Clinical science
Clinical outcomes and surgeon assessment after implantation of a new diffractive multifocal toric intraocular lens Florian T A Kretz,1 Antoine Bastelica,2 Humberto Carreras,3 Tiago Ferreira,4 Matthias Müller,5 Matthias Gerl,5 Ralf Gerl,5 Manzar Saeed,6 Stefanie Schmickler,7 Gerd U Auffarth1 1
David J Apple International Laboratory for Ocular Pathology and International Vision Correction Research Centre (IVCRC), Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany 2 Clinique Pasteur, Toulouse, France 3 Eurocanarias, Las Palmas de Gran Canaria, Spain 4 Hospital de Egas, Lisboa, Portugal 5 Augenklinik Ahaus, Ahaus, Germany 6 BMI Sandringham Hospital, Norfolk, UK 7 Augen- Zentrum- Nordwest, Ahaus, Germany Correspondence to Professor Gerd U Auffarth, David J Apple International Laboratory for Ocular Pathology and International Vision Correction Research Centre (IVCRC), Department of Ophthalmology, University of Heidelberg, Im Neuenheimer Feld 400, Heidelberg 69120, Germany; gerd.auffarth@med. uni-heidelberg.de Received 21 May 2014 Revised 2 August 2014 Accepted 24 August 2014 Published Online First 23 September 2014
ABSTRACT Purpose To evaluate the clinical outcome in eyes with significant corneal astigmatism after cataract surgery with implantation of a new diffractive multifocal toric intraocular lens (IOL). Methods Prospective, non-randomised multicentre clinical study including 57 eyes of 38 consecutive patients with an age between 37 and 84 years that underwent cataract surgery with implantation of the toric multifocal IOL Tecnis ZMT (Abbott Medical Optics, Santa Ana, California, USA). Changes in uncorrected and corrected logMAR distance, intermediate and near visual acuity ((uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), corrected near visual acuity) and manifest refraction were evaluated during a 2–4 month follow-up. Additionally, patients were asked about photic phenomena and spectacle dependence. The surgeons subjectively assessed various aspects of the surgery. Results A significant improvement in CDVA was observed postoperatively ( p1.0 D even between 36% and 39%2 the correction of pre-existing corneal astigmatism has become crucial when using multifocal IOLs.3 Different models of multifocal toric IOLs have been developed to provide a combined compensation for refractive spherical and cylindrical errors as well as presbyopia in patients with significant levels of corneal astigmatism. Studies on toric multifocal IOLs published to date have shown good visual and refractive results.4–11 Specifically, multifocal toric IOLs have demonstrated their ability to provide a functional vision at different distances to the presbyopic patient independently from the design of the IOL optics, including diffractive6–9 11 12 and refractive designs.10 However, there are still some concerns regarding the long-term performance, including rotational stability, refractive outcomes, photic phenomena and subjective satisfaction. The aim of this study was to evaluate the clinical outcomes in a group of presbyopic patients with significant amounts of corneal astigmatism after undergoing cataract surgery with implantation of a new diffractive multifocal toric IOL, as well as to analyse the surgeon assessment of the surgical procedure with this IOL.
PATIENTS AND METHODS Patients This prospective, non-randomised multicentre clinical study was performed in nine European centres in Austria, France, Germany, Portugal and Spain, and included 57 eyes of 38 consecutive patients with ages between 37 years and 84 years undergoing cataract surgery with implantation of the toric multifocal IOL Tecnis ZMT (Abbott Medical Optics, Santa Ana, California, USA). Inclusion criteria for the study were significant cataract, estimated postoperative corneal astigmatism of 0.75 D or higher, and presbyopia with the wish for postoperative spectacle or contact lens independence at all distances. Exclusion criteria included previous intraocular surgery, glaucoma, history of uveitis or retinal detachment, peripheral retinal lesions not treated prophylactically, iris atrophy, corneal disease, macular degeneration, unreal expectations and any neuro-ophthalmological disease. All patients were informed about the study and provided informed consent to undergo the clinical
Kretz FTA, et al. Br J Ophthalmol 2015;99:405–411. doi:10.1136/bjophthalmol-2014-305570
405
Clinical science examination and the surgical procedure in accordance with the tenets of the Declaration of Helsinki. The study received the approval of the local ethics committee.
