Clinical safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study

Björn Johansson, Ana C S Daniel, Claudia Herbers, Matthias Gerl, Florian T A Kretz, Björn Johansson, Ana C S Daniel, Claudia Herbers, Matthias Gerl, Florian T A Kretz

Abstract

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, 95% of eyes achieved monocular CDVA equal or better than 0.3 logMAR, mean postoperative CDVA was 0.06 ± 0.17 logMAR, and mean UDVA 0.31 ± 0.29 logMAR. Visual acuity outcomes were better in eyes with no pre-existing ocular pathologies, but both groups showed a statistically significant improvement after surgery compared with preoperative values (p ≤ 0.002). The mean sphere and spherical equivalent values also improved significantly postoperatively (p = 0.003). Overall, 62.1% of eyes had spherical equivalent within ±0.5 D and 80.9% within ±1.0 D. The IOL was stable in the capsular bag as demonstrated by tilt and decentration measurements. IOP, corneal status, and endothelial cell count values were in the normal range. Nd:YAG treatment was performed on 9.9% of the eyes.

Conclusion: The implantation of the monofocal CT ASPHINA 409 IOL was beneficial to restore vision in eyes with or without concomitant ocular pathology such as macular degeneration, glaucoma, Sicca syndrome, epiretinal membrane, cornea guttata, or amblyopia. Good to excellent long-term visual and refractive outcomes, and a low rate of complications in both healthy and pathological eyes were found 12 months after the surgery.

Trial registration: Trial registered on under the identification NCT03145103 (date of registration 9 May 2017).

Keywords: Human; IOL; Intraocular lens; Monofocal; Ocular pathology; Real-world; Visual outcome.

Conflict of interest statement

Dr. med. Florian Kretz (FEBO) is a consultant for Carl Zeiss Meditec, Oculentis, Mynosis, Rayner, Biotech, Glaukos LensAR and Teleon Surgical. His research is partially financed by Carl Zeiss Meditec, PhysIOL, Santen, AVS, Oculentis, Acufocus, Hoya, Johnson & Johnson, iSTAR Medical, Mynosis, Biotech, Infinite Vision and Glaukos. He receives travel reimbursement and honoraria from Carl Zeiss Meditec, PhysIOL, Santen, AVS, Oculentis, Acufocus, Hoya, Nidek, Mynosis, Biotech, Infinite Vision and Glaukos. VSY, MST and LensAR. MD PhD Björn Johansson (FEBO) is a consultant for Alcon, Bausch & Lomb, Carl Zeiss Meditec, Johnson & Johnson and Théa Laboratoires. The other authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Flow diagram of the clinical trial, showing the 3 populations analysed: the safety population, the “healthy eye” population and the “pathological eye” population
Fig. 2
Fig. 2
Distribution of monocular corrected distance visual acuity (CDVA) at 12 months
Fig. 3
Fig. 3
Distribution of monocular uncorrected distance visual acuity (UDVA) at 12 months

