Three-year clinical comparison of 3-piece acrysof and SI-40 silicone intraocular lenses

Three-year clinical comparison of 3-piece AcrySof and SI-40 silicone intraocular lenses Todd Daynes, MD, Terrence S. Spencer, MD, Kim Doan, MD, Nick Mamalis, MD, Randall J. Olson, MD Purpose: To compare the 3-year performance of the 3-piece AcrySof姞 (Alcon) and the SI-40 silicone (Allergan) intraocular lenses (IOLs). Setting: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. Methods: In this retrospective study, patients with no complications and at least a 3-year follow-up after IOL implantation were examined for signs of inflammation, visual function, posterior capsule opacification (PCO), and satisfaction. Results: One hundred eleven patients were enrolled with equivalent visual acuity, inflammation, and PCO parameters. The AcrySof eyes had less anterior capsule opacification and more intralenticular inclusions than the other group. Complete anterior capsule overlap was associated with decreased PCO, and significantly more SI-40 eyes had complete anterior capsule overlap. Conclusions: The second-generation silicone IOL was equivalent to the 3-piece AcrySof in patient satisfaction, visual function, inflammation, and PCO. The amount of anterior capsule overlap on the IOL may help to explain the study differences. J Cataract Refract Surg 2002; 28:1124 –1129 © 2002 ASCRS and ESCRS

W

hen foldable intraocular lenses (IOLs) first became available, it was not clear whether they were a novelty or actually had clinical usefulness and longterm advantages over poly(methyl methacrylate) (PMMA). In a clinical study with a 3-year follow-up comparing a second-generation silicone IOL (Allergan SI-30) with PMMA,1 Olson and Crandall showed significantly better long-term visual acuity with and without correction as well as significantly less astigmatism with the SI-30 lens. The improved best corrected visual acuity (BCVA) correlated with decreased posterior capsule opacification (PCO).2 Foldable IOLs now represent most of the market in the United States; however, in the foldable market, a new entry, hydrophobic acrylic, has become popular.3

Hydrophobic acrylic is stated to be superior to silicone because of reduced PCO4 and anterior capsule opacification (ACO)5 and fewer signs of inflammation such as giant-cell deposits.6 Some studies, however, show the 2 materials to be similar in the rate of PCO7 and signs of inflammation,8,9 particularly in studies comparing hydrophobic acrylic and second-generation silicone. The clinical differences between second-generation silicone and hydrophobic acrylic are not clear. In this study, we evaluated patients who had uneventful cataract surgery with implantation of a hydrophobic acrylic IOL (3-piece AcrySof威 [Alcon]) or a second-generation silicone 3-piece IOL with PMMA haptics (SI-40, Allergan).

Patients and Methods Accepted for publication April 19, 2002. Reprint requests to Randall J. Olson, MD, Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, 50 North Medical Drive, Salt Lake City, Utah 84132, USA. E-mail: randall.olson@hsc. utah.edu. © 2002 ASCRS and ESCRS Published by Elsevier Science Inc.

The charts of patients with at least 3 years of follow-up were reviewed consecutively and retrospectively for evidence of uneventful surgery with no evidence of sight-limiting pathology and at least 20/25 uncorrected visual acuity in the early postoperative period. Patients who met these prelimi0886-3350/02/$–see front matter PII S0886-3350(02)01460-8

