It is widely known that some optical phenomena frequently develop within the optics of particular types of intraocular lenses (IOLs) after surgery. These include glistenings1,2 and surface light scattering,3,4 which are most notably associated with hydrophobic acrylic IOLs (Acrysof, Alcon Laboratories, Inc.).5 Glistenings and surface light scattering are different in their definition and etiology.5 Glistenings are caused by fluid-filled microvacuoles that range in size from 1 to 20 μm and are located throughout the thickness of the IOL optics.6 On the other hand, surface light scattering is caused by nanovacuoles that are smaller than 200 nm and are situated 120 μm or less from the IOL surface.7
The appearance of surface light scattering associated with Acrysof IOLs, previously referred to as whitening8–10 or subsurface nanoglistenings11–15 by some researchers, is more prominent than that of glistenings. Thus, its influence on the visual function of patients has long been a subject of debate. Although the majority of related studies indicate that surface light scattering does not affect the visual function of patients11,16,17 and optical quality of the IOLs,12,18–21 several case reports indicate a possible association between an increase in surface light scattering and a decrease in patients’ visual function.13,14,22 In a cross-sectional study that evaluated 466 eyes with a mean follow-up of 4.2 ± 3.4 years, Miyata et al.23 reported that increased light scattering had no overall significant impact on the visual acuity; however, more cases with deteriorated visual acuity had severe surface light scattering. An in vitro experimental study12 found that surface light scattering reduced the irradiance and significantly diminished the retinal image; however, the effect on visual function in the absence of a severe retinal disease was minimal.
The surface light scattering with Acrysof hydrophobic acrylic IOLs is reported to continue to increase for many years after surgery. An in vivo study23 confirmed it lasts at least 15 years, and an in vitro experiment of accelerated aging24 found it lasts 20 years. Considering that tens of millions of patients have been had implantation of this IOL worldwide and that the patients’ life expectancy after surgery is increasing, it is crucial to clarify the long-term impact of surface light scattering. However, to our knowledge there is no published study of the influence of surface light scattering on patients’ visual function more than 10 years after surgery. Similarly, the long-term influence of glistenings on the patients’ vision must be further elucidated.25
We performed this study to assess the influence of surface light scattering and glistenings on the quality of vision in patients with a hydrophobic acrylic, silicone, or poly(methyl methacrylate) (PMMA) IOL 15 to 20 years after surgery.
Patients and methods
This study was performed as a nonrandomized observer-masked multicenter trial. The study protocol was reviewed and approved by the institutional review board or the ethical review committee of each participating institution. This study was in accordance with the tenets of the Declaration of Helsinki, the Ministerial Ordinance on Good Clinical Practice for Medical Devices (Ordinance of the Ministry of Health, Labour and Welfare, No. 36, 2005), and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare, No. 3, 2014). All patients provided written informed consent before enrollment. This study was registered with ClinicalTrials.gov (identifier NCT02450799).A
Patients who had cataract surgery with implantation of an Acrysof (MA30BA or MA60BM), silicone, or PMMA IOL from 1994 to 2000 and could return for ocular examinations were recruited from 11 surgical sites in Japan. The silicone and PMMA IOLs were not confined to specific manufacturers or models. The hydrophobic acrylic IOLs had a sharp-edged optic, and all silicone and PMMA IOLs had a round-edged optic.
Patients were included if they had clear intraocular media, a corrected distance visual acuity (CDVA) of 20/25 or better within 3 months postoperatively (baseline CDVA), and no ocular or systemic conditions that could affect the visual acuity in the eye under evaluation. Eyes with a history of ocular surgery other than the primary cataract surgery were excluded from the study. Eyes with posterior capsule opacification (PCO) were excluded; however, those who had neodymium:YAG (Nd:YAG) laser capsulotomy or peripheral opacification (outside the photopic pupil area) were not excluded. If both eyes were eligible for the study, the eye that had surgery on first was selected.
