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Original Research

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample

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Pages 1647-1657 | Published online: 20 Apr 2021

References

  • Congdon N, Vingerling JR, Klein BE, et al. Prevalence of cataract and pseudophakia/aphakia among adults in the United States. Arch Ophthalmol. 2004;122(4):487–494.
  • Lundstrom 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. doi:10.1016/j.jcrs.2012.03.006
  • Labuz G, Knebel D, Auffarth GU, et al. Glistening formation and light scattering in six hydrophobic-acrylic intraocular lenses. Am J Ophthalmol. 2018;196:112–120. doi:10.1016/j.ajo.2018.08.032
  • Hayashi K, Hirata A, Yoshida M, Yoshimura K, Hayashi H. Long-term effect of surface light scattering and glistenings of intraocular lenses on visual function. Am J Ophthalmol. 2012;152(2):240–251.e2. doi:10.1016/j.ajo.2012.03.011
  • Tognetto D, Toto L, Sanguinetti G, Ravalico G. Glistenings in foldable intraocular lenses. J Cataract Refract Surg. 2002;28(7):1211–1216. doi:10.1016/S0886-3350(02)01353-6
  • Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019;45(10):1490–1497. doi:10.1016/j.jcrs.2019.05.017
  • Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethylmethacrylate. J Cataract Refract Surg. 2020;46(5):682–687. doi:10.1097/j.jcrs.0000000000000142
  • Li N, Chen X, Zhang J, et al. Effect of AcrySof versus silicone or polymethyl methacrylate intraocular lens on posterior capsule opacification. Ophthalmology. 2008;115(5):830–838. doi:10.1016/j.ophtha.2007.06.037
  • Li Y, Wang J, Chen Z, Tang X. Effect of hydrophobic acrylic versus hydrophilic acrylic intraocular lens on posterior capsule opacification: meta-analysis. PLoS One. 2013;8(11):e77864.
  • Ursell PG, Dhariwal M, O’Boyle D, Khan J, Venerus A. 5 year incidence of YAG capsulotomy and PCO after cataract surgery with single-piece monofocal intraocular lenses: a real-world evidence study of 20,763 eyes. Eye (Lond). 2020;34(5):960–968. doi:10.1038/s41433-019-0630-9
  • Biber JM, Sandoval HP, Trivedi RH, et al. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009;35(7):1234–1238. doi:10.1016/j.jcrs.2009.03.013
  • Camparini M, Cassinari P, Ferrigno L, Macaluso C. ETDRS-fast: implementing psychophysical adaptive methods to standardized visual acuity measurement with ETDRS charts. Invest Ophthalmol Vis Sci. 2001;42(6):1226–1231.
  • Ophthalmic implants - intraocular lenses - part 7: clinical investigations (ISO 11979-7:2014). International Organization for Standardization; 2014.
  • Lane S, Collins S, Das K, et al. Evaluation of the mechanical behaviour of a new single-piece intraocular lens as compared to commercially available IOLs. Presented at: European Society of Cataract & Refractive Surgeons; 2017; Lisbon, Portugal.
  • Auffarth GU, Schickhardt S, Wang Q, Fang H, Hengerer FH. Laboratory evaluation of the new Clareon hydrophobic acrylic IOL material: biomaterial properties and capsular bag behavior. Presented at: European Society of Cataract & Refractive Surgeons; 2017; Lisbon, Portugal.
  • Nanavaty MA, Borkum S, Wedham M, et al. Clinical evaluation of visual, refractive, and adverse event outcomes of a new monofocal IOL: 6-month UK site–level results. Presented at: European Society of Cataract & Refractive Surgeons; 2019; Paris, France.
  • Thomes BE, Callaghan TA. Evaluation of in vitro glistening formation in hydrophobic acrylic intraocular lenses. Clin Ophthalmol. 2013;7:1529–1534. doi:10.2147/OPTH.S44208
  • Schaumberg DA, Dana MR, Christen WG, Glynn RJ. A systematic overview of the incidence of posterior capsule opacification. Ophthalmology. 1998;105(7):1213–1221. doi:10.1016/S0161-6420(98)97023-3
  • Apple DJ, Peng Q, Visessook N, et al. Eradication of posterior capsule opacification: documentation of a marked decrease in Nd: YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem. Ophthalmology. 2001;108(3):505–518. doi:10.1016/S0161-6420(00)00589-3
  • Mootha VV, Tesser R, Qualls C. Incidence of and risk factors for residual posterior capsule opacification after cataract surgery. J Cataract Refract Surg. 2004;30(11):2354–2358. doi:10.1016/j.jcrs.2004.03.038
  • Lindholm JM, Laine I, Tuuminen R. Five-year cumulative incidence and risk factors of Nd:YAG capsulotomy in 10 044 hydrophobic acrylic 1-piece and 3-piece intraocular lenses. Am J Ophthalmol. 2019;200:218–223. doi:10.1016/j.ajo.2019.01.010
  • Thom H, Ender F, Samavedam S, et al. Effect of AcrySof versus other intraocular lens properties on the risk of Nd:YAG capsulotomy after cataract surgery: a systematic literature review and network meta-analysis. PLoS One. 2019;14(8):e0220498. doi:10.1371/journal.pone.0220498
  • Leydolt C, Schartmuller D, Schwarzenbacher L, et al. Comparison of posterior capsule opacification development with 2 single-piece intraocular lens types. J Cataract Refract Surg. 2017;43(6):774–780. doi:10.1016/j.jcrs.2017.06.005
  • Hillenmayer A, Wertheimer CM, Kassumeh S, et al. Evaluation of posterior capsule opacification of the Alcon Clareon IOL vs the Alcon Acrysof IOL using a human capsular bag model. BMC Ophthalmol. 2020;20(1):77. doi:10.1186/s12886-020-01349-5
  • Oyewole K, Tsogkas F, Westcott M, Patra S. Benchmarking cataract surgery outcomes in an ethnically diverse and diabetic population: final post-operative visual acuity and rates of post-operative cystoid macular oedema. Eye (Lond). 2017;31(12):1672–1677. doi:10.1038/eye.2017.96
  • Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557–634.
  • Henderson BA, Kim JY, Ament CS, et al. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007;33(9):1550–1558. doi:10.1016/j.jcrs.2007.05.013
  • Chu CJ, Johnston RL, Buscombe C, et al. Risk factors and incidence of macular edema after cataract surgery: a database study of 81984 eyes. Ophthalmology. 2016;123(2):316–323. doi:10.1016/j.ophtha.2015.10.001
  • Hollo G, Aung T, Cantor LB, Aihara M. Cystoid macular edema related to cataract surgery and topical prostaglandin analogs: mechanism, diagnosis, and management. Surv Ophthalmol. 2020;65(5):496–512. doi:10.1016/j.survophthal.2020.02.004
  • Daien V, Papinaud L, Domerg C, et al. Incidence and characteristics of cystoid macular edema after cataract surgery. Ophthalmology. 2016;123(3):663–664. doi:10.1016/j.ophtha.2015.10.009
  • Packer M, Lowe J, Fine H. Incidence of acute postoperative cystoid macular edema in clinical practice. J Cataract Refract Surg. 2012;38(12):2108–2111. doi:10.1016/j.jcrs.2012.07.029
  • Aslam TM, Gupta M, Gilmour D, Patton N, Dhillon B. Long-term prevalence of pseudophakic photic phenomena. Am J Ophthalmol. 2007;143(3):522–524. doi:10.1016/j.ajo.2006.10.031