CLINICAL COMPARISON OF ACRYSOF AND SILICONE IOLS

nary criteria were called consecutively and asked to come in for a comprehensive examination. Approximately 60% of patients were contacted; half agreed to come for the examination. Only 1 eye of each patient was enrolled in the study. All examinations were carried out in a masked fashion. Technicians first completed a careful manifest refraction and then determined logMAR visual acuity with the manifest refraction and without correction. The best corrected brightness acuity test (BAT, Mentor O & O, Inc.) at medium setting (logMAR acuity) as well as the functional acuity contrast test (FACT, Stereo Optical Co.) were then performed. At this point, the pupil was dilated with tropicamide 1% and phenylephrine hydrochloride (Neo-Synephrine威 2.5%). After the eye was dilated, the lens opacity meter (Interzeag AG) measured the reflected light as a percentage of the total. Seven central readings were taken and the high and low measurements eliminated. The mean of the remaining measurements was determined and recorded.2 Retroillumination digital photographs and anterior surface photographs of the IOL were then taken. A slit digital photograph at ⫻25 (1.0 mm ⫻ 3.0 mm beam) was taken temporally, centrally, and nasally of each IOL. Digital fundus photographs of the optic nerve and macula were also taken. The digital retroillumination photographs were scored for PCO using the evaluation of posterior capsule opacification (EPCO) analysis10 to the anterior capsulorhexis edge, iris, or IOL edge depending on what was obscured in each patient. EPCO analysis of the central 3.0 mm of the posterior capsule under the IOL optic was also done and a third analysis of only the anterior capsule overlap on the IOL. The EPCO program allows the examiner to draw in all areas of opacification by tracing the regions on the retroillumination photograph and then scoring each area using comparison photographs of varying density. The program calculates the area of PCO multiplied by the severity to determine the average PCO in any area analyzed. Severity scores range from 1 (mild) to 4 (severe). The presence of anterior capsule overlap for 360 degrees on the IOL optic was also evaluated. Retroillumination photographs were evaluated in a masked fashion for the presence of a laser capsulotomy, and fundus photographs were scored for macular or optic nerve head pathology that were thought likely to affect visual acuity

(scattered hard drusen were not considered significant maculopathy). Glistenings were scored by counting all visible point defects at ⫻25 in each slitlamp field and averaged for each lens. The anterior lens surface was independently analyzed for cell deposits including lens epithelial cells (LECs) and giant cells. Comparison of the IOL types was conducted with an independent-sample t test. Equality of variances between groups was assessed using Levene’s tests for equality of variances, and the chi-square analysis was used for nonparametric comparisons.

Results One hundred eleven patients were enrolled; 51 had an SI-40 IOL and 60, a 3-piece AcrySof IOL (56 were MA60 and 4 were MA30 models). The mean age of the 28 women and 23 men in the SI-40 group was 77 years and of the 31 women and 29 men in the AcrySof group, 70 years. All visual acuity parameters were analyzed after the data for patients with significant drusen combined with retinal pigment epithelial changes were removed; ie, 8 patients in the SI-40 group and 7 in the AcrySof group. No other posterior segment pathology was noted. Uncorrected visual acuity, BCVA with and without brightness acuity testing, and contrast acuity testing were statistically similar between the groups (Table 1). All measures of PCO including the neodymium: YAG laser capsulotomy rate, the lens opacity meter measurements of reflected light, the EPCO retroillumination PCO analysis, and the central 3.0 mm analysis showed no statistically significant differences between the 2 IOL types. There was, however, significantly less ACO in the AcrySof group than in the SI-40 group; the mean ACO EPCO scores were 0.318 ⫾ 0.296 (SD) and 0.588 ⫾ 0.56, respectively; P ⫽ .001, t test) (Table 2).

Table 1. Measurements of visual function in patients with 3-piece AcrySof and SI-40 silicone IOLs after 3 years of follow-up. Patients with macular pathology were removed for this analysis (logMAR acuity; 0.00 ⫽ 20/20).

UCVA

BCVA

BCVA with BAT at Medium Setting

Contrast Testing (FACT)

3 piece AcrySof (n ⫽ 53)

0.31 ⫾ 0.23

0.075 ⫾ 0.16

0.086 ⫾ 0.19

133 ⫾ 78

SI-40 (n ⫽ 43)

0.28 ⫾ 0.20

0.056 ⫾ 0.11

0.084 ⫾ 0.13

136 ⫾ 87

Group

P value

.54

.51

.95

.86

UCVA ⫽ uncorrected visual acuity; BCVA ⫽ best corrected visual acuity; BAT ⫽ brightness acuity tester; FACT ⫽ functional acuity contrast test

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Table 2. Measurement of capsule opacification (posterior ⫽ PCO; anterior ⫽ ACO) with 3-piece AcrySof and SI-40 silicone IOLs after 3 years of follow-up. Patients with capsulotomy were eliminated. Group

