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BJO Online First, published on February 19, 2014 as 10.1136/bjophthalmol-2013-304591 Clinical science
Comparison of additional pseudophakic multifocal lenses and multifocal intraocular lens in the capsular bag J Schrecker,1 A Feith,1 A Langenbucher2 1
Department of Ophthalmology, RudolfVirchow-Klinikum Glauchau, Glauchau, Germany 2 Chair of Experimental Ophthalmology, Saarland University, Homburg/Saar, Germany Correspondence to Dr J Schrecker, Department of Ophthalmology, RudolfVirchow-Klinikum Glauchau, Virchowstraße 18, Glauchau 08371, Germany; [email protected] Received 8 November 2013 Accepted 19 January 2014
To cite: Schrecker J, Feith A, Langenbucher A. Br J Ophthalmol Published Online First: [ please include Day Month Year] doi:10.1136/bjophthalmol2013-304591
ABSTRACT Aims To compare the clinical results and the intraoperative and postoperative performance of an additional sulcusfixated multifocal intraocular lens (IOL) with a conventional multifocal IOL implanted in the capsular bag. Methods In this prospective, randomised, monocentric study, the intraoperative and postoperative outcomes after implantation of an additional sulcus-fixated multifocal IOL (group A; 29 eyes) and a conventional, multifocal posterior chamber IOL (group B; 25 eyes) are compared. 1-year postoperatively, visual acuity, contrast sensitivity and defocus curve were determined. Patients implanted bilaterally with the same IOL filled in a questionnaire to assess patient satisfaction. Results Between the groups, only slight differences were found in visual acuity at all distances. All patients achieved an uncorrected distance visual acuity of 0.1 LogMAR or better and an uncorrected intermediate/near visual acuity of 0.3 LogMAR or better. Slightly better results in contrast sensitivity were achieved in group A at high spatial frequencies under almost all lighting conditions. Patient survey showed a higher degree of satisfaction of patients in group B, while a smaller proportion of group A stated to have disturbing light phenomena. Conclusions Only small functional differences between the examined methods were found. Both types of multifocal IOL performed well at all distances. There were no intraoperative and postoperative complications in the add-on IOL group which affirms the high safety level such as with conventional multifocal IOL in the capsular bag. Developments in cataract and refractive surgery are driven by permanently growing demands for the recovery of a visual ability as close as possible to adolescence vision, especially regarding compensation of presbyopia. Up to now, all approaches intending a restoration of physiological accommodation, for example, by implementation of an accommodative intraocular lens (IOL), have failed. However, the use of multifocal optics, which simultaneously create multiple foci to produce sharp images of objects at different focal planes, has increasingly established over the last two decades. Nevertheless, even with current models of multifocal IOLs (MIOLs), postoperative issues which derogate patient’s satisfaction to a significant extent might occur and can be very challenging for the physician. A relatively new option, which offers an alternative in case of incompatibility of the multifocal optic, is the implantation of an additional pseudophakic IOL. These lenses are inserted into the sulcus ciliaris in addition to the previously or simultaneously implanted IOL in the capsular bag.
Schrecker J, et al. BrArticle J Ophthalmol 2014;0:1–5. doi:10.1136/bjophthalmol-2013-304591 Copyright author (or their employer) 2014. Produced
Thereby, they allow a chronologically flexible procedure of the implantation of the multifocal part of the optic and, if necessary, a reversibility of the intervention. The modern additional lenses differ fundamentally from formerly used piggyback-IOLs. Due to the design specifically optimised for their implantation site, problems such as ingrowth of epithelium between both IOLs, pigment abrasion of the back surface of the iris as well as postoperative intraocular pressure rise and enhanced inflammatory response are no longer observed.1 2 Our study compares the clinical results and the intraoperative and postoperative performance of an additional multifocal IOL (Diff-sPB, HumanOptics AG) with a conventional MIOL (Diff-aA, HumanOptics AG) implanted in the capsular bag. Both IOLs are based on the same multifocal optic, thereby allowing a direct comparison of the different methods.