References

    1. Lee CM, Afshari NA. The global state of cataract blindness. Curr Opin Ophthalmol. 2017;28:98–103. doi: 10.1097/ICU.0000000000000340.
    1. Zhou H, Zhu C, Xu W, Zhou F. The efficacy of accommodative versus monofocal intraocular lenses for cataract patients: a systematic review and meta-analysis. Medicine (Baltimore) 2018;97(40):e12693. doi: 10.1097/MD.0000000000012693.
    1. de Silva SR, Evans JR, Samantha R, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016;12:CD003169.
    1. Zvorničanin J, Zvorničanin E. Premium intraocular lenses: the past, present and future. J Curr Ophthalmol. 2018;30:287–296. doi: 10.1016/j.joco.2018.04.003.
    1. Alcon Laboratories Inc. Product Information: AcrySof Aspheric UV Absorbing IOL. 40–500-214-NEW. . Accessed 16 Dec 2019.
    1. Lundström M, Barry P, Henry Y, Rosen P, Stenevi U. Visual outcome of cataract surgery; study from the European registry of quality outcomes for cataract and refractive surgery. J Cataract Refract Surg. 2013;39:673–679. doi: 10.1016/j.jcrs.2012.11.026.
    1. Lee K-M, Park S-H, Joo C-K. Comparison of clinical outcomes with three different aspheric intraocular lenses. Acta Ophthalmol. 2011;89:40–46. doi: 10.1111/j.1755-3768.2009.01620.x.
    1. Cadarso L, Iglesias A, Ollero A, Pita B, Montés-Micó R. Postoperative optical aberrations in eyes implanted with AcrySof spherical and aspheric intraocular lenses. J Refract Surg. 2008;24:811–816. doi: 10.3928/1081597X-20081001-08.
    1. Lundström M, Brocato L, Dickman M, Henry Y, Manning S, Rosen P, Stenevi U, Tassignon MJ. EUREQUO annual report 2017 based on data from the European registry of quality outcomes for cataract and refractive surgery. 2017.
    1. Day AC, Donachie, P H J. Sparrow JM, Johnston RL. The Royal College of Ophthalmologists’ National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond) 2015;29:552–560. doi: 10.1038/eye.2015.3.
    1. Hahn U, Kummenauer F, Kölbl B, Neuhann T, Shayan-Arayi K, Schmickler S, et al. Determination of valid benchmarks for outcome indicators in cataract surgery: a multicenter, prospective cohort trial. Ophthalmology. 2011;118:2105–2012. doi: 10.1016/j.ophtha.2011.05.011.
    1. Gale RP, Saldana M, Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomes after NHS cataract surgery. Eye (Lond) 2009;23:149–152. doi: 10.1038/sj.eye.6702954.
    1. Mencucci R, Cennamo M, Venturi D, Vignapiano R, Favuzza E. Visual outcome, optical quality, and patient satisfaction with a new monofocal IOL, enhanced for intermediate vision: preliminary results. J Cataract Refract Surg. 2020;46:378–387. doi: 10.1097/j.jcrs.0000000000000061.
    1. Scorcia V, Soda M, Lucisano A, Lanza M, Giannaccare G. A preliminary comparative study of visual performance between two newly commercially available monofocal intraocular lenses implanted during cataract surgery. Clin Ophthalmol. 2020;14:831–835. doi: 10.2147/OPTH.S246319.
    1. Pedrotti E, Carones F, Aiello F, Mastropasqua R, Bruni E, Bonacci E, Talli P, Nucci C, Mariotti C, Marchini G. Comparative analysis of visual outcomes with 4 intraocular lenses: Monofocal, multifocal, and extended range of vision. J Cataract Refract Surg. 2018;44(2):156–167. doi: 10.1016/j.jcrs.2017.11.011.
    1. Gayton JL, Mackool RJ, Ernest PH, Seabolt RA, Dumont S. Implantation of multifocal intraocular lenses using a magnification strategy in cataractous eyes with age-related macular degeneration. J Cataract Refract Surg. 2012;38:415–418. doi: 10.1016/j.jcrs.2011.12.022.
    1. Furino C, Ferrara A, Cardascia N, Besozzi G, Alessio G, Sborgia L, Boscia F. Combined cataract extraction and intravitreal bevacizumab in eyes with choroidal neovascularization resulting from age-related macular degeneration. J Cataract Refract Surg. 2009;35:1518–1522. doi: 10.1016/j.jcrs.2009.04.032.
    1. Kubota T, Toguri I, Onizuka N, Matsuura T. Phacoemulsification and intraocular lens implantation for angle closure glaucoma after the relief of pupillary block. Ophthalmologica. 2003;217:325–328. doi: 10.1159/000071346.
    1. Jacobi PC, Dietlein TS, Krieglstein GK. The risk profile of trabecular aspiration versus trabeculectomy in glaucoma triple procedure. Graefes Arch Clin Exp Ophthalmol. 2000;238:545–551. doi: 10.1007/s004170000152.
    1. Inatani M, Tanihara H, Muto T, Honjo M, Okazaki K, Kido N, Honda Y. Transient intraocular pressure elevation after trabeculotomy and its occurrence with phacoemulsification and intraocular lens implantation. Jpn J Ophthalmol. 2001;45:288–292. doi: 10.1016/S0021-5155(01)00322-7.
    1. Kim DH, Chung JW, Chung H, Yu HG. Phacoemulsification and foldable intraocular lens implantation combined with vitrectomy and silicone oil tamponade for severe proliferative diabetic retinopathy. J Cataract Refract Surg. 2004;30:1721–1726. doi: 10.1016/j.jcrs.2003.12.042.
    1. Ohara K, Kato S, Hori S, Kitano S. Tilt and decentration of the intraocular lens following combined vitrectomy and pars plana lensectomy. Acta Ophthalmol Scand. 2006;84:388–389. doi: 10.1111/j.1600-0420.2006.00647.x.
    1. de Wit DW, Diaz JM, Moore TCB, Moore JE. Refractive lens exchange for a multifocal intraocular lens with a surface-embedded near section in mild to moderate anisometropic amblyopic patients. J Cataract Refract Surg. 2012;38:1796–1801. doi: 10.1016/j.jcrs.2012.06.046.

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