LOM

EPCO PCO

EPCO Central 3 mm PCO

EPCO ACO

3-piece AcrySof (n ⫽ 52)

6.7 ⫾ 1.8

0.55 ⫾ 0.66

0.46 ⫾ 0.73

0.32 ⫾ 0.30

SI-40 (n ⫽ 43)

6.8 ⫾ 2.0

0.42 ⫾ 0.52

0.28 ⫾ 0.55

0.59 ⫾ 0.46

.71

.27

.18

P value

.001

LOM ⫽ lens opacity meter (reflected light as percentage of total); EPCO ⫽ evaluation of PCO (the higher the number, the greater the opacity); PCO ⫽ posterior capsule opacification; ACO ⫽ anterior capsule opacification

Anterior capsule overlap could be determined in 77 patients; in 34, the iris blocked IOL-edge evaluation at some point. The overlap was associated with decreased PCO in the EPCO analysis, number of patients with no PCO, and patients with an EPCO score above 1.0. No statistically significant between-group difference was noted except in the number of patients with overlap, which was more common in the SI-40 group (21 of 35 patients) than in the AcrySof group (10 of 42 patients) (P ⫽ .001) (Table 3). Inclusions in the lens optic were defined as all point defects visible at ⫻25. This included classic glistenings as well as other defects. The mean inclusions per field was 31.2 ⫾ 29.5 in the AcrySof group and 8.5 ⫾ 11.8 in the SI-40 group (P ⫽ .001). No giant cells, other inflammatory cells, or LEC growth was noted on any IOL. Patients were satisfied with both IOL types, and there was no statistically significant difference in their rating

of the experience with the IOL as satisfied or very satisfied (70% of AcrySof patients and 71% of SI-40 patients).

Discussion The most striking result of our study was the clinical similarity between the SI-40 and 3-piece AcrySof IOLs. The long-term results of all studies and parameters of PCO, signs of chronic inflammation, and patient satisfaction were the same. The only statistically significant findings were a lower ACO rate with the AcrySof IOL and fewer optic inclusions with the SI-40 IOL. Both differences have been documented by others,5,11 and neither had an obvious effect on patient satisfaction scores. The literature supports our finding that these 2 IOLs are similar in signs of chronic inflammation.8,9

Table 3. Evaluation of patients with 360-degree anterior capsule overlap (N ⫽ 77). Measurement

Complete Overlap

Incomplete Overlap

EPCO score All patients

0.33 ⫾ 0.48 (n ⫽ 31)*

0.58 ⫾ 0.68 (n ⫽ 46)*

SI-40 patients

0.29 ⫾ 0.34 (n ⫽ 21)

0.46 ⫾ 0.56 (n ⫽ 14)

AcrySof patients

0.43 ⫾ 0.72 (n ⫽ 10)

0.64 ⫾ 0.73 (n ⫽ 32)

Patients with no PCO

9/31

†

4/46†

SI-40

6/21

2/14

AcrySof

3/10

2/32

Patients with EPCO ⬎ 1.0

1/31

‡

12/46‡

SI-40

0/21

2/14

AcrySof

1/10

10/32

EPCO ⫽ evaluation of posterior capsule opacification *P ⫽ .04 † P ⫽ .019 ‡ P ⫽ .009

