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. (AU)

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.

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.

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 (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.

MiSight Assessment Study Spain: A Comparison of Vision-Related Quality-of-Life Measures Between MiSight Contact Lenses and Single-Vision Spectacles.

OBJECTIVES: Recent research has shown that concentric contact lenses (CLs) can be a way to control the progression of myopia. The purpose of the current study was to compare vision-related quality-of-life measures in children wearing distance single-vision (SV) spectacles versus MiSight CLs, a specific concentric design for myopia control. METHODS: Subjects aged 8 to 12 with myopia from -0.75 to -4.00 diopters (D) of sphere and astigmatism less than 1.00 D of cylinder were allocated to the lenses study group (MiSight) or control group (SV). A Pediatric Refractive Error Profile (PREP) questionnaire was administered at 12- and 24-month intervals to evaluate children's perceptions in overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academic performance, handling, and peer perceptions. The mean score of all items was calculated as the overall score. RESULTS: In total, 74 children completed the study: n=41 in the MiSight group and n=33 in the SV group. In the MiSight group, the ratings at 12 and 24 months for appearance, satisfaction, effect on activities, handling, and peer perceptions were significantly better than those given by children in the SV group (P<0.001), as was the overall score. However, near vision was significantly better in the SV group at both 12 and 24 months (P<0.001). CONCLUSIONS: MiSight CL wear for controlling myopia improves vision-related quality of life in children when compared with spectacle wear.