Clinical protocol Before surgery, all patients underwent a comprehensive preoperative ophthalmological examination that included measurement of monocular and binocular uncorrected distance, intermediate (66 cm) and near (40 cm) visual acuity (uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA)), best-corrected distance and near visual acuity (CDVA, CNVA), biometry (IOL-Master 500, Carl Zeiss Meditec AG), manifest refraction, biomicroscopy, Goldmann applanation tonometry and fundoscopy in mydriasis. Patients were evaluated the day after the surgery, 1 week and 2–4 month postoperatively. UDVA, UIVA, UNVA, CDVA, CNVA and manifest refraction were assessed at all visits, except the day after surgery. In addition, patients were asked at the end of the follow-up about the need for using spectacles at various distances and about their overall satisfaction with uncorrected vision. Besides this, surgeons were also asked to evaluate some aspects of the surgery in each case, including ease of calculator use, ease of lens implantation, ease of axis alignment, achievement of target refraction and total satisfaction with the IOL.
Intraocular lens The Tecnis ZMT IOL (Abbott Medical Optics) is a single-piece diffractive multifocal IOL made of a hydrophobic acrylate. The total length of the IOL is 13 mm and the optical zone diameter is 6 mm. The base-model is the monofocal Tecnis ZCB00 IOL (Abbott Medical Optics) with an aspheric surface (−0.27 μm) to compensate for the average corneal spherical aberration. For prevention of posterior capsular opacification the IOL has 360° continuous frosted square edge. The haptic-optic junction has an offset to offer a 3-point fixation of the c-loop haptic and the optic itself and create better rotational stability. For the ZMT series different models are available depending on the magnitude of preoperative corneal cylinder. Specifically, the Tecnis ZMT 150, 225, 300 and 400 models provide a cylinder correction at the IOL plane of 1.5, 2.25, 3.0 and 4.0 D, respectively.
IOL calculation and surgery All surgeries were performed by one of nine experienced surgeons using a standard technique of sutureless phacoemulsification. According to the online toric IOL power calculation platform (http://www.tecnistoriccalc.com), different models of toric IOLs were implanted: Tecnis ZMT 150 in 17 eyes (29.8%), ZMT 225 in 15 eyes (26.3%), ZMT 300 in 12 eyes (21.1%) and ZMT 400 in 13 eyes (22.8%). Referring to the clinical protocol the surgeons were free to choose their favourite IOL power calculation formula. However, all surgeons preferred to use the online calculation provided by AMO: https://www. amoeasy.com It was free to the surgeon’s choice to confirm the corneal astigmatism by topography. As for the IOL power calculation only the IOL-Master K values were used, the posterior corneal astigmatism was not taken into account. In all cases, topical anaesthesia was administered and pharmacological mydriasis was induced using a combination of tropicamide and phenylephrine 10% every 10 min starting 45 min before the surgical procedure. Iodine solution 5% was also instilled in the eye 10 min prior to surgery. 406
Before surgery the 0 and 180 Degree axes were marked at the patient’s eye using a Geuder Pendulum Markeur (Geuder AG, Heidelberg, Germany). This was done with the patients being awake, sitting upright and looking straight at a distant target. A microincision was performed with a 2.5 mm knife on the steepest meridian. Two 23 gauge paracentesis were made at the 3 o’clock and 9 o’clock positions depending on the surgeon’s preferences, and the anterior chamber was filled with cohesive ocular viscosurgical device (OVD, Healon, Abbott Medical Optics). After crystalline lens removal, the IOL was implanted through the main incision using the Platinum Unfolder (Abbott Medical Optics). The OVD was then removed using a bimanual irrigation-aspiration system. Postoperative pharmacological treatment consisting of a combination of antibiotic and steroidal anti-inflammatory drops to be applied four times a day for a week and three times a day during the week after. Likewise, non-steroidal anti-inflammatory drops were prescribed to be applied three times daily for 2 weeks to prevent macular oedema.
