Reflection on refraction in multifocal intraocular lenses - Chapter 3: Multifocal intraocular lens implantation after previous hyperopic corneal refractive laser surgery

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(1)CHAPTER 3 Multifocal intraocular lens implantation after previous hyperopic corneal refractive laser surgery Violette Vrijman, MD Jan Willem van der Linden, BOpt, PhD Ivanka J.E. van der Meulen, MD, PhD Maarten P. Mourits, MD, PhD Ruth Lapid-Gortzak, MD, PhD [J Cataract Refract Surg 2018 Apr;44(4):466–470].

(2) Chapter 3. ABSTRACT Purpose: To describe the outcomes in terms of the refraction and visual acuity of multifocal intraocular lens (IOL) implantation in patients with previous hyperopic corneal refractive laser surgery. Setting: Academic Medical Center, University of Amsterdam, Amsterdam, and Retina Total Eye Care, Driebergen, the Netherlands. Design: Retrospective case series. Methods: Results were analyzed 3 months after implantation of a multifocal IOL (Acrysof Restor SN6AD1) in patients after previous corneal refractive laser surgery for hyperopia. The primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and refraction. The secondary outcome measures were the number of laser enhancements and posterior capsule opacification (PCO) rates. Results: Forty eyes of 40 patients were included. Sixteen eyes (40.0%) had lens extraction because of cataract, and 24 eyes (60.0%) had refractive lens exchange. The mean postoperative UDVA was 0.16 logarithm of the minimum angle of resolution (logMAR) ± 0.18 (SD), and the mean postoperative CDVA was 0.01 ± 0.08 logMAR. The mean postoperative spherical equivalent was 0.04 ± 0.92 diopter (D). Twenty-five eyes (62.5%) were within ±0.50 D of emmetropia, and 35 eyes (87.5%) were within ±1.00 D of emmetropia. Nine eyes (22.5%) had a laser enhancement because of a residual refraction error. Eleven eyes (27.5%) had a neodymium:YAG laser capsulotomy because of PCO. Conclusions: In general, multifocal IOL implantation after corneal refractive laser surgery for hyperopia resulted in good visual acuity and refraction. The magnitude of previous hyperopia did not influence the refractive predictability.. 34.

(3) Multifocal IOL after hyperopic laser surgery. INTRODUCTION Today, corneal refractive laser surgery is in widespread use. Previous studies1,2 have shown good results for myopia and low to moderate hyperopia. Most patients who have had refractive laser surgery have a strong desire for independence from spectacles. When they develop presbyopia or cataract, they might seek other options to recover spectacle independence. Multifocal intraocular lenses (IOL) have been shown to provide good visual quality for distance and near, with a high rate of spectacle independence.3-5 Halos and decreased contrast sensitivity are the most common side effects, but they are usually well tolerated by patients.3,6 Patients who have had previous refractive laser surgery and a cataract or presbyopia who wish for spectacle independence could be offered multifocal IOL implantation. Surgeons might be reluctant to do this because of the assumption that after refractive laser surgery the cornea will have become “multifocal” and that implantation of a multifocal IOL could deteriorate visual acuity and visual quality. However, some previous studies7-11 found good results for multifocal IOL implantation after previous corneal refractive laser surgery for myopia and hyperopia. Intraocular lens calculation is less accurate after corneal laser surgery. There are 3 main reasons for this inaccuracy. The first is instrument error; because of incorrect measurements of the anterior corneal curvature, the determination of the true total corneal power is inaccurate. Second is the index of refraction error; the index of refraction is based on the relationship between the anterior and posterior corneal curvatures, and this relationship is altered by the laser. The third reason is formula error; most modern IOL calculation formulas use the keratometry and axial length values for the estimated lens position. The changed corneal curvature causes an error in this prediction because the anterior chamber dimensions are not really changed.12 This inaccuracy in IOL calculation makes the results less predictable than they are in virgin eyes, causing an overestimation of IOL power in the case of a hyperopic laser. However, new IOL calculation formulas that increase the accuracy in eyes with previous refractive laser surgery have been developed.13-15 For the above-mentioned reasons, reports of multifocal IOL implantation after corneal refractive laser surgery are scarce. In this study, we evaluated the visual and refractive results of multifocal IOL implantation after previous hyperopic laser surgery in a cohort of 40 eyes.. PATIENTS AND METHODS This single-center retrospective study included eyes of consecutive patients. The study was performed according to the tenets of the Declaration of Helsinki, and the study protocol was reviewed by the Medical Ethics Committee of the Academic Medical Center 35. 3.

