In vivo assessment of human corneal epithelial cells in orthokeratology lens wearers: A pilot study.

SIGNIFICANCE: Central corneal epithelial thinning associated with midperipheral epithelial thickening has been reported as the main factor contributing to the effectiveness of orthokeratology (ortho-k) in myopia control. Yet, the cellular mechanism governing the regional change in refractive power remains elusive. PURPOSE: This study aimed to evaluate the correlation between the regional change in corneal epithelial thickness and cell density in ortho-k wearers. METHODS: A new human prototype of a polarization-dependent optical coherence microscope was developed to enable noncontact and noninvasive in vivo imaging of corneal epithelial cells in ortho-k wearers with and without their ortho-k lens. The epithelial thickness and cell density were evaluated at the central and midperipheral corneal locations in four ortho-k wearers and four spectacle wearers serving as controls. RESULTS: Polarization-dependent optical coherence microscope achieved in vivo volumetric imaging of all epithelial cell types in ortho-k wearers with and without their lens over a field of view of 0.5 × 0.5 mm 2 with an isotropic resolution of ~2.2 mm. The central epithelial thinning and midperipheral epithelial thickening were consistent across all ortho-k wearers. However, the inconsistency in their regional epithelial cell density highlighted a great variability in individual response to ortho-k treatment. There was no strong correlation between epithelial thickness and cell density, especially at the midperipheral cornea, in ortho-k participants. CONCLUSIONS: This study constitutes our first step toward uncovering the cellular mechanism underlying the effectiveness of ortho-k in myopia control. Future studies will focus on the longitudinal evaluation of epithelial cells before and during ortho-k treatment to identify factors governing individual response to ortho-k treatment and ultimately inform the dynamics of epithelial cells taking place during the ortho-k treatment.

Assessment of dynamic corneal response parameters in Chinese patients of different ages with myopia and orthokeratology lenses using the Corvis ST.

OBJECTIVE: To investigate the effects of orthokeratology lenses (OK lenses) on corneal biomechanics in subjects of different ages. METHODS: Fifty subjects with mild to moderate myopia were categorized into three groups (Group I-III) based on their age. Corvis ST was used to collect dynamic corneal response parameters (DCRs) at different follow-up time points. Repeated measures analysis of variance combined with simple effect analysis was used to analyze the changes in DCRs in different groups during the follow-up period. Multiple linear regression analysis was used to analyze the correlations between axial length growth (ALG) at 6 months (ALG-6M) or 12 months (ALG-12M) and sex, baseline spherical equivalent refraction (SER), and DCRs. RESULTS: The DCRs changed in all three groups after wearing OK lenses. Most DCRs showed significant differences between baseline and 6 months after wearing OK lenses, while the differences between DCRs at 6 months and 12 months were not statistically significant. No significant differences in DCRs were observed among the three groups at the same follow-up time point. Additionally, at 6 months post-OK lens wear, ALG-6M was significantly correlated with velocity of the corneal apex at the first applanation (A1V-6M) (P = 0.002), Corvis biomechanical index (CBI-6M) (P = 0.004), the maximum amount of corneal movement (DAM-6M) (P = 0.010), deformation amplitude ratio of 2 mm (DAR2-6M) (P = 0.010), and stress-strain index (SSI-6M) (P = 0.038) in Group I. Furthermore, ALG-12M showed significant correlations with SSI-6M (P = 0.031), peak distance at the DAM (PD)-6M (P = 0.037), baseline Ambrósio Relational Thickness to the horizontal profile (P = 0.013) in Group I. CONCLUSIONS: The majority of DCRs displayed significant changes within the initial 6 months of OK lens wear. Minimal variation in DCRs was observed across different age groups at the same follow-up time point. Certain DCR parameters exhibited correlations with ALG, suggesting their potential in predicting ALG in myopic children undergoing OK lenses correction.

Assessment of the Responses of the Artificial Intelligence-based Chatbot ChatGPT-4 to Frequently Asked Questions About Amblyopia and Childhood Myopia.

