Interim analysis from the Observational French Study in children presented at EPOS 2024 meeting in Paris
Paris, 16 September 2024- Data from an interim analysis of the Observational French Study, OPHTAMYOP, has demonstrated a significant trend of myopia control in children with spherical equivalent refraction (SER) from -0.25D to -8.00D with progressive myopia aged 4-16 years treated with Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses. The data were presented at the European Paediatric Ophthalmological Society (EPOS) Congress, 12-14 September, Paris, as part of a Rapid-Fire session.
The observational French study is a retrospective/prospective observational multicentre study which aims to assess the safety and effectiveness of DIMS Spectacle Lenses in children with progressive myopia in a French European population recruited and followed from September 2020 until present. It is the first study of its kind looking at DIMS Spectacle Lenses in France. Examinations were performed at baseline, at 3, 6, 12, 18, and 24-month follow-up consultations. Progressive myopia was characterized by a refraction increase of -0.50D over one year or -0.25D over six months, and/or an axial length increase of 0.2 mm over one year.
Professor Dominique Bremond-Gignac, Principal Investigator of observational French Study commented “The analysis showed that the DIMS Spectacle Lenses appear to be a safe and effective method for managing myopia among the study population. While the patient cohort was limited in this analysis, the trend of myopia control observed in children treated with the D.I.M.S. Technology underscores the potential of this approach.”
The results from this interim analysis suggested a significant trend of myopia control, similar to results observed previously in paediatric study populations in Hong Kong and the UK.
Internationally, the defocus theory is the currently accepted theory for explaining induced myopia progression due to single-vision spectacle lenses. D.I.M.S. Technology forms the basis for myopia management with MiYOSMART.
“We are delighted with the interim results from the observational study in a French paediatric population which adds to our growing data demonstrating the effectiveness of the MiYOSMART spectacle lenses in slowing down the progression of myopia in children. The prevalence of myopia in children worldwide continues to increase, posing a significant public health concern. We look forward to the additional data from this important study as we continue to work to slow the progression of myopia in children and preserve their vision and eye health for the future.” Jean Michel Lambert, Manager Director HOYA Vision Care France.
Since its launch in 2018, more than seven million MiYOSMART spectacle lenses have already been sold worldwide.1 HOYA Vision Care will continue bringing new evidence on the safety and effectiveness of MiYOSMART and share knowledge on myopia management to help combat and control the growing problem of myopia worldwide.
Product Disclaimer: MiYOSMART spectacle lenses have not been approved for use in the management of Myopia in all countries, including the U.S., and are not currently available for sale in all countries, including the U.S.
Refernece: 1. Based on number of MiYOSMART spectacle lenses sold as per HOYA sales data on file as of December 2023
