Visual and refractive outcomes and glistenings occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal IOLs (original) (raw)
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Clinical Ophthalmology, 2013
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 The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance.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.
Clinical Ophthalmology, 2018
Background: Clareon ® is a new hydrophobic acrylic optic biomaterial designed for enhanced clarity and greater resistance to glistening. The present study evaluated the effectiveness and safety of a three-piece hydrophobic, monofocal intraocular lens (IOL) Model MA60NM, made of this new optic material. Methods: In this prospective, multicenter, open-label study, eligible patients aged $60 years, underwent a unilateral implantation with IOL Model MA60NM following phacoemulsification. Patients were followed-up for up to 3 years after implantation. Visual outcome and serious adverse events (SAEs, cumulative and persistent) were compared to ISO grid rates (BS EN ISO 11979-7:2006). The primary effectiveness variable was Best Spectacle-Corrected Visual Acuity (BSCVA) at 1-year postoperative follow-up. In addition, posterior capsular opacification (PCO) was assessed qualitatively and graded by slit lamp exam on a 5-point scale at all visits. Results: Overall, 179 and 138 patients completed the 1-year and 3-year postoperative follow-up, respectively. The BSCVA outcomes were better with IOL Model MA60NM than the ISO grid rates with 95.5% of patients at 1 year and 94.2% of patients at 3 years having achieved a BSCVA of 20/40 or better vs 92.5% in ISO grid. The incidence of cumulative or persistent SAEs was lower after Model MA60NM implantation than the ISO grid reference. The incidence of clinically significant PCO was 1.1% at the 1-year and 2.2% at the 3-year visit. Posterior capsulotomy rate was 1.1% at 1 year and 1.4% at 3 years. Conclusion: The three-piece hydrophobic, monofocal IOL Model MA60NM was effective for the visual correction of aphakia and successfully met all the safety parameters as defined by the ISO criteria. PCO and posterior capsulotomy rates were low over the 3-year follow-up period. This study provides evidence and supports the long-term safety and effectiveness of the new optic biomaterial Clareon ® .
BMC Ophthalmology
Background This multicentre, retro-prospective real-world study evaluated the visual, refractive and safety outcomes of a monofocal lens 1 year after implantation in cataract patients with or without pre-existing ocular pathologies. Methods Records from 4 centres in Germany and Sweden were reviewed to select eyes with aged-related cataracts, having undergone crystalline lens extraction by phacoemulsification and implantation of a CT ASPHINA 409 IOL. Preoperative, 1-month and 3-month postoperative data was collected retrospectively. In addition, included patients attended a prospective visit 12 months or later after surgery. The examination included: monocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), subjective refraction, slit-lamp examination, optical biometry, intraocular pressure (IOP), endothelial cell count and postoperative complications. Results 282 eyes, including 94 with pre-existing ocular pathologies, were analysed. Twelve months after the surgery, ...
International ophthalmology, 2018
To evaluate clinical outcomes following sub-2-mm microincision cataract surgery (MICS) and intraocular lens (IOL) implantation. Five EU clinical sites. Prospective, multicenter, open-label, single-arm, non-randomized. Preoperative assessment involved visual acuity (VA), intraocular pressure and biometry measurements. 1.4-mm wound-assisted or 1.8-mm MICS was performed. Follow-up visits were made 1 day, 1-2 weeks, 1-2 and 4-6 months after surgery. The incision size, corrected distance VA (CDVA), uncorrected distance VA, manifest refraction spherical equivalent (MRSE), refraction predictability/stability and IOL decentration were assessed. At 12-, 18-, and 24-month, long-term centration, posterior capsular opacification (PCO) and Nd:YAG capsulotomy rates were investigated. A total of 103 eyes were implanted with the study IOL (INCISE, Bausch & Lomb), 96 of which were included in visual outcome analysis. A mean 6-month CDVA of - 0.02 logMAR (20/20 + 1) was observed and 75 eyes (79.8%) a...
BMC Ophthalmology, 2021
Background This study was designed to evaluate visual, refractive and safety outcomes in eyes after they underwent phacoemulsification and implantation of a preloaded monofocal hydrophobic acrylic intraocular lens. Methods This was a single center observational study conducted at Ashford and St Peter’s Hospitals NHS Foundation Trust, United Kingdom. Patients were included if they had cataract extraction with in-the-bag implantation of the EyeCee® One preloaded intraocular lens from August to October 2019. Pre-operative, surgery-related and 2 weeks and 3 months post-operative data was collected. Surgeons at this trust were then asked to complete a feedback form to evaluate their experience of implanting the EyeCee® One. Results One hundred fifty-two eyes were included in the study. Ninety-four (62%) of these eyes had cataract but no concomitant ocular pathology that could potentially affect visual acuity. Three months post-operatively, 98.7% of all eyes had monocular CDVA ≤0.3 logMAR...
Clinical evaluation of a new hydrophobic acrylic intraocular lens with a novel delivery system
Malaysian Journal of Ophthalmology, 2022
Purpose: To evaluate clinical outcomes of patients implanted with the Clareon® monofocal intraocular lens (IOL) with AutonoMe™, an automated disposable preloaded delivery device.Design: Retrospective review.Methods: One hundred and eight eyes of 88 patients underwent uneventful phacoemulsification cataract surgery and implantation with the Clareon IOL. The primary endpoints were best-corrected distance acuity (BCDA), uncorrected distance acuity (UCDA), and proportion of patients achieving UCDA of logarithm of Minimal Angle of Resolution (logMAR) 0.18 or better at 1 month. Secondary endpoints included refractive stability and predictability, contrast sensitivity as well as wound stretch and surgically induced astigmatism (SIA).Results: The mean BCDA and UCDA at 1 month were logMAR 0.06 ± 0.08 and 0.18 ± 0.17, respectively. 93.8% of eyes had BCDA of logMAR 0.18 or better, and all eyes had BCDA of logMAR 0.3 or better. 80.9% of eyes had UCDA of 0.18 or better, and 97.8% of eyes had UCD...