PURPOSE: To assess the responses of the ChatGPT-4, the forerunner artificial intelligence-based chatbot, to frequently asked questions regarding two common pediatric ophthalmologic disorders, amblyopia and childhood myopia. METHODS: Twenty-seven questions about amblyopia and 28 questions about childhood myopia were asked of the ChatGPT twice (totally 110 questions). The responses were evaluated by two pediatric ophthalmologists as acceptable, incomplete, or unacceptable. RESULTS: There was remarkable agreement (96.4%) between the two pediatric ophthalmologists on their assessment of the responses. Acceptable responses were provided by the ChatGPT to 93 of 110 (84.6%) questions in total (44 of 54 [81.5%] for amblyopia and 49 of 56 [87.5%] questions for childhood myopia). Seven of 54 (12.9%) responses to questions on amblyopia were graded as incomplete compared to 4 of 56 (7.1%) of questions on childhood myopia. The ChatGPT gave inappropriate responses to three questions about amblyopia (5.6%) and childhood myopia (5.4%). The most noticeable inappropriate responses were related to the definition of reverse amblyopia and the threshold of refractive error for prescription of spectacles to children with myopia. CONCLUSIONS: The ChatGPT has the potential to serve as an adjunct informational tool for pediatric ophthalmology patients and their caregivers by demonstrating a relatively good performance in answering 84.6% of the most frequently asked questions about amblyopia and childhood myopia. [J Pediatr Ophthalmol Strabismus. 2024;61(2):86-89.].

Cost-Effectiveness Analysis of Myopia Progression Interventions in Children.

Importance: Several interventions exist for treating myopia progression in children. While these interventions' efficacy has been studied, their cost-effectiveness remains unknown and has not been compared. Objective: To determine cost-effective options for controlling myopia progression in children. Design, Setting, and Participants: In this cost-effectiveness analysis, a Markov model was designed to compare the cost-effectiveness of interventions for controlling myopia progression over 5 years from a societal perspective in a simulated hypothetical cohort of patients aged 10 years with myopia. Myopia interventions considered included atropine eye drops, 0.05% and 0.01%, defocus incorporated multiple segment spectacles, outdoor activity, soft contact lenses (daily disposable and multifocal), rigid gas-permeable contact lenses, progressive addition lenses, bifocal spectacle lenses, orthokeratology, highly aspherical lenslets (HALs), and red light therapy; all interventions were compared with single-vision lenses. Deterministic and probabilistic sensitivity analysis determined the association of model uncertainties with the cost-effectiveness. Costs were obtained from the charges of the Hospital Authority of Hong Kong and The Chinese University of Hong Kong Eye Center. Main Outcome and Measures: The mean costs (in US dollars) per child included the cost of hospital visits, medications, and optical lenses. The outcomes of effectiveness were the annual spherical equivalent refraction (SER) and axial length (AL) reductions. Incremental cost-effectiveness ratios (ICERs) were calculated for each strategy relative to single-vision lenses over a time horizon of 5 years. Results: Outdoor activity, atropine (0.05%), red light therapy, HALs, and orthokeratology were cost-effective. The ICER of atropine, 0.05%, was US $220/SER reduction; red light therapy, US $846/SER reduction; and HALs, US $448/SER reduction. Outdoor activity yielded a savings of US $5/SER reduction and US $8/AL reduction. Orthokeratology resulted in an ICER of US $2376/AL reduction. Conclusions and Relevance: These findings suggest that atropine eye drops, 0.05%, and outdoor activity are cost-effective for controlling myopia progression in children. Though more expensive, red light therapy, HALs, and orthokeratology may also be cost-effective. The use of these interventions may help to control myopia in a cost-effective way.

Assessment of macular microvascular changes in children following treatment of anisometropic myopic amblyopia using optical coherence tomography angiography.

PURPOSE: To evaluate macular microvascular changes in the form of foveal avascular zone (FAZ) area and vessel density in the superficial, deep capillary plexuses, and choriocapillaris using optical coherence tomography angiography (OCTA) in children with anisometropic myopic amblyopia before and after treatment. METHODS: This prospective observational study included 32 patients younger than 12 years old with anisomyopic amblyopia. OCTA was done before patients' treatment with optical correction with or without patching and was repeated after successful amblyopia treatment. Outcomes included superficial, deep, and choriocapillaris vessel density (VD) and superficial and deep FAZ areas. RESULTS: The study included 13 males (40.6%) and 19 females (59.4%), and the mean age was 9.52 ± 1.33 years. Fifty-three percent (53%) of patients needed only optical correction, and the remaining 47% needed additional patching therapy. After successful treatment, there was a significant improvement in amblyopic eyes in best-corrected visual acuity (p < 0.001), with higher VD values in superficial capillary plexuses (p < 0.001), deep capillary plexuses (p < 0.001), and foveal choriocapillaris (p = 0.030). In the glasses with patching subgroup, the difference between pre-treatment and post-treatment parameters revealed a significant improvement in vessel density in superficial retinal plexuses (foveal and parafoveal; p values 0.023 and < 0.001, respectively) and deep retinal plexuses (whole image, foveal, and parafoveal; p values 0.003, < 0.001, and 0.002, respectively). While amblyopic eyes treated with glasses alone had a significantly greater difference in choriocapillaris foveal VD (p value = 0.022). CONCLUSION: After effective amblyopia treatment, amblyopic eyes exhibited improved best-corrected visual acuity and better macular perfusion along the superficial, deep vascular density, and choriocapillaris foveal VD. CLINICAL TRIAL REGISTRATION: CinicalTrials.gov Identifier: NCT05223153.

