Rayner announced it has now closed recruitment in the Investigational Device Exemption (IDE) study for the RayOne Galaxy intraocular lens (IOL) in the United States. 

Developed in collaboration between Rayner and ophthalmologist Dr. João Lyra from Brazil, RayOne Galaxy is the world’s first spiral IOL and the first IOL designed using AI, the company said in a press release. The lens features a non-diffractive spiral optic that delivers a smooth and continuous full range of vision with minimized dysphotopsia and 0% loss of transmitted light.* 

The company said that the closure of recruitment in the IDE study will ultimately lead to the introduction of the RayOne Galaxy lens for use in the United States, joining Rayner’s portfolio of products for cataract surgery and reflecting its continued focus on optimizing 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, Minnesota, 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 US!”

*2025 Rayner data on file