PATIENTS AND METHODS In this prospective, randomised, monocentric study, cataract surgery was performed in 67 eyes of 38 patients. Patients were divided into two groups: the eyes of group A were simultaneously implanted with a monofocal IOL in the capsular bag and an additional multifocal IOL in the sulcus ciliaris. The eyes of group B received a single MIOL in the capsular bag. The study involved patients between 40 and 85 years of age with the wish of a high degree of independence from glasses and an expected postoperative visual acuity of at least 0.3 LogMAR. Patients with previous eye surgery with eye pathologies which potentially influence visual acuity or with corneal astigmatism of ≥1.0 D were excluded. The present study conforms to the principles outlined in the Declaration of Helsinki. A written informed consent was obtained from all patients.
Intraocular lenses and implantation technique After phacoemulsification of the crystalline lens, all eyes of group A first received a monofocal IOL (Aspira-aA) into the capsular bag (IOL details see table 1 and figure 1). Subsequently, an additional multifocal IOL (Diff-sPB) was implanted into the sulcus ciliaris. The patients of group B primarily received a single multifocal posterior chamber lens (Diff-aA). The bifocal imaging properties are based on the same diffractive optic as that of the additional multifocal IOL of group A and with the same additional power of 3.5 D at IOL plane. All IOLs tested are products of the HumanOptics AG, Erlangen, Germany.
by BMJ Publishing Group Ltd under licence.
1
Downloaded from bjo.bmj.com on April 29, 2014 - Published by group.bmj.com
Clinical science Table 1 Technical details of the IOLs
Type Ø Optic (mm) Ø Total (mm) Optical design
Anterior
Posterior
ASPIRA-aA
DIFF-sPB
DIFF-aA
Monofocal PC-IOL 6 12.5 Biconvex, back surface with 360° epithelial cell barrier Aspheric aberration-free
Diffractive-refractive additional IOL 7 14 Convex–concave, rounded edges
Diffractive-refractive PC-IOL 6 12.5 Biconvex, back surface with 360° epithelial cell barrier
Aspheric aberration-free diffractive-refractive Spheric
Aspheric aberration-free diffractive-refractive Spheric
Spheric
Illustrations with friendly permission of the HumanOptics AG. ø, diameter of the optic lens; PC-IOL, posterior chamber intraocular lens.
In both groups, the power of the IOLs in the capsular bag was limited to the range of 18.0–26.0 D. On the anterior surface of both MIOLs, a central diffractive zone with a diameter of 3.6 mm simultaneously creates a distance and a near focus. Towards the periphery, height and width of the concentric ring structure gradually decrease. The monofocal periphery of the IOLs supports distance vision with a large pupil size. The power of the capsular bag IOLs was calculated with the IOL-Master (Carl Zeiss Meditec, Jena, Germany) using the Holladay formula. For distance vision, the additional IOL did not add any refractive power. All surgical procedures were performed by one surgeon ( JS). In group A, for the implantation of the monofocal posterior chamber IOL, the AccuJect-injector (Medicel AG, Bern, Switzerland) was used and for the additional MIOL, the Hoya-injector (ISH-001, Hoya Surgical Optics, Frankfurt/Main, Germany) (incision size: 2.8 mm). After filling the ciliary sulcus with a viscoelastic (Healon, Abbott Medical Optics, Santa Ana, USA), the leading haptic of the additional MIOL was inserted into the sulcus and the second haptic was afterwards positioned by a rotary motion with the help of an iris hook. In group B, the multifocal posterior chamber IOL was implanted into capsular bag with the same type of AccuJect-injector as in group A (incision size: 2.3 mm).
Preoperative and postoperative examinations Pre-examination of both patient groups included the assessment of the entire anterior and posterior eye segment, the determination of biometrical data, subjective refraction and corrected
distance visual acuity as well as the measurement of intraocular pressure, corneal power and pupillary size. One year postoperatively, the following parameters were determined: uncorrected and corrected distance visual acuity (UDVA, CDVA), uncorrected and distance corrected intermediate visual acuity at 100 cm (DCIVA) and uncorrected and distance corrected near visual acuity at 40 cm (DCNVA). Distance visual acuity was measured using standardised optotypes at 5 m distance. Intermediate and near visual acuity were measured using Early Treatment Diabetic Retinopathy Study (EDTRS) charts and Radner reading charts, respectively. Monocular distance corrected contrast sensitivity was measured with the CST 1800 DIGITAL Contrast Sensitivity View-in Tester (Vision Sciences Research Corporation, San Ramon, USA) under different lighting conditions (photopic: 85 cd/m2 and mesopic: 6 cd/m2). The evaluation of the results under photopic conditions is based on age-matched standard values reported by Hohberger et al3 (and personal communication). Determination of defocus curves was performed monocularly, with best distance correction, within a range of +1.0 D to −3.5 D in steps of 0.5 D. Pupillary size was measured with the Goldmann Perimeter (Carl Zeiss, Germany) under photopic (100 cd/m2) and mesopic (6 cd/m2) lighting conditions. To assess the patient’s postoperative subjective satisfaction, study participants were asked about the occurrence of disturbing photic phenomena and the need for spectacles. Study participants with bilateral implantation (10 patients in each group) were asked to fill in a questionnaire 1 year after IOL implantation in the second eye.
