The Brien Holden Vision Institute (BHVI) has a world-renowned reputation for driving innovation that leads to the development and licensing of ground-breaking contact, spectacle and intraocular lens designs.
This reputation made it the ideal choice for Mark’ennovy, who, recognising the increasing demand and potential for myopia management options, chose to partner with BHVI and launch an individually crafted monthly, soft myopia management contact lens in their own proprietary silicone hydrogel material.
The result of this collaboration between BHVI and Mark’ennovy was Mylo, an individually crafted silicone hydrogel contact lens specifically designed for myopia management. It is powered by BHVI’s patented Extended Depth of Focus (EDOF) technology, which is clinically proven to slow myopia progression.
The EDOF design supports a comfortable acclimation to the lens, enhancing the overall wearing experience. This monthly disposable contact lens features high water content and low coefficient of friction, which combine to improve comfort throughout the day.
Its wide range of parameters and low elastic modulus ensure an excellent fit and easy handling, especially for the youngest of contact lens wearers.
Mylo was granted CE approval for myopia management in 2019 and subsequently launched in a wide range of parameters from -0.25DS to -15.00DS in 0.25DS steps with a choice of diameters from 13.50 to 15.50 in 0.5mm steps and base curves from 7.10 to 9.80 in 0.3mm steps.
A clear myopia management effect must be demonstrated for products to be granted the CE mark for myopia management.
In addition to those studies carried out by or on behalf of BHVI, a recent further study looked at the efficacy of Mylo. At the Centro Oftalmologico Integral in Bilbao, Spain, and in collaboration with the Universidad Complutense Madrid, optometrist Sergio Diaz carried out a two-year study on the efficacy of Mylo soft contact lenses with EDOF technology for myopia management.
The study involved 90 myopic children between the ages of six and 13. The participants were assigned to two groups; one wearing Mylo soft contact lenses and the other wearing single-vision distance spectacles.
The aim of this prospective longitudinal study was to evaluate the progression rate of myopia by measuring changes in axial length and cycloplegic refraction. Researchers analysed visual acuities (VA) and subjective refraction at first visit and after 24 months.
Efficacy analysis
The study’s efficacy analysis focused on both spherical equivalent and axial length, an indicator of eye growth after two years of use. When comparing axial length, there was less axial elongation in the contact lens group compared to the control (0.37 vs 0.66mm respectively, p<0.001).
This indicates an efficacy of 44% on average. After two years of use, there was a statistically significant difference in the evolution of myopia between the experimental group and the control group (-0.62 versus -1.09D respectively, p<0.001). This could be translated as an efficacy of 45% on average, in terms of spherical equivalent.
The participants in the Mylo lens group reported high levels of satisfaction with visual clarity, vision stability, and overall comfort after a month of wearing the lenses. These subjective measurements indicated that the Mylo lenses are a promising option for myopia control in children.
Mylo Toric
Even with an ever-increasing proliferation of products for myopia management, there are still limited on-label, soft lens options available to eye care professionals in the UK and Ireland, especially when a potential candidate for myopia management presents with astigmatism.
The success of Mylo in its spherical form prompted the R&D team at Mark’ennovy to explore how they could bring this technology to a wider young myopic population.
Taking the original EDOF design found in Mylo and utilising their extensive experience of manufacturing custom lenses with high cylinder corrections, Mark’ennovy explored the possibility of bringing a toric version of Mylo to fulfil this unmet need. This cumulated in the launch of Mylo Toric earlier this year.
With its comprehensive range of spheres, cylinder and axes, it meets the soft contact lens needs of most astigmatic patients. This latest on-label addition helps to safeguard the future eye health of myopia management patients with astigmatism.
It has the same spherical powers as the Mylo sphere (from -0.25DS to -15.00DS) the cylinder starts at -0.75DC to -8.00DC in 0.25DC steps and, as it is custom made-to-order axis, is available in 1º steps.
The importance of compliance
With compliance being a key driver to successful myopia management, it is logical having a lens that corrects vision to optimum levels would help contribute to patient satisfaction levels and ultimately their compliance.
In addition to this, by using a silicone hydrogel material in Mylo, wearers can be encouraged to wear the lenses for at least six days per week and as many hours as their prescriber recommends.
The new toric parameters to the Mylo lens mean that you no longer need to compromise with soft contact lenses for your astigmatic patients. This is important because approximately a third of potential contact lens wearers have astigmatism and the prevalence of astigmatism is double in myopes compared with hyperopes.
Additionally, under-correcting a patient’s astigmatism has the potential to worsen their subjective visual comfort, which can be detrimental to compliance and the ultimate end goal of keeping their myopia low.
- Jim Dickson is head of professional affairs for the UK and Ireland at Mark’ennovy.