Examinations were performed by masked observers who were not informed of the model or type of the implanted IOLs. Data on CDVA, contrast sensitivity evaluated with the VCTS-6500 (Vistech) or CSV-1000 (Vectorvision, Inc.) devices, the degree of surface light scattering measured with a rotating Scheimpflug camera (Pentacam) or high-definition rotating Scheimpflug camera (Pentacam HR) (both Oculus Optikgeräte GmbH) densitometry (area value, %),26 and grading of glistenings assessed using a 4-point scale27 with a slitlamp microscope were obtained during the latest visit (15 to 21 years after implantation). The rotating Scheimpflug camera measurements were converted to those of the high-definition rotating Scheimpflug camera using a conversion equation after a significant linearity and strong correlation between the 2 densitometry measurements were confirmed.28 Details of the Nd:YAG laser capsulotomy for PCO and the interval between the cataract surgery and laser treatment were obtained by reviewing the medical files retrospectively. The occurrence of postoperative adverse events related to the IOLs was also checked during the chart review.
The primary objective of this study was to determine whether the hydrophobic acrylic IOLs were not inferior to the control IOLs (silicone and PMMA) with regard to changes in the CDVA from baseline to the latest visit. The primary analysis was preplanned and performed as follows: The Group means of the changes in the CDVA from the baseline and the intergroup differences were estimated with a 95% confidence interval (CI) based on an analysis-of-covariance (ANCOVA) model adjusted for the baseline CDVA and the interval from the baseline. If the upper limit of the 2-sided 95% CI of intergroup differences between the hydrophobic acrylic IOL and silicone IOL and between the hydrophobic acrylic IOL and PMMA IOL were below 0.1 logarithm of the minimum angle of resolution (logMAR) (noninferiority margin), the hydrophobic acrylic IOL was considered noninferior to the control IOLs. If noninferiority was shown, superiority was to be assessed similarly with a margin of 0.0 logMAR. The family-wise error rate in hypothesis testing was controlled at the 1-sided 0.025 by the intersection-union method to control multiplicity for comparing the hydrophobic acrylic IOL group with the 2 control groups, and sequential testing procedure to control multiplicity for switching from the non-inferiority test to the superiority test.
In addition, contrast sensitivity, surface light scattering densitometry, and glistening grading were analyzed using analysis of variance (ANOVA), the Tukey honestly significant difference (HSD) test, or the Kruskal-Wallis test depending on the variables. The Pearson correlation coefficient or Spearman rank correlation coefficient was used to test the relation between 2 variables. The time from surgery to Nd:YAG laser posterior capsulotomy was analyzed using Kaplan-Meier survival analysis with the log-rank test. The P values from the additional analyses should be interpreted in an exploratory manner in light of the multiple analyses and comparisons.
The target sample size to demonstrate noninferiority was determined to be 30 per treatment group. In this calculation, a standard deviation of CDVA changes from the baseline to the latest visit was assumed to be 0.065 logMAR based on a previous study.29 Statistical analyses were performed by a third-party contract research organization (A2 Healthcare Corp.) that was independent of investigational sites where patients were enrolled as well as of the IOL manufacturers. Statistical analyses were performed using SAS software (version 9.3, SAS Institute Inc.) and SPSS Statistics for Windows software (version 24, IBM Corp.).
Ninety-eight eyes of 98 patients met the inclusion criteria. Of the eyes, 31 had a hydrophobic acrylic IOL, 37 a silicone IOL, and 30 a PMMA IOL. All eyes had phacoemulsification with IOL implantation except for 1 eye in the PMMA IOL group that had extracapsular cataract extraction with IOL implantation. Table 1 shows the patients’ characteristics. The interval between the surgery and the latest visit was statistically significantly different between the groups (P = .0018, ANOVA), with the PMMA IOL group having a significantly longer interval than the hydrophobic acrylic IOL group and silicone IOL group (P = .0039 and P = .0063, respectively; Tukey HSD). There were no other significant differences in the baseline characteristics between the groups.
