Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study

Abstract

PurposeTo evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.Subjects and methodsThis was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.ResultsIn this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.ConclusionThis study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.

Effect of Co-Implantation of a Capsular Tension Ring on Clinical Outcomes after Cataract Surgery with Monofocal Intraocular Lens Implantation

“…Additionally, the IOL morphologically features step-vaulted haptics that push in the optic posterior direction for direct contact with the capsular bag. 12 That is, the haptics are offset anteriorly with respect to the optic body to enable consistent posterior movement of the optic under haptic compression. 12 Although we could not determine the exact configuration of the CTR and IOL in the capsular bag, the unique characteristics of the IOL may contribute to posterior movement of the IOL under conditions of co-implantation with a CTR.…”

“… 12 That is, the haptics are offset anteriorly with respect to the optic body to enable consistent posterior movement of the optic under haptic compression. 12 Although we could not determine the exact configuration of the CTR and IOL in the capsular bag, the unique characteristics of the IOL may contribute to posterior movement of the IOL under conditions of co-implantation with a CTR. Accordingly, we presume that, with a preplaced CTR, posterior movement of an aberration-free IOL in the capsular bag could be consolidated, resulting in the postoperative hyperopic refractive outcome.…”

Evaluation of Preloaded IOL Delivery System and Hydrophobic Acrylic Intraocular Lens in Cataract Surgery

“…Currently, acrylic and silicone foldable IOLs are available and used in small-incision cataract surgery. Between these two, acrylic lenses lead to a lower incidence of PCO and a higher rate of IOL stability in the bag [ 8 ]. Even in the acrylic IOLs, hydrophobic IOL are associated with lesser PCO and glare problems than hydrophilic IOL.…”

Clinical Outcomes of Secondary Scleral-Sutured Foldable Hydrophilic Acrylic Intraocular Lens Placement by Trainees: A Single-Site Analysis

“…The enVista MX60 lens is hydrophobic and not as susceptible to opacification, which may be useful in patients with or at an increased risk of retinal detachment. 30 , 31 …”