(4) Chapter 3. of Amsterdam. In conformance with the consensus of the Dutch Society of Refractive Surgery,A data were collected prospectively. Inclusion and Exclusion Criteria Included were eyes that had previous hyperopic corneal refractive laser surgery by laser in situ keratomileusis (LASIK) with cataract or presbyopia and that had phacoemulsification with implantation of an Acrysof Restor SN6AD1 multifocal IOL (Alcon Laboratories, Inc.) between March 2008 and March 2015 at the Retina Total Eye Care Center (Driebergen, the Netherlands). The multifocal IOL has an anterior apodized diffractive aspheric surface with a central diffractive zone and has an addition of +3.0 diopters (D). For statistical reasons, only 1 eye per patient was included by randomization (Research Randomizer 4.0B). Eyes with a target refraction for reading were also included. Although not all these eyes had a hyperopic refraction before the laser treatment, they had a hyperopic laser ablation to attain the myopic target refraction. Exclusion criteria were macular disease, glaucoma, a history of retinal detachment, toric Restor multifocal IOL implantation, amblyopia with a corrected distance visual acuity (CDVA) before the initial laser surgery of worse than 0.1 logarithm of the minimum angle of resolution (logMAR), and corneal disease other than refractive surgery with LASIK. Surgical Technique Patients who had previous hyperopic laser treatment were treated with a Zyoptix 217 Z100 excimer laser (Bausch & Lomb, Inc.) using the Keracor 3.21 dataware nomogram. Laser enhancements required after phacoemulsification because of residual refractive error were performed using a standard tissue-saving nomogram (Bausch & Lomb, Inc.). Phacoemulsification was performed using local anesthesia performed by 1 of 2 surgeons (I.J.E.M., R.L.-G.) and the Ozil phaco device (Alcon Laboratories, Inc.). The IOLs were implanted through a 2.2 mm incision with a Monarch D cartridge and Monarch II injector (Alcon Laboratories, Inc.). The phacoemulsification procedure was unchanged during the study period. Patient Assessment All patients had a full ophthalmic examination before and after the initial corneal refractive laser treatment and before and after IOL implantation. It included uncorrected distance visual acuity (UDVA) and CDVA, manifest refraction, slitlamp biomicroscopy, Goldmann applanation tonometry, and binocular fundoscopy. Corneal topography imaging (Orbscan, Bausch & Lomb, Inc.), including the corneal irregularity indices at the 3.0 mm and 5.0 mm. 36.

(5) Multifocal IOL after hyperopic laser surgery. zones, and biometry using partial coherence interferometry (PCI) (IOLMaster 2 and 5.1, Carl Zeiss Meditec AG) were performed before IOL implantation only. Intraocular Lens Power Calculation The IOL calculation was performed using the American Society of Cataract and Refractive Surgery (ASCRS) calculator.C The refractive and keratometry data from before and after the corneal laser treatment and the biometric data from the PCI device were imported into the online calculator. The IOL powers of the following formulas were calculated: clinical history, Feiz-Mannis, corneal bypass, Masket, modified Masket, Haigis-L, Shammas (added to calculator during study period), and the average of those formulas, the latter being the preferred formula. The postoperative target was emmetropia. Contact lens overrefraction was used in some cases. Outcome Measures The primary outcome measures were UDVA, CDVA, and refraction. The secondary outcome measures were the number of laser enhancements and posterior capsule opacification (PCO) rates. For the visual and refractive outcomes, the 3-month postoperative results were used. The longest available follow-up data were used for the secondary outcomes of PCO rate and number of corneal laser enhancements. Follow-up was at least 1 year. Statistical Analysis Data analysis was performed with SPSS for Windows software (version 22.0, IBM Corp.). Normal distribution of data was checked with normal probability plots and the Kolmogorov-Smirnov and Shapiro-Wilk tests. A t test or Mann-Whitney U test, depending on normality, was used to compare the outcomes between groups. A P value less than 0.05 was considered statistically significant.. RESULTS The study comprised 40 eyes of 40 patients (22 men, 18 women). Sixteen eyes (40.0%) had lens extraction because of cataract, and 24 eyes (60.0%) had refractive lens exchange. Table 1 shows the patients’ demographics.. 37. 3.