Table 2 shows the CDVA at baseline and the latest visit as well as the changes in CDVA from baseline to the latest visit. Intergroup differences adjusted by ANCOVA showed the noninferiority of the hydrophobic acrylic IOL to the silicone and PMMA IOLs (Table 3).
Figure 1 shows the degree of surface light scattering (area value, %). There was a statistically significant difference between the groups (P < .0001, ANOVA), and the hydrophobic acrylic IOLs (18.8% ± 8.3%) had significantly higher values than the silicone IOLs (mean 6.1% ± 3.6%) and PMMA IOLs (mean 4.7% ± 0.8%) (both P < .0001, Tukey HSD test). The degree of surface light scattering did not correlate significantly with the CDVA at the latest visit (Pearson r = 0.098, P = .336) or with the changes in CDVA from baseline to the latest visit (r = 0.008, P = .937) (Figure 2). The correlation between surface light scattering and CDVA at the latest visit was not significant in the hydrophobic acrylic group (r = .007, P = .969), the silicone group (r = 0.259, P = .122), or the PMMA group (r = 0.141, P = .459). The correlation between surface light scattering and the changes in CDVA from baseline to the latest visit also was not significant in the hydrophobic acrylic group (r = 0.040, P = .830), silicone group (r = −0.008, P = .965), or PMMA group (r = 0.155, P = .414).
Table 4 shows the grading scores of glistenings in each group. The hydrophobic acrylic IOL was associated with statistically significantly more glistenings than the other 2 IOLs (P < .0001, Kruskal-Wallis test). There was no significant correlation between the glistening grading and CDVA at the latest visit (Spearman r = 0.178; P = .079) or the changes in CDVA from the baseline to the latest visit (r = −0.098, P = .336).
With the VCTS-6500 device, contrast sensitivity was not different between the IOLs at all spatial frequencies (Table 5). With CSV-1000 device, there were significant intergroup differences at lower spatial frequencies of 3 cycles per degree (cpd) and 6 cpd (P = .0004 and P = .038, respectively; ANOVA) (Table 6). At 3 cpd, silicone IOLs had a significantly higher value than hydrophobic acrylic IOLs and PMMA IOLs (P = .0007 and P = .0099, respectively; Tukey HSD). At 6 cpd, the silicone IOL group had marginal, but significantly higher contrast sensitivity than the hydrophobic acrylic group (P = .046). There were no significant differences at higher spatial frequencies. Contrast sensitivity (logarithmic) at each spatial frequency with the CSV-1000 device did not correlate with the degree of surface light scattering at 3 cpd (r = −0.18, P = .162), at 6 cpd (r = −0.112, P = .395), at 12 cpd (r = − .179, P = .172), or at 18 cpd (r = −0.128, P = .328).
Figure 3 shows the Kaplan-Meier survival curve of eyes that did not require Nd:YAG laser posterior capsulotomy. An Nd:YAG laser posterior capsulotomy was required in 5 (16.1%) of 31 eyes, 16 (43.2%) of 37 eyes, and 21 (70.0%) of 30 eyes in the hydrophobic group, silicone group, and PMMA group, respectively. There were statistically significant differences in the survival rate (log-rank test) between hydrophobic acrylic and silicone groups (P = .0159), the hydrophobic acrylic and PMMA groups (P < .0001), and the silicone and PMMA groups (P = .0078). There were no other postoperative adverse events related to the IOLs.