Statistical analysis Data analysis was performed using the software SPSS for Windows V.19.0 (IBM, Armonk, New York, USA). Normality of data samples was evaluated by means of the Kolmogorov– Smirnov test. When parametric analysis was possible, the Student t test for paired data was used for comparisons between preoperative and postoperative data, whereas, the Wilcoxon rank sum test was applied to assess the significance of such differences when parametric analysis was not possible. For the comparison between independent groups (IOL model), the one-way analysis of variance with the Bonferroni posthoc analysis was used if parametric statistics could be applied whereas the Kruskal–Wallis test with the Bonferroni-adjusted Mann– Whitney posthoc analysis was used if parametric statistics could not be applied. Additionally, the χ2 test was used for comparing percentages between IOL model groups. For all statistical tests, a p value of
Clinical outcomes and surgeon assessment after implantation of a new diffractive multifocal toric intraocular lens Florian T A Kretz,1 Antoine Bastelica,2 Humberto Carreras,3 Tiago Ferreira,4 Matthias Müller,5 Matthias Gerl,5 Ralf Gerl,5 Manzar Saeed,6 Stefanie Schmickler,7 Gerd U Auffarth1 1
David J Apple International Laboratory for Ocular Pathology and International Vision Correction Research Centre (IVCRC), Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany 2 Clinique Pasteur, Toulouse, France 3 Eurocanarias, Las Palmas de Gran Canaria, Spain 4 Hospital de Egas, Lisboa, Portugal 5 Augenklinik Ahaus, Ahaus, Germany 6 BMI Sandringham Hospital, Norfolk, UK 7 Augen- Zentrum- Nordwest, Ahaus, Germany Correspondence to Professor Gerd U Auffarth, David J Apple International Laboratory for Ocular Pathology and International Vision Correction Research Centre (IVCRC), Department of Ophthalmology, University of Heidelberg, Im Neuenheimer Feld 400, Heidelberg 69120, Germany; gerd.auffarth@med. uni-heidelberg.de Received 21 May 2014 Revised 2 August 2014 Accepted 24 August 2014 Published Online First 23 September 2014
ABSTRACT Purpose To evaluate the clinical outcome in eyes with significant corneal astigmatism after cataract surgery with implantation of a new diffractive multifocal toric intraocular lens (IOL). Methods Prospective, non-randomised multicentre clinical study including 57 eyes of 38 consecutive patients with an age between 37 and 84 years that underwent cataract surgery with implantation of the toric multifocal IOL Tecnis ZMT (Abbott Medical Optics, Santa Ana, California, USA). Changes in uncorrected and corrected logMAR distance, intermediate and near visual acuity ((uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), corrected near visual acuity) and manifest refraction were evaluated during a 2–4 month follow-up. Additionally, patients were asked about photic phenomena and spectacle dependence. The surgeons subjectively assessed various aspects of the surgery. Results A significant improvement in CDVA was observed postoperatively ( p1.0 D even between 36% and 39%2 the correction of pre-existing corneal astigmatism has become crucial when using multifocal IOLs.3 Different models of multifocal toric IOLs have been developed to provide a combined compensation for refractive spherical and cylindrical errors as well as presbyopia in patients with significant levels of corneal astigmatism. Studies on toric multifocal IOLs published to date have shown good visual and refractive results.4–11 Specifically, multifocal toric IOLs have demonstrated their ability to provide a functional vision at different distances to the presbyopic patient independently from the design of the IOL optics, including diffractive6–9 11 12 and refractive designs.10 However, there are still some concerns regarding the long-term performance, including rotational stability, refractive outcomes, photic phenomena and subjective satisfaction. The aim of this study was to evaluate the clinical outcomes in a group of presbyopic patients with significant amounts of corneal astigmatism after undergoing cataract surgery with implantation of a new diffractive multifocal toric IOL, as well as to analyse the surgeon assessment of the surgical procedure with this IOL.
PATIENTS AND METHODS Patients This prospective, non-randomised multicentre clinical study was performed in nine European centres in Austria, France, Germany, Portugal and Spain, and included 57 eyes of 38 consecutive patients with ages between 37 years and 84 years undergoing cataract surgery with implantation of the toric multifocal IOL Tecnis ZMT (Abbott Medical Optics, Santa Ana, California, USA). Inclusion criteria for the study were significant cataract, estimated postoperative corneal astigmatism of 0.75 D or higher, and presbyopia with the wish for postoperative spectacle or contact lens independence at all distances. Exclusion criteria included previous intraocular surgery, glaucoma, history of uveitis or retinal detachment, peripheral retinal lesions not treated prophylactically, iris atrophy, corneal disease, macular degeneration, unreal expectations and any neuro-ophthalmological disease. All patients were informed about the study and provided informed consent to undergo the clinical
Kretz FTA, et al. Br J Ophthalmol 2015;99:405–411. doi:10.1136/bjophthalmol-2014-305570
405
Clinical science examination and the surgical procedure in accordance with the tenets of the Declaration of Helsinki. The study received the approval of the local ethics committee.
