Staar Surgical announced it has gained CE Mark approval for use of its ICL as a supplemental or “piggyback” lens in post-cataract IOL surgery patients (pseudophakics). A supplemental EVO ICL is placed in front of the cataract IOL lens in post-cataract patients, just like the EVO ICL is placed in front of the human crystalline lens in refractive patients. The EVO ICL in the post-cataract patient is supplemental to the cataract IOL. The approval is for Staar’s EVO/EVO+ and VISIAN Implantable Collamer Lenses for myopia and hyperopia, and EVO/EVO+ and VISIAN Toric Implantable Collamer Lenses for myopia and hyperopia with astigmatism.
Data from the European Registry of Quality Outcomes for Cataract and Refractive Surgery suggest that at least 13% of cataract patients have significant residual postoperative refractive error that may be corrected.2 Additional data suggests that up to 21% of patients with a history of corneal refractive surgery, including prior LASIK or RK, may need an enhancement procedure to achieve acceptable vision without eyeglasses or disposable contact lenses.3
“EVO ICL, implanted as a supplemental lens, offers an important safety net for a cataract patient’s vision and provides the opportunity for excellent uncorrected visual acuity and a spectacle-free lifestyle,” Mark Packer, MD, President of Mark Packer MD Consulting, said in a company news release. “Multiple authors of peer-reviewed, scientific publications have already reported successful deployment of the EVO ICL as a supplemental lens for the correction of residual refractive error following cataract surgery. The ability to enhance the outcomes of cataract surgery is essential for the success of a cataract surgeon’s practice, particularly when caring for patients who have already demonstrated their commitment to a spectacle-free lifestyle by having had LASIK when they were younger. The outstanding effectiveness and demonstrated safety of EVO implantation in phakic eyes make EVO an excellent choice for correction of residual pseudophakic refractive error, especially in those eyes with a history of prior corneal refractive surgery. Regulatory approval of the EVO ICL family of lenses for use as a supplemental lens will now provide surgeons with greater confidence to use this critical tool to help patients who are dissatisfied with residual refractive error after cataract surgery.”
Globally, an estimated 131 million eyes had cataract surgery for the 5-year period from 2015 through 2019 according to Market Scope, an independent Healthcare data market research firm.4
“The ICL’s new CE Mark approval expands the indications for the EVO Visian ICL product family to include a much-needed therapeutic option for the population of post-surgery cataract patients that find themselves back in glasses or contact lenses,” said Caren Mason, President & CEO of STAAR Surgical. “This new approval demonstrates the safety, versatility and significant market opportunity for our EVO ICL family of lenses and supports those surgeons who are actively building lens-based practices.”
1 Market Scope, September 2019.
2 Lundström M, Barry P, Henry Y, Rosen P, Stenevi U. Evidence-based guidelines for cataract surgery: guidelines based on data in the European Registry of Quality Outcomes for Cataract and Refractive Surgery database. J Cataract Refract Surg. 2012;38(6):1086–1093.
3 Vrijman V, van der Linden J W, van der Meulen I J E, et al. Multifocal intraocular lens implantation after previous corneal refractive laser surgery for myopia. J Cataract Refract Surg 2017 Jul;43(7):909-914.
4 Market Scope, IOL Market Report, A Global Analysis, 2016, 2017, 2018, 2019.