A previous study using Pentacam rotating Scheimpflug camera densitometry26 reported a mean surface light scattering of 8.6% ± 5.1% in Acrysof hydrophobic acrylic IOLs 6.2 ± 5.3 years (range 1 to 18 years) postoperatively. In this study, we used similar methodology and obtained a mean surface light scattering of 18.8% ± 8.3% in Acrysof IOLs 15 to 20 years postoperatively, indicating this hydrophobic acrylic IOL showed a significant degree of surface light scattering. Similarly, the degree of glistenings associated with Acrysof IOLs was greater in our study than in a previous study of pseudophakic eyes 2 to 16 months after surgery.27 Regarding IOLs of different materials, we found that hydrophobic acrylic IOLs showed a significantly greater degree of surface light scattering and glistenings than the silicone and PMMA IOLs 15 to 20 years postoperatively. These results are consistent with those in previous long-term follow-ups of surface light scattering23 and glistenings25 in patients with Acrysof IOLs as well as laboratory testing using an accelerated aging model of that IOL.24 In the present study, the CDVA at the latest visit and the changes in CDVA from baseline to the latest visit were not different between the 3 IOLs. In addition, there were no significant correlations between the CDVA and the severity of surface light scattering or the grade of the glistenings. Thus, we conclude that the long-term effect of surface light scattering and glistenings of the hydrophobic acrylic IOL on CDVA is negligible.
The results of contrast sensitivity testing seemed inconclusive; intergroup differences were not significant when measured with 1 device but were with the other. With the device with which differences were found, they occurred at 3 and 6 cpd only, with no significant difference was between the IOLs at higher spatial frequencies. At 3 cpd, silicone IOLs had significantly better contrast sensitivity than hydrophobic acrylic IOLs and PMMA IOLs. It is unlikely that these results are attributable to different degrees of surface light scattering or glistenings because the PMMA IOLs had the lowest degree of surface light scattering and glistenings. Moreover, the contrast sensitivity level at each spatial frequency, including 3 and 6 cpd, did not correlate significantly with the degree of surface light scattering. In general, neurological diseases tend to cause deterioration of contrast sensitivity at lower spatial frequencies,30 whereas optical problems, such as cataract, are more likely to decrease the contrast sensitivity at higher spatial frequencies.31 These principles do not apply to the findings in this study.
Differences in the age of patients might have played a role in our contrast sensitivity findings because patients with hydrophobic acrylic IOLs were approximately 4 years older than those with silicone or PMMA IOLs. Another possible explanation is that the posterior capsule was left intact in the hydrophobic acrylic group more frequently than in the silicone group, in which mild PCO might have reduced the contrast sensitivity. According to a previous study, PCO degrades the contrast sensitivity at lower spatial frequencies more severely than at higher spatial frequencies.32 However, this explanation is not applicable to PMMA IOLs, as eyes in this group had the highest rate of Nd:YAG laser posterior capsulotomy but still showed decreased contrast sensitivity at 3 cpd. Considering these conflicting results and the fact that no intergroup differences were noted with VCTS-6500, it appears that surface light scattering and glistenings had little effects on the contrast sensitivity of the patients included in this study.
Several previous studies4,9,11,15,17,19–21,23,24,33 used the EAS-1000 the anterior segment analyzer (Nidek Co., Ltd.), a Scheimpflug imaging system, to quantify the degree of surface light scattering. This system, however, is no longer available on the market, and the manufacturer no longer provides spare parts. Recently, the Pentacam rotating Scheimpflug imaging system was used to quantify the surface light scattering in IOLs.16,25,26 This device was also used to measure the degree of glistenings.34 In addition, its densitometry values were significantly correlated and found to be interchangeable with EAS-1000 densitometry values.26 Moreover, EAS-1000 densitometry becomes saturated in cases of intense light scatterings, while Pentacam densitometry does not.26 This indicates that Pentacam densitometry is more suitable for the measurement of surface light scattering in eyes over the long term.
The Kaplan-Meier analysis showed that the rate of Nd:YAG laser treatment for PCO was the lowest with hydrophobic acrylic IOL, followed by the silicone IOL and then the PMMA IOLs. Several studies compared the incidence of PCO with different IOLs. A metaanalysis of randomized controlled trials35 showed that the hydrophobic acrylic Acrysof IOL and sharp-edged silicone IOLs are similarly effective inhibiting PCO after cataract surgery. In that metaanalysis, eyes with the Acrysof IOL developed significantly less PCO than with round-edged silicone or PMMA IOLs. The follow-up in those studies ranged from 1 to 3 years. In our study, the hydrophobic acrylic IOL had a sharp-edged optic, while all silicone and PMMA IOLs had round-edged optics. As such, the results in this study are in good agreement with those in previous reports. To our knowledge, this study is the longest follow-up comparing the rate of Nd:YAG laser treatment for PCO between hydrophobic acrylic, silicone, and PMMA IOLs.
