Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista)

Abstract

Mark Packer,1 Luther Fry,2 Kevin T Lavery,3 Robert Lehmann,4 James McDonald,5 Louis Nichamin,6 Brian Bearie,7,† Jon Hayashida,8 Griffith E Altmann,8 Omid Khodai8 1Department of Ophthalmology, Oregon Health and Science University, Eugene, OR, USA; 2University of Kansas Medical Center, Kansas City, KS, USA; 3Wayne State University, Detroit, MI, USA; 4Baylor College of Medicine, Houston, TX, USA; 5University of Arkansas for Medical Sciences, Little Rock, AR, USA; 6Laurel Eye Clinic, Brookville, PA, USA; 7Grand Rapids Eye Institute, Grand Rapids, MI, USA; 8Bausch & Lomb, Aliso Viejo, CA, USA †Brian Bearie passed away on March 9, 2011 Purpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. Methods: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. Results: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. Conclusion: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score. Keywords: cataract surgery, enVista, glistenings, intraocular lens, hydrophobic acrylic