Centration assessment of an extended depth of focus contact lens for myopic progression control.

PURPOSE: To evaluate the accuracy and the inter and intra-observer reliability of the centration assessment of extended depth of focus (EDOF) contact lenses (CL) using corneal topography. METHOD: EDOF soft CLs (Mylo, Mark'Ennovy) were fitted on thirty-three myopic students (25 females), aged 19-28 years (22.7 ± 2.0 years). For any EDOF CL, a topography over the CL and a slit lamp (SL) digital picture were taken in random order. For the topographic images, the position of the EDOF CL centre, with respect to the pupil centre, was detected by two different practitioners (one newly graduated and one with more than 20 years of clinical experience respectively) and repeated after 15 days. This measurement was compared to the one taken through the SL, considered as the gold standard, and assessed using the instrument software. RESULTS: EDOF CLs resulted decentred inferiorly and temporally ranging, in the case of slit lamp assessment, between -0.27 ± 0.19 and 0.22 ± 0.23 mm horizontally and between -0.12 ± 0.31 and -0.17 ± 0.34 mm vertically, for the right and left eye respectively. The accuracy of the topographic assessment in determining EDOF CL centration was found to be very good compared to the SL assessment. No differences were found for the left eye, whereas in the right eye, a less temporally decentred position of the CL was detected by the topographical method (p < 0.05). However, this difference appeared clinically negligible (0.14 ± 0.22 mm). Inter-observer reliability (the differences between the two practitioners in assessing the EDOF centre) resulted significant only for the vertical coordinates of the centre position (p < 0.05). Concerning intra-observer reliability, better coefficient of precision and reliability between measurements within the same session were achieved by the more experienced practitioner, as well as a better level of the intraclass correlation coefficient in test-retest. CONCLUSION: The centration of the EDOF CL investigated in this study can be accurately detected by a corneal topography performed over CLs. Inter-observer reliability resulted good whereas the intra-observer reliability resulted partially affected by the level of clinical experience of the practitioner.

Myopia, its prevalence, current therapeutic strategy and recent developments: A Review.

Myopia is a widespread and complex refractive error in which a person's ability to see distant objects clearly is impaired. Its prevalence rate is increasing worldwide, and as per WHO, it is projected to increase from 22% in 2000 to 52% by 2050. It is more prevalent in developed, industrial areas and affects individuals of all ages. There are a number of treatments available for the control of myopia, such as glasses, contact lenses, laser surgery, and pharmaceuticals agents. However, these treatments are less beneficial and have significant side effects. A novel molecule, 7-methylxanthine (7-MX), has been found to be a highly beneficial alternate in the treatment of myopia and excessive eye elongation. Many preclinical and clinical studies showed that 7-MX is effective for the treatment of myopia and is presently under phase II of clinical investigation. We have also investigated preclinical toxicity studies such as acute, sub-acute, sub-chronic, and chronic on rats. In these studies, 7-MX was found to be non-toxic as compared to other reported anti-myopic agents. Moreover, as an ideal drug, 7-MX is observed to have no or low toxicity, brain permeability, non-allergic, higher oral administration efficacy, and low treatment costs and thus qualifies for the long-term treatment of myopia. This review article on 7-MX as an alternative to myopia treatment will highlight recent findings from well-designed preclinical and clinical trials and propose a potential future therapy.

Healthcare utilization and economic burden of myopia in urban China: A nationwide cost-of-illness study.