The current study has several limitations. First, patients were recruited from 11 surgical sites and the surgeries were performed between 1994 and 2000; therefore, the follow-up varied within and between the IOL groups. The interval between surgery to the latest visit was significantly longer in the PMMA IOL group than in the hydrophobic acrylic and silicone IOL groups. This, however, did not negatively affect the parameters we assessed. The degree of surface light scattering and glistenings in the PMMA IOL group was similar to that in the silicone IOL group and less than that in the hydrophobic acrylic IOL group. Comparable levels of visual acuity were attained in all 3 groups. Therefore, it is reasonable to assume that a different interval from surgery to the latest visit was not a confounding factor in this study.
Second, the study comprised a small number of eyes because we recruited patients who had surgery 15 to 20 years ago and those with ocular or systemic pathology that might have affected visual acuity were excluded. Eyes with a history of ocular surgery other than the primary cataract surgery were also excluded. The mean age of the potential candidates was approximately 80 years, and several were rejected because of the stringent exclusion criteria. Nevertheless, we exceeded the predetermined target sample size set based on a power calculation of the number it would take to show noninferiority in terms of CDVA changes from baseline.
Third, the indication for Nd:YAG laser posterior capsulotomy was not predetermined but was dependent on the individual facilities because of the retrospective nature of that part of the study. However, the Kaplan-Meier survival curves after surgery showed obvious difference in the posterior capsulotomy rates between the 3 IOL groups. Finally, additional analyses were performed and presented in this paper with corresponding P values. Because it is not possible to fully account for type I error inflation related to these additional analyses, strong statistical evidence may not be derived from these analyses. However, judged by the observed significance levels, the consistency of our results and their strength as suggest that the findings are meaningful.
In conclusion, this study found that the Acrysof hydrophobic acrylic IOL was associated with a significantly greater level of surface light scattering and glistenings than silicone IOLs and PMMA IOLs 15 to 20 years postoperatively. However, these optical phenomena within the optic of the hydrophobic acrylic IOL did not influence the patients’ visual function. There was no correlation between CDVA and the degree of surface light scattering or glistenings. The long-term probability of a patient not requiring an Nd:YAG laser posterior capsulotomy was highest in the hydrophobic acrylic group followed by the silicone group and then the PMMA group.
What Was Known
- Surface light scattering and glistenings are often associated with acrylic IOLs. Both phenomena continue to increase in intensity, even for as long as 10 years postoperatively.
What This Paper Adds
- Surface light scattering, and glistenings 15 to 20 years after surgery were significantly greater with the hydrophobic acrylic IOL than with the silicone and PMMA IOLs. However, these optical phenomena did not affect the patients’ long-term visual function.
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Drs. Oshika and Eguchi, have received grants, consultation fees, and speaker’s fees from Alcon Laboratories, Inc. Drs. Inoue and Hayashi have received grants from Alcon Laboratories, Inc. Drs. Sugita and A. Miyata have received speaker’s fees from Alcon Laboratories, Inc. Drs. Nishimura, Fujita, and K. Miyata have received grants and speaker’s fees from Alcon Laboratories, Inc. Dr. Sasaki is an employee of Alcon Japan Ltd. Drs. Ando and Sato have no financial or proprietary interest in any material or method mentioned.
Other cited material
A. U.S. National Institutes of Health Clinical Trials. Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation. NCT02450799. Available at: https://clinicaltrials.gov/ct2/show/NCT02450799
. Accessed December 7, 2017