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The confusion results from a comparison that used firstgeneration silicone in which the hydrophobic acrylic had fewer signs of inflammation.6,9 This has not been the case with second-generation silicone and, therefore, the question is not whether there is a difference between second-generation silicone IOLs and hydrophobic acrylic in signs of inflammation but rather what the difference is between first- and second-generation silicone IOLs.8 An obvious difference is the lower refractive index of first-generation silicone in which the greater bulk may lead to contact with the posterior iris surface, creating some chronic inflammation. Another factor is the refinement of the material, which may result in less inflammation with the second-generation material that we studied. Our present study cannot answer these questions; however, it supports the concept that it is a mistake to categorize all silicone lenses together in clinical studies. The evidence is that first- and second-generation silicone respond differently in signs of inflammation; for conclusions to be accurate, authors must indicate the specific silicone IOL studied. Several studies suggest that 3-piece AcrySof IOLs are superior to SI-40 IOLs in preventing PCO.12,13 Another study,7 however, supports our finding of longterm equivalence between the 2 IOLS in PCO rates over time; therefore, an important issue is why some studies show equivalence such as ours while others show a disparity in favor of hydrophobic acrylic. We believe the strength of our study is that we used multiple measurements of PCO and all showed statistical equivalence. In fact, the similarity of all parameters is striking. Again, there appears to be a difference between first- and second-generation silicone, most markedly noted in a study by Hollick et al.4 in which the AcrySof was clearly better than a first-generation silicone lens. However, in another study without a direct comparison with hydrophobic acrylic,14 these authors showed that a secondgeneration silicone IOL similar to ours had excellent long-term PCO results. While these results suggest a difference between first- and second-generation silicone in PCO, they do not explain why some studies using the same second-generation silicone lens that we used show an advantage for hydrophobic acrylic and others agree with our results and show no long-term difference in PCO. Two main theories of PCO prevention exist at this time: the sandwich theory advanced by Linnola15 and

Linnola et al.16 and the discontinuous barrier theory advanced by Nishi and coauthors17 and Nishi and Nishi.18 The sandwich theory suggests that the hydrophobic acrylic material is the most important factor in PCO prevention because of the elucidation of fibronectin and other proteins and its inherent tackiness, while the barrier theory suggests that the mechanical barrier produced by a 360-degree discontinuous bend in the capsule created by a truncated edge is the critical factor, with material either less or possibly not important in PCO prevention. In their rabbit model,18 Nishi and Nishi have shown that flattened PMMA, hydrophobic acrylic, and silicone are equivalent in PCO prevention, while rounding the edges of all 3 eliminates this PCO prevention. The sandwich theory cannot explain Nishi’s results. The only documented material issue associated with PCO appears to be hydrophilicity, which appears to enhance LEC growth and thereby promote PCO.8,19 To our knowledge, only 3 studies compare truncated silicone and 3-piece acrylic IOLs (S. Borin, MD, et al., “PCO Rate with Three IOLs: CeeOn 911, AcrySof MA60BM, Hydroview H60M,” and G.U. Auffarth, MD, et al., “Quantification of Posterior Capsule Opacification with Sharp Edge Foldable Intraocular Lenses,” presented at the XIXth Congress of the European Society of Cataract & Refractive Surgeons, Amsterdam, The Netherlands, September 2001).20 Two of the studies showed a similar PCO rate between the 2 lenses, while 1 study (Borin) showed truncated silicone was statistically superior to truncated hydrophobic acrylic in reducing PCO. Our results, the study by Hayashi and coauthors,7 and these 3 studies do not support the sandwich theory as being clinically significant but strongly support the discontinuous bend theory of Nishi. To prevent PCO, it is therefore critically important to determine how a mechanical barrier is created by the edge of the lens. A study by Schauersberger et al.,20 which is the only long-term comparison of truncated silicone and hydrophobic acrylic to date, has 3 years of follow-up and uses PCO rather than a neodymium:YAG rate as the endpoint. The authors did not show a PCO difference but did demonstrate a statistically significant advantage of the second-generation silicone IOL in anterior chamber cells, flare, and chronic inflammatory cells on the IOL optic. Additional studies are needed to confirm this long-term inflammatory advantage.