Background: China contributes to a significant proportion of the myopia in the world. The study aims to investigate the utilization of various correction methods and health service in urban China, and to estimate the cost of myopia treatment and prevention. In addition, we aimed to estimate the cost of productivity loss due to myopia. Methods: The study was a cross-sectional investigation carried out in urban areas in three provinces located in the east (Shanghai), middle (Anhui) and west part (Yunnan) of China, in 2016. A total of 23819 people aged between 5 to 50 years were included. Health utilization and the cost of myopia were analyzed from patients' perspective. Results: The total number of people with myopia in the urban China was estimated to be 143.6 million. The correction rate was 89.5%, 92.1%, and 92.7% for Anhui, Shanghai, and Yunnan (χ2 = 19.5, P < 0.01). Over the recent year, 20.6%, 16.8%, and 28.8% of myopic subjects visited hospital due to myopia, in Anhui, Shanghai and Yunnan. The annual cost of treatment and prevention of myopia was 10.1 billion US dollar (US$, floating from 9.2 to 11.2 billion US$), and the cost per person was 69US$. The annual cost of loss of productivity was estimated to be 6.7 billion US$ for those with mild to moderate visual impairment (floating from 6.1 to 7.4 billion US$), and 9.4 billion US$ (floating from 8.5 to 10.4 billion US$) for those with severe visual impairment to blindness. Therefore, the total economic burden of myopia was estimated as 173.6 billion CNY (26.3 billion US$). Conclusions: The present study shows that myopia leads to substantial economic burden in China. The loss of productivity caused by myopia is an important part of the disease burden compared to the cost of correction and treatment paid by individuals. Therefore, the focus of myopia prevention and control should be to decrease the myopia prevalence, and prevent the uncorrected refractive errors and the irreversible damage of visual acuity by high myopia.

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.

Assessment of patient compliance in orthokeratology and analysis of influencing factors: a cross-sectional study.

BACKGROUND: Patient non-compliance, that is, failure to perform standard wear and care orthokeratology (ortho-k) lenses procedures, has been shown to be a major risk factor for contact lens-associated complications. Therefore, this study aimed to investigate the compliance with wear and care behaviors of ortho-k patients and analyze its influencing factors. METHODS: Patients who were successfully prescribed ortho-k lenses at the Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine (ECSAHZU) were enrolled in the study. Patient compliance with wear and care behaviors was examined through a questionnaire. RESULTS: This study assessed 238 subjects. The subjects' ages ranged from 7 to 25 (mean ± SD, 11.3 ± 2.5) years. The compliance with wear and care behaviors was 19.7%, and the subjects' self-assessment compliance was 96.6%. The compliance rate of subjects wearing lenses for less than 1 year was higher than that of subjects wearing lenses for more than 1 year (p < 0.001). In the first year, the compliance rates of wearing experiences for less than 1 month, 1 month, 3 months, 6 months, and more than 6 months were 45, 29, 21.6, 20, and 27.6%, respectively, and there were no statistically significant differences in compliance among these periods (p = 0.314). No correlation was identified between compliance and age (r = - 0.061, p = 0.527) or sex (r = 0.114, p = 0. 751). There was no correlation between compliance and lens care operator (r = - 0.626, p = 0.151). CONCLUSIONS: The compliance of ortho-k patients was poor. After wearing ortho-k lenses for more than 1 year, compliance with wear and care behaviors declined. In clinical practice, measures should be taken to solve these problems and improve the safety of wearing ortho-k lenses.

Computerised dynamic posturography for postural control assessment in subjects wearing multifocal contact lenses dedicated for myopia control.

PURPOSE: To measure body balance using computerised dynamic posturography in young adults wearing multifocal contact lenses (MFCL) with high addition powers designed for myopia control. METHODS: Twenty-four young adults (mean age: 24 years) wearing distance-centred soft MFCL (SwissLens Orbis Relax) with two different central zones (3 and 4.5 mm), two addition powers (+2 D, +4 D) and single vision control lenses. Body balance was measured on a moving platform under three viewing conditions: (1) eyes open when fixating on letters at 3 m or (2) at 40 cm, as well as (3) with the eyes closed. Parameters of body stabilisation were analysed: the rate of body stabilisation (τrelax ), the stabilisation time (Tmax ) and the number of oscillations (Nosc ). RESULTS: The MFCLs did not produce a significant difference in the mean values of the analysed parameters (p > 0.05 for τrelax, Tmax, Nosc ). However, a positive correlation was found between pupil size and Nosc and Tmax (p < 0.01), suggesting an effect of the +4 D add with the 3 mm central zone on the posturographic parameters. As was expected, dynamic body stabilisation was better with eyes open versus eyes closed (p < 0.005). CONCLUSIONS: Distance-centred MFCLs with a medium addition (+2 D) do not disturb body stabilisation in young adults. However, high additions (+4 D) with a small central zone may affect body balance control in subjects with large pupil size.