Clinical protocol Before surgery, all patients underwent a comprehensive preoperative ophthalmological examination that included measurement of monocular and binocular uncorrected distance, intermediate (66 cm) and near (40 cm) visual acuity (uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA)), best-corrected distance and near visual acuity (CDVA, CNVA), biometry (IOL-Master 500, Carl Zeiss Meditec AG), manifest refraction, biomicroscopy, Goldmann applanation tonometry and fundoscopy in mydriasis. Patients were evaluated the day after the surgery, 1 week and 2–4 month postoperatively. UDVA, UIVA, UNVA, CDVA, CNVA and manifest refraction were assessed at all visits, except the day after surgery. In addition, patients were asked at the end of the follow-up about the need for using spectacles at various distances and about their overall satisfaction with uncorrected vision. Besides this, surgeons were also asked to evaluate some aspects of the surgery in each case, including ease of calculator use, ease of lens implantation, ease of axis alignment, achievement of target refraction and total satisfaction with the IOL.
Intraocular lens The Tecnis ZMT IOL (Abbott Medical Optics) is a single-piece diffractive multifocal IOL made of a hydrophobic acrylate. The total length of the IOL is 13 mm and the optical zone diameter is 6 mm. The base-model is the monofocal Tecnis ZCB00 IOL (Abbott Medical Optics) with an aspheric surface (−0.27 μm) to compensate for the average corneal spherical aberration. For prevention of posterior capsular opacification the IOL has 360° continuous frosted square edge. The haptic-optic junction has an offset to offer a 3-point fixation of the c-loop haptic and the optic itself and create better rotational stability. For the ZMT series different models are available depending on the magnitude of preoperative corneal cylinder. Specifically, the Tecnis ZMT 150, 225, 300 and 400 models provide a cylinder correction at the IOL plane of 1.5, 2.25, 3.0 and 4.0 D, respectively.
IOL calculation and surgery All surgeries were performed by one of nine experienced surgeons using a standard technique of sutureless phacoemulsification. According to the online toric IOL power calculation platform (http://www.tecnistoriccalc.com), different models of toric IOLs were implanted: Tecnis ZMT 150 in 17 eyes (29.8%), ZMT 225 in 15 eyes (26.3%), ZMT 300 in 12 eyes (21.1%) and ZMT 400 in 13 eyes (22.8%). Referring to the clinical protocol the surgeons were free to choose their favourite IOL power calculation formula. However, all surgeons preferred to use the online calculation provided by AMO: https://www. amoeasy.com It was free to the surgeon’s choice to confirm the corneal astigmatism by topography. As for the IOL power calculation only the IOL-Master K values were used, the posterior corneal astigmatism was not taken into account. In all cases, topical anaesthesia was administered and pharmacological mydriasis was induced using a combination of tropicamide and phenylephrine 10% every 10 min starting 45 min before the surgical procedure. Iodine solution 5% was also instilled in the eye 10 min prior to surgery. 406
Before surgery the 0 and 180 Degree axes were marked at the patient’s eye using a Geuder Pendulum Markeur (Geuder AG, Heidelberg, Germany). This was done with the patients being awake, sitting upright and looking straight at a distant target. A microincision was performed with a 2.5 mm knife on the steepest meridian. Two 23 gauge paracentesis were made at the 3 o’clock and 9 o’clock positions depending on the surgeon’s preferences, and the anterior chamber was filled with cohesive ocular viscosurgical device (OVD, Healon, Abbott Medical Optics). After crystalline lens removal, the IOL was implanted through the main incision using the Platinum Unfolder (Abbott Medical Optics). The OVD was then removed using a bimanual irrigation-aspiration system. Postoperative pharmacological treatment consisting of a combination of antibiotic and steroidal anti-inflammatory drops to be applied four times a day for a week and three times a day during the week after. Likewise, non-steroidal anti-inflammatory drops were prescribed to be applied three times daily for 2 weeks to prevent macular oedema.
Statistical analysis Data analysis was performed using the software SPSS for Windows V.19.0 (IBM, Armonk, New York, USA). Normality of data samples was evaluated by means of the Kolmogorov– Smirnov test. When parametric analysis was possible, the Student t test for paired data was used for comparisons between preoperative and postoperative data, whereas, the Wilcoxon rank sum test was applied to assess the significance of such differences when parametric analysis was not possible. For the comparison between independent groups (IOL model), the one-way analysis of variance with the Bonferroni posthoc analysis was used if parametric statistics could be applied whereas the Kruskal–Wallis test with the Bonferroni-adjusted Mann– Whitney posthoc analysis was used if parametric statistics could not be applied. Additionally, the χ2 test was used for comparing percentages between IOL model groups. For all statistical tests, a p value of