Statistical methods Data were recorded in an electronic data base and analysed with the support of an external professional statistic service by SPSS V.20 (IBM Corp., Chicago, USA). Visual acuity was primarily measured in decimal units and afterwards converted into LogMAR for statistical analysis. For comparisons between groups, non-parametric Mann–Whitney U test and the χ2 test were applied. p Values less than 0.05 were considered statistically significant.
RESULTS Preoperative and intraoperative outcomes The preoperative comparison of both groups showed no statistically significant differences regarding CDVA ( p=0.219) and corneal astigmatism ( p=0.274). The mean target refraction was 0.14 D (0.0 D to +0.37 D) in group A and 0.08 D (−0.07 D to
Figure 1 Schematic illustration of the (A) monofocal PC-IOL (ASPIRA-aA), (B) multifocal additional IOL (DIFF-sPB) and (C) multifocal PC-IOL (DIFF-aA). 2
Schrecker J, et al. Br J Ophthalmol 2014;0:1–5. doi:10.1136/bjophthalmol-2013-304591
Downloaded from bjo.bmj.com on April 29, 2014 - Published by group.bmj.com
Clinical science Pupillary size (mean±SD) in group A under photopic and mesopic lighting conditions was 3.18±0.46 and 4.14 ±0.46 mm, respectively. In group B, pupil sizes were significantly smaller under both conditions: 2.68±0.43 mm ( photopic, p
BJO Online First, published on February 19, 2014 as 10.1136/bjophthalmol-2013-304591 Clinical science
Comparison of additional pseudophakic multifocal lenses and multifocal intraocular lens in the capsular bag J Schrecker,1 A Feith,1 A Langenbucher2 1
Department of Ophthalmology, RudolfVirchow-Klinikum Glauchau, Glauchau, Germany 2 Chair of Experimental Ophthalmology, Saarland University, Homburg/Saar, Germany Correspondence to Dr J Schrecker, Department of Ophthalmology, RudolfVirchow-Klinikum Glauchau, Virchowstraße 18, Glauchau 08371, Germany; [email protected] Received 8 November 2013 Accepted 19 January 2014
To cite: Schrecker J, Feith A, Langenbucher A. Br J Ophthalmol Published Online First: [ please include Day Month Year] doi:10.1136/bjophthalmol2013-304591
ABSTRACT Aims To compare the clinical results and the intraoperative and postoperative performance of an additional sulcusfixated multifocal intraocular lens (IOL) with a conventional multifocal IOL implanted in the capsular bag. Methods In this prospective, randomised, monocentric study, the intraoperative and postoperative outcomes after implantation of an additional sulcus-fixated multifocal IOL (group A; 29 eyes) and a conventional, multifocal posterior chamber IOL (group B; 25 eyes) are compared. 1-year postoperatively, visual acuity, contrast sensitivity and defocus curve were determined. Patients implanted bilaterally with the same IOL filled in a questionnaire to assess patient satisfaction. Results Between the groups, only slight differences were found in visual acuity at all distances. All patients achieved an uncorrected distance visual acuity of 0.1 LogMAR or better and an uncorrected intermediate/near visual acuity of 0.3 LogMAR or better. Slightly better results in contrast sensitivity were achieved in group A at high spatial frequencies under almost all lighting conditions. Patient survey showed a higher degree of satisfaction of patients in group B, while a smaller proportion of group A stated to have disturbing light phenomena. Conclusions Only small functional differences between the examined methods were found. Both types of multifocal IOL performed well at all distances. There were no intraoperative and postoperative complications in the add-on IOL group which affirms the high safety level such as with conventional multifocal IOL in the capsular bag. Developments in cataract and refractive surgery are driven by permanently growing demands for the recovery of a visual ability as close as possible to adolescence vision, especially regarding compensation of presbyopia. Up to now, all approaches intending a restoration of physiological accommodation, for example, by implementation of an accommodative intraocular lens (IOL), have failed. However, the use of multifocal optics, which simultaneously create multiple foci to produce sharp images of objects at different focal planes, has increasingly established over the last two decades. Nevertheless, even with current models of multifocal IOLs (MIOLs), postoperative issues which derogate patient’s satisfaction to a significant extent might occur and can be very challenging for the physician. A relatively new option, which offers an alternative in case of incompatibility of the multifocal optic, is the implantation of an additional pseudophakic IOL. These lenses are inserted into the sulcus ciliaris in addition to the previously or simultaneously implanted IOL in the capsular bag.
