Cataract surgery product manufacturer Rayner has now closed recruitment for an Investigational Device Exemption (IDE) study in the US for the RayOne EMV Toric intraocular lens (IOL) developed with Australian ophthalmologist Professor Graham Barrett.
The study could pave the way towards FDA approval in the US for the lens.
“The study reflects Rayner’s continued focus on optimising visual outcomes for surgeons and their patients and will ultimately enable the introduction of the RayOne EMV Toric lens for use in the USA,” the company said on 27 June 2024.
“Developed in collaboration with Professor Graham Barrett, RayOne EMV’s truly non-diffractive optic utilises positive spherical aberration to extend vision on the rotationally stable RayOne toric platform.”
Mr Jim Nevelos, Rayner’s head of global clinical, said closing recruitment on this study was “a huge milestone for us”.
“All patients will have their final follow ups well before the end of the year and the PMA (Premarket Approval) submission will follow that. This IDE will allow us to complete our range of the highly clinically successful RayOne EMV platform in the USA.”
After receiving news of the recruitment closure, Dr James Fox, from ICON Eyecare in Grand Junction, Colorado, said his clinic was proud to be the number one enrolling site for the pivotal study.
“Our clinical experience with this lens has been excellent and we are excited to help this study progress to PMA and ultimately approval by the FDA,” he said.
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