(6) Chapter 3 Demographics. Mean ± SD. Range. Age at lens extraction (y). 62.9 ± 6.9. 41 to 76. Pre-laser SE (D). 1.53 ± 1.23. -1.50 to 4.25. Post-laser SE (D). -0.57 ± 0.92. -2.25 to 0.50. Pre-IOL SE (D). 0.66 ± 1.13. -2.38 to 2.75. Pre-IOL mean K value (D). 44.76 ± 1.59. 41.88 to 47.96. Axial length (mm). 23.06 ± 0.98. 21.37 to 25.69. Implanted IOL power (D). 21.11 ± 2.91. 14.50 to 26.50. Table 1. Patient demographics. IOL = intraocular lens; K = keratometry; SE = spherical equivalent.. Phacoemulsification with multifocal IOL implantation was uneventful in all cases. The mean spherical equivalent (SE) after lens extraction and IOL implantation was 0.04 ± 0.92 D. The absolute error of the mean SE was 0.61 ± 0.68 D. The mean postoperative UDVA was 0.16 ± 0.18 logMAR. The mean postoperative CDVA was 0.01 ± 0.08 logMAR. The mean postoperative uncorrected near visual acuity was 0.16 ± 0.24 logMAR. Figure 1 shows the refractive accuracy histogram. Twenty-five eyes (62.5%) were within ±0.50 D and 35 eyes (87.5%) within ±1.00 D of emmetropia. Figure 2 shows the attempted SE versus the achieved SE refraction.. Figure 1. Refractive accuracy.. 38.

(7) Multifocal IOL after hyperopic laser surgery. 3. Figure 2. Attempted versus achieved refraction. The green line indicates within ± 0.50 D and red line within ± 1.00 D of target refraction.. The efficacy index (ratio of mean postoperative UDVA to mean preoperative CDVA) was 0.81. The safety index (ratio of mean postoperative CDVA to mean preoperative CDVA) was 1.07. The SE before the laser treatment was not statistically significantly correlated with the refractive outcome (Pearson r = 0.192, P = .235). There was no statistically significant difference in refractive outcome between eyes with more or less than 2.00 D of pre-laser hyperopia (P = .190, Mann-Whitney U test) or with more or less than 3.00 D of pre-laser hyperopia (P = .267, Mann-Whitney U test). The refractive outcomes postoperatively between eyes that had had emmetropia as a target and eyes that had had a hyperopic ablation targeting a reading refraction in the previous corneal refractive laser surgery were comparable. The absolute error of the mean SE was 0.64 ± 0.79 D and 0.55 ± 0.35 D, respectively (P=.503, Mann-Whitney U test). For the previous LASIK procedure, 2 flap diameters (8.5mm and 9.5 mm) were used. There was no statistically significant difference in the postoperative absolute error of the mean SE between the 2 groups (0.64 ± 0.72 D and 0.64 ± 0.70 D, respectively) (P=.903, Mann-Whitney U test). There was no correlation between the postoperative refractive outcome and the corneal irregularity index (Orbscan, Bausch & Lomb, Inc.) at the 3.0 mm zone (r = -0.305, P = .056) or 5.0 mm zone (r = -0.191, P = .238).. 39.

