The Menicon Bloom Myopia Control Management System is a holistic approach for myopia control management that has been developed by Menicon to help stem the growing incidence of myopia and its health consequences worldwide. The system features Menicon Bloom Night, the first CE-approved orthokeratology contact lens for myopia control management, which will be launched to the Australian market this year. This article describes the way the new technology works.
Myopia is the most common refractive error and the major cause of vision impairment worldwide.1,2 Globally, it is recognised as a significant public health concern associated with increased ocular-related morbidity and considerable healthcare costs.3-6 It affects approximately 30% of the world’s population and its prevalence has been forecast to affect about 50% of the world’s population by 2050.1 The prevalence of myopia in young adolescents has been increasing in recent decades to about 30% in industrialised societies of the West and epidemic levels of over 90% in some parts of Far East Asia.1,7-12
AN OVERNIGHT THERAPY
Menicon Bloom Night therapy involves the overnight wear of a specially designed orthokeratology contact lens, manufactured in hyper oxygen permeable Menicon Z material to ensure optimal corneal oxygenation for safe and comfortable lens wear.13-17 The treatment temporarily changes the shape of the cornea by flattening and steepening the central and mid-peripheral corneal curvatures, respectively. These corneal changes occur overnight and reduce refractive error, thus eliminating the need to wear contact lenses throughout the waking hours after lenses are removed.18 The new corneal shape also provides a particular optical path for incoming light that counters the ocular growth response associated with myopia development.19
Menicon Bloom Night is indicated for the correction of refractive myopia and for the control of myopia when prescribed and managed by a qualified optometrist.
The myopia control therapy is currently available in two different contact lens designs: Menicon Bloom Night and Menicon Bloom Night Toric. Both lens types can correct up to -4.00D of myopia, with Menicon Bloom Night Toric providing additional options for correcting higher levels of corneal and refractive astigmatism.
IS MENICON BLOOM NIGHT SAFE AND EFFECTIVE?
Menicon Bloom Night contact lenses have been reviewed and validated via numerous comprehensive, peer-reviewed studies related to myopia control management. These studies provide conclusive support for the safety and efficacy of this treatment for myopia control management.18, 20-31
Like any other treatment, Menicon Bloom Night can be associated with the development of adverse events and complications. However, recent large studies, including meta-analyses and systematic reviews, have demonstrated that Menicon Bloom Night contact lenses, if fitted correctly by an optometrist according to the manufacturer’s instructions, are safe to use in younger populations.32-35 Specific studies performed with Menicon Bloom Night for myopia control management have shown that the complications associated with the use of the device are typically not considered to be serious; are similar to those reported with other contact lens types; and can be managed straightforwardly in clinical practice.22-25 Additionally, post-marketing surveillance and complaint trend data from the manufacturer, as well as potential adverse events reported with Menicon Bloom Night orthokeratology contact lenses in external databases, have been reviewed. Analysis of all this data has provided conclusive evidence supporting Menicon Bloom Night as a safe, viable myopia control treatment option.36
Several peer-reviewed studies specifically conducted with Menicon Bloom Night for myopia control treatment have demonstrated significant levels of efficacy.22,23, 25 Furthermore, recent results demonstrate the successful long-term efficacy of Menicon Bloom Night in reducing myopia progression in children.18 All together, these studies have provided consistent evidence supporting the efficacy of the treatment for myopia control management.
With the accumulation of long-term and comprehensive scientific evidence over the years, Menicon Bloom Night has met the highest standards of safety, efficacy and quality required to grant the treatment CE approval for myopia control management in Europe. Menicon Bloom Night, if used correctly in accordance with the instructions for use, provides excellent benefits with very limited risks.
HOW WELL IS MENICON BLOOM NIGHT ACCEPTED?
Menicon Bloom Night therapy has shown to be well-accepted by parents and to significantly improve vision-related quality of life in comparison to children wearing spectacles, thus providing an incentive to engage in its use for the control of myopia in children.27
HOW AND WHO CAN FIT MENICON BLOOM NIGHT?
The fitting of Menicon Bloom Night is optimised by the use of a corneal topographer to precisely measure corneal shape, in conjunction with Easyfit software, a sophisticated, user-friendly tool which accurately guides the optometrist through the fitting process. Additionally, a specially designed mobile phone application, the Bloom App, has been developed to enhance the monitoring and communication process between optometrists and patients. Menicon Bloom Night is only available for certified optometrists.
WHY CE-APPROVAL MATTERS
Marketing a medical device in Europe requires a marketing authorisation (‘product license’) for specified indications under specified conditions (e.g., target population, indication, specific use), regulated by the European Medical Agency.37,38 This process is employed to ensure that medical products meet the highest standards of safety, efficacy and quality before being issued a marketing authorisation. In Europe, products that hold a marketing authorisation are designated a ‘CE’ marking.
Prescribing a licensed product outside the approved scope of use is called ‘off-label’ prescribing. An example of off-label prescribing occurs when an orthokeratology contact lens, which is approved for the correction of manifest myopia in adults, is prescribed for reducing myopia progression in children, where both the indication (i.e. correcting manifest myopia vs. reducing myopia progression) and target group (i.e. adults vs. children) are different from those for which the product has been approved for.
When prescribing a treatment for myopia control, the optometrist should ideally start by considering all on-label products that may be available and only contemplate off-label prescribing if there are no on-label options, or if approved products are not effective or appropriate.41 In off-label prescribing, the patient must be adequately informed about the lack of product authorisation and the possible existence of unknown risks.40-44 Parents and legal guardians should be informed of all options and associated risks in order to decide whether the child should be treated with a tested and approved on-label treatment, or with an off-label treatment that might give a successful result, but has unknown risks.
With the official marketing authorisation for myopia control management, Menicon Bloom Night has met the highest standards of safety, efficacy and quality required to grant the treatment CE-approval for myopia control management in Europe. With such approval, optometrists can now have peace of mind with the on-label prescription of this myopia control therapy.
*Bloom, Bloom Night, Menicon Z and Easyfit are trademarks of Menicon Co., Ltd. menicon.com.au.
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- Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, et al. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017;5(12):e1221-e34.
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