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Rayner completes enrollment in IDE study of RayOne EMV Toric Intraocular lens
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The company states this will enable movement toward US approval
(Image Credit: AdobeStock/Worawut)
Rayner has announced that it has completed enrollment in its Investigational Device Exemption (IDE) study for the RayOne EMV Toric Intraocular lens in the United States.
According to the company, this will ultimately enable the introduction of the RayOne EMV Toric lens for use in the US.1
Jim Nevelos PhD, Head of Global Clinical at Rayner, commented in a press release from the company that “closing recruitment on this study is 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.”
Most recently, the RayOne EMV Toric IOL underwent a multicentre, retrospective evaluation involving 16 surgeons across 8 countries and 56 patients (89 eyes). The average follow up after surgery was 1 month.
According to the company, the results showed that “implantation of the enhanced monofocal toric RayOne EMV Toric IOL provided excellent uncorrected distance vision, similar to that of a standard monofocal IOL, excellent uncorrected intermediate vision, and very good functional near vision.”2
Furthermore, the mean manifest spherical equivalent was -0.47± 0.58 D, with 96% of eyes within ±1.00 D of target. While manifest cylinder was reduced from -1.32 ± 0.91 D preoperatively to -0.35 ±0.44 D postoperatively (p<0.001), with 74% of eyes with equal or less than 0.50 D of residual refractive astigmatism.2
The RayOne EMV Toric IOL is made of a hydrophilic acrylic copolymer (Rayacryl) with a refractive index of 1.46 and includes a benzophenone-based ultraviolet absorbing agent.2
References:
Rayner closes recruitment for IDE for RayOne EMV Toric IOLs. Press Release; June 27, 2024. Accessed July 8, 2024. https://rayner.com/rayner-closes-recruitment-for-ide-for-rayone-emv-toric-iols/
RayOne EMV Toric First-in-Eye Multicentre Real World Clinical Results. Accessed July 8, 2024. https://rayner.com/peer2peer/wp-content/uploads/sites/8/2023/06/RayOne-EMV-Toric-FIE-White-Paper.pdf