(8) Chapter 3. One patient (2.5%) had a repositioning of the IOL in 1 eye because of slight (1.0 mm) decentration of the IOL. The repositioning procedure was uneventful and resulted in a well-centered IOL. Nine eyes (22.5%) had a laser enhancement after IOL implantation for a residual refraction. The mean time between IOL implantation and laser enhancement was 12.89 months (range 2.30 to 34.98 months). Eleven eyes (27.5%) had a neodymium:YAG (Nd:YAG) laser capsulotomy because of PCO. The mean time after IOL implantation was 27.09 months (range 6.0 to 64.0 months). No complications were seen after the Nd:YAG laser capsulotomy.. DISCUSSION Multifocal IOL implantation after previous corneal refractive surgery is considered by many to be controversial. However, we decided to implant a multifocal IOL because of the technical feasibility of meeting the wish of patients to have a high degree of freedom from spectacles. Patients were extensively informed and counseled and concluded that their wish for spectacle independence was in balance with the expected side effects. In this study, we report the visual and refractive results of multifocal IOL implantation after previous hyperopic laser surgery in a cohort of 40 eyes of 40 patients. To our knowledge, this cohort includes the highest number of patients reported in the literature to date.7,16 The uncorrected visual acuity and predictability results were good, with 25 eyes (62.5%) within ±0.50 D and 35 eyes (87.5%) within ±1.00 D of emmetropia, which is comparable to the results of monofocal IOL implantation after corneal refractive laser surgery for hyperopia.17 The predictability in our study is slightly less than in a study by Alfonso et al.,7 in which 73% of patients were within ±0.50 D and 100% were within ±1.25 D of emmetropia. However, these authors did not indicate whether their results were evaluated before or after corneal laser enhancement, and their patient cohort was smaller (41 eyes of 23 patients), which might in part explain this difference. We realize that apart from visual and refractive results, more detailed data, such as wavefront analysis and contrast sensitivity, should be analyzed to obtain a more thorough representation of the performance. Unfortunately, these data were not available for this cohort. Our previous study of multifocal IOLs after myopic refractive laser surgery11 found that eyes with more than 6.00 D of myopia had less predictable refractive outcomes. In the current study, we found no statistically significant difference in outcomes between eyes with more or less than 2.00 D or 3.00 D of hyperopia (P = .190 and P = .267, respectively). No contributory statistical analysis could be performed regarding the outcome in eyes with more than 4.00 D of hyperopia in comparison with eyes having less hyperopia. This. 40.

(9) Multifocal IOL after hyperopic laser surgery. was because of the limited number of eyes with more than 4.00 D of hyperopia in the study. This can be explained by the limited indications for refractive laser surgery for high hyperopia in general. Nine eyes (22.5%) required a laser enhancement because of a residual refractive error, with fewer eyes requiring an enhancement in the second half of the study (2 [10%] of 20 eyes) than in the first half (7 [35%] of 20 eyes). The decrease could be explained by the improved accuracy of the ASCRS calculatorC over time and by the implementation of multifocal toric IOLs by the end of 2010. Before 2010, patients with astigmatism were offered a multifocal IOL with the warning that a laser enhancement would be necessary afterward to treat the astigmatism. After 2010, patients with astigmatism were offered a multifocal toric IOL, and this led to fewer laser enhancements for preexisting residual astigmatism after IOL implantation. Posterior capsule opacification is a common complication after cataract surgery, occurring at a higher rate in eyes with a multifocal IOL.18,19 It is thought that patients with multifocal IOLs have higher visual demands and that the interaction of PCO with the multifocal optic leads to complex visual phenomena that warrant an early posterior capsulotomy. In our study, 11 eyes (27.5%) had an Nd:YAG capsulotomy, which is comparable to findings in other studies of multifocal pseudophakia.8,18,19 Earlier studies suggest that aspheric multifocal IOL implantation after previous myopic laser surgery gives better results in visual and optical quality than implantation of spherical multifocal IOLs.9 The hypothesis is that a myopic laser ablation induces spherical aberrations and that an aspheric IOL profile neutralizes these aberrations. Hyperopic laser ablation alters the cornea, which becomes more aspheric; thus, one could presume that in these cases a spherical IOL would give better results than an aspheric IOL. In our study, the refraction and visual acuity with an aspheric multifocal IOL were good and comparable to those in the earlier study by Alfonso et al.,7 in which a spherical multifocal IOL was used. More studies are needed to compare the visual quality outcome with these 2 IOL designs. A limitation of our study is its retrospective design. Also, we did not address photopic side effects, spectacle independence, and patient satisfaction. Future studies should include these topics. In conclusion, multifocal IOL implantation after previous hyperopic corneal laser surgery gave good visual acuity and refraction results. A limited number of patients required a laser enhancement for residual refraction. The magnitude of the previous hyperopia did not affect the refractive predictability after multifocal IOL implantation.. 41. 3.

(10) Chapter 3. WHAT WAS KNOWN - Intraocular lens calculation after previous corneal refractive laser surgery is less accurate because of the inaccurate determination of the corneal curvature and the inaccurate estimation of the effective lens position. - Multifocal IOL implantation after previous corneal refractive laser surgery for hyperopia is controversial because of the assumption that the previous will have changed the cornea in such manner that multifocal IOL implantation could cause vision to deteriorate.. WHAT THIS PAPER ADDS - With the current IOL calculation methods for multifocal IOL implantation after previous corneal refractive laser surgery for hyperopia, good visual acuity and refraction results were achieved. - The magnitude of low to moderate hyperopia before corneal refractive laser surgery did not influence the refractive predictability after multifocal IOL implantation. - Predictability was comparable to results with monofocal IOLs after hyperopic corneal laser surgery.. 42.

