear for myopia control produces rebound effect. MATERIAL AND METHODS: This study recruited participants who had just completed the MASS Study, a two-year randomized clinical trial designed to assess the efficacy of MiSight® CLs versus distance single vision (SV) spectacles in myopic children. To assess the rebound effect, axial length progression was taken into account in those children that continued one more year of follow-up. At this visit, children were divided into three groups: MiSight-C group, in which children from the original study group continued MiSight CLs wear for the duration of the study; MiSight-D group, in which children from the original study group discontinued MiSight CLs wear in the last year; and SV-C group, in which children from the original control group continued wearing single-vision spectacles for the duration of the study. The last group was considered as the control group. RESULTS: Of the 74 children who completed the MASS study, 55 children completed the 1-year follow-up and were included in the analysis. Thirteen children were included in the MiSight-C group, 18 in the MiSight-D group, and 24 in the Single Vision-C group. Axial length and myopia progression in the last year were 0.15± 0.11 mm, 0.22± 0.11 mm, 0.21± 0.10 mm and -0.37±0.44D, -0.46±0.39D and -0.55±0.45D for the three groups, respectively. No significant differences in axial elongation and myopia progression were found among the three groups of participants. CONCLUSIONS: Over a one-year period, neither myopia progression nor eye growth was faster for the subjects who discontinued MiSight contact lens wear compared to those who continued to wear MiSight contact lenses or those who continued to wear single-vision spectacles, indicating no rebound effect with MiSight contact lenses for 2 years.ClinicalTrials.gov Identifier: NCT01917110.

Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence.

Myopia has become a major public health problem in the world due to the increase in its prevalence in the past few decades and due to sight-threatening pathologies associated with high myopia such as cataracts, glaucoma and especially myopic maculopathy. This article is a narrative review of the evidence that currently exists on a contact lenses (CLs) specifically designed to correct myopia and to slow its progression. To contextualise the topic we discuss the different classifications and definitions that have been used for myopia, the current burden of being myopic, and current treatment options to prevent and control its progression. There is evidence that exposure to sunlight reduces the risk of myopia onset and pharmacological treatment with atropine has been shown to be the most effective therapy for controlling its progression, followed by optical interventions such as CL fitting (orthokeratology or CLs specific for myopia control) designed to decrease retinal peripheral hyperopic defocus that seems to be the theory that suggests that axial elongation is driven by this defocus and explains why the eye continues to grow abnormally after emmetropisation and generates myopia. We will especially focus on MiSight CLs. MiSight is a daily replacement soft contact lens that has been clinically proven and approved by the US Food and Drug Administration (FDA) to control the progression of myopia in children. We analyse the optical design of MiSight CLs, as well as the results of the different efficacy and safety studies that led to the approval of the lens by the FDA. We also expose current knowledge gaps, limitations and future directions.

Bibliometric study of scientific research on optometric visual therapy.

PURPOSE: To analyze scientific research in the field of visual therapy through a bibliometric study. METHODS: The database used in this bibliometric study was SCOPUS, the largest abstract and citation database of peer-reviewed literature, covering scientific journals, books, and conference proceedings. Using remote downloading techniques, articles published between 1946 and 2017 were selected by entering the main descriptors: "optometric vis* training", "optometric vis* therapy", "vis* therapy", "vis* training" limited to the title, key words and/or abstract. We applied the following bibliometric indicators: Price's index, doubling time and annual growth rate, Price's transience index, Lotka's Law, h factor, and Bradford's zones. RESULTS: The authors retrieved 294 original articles from the temporal interval 1946-2017 (articles, reviews, letters to the director, etc.), discarding 15 of them for not meeting the study requirements. Annual growth rate was 39.62%, the timeframe 1987-1983 containing the most number of documents. United States was the country with the highest production, with more than 60% of the records. The most productive institutions are State University of New York System, SUNY State College of Optometry, and Southern California College of Optometry. Classification of authors based on productivity is strongly concentrated in small producers, with a transient index of 80.53. The total number of authors was 488, representing a co-authorship index of 1.75. CONCLUSION: Bibliometric studies have become essential tools for assessing scientific publications.

Binocular and accommodative function in the controlled randomized clinical trial MiSight® Assessment Study Spain (MASS).

PURPOSE: To evaluate the binocular and accommodative function in children wearing dual focus (DF) MiSight® contact lenses (CLs) for myopia control compared with children wearing single-vision (SV) spectacles. METHODS: This was a randomized, controlled clinical trial involving subjects aged 8 to 12, with myopia ranging from - 0.75 to - 4.00D and astigmatism < 1.00D, allocated to MiSight® study CLs group or control group wearing SV. Binocular and accommodative function was determined at baseline, 12-, and 24-month visits, assessed by the following sequence of tests: distance and near horizontal phoria, accommodative convergence/accommodation (AC/A) ratio, stereopsis, accommodative amplitude (AA), and accommodative response (AR) at 33, 25 and 20 cm. RESULTS: Seventy-four children completed the study: 41 in the CL group and 33 in the SV group. CLs group did not show any significant differences in binocular and accommodative measurements throughout the study. In control group, distance and near phoria, stereopsis, AC/A and AR at 20 cm did not show any significant change, but AA, AR at 33 cm and AR at 25 cm were greater at 24-month visit compared with baseline (p < 0.05). CONCLUSIONS: DF lenses do not change the binocular and accommodative function in children wearing dual focus CLs. TRIAL REGISTRATION: NCT01917110.

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations.

OBJECTIVES: To assess the relative clinical success of MiSight contact lenses (CLs) (study group) and distance single-vision (SV) spectacles (control group) in children in terms of adverse events (AEs), discontinuations, and tear film osmolarity over a 2-year period. METHODS: Seventy-four subjects aged 8 to 12 with myopia of -0.75 to -4.00 D and astigmatism less than 1.00 D were randomly assigned to MiSight CLs or SV groups. Subjects were monitored at 6-month intervals over the course of 24 months and advised to report to the clinic immediately should AEs occur. Adverse events were categorized as serious, significant, and nonsignificant. Discontinuation was defined as cessation of participation in the study. RESULTS: Forty-four children were corrected with MiSight CLs and 33 with SV spectacles. No serious or significant AEs were found in any of the participants in either group. Two nonsignificant AEs were found in MiSight group, corresponding to a foreign body on the cornea in two children. There were five discontinuations in MiSight group, one because of change of residence and four because of unwillingness to use the CL. There were no discontinuations in SV group. Neither group showed any significant changes in osmolarity data over the 24 months of follow-up (P≥0.05). CONCLUSIONS: No clinically serious events were observed in either group. Our results show that correct use of MiSight CLs is a safe option for myopia correction. The success of this treatment requires a combination of proper lens fitting, good adherence to routine follow-ups, and timely treatment of complications.

MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial.

PURPOSE: To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period. METHODS: Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits. RESULTS: Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n = 41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: -2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use. CONCLUSIONS: MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.