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.

Potential Lost Productivity Resulting from the Global Burden of Myopia: Systematic Review, Meta-analysis, and Modeling.

PURPOSE: We estimated the potential global economic productivity loss resulting from vision impairment (VI) and blindness as a result of uncorrected myopia and myopic macular degeneration (MMD) in 2015. CLINICAL RELEVANCE: Understanding the economic burden of VI associated with myopia is critical to addressing myopia as an increasingly prevalent public health problem. METHODS: We estimated the number of people with myopia and MMD corresponding to critical visual acuity thresholds. Spectacle correction coverage was analyzed against country-level variables from the year of data collection; variation in spectacle correction was described best by a model based on a human development index, with adjustments for urbanization and age. Spectacle correction and myopia data were combined to estimate the number of people with each level of VI resulting from uncorrected myopia. We then applied disability weights, labor force participation rates, employment rates, and gross domestic product per capita to estimate the potential productivity lost among individuals with each level and type of VI resulting from myopia in 2015 in United States dollars (US$). An estimate of care-associated productivity loss also was included. RESULTS: People with myopia are less likely to have adequate optical correction if they are older and live in a rural area of a less developed country. The global potential productivity loss associated with the burden of VI in 2015 was estimated at US$244 billion (95% confidence interval [CI], US$49 billion-US$697 billion) from uncorrected myopia and US$6 billion (95% CI, US$2 billion-US$17 billion) from MMD. Our estimates suggest that the Southeast Asia, South Asia, and East Asia Global Burden of Disease regions bear the greatest potential burden as a proportion of their economic activity, whereas East Asia bears the greatest potential burden in absolute terms. CONCLUSIONS: Even under conservative assumptions, the potential productivity loss associated with VI and blindness resulting from uncorrected myopia is substantially greater than the cost of correcting myopia.

Light disturbance analysis in the controlled randomized clinical trial MiSight® Assessment Study Spain (MASS).

PURPOSE: To evaluate the perception of light disturbances (LD) in children wearing Dual Focus (DF) MiSight® contact lenses (CLs) for myopia control compared with children wearing single vision spectacles (SV). METHODS: This was a randomized, controlled clinical trial involving subjects aged 8-12 with myopia of -0.75 to -4.00D and astigmatism <1.00D allocated to MiSight® study CLs group or control group wearing SV. LD was determined at baseline, 12 and 24 months visit with a validated device, Light Disturbance Analyzer (LDA) to determine the shape, size and regularity of the LD phenomena with parameters of Light Disturbance Index (LDI) Best Fit Circle (BFC) and Standard Deviation between LD and BFC (BFCIrreg.SD). RESULTS: 74 children completed the study, 41 in the CL group and 33 in the SV group. SV group didn´t show any significant differences between monocular and binocular LD measurements throughout the study. Binocular BFCRadius was smaller at 24 months visit compared with 12 month visit (p < 0.05) and for BFCIrreg.SD was significantly smaller at 24 month visit compared with baseline (p < 0.05). In MiSight® group, binocular and monocular LDI, BFCRadius and BFCIrreg.SD measurements didn't show any significant change between 12 and 24 month visits (p > 0.05). However, monocular BFCIrreg. as well as monocular and binocular BFCIrreg.SD showed a significant decrease at 24 month visit compared with 12 month visit. CONCLUSIONS: DF lenses increase the monocular light disturbance perception compared with a single vision spectacle correction. However, this effect decreased over the follow-up time and presented a significant binocular attenuation effect.

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: 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.

Assessment of Clinical Trials for Devices Intended to Control Myopia Progression in Children.

The increased prevalence of myopia in the United States and other regions of the world, and the sight-threatening problems associated with higher levels of myopia have led to great interest in research designed to reduce these rates. As most of the progression of myopia occurs in childhood, these investigations have been directed toward slowing the progression of myopia in children. Treatments described to potentially slow the progression of myopia have included pharmacological interventions, multifocal spectacles, and multifocal correction created by contact lenses. Although some contact lens clinical trials have demonstrated promising results in slowing the progression of myopia, many of these studies have significant limitations, including only short follow-up times, limited randomization, and incomplete masking. Such limitations have underscored the need to develop a more robust clinical study design, so that future studies can demonstrate whether contact lenses, as well as other medical devices, can be used in a safe and effective manner to control myopia progression. We review previous key studies and discuss study design and regulatory issues relevant to future clinical trials.