Rayner completes recruitment for RayOne Galaxy IOL IDE
Posted on 3/02/2025
03.02.25 | Just 18 weeks on from the first implantation, Rayner is delighted to announce that it has now closed recruitment in the Investigational Device Exemption (IDE) study for the RayOne Galaxy intraocular lens in the USA.
Developed in collaboration between Rayner, a global manufacturer of cataract surgery solutions, and ophthalmologist Dr João Lyra from Brazil, RayOne Galaxy is the world’s first spiral IOL and the first IOL designed using AI. The lens features a unique non-diffractive spiral optic that delivers a smooth and continuous full range of vision with minimised dysphotopsia and 0% loss of transmitted light*.
The closure of recruitment in the IDE study will ultimately lead to the introduction of the RayOne Galaxy lens for use in the USA, joining Rayner’s wide portfolio of products for cataract surgery and reflecting its continued focus on optimising visual outcomes for surgeons and their patients globally.
Jim Nevelos PhD, Head of Global Clinical at Rayner, commented “The engagement we have experienced with this study has been nothing short of incredible. The last patient was enrolled just 18 weeks after the first implantation in the study, and surgeons from all our top performing sites have commented that this has been the fastest-recruited IOL study they have ever participated in! We are grateful for the support and enthusiasm from all the sites, and I look forward to supporting the next phase of the process.”
After receiving news of the recruitment completion, Dr Deborah Ristvedt from Vance Thompson Vision in Alexandria MN, the lead clinical site, commented, “The RayOne Galaxy IOL is a truly remarkable advancement, and we are so excited that we got to take part in this study. Our patients’ results are very promising, and all are doing well. We look forward to submitting our data to the FDA and ultimately getting this lens approved in the USA!”
*2025 Rayner data on file
About Rayner:
Since the implantation of the first Rayner intraocular lens by Sir Harold Ridley 1949, Rayner has had the goal to improve vision and restore sight worldwide. Today, Rayner’s mission remains to deliver innovative and clinically superior ophthalmic products that respond to the expectations of our global customers to improve the sight and quality of life of their patients.
Headquartered in Worthing, United Kingdom, Rayner markets its medical devices, pharmaceuticals, and digital solutions worldwide in over 80 countries through a network of distributors and includes direct sales teams in the United Kingdom, Eire, USA, Canada, Brazil, India, Poland, Australia, Germany, Austria, Switzerland, France, Italy, Spain, and Portugal.
Not all Rayner products are approved for sale in every country. Please contact your local Rayner distributor for details of which products are available in your area.
©2025 Rayner Group, all rights reserved. ‘Rayner’ ‘RayOne’ and ‘Galaxy’ are proprietary marks of the Rayner Group. All other trademarks are property of their respective owners.
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