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Present clinical evidence supports Nishi’s barrier theory; therefore, it is not clear how the SI-40, which does not have a sharpened posterior edge, might be creating a barrier. Looking at the SI-40 IOL, it appears to have a lenticular edge that, with posterior pressure by a tightened anterior capsule, can be seen clinically to push against the posterior capsule, producing a discontinuous bend. The absence of a sharpened posterior edge would decrease the efficiency of this bend; however, the increased ACO associated with this silicone lens could result in greater posterior pressure, overcoming the inefficient creation of a discontinuous bend by the rounded edge. If this theory of why the SI-40 lens does so well in preventing PCO is correct, the overlap of the anterior capsule should be more critical in PCO prevention for the SI-40 than it is for the 3-piece AcrySof. We looked at the anterior capsule overlap of the IOL optic in all our patients. Patients with a 360-degree anterior capsule overlap were associated with decreased PCO. The SI-40 had an anterior capsule overlap more frequently than the AcrySof . Our patients were pooled from many surgeons, and our review shows marked disparity in the IOLs used by the surgeons. This disparity probably represents a technique variation in which surgeons who used the AcrySof on average made a larger capsulorhexis. The increased ACO and anterior capsule contracture with the SI-40 may have enhanced maintenance of anterior capsule coverage and be an advantage of the SI-40. Having a greater anterior capsule overlap would represent an advantage in PCO prevention regardless of the material or edge design. We are certain that the truncated edge of the AcrySof is an advantage over the SI-40 IOL in that the PCO results are similar with an anterior capsule overlap advantage for these SI-40 patients. Increased ACO with less efficient production of a discontinuous bend produced by the lenticular edge of the SI-40 may explain the differences between some studies showing the SI-40 doing very well if there is good anterior capsule overlap and not doing well without it. Additional studies with greater statistical power are necessary to support or refute this theory of the importance of anterior capsule overlap with the SI-40. An important corollary of this may be that increased ACO may actually be an advantage for second-generation silicone in PCO prevention. However, we think the PCO differences or similarities between the SI-40 and 3-piece Acry1128

Sof probably have more to do with surgical technique and anterior capsule overlap than with other factors. All this supports Nishi’s biomechanical theory and refutes the sandwich theory. As further evidence of the importance of the anterior capsule reaction, Petternel recently presented results that showed that aggressive removal of LECs from the anterior capsule resulted in decreased ACO but increased PCO, probably because of a lack of anterior capsule contracture, pushing the IOL optic posteriorly (V. Petternell, MD, et al., “Effect of Capsule Polishing on PCO,” presented at the XIXth Congress of the European Society of Cataract & Refractive Surgeons, Amsterdam, The Netherlands, September 2001). Our results and those of others clearly show PCO is multifactorial. At this time, a truncated IOL edge, hydrophobicity, and 360-degree anterior capsule overlap are the 3 most important factors in PCO prevention that we can identify. What role the interplay of edge design and anterior capsule overlap plays is poorly understood and deserves more research. Capsulorhexis size is a double-edged sword; if too small, it makes surgery more difficult and increases the risk of clinically significant anterior capsule contraction. For a 6.0 mm optic, a wellcentered 5.0 mm capsulorhexis would be ideal; however, this would be too large for a 5.5 mm optic. The eccentricity of the capsule means a well-centered capsulorhexis may not overlap an in-the-bag IOL, so we have erred on the smaller side lately (about 4.5 mm). It is now clear that we should not be polishing the anterior capsule leaves because this induces PCO by limiting anterior capsule pressure on the IOL optic. Posterior capsule polishing may be important only in posterior subcapsular cataract (PSC) in which LECs are thought to migrate posteriorly. Although to our knowledge no study has provided clear evidence that posterior capsule polishing is important in PCO prevention, it makes sense to polish the capsule in PSC and we recommend it. Verification of this recommendation is necessary. In our long-term study comparing the SI-40 and 3-piece AcrySof IOLs, the results of visual acuity, patient satisfaction, chronic inflammation, and PCO parameters were similar. Anterior capsule overlap may be more important for the SI-40 IOL than for the 3-piece AcrySof, which may explain some of the disparity in PCO results in other studies. Additional studies are required to help us further understand the many

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factors that contribute to positive results such as PCO prevention.

12.

