Rayner Announces First RayOne Galaxy Implantations in the US

Rayner has announced the implantation of the first IOL in the RayOne Galaxy FDA-approved investigational device exemption (IDE) study. This milestone marks the beginning of a prospective, multicenter, randomized, masked, and active-controlled study aimed at evaluating the RayOne Galaxy IOL. The study's results will support a pre-market approval (PMA) submission to the FDA.

The RayOne Galaxy, which was recently launched in Europe, is designed to enhance visual outcomes for patients undergoing cataract surgery. 

Developed in collaboration with Brazilian ophthalmologist João Lyra, MD, PhD, the RayOne Galaxy features a unique spiral design created by a proprietary AI engine trained on patient outcomes. According to Rayner, this spiral design provides a continuous full range of vision while minimizing dysphotopsia, achieved through a non-diffractive optic with 0% light loss.

Vance Thompson, MD, of Vance Thompson Vision in South Dakota, and James Fox, MD, of Icon Eyecare in Colorado, performed the first implantations in the US. 

“We have been eagerly awaiting the opportunity to implant this new IOL. The early experience in Europe has been very encouraging, and we now get to collect detailed clinical performance data in this IDE," Dr. Thompson said. "The first case went very well, and we look forward to collecting the clinical outcomes.”