(11) Multifocal IOL after hyperopic laser surgery. REFERENCES 1. . Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL, for the Joint LASIK Study Task Force. LASIK world literature review; quality of life and patient satisfaction. Ophthalmology 2009; 116:691–701 2. Jaycock PD, O’Brart DPS, Rajan MS, Marshall J. 5-year follow-up of LASIK for hyperopia. Ophthalmology 2005; 112:191–199 3. Rosen E, Alió JL, Dick HB, Dell S, Slade S. Efficacy and safety of multifocal intraocular lenses following cataract and refractive lens exchange: Metaanalysis of peer-reviewed publica tions. J Cataract Refract Surg 2016;42:310–328 4. van der Linden JW, van der Meulen IJ, Mourits MP, Lapid-Gortzak R. Comparison of a hydro philic and a hydrophobic apodized diffractive multifocal intraocular lens. Int Ophthalmol 2013; 33:493–500 5. Yoshino M, Bissen-Miyajima H, Minami K, Taira Y. Five-year postoperative outcomes of apodized diffractive multifocal intraocular lens implantation. Jpn J Ophthalmol 2013; 57:510–513 6. Braga-Mele R, Chang D, Dewey S, Foster G, Henderson BA, Hill W , Hoffman R, Little B, Mamalis N, Oetting T, Serafano D, Talley-Rostov A, Vasavada A, Yoo S, for the ASCRS Cata ract Clinical Committee. Multifocal intraocular lenses: Relative indications and contraindi cations for implantation. J Cataract Refract Surg 2014; 40:313–322 7. Alfonso JF, Fernández-Vega L, Baamonde B, Madrid-Costa D, Montés-Micó R. Refractive lens exchange with spherical diffractive intraocular lens implantation after hyperopic laser in situ keratomileusis. J Cataract Refract Surg 2009; 35:1744–1750 8. Muftuoglu O, Dao L, Mootha VV, Verity SM, Bowman RW, Cavanagh HD, McCulley JP. Apodized diffractive intraocular lens implantation after laser in situ keratomileusis with or without subsequent excimer laser enhancement. J Cataract Refract Surg 2010; 36:1815–1821 9. Fernández-Vega L, Madrid-Costa D, Alfonso JF, Montés-Micó R, Poo-López A. Optical and visual performance of diffractive intraocular lens implantation after myopic laser in situ keratomileusis. J Cataract Refract Surg 2009; 35:825–832 10. Khor WB, Afshari NA. The role of presbyopia-correcting intraocular lenses after laser in situ keratomileusis. Curr Opin Ophthalmol 2013; 24:35–40 11. Vrijman V, van der Linden JW, van der Meulen IJE, Mourits MP, Lapid-Gortzak R. Multifocal intraocular lens implantation after previous corneal refractive laser surgery for myopia. J Cataract Refract Surg 2017;43:909–914 12. Hoffer KJ. Intraocular lens power calculation after previous laser refractive surgery. J Cata ract Refract Surg 2009; 35:759–765 13. Fram NR, Masket S, Wang L. Comparison of intraoperative aberrometry, OCT-based IOL formula, Haigis-L, and Masket formulae for IOL power calculation after laser vision correc tion. Ophthalmology 2015; 122:1096–1101 14. Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg 2016; 42:363–369. 43. 3.

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(13) Multifocal IOL after hyperopic laser surgery. AUTHOR CONTRIBUTIONS Violette Vrijman contributed to the study concept and design, data acquisition, data analysis and interpretation, writing the manuscript and producing the final manuscript Jan Willem van der Linden contributed to the data acquisition, data interpretation and critical revision of the manuscript. Ivanka J.E. van der Meulen contributed to the data acquisition, data interpretation and critical revision of the manuscript. Maarten P. Mourits contributed to the data interpretation and critical revision of the manuscript. Ruth Lapid-Gortzak contributed to the study concept and design, data acquisition, data interpretation, writing the manuscript, critical revision of the manuscript and submission of the final manuscript. 45. 3.

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