Schrecker J, et al. BrArticle J Ophthalmol 2014;0:1–5. doi:10.1136/bjophthalmol-2013-304591 Copyright author (or their employer) 2014. Produced
Thereby, they allow a chronologically flexible procedure of the implantation of the multifocal part of the optic and, if necessary, a reversibility of the intervention. The modern additional lenses differ fundamentally from formerly used piggyback-IOLs. Due to the design specifically optimised for their implantation site, problems such as ingrowth of epithelium between both IOLs, pigment abrasion of the back surface of the iris as well as postoperative intraocular pressure rise and enhanced inflammatory response are no longer observed.1 2 Our study compares the clinical results and the intraoperative and postoperative performance of an additional multifocal IOL (Diff-sPB, HumanOptics AG) with a conventional MIOL (Diff-aA, HumanOptics AG) implanted in the capsular bag. Both IOLs are based on the same multifocal optic, thereby allowing a direct comparison of the different methods.
PATIENTS AND METHODS In this prospective, randomised, monocentric study, cataract surgery was performed in 67 eyes of 38 patients. Patients were divided into two groups: the eyes of group A were simultaneously implanted with a monofocal IOL in the capsular bag and an additional multifocal IOL in the sulcus ciliaris. The eyes of group B received a single MIOL in the capsular bag. The study involved patients between 40 and 85 years of age with the wish of a high degree of independence from glasses and an expected postoperative visual acuity of at least 0.3 LogMAR. Patients with previous eye surgery with eye pathologies which potentially influence visual acuity or with corneal astigmatism of ≥1.0 D were excluded. The present study conforms to the principles outlined in the Declaration of Helsinki. A written informed consent was obtained from all patients.
Intraocular lenses and implantation technique After phacoemulsification of the crystalline lens, all eyes of group A first received a monofocal IOL (Aspira-aA) into the capsular bag (IOL details see table 1 and figure 1). Subsequently, an additional multifocal IOL (Diff-sPB) was implanted into the sulcus ciliaris. The patients of group B primarily received a single multifocal posterior chamber lens (Diff-aA). The bifocal imaging properties are based on the same diffractive optic as that of the additional multifocal IOL of group A and with the same additional power of 3.5 D at IOL plane. All IOLs tested are products of the HumanOptics AG, Erlangen, Germany.
by BMJ Publishing Group Ltd under licence.
1
Downloaded from bjo.bmj.com on April 29, 2014 - Published by group.bmj.com
Clinical science Table 1 Technical details of the IOLs
Type Ø Optic (mm) Ø Total (mm) Optical design
Anterior
Posterior
ASPIRA-aA
DIFF-sPB
DIFF-aA
Monofocal PC-IOL 6 12.5 Biconvex, back surface with 360° epithelial cell barrier Aspheric aberration-free
Diffractive-refractive additional IOL 7 14 Convex–concave, rounded edges
Diffractive-refractive PC-IOL 6 12.5 Biconvex, back surface with 360° epithelial cell barrier
Aspheric aberration-free diffractive-refractive Spheric
Aspheric aberration-free diffractive-refractive Spheric
Spheric
Illustrations with friendly permission of the HumanOptics AG. ø, diameter of the optic lens; PC-IOL, posterior chamber intraocular lens.
