Capsular bag performance of a novel hydrophobic acrylic single-piece intraocular lens: Two-year results of a randomised controlled trial

Abstract

Purpose:

To determine the visual outcome, intraocular lens (IOL) stability and posterior capsule opacification (PCO) rate of a hydrophobic acrylic intraocular lens.

Setting:

Vienna Institute for Research in Ocular Surgery, Hanusch Hospital, Vienna, Austria

Design:

This double-masked randomised study included patients who underwent standard cataract surgery.

Method:

Patients received either the hydrophobic acrylic IOL (iPure, PhysIOL) or the hydrophobic acrylic control IOL (Tecnis ZCB00, Johnson&Johnson). Subjective refraction, uncorrected and corrected distance visual acuity (UDVA, CDVA), IOL tilt and decentration (Purkinje meter) and PCO intensity using retroillumination images with automated image analysis (automated quantification of after-cataract, AQUA), were evaluated for both groups 2 years after surgery.

Results:

A total number of 31 patients completed the 2-year follow-up, 16 in the study group and 15 in the control group. The CDVA was 0.0 logMAR (standard deviation – SD: 0.1) for the study IOL and 0.1 logMAR (SD: 0.2) for the control IOL, p = 0.001. The AQUA PCO score for the study group was 2.1 and 1.4 for the control group, p = 0.44. Mean IOL tilt was 2.9° (SD: 1.8) in the study group and 5.0° (SD: 4.5) in the control group, whilst the mean decentration was 0.37 mm (SD: 0.18) and 0.45 mm (SD: 0.3), p = 0.610.

Conclusion:

The studied parameters revealed a good performance for both IOLs. Both IOLs had good CDVA, a small amount of tilt and decentration and none of the patients required laser capsulotomies during the follow-up time of 2 years after surgery.

Presented at the 37th ESCRS Congress Paris, France, September 2019

Keywords

IOLs < Lens / Cataract postoperative anterior segment problems pre-op medical testing clinical tests

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References

Bozukova

Pagnoulle

Jérôme

Biomechanical and optical properties of 2 new hydrophobic platforms for intraocular lenses. J Cataract Refract Surg 2013; 39(9): 1404–1414.

Lane

Collins

Das

, et al. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg 2019; 45(4): 501–506.

Pagnoulle

Bozukova

Gobin

, et al. Assessment of new-generation glistening-free hydrophobic acrylic intraocular lens material. J Cataract Refract Surg 2012; 38(7): 1271–1277.

Findl

Buehl

Bauer

, et al. Interventions for preventing posterior capsule opacification. Cochrane Database of Syst Rev 2010; 17(2): CD003738.

Findl

Buehl

Menapace

, et al. Comparison of 4 methods for quantifying posterior capsule opacification. J Cataract Refract Surg 2003; 29(1): 106–111.

Buehl

Findl

Menapace

, et al. Long-term effect of optic edge design in an acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg 2005; 31(5): 954–961.

Sacu

Findl

Menapace

, et al. Influence of optic edge design, optic material, and haptic design on capsular bend configuration. J Cataract Refract Surg 2005; 31(10): 1888–1894.

Nishi

Hirnschall

Crnej

, et al. Reproducibility of intraocular lens decentration and tilt measurement using a clinical Purkinje meter. J Cataract Refract Surg 2010; 36(10): 1529–1535.

Tabernero

Piers

Benito

, et al. Predicting the optical performance of eyes implanted with IOLs to correct spherical aberration. Invest Ophthalmol Vis Sci 2006; 47(10): 4651–4658.

10.

Salvatore

Lupo

Nebbioso

, et al. New insight into visual function with aspherical intraocular lenses (IOLs): Tecnis ZCB00 and Acrysof SN60WF. Int Ophthalmol 2011; 31(5): 417–419.

11.

Roshdy

Riad

Morkos

, et al. Effect of a single-piece aspheric hydrophobic acrylic intraocular lens design on centration and rotation. J Cataract Refract Surg 2013; 39(3): 408–413.

12.

Wahba

Riad

Morkos

, et al. Visual performance of the tecnis one-piece lens ZCB00. Clin Ophthalmol 2011; 5: 1803–1808.

13.

Leydolt

Kriechbaum

Schriefl

, et al. Posterior capsule opacification and neodymium:YAG rates with 2 single-piece hydrophobic acrylic intraocular lenses: three-year results. J Cataract Refract Surg 2013; 39(12): 1886–1892.

14.

Maedel

Hirnschall

Bayer

, et al. Comparison of intraocular lens decentration and tilt measurements using 2 Purkinje meter systems. J Cataract Refract Surg 2017; 43(5): 648–655.

15.

Kronschläger

Siegl

Pinz

, et al. Automated qualitative and quantitative assessment of posterior capsule opacification by Automated Quantification of After-Cataract II ( AQUA II) system. BMC Ophthalmol 2019; 19(1): 114–120.

16.

Reed

Lynn

Meade

BD.

Use of coefficient of variation in assessing variability of quantitative assays. Clin Diagn Lab Immunol 2002; 9(6): 1235–1239.

17.

Findl

Hirnschall

Nishi

, et al. Capsular bag performance of a hydrophobic acrylic 1-piece intraocular lens. J Cataract Refract Surg 2015; 41(1): 90–97.

18.

Holladay

Piers

Koranyi

, et al. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg 2002; 18(6): 683–691.

19.

Baumeister

Bühren

Kohnen

Tilt and decentration of spherical and aspherical intraocular lenses: effect on higher-order aberrations. J Cataract Refract Surg 2009; 35(6): 1006–1012.

20.

Vock

Menapace

Stifter

, et al. Posterior capsule opacification and neodymium:YAG laser capsulotomy rates with a round-edged silicone and a sharp-edged hydrophobic acrylic intraocular lens 10 years after surgery. J Cataract Refract Surg 2009; 35(3): 459–465.

21.

Gregori

Spencer

Mamalis

, et al. In vitro comparison of glistening formation among hydrophobic acrylic intraocular lenses. J Cataract Refract Surg 2002; 28(7): 1262–1268.

22.

Werner

Glistenings and surface light scattering in intraocular lenses. J Cataract Refract Surg 2010; 36(8): 1398–1420.

23.

Kahraman

Amon

Ferdinaro

, et al. Intraindividual comparative analysis of capsule opacification after implantation of 2 single-piece hydrophobic acrylic intraocular lenses models: three-year follow-up. J Cataract Refract Surg 2015; 41(5): 990–996.

24.

Kahraman

Ferdinaro

Wetzel

, et al. Intraindividual comparison of capsule behavior of 2 hydrophobic acrylic intraocular lenses during a 5-year follow-up. J Cataract Refract Surg 2017; 43(2): 228–233.