The Refractive Error and Vision Impairment Estimation with Spectacle Data Study

Purpose: To investigate whether spectacle lens sales data can be used to estimate the population distribution of refractive error among patients with ametropia and hence to estimate the current and future risk of vision impairment. Design: Cross-sectional study. Participants: A total of 141 547 436 spectacle lens sales records from an international European lens manufacturer between 1998 and 2016. Methods: Anonymized patient spectacle lens sales data, including refractive error information, was provided by a major European spectacle lens manufacturer. Data from the Gutenberg Health Survey was digitized to allow comparison of a representative, population-based sample with the spectacle lens sales data. A bootstrap analysis was completed to assess the comparability of both datasets. The expected level of vision impairment resulting from myopia at 75 years of age was calculated for both datasets using a previously published risk estimation equation combined with a saturation function. Main Outcome Measures: Comparability of spectacle lens sales data on refractive error with typical population surveys of refractive error and its potential usefulness to predict vision impairment resulting from refractive error. Results: Equivalent estimates of the population distribution of spherical equivalent refraction can be provided from spectacle lens data within limits. For myopia, the population distribution was equivalent to the Gutenberg Health Survey (\u3c 5% deviation) for levels of e2.0 diopters (D) or less, whereas for hyperopia, the distribution was equivalent (\u3c 5% deviation) for levels of þ3.0 D or more. The estimated rates of vision impairment resulting from myopia were not statistically significantly different (chi-square, 182; degrees of freedom, 169; P ¼ 0.234) between the spectacle lens dataset and Gutenberg Health Survey dataset. Conclusions: The distribution of refractive error and hence the risk of vision impairment resulting from refractive error within a population can be determined using spectacle lens sales data. Pooling this type of data from multiple industry sources could provide a cost-effective, timely, and globally representative mechanism for monitoring the evolving epidemiologic features of refractive error and associated vision impairment

Application of big-data for epidemiological studies of refractive error

Purpose To examine whether data sourced from electronic medical records (EMR) and a large industrial spectacle lens manufacturing database can estimate refractive error distribution within large populations as an alternative to typical population surveys of refractive error. Subjects A total of 555,528 patient visits from 28 Irish primary care optometry practices between the years 1980 and 2019 and 141,547,436 spectacle lens sales records from an international European lens manufacturer between the years 1998 and 2016. Methods Anonymized EMR data included demographic, refractive and visual acuity values. Anonymized spectacle lens data included refractive data. Spectacle lens data was separated into lenses containing an addition (ADD) and those without an addition (SV). The proportions of refractive errors from the EMR data and ADD lenses were compared to published results from the European Eye Epidemiology (E3) Consortium and the Gutenberg Health Study (GHS). Results Age and gender matched proportions of refractive error were comparable in the E3 data and the EMR data, with no significant difference in the overall refractive error distribution (χ2 = 527, p = 0.29, DoF = 510). EMR data provided a closer match to the E3 refractive error distribution by age than the ADD lens data. The ADD lens data, however, provided a closer approximation to the E3 data for total myopia prevalence than the GHS data, up to age 64. Conclusions The prevalence of refractive error within a population can be estimated using EMR data in the absence of population surveys. Industry derived sales data can also provide insights on the epidemiology of refractive errors in a population over certain age ranges. EMR and industrial data may therefore provide a fast and cost-effective surrogate measure of refractive error distribution that can be used for future health service planning purposes

Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial

BACKGROUND: Myopia prevalence has been increasing in the last decades, and its pathological consequences, including myopic maculopathy and high myopia-associated optic neuropathy, are now one of the most common causes of visual impairment. It is estimated that by 2050, more than 50% of Europeans and Americans will be myopes, which is alarming due to the high morbidity of myopes over - 6.00D. Once myopia has appeared, there are different options with scientific evidence to try to slow the axial length growth. Ophthalmic lenses are the less invasive treatment to control myopia, and there is evidence about the efficacy of different designs, mainly in the Asiatic population. However, new designs have been launched, and it is not known if efficacy is the same between Asiatic and European subjects. Thus, we have set up a randomized, controlled, double-blind, and multicenter trial to investigate the efficacy of a new design of ophthalmic lenses for myopia control in European children. METHODS: A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. Three hundred children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between - 0.75D and - 5.00D, astigmatism < 1.50D, and anisometropia < 1.00D and having a historical evolution of at least - 0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups. DISCUSSION: This study will be the first randomized and controlled clinical trial in European children with spectacle lenses based on simultaneous competing defocus. The results will shed light on the clinical evidence of spectacle lenses relying on this new design for the management of myopia with results of efficacy in the non-Asiatic population

IMI – industry guidelines and ethical considerations for myopia control report

PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC). METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments. RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed. CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.</p

Steps towards Smarter Solutions in Optometry and Ophthalmology—Inter-Device Agreement of Subjective Methods to Assess the Refractive Errors of the Eye

Purpose: To investigate the inter-device agreement and mean differences between a newly developed digital phoropter and the two standard methods (trial frame and manual phoropter). Methods: Refractive errors of two groups of participants were measured by two examiners (examiner 1 (E1): 36 subjects; examiner 2 (E2): 38 subjects). Refractive errors were assessed using a trial frame, a manual phoropter and a digital phoropter. Inter-device agreement regarding the measurement of refractive errors was analyzed for differences in terms of the power vector components (spherical equivalent (SE) and the cylindrical power vector components J0 and J45) between the used methods. Intraclass correlation coefficients (ICC’s) were calculated to evaluate correlations between the used methods. Results: Analyzing the variances between the three methods for SE, J0 and J45 using a two-way ANOVA showed no significant differences between the methods (SE: p = 0.13, J0: p = 0.58 and J45: p = 0.96) for examiner 1 and for examiner 2 (SE: p = 0.88, J0: p = 0.95 and J45: p = 1). Mean differences and ±95% Limits of Agreement for each pair of inter-device agreement regarding the SE for both examiners were as follows: Trial frame vs. digital phoropter: +0.10 D ± 0.56 D (E1) and +0.19 D ± 0.60 D (E2), manual phoropter vs. trial frame: −0.04 D ± 0.59 D (E1) and −0.12 D ± 0.49 D (E2) and for manual vs. digital phoropter: +0.06 D ± 0.65 D (E1) and +0.08 D ± 0.45 D (E2). ICCs revealed high correlations between all methods for both examiner (p &lt; 0.001). The time to assess the subjective refraction was significantly smaller with the digital phoropter (examiner 1: p &lt; 0.001; examiner 2: p &lt; 0.001). Conclusion: “All used subjective methods show a good agreement between each other terms of ICC (&gt;0.9). Assessing refractive errors using different subjective methods, results in similar mean differences and 95% limits of agreement, when compared to those reported in studies comparing subjective refraction non-cylcoplegic retinoscopy or autorefraction”