In both groups, the power of the IOLs in the capsular bag was limited to the range of 18.0–26.0 D. On the anterior surface of both MIOLs, a central diffractive zone with a diameter of 3.6 mm simultaneously creates a distance and a near focus. Towards the periphery, height and width of the concentric ring structure gradually decrease. The monofocal periphery of the IOLs supports distance vision with a large pupil size. The power of the capsular bag IOLs was calculated with the IOL-Master (Carl Zeiss Meditec, Jena, Germany) using the Holladay formula. For distance vision, the additional IOL did not add any refractive power. All surgical procedures were performed by one surgeon ( JS). In group A, for the implantation of the monofocal posterior chamber IOL, the AccuJect-injector (Medicel AG, Bern, Switzerland) was used and for the additional MIOL, the Hoya-injector (ISH-001, Hoya Surgical Optics, Frankfurt/Main, Germany) (incision size: 2.8 mm). After filling the ciliary sulcus with a viscoelastic (Healon, Abbott Medical Optics, Santa Ana, USA), the leading haptic of the additional MIOL was inserted into the sulcus and the second haptic was afterwards positioned by a rotary motion with the help of an iris hook. In group B, the multifocal posterior chamber IOL was implanted into capsular bag with the same type of AccuJect-injector as in group A (incision size: 2.3 mm).
Preoperative and postoperative examinations Pre-examination of both patient groups included the assessment of the entire anterior and posterior eye segment, the determination of biometrical data, subjective refraction and corrected
distance visual acuity as well as the measurement of intraocular pressure, corneal power and pupillary size. One year postoperatively, the following parameters were determined: uncorrected and corrected distance visual acuity (UDVA, CDVA), uncorrected and distance corrected intermediate visual acuity at 100 cm (DCIVA) and uncorrected and distance corrected near visual acuity at 40 cm (DCNVA). Distance visual acuity was measured using standardised optotypes at 5 m distance. Intermediate and near visual acuity were measured using Early Treatment Diabetic Retinopathy Study (EDTRS) charts and Radner reading charts, respectively. Monocular distance corrected contrast sensitivity was measured with the CST 1800 DIGITAL Contrast Sensitivity View-in Tester (Vision Sciences Research Corporation, San Ramon, USA) under different lighting conditions (photopic: 85 cd/m2 and mesopic: 6 cd/m2). The evaluation of the results under photopic conditions is based on age-matched standard values reported by Hohberger et al3 (and personal communication). Determination of defocus curves was performed monocularly, with best distance correction, within a range of +1.0 D to −3.5 D in steps of 0.5 D. Pupillary size was measured with the Goldmann Perimeter (Carl Zeiss, Germany) under photopic (100 cd/m2) and mesopic (6 cd/m2) lighting conditions. To assess the patient’s postoperative subjective satisfaction, study participants were asked about the occurrence of disturbing photic phenomena and the need for spectacles. Study participants with bilateral implantation (10 patients in each group) were asked to fill in a questionnaire 1 year after IOL implantation in the second eye.
Statistical methods Data were recorded in an electronic data base and analysed with the support of an external professional statistic service by SPSS V.20 (IBM Corp., Chicago, USA). Visual acuity was primarily measured in decimal units and afterwards converted into LogMAR for statistical analysis. For comparisons between groups, non-parametric Mann–Whitney U test and the χ2 test were applied. p Values less than 0.05 were considered statistically significant.
RESULTS Preoperative and intraoperative outcomes The preoperative comparison of both groups showed no statistically significant differences regarding CDVA ( p=0.219) and corneal astigmatism ( p=0.274). The mean target refraction was 0.14 D (0.0 D to +0.37 D) in group A and 0.08 D (−0.07 D to
Figure 1 Schematic illustration of the (A) monofocal PC-IOL (ASPIRA-aA), (B) multifocal additional IOL (DIFF-sPB) and (C) multifocal PC-IOL (DIFF-aA). 2
Schrecker J, et al. Br J Ophthalmol 2014;0:1–5. doi:10.1136/bjophthalmol-2013-304591
Downloaded from bjo.bmj.com on April 29, 2014 - Published by group.bmj.com
Clinical science Pupillary size (mean±SD) in group A under photopic and mesopic lighting conditions was 3.18±0.46 and 4.14 ±0.46 mm, respectively. In group B, pupil sizes were significantly smaller under both conditions: 2.68±0.43 mm ( photopic, p
