Project

Ophthalmic product for the prevention of myopia progression

Kubota Vision Inc.

Myopia is one of the most common lifestyle-related diseases with 2.6 billion patients worldwide. The global prevalence of myopia is increasing, and the World Health Organization (WHO) predicts that 50 percent of the world’s population will have myopia by 2050. Over the past 20 years, the number of children with myopia has increased significantly and is expected to continue to increase. In Asia up to 80 percent of children are myopic.

Excessive eye length associated with myopia increases the risk for severe, sight-threatening complications later in life including glaucoma, cataracts, myopic maculopathies and retinal detachment. Those with high myopia (approximately –5 diopters or more ) have the greatest risk for complications.

While myopia can occur at any age, it often begins in children between 8 and 12 years old. Myopia often progresses after initial diagnosis because of excessive axial elongation (lengthening of the eye). Myopia progression often continues into the teenage years or twenties, and some individuals develop severe myopia, also called high myopia.

Kubota Vision and its founder Ryo Kubota, MD, PhD, chairman, president and CEO, decided to develop a spectacle lens-based phototherapy to slow the progression of myopia to help hundreds of millions of children worldwide and reduce their risk of future sight-threatening complications. Kubota Glass® creates a Custom Visual Environment using augmented reality technology and features:

• a miniaturized electronics assembly, incl. white light-producing micro-LEDs, a power
   source and a control mechanism to actuate the micro-LEDs
• miniature micro-lenslets and paracentral mirror to project a defocused stimulus to 
   the retinal periphery
• a refractive passive optic adapted to the eyes of the patient
 
Kubota Vision demonstrated during clinical studies a decrease of the axial length of the eye with the application of projected myopically defocused images. Kubota Glass® configures the peripheral myopic defocus parameters for maximum effectiveness and actively stimulates the retina. Higher illumination of the outside environment is believed to be one reason for a lower risk of onset of myopia in children who spend more time outdoors. Kubota Glass® can actively control the luminosity of the peripheral defocus targets to mimic bright photopic conditions in the retinal periphery and to be brighter than the illumination from the environment. The patient can wear Kubota Glass® while performing normal daily activities such as classroom work, watching TV, or playing video games. The Kubota Glass® System would be turned off, or not worn, for outdoor activities. This part-time treatment approach to myopia progression will likely add more value by increasing compliance and by having a minimal effect on the activities of daily living.

Key Figures

  • 2.6 billion myopic patients worldwide
  • 80 percent of children are myopic in Asia
  • 100% of myopic children can use the technology

Our Contribution

  • Product development from the idea to market launch and continuation engineering
  • Development according to medical regulation in Europe and the USA
  • Technology development, incl. demonstrators, prototypes, investigational devices
  • Support during human clinical studies worldwide
  • Usability engineering, incl. formative studies with children
  • Organization and support of conformity assessment
  • Identification and evaluation of suppliers
  • Organization of the supply chain across 3 continents
  • Design transfer of a highly integrated opto-electronic system to a contract manufacturer
  • Support in setting up the series production
  • Life cycle management

Outcome

Kubota Glass® has been developed, built, verified and transferred to the contract manufacturing organization distributed over three continents. Multiple patents and publications have been generated.

In a few years, Helbling’s multidisciplinary engineering team developed a highly integrated augmented reality product from the initial idea to the commercial stage. Our team remained focused on achieving the best technical, economical and temporal project success for our client and the hundreds of millions of children potentially benefiting from this technology. With this project, our team demonstrated our commitment to our company vision: Innovating a sustainable future.

Contact

Stefan Bauer

Stationsstrasse 12
3097 Liebefeld-Bern

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