References 1. Olson RJ, Crandall AS. Prospective randomized comparison of phacoemulsification cataract surgery with a 3.2-mm vs a 5.5-mm sutureless incision. Am J Ophthalmol 1998; 125:612⫺620 2. Olson RJ, Crandall AS. Silicone versus polymethylmethacrylate intraocular lenses with regard to capsular opacification. Ophthalmic Surg Lasers 1998; 29:55⫺58 3. Leaming DV. Practice styles and preferences of ASCRS members—2000 survey. J Cataract Refract Surg 2001; 27:948⫺955 4. Hollick EJ, Spalton DJ, Ursell PG, et al. The effect of polymethylmethacrylate, silicone, and polyacrylic intraocular lenses on posterior capsule opacification 3 years after cataract surgery. Ophthalmology 1999; 106:49⫺54; discussion by RC Drews, 54⫺55 5. Werner L, Pandey SK, Escobar-Gomez M, et al. Anterior capsule opacification; a histopathological study comparing difference IOL styles. Ophthalmology 2000; 107: 463⫺471 6. Hollick EJ, Spalton DJ, Ursell PG, Pande MV. Biocompatibility of poly(methyl methacrylate), silicone, and AcrySof intraocular lenses: randomized comparison of the cellular reaction on the anterior lens surface. J Cataract Refract Surg 1998; 24:361⫺366 7. Hayashi H, Hayashi K, Nakao F, Hayashi F. Quantitative comparison of posterior capsule opacification after polymethylmethacrylate, silicone, and soft acrylic intraocular lens implantation. Arch Ophthalmol 1998; 116:1579⫺1582 8. Hollick EJ, Spalton DJ, Ursell PG. Surface cytologic features on intraocular lenses; can increased biocompatibility have disadvantages? Arch Ophthalmol 1999; 117: 872⫺878 9. Samuelson TW, Chu YR, Krieger RA. Evaluation of giant-cell deposits on foldable intraocular lenses after combined cataract and glaucoma surgery. J Cataract Refract Surgery 2000; 26:817⫺823 10. Tetz MR, Auffarth GU, Sperker M. Photographic image analysis system of posterior capsule opacification. J Cataract Refract Surg 1997; 23:1515⫺1520 11. Christiansen G, Durcan FJ, Olson RJ, Christiansen K.

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Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract Surg 2001; 27:728⫺733 Hayashi K, Hayashi H, Nakao F, Hayashi F. Changes in posterior capsule opacification after poly(methyl methacrylate), silicone, and acrylic intraocular lens implantation. J Cataract Refract Surg 2001; 27:817⫺824 Apple DJ, Peng Q, Visessook N, et al. Eradication of posterior capsule opacification; documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem. Ophthalmology 2001; 108: 505⫺518 Hollick EJ, Spalton DJ, Ursell PG, Pande MV. Lens epithelial cell regression on the posterior capsule with different intraocular lens materials. Br J Ophthalmol 1998; 82:1182⫺1188 Linnola RJ. Sandwich theory: bioactivity-based explanation for posterior capsule opacification. J Cataract Refract Surg 1997; 23:1539⫺1542 Linnola RJ, Werner L, Pandey SK, et al. Adhesion of fibronectin, vitronectin, laminin, and collagen type IV to intraocular lens materials in pseudophakic human autopsy eyes. Part 1: histological sections. J Cataract Refract Surg 2000; 26:1792⫺1806 Nishi O, Nishi K, Sakanishi K. Inhibition of migrating lens epithelial cells at the capsular bend created by the rectangular optic edge of a posterior chamber intraocular lens. Ophthalmic Surg Lasers 1998; 29:587⫺594 Nishi O, Nishi K. Preventing posterior capsule opacification by creating a discontinuous sharp bend in the capsule. J Cataract Refract Surg 1999; 25:521⫺526 ¨ F. PosteKu¨ c¸u¨ ksu¨ mer Y, Bayraktar S, S¸ ahin S¸ , Yilmaz O rior capsule opacification 3 years after implantation of an AcrySof and a MemoryLens in fellow eyes. J Cataract Refract Surg 2000; 26:1176⫺1182 Schauersberger J, Amon M, Kruger A, et al. Comparison of the biocompatibility of 2 foldable intraocular lenses with sharp optic edges. J Cataract Refract Surg 2001; 27:1579 –1585

From the Department of Ophthalmology and Visual Sciences, University of Utah Health Sciences Center, Salt Lake City, Utah, USA. Supported in part by a grant from Research to Prevent Blindness, Inc., New York, New York, USA, to the Department of Ophthalmology and Visual Sciences, University of Utah. Dr. Olson is a consultant to Allergan, Inc. None of the other authors has a financial interest in any product mentioned.

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